Periactin (Cyproheptadine HCl)

PERIACTIN®

Johnson & Johnson Merck

Cyproheptadine HCl

Antihistaminic

Action And Clinical Pharmacology: Cyproheptadine is a serotonin and histamine antagonist with anticholinergic and sedative effects recommended for the symptomatic treatment of allergic disorders and pruritic dermatoses, as well as certain types of vascular headaches.

Indications And Clinical Uses: Cyproheptadine has a wide range of antiallergic and antipruritic activity and can be used successfully in the treatment of acute and chronic allergies and pruritus, such as: dermatitis, including neurodermatitis and neurodermatitis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild local allergic reactions to insect bites, hay fever and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, urticaria, including “cold urticaria”, angioneurotic edema, drug and serum reactions, anogenital pruritus and pruritus of chickenpox, as well as certain types of vascular headaches.

Cyproheptadine may be used as therapy for anaphylactic reactions, adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Cyproheptadine has been reported to have a beneficial effect in many patients diagnosed as having vascular types of headaches, such as migraine and histamine cephalalgia. Patients who have not been able to obtain adequate relief from any other agent have reported amelioration of symptoms with cyproheptadine. The characteristic headache and feeling of malaise may disappear within an hour or two after the first dose.

Contra-Indications: Although peripheral anticholinergic effects are minimal with recommended doses, as with all anticholinergic agents, cyproheptadine is contraindicated in patients with angle-closure glaucoma, in patients predisposed to urinary retention, and in patients with stenosing peptic ulcer or pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder neck obstruction.

It is also contraindicated with concurrent MAO inhibitor therapy and in patients allergic to cyproheptadine.

Geriatrics: This drug should not be prescribed for elderly debilitated patients.

Lactation and Children: Antihistamines should not be used in nursing mothers, or in newborn or premature infants.

In an acute asthmatic attack, cyproheptadine should not be used.

Precautions: Antihistamines should not be used to treat lower respiratory tract symptoms including those of acute asthma.

Children: Safety and effectiveness in children below the age of 2 years have not been established.

Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, CNS depression, convulsions and death.

Antihistamines may diminish mental alertness; conversely, particularly in the young child, they may occasionally produce excitation.

Occupational Hazards: This drug may impair alertness in some patients. 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.

Although not reported with cyproheptadine, rarely, prolonged therapy with antihistamines may cause blood dyscrasias.

Cyproheptadine 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.

Pregnancy: The use of any drug in pregnancy, lactation, or in women of childbearing age requires that the potential benefits be weighed against its possible hazards to mother and child. Lactation may be inhibited.

The safe use of this drug in pregnancy has not been established.

Lactation: 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, 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).

Drug Interactions: MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines.

Patients using this drug should be cautioned against the ingestion of alcohol and other CNS depressants, such as: hypnotics, sedatives, tranquilizers, antianxiety agents. Additive effects may occur.

Adverse Reactions: The adverse reactions that appear frequently are drowsiness and somnolence. Many patients who initially complain of drowsiness may no longer do so after the first 3 or 4 days of continuous administration. Drowsiness is often a desirable effect in patients with dermatitis and pruritus, since it tends to decrease the level of perception and may also decrease emotional tension caused by the disease.

Adverse reactions which have been reported with the use of antihistamines are as follows: CNS: sedation, sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria and faintness.

Integumentary: allergic manifestation of rash and edema, excessive perspiration, urticaria and photosensitivity.

Special Senses: acute labyrinthitis, blurred vision, diplopia, vertigo and tinnitus.

Cardiovascular: hypotension, palpitation, tachycardia, extrasystoles and anaphylactic shock.

Hematologic: hemolytic anemia, leukopenia, agranulocytosis and thrombocytopenia.

Digestive System: dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation and jaundice.

Genitourinary: frequency of micturition, difficult micturition, urinary retention and early menses.

Respiratory: dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing and nasal stuffiness.

Miscellaneous: fatigue, chills and headache.

Symptoms And Treatment Of Overdose: Symptoms: Antihistamine overdosage reactions may vary from CNS depression or stimulation to convulsions and death, especially in infants and children. Also, atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing, etc.); gastrointestinal symptoms may occur as well.

Treatment: If vomiting has not occurred spontaneously the patient should be induced to vomit if conscious 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, i.v. 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, such as milk of magnesia, draw water into the bowel by osmosis 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.

Dosage And Administration: Allergies and Pruritus: Dosage must be individualized. Since the antiallergic effect of a single dose usually lasts 4 to 6 hours, the daily requirement should be given in divided doses 3 times a day or as often as necessary to provide continuous relief.

There is no recommended dosage schedule for children under 2 years of age.

Although intended primarily for administration to children, the syrup is also useful for administration to adults who cannot swallow tablets.

Adults: 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 the dosage be initiated with 4 mg 3 times a day and adjusted according to the size and response of the patient. The dosage is not to exceed 32 mg a day.

Children (7 to 14 years): It is suggested that dosage be initiated with 2 mg 3 or 4 times a day depending on the age of the patient. The usual maintenance dosage is 4 mg 2 or 3 times a day. This dosage may be adjusted as necessary according to the size and response of the patient. If an additional daily dose is required, it should be taken preferably at bedtime. The dosage is not to exceed 16 mg a day.

Children (2 to 6 years): It is suggested that dosage be initiated with 2 mg 2 or 3 times a day, every 8 to 12 hours, and adjusted as necessary according to the size and response of the patient. If an additional daily dose is required, it should be taken preferably at bedtime. The dosage is not to exceed 12 mg a day.

Caution: One teaspoonful is assumed to be equivalent to 5 mL. Attention is called to the potential error in the use of household units. A teaspoon may hold from 4 to 7 mL. It is recommended therefore, that a medicinal spoon (5 mL) or calibrated medicine glass be used.

Migraine and Vascular Types of Headache: Adults: For prophylaxis or therapy, recommended dosage is 4 mg immediately, to be repeated in 1/2 hour if necessary, not to exceed 8 mg in a 4- to 6-hour period. Relief usually is obtained in responsive patients with 8 mg and maintained by 4 mg every 4 to 6 hours.

Availability And Storage: Syrup: Each 5 mL of clear, yellow, syrupy liquid contains: cyproheptadine HCl 2 mg. Nonmedicinal ingredients: alcohol 5%, flavors, glycerin, purified water, quinoline yellow, sodium hydroxide, sorbic acid as preservative and sucrose. Gluten-, lactose- and tartrazine-free. Bottles of 250 and 500 mL. Store syrup between 15 and 30°C. Do not expose to temperatures below -20°C. Keep container tightly closed, protected from sunlight.

Tablets: Each round, white, flat, compressed tablet, with bevelled edge, scored on one side with MSD 62 on the other, contains: cyproheptadine HCl 4 mg. Nonmedicinal ingredients: calcium phosphate dibasic, cornstarch, lactose and magnesium stearate. Gluten- and tartrazine-free. Bottles of 45, 100 and 500. Store between 15 and 30°C. Keep container tightly closed, protected from sunlight. (Shown in Product Recognition Section)

PERIACTIN® Johnson & Johnson • Merck Cyproheptadine HCl Antihistaminic

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