Cyproheptadine Syrup label

Cyproheptadine Syrup

Cyproheptadine Syrup Recall

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Side Effects & Adverse Reactions

Children

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.

CNS Depressants

Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

Activities Requiring Mental Alertness

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.

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:

Chemical Structure

Cyproheptadine Syrup Manufacturers

  • Pharmaceutical Associates, Inc.
    Cyproheptadine Syrup | Pharmaceutical Associates, Inc.
    No Recall

    Cyproheptadine Syrup | 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.

    Children

    The 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 years

    The 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 years

    The 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.

    Adults

    The 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.