toff™ MD

Product Information - toff™ MD Tablets

Product Name	toff™ MD
Composition	Each uncoated flavored dispersible tablet contains: Dextromethorphan Hydrobromide IP 10 mg Phenylephrine Hydrochloride IP 5 mg Chlorpheniramine Maleate IP 2 mg
Description	toff™ MD is an antitussive (cough suppressant), antihistamine, decongestant (mouth dispersible) tablet for oral use.
Clinical Pharmacology	Dextromethorphan is the ‘dextro’ isomer of methorphan, a codeine analog. However, unlike codeine it has no analgesic or addictive properties and fewer gastrointestinal side effects. Dextromethorphan Hydrobromide is a centrally acting antitussive (cough suppressant) which increases the threshold for coughing. The onset of action starts 15-30 minutes after administration and persists for 5-6 hours. Phenylephrine hydrochloride is a sympathomimetic drug which exerts its vasoconstrictor effect by stimulation of α1-adrenergic receptors. The nasal decongestant action of Phenylephrine is attributed to this vasoconstrictor effect (i.e. constriction of blood vessels in the nose). It is readily absorbed from gastrointestinal tract after oral administration. Chlorpheniramine Maleate is a potent histamine antagonist (antihistamine) acting specifically on H1 receptors. It competes with histamine for the receptor site and reversibly inhibits interaction of histamine with H1 receptors. It exerts antiallergic effects by antagonizing the allergic response (vasodilatation, increased capillary permeability and increased secretion). Besides, it reduces secretions (drying effect) due to its anticholinergic actions and it also has sedative effects. Chlorpheniramine is well absorbed from gastrointestinal tract, peak plasma concentration is achieved in 2-3 hours and the effect lasts for 4-6 hours. It is metabolized in the liver and excreted primarily in urine.
Indications	toff™ MD tablets are intended for relief from cough, symptoms of common cold and allergy (including nasal congestion, discharge and sneezing).
Dosage	Adults & Children above 12 years: 1-2 tablets, 6 hourly or as per medical advice Children aged 6 to 12 years:1 tablet, 6 hourly or as per medical advice Children aged 2 to 6 years: Consult your physician Children aged less than 2 years: Not recommended Do not exceed the recommended doses.
Directions for use	Place the tablet on the tongue, it disperses in few seconds. No water is required while taking the tablet.
Precautions	Stop use and consult your physician if the cough persists after 4 to 5 days, tends to recur or is accompanied by high fever, rash or persistent headache.
Caution	toff™ MD should be used with caution in patients with bronchial asthma, chronic bronchitis, emphysema, narrow angle glaucoma, hypertension, coronary artery disease, thyroid problems, diabetes, liver disease and kidney disease or bladder neck obstruction.
Contraindications	toff™ MD is not recommended for use in children below 2 years of age, during pregnancy and breast feeding, if hypersensitive to any of the ingredients and in patients receiving MAO inhibitors.
Information for patients	Activities requiring mental alertness such as driving or working on machinery should best be avoided.
Adverse effects	The most common side effects include sedation, dryness of mouth, nose & throat and thickening of bronchial secretions. Other adverse reactions include urticaria, skin rash, photosensitivity, itching, palpitation, hypotension, hypertension, cardiac arrhythmias, tremors, irritability, insomnia, nervousness and agitation, confusion, dizziness, visual disturbances, anorexia, nausea, vomiting, constipation, diarrhea, retention of urine, wheezing. Thrombocytopenia, hemolytic anemia and agranulocytosis have also been reported.
Overdosage	Overdosage of Dextromethorphan may be associated with drowsiness, ataxia, nystagmus, opisthotonus and convulsions. Phenylephrine in toxic doses may cause hypertension and cardiac arrhythmias. Effect of Chlorpheniramine in excess doses may vary from depression to stimulation of central nervous system (CNS), especially in children. Treatment includes gastric lavage, oxygen, intravenous fluids and other supportive measures. Depending upon the signs and symptoms of over dosage, some times, naloxone, barbiturates, tracheostomy or antiarrhythmics may also be employed. In case of overdosage, consult your Physician or Poison control center immediately.
Drug interactions	With alcohol and other CNS depressants (sedatives, hypnotics, tranquillizers, anti-anxiety agents) antihistamines have additive effects. The anticholinergic effects of antihistamines and sympathomimetic effects of Phenylephrine may be potentiated by MAO inhibitors. Concurrent administration of other anti-depressants (e.g. fluoxetine, paroxetine etc) is to be avoided.
Storage	Store at temperature below 30° C, protect from light and moisture.
Supply	toff™ MD tablets are supplied in a blister pack of 10 tablets.
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