Cyproheptadine Hydrochloride - Cyproheptadine Hydrochloride solution prescribing information
INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
Each 5 mL of Cyproheptadine Hydrochloride Oral Solution contains 2 mg of Cyproheptadine hydrochloride.
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/m 2 ).
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 teaspoonsful) 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 teaspoonsful) three times a day and adjusted according to the size and response of the patient.
CONTRAINDICATIONS
Newborn or Premature Infants
This drug should not be used in newborn or premature infants.
Nursing Mothers
Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.
Other Conditions
Hypersensitivity to cyproheptadine and other drugs of similar chemical structure
Monoamine oxidase inhibitor therapy (see Drug Interactions )
Angle-closure glaucoma
Stenosing peptic ulcer
Symptomatic prostatic hypertrophy
Bladder neck obstruction
Pyloroduodenal obstruction
Elderly, debilitated patients
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: 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 Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088.
Drug Interactions
MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.
DESCRIPTION
Each 5 mL (one teaspoonful) contains: Cyproheptadine Hydrochloride 2 mg
Inactive Ingredients: Alcohol 5%, citric acid, D&C Yellow #10, flavors, purified water, sodium citrate, sorbic acid (0.1% as preservative) and sucrose.
Cyproheptadine HCl is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a white to slightly yellowish, crystalline solid, with a molecular weight of 350.89, 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 C 21 H 21 N∙HCl and the structural formula of the anhydrous salt is:
CLINICAL PHARMACOLOGY
Cyproheptadine is a serotonin and histamine antagonist with anticholinergic and sedative effects. Antiserotonin and antihistamine drugs appear to compete with serotonin and histamine, respectively, for receptor sites.
Pharmacokinetics and Metabolism
After a single 4 mg oral dose of 14 C-labeled cyproheptadine HCl in normal subjects, given as tablets or oral solution, 2-20% of the radioactivity was excreted in the stools. Only about 34% of the stool radioactivity was unchanged drug, corresponding to less than 5.7% of the dose. At least 40% of the administered radioactivity was excreted in the urine. No detectable amounts of unchanged drug were present in the urine of patients on chronic 12-20 mg daily doses of cyproheptadine oral solution. The principal metabolite found in human urine has been identified as a quaternary ammonium glucuronide conjugate of cyproheptadine. Elimination is diminished in renal insufficiency.
HOW SUPPLIED
Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL in a yellow, peppermint-flavored vehicle, is supplied in a 473 mL (16 FL. OZ.) bottle.
Store at 20-25°C (68-77°F). Excursion permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP.
| NDC#39328-544-16 | 473 mL (16 FL. OZ.) |
