Generic Name : PARACETAMOL, GUAIFENESIN, DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCl

Active Ingradiant: PARACETAMOL, GUAIFENESIN, DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCl

Supplied:
Paracetamol 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 10 mg, Pseudoephedrine HCl 25 mg film-coated tablets - Cold & Cough

CLINICAL PHARMACOLOGY:

Guaifenesin promotes lower respiratory tract drainage by thinning bronchial secretions, lubricates irritated respiratory tract membranes through increased mucus flow, and facilitates removal of viscous, inspissated mucus. As a result of these drugs, sinus and bronchial drainage is improved and dry, nonproductive coughs become more productive and less frequent.

Pseudoephedrine hydrochloride is an α-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating α-receptors within the mucosa of the respiratory tract. Clinically, Pseudoephedrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion and increases nasal airway patency.

Dextromethorphan is an antitussive agent, which, unlike the isomeric levorphanol, has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic doses, it does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine.

Acetaminophen is an analgesic and antipyretic and is metabolized primarily in the liver. Little unchanged drug is excreted in the urine, but most metabolic products appear in the urine within 24 hours.

INDICATIONS AND USAGE:

For the temporary relief from minor aches and pains, headache, muscular aches and sore throat associated with cold or flu, and to reduce fever. Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with a cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive. It is also indicated for the relief of nasal congestion due to the common cold, hay fever, or other respiratory allergies and nasal congestion associated with sinusitis.

CONTRAINDICATIONS:

Patients with a known hypersensitivity to any of its ingredients, in nursing mothers, or in patients with severe hypertension, severe coronary artery disease, prostatic hypertrophy, or in patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy).

WARNINGS:

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports almost invariably involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

PRECAUTIONS:

General

Hypertensive patients should use only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction.

Information for Patients

Persistent cough may indicate a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a high fever, rash, or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Drug Interactions:

Monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy) and beta-adrenergic blockers increase the effects of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids.

Drug/Laboratory Test Interactions:

Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA).

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Flutabs™ tablets. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Product should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents.

Usage in Elderly:

Patients 60 years and older are more likely to experience adverse reactions to sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death.

Demonstrate safe use of a short-acting sympathomimetic before use of a sustained action formulation in elderly patients.

Pediatric Use:
Safety and effectiveness in the pediatric population, under 12, have not been established.

ADVERSE REACTIONS

Gastrointestinal: nausea and vomiting.
Central Nervous System: nervousness, dizziness, sleeplessness, lightheadedness, tremor, hallucinations, convulsions, CNS depressions, fear, anxiety, headache, increased irritability or excitement.
Cardiovascular: palpitations, tachycardia, cardiovascular collapse and death.
General: weakness; slight drowsiness.
Respiratory: respiratory difficulties.

OVERDOSAGE

Symptoms: Overdosage may cause hallucination, convulsions, CNS depression, cardiovascular collapse and death. Overdosage with dextromethorphan HBr may produce nausea, and vomiting, central nervous system excitement and mental confusion, visual disturbances, and urinary retention. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperreactivity, marked visual and auditory hallucinations) after a single 300 mg dose of dextromethorphan has been reported.

Stored: Store at 25°C (77°F), excursions permitted to 15°-30°C (59°- 86°F).

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The products discussed herein may have different product labeling in different countries. The product information provided in this site is intended only for the residents of India.

                    
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