Special Alerts:
[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.
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Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Treatment of cold urticaria.
Symptomatic relief of perennial (nonseasonal) and seasonal (e.g., hay fever) allergic rhinitis.
Management of nonallergic (vasomotor) rhinitis.
Management of allergic conjunctivitis caused by foods or inhaled allergens.
Management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Treatment of dermatographism.
Amelioration of allergic reactions to blood or plasma.
Adjunct to epinephrine and other standard measures for management of anaphylactic reactions after acute manifestations have been controlled.
Has been effective in some patients for the treatment of Cushing’s syndrome† secondary to pituitary disorders; however, in most patients, other therapy (e.g., surgery, radiation therapy) is preferred.
Has been effective for the management of inhibited male or female orgasm† (anorgasmy) induced by tricyclic antidepressants, MAO inhibitors, fluoxetine, or antipsychotic agents. However, consider the potential for interactions between these drugs and cyproheptadine. (See Interactions.)
Has been shown to stimulate appetite and weight gain in children and adults; however, few indications for clinical use. May be of some value in the treatment of anorexia nervosa†; may be more effective in nonbulimic patients than in those who are bulimic.
Reportedly has been effective in some patients for the management of vascular headaches† (e.g., migraine). Efficacy for prophylaxis of migraine not established in randomized controlled studies, but some experts consider the drug to be effective based on consensus and clinical experience.
Administer orally as tablets or oral solution.
Available as cyproheptadine hydrochloride; dosage expressed in terms of the salt.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Children 2–6 years of age: Usual dosage is 2 mg 2 or 3 times daily; adjust as needed based on the size and response of the patient, up to maximum of 12 mg daily. (See Pediatric Use under Cautions.)
Children 7–14 years of age: Usual dosage is 4 mg 2 or 3 times daily; adjust as needed based on the size and response of the patient, up to maximum of 16 mg daily.
Adolescents ≥15 years of age: Initially, 4 mg 3 times daily; adjust based on the size and response of the patient, up to 0.5 mg/kg daily. Dosage range: 4–20 mg daily; most patients require 12–16 mg daily.
Alternatively, children ≥2 years of age may receive 0.25 mg/kg or 8 mg/m2 daily in divided doses.
Adolescents ≥13 years of age: Dosage of 2 mg 4 times daily, increased gradually over a 3-week period to up to 8 mg 4 times daily, has been used.†
Initially, 4 mg 3 times daily; adjust as needed based on the size and response of the patient, up to 0.5 mg/kg daily.
Dosage range: 4–20 mg daily; most patients require 12–16 mg daily. Some patients may require up to 32 mg daily.
Initially, 8 mg daily in divided doses; gradually increase dosage to up to 24 mg daily in divided doses.†
Dosage of 2 mg 4 times daily, increased gradually over a 3-week period to up to 8 mg 4 times daily, has been used.†
Children 2–6 years of age: Maximum 12 mg daily.
Children 7–14 years of age: Maximum 16 mg daily.
Adolescents ≥15 years of age: Maximum 0.5 mg/kg daily.
Adolescents ≥13 years of age: Maximum 32 mg daily.†
Maximum 0.5 mg/kg daily.
Maximum 24 mg daily.†
Maximum 32 mg daily.†
Select dosage with caution, starting at the lower end of the usual dosage range. (See Geriatric Use under Cautions.)
Last Updated: November 01, 2008