CYPROHEPTADINE HYDROCHLORIDE (Page 2 of 2)

OVERDOSAGE

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation especially in pediatric patients. Also, atropine-like signs and symptoms (dry-mouth; fixed, dilated pupils; flushing etc.) as well as gastrointestinal symptoms may occur.

the patient should be induced to vomit with syrup of ipecac. If vomiting has not occurred spontaneously,

perform gastric lavage followed by activated charcoal. Isotonic or 1⁄2 isotonic saline is the lavage of choice. Precautions against aspiration must be taken especially in infants and children. If patient is unable to vomit,

When life threatening CNS signs and symptoms are present, intravenous physostigmine salicylate may be considered. Dosage and frequency of administration are dependent on age, clinical response and recurrence after response. (See package circulars for physostigmine products.)

as milk of magnesia, by osmosis draw water into the bowel and, therefore, are valuable, for their action in rapid dilution of bowel content. Saline cathartics,

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

The oral LD of Cyproheptadine is 123 mg/kg, and 295 mg/kg in the mouse and rat, respectively. 50

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.

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). Pediatric Patients:
Age 2 to 6 years:

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.

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. Age 7 to 14 years:

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. Adults:

HOW SUPPLIED

NDC:68151-2506-0 in a PACKAGE of 1 TABLETS

Cyproheptadine 4 MG TAB

Label ImageLabel Image
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2506(NDC:60258-850)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE) CYPROHEPTADINE HYDROCHLORIDE 4 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code CYP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-2506-0 1 TABLET in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040644 06/15/2010
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-2506)

Revised: 08/2016 Carilion Materials Management

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