CLENBUTEROL TABLETS INSTRUCTIONS

Clenbuterol Sofarma - instructions for use

Buy Clenbuterol


INSTRUCTION on medical use of the drug

Registration number

Trade name:

Clenbuterol Sofarma.

International non-proprietary name:

Clenbuterol

Dosage form:

Tablets

Composition per 1 tablet:

Active substance: 0.02 mg clenbuterol hydrochloride

Excipients: lactose monohydrate - 70.00 mg, wheat starch - 31.48 mg, microcrystalline cellulose - 48.50 mg, colloidal silicon dioxide - 2.00 mg, magnesium stearate - 2.00 mg, povidone (povidone K25) - 6.0 mg.

Description:

Round flat tablets with a chamfer and a dividing groove on one side, white or almost white in color.

Pharmacotherapeutic group:

Bronchodilator - beta -2-adrenomimetic selective agent

ATX code

[R03CC13]

Pharmacological properties

Pharmacological action

Selective beta-2-adrenergic stimulant, has bronchodilator and secretolytic action. Excites p2 - adrenoreceptors, stimulates adenylate cyclase, increases the content of cyclic adenosine monophosphate (cAMP) in cells. The latter has an effect on the protein kinase system, as a result of which myosin is deprived of the ability to connect to actin and bronchodilation occurs. Inhibits the release of mediators from mast cells that cause bronchospasm and bronchial inflammation.

Prevents bronchospasm caused by histamine, serotonin, and acetylcholine. Reduces edema or congestion in the bronchi, improves mucociliary clearance. Secretolytic effect of the drug is associated with a decrease in the viscosity of sputum and facilitates its excretion. Causes dilation of cerebral vessels and skeletal muscles. It has a tocolytic effect. Side effects are associated with its ability, albeit weakly, to excite p1 - adrenoreceptors of the heart, resulting in a positive in- and chronotropic effect.

It has a slight anabolic effect, can increase body temperature.

The maximum effect of the drug is observed in 2-3 hours and lasts up to 6-8 hours.

Pharmacokinetics

It is rapidly and completely absorbed in the gastrointestinal tract. Metabolized to a small extent in the liver, resulting in the formation of 8 metabolites that have no pharmacological activity. Excretion from plasma takes place in two phases. The half-life of the first phase is 1 hour, the second - 34 hours. Most of the body is excreted unchanged through the kidneys, with 87% of the dose excreted within 168 hours.

Indications for use:

Chronic obstructive pulmonary disease, bronchoobstructive syndrome, bronchial asthma.

Contraindications:

Hypersensitivity to clenbuterol or to the excipients of the drug, thyrotoxicosis, tachyarrhythmia; hypertrophic obstructive cardiomyopathy; myocardial infarction (acute phase), severe ischemic heart disease, lactase insufficiency, lactose intolerance, glucose-galactose malabsorption, children under 6 years of age, pregnancy (I and III trimester).

With caution:

hyperthyroidism, myocardial infarction in the anamnesis, ischemic heart disease, arterial hypertension, prostatic hypertrophy, diabetes mellitus, II trimester of pregnancy.

Pregnancy and lactation period

It is necessary to avoid administration of the drug in the first 3 months of pregnancy due to possible adverse effect on fetal development. Its administration is not recommended in the last months of pregnancy and during labor due to the presence of tocolytic action of the drug and possible suppression of uterine tone. There have been no special clinical studies of the drug penetration into breast milk, therefore its administration to nursing women is not recommended.

Method of administration and dosage

Inside.

Adults: 0.02 mg (one tablet) 2 times a day (morning and evening). Maintenance dose of 0.01 mg (1/2 tablet) 2 times a day. In more severe conditions in the first days prescribe 0.04 mg (two tablets) 2 times a day (morning and evening). After improvement of the patient's condition, the dose of the drug should be reduced.

Children: from 6 to 12 years - 0.01 mg (1/2 tablet) 2 times a day (morning and evening). Children over 12 years of age - 0.01 mg (1/2 tablet) 2-3 times a day or 0.02 mg (1 tablet) 2 times a day (morning and evening).

Side effects

Central nervous system - fear, psychiatric disorders, hyperkinesis, sleep disturbance, headache, facial redness, sweating, trembling and restlessness, dizziness, Parkinson's disease patients may experience increased tremor and muscle rigidity.

Cardiovascular system - palpitations, tachycardia, decreased or (more often) increased blood pressure.

Urinary system - urinary retention associated with spasm of renal vessels and bladder sphincter.

Metabolism - hyperglycemia may occur in patients with diabetes mellitus as a result of stimulation of glycogenolysis. Appearance of this side effect requires reduction of the drug dose without discontinuation of treatment.

Digestive system - dry mouth, nausea.

Possible allergic reactions: skin rash, urticaria.

Others - hypokalemia.

Overdose

Manifested by an increase in adverse reactions: arrhythmia, tachycardia, increased blood pressure, cardialgia, tremor of the extremities. There is a risk of hypokalemia after overdose, so it is necessary to monitor the serum concentration of potassium.

Treatment: gastric lavage, intake of activated charcoal, use of water-saline solutions, symptomatic (including selective beta-adrenoblockers with caution).

Interaction with other medicinal products

Beta-adrenoblockers due to antagonism with clenbuterol may reduce or eliminate its bronchodilator effect.

Reduces the effect of hypoglycemic drugs.

Concomitant use with cardiac glycosides, monoamine oxidase inhibitors and theophylline increases the risk of cardiac rhythm disturbances.

Reduces the effectiveness of hypotensive drugs.

The effect of the drug is potentiated by tricyclic antidepressants, beta-adrenomimetics and anticholinergic agents. In combination with sympathomimetic drugs mutually increases toxicity.

Halothane and other halogenated hydrocarbon agents for anesthesia, as well as cyclopropane, can potentiate proarrhythmogenic effect of p2 - adrenomimetics, including clenbuterol.

Special instructions

When treating patients with diabetes mellitus, it is necessary to periodically monitor blood glucose levels. The use of the drug may lead to an increase in body weight due to the presence of anabolic effect, and when administered to athletes, the drug may cause a positive result during doping control.

During treatment with the drug it is possible to develop resistance and "ricochet" syndrome.

The drug contains wheat starch. Wheat starch may contain gluten, but only in insignificant amounts, and therefore it is considered safe for people with celiac disease.

Due to the possibility of tremor, dizziness and weakness, during treatment with the drug it is necessary to refrain from performing potentially dangerous activities requiring special attention and quick reactions (driving a car and other vehicles, work with moving mechanisms).

Form of release:

Tablets 0.02 mg.

10 tablets in a blister of PVC film/aluminum foil.

5 blisters together with instructions for use in a carton pack.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ° C.

Keep out of reach of children!

Shelf life

3 years. Do not use after expiration date.

Conditions of release

By prescription.

Name and address of the manufacturer

SOPHARMA S.A.

Bulgaria, 1220 Sofia, Ilienskoye shosse Str. No. 16