Thursday, 29 September 2016

levobunolol ophthalmic


Generic Name: levobunolol ophthalmic (lee voe BYOO noe lole)

Brand names: Akbeta, Betagan, Levobunolol, Betagan C-Cap


What is levobunolol ophthalmic?

Levobunolol is a beta-blocker that reduces pressure inside the eye.


Levobunolol ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Levobunolol ophthalmic may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about levobunolol ophthalmic?


Do not use this medication if you are allergic to levobunolol, or if you have asthma, or severe chronic obstructive pulmonary disease (COPD), slow heartbeats, or a heart condition called "AV block."

Before using this medication, tell your doctor if you have breathing problems such as bronchitis or emphysema, a history of heart disease or congestive heart failure, diabetes, history of stroke, blood clot, or circulation problems, a thyroid disorder, or a muscle disorder such as myasthenia gravis.


Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Levobunolol ophthalmic is sometimes given together with other eye medications. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using levobunolol ophthalmic. Do not use the medications at the same time.


Levobunolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly. Do not use this medication while you are wearing contact lenses. Levobunolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using levobunolol before putting your contact lenses in.

What should I discuss with my healthcare provider before using levobunolol ophthalmic?


Do not use this medication if you are allergic to levobunolol, or if you have:

  • asthma, or severe chronic obstructive pulmonary disease (COPD);




  • slow heartbeats; or




  • a heart condition called "AV block."



If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:



  • breathing problems such as bronchitis or emphysema;




  • a history of heart disease or congestive heart failure;




  • diabetes;




  • history of stroke, blood clot, or circulation problems;




  • a thyroid disorder; or




  • a muscle disorder such as myasthenia gravis.




FDA pregnancy category C. It is not known whether levobunolol ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether levobunolol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use levobunolol ophthalmic?


Use levobunolol ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.


Wash your hands before using the eye drops. Do not use this medication while you are wearing contact lenses. Levobunolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using levobunolol before putting your contact lenses in.

To apply the eye drops:



  • Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.




  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.




  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.



Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.


Tell your doctor right away if you have any eye injury or infection. If you have any type of surgery, tell the surgeon ahead of time that you are using levobunolol ophthalmic. You may need to stop using the medicine for a short time. Store this medication at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?


Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, feeling short of breath, swelling, rapid weight gain, or fainting.


What should I avoid while using levobunolol ophthalmic?


Levobunolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Levobunolol ophthalmic is sometimes given together with other eye medications. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using levobunolol ophthalmic. Do not use the medications at the same time.


Levobunolol ophthalmic side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;




  • drainage, crusting, or oozing of your eyes or eyelids;




  • bronchospasm (wheezing, chest tightness, trouble breathing);




  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);




  • feeling short of breath, even with mild exertion;




  • swelling, rapid weight gain; or




  • severe blistering, peeling, and red skin rash.



Less serious side effects may include:



  • mild burning, stinging, itching, or discomfort of your eyes;




  • blurred vision;




  • mildly swollen or puffy eyes;




  • headache, dizziness, spinning sensation;




  • depression, confusion, tired feeling;




  • muscle weakness;




  • mild skin rash or itching; or




  • nausea, diarrhea.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Levobunolol ophthalmic Dosing Information


Usual Adult Dose for Intraocular Hypertension:

levobunolol 0.5% solution: 1 to 2 drops to affected eye(s) once a day
or
levobunolol 0.25% solution: 1 to 2 drops to affected eye(s) twice a day

Usual Adult Dose for Glaucoma (Open Angle):

levobunolol 0.5% solution: 1 to 2 drops to affected eye(s) once a day
or
levobunolol 0.25% solution: 1 to 2 drops to affected eye(s) twice a day


What other drugs will affect levobunolol ophthalmic?


Before using levobunolol ophthalmic, tell your doctor if you are using any of the following drugs:



  • digoxin (digitalis, Lanoxin);




  • reserpine;




  • insulin or diabetes medications you take by mouth;




  • any other beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others;




  • a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan); or




  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), or thioridazine (Mellaril).



This list is not complete and there may be other drugs that can interact with levobunolol ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More levobunolol ophthalmic resources


  • Levobunolol ophthalmic Side Effects (in more detail)
  • Levobunolol ophthalmic Dosage
  • Levobunolol ophthalmic Use in Pregnancy & Breastfeeding
  • Levobunolol ophthalmic Drug Interactions
  • Levobunolol ophthalmic Support Group
  • 0 Reviews for Levobunolol - Add your own review/rating


  • Betagan Prescribing Information (FDA)

  • Betagan Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Betagan Monograph (AHFS DI)

  • Betagan Advanced Consumer (Micromedex) - Includes Dosage Information

  • Levobunolol Prescribing Information (FDA)

  • Levobunolol Professional Patient Advice (Wolters Kluwer)



Compare levobunolol ophthalmic with other medications


  • Glaucoma, Open Angle
  • Intraocular Hypertension


Where can I get more information?


  • Your pharmacist can provide more information about levobunolol ophthalmic.

See also: levobunolol side effects (in more detail)


Wednesday, 28 September 2016

Gastrinoma Medications


Definition of Gastrinoma: Zollinger-Ellison syndrome is caused by gastrin-secreting tumors of the pancreas that causes severe ulceration (areas of irritation) of the upper gastrointestinal tract (stomach and small bowel). More...

Drugs associated with Gastrinoma

The following drugs and medications are in some way related to, or used in the treatment of Gastrinoma. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Gastrinoma

  • Achlorhydria (0 drugs)

Learn more about Gastrinoma





Drug List:

Dexketoprofen




Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

M01AE17

CAS registry number (Chemical Abstracts Service)

0022161-81-5

Chemical Formula

C16-H14-O3

Molecular Weight

254

Therapeutic Categories

Analgesic, antipyretic and anti-inflammatory agent

Non-steroidal anti-inflammatory drug, NSAID

Chemical Name

Benzeneacetic acid, 3-benzoyl-alpha-methyl-, (S)-

Foreign Names

  • Dexketoprofenum (Latin)
  • Dexketoprofen (German)
  • Dexkétoprofène (French)
  • Dexketoprofeno (Spanish)

Generic Names

  • Dexketoprofen (OS: BAN)
  • Dexkétoprofène (OS: DCF)
  • (+)-(S)-m-Benzoylhydratropic acid (IS)
  • (+)-Ketoprofen (IS)
  • (S)-Ketoprofen (IS)
  • Hydratropic acid, m-benzoyl-, (+)- (IS)
  • LM 1158 (IS)
  • Dexketoprofen Trometamol (OS: BANM)
  • Dexketoprofen trometamol (IS)
  • Nosatel (IS)
  • Viaxal (IS)

Brand Names

  • Dexomen
    Berlin Chemie, Bosnia & Herzegowina; Berlin-Chemie, Serbia


  • Dolmen
    Berlin-Chemie, Latvia


  • Enantyum
    Menarini, Argentina


  • Ketesse
    Menarini, Latvia; Menarini, Slovenia


  • Menadex
    Sanolabor, Slovenia


  • Tador
    Berlin-Chemie, Romania


  • Adolquir
    Fermon, Spain


  • Arveles
    I.E. Ulagay, Turkey


  • Desketo
    Malesci, Italy; Recalcine, Chile


  • Dexadol
    Berlin-Chemie, Slovakia


  • Dexak
    Berlin-Chemie, Poland


  • Dexalgin
    Berlin-Chemie, Georgia; Berlin-Chemie, Russian Federation


  • Dexofen
    Menarini, Bulgaria


  • Dexoket
    Berlin-Chemie, Czech Republic


  • Enangel
    Menarini, Spain


  • Enantyum
    Berlin-Chemie, Germany; Menarini, Austria; Menarini, Costa Rica; Menarini, Dominican Republic; Menarini, Spain; Menarini, Guatemala; Menarini, Honduras; Menarini, Italy; Menarini, Luxembourg; Menarini, Nicaragua; Menarini, Panama; Menarini, El Salvador


  • Keral
    A. Menarini, United Kingdom; Menarini, Ireland; Menarini, Malta


  • Ketesgel
    Rovi, Spain


  • Ketesse
    Ferron, Indonesia; Lusofarmaco, Italy; Menarini, Austria; Menarini, Switzerland; Menarini, Estonia; Menarini, Lithuania; Menarini, Luxembourg; Menarini, Portugal; Menarini, Slovakia; Rovi, Spain; Tecefarma, Spain


  • Ketodex
    Berlin-Chemie, Hungary


  • Nosatel
    Guidotti, Greece


  • Quiralam
    Juste, Spain; Menarini, Costa Rica; Menarini, Dominican Republic; Menarini, Guatemala; Menarini, Honduras; Menarini, Nicaragua; Menarini, Panama; Menarini, El Salvador


  • Quirgel
    Juste, Spain


  • Stadium
    Menarini, Netherlands; Sanfer, Mexico


  • Sympal
    Berlin-Chemie, Germany

International Drug Name Search

Glossary

BANBritish Approved Name
BANMBritish Approved Name (Modified)
DCFDénomination Commune Française
ISInofficial Synonym
OSOfficial Synonym
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Ibuprofène Biogaran Conseil




Ibuprofène Biogaran Conseil may be available in the countries listed below.


Ingredient matches for Ibuprofène Biogaran Conseil



Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofène Biogaran Conseil in the following countries:


  • France

International Drug Name Search

Loprox Topical Suspension





Dosage Form: topical suspension

FOR DERMATOLOGIC USE ONLY.

NOT FOR USE IN EYES.


Rx Only



Loprox Topical Suspension Description


LOPROX® Topical Suspension (ciclopirox) 0.77% is for topical use.


Each gram of LOPROX® Topical Suspension contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible suspension base consisting of Purified Water USP, Cocamide DEA, Octyldodecanol NF, Mineral Oil USP, Stearyl Alcohol NF, Cetyl Alcohol NF, Polysorbate 60 NF, Myristyl Alcohol NF, Lactic Acid USP, Sorbitan Monostearate NF, and Benzyl Alcohol NF (1%) as preservative.


LOPROX® Topical Suspension contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.


The CAS Registry Number is 41621-49-2.


LOPROX® Topical Suspension has a pH of 7.


The chemical structure is:




Loprox Topical Suspension - Clinical Pharmacology


Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans. Pharmacokinetic studies in men with radiolabeled ciclopirox solution in polyethylene glycol 400, showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm2 on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible. Autoradiographic studies with human cadaver skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum. In vitro penetration studies in frozen or fresh excised human cadaver and pig skin indicated that the penetration of LOPROX® Topical Suspension is equivalent to that of LOPROX® Cream (ciclopirox olamine) 0.77%. Therapeutic equivalence of cream and suspension formulations also was indicated by studies of experimentally induced guinea pig and human trichophytosis.



Indications and Usage for Loprox Topical Suspension


LOPROX® Topical Suspension is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.



Contraindications


LOPROX® Topical Suspension is contraindicated in individuals who have shown hypersensitivity to any of its components.



Warnings



General


LOPROX® Topical Suspension is not for ophthalmic use.


Keep out of reach of children.



Precautions


If a reaction suggesting sensitivity or chemical irritation should occur with the use of LOPROX® Topical Suspension, treatment should be discontinued and appropriate therapy instituted.



Information for Patients


The patient should be told to:


  1. Use the medication for the full treatment time even though signs/symptoms may have improved and notify the physician if there is no improvement after four weeks.

  2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.

  3. Avoid the use of occlusive wrappings or dressings.


Carcinogenesis, Mutagenesis, Impairment of Fertility


A carcinogenicity study in female mice dosed cutaneously twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application site. The following in vitro and in vivo genotoxicity tests have been conducted with ciclopirox olamine: studies to evaluate gene mutation in the Ames Salmonella/Mammalian Microsome Assay (negative) and Yeast Saccharomyces Cerevisiae Assay (negative) and studies to evaluate chromosome aberrations in vivo in the Mouse Dominant Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative). The following battery of in vitro genotoxicity tests were conducted with ciclopirox: a chromosome aberration assay in V79 Chinese Hamster Cells, with and without metabolic activation (positive); a gene mutation assay in the HGPRT - test with V79 Chinese Hamster Cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA Synthesis Assay in A549 Human Cells (negative)). An in vitro Cell Transformation Assay in BALB/C3T3 Cells was negative for cell transformation. In an in vivo Chinese Hamster Bone Marrow Cytogenetic Assay, ciclopirox was negative for chromosome aberrations at 5000 mg/kg.



Pregnancy Category B


Reproduction studies have been performed in the mouse, rat, rabbit, and monkey, via various routes of administration, at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.



Nursing Mothers


It is not known whether this drug is excreted in human milk. Caution should be exercised when LOPROX® Topical Suspension is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in pediatric patients below the age of 10 years have not been established.



Adverse Reactions


In the controlled clinical trial with 89 patients using LOPROX® Topical Suspension and 89 patients using the vehicle, the incidence of adverse reactions was low. Those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox topical suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox topical suspension.



Loprox Topical Suspension Dosage and Administration


Gently massage LOPROX® Topical Suspension into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with LOPROX® Topical Suspension the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.



How is Loprox Topical Suspension Supplied


LOPROX® Topical Suspension (ciclopirox) 0.77% is supplied in 30 mL bottles (NDC 99207-022-30), and 60 mL bottles (NDC 99207-022-60).


Bottle space provided to allow for vigorous shaking before each use.


Store between 5°– 25°C (41°– 77°F).



US Patent Pending


Prescribing Information as of May 2003.


Manufactured for:

MEDICIS, The Dermatology Company

Scottsdale, AZ 85258


REG TM MEDICIS


IN-5165/S








LOPROX 
ciclopirox  suspension










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)99207-022
Route of AdministrationTOPICALDEA Schedule    









































INGREDIENTS
Name (Active Moiety)TypeStrength
ciclopirox olamine (ciclopirox)Active7.7 MILLIGRAM  In 1 GRAM
WaterInactive 
Cocamide DEAInactive 
OctyldodecanolInactive 
Mineral OilInactive 
Stearyl AlcoholInactive 
Cetyl AlcoholInactive 
Polysorbate 60Inactive 
Myristyl AlcoholInactive 
Lactic AcidInactive 
Sorbitan MonostearateInactive 
Benzyl Alcohol (1%)Inactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
199207-022-3030 mL (MILLILITER) In 1 BOTTLENone
299207-022-6060 mL (MILLILITER) In 1 BOTTLENone

Revised: 11/2006MEDICIS, The Dermatology Company

More Loprox Topical Suspension resources


  • Loprox Topical Suspension Side Effects (in more detail)
  • Loprox Topical Suspension Use in Pregnancy & Breastfeeding
  • Loprox Topical Suspension Support Group
  • 9 Reviews for Loprox Topical - Add your own review/rating


Compare Loprox Topical Suspension with other medications


  • Cutaneous Candidiasis
  • Onychomycosis, Fingernail
  • Onychomycosis, Toenail
  • Seborrheic Dermatitis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor

Minpres




Minpres may be available in the countries listed below.


Ingredient matches for Minpres



Prazosin

Prazosin hydrochloride (a derivative of Prazosin) is reported as an ingredient of Minpres in the following countries:


  • Venezuela

International Drug Name Search

Tuesday, 27 September 2016

Magnesium Trisilicate Mixture BP (Boots Company plc)





1. Name Of The Medicinal Product



Boots Magnesium Trisilicate Mixture BP


2. Qualitative And Quantitative Composition













Active ingredients


 



 




Heavy magnesium trisilicate EP




0.1667 gm




Light magnesium trisilicate EP




0.0833 gm




Light magnesium carbonate EP




0.25 gm



Sodium bicarbonate EP


0.25 gm



3. Pharmaceutical Form



Oral Suspension



4. Clinical Particulars



4.1 Therapeutic Indications



For the relief of indigestion.



4.2 Posology And Method Of Administration



For oral administration.



Adults and children over 12 years



10ml (2 teaspoonfuls) 3-4 times a day in a little water, after meals or as required.



Children 5 to 12 years



5ml (1 teaspoonful) 3-4 times a day in a little water, after meals or as required.



Children under 5 years



Not recommended except on the advice of a doctor.



Elderly



There is no need for dosage reduction in the elderly.



4.3 Contraindications



Hypersensitivity to any of the ingredients.



4.4 Special Warnings And Precautions For Use



If symptoms persist for more than 5 days, talk to your doctor.



Because of the sodium content, Magnesium Trisilicate Mixture should be used with caution in patients with renal impairment, heart failure, hypertension and in those on a low sodium diet.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Magnesium Trisilicate Mixture may interfere with the absorption of the tetracyclines when these are taken concurrently. The renal excretion of lithium appears to be increased by sodium bicarbonate and this could lead to reduced plasma levels of lithium and impairment of the therapeutic response.



4.6 Pregnancy And Lactation



The safety of Magnesium Trisilicate Mixture during pregnancy and lactation has not been established but use during these periods is not considered to constitute a hazard.



4.7 Effects On Ability To Drive And Use Machines



No adverse effects known.



4.8 Undesirable Effects



Magnesium Trisilicate Mixture may cause diarrhoea and flatulence.



4.9 Overdose



Symptoms of overdosage include diarrhoea, flatulence and gastrointestinal irritation.



Treatment need only be symptomatic.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Magnesium trisilicate, magnesium carbonate and sodium bicarbonate have antacid properties.



5.2 Pharmacokinetic Properties



Magnesium trisilicate is converted to magnesium chloride and silicon dioxide during neutralisation of gastric acid. Some magnesium is absorbed and traces of the silicon dioxide may be absorbed and excreted in the urine.



Magnesium carbonate reacts with gastric acid to form magnesium chloride and carbon dioxide in the stomach. Some magnesium is absorbed, but is usually excreted rapidly in the urine.



Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. Any bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine that is rendered alkaline and there is an accompanying diruresis.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sodium methyldroxybenzoate



Sodium propylhydroxybenzoate



Peppermint oil



Tween 20



Chloroform



Purified water



6.2 Incompatibilities



None stated.



6.3 Shelf Life



18 months.



6.4 Special Precautions For Storage



Store below 25°C.



6.5 Nature And Contents Of Container



An amber medical glass bottle fitted with a rolled on pilfer proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner, alternative cap: a wadless polypropylene screw cap.



Pack size: 200 ml.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



The Boots Company PLC



1 Thane Road West



Nottingham NG2 3AA



8. Marketing Authorisation Number(S)



PL 00014/0310



9. Date Of First Authorisation/Renewal Of The Authorisation



Date of First Authorisation: 31 May 1984



Last Renewal: 27 January 1995



10. Date Of Revision Of The Text



September 1999.




Ibuprofena




Ibuprofena may be available in the countries listed below.


Ingredient matches for Ibuprofena



Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofena in the following countries:


  • Latvia

International Drug Name Search

Cloxine




Cloxine may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Cloxine



Cloxacillin

Cloxacillin benzathine (a derivative of Cloxacillin) is reported as an ingredient of Cloxine in the following countries:


  • France

International Drug Name Search

Urelle


Generic Name: hyoscyamine, methenamine, methylene blue, and phenyl salicylate (HYE oh SYE a meen, meth EN a meen, METH il een BLUE, FEEN il sa LIS il ate)

Brand Names: Darpaz, Hyophen, Phosenamine, Phosphasal, Prosed/DS, Urelle, Uribel, Uro Blue, Ustell, Uta, UTICAP, Utira, Utira-C


What is Urelle (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.


Methenamine and methylene blue work as mild antiseptics that fight bacteria in the urine and bladder.


Phenyl salicylate is a mild pain reliever.


The combination of hyoscyamine, methenamine, methylene blue, and phenyl salicylate is used to treat bladder irritation (pain, burning, inflammation) caused by urinary tract infection. This medication is also used to prevent bladder discomfort during a medical procedure.


Hyoscyamine, methenamine, methylene blue, and phenyl salicylate may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Urelle (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?


You should not use hyoscyamine, methenamine, methylene blue, and phenyl salicylate if you are allergic to it.

Before taking this medication, tell your doctor if you have any type of heart problem (congestive heart failure, coronary heart disease, a heart valve or heart rhythm disorder), glaucoma, an enlarged prostate, bladder obstruction, myasthenia gravis, a stomach ulcer or obstruction, or if you are allergic to belladonna (Donnatal and others).


Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and phenyl salicylate.

Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use.


What should I discuss with my healthcare provider before taking Urelle (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?


You should not use hyoscyamine, methenamine, methylene blue, and phenyl salicylate if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:



  • heart disease;




  • a heart rhythm disorder;




  • congestive heart failure;




  • coronary heart disease;




  • a heart valve disorder;




  • glaucoma;




  • an enlarged prostate or bladder obstruction;




  • myasthenia gravis;




  • an ulcer or obstruction in your stomach; or




  • if you are allergic to belladonna (Donnatal and others).




FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine, methenamine, methylene blue, and phenyl salicylate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hyoscyamine, methenamine, methylene blue, and phenyl salicylate should not be given to a child younger than 7 years old. Older adults may be more likely to have side effects from this medication.

How should I take Urelle (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Hyoscyamine, methenamine, methylene blue, and phenyl salicylate is usually taken 4 times daily. Follow your doctor's instructions.


Do not crush, chew, or break an enteric coated pill. Swallow it whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating. Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness or rapid pulse.


What should I avoid while taking Urelle (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?


Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Antacids or anti-diarrhea medicine can make it harder for your body to absorb hyoscyamine.


If you also take ketoconazole (Nizoral), wait at least 2 hours after taking it before you take hyoscyamine, methenamine, methylene blue, and phenyl salicylate.


Urelle (hyoscyamine, methenamine, methylene blue, and phenyl salicylate) side effects


Methylene blue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, blurred vision, fast heart rate;




  • agitation, confusion, feeling restless or excited;




  • painful or difficult urination; or




  • feeling short of breath.



Less serious side effects may include:



  • mild dizziness;




  • drowsiness; or




  • flushing (warmth, redness, or tingly feeling).



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Urelle (hyoscyamine, methenamine, methylene blue, and phenyl salicylate)?


Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use, especially:



  • atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);




  • a diuretic (water pill);




  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);




  • glycopyrrolate (Robinul);




  • homatropine (Hycodan, Tussigon);




  • methantheline;




  • neostigmine (Prostigmin) or pyridostigmine (Mestinon);




  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or




  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);




  • medicines to treat symptoms of Alzheimer's disease such as donepezil (Aricept), galantamine (Razadyne), memantine (Namenda), rivastigmine (Exelon), or tacrine (Cognex);




  • narcotic pain medication such as codeine (Tylenol #3, Cheratuss, Guaiatuss), fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid), methadone (Dolophine, Methadose), morphine (Avinza, Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Endocet, Percocet), propoxyphene (Darvocet, Propacet), and others;




  • sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra);




  • sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or




  • ulcer or irritable bowel medications such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Hyomax), mepenzolate (Cantil), or propantheline (Pro Banthine).



This list is not complete and there are many other drugs that can interact with hyoscyamine, methenamine, methylene blue, and phenyl salicylate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.



More Urelle resources


  • Urelle Use in Pregnancy & Breastfeeding
  • Drug Images
  • Urelle Drug Interactions
  • Urelle Support Group
  • 0 Reviews for Urelle - Add your own review/rating


  • Urelle Prescribing Information (FDA)

  • Urelle Advanced Consumer (Micromedex) - Includes Dosage Information

  • Darcalma Prescribing Information (FDA)

  • Darpaz Prescribing Information (FDA)

  • Phosenamine Prescribing Information (FDA)

  • Phosphasal Prescribing Information (FDA)

  • Prosed EC Advanced Consumer (Micromedex) - Includes Dosage Information

  • Prosed/DS MedFacts Consumer Leaflet (Wolters Kluwer)

  • Uribel Prescribing Information (FDA)

  • Urimax Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Urised MedFacts Consumer Leaflet (Wolters Kluwer)

  • Uritact-EC Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ustell Prescribing Information (FDA)

  • Uta MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Urelle with other medications


  • Urinary Tract Infection


Where can I get more information?


  • Your pharmacist can provide more information about hyoscyamine, methenamine, methylene blue, and phenyl salicylate.


Monday, 26 September 2016

Oxycodone/Acetaminophen


Pronunciation: OX-i-KOE-done/a-SEET-a-MIN-oh-fen
Generic Name: Oxycodone/Acetaminophen
Brand Name: Examples include Endocet and Percocet

Oxycodone/Acetaminophen contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.





Oxycodone/Acetaminophen is used for:

Relieving moderate to moderately severe pain. Oxycodone/Acetaminophen may also be used to treat other conditions as determined by your doctor.


Oxycodone/Acetaminophen is a combination of a narcotic and an analgesic/antipyretic. It works in the brain and nervous system to decrease pain.


Do NOT use Oxycodone/Acetaminophen if:


  • you are allergic to any ingredient in Oxycodone/Acetaminophen

  • you have high blood carbon dioxide levels (hypercarbia) or a certain severe bowel problem (paralytic ileus)

  • you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack

  • you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Oxycodone/Acetaminophen:


Some medical conditions may interact with Oxycodone/Acetaminophen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have had an allergic reaction to any codeine- or morphine-related medicine (eg, hydrocodone, dihydrocodeine, hydromorphone)

  • if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems

  • if you have or recently have had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or infection of the brain or nervous system

  • if you have a history of heart problems (eg, cor pulmonale), low blood pressure, the blood disease porphyria, stomach or bowel problems (eg, blockage, paralysis), inflammation of the pancreas (pancreatitis), gallbladder problems, liver problems (eg, hepatitis), kidney problems, seizures, thyroid problems, adrenal gland problems (eg, Addison disease), curvature of the spine (scoliosis), prostate problems (eg, an enlarged prostate), or trouble urinating

  • if you are in very poor health; are dehydrated or have low blood volume; or have drowsiness, stomach pain, or severe diarrhea caused by antibiotic use (pseudomembranous colitis)

  • if you drink alcohol; have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or actions; or are going through withdrawal from alcohol or other substances

Some MEDICINES MAY INTERACT with Oxycodone/Acetaminophen. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticholinergics (eg, scopolamine, oxybutynin) because the risk of a certain severe bowel problem (paralytic ileus) may be increased

  • Cimetidine, muscle relaxants (eg, cyclobenzaprine), phenothiazines (eg, chlorpromazine), or sulfinpyrazone because the risk of side effects, such as severe drowsiness, slow or difficult breathing, confusion, and seizures, may be increased

  • Azole antifungals (eg, itraconazole, ketoconazole), beta-blockers (eg, propranolol), clarithromycin, isoniazid, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Oxycodone/Acetaminophen's side effects

  • Buprenorphine, butorphanol, nalbuphine, naltrexone, pentazocine, or rifamycins (eg, rifampin) because they may decrease Oxycodone/Acetaminophen's effectiveness

  • Lamotrigine, loop diuretics (eg, furosemide), or zidovudine because their effectiveness may be decreased by Oxycodone/Acetaminophen

  • Anticoagulants (eg, warfarin) or sodium oxybate (GHB) because the risk of their side effects may be increased by Oxycodone/Acetaminophen

  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxycodone/Acetaminophen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Oxycodone/Acetaminophen:


Use Oxycodone/Acetaminophen as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Oxycodone/Acetaminophen by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • If you have been taking Oxycodone/Acetaminophen regularly or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose.

  • If Oxycodone/Acetaminophen is no longer needed, dispose of the unused tablets by flushing them down the toilet.

  • If you miss a dose of Oxycodone/Acetaminophen and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Oxycodone/Acetaminophen.



Important safety information:


  • Oxycodone/Acetaminophen may cause dizziness, light-headedness, blurred vision, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Oxycodone/Acetaminophen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Oxycodone/Acetaminophen may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Do not drink alcohol while you are using Oxycodone/Acetaminophen.

  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using Oxycodone/Acetaminophen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do NOT take more than the recommended dose or take more often than prescribed without checking with your doctor.

  • Tell your doctor or dentist that you take Oxycodone/Acetaminophen before you receive any medical or dental care, emergency care, or surgery.

  • Oxycodone/Acetaminophen may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Oxycodone/Acetaminophen, talk with your doctor or pharmacist.

  • Oxycodone/Acetaminophen may harm your liver. Your risk may be greater if you drink alcohol while you are using Oxycodone/Acetaminophen. Talk to your doctor before you take Oxycodone/Acetaminophen or other fever reducers if you drink alcohol.

  • Oxycodone/Acetaminophen has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.

  • Oxycodone/Acetaminophen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Oxycodone/Acetaminophen.

  • Use Oxycodone/Acetaminophen with caution in the ELDERLY; they may be more sensitive to its side effects, especially breathing problems and drowsiness.

  • Oxycodone/Acetaminophen should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxycodone/Acetaminophen while you are pregnant. Oxycodone/Acetaminophen is found in breast milk. Do not breast-feed while taking Oxycodone/Acetaminophen.

When used for long periods of time or at high doses, Oxycodone/Acetaminophen may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Oxycodone/Acetaminophen stops working well. Do not take more than prescribed.


Some people who use Oxycodone/Acetaminophen for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Oxycodone/Acetaminophen, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.



Possible side effects of Oxycodone/Acetaminophen:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dizziness; drowsiness; flushing; light-headedness; nausea; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; hearing loss; mental or mood changes (eg, agitation, anxiety, depression); seizures; severe or persistent constipation; severe or persistent dizziness, headache, or light-headedness; shortness of breath; slow or difficult breathing; stomach or back pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, persistent loss of appetite); tremors; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Oxycodone/Acetaminophen side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold or clammy skin; fainting; limp muscles; loss of consciousness; persistent nausea or vomiting; pinpoint pupils; severe dizziness, drowsiness, or light-headedness; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite); unusual sweating.


Proper storage of Oxycodone/Acetaminophen:

Store Oxycodone/Acetaminophen at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container away from heat, moisture, and light. Do not store in the bathroom. Keep Oxycodone/Acetaminophen out of the reach of children and away from pets.


General information:


  • If you have any questions about Oxycodone/Acetaminophen, please talk with your doctor, pharmacist, or other health care provider.

  • Oxycodone/Acetaminophen is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Oxycodone/Acetaminophen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Oxycodone/Acetaminophen resources


  • Oxycodone/Acetaminophen Side Effects (in more detail)
  • Oxycodone/Acetaminophen Dosage
  • Oxycodone/Acetaminophen Use in Pregnancy & Breastfeeding
  • Drug Images
  • Oxycodone/Acetaminophen Drug Interactions
  • Oxycodone/Acetaminophen Support Group
  • 281 Reviews for Oxycodone/Acetaminophen - Add your own review/rating


Compare Oxycodone/Acetaminophen with other medications


  • Pain

Para-don




Para-don may be available in the countries listed below.


Ingredient matches for Para-don



Paracetamol

Paracetamol is reported as an ingredient of Para-don in the following countries:


  • Netherlands

Propyphenazone

Propyphenazone is reported as an ingredient of Para-don in the following countries:


  • Netherlands

International Drug Name Search

Fluocinolone Ear Drops





Dosage Form: otic oil
Fluocinolone Acetonide Oil 0.01%

Ear Drops

For Otic Use Only-


Not for Ophthalmic Use



DESCRIPTION


Fluocinolone Acetonide Oil 0.01% Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α) - 6,9 - difluoro - 11,21 - dihydroxy - 16,17[(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide is C24 H30 F2O6 anhydrous. It has the following structural formula:



Fluocinolone acetonide in Fluocinolone Acetonide Oil 0.01% has a molecular weight of 452.49. It is a white crystalline powder that is odorless, stable in light, and melts at 270ºC with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.


Each gram of Fluocinolone Acetonide Oil 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF.



CLINICAL PHARMACOLOGY


Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.



Pharmacokinetics:


The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.


Fluocinolone Acetonide Oil 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.



CLINICAL STUDIES


Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of fluocinolone acetonide oil 0.01% twice daily, after 7 days of treatment, showed Fluocinolone Acetonide Oil 0.01% to be superior to placebo in clearing the signs and symptoms of eczematous external otitis.


Clinical safety studies were conducted on the same formulation of fluocinolone acetonide oil 0.01%, marketed as Fluocinolone Acetonide 0.01% Topical Oil. Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 mcg/dL; normal: cortisol > 7mcg/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 mcg/dL).


A clinical study was conducted to assess the safety of Fluocinolone Acetonide 0.01% Topical Oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing peanut oil NF, Fluocinolone Acetonide 0.01% Topical Oil and histamine/saline controls on the 13 individuals. These subjects were also treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Fluocinolone Acetonide 0.01% Topical Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Fluocinolone Acetonide 0.01% Topical Oil use. Importantly, the bulk peanut oil NF, used in fluocinolone acetonide oil is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.



INDICATIONS AND USAGE


Fluocinolone Acetonide Oil 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older.



CONTRAINDICATIONS


Fluocinolone Acetonide Oil 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.


This product contains refined peanut oil NF (See PRECAUTIONS).



PRECAUTIONS



General:


Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.


Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.


If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.


Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric use)


Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic testing.


If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, fluocinolone acetonide oil 0.01% should be discontinued immediately and appropriate therapy instituted.


If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of fluocinolone acetonide oil 0.01% should be discontinued until the infection has been adequately controlled.


Fluocinolone acetonide oil 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Oil 0.01% for peanut-sensitive individuals.



Information for Patients:


Patients using topical corticosteroids should receive the following information and instructions:


1. This medication is to be used as directed by the physician. It is for external ear use only. Do not use occlusive dressings.


2. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.


3. This medication should not be used for any disorder other than that for which it was prescribed.


4. Patients should promptly report to their physician any worsening of their skin condition.


5. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.



Laboratory Tests:


The following tests may be helpful in evaluating patients for HPA axis suppression:


ACTH stimulation test


A.M. plasma cortisol test


Urinary free cortisol test



Carcinogenesis, mutagenesis, and impairment of fertility:


Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of fluocinolone acetonide oil 0.01%. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in fluocinolone acetonide oil 0.01%. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).



Pregnancy:


Teratogenic effects:

Pregnancy category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.


There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide oil 0.01%. Therefore, fluocinolone acetonide oil 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Nursing Mothers:


Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide oil 0.01% is administered to a nursing woman.



Pediatric Use:


Fluocinolone acetonide oil 0.01% may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis.


Fluocinolone acetonide oil 0.01% is not recommended for use on the face (See ADVERSE REACTIONS section).


Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA-axis-suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS).


HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.


Fluocinolone acetonide oil 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Oil 0.01% for peanut-sensitive individuals.



ADVERSE REACTIONS


The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.



OVERDOSAGE


Topically applied fluocinolone acetonide oil 0.01% can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).



DOSAGE AND ADMINISTRATION


For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil 0.01% into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil 0.01% into the ear. Keep head tilted for about a minute to allow fluocinolone acetonide oil 0.01% to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.



HOW SUPPLIED


Fluocinolone Acetonide Oil 0.01% Ear Drops is supplied in 1 fluid ounce bottles with a net contents of 20 mL (Dropper Included) (NDC # 65162-702-94).


Keep tightly closed. Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86°F) [See USP Controlled Room Temperature]


Caution: Rx only


Manufactured by:


Amneal Pharmaceuticals

Branchburg, NJ 08876


Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141


Rev. 09-2011



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL










FLUOCINOLONE ACETONIDE 
fluocinolone acetonide  oil










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)65162-702
Route of AdministrationAURICULAR (OTIC)DEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)FLUOCINOLONE ACETONIDE0.11 mg  in 20 mL














Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
LIGHT MINERAL OIL 
OLETH-2 
PEANUT OIL 


















Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
165162-702-941 BOTTLE In 1 CARTONcontains a BOTTLE
120 mL In 1 BOTTLEThis package is contained within the CARTON (65162-702-94)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09130610/17/2011


Labeler - Amneal Pharmaceuticals, LLC (123797875)

Registrant - Identi Pharmaceuticals LLC (832355189)









Establishment
NameAddressID/FEIOperations
Amneal Pharmaceuticals, LLC963900878MANUFACTURE, ANALYSIS
Revised: 11/2011Amneal Pharmaceuticals, LLC

More Fluocinolone Ear Drops resources


  • Fluocinolone Ear Drops Use in Pregnancy & Breastfeeding
  • Fluocinolone Ear Drops Support Group
  • 0 Reviews for Fluocinolone Ear - Add your own review/rating


Compare Fluocinolone Ear Drops with other medications


  • Eczema

Friday, 23 September 2016

Urocit-K 10 Oral, Parenteral


Generic Name: potassium supplement (Oral route, Parenteral route)


Commonly used brand name(s)

In the U.S.


  • Effer-K

  • Glu-K

  • K+Care ET

  • K-Lyte

  • K-Lyte Cl

  • K-Tab

  • Potassimin

  • Tri-K

  • Urocit-K 10

In Canada


  • K-10 Solution

  • Kaochlor 10

  • Kaochlor 20

  • Kaon

  • K-Lor

  • K-Lyte/Ci

  • Potassium Chloride

  • Potassium-Rougier

  • Roychlor

Available Dosage Forms:


  • Tablet, Effervescent

  • Solution

  • Capsule

  • Tablet, Extended Release

  • Powder for Suspension, Extended Release

  • Tablet

  • Powder for Suspension

  • Liquid

  • Elixir

  • Granule

  • Capsule, Extended Release

  • Powder for Solution

Uses For Urocit-K 10


Potassium is needed to maintain good health. Although a balanced diet usually supplies all the potassium a person needs, potassium supplements may be needed by patients who do not have enough potassium in their regular diet or have lost too much potassium because of illness or treatment with certain medicines.


There is no evidence that potassium supplements are useful in the treatment of high blood pressure.


Lack of potassium may cause muscle weakness, irregular heartbeat, mood changes, or nausea and vomiting.


Injectable potassium is administered only by or under the supervision of your doctor. Some forms of oral potassium may be available in stores without a prescription. Since too much potassium may cause health problems, you should take potassium supplements only if directed by your doctor.


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods.


The following table includes some potassium-rich foods.






























































Food (amount)Milligrams

of potassium
Milliequivalents

of potassium
Acorn squash, cooked

(1 cup)
89623
Potato with skin, baked

(1 long)
84422
Spinach, cooked

(1 cup)
83821
Lentils, cooked

(1 cup)
73119
Kidney beans, cooked

(1 cup)
71318
Split peas, cooked

(1 cup)
71018
White navy beans, cooked

(1 cup)
66917
Butternut squash, cooked

(1 cup)
58315
Watermelon

(1/16)
56014
Raisins

(½ cup)
55314
Yogurt, low-fat, plain

(1 cup)
53114
Orange juice, frozen

(1 cup)
50313
Brussel sprouts, cooked

(1 cup)
49413
Zucchini, cooked, sliced

(1 cup)
45612
Banana

(medium)
45112
Collards, frozen, cooked

(1 cup)
42711
Cantaloupe

(¼)
41211
Milk, low-fat 1%

(1 cup)
3489
Broccoli, frozen, cooked

(1 cup)
3329

The daily amount of potassium needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Because lack of potassium is rare, there is no RDA or RNI for this mineral. However, it is thought that 1600 to 2000 mg (40 to 50 milliequivalents [mEq]) per day for adults is adequate.


Remember:


  • The total amount of potassium that you get every day includes what you get from food and what you may take as a supplement. Read the labels of processed foods. Many foods now have added potassium.

  • Your total intake of potassium should not be greater than the recommended amounts, unless ordered by your doctor. In some cases, too much potassium may cause muscle weakness, confusion, irregular heartbeat, or difficult breathing.

Before Using Urocit-K 10


If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Although there is no specific information comparing use of potassium supplements in children with use in other age groups, they are not expected to cause different side effects or problems in children than they do in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of potassium supplements in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.


Older adults may be at a greater risk of developing high blood levels of potassium (hyperkalemia).


Pregnancy


Potassium supplements have not been shown to cause problems in humans.


Breast Feeding


Potassium supplements pass into breast milk. However, this medicine has not been reported to cause problems in nursing babies.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.


  • Amantadine

  • Atropine

  • Belladonna

  • Belladonna Alkaloids

  • Benztropine

  • Biperiden

  • Clidinium

  • Darifenacin

  • Dicyclomine

  • Eplerenone

  • Glycopyrrolate

  • Hyoscyamine

  • Methscopolamine

  • Oxybutynin

  • Procyclidine

  • Scopolamine

  • Solifenacin

  • Tolterodine

  • Trihexyphenidyl

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alacepril

  • Amiloride

  • Benazepril

  • Canrenoate

  • Captopril

  • Cilazapril

  • Delapril

  • Enalaprilat

  • Enalapril Maleate

  • Fosinopril

  • Imidapril

  • Indomethacin

  • Lisinopril

  • Moexipril

  • Pentopril

  • Perindopril

  • Quinapril

  • Ramipril

  • Spirapril

  • Spironolactone

  • Temocapril

  • Trandolapril

  • Triamterene

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Addison's disease (underactive adrenal glands) or

  • Dehydration (excessive loss of body water, continuing or severe)

  • Type 2 diabetes mellitus or

  • Kidney disease—Potassium supplements may increase the risk of hyperkalemia (high blood levels of potassium), which may worsen or cause heart problems in patients with these conditions.

  • Diarrhea (continuing or severe)—The loss of fluid in combination with potassium supplements may cause kidney problems, which may increase the risk of hyperkalemia (high blood levels of potassium).

  • Heart disease—Potassium supplements may make this condition worse.

  • Intestinal or esophageal blockage—Potassium supplements may damage the intestines.

  • Stomach ulcer—Potassium supplements may make this condition worse.

Proper Use of potassium supplement

This section provides information on the proper use of a number of products that contain potassium supplement. It may not be specific to Urocit-K 10. Please read with care.


For patients taking the liquid form of this medicine:


  • This medicine must be diluted in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.

  • If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the soluble granule, soluble powder, or soluble tablet form of this medicine:


  • This medicine must be completely dissolved in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.

  • Allow any "fizzing" to stop before taking the dissolved medicine.

  • If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the extended-release tablet form of this medicine:


  • Swallow the tablets whole with a full (8-ounce) glass of water. Do not chew or suck on the tablet.

  • Some tablets may be broken or crushed and sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most tablets.

  • If you have trouble swallowing tablets or if they seem to stick in your throat, check with your doctor. When this medicine is not properly released, it can cause irritation that may lead to ulcers.

For patients taking the extended-release capsule form of this medicine:


  • Do not crush or chew the capsule. Swallow the capsule whole with a full (8-ounce) glass of water.

  • Some capsules may be opened and the contents sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most capsules.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important if you are also taking both diuretics (water pills) and digitalis medicines for your heart.


Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For potassium bicarbonate

  • For oral dosage forms (tablets for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—25 to 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium bicarbonate and potassium chloride

  • For oral dosage form (granules for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For oral dosage form (tablets for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20, 25, or 50 mEq dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium bicarbonate and potassium citrate

  • For oral dosage form (tablets for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—25 or 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium chloride

  • For long-acting oral dosage form (extended-release capsules):
    • To replace potassium lost by the body:
      • Adults and teenagers—40 to 100 milliequivalents (mEq) a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.


    • To prevent potassium loss:
      • Adults and teenagers—16 to 24 mEq a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For long-acting oral dosage forms (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 mEq mixed into one-half glass of cold water or juice, taken one to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq of potassium per kilogram (kg) (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed in water or juice.



  • For oral dosage form (powder for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—15 to 25 mEq dissolved in four to six ounces of cold water, taken two or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq per kg (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be mixed into water or juice.



  • For oral dosage form (powder for suspension):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 mEq dissolved in two to six ounces of cold water, taken one to five times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For long-acting oral dosage form (extended-release tablets):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—6.7 to 20 mEq taken three times a day. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight a day, taken in smaller doses during the day. The solution should be completely mixed into water or juice.



  • For oral dosage form (tablets):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—5 to 10 mEq taken two to four times a day. However, most people will not take more than 100 mEq a day.

      • Children—Dose must be determined by your doctor.



  • For potassium gluconate and potassium chloride

  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) diluted in 2 tablespoonfuls or more of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



  • For oral dosage form (powder for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 mEq mixed in 2 tablespoonfuls or more of cold water or juice taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is base on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



  • For potassium gluconate and potassium citrate

  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



  • For trikates

  • For oral dosage form (liquid for solution):
    • To prevent potassium loss or replace potassium lost by the body:
      • Adults and teenagers—15 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken three or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.

      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Urocit-K 10


Your doctor should check your progress at regular visits to make sure the medicine is working properly and that possible side effects are avoided. Laboratory tests may be necessary.


Do not use salt substitutes, eat low-sodium foods, especially some breads and canned foods, or drink low-sodium milk unless you are told to do so by your doctor, since these products may contain potassium. It is important to read the labels carefully on all low-sodium food products.


Check with your doctor before starting any physical exercise program, especially if you are out of condition and are taking any other medicine. Exercise and certain medicines may increase the amount of potassium in the blood.


Check with your doctor at once if you notice blackish stools or other signs of stomach or intestinal bleeding. This medicine may cause such a condition to become worse, especially when taken in tablet form.


Urocit-K 10 Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Stop taking this medicine and check with your doctor immediately if any of the following side effects occur:


Less common
  • Confusion

  • irregular or slow heartbeat

  • numbness or tingling in hands, feet, or lips

  • shortness of breath or difficult breathing

  • unexplained anxiety

  • unusual tiredness or weakness

  • weakness or heaviness of legs

Check with your doctor as soon as possible if any of the following side effects occur:


Rare
  • Abdominal or stomach pain, cramping, or soreness (continuing)

  • chest or throat pain, especially when swallowing

  • stools with signs of blood (red or black color)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Diarrhea

  • nausea

  • stomach pain, discomfort, or gas (mild)

  • vomiting

Sometimes you may see what appears to be a whole tablet in the stool after taking certain extended-release potassium chloride tablets. This is to be expected. Your body has absorbed the potassium from the tablet and the shell is then expelled.


Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.