Medox - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose - 90.00 mg, sodium carboxymethyl starch - 8.00 mg, Silica colloidal dioxide - 0.70 mg, magnesium stearate - 1.30 mg.

Description:

From white to almost white color round flat tablets with a risk for dividing from one side.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is an active metabolite of bromhexine with pronounced secretory (secretion-producing) and secretolitic (secretion-freshening) properties. Ambroxol, acting directly on the alveolar pneumocytes type II and Clara cells in the lower respiratory tract, causes the activation of the surfactant system (surface-active compounds), which facilitates the formation of surface active compounds in the alveoli and bronchus and their subsequent outflow. Ambroxol increases the proportion of the serous component of the bronchial secretion. Due to the decrease in the viscosity of secretion and the activation of ciliated epithelium (stimulation of mucociliary mobility) ambroxol promotes release of the accumulated and tightly adherent secretion from the bronchi and accelerates the excretion of mucus.

On average, the effect of the drug after oral administration begins after 30 minutes and persists for 6-12 hours, depending on the size of a single dose.

Pharmacokinetics:

Absorption

After intake, absorption is high, the time to reach the maximum concentration in the blood plasma is 0.5-3 hours.Approximately 30% of the dose taken internally is eliminated on first passage through the liver.

Distribution

Connection with blood plasma proteins - 80%. After oral administration ambroxol quickly spreads into the lungs (maximal concentrations are created in the lungs), kidneys and gastrointestinal tract, penetrates the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolism

Ambroxol is metabolized in the liver, forms dibromantranilic acid and conjugates with glucuronic acid.

Excretion

Plasma half-life is 7-12 hours, the accumulation of the drug is not observed. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, and 5% - in unchanged form.

Pharmacokinetics in specific patient groups

Patients with hepatic impairment

If there is a violation of the liver, the half-life of ambroxol does not change. Patients with severe renal insufficiency

In severe chronic renal failure, the half-life of ambroxol and its metabolites increases, and therefore the accumulation of metabolites in the blood is possible.

Indications:

Symptomatic treatment of acute and chronic respiratory diseasesaccompanied by a cough with the formation of difficult-to-detachable sputum of increased viscosity: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectatic disease.

Contraindications:

Hypersensitivity to ambroxol hydrochloride and excipients of the drug.

Pregnancy (first trimester).

Children under 6 years.

Carefully:

- When hepatic insufficiency, renal failure, peptic ulcer of the stomach and duodenum (see section "Special instructions").

- When of pregnancy (II-III trimester), during lactation (see the section "Pregnancy and the period of breastfeeding").

- With violations of the bronchomotor function and a large number of secretions (for example, with a rare syndrome of immobility of the ciliated epithelium).

Pregnancy and lactation:

Pregnancy

Ambroxol hydrochloride penetrates the placental barrier. Studies conducted on animals did not reveal direct adverse effects of ambroxol on the course of pregnancy, embryonic / fetal development, childbirth and postnatal development.The wide clinical experience of using ambroxol after the 28th week of pregnancy showed no adverse effects on the fetus. Despite this, the usual precautionary measures regarding the use of the drug during pregnancy should be observed. In particular, during the first trimester of pregnancy, the use of drugs containing ambroxol, Not recommended.

Breastfeeding period

Ambroxol is excreted into breast milk. Therefore Medox® is not recommended for use in nursing mothers, despite the fact that it is not expected to have adverse effects on the infant.

Dosing and Administration:

Tablets are taken inside. Tablets should be taken whole, preferably after eating and drink plenty of water.

If no other doses are prescribed by the doctor, then the following doses are usually recommended: children 6-12 years: 1/2 tablet 2 or 3 times a day; children over 12 years and adults: usually 1 tablet 3 times a day during the first 2-3 days, then 1 tablet 2 times a day. If necessary, in adult doses can be increased to 2 tablets (60 mg) 2 times a day.

The drug is not recommended immediately before going to bed.

During treatment with Medox®, a lot of liquid must be drunk to facilitate the formation and dilution of mucus in the airways.

Side effects:

Usually the drug Medox® is transferred well.

Below are the undesirable reactions to ambroxol hydrochloride, separated according to the system-organ classes according to the classification MedDRA (Medical Dictionary of Regulatory Activities), indicating the frequency of their occurrence in accordance with the following classification: very often (> 1/10); often (≥1 / 100 - <1/10); infrequently (≥1 / 1000 - <1/100); rarely (≥1 / 10000 - <1/1000); very rarely (<1/10000), unknown frequency (estimates of the frequency of occurrence according to available data are not possible).

Disturbances from the nervous system

Unknown frequency: headache.

Disturbances from the respiratory system, organs of the chest and mediastinum

Unknown frequency: dryness of the mucous membrane of the respiratory tract, rhinorrhea.

Disorders from the gastrointestinal tract

Often: nausea.

Infrequently: vomiting, diarrhea, dyspepsia and abdominal pain, dryness of the oral mucosa, constipation.

Disturbances from the skin and subcutaneous tissues

Rarely: rash, hives.

Rarely: severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see section "Special instructions").

Unknown frequency: exanthema.

Immune system disorders

Unknown frequency: anaphylactic reactions, including anaphylactic shock, angioedema, itching and other hypersensitivity reactions, contact dermatitis.

Disorders from the kidneys and urinary tract

Unknown frequency: dysuria.

In the event of such undesirable effects or other unusual reactions, it is necessary to consult a doctor regarding the advisability of further taking the drug.

Overdose:

Symptoms

There is no experience of an overdose of ambroxol in humans, but it is expected to have low toxicity. In case of an overdose, symptoms may appear, corresponding to known side effects of ambroxol, but more pronounced, including increased salivation, nausea, vomiting, vomiting, diarrhea, or excessive lowering of blood pressure.

Treatment

With a small overdose, active interventions such as vomiting,or gastric lavage are usually not shown, and their use can be considered only in the event of an extreme overdose. If necessary, symptomatic therapy is recommended.

Interaction:

Joint use with antitussive medicinal drugs leads to difficulty in sputum discharge in the background suppression of cough reflex. Ambroxol increases penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin and doxycycline and increases their concentration in the lung tissue.

No clinically significant adverse interaction with other drugs has been reported.

Special instructions:

Usually the duration of drug treatment Medox® is 7-10 days. Longer treatment should be carried out on the advice of a doctor.

If the state of health does not improve within 3 days of starting the drug or if there are undesirable reactions, you should consult your doctor.

Do not combine the drug Medox® with antitussive medicinal drugs, impeding the excretion of phlegm (cm.section "Interaction with other drugs").

There were very rare reports of severe skin lesions, such as Stevens-Johnson syndrome (severe condition with fever, the appearance of erythematous skin rashes, joint pain and / or eye infection) and toxic epidermal necrolysis (TEN), coinciding with the use of expectorants drugs, such as ambroxol. In most cases, their occurrence may be due to the severity of the patient's underlying illness and / or concomitant therapy. It should be remembered that during the early phase of Stevens-Johnson syndrome or TEN, the patient may first experience nonspecific flu-like prodromal symptoms, such as fever, body aches, runny nose, cough and sore throat, for which symptomatic treatment with drugs may be used , used for cough and cold, including ambroxol. In these cases, when new lesions of the skin or mucous membranes occur, you should immediately consult a doctor, and as a precautionary measure stop taking ambroxol.

In the presence of impaired renal function or severe liver damage ambroxol can only be used after consultation with a doctor. As for any other drug metabolized in the liver with subsequent excretion of metabolites by the kidneys, in the presence of severe renal failure, one can expect the accumulation of inactive water-soluble metabolites of ambroxol formed in the liver.

In patients with bronchial asthma ambroxol at the beginning of treatment can enhance cough.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities. Studies on the impact on the ability to drive vehicles and the use of mechanisms have not been carried out.

Form release / dosage:Tablets 30 mg.

Packaging:

For 10 tablets in PVC/PVDC/A1 blister. For 2 or 3 blisters per pack of cardboard along with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-002157/09

Date of registration:20.03.2009

Date of cancellation:2017-11-14

The owner of the registration certificate:Zentiva as.Zentiva as. The Slovak Republic

Manufacturer: & nbsp

ZENTIVA, a.s. Czech Republic

Representation: & nbspZENTIVA ZENTIVA Czech Republic

Information update date: & nbsp14.11.2017

Illustrated instructions

Instructions

Medox® (Medox®)