COMPOSITION:
Each 5ml contains:
Diphenhydramine Hydrochloride BP 14.08 mg
Ammonium Chloride BP 138.00 mg
Sodium Citrate BP 57.03 mg
Menthol USP 0.90 mg
In a flavoured syrupy base q.s.
DESCRIPTION:
Diphenhydramine hydrochloride, is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride and has the empirical formula C17H21NO.HCI. It occurs as a white, crystalline powder and is freely soluble in water and alcohol and has a molecular weight of 291.82.
MECHANISM OF ACTION: Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.
PHARMACOKINETICS: It is well absorbed from G.I.T. Diphenhydramine hydrochloride is widely distributed throughout the body, including the CNS. Aportion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver.
INDICATIONS: Diphenhydramine hydrochloride, is an antihistamine and used in the treatment of Allergic diseases such as hay fever, allergic rhinitis, urticaria, angioedema, atopic dermatitis, contact dermatitis, gastrointestinal allergy, pruritus, physical allergies, reactions to injection of contrast media, reactions to therapeutic preparations and allergic transfusion reactions. Symptomatic relief of perennial and seasonal allergic rhinitis, vasomotor rhinitis and allergic conjunctivitis; temporary relief of runny nose and sneezing caused by common cold; Ammonium chloride act as a expectorant. Its expectorant action is caused by irritative action on the bronchial mucosa. This causes the production of excess respiratory tract fluid which presumably is easier to cough.
DOSAGE AND ADMINISTRATION:
Children below 4 years: Consult the physician.
Adults: 2 teaspoonfuls (10m1) every 4 hours.
SHAKE WELL BEFORE USE.
CONTRAINDICATIONS: Hypersensitivity to any ingredient of the product.
SIDE-EFFECTS: CNS Depression with dizziness, dry mouth, G.I.disturbances. Others are headache, psychomotor impairment, blurred vision, urinary retention etc.
DRUG INTERACTIONS:
Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
PRECAUTIONS:
Diphenhydramine is considered unsafe in porphyric patients, should betaken safely in Pregnancy, Reports of dystonic extra pyramidal reactions.
STORAGE: Store at a temperature not exceeding 30°C. Protect from light.
PRESENTATION: 100 ml Flat Glass bottle in Graphics carton.