CYPROHEPTADINE HYDROCHLORIDE (Page 2 of 2)
DOSAGE AND ADMINISTRATION
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/m2).
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.
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.
HOW SUPPLIED
Cyproheptadine Hydrochloride Tablets USP are available as white to off white, flat-faced, bevel-edged, round shaped tablets, one side debossed with “CYP”, the other side bisected, containing 4 mg of Cyproheptadine HCl packaged in bottles of 100 tablets, NDC 0463-6080-01
PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required).
Store at 20° — 25° C (68° — 77° F) excursions permitted to 15° — 30° C (59° — 86° F) [see USP Controlled Room Temperature]
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Manufactured for: Cypress Pharmaceutical, Inc., Madison, MS 39110
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Labeler — C.O. Truxton, Inc. (011157559) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Stason Pharmaceuticals, Inc. | 807437553 | manufacture (0463-6080) |
Revised: 04/2014 C.O. Truxton, Inc.
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