CYPROHEPTADINE HYDROCHLORIDE
- 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.
Each tablet contains 4 mg of cyproheptadine hydrochloride.
Pediatric Patients
Age 2 to 6 years
The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m ).
The usual dose is 2 mg (½ 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. 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.
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
Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, 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.
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
- Pediatric Patients
Overdosage of antihistamines, particularly in infants and young children, may produce hallucinations, central nervous system depression, convulsions, respiratory and cardiac arrest, 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 (see PRECAUTIONS, Geriatric Use).
PRECAUTIONS
- 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