Mycostatin oral suspension
Nystatin 100,000 units per rnl oral suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION :
Each mI of oral suspension contains 100,000 units nystatin.
Exeiplents :Sucrose, Glycerine. Sodium saccharin, Carboxymethyl cellulose sodium, Sodium phosphate, Methylparaben, Propylparaben, Alcohol, Flavor imitation cherry No. 9077R (Standard aromatics), Peppermint oil, Cimamic aIdetIyde, Hydrochloric acid, Sodium hydroxide. Purified water.
PHARMACEUTICAl FORM :
Pale yellow suspension flavoured with cherry mint
CLINICAL INFORMATION :
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 wnh positive vaginal cultures
Dosage and administration :
Route of Administration
For oral use.
Adults
Treatment of candidaJ 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 swallGwilg, 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 intesOOal candidiasis in patients
given broad-specVum antibacterials, a total dose of 1 000 000 units daily may be given.
Children
The usual prophylactic and therapeut dosage is 1 ml (100,0IX) units) 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.
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.
Warnings and Precautions :
Hypersensitivit :it irritation or sensitisatioo 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.
Alc0hol :This medicinal product contains smaI amounts of ethanol (alc0hoi), 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).
Interactions :
None known.
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. Animal reproductive stucfl8S have not been conducted with,nystatin. It is not known whether nystatin can cause foetal harm when administertld to a pregnant women, however absorption of nystatin from the gastro-intestinal tract is negligible.
lactation
Though gastro intestinal absorption is insignificant it is not known whether nystml is excreted in human breast milk and caution $hotid be exercised when ny$latin is prescribed for rusing women.
Ability to perform tasks that require judgement, motor or cognitive skills :
None known.
Adverse Reactions :
Clinical Trial Data :
Not relevant for this product
Post Marketing Data :
Adverse reacttons 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 estmated from the available data )Nystatin ~ generally well tolerated by all age groups. even during prolonged useJmmune system disorders
Rare: hypersensi1ivity , angioedema, including face oedema
GastrointesrinaJ djsorders
Skin and subcutaneous tissue disorders:
Rare: Steven·Johnson Syndrome, L.l’ticaria.
Uncommon: rash
Generaraisorders and administration site conditions
Not known: sensitizatinal, irritation
Overdosage :
Since the absorption 01 nystatin from the gastrointestinaJ 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.
Clinical Pharmacology :
Pharmacodynamics :
Nystatin is a potyene antifungal antibiotic that interferes with the penneabiIity 01 the cell membrane 01 sensitive fungi by binding to sterols. chiefly ergosterol lts main action is against Candida spp.
Pharmacotherapeutic group :Antimycoticwn, antibiotics.
Pharmacokinetics :Nystatin ~ lormuIated ” oral and topical dosage lorms and is not systemically absort>ed from arry of these
preparations.
Clinical Studies :Not relevant for this product.
NON-CLINICAL INFORMATION :
Not relevant IOf tf1is product
PHARMACEUTICAl INFORMATION :
Storage :
Store at temperature less than 30 0 C.
Nature and Contents of Container :
Carton box containing bottle of 30 ml, dropper and inner leaflet.
Incompatibitities :
There are no relevant data available.
Use and Handling :
There are no special requinments for use or handling
of this product
Keep out of the reach of children.
Manufactured by :
GlaxoSmithKline Egypt
Elsatam City,Cairo
for SmithKline Beecham Egypt
