Apitol Tablets

Perennial and seasonal allergic rhinitis, Vasomotor rhinitis, Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

• DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT
• Children: The total daily dosage for children may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day (0.11 mg/lb/day) or 8 mg per square meter of body surface (8 mg/m 2 )
• In small children for whom the calculation of the dosage based upon body size is important, it may be necessary to use cyproheptadine syrup to permit accurate dosage
• Age 2 to 6 years: The usual dose is 2 mg (1/2 tablet) two or three times a day, adjusted as necessary to the size and response of the patient
• The dose is not to exceed 12 mg a day
• Age 7 to 14 years: The usual dose is 4 mg (1 tablet) two or three times a day, adjusted as necessary to the size and response of the patient
• The dose is not to exceed 16 mg a day
• Adults: The total daily dose for
• Adults should not exceed 0.5 mg/kg/day (0.23 mg/lb/day)
• The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 to 16 mg, a day
• An occasional patient may require as much as 32 mg a day for adequate relief
• It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient

• Newborn or Premature
• Infants: This drug should not be used in newborn or premature
• Infants
• Nursing Mothers: Because of the higher risk of antihistamines for
• Infants generally, and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers
• Other Conditions: Hypersensitivity to cyproheptadine and other drugs of similar chemical structure
• Monoamine oxidase inhibitor therapy (see DRUG INTERACTIONS )
• Angle-closure glaucoma
• Stenosing peptic ulcer. …

Children - Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions, and death. Antihistamines may diminish mental alertness conversely particularly in the young child they may occasionally produce excitation. CNS Depressants - Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents. Activities Requiring Mental Alertness - Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. …

Adverse reactions which have been reported with the use of antihistamines are as follows: Central Nervous System: Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Integumentary: Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity. Special Senses: Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus. Cardiovascular: Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock. …

PREGNANCY Pregnancy Category B: Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine. Cyproheptadine has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose. …

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation, especially in children. Also, atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing, etc.) as well as gastrointestinal symptoms may occur. If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac. If patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or 1/2 isotonic saline is the lavage of choice. Precautions against aspiration must be taken, especially in infants and children. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.