Paracetamol, phenylephrine hydrochloride, dextromethorphan hydrobromide.
Paracetamol + Phenylephrine hydrochloride + Dextromethorphan hydrobromide (Nasatapp Cough) is white to off-white free-flowing powder free from dirt and lumps encapsulated in empty gelatine capsule size# 0 with green cap and yellow body.
Each capsule contains: Paracetamol, USP 325 mg, Phenylephrine hydrochloride 25 mg, Dextromethorphan hydrobromide 10 mg.
Pharmacology: Pharmacodynamics: Dextromethorphan HBr: Dextromethorphan is a methylated dextroisomer of Codeine analog, Levorphanol. Unlike Levorphanol, however, it has no significant analgesic properties and does not depress respiration or predispose to addiction.
Dextromethorphan acts centrally by depressing the cough center in the medulla of the brain and therefore elevates the threshold for coughing. Its antitussive potency is nearly equal to that of Codeine.
Phenylephrine HCl: Phenylephrine is a powerful vasoconstrictor. It is used as a nasal decongestant and cardiotonic agent. Phenylephrine is a postsynaptic α1-receptor agonist with little effect on β-receptors of the heart. Parenteral administration of phenylephrine causes a rise in systolic and diastolic pressures, a slight decrease in cardiac output, and a considerable increase in peripheral resistance; most vascular beds are constricted, and renal, splanchnic, cutaneous, and limb blood flows are reduced while coronary blood flow is increased. Phenylephrine also causes pulmonary vessel constriction and subsequent increase in pulmonary arterial pressure. Vasoconstriction in the mucosa of the respiratory tract leads to decreased edema and increased drainage of sinus cavities.
Paracetamol: Paracetamol exhibits analgesic and antipyretic activity by inhibiting prostaglandin synthesis. It produces analgesia by elevating the pain threshold and antipyresis through its action on the hypothalamic heat regulating center.
In therapeutic doses, the analgesic and antipyretic actions of Paracetamol are comparable to that of aspirin. Paracetamol does not adversely affect platelet function and hemostasis.
Pharmacokinetics: Dextromethorphan HBr: Dextromethorphan is rapidly absorbed from the gastrointestinal tract and 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.
Dextromethorphan is metabolized in the liver and excreted as unchanged dextromethorphan and demethylated morphinan compounds. Up to 56% of dose is excreted in the urine, with about 8% being excreted unchanged in 6 hours.
Phenylephrine HCl: Phenylephrine is completely absorbed after oral administration. It has a reduced bioavailability (compared to pseudoephedrine) following oral administration due to significant first-pass metabolism in the intestinal wall. Compared to IV administration, bioavailability is approximately 38%. Peak serum concentrations are achieved approximately 0.75-2 hours following oral administration.
Phenylephrine undergoes extensive first-pass metabolism in the intestinal wall and extensive metabolism in the liver. Sulfate conjugation, primarily in the intestinal wall, and oxidative metabolism by monoamine oxidase (MAO) represent the principle routes of metabolism. Glucuronidation occurs to a lesser extent. Phenylephrine and its metabolites are mainly excreted in urine.
Paracetamol: Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. After oral administration, peak plasma concentrations of Paracetamol are attained within 10 to 60 minutes, after 8 hours, only small amounts of the drug are detectable in plasma.
Paracetamol is rapidly and uniformly distributed into most body tissues. About 25% of Paracetamol in the blood is bound to plasma proteins.
Paracetamol has 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 systems in the liver. About 80 to 85% of Paracetamol in the body undergoes conjugation principally with glucuronic acid to a lesser extent with sulphuric acid. A small amount is conjugated with cystene and also deacylated, probably to p-aminophenol, which can cause methemoglobinemia.
Paracetamol is excreted in urine principally as glucuronide with small amounts of sulfate, 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.
Paracetamol + Phenylephrine hydrochloride + Dextromethorphan hydrobromide (Nastapp Cough) is used for the relief of cough, clogged nose, postnasal drip, headache, body aches, and fever associated with the common cold, allergic rhinitis, sinusitis, flu, and other minor respiratory tract infections. It also helps decongest sinus openings and passages.
Adults and children 12 years and older: Orally 1 capsule every 6 hours, or as recommended by a doctor.
Dextromethorphan HBr: Acute overdosage of dextromethorphan may cause nausea, vomiting, drowsiness, dizziness, excitation, confusion, psychosis, CNS depression, stupor (decreased mental alertness), blurred vision, nystagmus, (involuntary and rapid movement of the eyeball), dysarthria (slurred speech), respiratory depression, shallow respiration, ataxia (uncontrolled muscle movement), tremor, urinary retention, seizures, and coma.
Phenylephrine HCl: Increased blood pressure, headache, seizures, palpitation, paresthesia (sensation of tingling, pricking, or numbness of the skin), vomiting, cerebral hemorrhage (bleeding from a ruptured blood vessel in the brain).
Paracetamol: Overdosage of paracetamol usually involves 4 phases with the following signs and symptoms: Eating disorder, nausea, vomiting, malaise, and excessive sweating.
Right upper abdominal pain or tenderness, liver enlargement which may be characterized by abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentrations, prolongation of prothrombin time, and occasionally decreased urine output.
Eating disorder, nausea, vomiting, and malaise recur and signs of liver failure (e.g., jaundice) and possibly kidney failure and cardiomyopathy (disorder of the heart muscle) may develop.
Recovery or progression to fatal complete liver failure.
If the patient has taken more than the recommended dosage, consult a doctor or contact a poison control center right away, even if the patient seems well, because of the risk of delayed, serious liver damage. Quick medical attention is important for adults as well as for children even if the patient do not notice any signs or symptoms.
Hypersensitivity to any ingredient in the product.
Patients with severe coronary disease or cardiovascular disease including myocardial infarction, severe hypertension and ventricular arrhythmia.
Repeated administration is contraindicated in patients with anemia, cardiac, pulmonary, renal, or hepatic disease.
Liver Warning: The product contains paracetamol. Severe liver damage may occur if: An adult or child 12 years and older takes more than 4g of paracetamol in 24 hours, which is the maximum daily amount; Taken with other medicines containing paracetamol (or acetaminophen); An adult has 3 or more alcoholic drinks everyday while using the product.
Use with caution in patients with high blood pressure, toxic goiter, benign prostatic hypertrophy, heart rate irregularity, glaucoma, and in those taking antidepressants.
Do not use with any other medicine containing dextromethorphan, phenylpropanolamine or paracetamol (prescription or non-prescription). If the patient is not sure whether a medicine contains these three active ingredients, ask a doctor.
Do not take the medicine if the patient is at risk of developing respiratory failure (e.g., those with chronic bronchitis, emphysema or during an asthma attack).
Do not take the medicine if the patient has persistent or chronic cough (i.e., cough lasting for more than 3 weeks) or when coughing is accompanied by excessive secretions unless directed by a doctor.
A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
May cause drowsiness and dizziness; patients should observe caution while driving or performing other tasks requiring alertness.
Ask a doctor before use if the patient has liver or kidney disease.
Ask a doctor before use if the patient is taking warfarin, a blood thinning medicine.
Do not take more than the recommended dose.
Paracetamol + Phenylephrine hydrochloride + Dextromethorphan hydrobromide (Nasatapp Cough) should not be taken if the patient is pregnant or breastfeeding.
Dextromethorphan HBr: Adverse effects with Dextromethorphan are rare and include nausea, gastrointestinal discomfort, dizziness, drowsiness, excitation, and mental confusion.
Phenylephrine HCI: Phenylephrine may cause tremor (muscle shaking), restlessness, anxiety (feeling of uneasiness), insomnia/sleeplessness, nervousness, dizziness, increased blood pressure, palpitation, arrhythmia (irregular heartbeat), weakness, respiratory distress (noisy, congested breathing), and pallor.
Paracetamol: Paracetamol, when taken within the recommended dose and duration of treatment, has low incidence of side effects. Skin rashes, hypersensitivity reactions, changes in the number of white blood cells and platelet, and minor stomach and intestinal disturbances have been reported.
Dextromethorphan HBr: Patients on monoamine oxidase (MAO) inhibitors (e.g., tricyclic antidepressants) should not use products containing dextromethorphan without the supervision of a physician. Dextromethorphan has a tendency to inhibit the metabolism of and thus potentiate the effects of certain MAO inhibitors.
Phenylephrine HCI: Do not use the product together with sympathomimetic agents (e.g., Epinephrine, etc.) and general anesthetics (e.g., Halothane, etc.) because of the possibility for increased toxicity. Concurrent administration with medicines for depression (e.g., Amitriptyline, Imipramine, Sertraline, Moclobemide, etc.) may result in hypertensive crisis (sudden, severe increase in blood pressure that can lead to stroke). Taking an adrenergic-blocking agent (e.g., Phenothiazine drugs, Phentolamine, Propranolol, etc.) before the administration of the product may decrease the effect of phenylephrine. Tell the doctor about other medicines the child is taking, especially other medicines for cough, cold, or allergy.
Paracetamol: Paracetamol in therapeutic doses produces only slight increases in the hypoprothrombinemic response to Warfarin or Coumadin.
Concomitant use of Paracetamol and Phenothiazine may possibly cause severe hypothermia.
Concomitant administration with Isoniazid may result in an increased risk of hepatotoxicity.
Anticonvulsants (e.g., Phenytoin, barbiturates, carbamazepine) that induce hepatic microsomal enzymes may increase Paracetamol-induced liver toxicity because of increased conversion of the drug to hepatic metabolites.
Store at temperatures not exceeding 30°C.
N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
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