CLENBUTEROL – base-line

Description

1 tablet of 40 µg contains:

• Active substance: Clenbuterol hydrochloride 0.04 mg.

• Excipients: Magnesium stearate, Ludipress™ (lactose, povidone, crospovidone).

DESCRIPTION OF THE PREPARATION

20 µg Tablets: Brown tablets, square-shaped, with flat upper and lower surfaces and beveled edges. One side features a dividing line and the imprint “BP”, and the other side features the imprint “20”. The lateral surface has rounded edges.

40 µg Tablets: White or white with a yellowish tint tablets, square-shaped, with flat upper and lower surfaces and beveled edges. One side features a dividing line and the imprint “BP”, and the other side features the imprint “40”. The lateral surface has rounded edges.

PHARMACOLOGICAL PROPERTIES

Long-acting bronchodilator. It stimulates beta-2 adrenergic receptors, relaxing the bronchial musculature. It inhibits the release of mediators from mast cells that cause bronchospasm and bronchial inflammation. It reduces edema and stasis phenomena in the bronchi and improves mucociliary clearance. It manifests tocolytic action: it reduces the tone and contractile activity of the uterus.

THERAPEUTIC INDICATIONS

Bronchial asthma, pulmonary diseases with broncho-obstructive syndrome, including chronic obstructive bronchitis and pulmonary emphysema.

DOSAGE AND METHOD OF ADMINISTRATION

Adults and children over 12 years: 10-20 µg twice a day; in severe bronchospasm — up to 80 µg per day. Maintenance dose: 10 µg twice a day. Children: Administered in reduced doses, depending on age, twice a day.

ADVERSE REACTIONS

• Nervous system disorders: Tremor of the fingers/hands at the start of treatment, insomnia, restlessness, headache.

• Cardiac disorders: Extrasystoles, tachycardia.

• Vascular disorders: Arterial hypotension.

• Gastrointestinal disorders: Xerostomia (dry mouth), nausea.

• Skin and subcutaneous tissue disorders: Allergic skin reactions.

CONTRAINDICATIONS

Hypersensitivity to clenbuterol, hyperthyroidism, idiopathic hypertrophic subvalvular aortic stenosis, tachycardia, tachyarrhythmia, acute myocardial infarction, pregnancy in the first trimester, and the prenatal period.

OVERDOSE

• Symptoms: Tremor of the limbs, restlessness, tachycardia.

• Treatment: Dose reduction, symptomatic treatment.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Clenbuterol tablets contain lactose. Patients with rare hereditary conditions of galactose intolerance, lactase deficiency (Lapp), or glucose-galactose malabsorption syndrome should not use this medicine.

Clenbuterol 20 µg tablets contain the azo dye FD&C Yellow no. 5 (tartrazine, E 102), which may cause allergic reactions.

Administration during pregnancy and breastfeeding:

• Administration is contraindicated during the first trimester of pregnancy.

• Do not administer during the prenatal period (just before birth), as clenbuterol relaxes the myometrium and inhibits labor.

Influence on the ability to drive vehicles or use machines: The preparation does not influence the ability to drive motor vehicles or maneuver machinery.