Drug: Cyproheptadine

Cyproheptadine (cyproheptadine hydrochloride) HCl is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride (cyproheptadine (cyproheptadine hydrochloride) hydrochloride) is a white to slightly yellowish, crystalline solid, which is 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 and structural formula of the anhydrous salt is:
C21H21N•HCl..................MW: 350.89 Cyproheptadine (cyproheptadine hydrochloride) HCl is available in tablets for oral administration containing 4 mg of cyproheptadine hydrochloride (cyproheptadine (cyproheptadine hydrochloride) hydrochloride) . Each tablet also contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyoxyl (40) stearate, purified water, sodium starch glycolate, and stearic acid.

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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, hallucination, 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, heptatic 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. Read the Cyproheptadine (cyproheptadine hydrochloride) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Each Cyproheptadine HCl Tablet contains 4 mg of cyproheptadine hydrochloride (cyproheptadine (cyproheptadine hydrochloride) 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 (1/2 tablet) two or three times a day, adjusted as necessry 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.

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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. Last reviewed on RxList: 4/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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.

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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 (cyproheptadine hydrochloride) and other drugs of similar chemical structure: Monoamine oxidase inhibitor therapy (see PRECAUTIONS: DRUG INTERACTIONS)
Angle-closure glaucoma
Stenosing peptic ulcer
Symptomatic prostatic hypertrophy
Bladder neck obstruction
Pyloroduodenal obstruction
Elderly, debilitated patientsLast reviewed on RxList: 4/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 the patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or 1/2 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 (cyproheptadine hydrochloride) is 123 mg/kg, and 295 mg/kg in the mouse and rat, respectively.

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Cyproheptadine Hydrochloride (cyproheptadine (cyproheptadine hydrochloride) hydrochloride) Tablets 4 mg are white, round, scored, compressed tablets, debossed "Par 043" on one side. They are available in bottles of 100 (NDC 49884-043-01), and 1000 (NDC 49884-043-10). Store at controlled room temperature, 15° to 30°C (59° to 86°F), in a well-closed container. Manufactured by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977. Revised: 04/08. Last reviewed on RxList: 4/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Cyproheptadine (cyproheptadine hydrochloride) has an atropine-like action and, therefore, should be used with caution in patients with: History of bronchial asthma
Increased intraocular pressure
Hyperthyroidism
Cardiovascular disease
Hypertension Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenic studies have not been done with cyproheptadine (cyproheptadine hydrochloride) . Cyproheptadine (cyproheptadine hydrochloride) had no effect on fertility in a two-litter study in rats or a two generation study in mice at about 10 times the human dose. Cyproheptadine (cyproheptadine hydrochloride) did not produce chromosome damage in human lymphocytes or fibroblasts in-vitro; high doses (10-4M) were cytotoxic. Cyproheptadine (cyproheptadine hydrochloride) did not have any mutagenic effect in the Ames microbial mutagen test; concentrations of above 500 mcg/plate inhibited bacterial growth. Pregnancy Pregnancy Category B: Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine (cyproheptadine hydrochloride) . Cyproheptadine (cyproheptadine hydrochloride) has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose.Two studies in pregnant women, however, have not shown that cyproheptadine (cyproheptadine hydrochloride) increases the risk of abnormalities when administered during the first, second and third trimesters of pregnancy. No teratogenic effects were observed in any of the newborns. Nevertheless, because the studies in humans cannot rule out the possibility of harm, cyproheptadine (cyproheptadine hydrochloride) should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from cyproheptadine (cyproheptadine hydrochloride) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see CONTRAINDICATIONS). Pediatric Use Safety and effectiveness in pediatric patients below the age of two have not been established (see CONTRAINDICATIONS, Newborn or Premature Infants,and WARNINGS, Pediatric Patients). Geriatric Use Clinical studies of Cyproheptadine (cyproheptadine hydrochloride) HCl Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS, Activities Requiring Mental Alertness). Last reviewed on RxList: 4/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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