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.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 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 mg to 20 mg a day, with the majority of patients requiring 12 mg 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 supplied as white, round, compressed tablets, debossed “cor ” above the bisect and “150 ” below the bisect and the other side is plain.
They are supplied as follows:
Bottles of 100: NDC 0115-1757-01
Bottles of 1000: NDC 0115-1757-03
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Product of Italy
Rev. 05-2019-01
PRINCIPAL DISPLAY PANEL
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Labeler — Amneal Pharmaceuticals of New York LLC (123797875) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Amneal Pharmaceuticals Private Limited | 650762060 | analysis (0115-1757), label (0115-1757), manufacture (0115-1757), pack (0115-1757) |
Revised: 12/2023 Amneal Pharmaceuticals of New York LLC
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