Suprastin^® (Tablets, Solution) Instructions for Use

ATC Code

R06AC03 (Chloropyramine)

Active Substance

Chloropyramine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker, an ethylenediamine derivative. It has antiallergic and antipruritic effects. It causes a sedative effect. It possesses peripheral anticholinergic activity and moderate antispasmodic properties.

Pharmacokinetics

After oral administration, chloropyramine hydrochloride is rapidly and completely absorbed from the gastrointestinal tract. C_max in blood plasma is reached within the first 1-2 hours, and the therapeutic concentration level is maintained for 3-6 hours.

Regardless of the route of administration, it is well distributed in the body, including the CNS.

The binding of chloropyramine to plasma proteins is 7.9%. The binding peak is noted at pH 7.4.

It is metabolized in the liver.

It is excreted mainly by the kidneys in the form of metabolites. Elimination in children occurs faster than in adults.

Indications

Allergic diseases, including urticaria, serum sickness, angioneurotic edema, hay fever, allergic rhinopathy, allergic conjunctivitis.

Skin diseases, including contact dermatitis, acute and chronic eczema, drug rashes, pruritic dermatoses.

Itching from insect bites.

ICD codes

Dosage Regimen

Administer tablets orally with food. Take the solution orally, using the provided measuring device for accurate dosing.

For adults, the standard dose is 25 mg three to four times daily. Do not exceed the maximum daily dose of 150 mg.

For pediatric patients, adjust the dose based on age. For children aged 1 to 12 months, administer 6.25 mg (one quarter of a 25 mg tablet) two to three times daily. For children aged 1 to 6 years, administer 8.3 mg of the oral solution or 6.25 mg to 8.3 mg two to three times daily. For children aged 6 to 14 years, administer 12.5 mg (one half of a 25 mg tablet) two to three times daily.

For parenteral administration in a hospital setting, administer intramuscularly or by slow intravenous injection. The single dose for adults is 20 mg to 40 mg.

Adjust the dosage and frequency based on clinical response and tolerance. Reduce the dose or increase the dosing interval in patients with hepatic impairment.

Initiate therapy at the lower end of the dosage range for elderly patients and for all patients at increased risk of adverse effects. Monitor for excessive drowsiness or anticholinergic effects.

Limit the duration of therapy to the shortest period necessary for symptomatic relief. Re-evaluate the need for continued treatment periodically.

Adverse Reactions

From the CNS: lethargy, drowsiness, weakness, mild tremor, dizziness are possible. In children, some stimulating effect on the CNS may occur, manifested by anxiety, increased irritability, insomnia.

From the digestive system: dry mouth, nausea, vomiting, diarrhea or constipation are possible.

From the cardiovascular system: rarely – decreased blood pressure (more often in elderly patients), tachycardia, arrhythmia.

Allergic reactions: skin rash, itching are possible.

Other: rarely – difficulty urinating.

Contraindications

Glaucoma (for parenteral administration), benign prostatic hyperplasia, urinary retention (for parenteral administration), simultaneous use of MAO inhibitors (for parenteral administration), peptic ulcer in the acute phase (for parenteral administration), acute attack of bronchial asthma, pregnancy, lactation period, early childhood under 1 month, hypersensitivity to chloropyramine or other ethylenediamine derivatives.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Should be used with caution in hepatic insufficiency.

Pediatric Use

Contraindicated in early childhood under 1 month.

Use with caution in children due to the increased sensitivity of this category of patients to antihistamines.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Should be used with caution in elderly patients, in patients with hepatic insufficiency and/or heart disease.

Use with caution in children due to the increased sensitivity of this category of patients to antihistamines.

Oral administration should be used with particular caution in patients with angle-closure glaucoma, urinary retention, and prostatic hypertrophy.

When taken at night, Chloropyramine may exacerbate symptoms of reflux esophagitis.

Alcohol consumption should be avoided during treatment.

Effect on the ability to drive vehicles and operate machinery

During the initial, individually determined period of chloropyramine use, driving vehicles and engaging in other potentially hazardous activities requiring speed of psychomotor reactions are not permitted. During further treatment, the degree of restrictions is determined depending on treatment tolerance.

Drug Interactions

With simultaneous use, Chloropyramine potentiates the effects of anesthetics, hypnotics, tranquilizers, analgesics, MAO inhibitors, tricyclic antidepressants, atropine, and sympatholytics (such a combination requires caution).

With simultaneous use of chloropyramine and caffeine or phenamine, a decrease or elimination of the inhibitory effect of chloropyramine on the CNS is noted.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.