CYPROHEPTADINE

Product Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form:

NDC: 62135-949

Application: ANDA203191

Effective: 20231005

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 DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Although intended primarily for administration to children, the syrup is also used for administration to adults who cannot swallow tablets. 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 ). Age 2 to 6 years: The usual dose is 2 mg (one teaspoonful) 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 (two teaspoonsful) 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 (two teaspoonsful) three times a day and adjusted according to the size and response of the patient.

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

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. 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. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.

ADVERSE REACTIONS 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. Hematologic: Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. Digestive System: Dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice. Genitourinary: Urinary frequency, difficult urination, urinary retention, early menses. Respiratory: Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Miscellaneous: Fatigue, chills, headache, increased appetite/weight gain.