Clenbuterol Sopharma (Tablets, Syrup) Instructions for Use

ATC Code

R03CC13 (Clenbuterol)

Active Substance

Clenbuterol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Bronchodilator drug – beta₂-adrenergic agonist

Pharmacotherapeutic Group

Selective beta2-adrenomimetic

Pharmacological Action

Bronchodilator, is a long-acting β₂-adrenergic receptor stimulant.

The bronchodilatory effect is due to a direct relaxing effect on the bronchial muscles.

It may somewhat increase the heart rate.

It also has a tocolytic effect.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract.

It is metabolized to a small extent in the liver, resulting in the formation of 8 metabolites that do not possess pharmacological activity.

Elimination from plasma occurs in two phases.

The T_1/2 of the first phase is 1 hour, and of the second phase — 34 hours.

It is mostly excreted from the body unchanged by the kidneys, with 87% of the administered dose excreted within 168 hours.

Indications

COPD, bronchial obstruction syndrome, bronchial asthma.

ICD codes

Dosage Regimen

Administer orally with water.

Determine the individual dose based on the clinical situation, indication, and patient age.

For adults, the typical dose is 20 mcg (0.02 mg) twice daily.

Increase the dose gradually if necessary, under strict medical supervision.

The maximum single dose for adults should not exceed 40 mcg (0.04 mg).

The maximum daily dose for adults should not exceed 80 mcg (0.08 mg).

For pediatric patients, calculate the dose based on body weight.

The typical pediatric dose is 1 mcg per kg of body weight per day, divided into two or three doses.

Do not exceed a daily dose of 40 mcg (0.04 mg) in children.

Use the syrup formulation for precise dosing in children and patients with difficulty swallowing.

Adhere strictly to the prescribed administration schedule.

The duration of therapy is determined by the treating physician based on therapeutic response.

Monitor for adverse effects, particularly tachycardia and tremor, when initiating or increasing the dose.

Do not abruptly discontinue treatment; taper the dose under medical guidance to avoid rebound bronchospasm.

Adverse Reactions

From the cardiovascular system: palpitations, tachycardia, decrease or (more often) increase in blood pressure.

From the nervous system: feeling of fear, mental disorders, hyperkinesis, sleep disturbance, headache, facial redness, sweating, tremor and restlessness, dizziness; in patients with Parkinson’s disease, increased tremor and muscle rigidity may be observed.

From the digestive system: dry mouth, nausea.

From metabolism: hyperglycemia is possible in patients with diabetes mellitus.

From the musculoskeletal system: urinary retention associated with spasm of the renal vessels and the bladder sphincter.

Allergic reactions: skin rash, urticaria.

Other: hypokalemia.

Contraindications

Hypersensitivity to clenbuterol; thyrotoxicosis, tachyarrhythmia; hypertrophic obstructive cardiomyopathy; myocardial infarction (acute phase), severe coronary artery disease; pregnancy (I and III trimesters), lactation period (breastfeeding); pediatric age – depending on the dosage form.

With caution hyperthyroidism, history of myocardial infarction, coronary artery disease, arterial hypertension, prostatic hypertrophy, diabetes mellitus, II trimester of pregnancy.

Use in Pregnancy and Lactation

The use is contraindicated in the I and III trimesters of pregnancy.

Use in the II trimester of pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the clenbuterol drug labels regarding contraindications for the use of specific clenbuterol dosage forms in children of different ages. The dose for children is calculated depending on age and body weight.

Special Precautions

When treating patients with diabetes mellitus, periodic monitoring of blood glucose levels is necessary.

The use of clenbuterol may lead to an increase in body weight due to the presence of an anabolic effect, and when prescribed to athletes, Clenbuterol may cause a positive result in doping control.

During treatment with clenbuterol, the development of resistance and a “rebound” syndrome is possible.

Effect on the ability to drive vehicles and operate machinery

Due to the possibility of tremor, dizziness, and weakness, during treatment with clenbuterol it is necessary to refrain from performing potentially hazardous activities that require special attention and quick reactions (driving a car and other vehicles, working with moving mechanisms).

Drug Interactions

Beta-blockers are pharmacological antagonists of clenbuterol and may eliminate its effect.

Clenbuterol reduces the effect of hypoglycemic agents.

It increases the risk of impaired intracardiac conduction when co-administered with MAO inhibitors and theophylline.

It increases the toxicity of cardiac glycosides and increases the risk of arrhythmia.

In combination with sympathomimetic agents, mutual enhancement of toxicity occurs.

Clenbuterol reduces the effect of hypoglycemic drugs.

Clenbuterol reduces the effectiveness of antihypertensive drugs.

The effect of clenbuterol is potentiated by tricyclic antidepressants, beta-adrenergic agonists, and anticholinergic agents.

Halothane and other halogenated hydrocarbon anesthetic agents, as well as cyclopropane, may potentiate the proarrhythmic effect of clenbuterol.

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

Rx Only

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.