Codelac Broncho, elixir with thyme 100ml

Composition

Composition per 5 ml of elixir:

Active ingredients:

ambroxol hydrochloride-10 mg,

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

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

Auxiliary substances:

Methylparahydroxybenzoate-3.75 mg, propylparahydroxybenzoate-1.25 mg, sorbitol (sorbitol) – 3000 mg, purified water-up to 5 ml

Pharmacological action

Pharmacodynamics

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

Ambroxol has secretomotor, secretolytic and expectorant effects, normalizes the disturbed ratio of serous and mucosal components of sputum, increases the secretion of surfactant in the alveoli. Reduces the viscosity of sputum and promotes its discharge.

On average, when taken orally, the effect of ambroxol occurs in 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 anti-allergic effects.

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

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

Pharmacokinetics

of Ambroxol.

After oral use, ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration (cmax) in blood plasma with oral use is reached after 1-3 hours. The volume of distribution is 552 liters.

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 the placental and blood-brain barriers and is excreted in breast milk. Approximately 30% of the oral dose received is affected by the primary passage through the liver.

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

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

There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to select the dosage based on these signs.

Sodium glycyrrhizinate (trisodium salt of glycyrrhizic acid).

After oral use, 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-glycyrrhetoic acid, which is absorbed into the systemic circulation.

In the blood, beta-glycyrrhetic acid binds to albumin and is almost completely transported to the liver. The release of β-glycyrrhetoic acid occurs mainly with bile, in the residual amount – with urine.

Herb extract of thyme creeping (thyme).

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

Use during pregnancy and lactation

Application of Kodelak® Bronco with thyme elixir is contraindicated during pregnancy. If you need to take the drug during breastfeeding, breast feeding should be discontinued.

Contraindications

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

With caution.

In case of hepatic and / or renal insufficiency, peptic ulcer of the stomach and duodenum, bronchial asthma, diabetes mellitus. For liver diseases, alcoholism, traumatic brain injury, brain diseases, children aged 2 years and older.

Side effects

Allergic reactions.

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

If you experience any of 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 concomitantly with amoxicillin, cefuroxime, erythromycin, doxycycline, ambroxol increases their penetration into the bronchial secret.

How to take, course of use and dosage

Inside, during a meal, 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 are prescribed 2.5 ml of elixir 3 times a day, from 6 to 12 years-5 ml 3 times a day.

The maximum duration of treatment without consulting a doctor is 5 days.

If there is no improvement during the treatment period, or if the symptoms worsen or new symptoms appear, you should consult your doctor.

Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

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

Special instructions

Do not combine with antitussive agents.

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

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

Form of production

The Elixir

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

Active Ingredient

Ambroxol, Sodium glycerrizinate, Thyme creeping herb extract

Dosage form

oral solution