Finished product reference
Cyproheptadine Hydrochloride
Solution · Oral · 2 mg/5mL · 150 mL
- List code
- 52811
Indications
INDICATIONS AND USAGE: 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 and administration (summary)
DOSAGE AND ADMINISTRATION: 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.
Contraindications
CONTRAINDICATIONS 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.
Warnings and precautions
WARNINGS 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.
Pregnancy
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.
Storage and supply
HOW SUPPLIED: Each tablet contains 4 mg of cyproheptadine hydrochloride, are white to off-white, round, flat faced, beveled edge tablets debossed with “CE 73” on one side and a score on other side. They are supplied as follows: bottles of 90 count, NDC 62135-236-90. Dispensing Information: Dispense in tight containers as defined by the USP/NF.
Source: Cyproheptadine Hydrochloride (Cyproheptadine Hydrochloride) — US FDA prescribing information, 2023-01-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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