Mycostatin oral suspension

Mycostatin oral suspension PHARMACEUTICAl FORM :

Pale yellow suspension flavoured with cherry mint

Mycostatin oral suspension CLINICAL INFORMATION :

Mycostatin oral suspension Indications :

– For the prevention and treatment of : candidal infections of the oral cavity, oesophagus and intestinal tract.
– For the prevention of: oral candidalis (thrush) in the newborn especially in those born of moIhers with positive vaginal cultures

Mycostatin oral suspension Route of Administration

For oral use.
Adults
Treatment of candida infections of the oral cavity The usual therapeutic dose for oral candidiasis is 1 rnl (100,000 units) four times daily, dropped into mouth and held for sometime before swallowing. The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect. Treatment should be continued at least 48 hours following clinical cure to  relapse. Dosage may be increased it desired.
Treatment of intestinal or oesophageal candidiasis For the treatment of intestinal or oesophageal candidiasis, nystatin is given in oral doses of 500 000 or 1 000 000 units. 3 or 4 times daily.
Prophylaxis For prophylaxis of intestinal candidiasis in patients given broad spectrum antibacterials, a total dose of 1 000 000 units daily may be given.
Children
The usual prophylactic and therapeutic  dosage is 1 ml four times daily, dropped into the mouth agent, the suspension should be continued at least as long as the antibacterial agent therapeutic admnistration should generally be continued for at least 48 hours after clinical cure to prevent relapse.
For prophylaxis in the newborn the suggested dosage regimen is 1 ml (100,000 units) once daily, by dropper directly into the mouth.
Elderly
No specific dosage recommendations or precautions.
Renal impairment
There are no relevant data available.
Hepatic impairment
There are no relavent data available.

Mycostatin oral suspension Contraindications :

Nystatin is contraindicated in:
– patients with a history of hyperseflsitivity to any of the components
– Due to saccharin sodium, not to be used for patients with liver disease as the reports of increasing in liver enzymes when using this ingredient even in small doses.

Mycostatin oral suspension Warnings and Precautions :

Hypersensitivit :if irritation or sensitization develops, treatment should be discontinued.
Systemic mycoses :Should not be used for treatment of systemic mycoses.
Candidal infections :In the therapy of Candida! infections, all potential sites of infections should be treated simultaneousty.
Alcohol :This medicinal product contains smaI amounts of ethanol (alcohol), less than 100mg per dose.
Sucrose :This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
Patabens :This medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic raections (possibly delayed).

Mycostatin oral suspension Interactions :

None known.

Mycostatin oral suspension Pregnancy and loctation :

Fertility 
There are no relevant data available.
Pregnancy
Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the possible risks involved.
lactation
Though gastro intestinal absorption is insignificant it is not known whether nystatin is excreted in human breast milk and caution should be exercised when nystatin is prescribed for rusing women.

Mycostatin oral suspension Ability to perform tasks that require judgement, motor or cognitive skills  :

None known.

Mycostatin oral suspension Clinical Trial Data :

Not relevant for this product

Mycostatin oral suspension Post Marketing Data :

Adverse reactions are ranked under headings of frequency using the following convention:
Very common :>1/10
Common : >1/100 to < 1/10
Uncommon : >1/1000 to <1/100
Rare : > 1/10000 to <1/1000
Very rare  : < 1/10000
Not known (cannot be estimated from the available data )Nystatin generally well tolerated by all age groups. even during prolonged use immune system disorders
Rare: hypersensitivity , angioedema, including face oedema
Gastrointesrinal disorders
Skin and subcutaneous tissue disorders:
Rare: Steven-Johnson Syndrome, articaria.
Uncommon: rash
Generaraisorders and administration site conditions
Not known: sensitizatinal, irritation

Mycostatin oral suspension Overdosage :

Since the absorption of nystatin from the gastrointestinal tract is negligible overdosage or accidental ingestion causes no systemic toxicity. Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset.

Mycostatin oral suspension Pharmacodynamics :

Nystatin is a potyene antifungal antibiotic that interferes with the penneabiIity of the cell membrane of sensitive fungi by binding to sterols. chiefly ergosterol lts main action is against Candida spp.
Pharmacotherapeutic group :Antimycoticwn, antibiotics.
Pharmacokinetics :Nystatin oral and topical dosage forms and is not systemically absorbed from any of these preparations.
Clinical Studies :Not relevant for this product.

Mycostatin oral suspension Storage :

Store at temperature less than 30 0 C.

Mycostatin oral suspension Nature and Contents of Container :

Carton box containing bottle of 30 ml, dropper and inner leaflet.

Mycostatin oral suspension Incompatibitities :

There are no relevant data available.

Mycostatin oral suspension Use and Handling :

There are no special requinments for use or handling of this product
Keep out of the reach of children.

Mycostatin oral suspension Manufactured by :

GlaxoSmithKline Egypt
Elsatam City,Cairo
for SmithKline Beecham Egypt