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

Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectasis.

Pharmacological effect

Pharmacodynamics

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

Ambroxol has a secretomotor, secretolytic and expectorant effect, normalizes the disturbed ratio of serous and mucous components of sputum, and increases the secretion of surfactant in the alveoli. Reduces the viscosity of sputum and promotes its removal.

On average, when taken orally, the effect of ambroxol occurs within 30 minutes, the 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. Enhances the effect of endogenous glucocorticosteroids, providing anti-inflammatory and antiallergic effects.

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

Creeping thyme (thyme) herb extract contains a complex of biologically active substances that have expectorant, anti-inflammatory, and antimicrobial effects. In addition, the herb extract of creeping thyme (thyme) has weak antispasmodic and reparative properties.

Pharmacokinetics

Ambroxol.

After oral administration, ambroxol is quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration (Cmax) in blood plasma after oral administration is reached after 1–3 hours. The volume of distribution is 552 l.

In the therapeutic concentration range, binding to plasma proteins is 80-90%. The highest concentrations of the active component of the drug are observed in the lungs. Ambroxol penetrates the placental and blood-brain barriers and is excreted in breast milk. Approximately 30% of an oral dose is subject to first pass effects through the liver.

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

The terminal half-life (T1/2) 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% in the form of metabolites, 10% unchanged.

No clinically significant effect of age and gender on the pharmacokinetics of ambroxol was found, so there is no basis for selecting the dosage based on 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, an active metabolite is formed from glycyrrhizic acid – β-glycyrrhetic acid, which is absorbed into the systemic circulation.

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

Creeping thyme herb extract (thyme).

The effect of the drug is the result of the combined action of the active substances of the creeping thyme herb extract (thyme), so pharmacokinetic studies are not possible; Collectively, the components cannot be traced using markers or bioassays.

Special instructions

Do not combine with antitussives.

Patients with diabetes can use the drug, taking into account the sorbitol content in the amount of 0.18 XE per 5 ml of elixir.

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

Influence on the ability to drive vehicles and machinery.

During the period of use of the drug, care must be taken when performing potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, working as a dispatcher, operator).

Active ingredient

Ambroxol, Sodium glycerrisinate, Creeping thyme herb extract

Composition

Composition for 5 ml of elixir:

Active ingredients:

ambroxol hydrochloride – 10 mg,

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

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

Excipients:

Methyl parahydroxybenzoate – 3.75 mg,

propyl parahydroxybenzoate – 1.25 mg,

sorbitol (sorbitol) – 3000 mg,

purified water – up to 5 ml.

Pregnancy

The use of Codelac® Bronco with thyme elixir is contraindicated during pregnancy. In case
the need to take the drug during breastfeeding, feeding
breastfeeding should be stopped.

Contraindications

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

With caution.

For liver and/or kidney failure, gastric and duodenal ulcers, bronchial asthma, diabetes mellitus. For liver diseases, alcoholism, traumatic brain injury, brain diseases, children over 2 years of age.

Side Effects

Allergic reactions.

Rarely – weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With long-term use in high doses – gastralgia, nausea, vomiting.

If you experience the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Combined use with antitussive drugs leads to difficulty in sputum discharge.
When used simultaneously with amoxicycline, cefuroxime, erythromycin, and doxycycline, ambroxol increases their penetration into bronchial secretions.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

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

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of
children place.

Shelf life

3 years.

Manufacturer

Pharmstandard-Leksredstva, Russia