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Indications:

Tonic and appetizer

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 Stenosing peptic ulcer Symptomatic prostatic hypertrophy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients.

Adverse reactions:

Slight to moderate drowsiness, fatigue; dry mouth, GI upsets, nausea; appetite increase, wt gain and impaired alertness.

Interactions:

Masks ototoxicity produced by aminoglycosides and antibiotics. Potentially Fatal: Potentiate CNS depressant actions of alcohol, barbiturates, sedatives, opioid analgesics and neuroleptics. Additive antimuscarinic action with MAOIs, atropine and tricyclic antidepressants.

Warnings:

General: Cyproheptadine has an atropine-like action and, therefore, should be used with caution in patients with: History of bronchial asthma Increased intraocular pressure Hyperthyroidism Cardiovascular disease Hypertension Information for Patients: Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation. Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Drug Interactions: MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term carcinogenic studies have not been done with Cyproheptadine. Cyproheptadine had no effect on fertility in a two-litter study in rats or a two generation study in mice at about 10 times the human dose. Cyproheptadine did not produce chromosome damage in human lymphocytes or fibroblasts in vitro; high doses (10-4M) were cytotoxic. Cyproheptadine did not have any mutagenic effect in the Ames microbial mutagen test; concentrations of above 500 mcg/plate inhibited bacterial growth. 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. Two studies in pregnant women, however, have not shown that Cyproheptadine increases the risk of abnormalities when administered during the first, second and third trimesters of pregnancy. No teratogenic effects were observed in any of the newborns. Nevertheless, because the studies in humans cannot rule out the possibility of harm, Cyproheptadine should be used during pregnancy only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Cyproheptadine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother . Pediatric Use: Safety and effectiveness in pediatric patients below the age of two have not been established. Geriatric Use: Clinical studies of Cyproheptadine HCI tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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