Cyproheptadine Hydrochloride (Page 2 of 2)

Integumentary

Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity.

Special Senses

Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus.

Cardiovascular

Hypotension, palpitation, tachycardia, extra systoles, anaphylactic shock.

Hematologic

Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia.

Digestive Sys tem

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 maybe 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 LD50 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 to off-white round convex tablets, engraved IT above bisect and 68 below bisect on one side with other side is plain, containing 4 mg of cyproheptadine HCl packaged in bottles of 100 tablets (NDC 10135-0638-01 and 1000 tablets (NDC 10135-0638-10).

PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).

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

Distributed By:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720

Rev. 1-18TG

PRINCIPAL DISPLAY PANEL

NDC 10135-0638-01
MARLEX
PHARMACEUTICALS, INC.
Cyproheptadine
Hydrochloride
Tables, USP
4 mg
Rx Only
100 Tablets

NDC 10135-0638-01
MARLEX
PHARMACEUTICALS, INC.
Cyproheptadine
Hydrochloride
Tables, USP
4 mg
Rx Only
100 Tablets
(click image for full-size original)
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-638
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 CORN
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (Round) Size 7mm
Flavor Imprint Code IT;56
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-638-01 100 TABLET in 1 BOTTLE None
2 NDC:10135-638-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207555 01/01/2018
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 01/2018 Marlex Pharmaceuticals Inc

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