Peritol^® (Tablets, Syrup) Instructions for Use

ATC Code

R06AX02 (Cyproheptadine)

Active Substance

Cyproheptadine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H₁-receptor blocker with antiserotonin activity

Pharmacotherapeutic Group

H1 histamine receptor blocker

Pharmacological Action

Cyproheptadine is an active antagonist of histamine, acetylcholine, and serotonin.

Peritol^® prevents the development and alleviates the course of allergic reactions.

In addition to its antiallergic effect, it has antipruritic, antiexudative, anticholinergic, and sedative effects.

The drug stimulates appetite; it blocks the hypersecretion of somatotropin in acromegaly and the secretion of ACTH in Cushing’s syndrome.

Pharmacokinetics

When taken orally, it is rapidly and well absorbed from the gastrointestinal tract.

C_max in the blood is reached within the first 2 hours; the therapeutic concentration level is maintained for 4-6 hours.

It is well distributed in the body, including the CNS.

Penetration of the drug through the placental barrier and its excretion in breast milk has not been confirmed.

Cyproheptadine is metabolized in the liver.

After a single oral dose of 4 mg, 2-20% is excreted through the intestines, and at least 40% of the administered dose is excreted in the urine, mainly in the form of conjugates with glucuronic acid.

Elimination of the drug is reduced in renal failure.

Indications

• Allergic diseases: urticaria, hay fever, serum sickness, angioneurotic edema (Quincke’s edema);
• Skin diseases: contact dermatitis and toxicoderma, neurodermatitis, eczema;
• Vascular headaches (migraine, histamine headache);
• Vasomotor rhinitis;
• Allergic reactions to medication intake, blood transfusion, administration of radiopaque substances;
• Anorexia of various origins.

ICD codes

Dosage Regimen

Tablets

Taking into account the sedative effect characteristic of the beginning of treatment, the first dose of Peritol^® is recommended to be taken after dinner.

The maximum daily dose is 32 mg.

For adults the usual daily dose is 12 mg (1 tablet 3 times).

For chronic urticaria – 6 mg/day (1/2 tablet 3 times).

For an acute migraine attack – 1 tablet.

If the headache does not subside, take another tablet after 30 minutes.

The total dose taken within 4-6 hours should not exceed 8 mg.

For maintenance therapy, 1 tablet (4 mg) 3 times/day is usually sufficient.

For anorexia – 1 tablet (4 mg) 3 times/day.

Children under 2 years should not be prescribed Peritol^®.

Children aged 2 to 3 years – the dose is set at 0.25 mg/kg of body weight per day.

Children aged 3 to 6 years – 4-6 mg/day (1/2 tablet 2 or 3 times/day).

Maximum dose – 12 mg/day.

Children aged 7 to 14 years – 8-12 mg/day (1 tablet 2 or 3 times/day).

Maximum dose – 16 mg/day.

Children with anorexia aged 3 to 6 years – 6 mg/day (1/2 tablet 3 times/day).

The dose can be increased to a maximum of 8 mg/day.

Syrup

Taking into account the sedative effect characteristic of the beginning of treatment, the first dose of Peritol^® is recommended to be taken after dinner.

Children aged 6 to 24 months Peritol^® is prescribed at a dose of 0.4 mg/kg of body weight per day.

For children aged 2 to 6 years the daily dose is 6 mg/day (5 ml of syrup 3 times), maximum daily dose 8 mg.

Children suffering from anorexia are prescribed from 6-8 mg/day.

Children aged 7 to 14 years Peritol^® is prescribed at a dose of 12 mg/day (10 ml of syrup 3 times/day).

For adults the usual daily dose of Peritol^® for adults is 12 mg (10 ml of syrup 3 times/day).

The maximum daily dose for adults can be 32 mg (80 ml of syrup).

For the treatment of chronic urticaria, 6 mg/day (5 ml of syrup 3 times/day) is prescribed.

For the treatment of anorexia, Peritol^® is prescribed at 12 mg/day (10 ml of syrup 3 times/day).

For an acute migraine attack, it is recommended to take 4 mg of Peritol^® once (10 ml of syrup); if there is no effect, the same dose is repeated after 30 minutes, but within 4-6 hours the dose of the drug should not exceed 8 mg (20 ml of syrup).

For maintenance therapy, 4 mg (10 ml of syrup) 3 times/day is usually prescribed.

The dose of Peritol^® for the treatment of patients with impaired liver function should be reduced.

Elderly patients should be systematically monitored during treatment with Peritol^®.

Adverse Reactions

From the CNS drowsiness, dizziness, headache, anxiety, tremor, ataxia, visual hallucinations.

From the gastrointestinal tract dry mouth, nausea, vomiting, diarrhea.

From the cardiovascular system hypotension, tachycardia.

From the hematopoietic system hemolytic anemia, leukopenia, agranulocytosis.

Allergic reactions angioedema, urticaria, exanthema, photosensitivity.

Contraindications

• Pregnancy;
• Lactation period;
• Closed-angle glaucoma;
• Benign prostatic hyperplasia, urinary retention;
• Predisposition to edema;
• Hypersensitivity to the drug;
• Concomitant use with MAO inhibitors;
• Children under 6 months of age.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and during the lactation (breastfeeding) period.

Use in Hepatic Impairment

The dose of Peritol^® for the treatment of patients with impaired liver function should be reduced.

Pediatric Use

Children under 6 months the drug is contraindicated.

Children aged 6 to 24 months Peritol^® is prescribed at a dose of 0.4 mg/kg of body weight per day.

For children aged 2 to 6 years the daily dose is 6 mg/day (5 ml of syrup 3 times), maximum daily dose 8 mg.

Children suffering from anorexia are prescribed from 6 mg to 8 mg of Peritol^® per day.

Children aged 7 to 14 years Peritol^® is prescribed at a dose of 12 mg/day (10 ml of syrup 3 times/day).

Geriatric Use

Elderly patients should be systematically monitored during treatment with Peritol^®.

Special Precautions

Treatment of the elderly and children requires special attention, as this group of patients is more sensitive to the side effects of antihistamines.

Caution should also be exercised when treating with Peritol^® in patients suffering from cardiovascular diseases, as well as in the presence of a history of bronchial asthma, hyperthyroidism, or arterial hypertension.

Consumption of alcoholic beverages during treatment with Peritol^® is contraindicated.

Effect on the ability to drive vehicles and operate machinery

Patients during treatment with Peritol^® should refrain from driving vehicles and operating machinery, as well as performing work associated with increased risk.

Overdose

Overdose of Peritol^® may be accompanied by both depression and excitation of the CNS, up to the development of convulsions and a fatal outcome, especially in infants and children.

Development of atropine-like effects and impaired gastrointestinal function is possible.

In children: mydriasis and fixed pupils, facial skin flushing, vascular collapse, coma.

In adults: lethargy, depression, coma, psychomotor agitation, convulsions; hyperthermia, skin flushing.

Treatment gastric lavage, activated charcoal; in the treatment of conscious patients, if vomiting does not occur spontaneously, it is induced with ipecac preparations.

If vomiting cannot be induced, gastric lavage is performed with an isotonic or semi-isotonic sodium chloride solution followed by the administration of activated charcoal.

Saline laxatives have a rapid effect by increasing osmotic pressure in the intestine and delaying the absorption of the drug.

In case of threatening symptoms of impaired function of the CNS and other organs, appropriate treatment should be carried out.

CNS stimulants, as well as vasopressor agents to eliminate arterial hypotension, should be used.

Drug Interactions

Combined use of cyproheptadine with fluoxetine and other serotonin neuronal reuptake inhibitors leads to a decrease in the effectiveness of antidepressants.

Caffeine reduces the depressant effect of Peritol^® on the CNS.

Additive action may be observed with the combined use of Peritol^® with ethanol and other substances that depress the CNS (sedatives, hypnotics, anxiolytics).

Concomitant use of Peritol^® with other drugs that depress the CNS requires constant monitoring of the patient and discontinuation of the drug if necessary.

Concomitant use of Peritol^® with MAO inhibitors is contraindicated.

MAO inhibitors, as well as tricyclic antidepressants, can prolong and enhance the m-anticholinergic effect of cyproheptadine and enhance the depressant effect on the CNS.

Storage Conditions

Store the drug at a temperature of 15-25°C (59-77°F).

Keep out of reach of children!

Shelf Life

Shelf life – 3 years.

Dispensing Status

Dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.