Codelac Broncho with thyme, elixir 100 ml

Pharmacodynamics

A combined product for the treatment of cough, has mucolytic and expectorant effects, and also has anti-inflammatory activity. The action of Codelac elixir ^® Broncho with thyme is due to the pharmacological properties of its components:

Ambroxol has secretomotor, secretolytic and expectorant action, normalizes the disturbed ratio of serous and mucous components of sputum, increases the secretion of surfactant in the alveoli. It reduces the viscosity of sputum and promotes its expulsion.

On average when taken orally the action of ambroxol occurs within 30 minutes, duration of action is 6-12 hours depending on the dose taken.

Sodium glycyrrhizinate (trisodium salt of glycyrrhizic acid) has anti-inflammatory and antiviral effects. It has a cytoprotective effect due to its antioxidant and membrane stabilizing activity. It enhances the effect of endogenous glucocorticosteroids with anti-inflammatory and anti-allergic effect.

Owing to its pronounced anti-inflammatory activity, it helps to reduce inflammation in the respiratory tract.

Extract of thyme herb creeping (thyme) contains a complex of biologically active substances with expectorant, anti-inflammatory, antimicrobial action. In addition, thyme herb extract (thyme) has weak antispasmodic and reparative properties.

Pharmacokinetics

Ambroxol.

Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration. Maximum concentration (C_max) in blood plasma with oral administration is reached after 1-3 hours. The volume of distribution is 552 l.

In the therapeutic range of concentrations, binding to plasma proteins is 80-90%. The highest concentrations of the active component of the drug are observed in the lungs. Ambroxol penetrates through the placental and blood-brain barrier, is excreted with breast milk. About 30% of the oral dose taken is subjected to the effect of primary passage through the liver.

Studies on human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoform responsible for metabolizing ambroxol to dibromanthranilic acid. The remainder of ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.

The terminal elimination half-life (T_1/2) of ambroxol from blood plasma is 10 hours. The total half-life of ambroxol and its metabolites is about 22 hours. Excreted by the kidneys: 90% as metabolites, 10% unchanged.

There is no clinically significant effect of age and sex on pharmacokinetics of ambroxol, so there is no reason to choose dosage according to these characteristics.

Sodium glycyrrhizinate (trisodium salt of glycyrrhizic acid).

After oral administration, in the intestine under the influence of the enzyme β-glucuronidase produced by bacteria of normal microflora, from glycyrrhizic acid is formed the active metabolite – β-glycyrrhetic acid, which is absorbed into the systemic bloodstream.

In the blood β-glycyrrhetic acid binds to albumin and is almost completely transported to the liver. Excretion of β-glycyrrhetic acid occurs mainly in the bile, with residual amounts in the urine.

Extract of thyme creeping herb (thyme).

The action of the drug is the result of the combined action of the active substances of thyme herb extract, therefore pharmacokinetic studies are not possible; all components together cannot be traced by markers or bioassays.

Indications

Active ingredient

Composition

The composition per 5 ml of the elixir:

The active ingredients are:

Ambroxol hydrochloride – 10 mg,

Glycyrrhizinate sodium (trisodium salt of glycyrrhizic acid) – 30 mg,

Thyme creeping herb extract (thyme extract liquid) – 500 mg.

Auxiliary substances:

Methyl parahydroxybenzoate – 3.75 mg,

propyl parahydroxybenzoate – 1.25 mg,

sorbitol (sorbitol) – 3000 mg,

purified water – up to 5 ml.

How to take, the dosage

Overly, with meals, with a small amount of water.

Adults and children over 12 years of age – 10 ml 4 times a day.

Children from 2 to 6 years of age should take 2.5 ml of the elixir 3 times a day, from 6 to 12 years of age – 5 ml 3 times a day.

The maximum duration of treatment without medical consultation is 5 days.

If during the treatment period there is no improvement or if symptoms worsen or new symptoms appear, a doctor should be consulted.

To use the drug only according to the indication, route of administration, and dosage listed in the directions.

Interaction

When used simultaneously with amoxicillin, cefuroxime, erythromycin, doxycycline, ambroxol increases their penetration into the bronchial secret.

Special Instructions

Do not combine with cough suppressants.

Patients with diabetes mellitus may use the drug with 0.18 units of sorbitol in 5 ml of the elixir.

The content of absolute ethyl alcohol in the maximum single dose of the product is 0.24 grams, in the maximum daily dose of the product – 0.96 grams.

Impact on the ability to drive vehicles, machinery.

When using the drug it is necessary to be careful when performing potentially hazardous activities requiring high concentration and quick psychomotor reactions (driving vehicles, operating moving mechanisms, work of dispatcher, operator).

Contraindications

Hypersensitivity to the ingredients of the drug, children under 2 years of age, pregnancy, breastfeeding.

With caution.

In case of hepatic and/or renal failure, gastric and duodenal ulcer, bronchial asthma, diabetes mellitus. In liver disease, alcoholism, craniocerebral trauma, brain disease, children from the age of 2 years.

Side effects

Allergic reactions.

Rarely – weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. If prolonged use in high doses – gastralgia, nausea, vomiting.

If you experience or worsen the side effects listed in the instructions, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug.

Pregnancy use