Cyproheptadine Hydrochloride (Page 2 of 2)

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

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.

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.

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

If patient is unable to vomit , perform gastric lavage followed by activated charcoal. Isotonic or ½ isotonic saline is the lavage of choice. Precautions against aspiration must be taken especially in infants and children.

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.)

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

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

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

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 (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.

HOW SUPPLIED

Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white, round, flat-faced, beveled-edged tablets, bisected on one side with debossed “93” above the bisect and debossed “2929” below the bisect, plain on the other side, containing 4 mg of cyproheptadine HCl.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-1030-1 4 MG 30 Tablets in a Blister Pack WHITE 0093-2929

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured In India By:

EMCURE PHARMACEUTICALS LTD.

Hinjwadi, Pune, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

PACKAGE LABEL

Label Image for 53808-1030 4mg

Label Image for 4mgLabel Image for 4mg
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1030(NDC:0093-2929)
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 2929;93
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1030-1 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087056 11/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-1030)

Revised: 01/2015 State of Florida DOH Central Pharmacy

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