Bromhexin, tablets 8 mg 20 pcs

Bromhexin is a mucolytic agent with expectorant action. It reduces the viscosity of bronchial secretion due to depolarization of acidic polysaccharides contained in it and stimulation of secretory cells of the bronchial mucosa that produce secretion containing neutral polysaccharides. Bromhexin is believed to promote the formation of surfactant.

Pharmacokinetics

Bromhexine is rapidly absorbed from the GI tract and undergoes intense metabolism during “first passage” through the liver. Bioavailability is about 20%. In healthy patients Cmax in plasma is determined after 1 hour.

Widely distributed in body tissues. About 85-90% is excreted with urine mainly in the form of metabolites. The metabolite of bromhexin is ambroxol.

The binding of bromhexine to plasma proteins is high. T1/2 in the terminal phase is about 12 hours.

Bromhexin penetrates through the HEB. In small amounts it penetrates through the placental barrier.

Only small amounts are excreted in the urine with a T1/2 of 6.5 h.

The clearance of bromhexine or its metabolites may be decreased in patients with severe hepatic and renal impairment.

Indications

Diseases of the respiratory tract accompanied by the formation of difficult-to-discharge viscous secretions: tracheobronchitis, chronic bronchitis with a broncho-obstructive component, bronchial asthma, cystic fibrosis, chronic pneumonia.

Pharmacological effect

Bromhexine is a mucolytic agent with an expectorant effect. Reduces the viscosity of bronchial secretions by depolarizing the acidic polysaccharides it contains and stimulating the secretory cells of the bronchial mucosa, which produce secretions containing neutral polysaccharides. It is believed that bromhexine promotes the formation of surfactant.

Pharmacokinetics

Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes intensive metabolism during the “first pass” through the liver. Bioavailability is about 20%. In healthy patients, Cmax in plasma is determined after 1 hour.

Widely distributed in body tissues. About 85-90% is excreted in the urine, mainly in the form of metabolites. Ambroxol is a metabolite of bromhexine.

The binding of bromhexine to plasma proteins is high. T1/2 in the terminal phase is about 12 hours.

Bromhexine penetrates the BBB. In small quantities it penetrates the placental barrier.

Only small amounts are excreted in urine with a T1/2 of 6.5 hours.

The clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.

Special instructions

For gastric ulcers, as well as when there is a history of gastric bleeding, bromhexine should be used under the supervision of a physician.

Use with caution in patients suffering from bronchial asthma.

Bromhexine is not used simultaneously with medications containing codeine, because this makes it difficult to cough up liquefied mucus.

Used as part of combination preparations of plant origin with essential oils (including eucalyptus oil, anise oil, peppermint oil, menthol).

Active ingredient

Bromhexine

Composition

1 tablet contains the active ingredient:

Bromhexine hydrochloride – 8 mg.

Excipients:

potato starch,

lactose (milk sugar),

sucrose (sugar),

calcium stearate.

Pregnancy

Bromhexine penetrates the placental barrier and also into breast milk. The drug is contraindicated for use during pregnancy and breastfeeding.
If it is necessary to use the drug during lactation, breastfeeding should be stopped during treatment.

Contraindications

Hypersensitivity to the components of the drug.
Hereditary fructose intolerance.
Pregnancy (1st trimester).
Lactation period.
Peptic ulcer (in the acute stage).
Children’s age up to 6 years.

With caution: renal and/or liver failure, bronchial diseases accompanied by excessive accumulation of secretions, a history of gastric bleeding.

Side Effects

From the digestive system: dyspeptic symptoms, transient increase in the activity of liver transaminases in the blood serum.

From the side of the central nervous system: headache, dizziness.

Dermatological reactions: increased sweating, skin rash.

From the respiratory system: cough, bronchospasm.

Interaction

Bromhexine can be prescribed simultaneously with other drugs used in the treatment of bronchopulmonary diseases.

With the combined use of the drug Bromhexine and antitussives that suppress the cough reflex (including those containing codeine), due to a weakening of the cough reflex, there may be a risk of congestion.

Bromhexine promotes the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline, ampicillin, amoxicillin) into the lung tissue.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspeptic disorders.

Treatment: artificial vomiting, gastric lavage (in the first 1-2 hours after administration).

Storage conditions

In a dry place, protected from light

Shelf life

5 years. Do not use after expiration date.

Manufacturer

Pharmstandard-Leksredstva, Russia