FDA records indicate that there are no current recalls for this drug.
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Cyproheptadine Syrup Recall
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Questions & Answers
Side Effects & Adverse Reactions
Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions and death.
Antihistamines may diminish mental alertness; conversely, particularly in the young child, they may occasionally produce excitation.
Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.
Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery.
Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
Amelioration of allergic reactions to blood or plasma
Cold urticaria
Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
History
There is currently no drug history available for this drug.
Other Information
Each 5 mL (one teaspoonful) contains: Cyproheptadine hydrochloride 2 mg. Alcohol 5%.
Inactive ingredients: citric acid, D&C Yellow No.10, peppermint flavor, purified water, sodium benzoate, sodium citrate and sucrose.
Cyproheptadine hydrochloride is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a white to slightly yellowish, crystalline solid, with a molecular weight of 350.88, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform and practically insoluble in ether. It is the sesquihydrate of 4-(5H-Dibenzo [a,d] cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21N • HCl and the structural formula of the anhydrous salt is:
Sources
Cyproheptadine Syrup Manufacturers
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Pharmaceutical Associates, Inc.
Cyproheptadine Syrup | Pharmaceutical Associates, Inc.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
Although intended primarily for administration to children, the oral solution is also used for administration to adults who cannot swallow tablets.
ChildrenThe total daily dosage for children may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day (0.11 mg/lb/day) or 8 mg per square meter of body surface (8 mg/m2).
Age 2 to 6 yearsThe usual dose is 2 mg (one teaspoonful) 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 yearsThe usual dose is 4 mg (two teaspoonfuls) 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.
AdultsThe total daily dose for adults should not exceed 0.5 mg/kg/day (0.23 mg/lb/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 (two teaspoonfuls) three times a day and adjusted according to the size and response of the patient.
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