Contents

Per cap Dextromethorphan HBr 15 mg, phenylpropanolamine HCl 25 mg, paracetamol 325 mg. Per 5 mL susp Dextromethorphan HBr 10 mg, phenylpropanolamine HCl 12.5 mg, paracetamol 250 mg

Indication

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Dosage / Direction For Use

Cap Adult & childn >12 yr 1 cap every 6 hr. Susp Adult & childn >12 yr 10 mL every 6 hr. Childn 7-12 yr 5 mL every 6 hr, 2-6 yr 2.5 mL every 6 hr.

Overdosage

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Administration

May be taken with or without food.

Contraindication

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Special Precaution

Use with caution in patients with high blood pressure, toxic goiter, benign prostatic hyperplasia, heart rate irregularity, glaucoma, and in those taking anti-depressant.Patients with heart disease and uncontrolled/untreated high blood pressure should consult a doctor prior to taking phenylpropanolamine.Do not give this medicine if the patients has persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions unless directed by a physician.A persistent cough may be a sign of a serious condition. If cough resists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician.Paracetamol may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes in certain susceptible individuals. This medicine should be discontinued if hypersensitivity reactions recur.Paracetamol should be used with caution in patients with pre-existing anemia, since cyanosis may not be apparent despite dangerously high blood concentration of methemoglobin.Alcohol warning: Patients who consume 3 or more alcoholic drinks everyday should consult a physician before taking paracetamol or any other pain reliever/pain reducers. Paracetamol can cause liver damage.This medicine should be given with care to patients with kidney or liver disease including patients taking other drug that affect the liver.Do not use with any other product containing paracetamol.Do not exceed recommended dose. In case of accidental overdose, contact a physician or poison control center immediately. Prompt medical attention is critical for adults as well as for children even if they do not notice any signs or symptoms.Discontinue use and consult a physician if symptoms do not improve or new symptoms appear.

Adverse Reactions

Dextromethorphan HBr: Adverse effects with Dextromethorphan are rare and include nausea, gastrointestinal discomfort, dizziness, drowsiness, excitation, and mental confusion.Phenylpropanolamine HCl: The incidence of adverse effects is low in patients receiving therapeutic doses of Phenylpropanolamine. These are related to its central nervous system (CNS) and cardiovascular stimulant actions. The CNS stimulant effects may result in nervousness, restlessness, irritability, aggressiveness, insomnia, dizziness, headache and tremor. Nausea and palpitations may occur. The cardiovascular stimulant effects include increases in blood pressure which are usually proportionate to dosage, and chest tightness. Ventricular or atrial premature contractions and paroxysms of ventricular and atrial tachycardia have occurred with usual therapeutic doses; these effects probably represent idiosyncratic reactions to the drug. Excessive doses of Phenylpropanolamine may produce tachycardia, excitation, and arrhythmias.When Phenylpropanolamine is used as a nasal decongestant, rebound congestion and tachyphylaxis can occur within a few days.Paracetamol: Paracetamol has a low incidence of side effects when used within therapeutic doses. Minor gastrointestinal disturbances have been reported. Dermatologic reactions like pruritic maculopapular rash and urticarial have been reported. Other sensitivity reactions including laryngeal edema, angioedema and anaphylactoid reactions may occur rarely.Hepatotoxicity can occur after ingestion of a single toxic dose or multiple excessive doses of Paracetamol. Substantial elevations in alanine aminotransferase (ALT) occurred after receiving Paracetamol in a dosage of 4 g daily for two weeks.Paracetamol very rarely aggravates bronchospasm in patients who are sensitive to aspirin and other non-steroidal inflammatory drugs. Although Paracetamol does not normally produce methemoglobinemia or hemolysis even after overdosage or in patients with glucose-6-phosphate dehydrogenase deficiency, there have been isolated reports of these complications.Prolonged administration of large doses of Paracetamol may lead to thrombocytopenia, leukopenia, agranulocytosis, and pancytopenia. Physical dependence does not develop even with prolonged use.

Drug Interaction

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Storage

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Description

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Action

Pharmacologic Classification: Antitussive/Nasal Decongestant/Analgesic-Antipyretic.Pharmacology: Pharmacokinetics: Bioavailability: Dextromethorphan HBr: Dextromethorphan is rapidly absorbed from gastrointestinal tract exerts its effect within 15 to 30 minutes after oral administration. The duration of action is approximately 3 to 6 hours with conventional dosage forms. It is metabolized in the liver and excreted as unchanged dextromethorphan and demethylated mophinan compounds. Up to 56% of a dose is excreted in the urine, with about 8% being excreted unchanged in 6 hours.Phenylpropanolamine HCl: Phenylpropanolamine is readily absorbed from gastrointestinal tract. Plasma concentrations of drug required for a therapeutic effect are not known. In one study, peak plasma concentrations of 100 ng/mL were reached within 1 to 2 hours. Concentrations remained greater than 60 ng/mL for 6 hours after oral administration of 50 mg of phenylpropanolamine to fasting adults.Animal studies indicate that Phenylpropanolamine is distributed in various tissues, including cerebral fluid and the brain.Phenylpropanolamine has a half-life of 3 to 6 hours. Small amounts of the drug are slowly metabolized in the liver to an active hydroxylated metabolite. About 80 to 90% of a dose of Phenylpropanolamine is excreted unchanged in the urine within 2 hours.Paracetamol: Paracetamol is rapidly and almost completely absorbed from gastrointestinal tract. After oral administration, peak plasma concentration of paracetamol are attained within 10-60 minutes. After 8 hours, only small amounts of the drug are detectable in plasma. It is rapidly and uniformly distributed into most body tissues. About 25% of paracetamol in blood is bound to plasma proteins.Paracetamol has a plasma half-life of 1.25 to 3 hours which may be prolonged after toxic doses or in patients with liver damage. It is metabolized by microsomal enzyme system in the liver. About 80 to 85% of Paracetamol in the body undergoes conjugation principally with glucuronic acid and to a lesser extent with sulfuric acid. A small amount is conjugated with cysteine and also deacylated, probably to p-aminophenol, which can cause methemoglobinemia.Paracetamol is excreted in urine principally as glucuronide with small amounts of sulphate, mercaptate, and unchanged drug. Approximately 85% of a dose of Paracetamol is excreted in urine as free and conjugated Paracetamol within 24 hours after ingestion.