Macrotap

Macrotap

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab
Full Prescribing Info
Contents
Paracetamol, dextromethorphan HBr.
Description
Each capsule contains Paracetamol 300 mg, dextromethorphan HBr 10 mg.
Action
Pharmacology: Pharmacodynamics: Paracetamol: Paracetamol is the active metabolite of phenacetin and has antipyretic and analgesic activities. In peripheral tissues, paracetamol is a weak COX-1 and COX-2 inhibitor. Paracetamol appears to be equivalent to aspirin as an analgesic and antipyretic agent. However, paracetamol lacks anti-inflammatory properties, does not affect uric acid levels, and does not inhibit platelet function.
Dextromethorphan HBr: Dextromethorphan is the d-isomer of the codeine analog of levorphanol; it lacks analgesic and additive properties. Its cough suppressant action is due to a central action on the cough center in the medulla. Dextromethorphan 15 to 30 mg equals codeine 8 to 15 mg as an antitussive.
Pharmacokinetics: Paracetamol: Paracetamol is rapidly and almost completely absorbed from GI tract that rapidly and uniformly distributed into most body tissues. About 25% of Paracetamol in blood is bound to plasma proteins and approximately 85% of a dose of Paracetamol is excreted in urine within 24 hours after ingestion.
Dextromethorphan HBr: Dextromethorphan is rapidly absorbed from the GI tract and exerts its effect in 15-30 minutes after oral administration. The duration of action is approximately 3-6 hours.
Indications/Uses
Macrotap is used for short term relief of fever and cough.
Dosage/Direction for Use
Adults and children ≥12 years: 2 capsules every 4-6 hours, not exceed 12 capsules daily.
Children 6-<12 years: 1 capsule every 4 hours, not exceed 6 capsules daily.
Mode of Administration: Macrotap is usually administered by orally.
Overdosage
Symptoms: In adults, an acute ingestion of more than 7.5 g of paracetamol (25 cap of Macrotap) is capable of causing toxicity divided into 4 stages: Stage 1: Onset may be within a few hours of ingestion and may resolve within 24 hours. Symptoms include abdominal pain, diaphoresis, malaise, nausea, pallor, and vomiting. Liver function tests may be normal.
Stage 2: Onset is 24 to 36 hours post-acute ingestion. Liver injury develops and is noted by right upper quadrant pain and elevations of liver function tests e.g. ALT, AST, bilirubin, prothrombin time.
Stage 3: Onset is 72 to 96 hours post-acute ingestion. Hepatotoxicity peaks and is evident by fulminant hepatic failure, encephalopathy, coma, AST and ALT levels of more than 10,000 units/L, and abnormal PT, bilirubin, glucose, lactate, and phosphate. Fatalities caused by hepatic failure generally occurs 3 to 5 days after an acute ingestion.
Stage 4: Recovery stage for those patients who survive stage 3.
Treatment: For recent paracetamol ingestions, administer activated charcoal to limit GI absorption. Provide general supportive care. N-acetylcysteine is the specific antidote for paracetamol.
Loading dose: 140 mg/kg as a one time oral dose.
Maintenance dosage: 70 mg/kg orally 4 hours after loading dose and at 4-hour intervals thereafter for 17 total doses.
If the patient vomits any oral dose within 1 hour of administration, repeat that dose. If the patient is persistently unable to retain the orally administered acetylcysteine, it may be administered by duodenal intubation.
Contraindications
Hypersensitivity to paracetamol or dextromethorphan or to any of its components.
Warnings
Hepatotoxicity will occur, in the case of overdose, not as on the label, and do not continue using this medicine more than 5 days.
Patient with liver disease and kidney disease should consult with the physician or pharmacist before using this medicine.
Dextromethorphan is used for cough relief, as the dosage on leaflet. The use of high dose dextromethorphan (more than 120 mg or 12 capsules per day in adults and more than 60 mg or 6 capsules per day in children), will lead to respiratory suppression which may cause death.
Special Precautions
Chronic alcoholics should be cautioned to avoid regular or excessive use of paracetamol or alternatively, to avoid chronic ingestion of alcohol.
Should be used with caution in atopic children.
Should be used with caution in sedated or debilitated patients and in patients confined to the supine position.
Should not be taken for persistent or chronic cough or when coughing is accompanied by excessive secretions.
If cough persists for longer than 1 week, tends to recur, or is accompanied by high fever, rash or persistent headache, a physician should be consulted.
Should not be used in patients receiving Monoamine oxidase (MAO) inhibitors or for 2 weeks after discontinuing them.
Should not be used in children younger than 2 years of age.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Category C. It is not known if Macrotap can cause fetal harm or affect reproduction capacity when administered to a pregnant woman. Give to a pregnant woman only if clearly needed.
Use in Lactation: Macrotap suggests that passage into milk probably occurs.
Adverse Reactions
Dizziness, drowsiness and GI disturbances.
Dermatologic and sensitivity reactions: Rash, urticaria, laryngeal edema, angioedema and anaphylactoid reactions.
Hematologic effects: Neutropenia and thrombocytopenic purpura.
Hepatic effects: Hepatotoxicity.
Drug Interactions
Alcohol: Alcohol may increase the risk of paracetamol-induced hepatotoxicity.
Anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine): Increased conversion of the drug to hepatotoxic metabolites.
Isoniazid: Increased risk of hepatotoxicity.
Anticoagulant: Chronic ingestion of large doses of Paracetamol has effect to increase risk of adverse effect of coumarin and indandione derivative coagulant.
Phenothiazines: Possibility of severe hypothermia.
Storage
Keep in tight, light-resistant container, dry place and store below 30°C.
ATC Classification
N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Presentation/Packing
Cap (orange, clear, oblong, soft gelatin capsule containing clear liquid) 1 x 12 x 10's.
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