CLENBUTEROL

Clenbuterol Sopharma - the official instruction for use


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INSTRUCTION for medical use of the drug

Registration number

Tradename:

Clenbuterol Sopharma.

International Nonproprietary Name:

Clenbuterol

Dosage form:

pills

Composition per 1 tablet:

Active substance: 0.02 mg clenbuterol hydrochloride

Auxiliary substances: lactose monohydrate - 70,00 mg, wheat starch - 31,48 mg, microcrystalline cellulose - 48,50 mg, silicon dioxide colloid - 2,00 mg, magnesium stearate - 2,00 mg, povidone (povidone K25) - 6.0 mg.

Description:

Round flat tablets with a facet and dividing risk on one side, white or almost white.

Pharmacotherapeutic group:

Bronchodilator - beta-2-adrenergic selective

ATX code

[R03CC13]

Pharmacological properties

pharmachologic effect

Selective beta-2-adrenostimulant, has a bronchodilator and secretolytic effect. 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 bind to actin and bronchodilation occurs. It inhibits the release from the mast cells of mediators, which cause bronchospasm and inflammation of the bronchi.

Prevents bronchospasm caused by histamine, serotonin and acetylcholine. Reduces edema or stagnation in the bronchi, improves mucociliary clearance. The secretolitic effect of the drug is associated with a decrease in the viscosity of the sputum and the relief of its secretion. It causes the expansion of the vessels of the brain and skeletal muscles. Possesses tocolytic action. Side effects are associated with its ability, albeit poorly, to induce p1-adrenergic receptors of the heart, resulting in a positive foreign and chronotropic effect.

Has a slight anabolic effect, can increase body temperature.

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

Pharmacokinetics

Quickly and completely absorbed in the gastrointestinal tract. Metabolized to a small extent in the liver, resulting in the formation of 8 metabolites, which do not have pharmacological activity. The release from the plasma passes in two phases. The half-life of the first phase is 1 hour, the second - 34 hours. For the most part, it is excreted unchanged through the kidneys, with 87% of the dose taken within 168 hours.

Indications for use:

Chronic obstructive pulmonary disease, bronchial obstructive syndrome, bronchial asthma.

Contraindications:

Hypersensitivity to clenbuterol or to auxiliary substances 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, pregnancy (I and III trimester).

Carefully:

Hyperthyroidism, myocardial infarction in anamnesis, coronary heart disease, hypertension, prostatic hypertrophy, diabetes mellitus, II trimester of pregnancy.

Pregnancy and lactation

It is necessary to avoid prescribing the drug in the first 3 months of pregnancy due to possible adverse effects on fetal development. His appointment is not recommended in the last months of pregnancy and during childbirth due to the presence of tocolytic action of the drug and possible suppression of the tone of the uterus. No special clinical studies of the penetration of the drug into breast milk, and therefore its appointment to lactating women is not recommended.

Dosing and Administration

Inside.

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

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

  • From the central nervous system - a sense of fear, mental disorders, hyperkinesis, sleep disturbance, headache, redness of the face, sweating, trembling and anxiety, dizziness, patients with Parkinson's disease may experience increased tremor and muscle rigidity.
  • From the cardiovascular system - palpitations, tachycardia, decrease or (more often) increase in blood pressure.
  • From the urinary system - urinary retention, associated with spasm of renal vessels and sphincter of the bladder.
  • From the side of metabolism - as a result of stimulation of glycogenolysis in patients with diabetes mellitus, hyperglycemia may appear. The appearance of this side effect requires a reduction in the dose of the drug without discontinuing treatment.
  • On the part of the digestive system - dry mouth, nausea.
  • Allergic reactions are possible: skin rash, hives.
  • Others are hypokalemia.

Overdose

It is manifested by an increase in adverse reactions: arrhythmia, tachycardia, increased blood pressure, cardialgia, tremor of the extremities. There is a danger of hypokalemia after an overdose, so you need to monitor the serum potassium concentration.

Treatment: gastric lavage, reception of activated carbon, use of water-salt solutions, symptomatic (including with caution selective beta-blockers).

Interaction with other drugs

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

Reduces the effect of hypoglycemic drugs.

When used simultaneously with cardiac glycosides, monoamine oxidase inhibitors and theophylline, the risk of cardiac rhythm disturbances increases.

Reduces the effectiveness of antihypertensive drugs.

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

Halothane and other halogenated hydrocarbon anesthetics, as well as cyclopropane, can potentiate the pro-rhythmogenic effect of p2-adrenomimetics, including clenbuterol.

special instructions

When treating patients with diabetes, periodic monitoring of blood glucose levels is necessary. The use of the drug may lead to an increase in body weight due to the presence of anabolic effect, and when prescribed to athletes, the drug can cause a positive result in doping control.

During treatment with the drug, the development of resistance and the syndrome of "ricochet" is possible.

The composition contains wheat starch. Wheat starch may contain gluten, but only in a small amount, and is therefore considered safe for individuals with celiac disease.

In connection with the possibility of tremors, dizziness and weakness, during the treatment with the drug it is necessary to refrain from carrying out potentially dangerous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms).

Form of issue:

Tablets 0.02 mg.

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

For 5 blisters together with instructions for use in a pack of cardboard.

Storage conditions

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life

3 years. Do not use after expiry date.

Leave conditions

On prescription.

Name and address of the manufacturer

SOFARMA SA

Bulgaria, 1220 Sofia, Str. Ilyenskoe Highway 16


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