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Dynaphan
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DESCRIPTION |
CONTENT |
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DYNAPHAN SYRUP |
SYRUP
Colour : Orange
Flavour : Orange |
Each 5 ml contains:
Dextromethorphan HBr
........ 15 mg
Preservatives :
Methyl Paraben
.................... 0.1% w/v
Propyl Paraben
................... 0.01% w/v
Sodium Benzoate
...............0.1% w/v |
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DYNAPHAN TABLET |
TABLET
Colour : Orange
Shape : Round, Biconvex,
Scored
Coating : Film-coated |
Each tablet contains:
Dextromethorphan HBr
....... 15 mg |
PHARMACODYNAMICS
Dextromethorphan suppresses the cough reflex by a direct central action,
probably in the medulla or pons.
PHARMACOKINETICS:
Dextromethorphan HBr is absorbed after oral administration. After an oral
dose of 30 mg, 10, 25 and 10% of the dose is detectable in the blood at 1,
2.5, and 6 hours respectively after administration. It is metabolised by
N-Demethylation and O-Demethylation followed by Sulphate or Glucuronic Acid
conjugation; the major metabolite is (+)-3-hydroxy-N-methylmorphinan and the
other metabolites are (+)-3-hydroxymorphinan and possibly
(+)-3-methoxymorphinan and their respective conjugates. Up to 56% of a dose
is excreted in the urine, about 8 % being excreted unchanged in 6 hours, in
rats, Dextromethorphan is excreted in the bile and twice as much may be
detectable in the faeces as in the urine.
INDICATION
Symptomatic relief of unproductive cough caused by minor throat and
bronchial irritation occurring with colds or inhaled irritants.
RECOMMENDED DOSE
Adults : 15 - 30 mg, 1 to 4 times daily (not to exceed 120 mg daily).
Children :
7 - 12 years : 7.5 - 15 mg, 1 to 4 times daily (not to exceed 60 mg
daily).
2 - 6 years : 7.5 mg, 1 to 4 times daily (not to exceed 30 mg daily). (For
DYNAPHAN SYRUP Only)
WARNING (When Used For
Treatment of Cough and Cold)
1. Not to be used in children less than 2 years of age.
2. To be used with caution and doctor's advice in children 2 to 6 years of
age.
CONTRAINDICATION
It is contraindicated In patients receiving monoamine oxidase inhibitor (MAOI).
WARNING AND PRECAUTIONS
It should be administered with caution to patients with liver disease and to
asthmatic patients. It should not be taken for persistent or chronic coughs
or when coughing is accompanied by excessive secretions.
PREGNANCY AND LACTATION
It is not known whether Dextromethorphan or its metabolites are excreted in
breast milk.
There is insufficient information available to determine whether
Dextromethorphan has teratogenic potential.
There is no data on the secretion of Dextromethorphan into breast milk and
therefore use of this product during lactation should be avoided.
SIDE EFFECTS/ADVERSE REACTIONS:
Drowsiness, dizziness, excitation, mental confusion, gastrointestinal
disturbances, nervousness, restlessness or irritability.
SYMPTOMS AND TREATMENT OF OVERDOSE:
Symptoms of overdosage include respiratory depression, ataxia and
excitability. Treatment is by naloxone intravenous injection which is an
antidote.
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PACKING/PACK SIZES |
SHELF LIFE |
|
DYNAPHAN SYRUP |
Amber glass bottle of
60 ml.
Plastic bottles of 60 ml,
100 ml and 120 ml |
3 years from the date of
manufacture. |
|
DYNAPHAN TABLET |
Plastic container of
1000's (For export/Tender Only).
Blister pack of 100 x
10's. |
4½ years from the date of
manufacture. |
STORAGE CONDITIONS
Store in Dry Place below 25°C
Protect from light |
