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.