Ambrobene Stoptussin, tablets 4 mg+100 mg 20 pcs

Pharmacological properties

Pharmacodynamics.

A combined drug with anti-cough and expectorant effect. Butamirate has a peripheral local anesthetic effect on the sensitive nerve endings of the bronchial mucous membrane, which provides anti-coughing effect. Guaifenesin increases secretion of bronchial glands and reduces mucus viscosity.

The increase in secretion is caused both by direct action on the bronchial glands – stimulation of secretion from the bronchial glands and removal of acidic glycoproteins from acinar cells – and by reflexive way, when irritation of afferent parasympathetic fibers of the gastric mucosa and suppression of the respiratory center occur.

The increase in the tone of N. vagus stimulates the production of bronchial secretion. Mucus produced by bronchial glands increases activity of ciliated epithelium, as a result, evacuation of mucus from bronchi and coughing it up is facilitated.

Pharmacokinetics.

Butamirate is rapidly and completely absorbed when ingested. The binding to plasma proteins is 94%. It is metabolized to form 2 metabolites, also having antitussive effects. Metabolites are eliminated mainly (90%) by the kidneys and only a small part via the intestine. The elimination half-life (T1/2) is 6 hours.

Guifenesin when taken orally is rapidly absorbed from the gastrointestinal tract. Binding to plasma proteins is insignificant. Guaifenesin is rapidly metabolized to form inactive metabolites, which are excreted by the kidneys. T1/2 – 1 hour.

Indications

Dry and irritating cough of various etiologies (including infectious inflammatory diseases of the upper and lower respiratory tracts).

Active ingredient

Butamirate, Guaifenesin

Composition

1 tablet contains the active ingredients: butamirate citrate 4.0 mg, guaifenesin 100.0 mg; excipients: silica dioxide 1.0 mg, mannitol 60.0 mg, microcrystalline cellulose (PH 200) 60.0 mg, glyceryl behenate 1.0 mg, magnesium stearate 4.0 mg.

How to take, the dosage

Ingestion, after meals, without chewing, with liquids (water, tea, fruit juice
, etc.).

The dose depends on the body weight of the patient.

Adults and children over 12 years of age with weight

under 50 kg: for ½ tablet 4 times a day;

– 50 to 70 kg: 1 tablet 3 times a day;

– 70 to 90 kg:about 1½ tablets 3 times a day;

– over 90 kg: about 1½ tablets 4 times a day.

The interval between doses should be 4-6 hours.

Interaction

Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid, the effect of alcohol, sedatives, hypnotics and general anesthetics on the CNS, the effect of muscle relaxants.

False positive results may be obtained when determining concentrations of vanillylmindalic acid and 5-hydroxyindolacetic acid using nitrosonaphthol as a reagent.

Hence, treatment with guaifenesin must be discontinued 48 hours before urine collection for this test.

Special Instructions

If symptoms persist, a change in treatment should be considered.

The drug should not be prescribed for productive cough in patients with prolonged or chronic cough (including that caused by smoking), bronchitis or pulmonary emphysema.

Impact on the ability to drive a car or perform work requiring increased speed of physical and mental reactions.

The drug Stoptussin may have an adverse effect on the ability to drive vehicles and to engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions due to the fact that it may cause dizziness and other side effects.

Contraindications

Do not prescribe in myasthenia gravis, pregnancy (in exceptional cases the drug can be prescribed only in the 2-3 trimesters), lactation, hypersensitivity.

Side effects

If the recommended dosing regimen is followed, patients usually tolerate the drug well. Nausea, vomiting, decreased appetite, stomach pain, dizziness, headache, drowsiness, urticaria and skin rash may occur. These effects
appear in about 1% of patients and usually go away without reducing the dose.

The adverse reactions are classified according to the World Health Organization (WHO) Classification: Very common (≥1/10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); frequency unknown (cannot be determined from available data).

From the central nervous system:often – headache.

Hearing and balance:often – dizziness.

From the digestive organs:often – nausea, anorexia, abdominal pain, vomiting,
diarrhea; very rarely – bitter taste in the mouth, heartburn, feeling of heaviness in the epigastrium.

Respiratory organs:very rarely – shortness of breath.

Cardiovascular system disorders: rarely – chest pain; very rarely – tachycardia, palpitations.

Skin and subcutaneous fat: very rarely – itching, exanthema,
hives, “hot flashes”.

Others:very rarely – pain around the eyes.

Overdose

Symptoms: in case of overdose prevail signs of toxic effects of guaifenesin – drowsiness, muscle weakness, nausea, vomiting, urolithiasis.

Treatment: in case of overdose it is necessary to consult a doctor. Guaifenesin has no specific antidote. Gastric lavage, activated charcoal, symptomatic therapy (support of cardiovascular, respiratory and renal functions, electrolyte balance) are prescribed.

Pregnancy use

The drug should not be used in the first trimester of pregnancy.

If it is necessary to use in the second and third trimesters of pregnancy, it should be made sure that the expected benefits to the mother outweigh the potential risk to the fetus.

There are no reliable data on the penetration of butamirate and guaifenesin into breast milk.

Breastfeeding should be stopped for the period of use of Stoptussin.