Adverse reactions which have been reported with the use of antihistamines are as follows:
Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness.
Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity.
Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus.
Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock.
Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia.
Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice.
Urinary frequency, difficult urination, urinary retention, early menses.
Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
Fatigue, chills, headache, increased appetite/weight gain.
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 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).
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.
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.
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.
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
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
Label Image for 53808-1030 4mgLabel Image for 4mg
| CYPROHEPTADINE HYDROCHLORIDE |
cyproheptadine hydrochloride tablet
|Labeler — State of Florida DOH Central Pharmacy (829348114)|
|State of Florida DOH Central Pharmacy||829348114||repack (53808-1030)|
Revised: 01/2015 State of Florida DOH Central Pharmacy
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