MYCOSTATIN

MYCOSTATIN 

MYCOSTATIN
ORAL SUSPENSION
Nystatin 100,000 units per ml oral suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains 100,000 units
nystatin.
Excipients
Sucrose, Glyceririe, Sodium saccharin,
Carboxymethylcellulose sodium, Sodium phosphate,
Methylparaben, Propylparaben, Alcohol, Flavor imitation
cherry No. 9077R (Standard aromatics), Peppermint
oil, Cinnamic aldehyde, 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 candidiasis (thrush) in the newborn especially in
those born of mothers with positive vaginal cultures
Dosage and Administration
Route of Administration
For oral use.
Adults
Treatment of candidal infections of the oral cavity
The usual therapeutic dose for oral candidiasis is 1 ml
(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 prevent relapse. Dosage may
be increased if 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 I ml
(100,000 units) four times daily, dropped into the mouth
and swallowed. Dosage may be increased if desired.
When given concomitantly with an oral antibacterial
agent, the suspension•hould be continued at least as
long as the antibacterial agent,
Therapeutic administration 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 relevant data available.
Contraindications
Nystatin is contrai€cated in:
• patients with ahiStory of hypersensitivity 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
Hypersensitivity
If irritation or sensitisation develops, treatment should
be discontinued.
Systemic mycoses
Should not be used for tieatment of systemic mycoses.
Candida/ infections
In the therapy of Candidal infections, all potential sites of
infections should be treated simultaneously.
Alcohol
This medicinal product contains small 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.
Parabens
This medicinal product contains methyl
parahydroxybenzoate and propyl parahydroxybenzoate
which may cause allergic reactions (possibly delayed).
Interactions
None known.
9•rvthKhm Egypt
Pregnancy and Lactation
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 studies have not been conducted
with nystatin.
It is not known whether nystatin can cause foetal harm
when administered 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 nystatin is excreted in human breast
milk and caution should be exercised when nystatin is
prescribed for nursing 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 reactions are ranked under headings of
frequency using the following convention:
Very common 21/10
Common 21/100 to (1/10
Uncommon 21/1000 to (1/100
Rare 21/10000 to «1/1000
Very rare «I/IOOOO
Not known (cannot be estimated from the available
data).
Nystatin is generally well tolerated by all age groups,
even during prolonged use.lmmune system disorders
Rare: hypersensitivity , angioedema, including face
oedema
Gastrointestinal disorders
Uncommon: diarrhoea, abdominal discomfort , nausea,
vomiting
Skin and subcutaneous tissue disorders:
Rare: Steven-Johnson Syndrome, urticaria,
Uncommon: rash
General disorders and administration site conditions
Not knoWn: sensttlzatiöh, irritation
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.
Clinical Pharmacology
Pharmacodynamics
Nystatin is a polyene antifungal antibiotic that interferes
with the permeability of the cell membrane of sensitive
fungi by binding to sterols, chiefly ergosterol. Its main
action is against Candida spp.
Pharmacotherapeutic group
Antimycoticum, antibiotics.
ATC Code
A07AA02
Pharmacokinetics
Nystatin is formulated in oral and topical dosage forms
and is not systemically absorbed from any pf these
preparations.
Clinical Studies
Not relevant for this product.
NON-CLINICAL INFORMATION
Not relevant for this product.
PHARMACEUTICAL INFORMATION
Storage
Store at temperature less than 30 C.
Nature and Contents of Container
Carton box containing bottle of 30 ml, dropper and
inner leaflet.
Incompatibilities
There are no relevant data available.
Use and Handling
There are no special requirements for use or handling
of this product.
Keep out of the reach Of children.
Version number: 02
Version date: 26 September 2013
Manufactured by GlaxoSmithKline Egypt
Elsalam City,Cairo
for SmithKline Beecham Egypt
17 Studio Misr
72051G