COMPOSITION: each lozenge contains:
Active ingredient:
Dextromethorphan HBr 5 mg
Benzocaine 7.5 mg
Excipients: colloidal anhydrous silica, sorbitol, mannitol 60, aspartame, peppermint flavor, strawberry flavor, ponceau 4R, menthol, magnesium stearate, (*) ethanol 96-98%
(*)not appeared in the finished product
DESCRIPTION OF PRODUCT :
The tablet is round shaped, pink, bossed with “STAR” on two sides, characteristic flavor, sweet taste.
PHARMACODYNAMICS:
Dextromethorphan hydrobromide is a cough suppressant, which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.
Benzocaine, a local anesthetic, is a derivative of para-aminobenzoic acid. It is commonly used as a topical pain reliever in the mouth or throat. Pain is caused by the stimulation of free nerve endings. Benzocaine acts to inhibit the voltage-dependant sodium channels on the nerve membrane, stopping the propagation of the action potential toward the central nervous system from the stimulation of free nerve endings.
PHARMACOKINETICS:
Dextromethorphan hydrobromide is rapidly absorbed from the gastrointestinal tract and has effect in 15 – 30 minutes after oral doses; duration is about 6-8 hours. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan, which has some cough suppressant activity.
Benzocaine exhibits negligible absorption and is distributed in the body, crosses the placenta and is metabolised in the liver and in the plasma by non-specific cholinesterases. Benzocaine and its main metabolite (para-aminobenzoic acid) are excreted into urine.
INDICATIONS:
Temporarily suppress coughs due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.
ADMINISTRATION AND DOSAGE:
Adults and children 12 years and older:
Dissolve 2 lozenges slowly in the mouth, one after the other every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor.
Children 6 to under 12 years:
Dissolve 1 to 2 lozenges one after the other every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor.
Children under 6 years: Consult a physician
CONTRAINDICATIONS:
Hypersensitivity to any component of the formulation. Patients have taking MAOI. Children under 2 ages.
WARNINGS AND PRECAUTIONS:
Do not exceed recommended dosage.
Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other caine anesthetics.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
– Pregnancy and Lactation: If pregnant or breast-feeding, consult a doctor.
– Effects on ability to drive and use machines: none reported
SIDE EFFECTS:
- Common, ADR>1/100: Drowsiness, tachycardia, nausea, flushing
- Rare, 1/1000<ADR<1/100: Urticaria, drowsiness, digestive disorders.
In case of an unexpected reaction, consult your physician.
INTERACTIONS:
– Do not use if you are taking a prescription of monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease), or for two weeks after stopping the MAOI. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product.
OVERDOSE AND TREATMENT:
Symptoms:
- Dextromethorphan: Nausea, vomiting, blurred vision; confusion; hallucinations, convulsion, respiratory impairment.
- Benzocaine: No information is available.
Treatment:
- Dextromethorphan: Support, use 2 mg of naloxon injects in intravenous, repeated if necessary to use a total dose of 10 mg
PRESENTATION:
Box of 2 blisters x 12 lozenges, each blister packed in 1 bag of aluminum
Box of 5 blisters x 12 lozenges, each blister packed in 1 bag of aluminum
Box of 10 blisters x 12 lozenges, each blister packed in 1 bag of aluminum
STORAGE: Store at temperature below 300C, in a dry place and protect from light.
SHELF-LIFE: 36 months from manufacturing date. Do not use after expiry date.
DATE OF REVISION OF PACKAGE INSERT:…
