Viks Active AmbroMed - instructions for use, dose, side effects, contraindications

Excipients: citric acid monohydrate 1.000 mg / 2.000 mg, 70% liquid sorbitol 2250.000 mg / 2250.000 mg glycerol 860,000 mg / 860.000 mg methyl parahydroxybenzoate 6.000 mg / 6.000 mg propyl parahydroxybenzoate 1.500 mg / 1,500 mg, propyleneglycol 150.000 mg / 150.000 mg , strawberry flavor 2,500 mg / -, raspberry aroma - / 2,500 mg, water up to 5 ml.

Description:

15 mg / 5 ml. Colorless or colorless with a brown tinge, a clear solution with a strawberry smell.

30 mg / 5 ml. Colorless or colorless with a brown tint, a clear solution with a crimson smell.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

In studies it is shown that ambroxol, active ingredient of the preparation Vix Active AmbroMed, increases secretion in the respiratory tract. It increases the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.

In patients with chronic obstructive pulmonary disease, ambroxol therapy (for at least 2 months) resulted in a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics:

For all immediate-release ambroxol dosage forms, rapid and almost complete absorption with a linear dose-response in the therapeutic range of concentrations is characteristic.

Maximum concentration in plasma (FROM_m_Oh) when taken orally is achieved after 1-2.5 hours.The volume of distribution is 552 liters. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.

The transfer of ambroxol from the blood to the tissue during oral administration occurs rapidly. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of the dose is exposed to the effect of a primary pass through the liver.

Studies on microsomes of the human liver showed that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoanthranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites.

The terminal half-life of ambroxol is 10 hours. The total clearance is within 660 ml / min.

With the radioactive label method, it was estimated that after taking a single dose of the drug for the next 5 days, about 83% of the dose taken is excreted in the urine.

There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no reason to select a dosage for these features.

Indications:

Diseases of the respiratory tract with difficulty of sputum discharge: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, cystic fibrosis.

Contraindications:

Hypersensitivity to ambroxol, bromhexine or other components of the drug, hereditary fructose intolerance and fructose malabsorption, pregnancy I trimester, the period of breastfeeding, children under 2 years.

Carefully:

Pregnancy II-III trimester, hepatic insufficiency, renal failure, peptic ulcer and duodenal ulcer, decreased cough reflex or sputum retention, impaired bronchial motor function, and increased sputum production (with the syndrome of immobile cilia).

Pregnancy and lactation:

Pregnancy

Ambroxol penetrates the placental barrier. Preclinical studies did not reveal a direct or indirect adverse effect on pregnancy, fetal / fetal, postnatal development, labor activity. The extensive clinical experience of using ambroxol after the 28th week of pregnancy found no evidence of a negative effect of the drug on the fetus.Nevertheless, care should be taken when applying the drug during pregnancy.

The use of Vix Active AmbroMed during the first trimester of pregnancy is not recommended, and in the second and third trimesters of pregnancy is possible only if the potential benefit to the mother exceeds the potential risk to the fetus.

Breast-feeding

Ambroxol can be excreted in breast milk.

The use of Vix Active AmbroMed during breastfeeding is not recommended.

Fertility

Preclinical studies of ambroxol did not reveal a negative effect on fertility.

Dosing and Administration:

Inside, after eating.

The drug should not be taken immediately before bedtime.

Syrup 15 mg / 5 ml - 1 measuring spoon (5 ml) contains 15 mg of ambroxol

Adults and children over 12 years of age

During the first 2-3 days, take 10 ml of syrup (2 scoops) 3 times a day, then reduce the dose to 10 ml of syrup (2 measuring spoons) 2 times a day.

Children from 6 to 12 years old

5 ml of syrup (1 measuring spoon) 2-3 times a day.

Children from 2 to 6 years old

For 2.5 ml of syrup (1/2 measuring spoon) 3 times a day.

Syrup 30 mg / 5 ml - 1 measuring spoon (5 ml) contains 30 mg of ambroxol.

Adults and children over 12 years of age

During the first 2-3 days take 5 ml of syrup (1 measuring spoon) 3 times a day, then reduce the dose to 5 ml of syrup (1 measuring spoon) 2 times a day.

Children from 6 to 12 years old

2.5 ml syrup (1/2 measuring spoon) 2-3 times a day.

Children from 2 to 6 years old

For 1.25 ml of syrup (1/2 measuring spoon) 3 times a day.

Duration of treatment is 7-14 days.

If further use is necessary, consult a physician.

Side effects:

The incidence of adverse reactions developing with ambroxol is classified according to WHO recommendations: very often - at least 10%; often - not less than 1% and less than 10%; infrequently - not less than 0.1% and less than 1%; rarely - not less than 0.01% and less than 0.1%; very rarely - less than 0.01%, including isolated cases; the frequency is unknown (the frequency can not be estimated from available sources).

From the digestive tract: often - diarrhea; infrequently - nausea, abdominal pain, indigestion, vomiting; rarely - heartburn, dryness of the oral mucosa, decreased sensitivity in the oral cavity or pharynx, constipation.

From the respiratory system: rarely - dryness of the mucous membrane of the respiratory tract, rhinorrhea, respiratory distress syndrome.

Allergic reactions: infrequently - hypersensitivity reactions (skin rash, itching,angioedema); very rarely - anaphylactic reactions, including anaphylactic shock, urticaria, Stevens-Johnson syndrome, Lyell's syndrome.

Other: often - dysgeusia. rarely - adynamia, fever.

Reporting on unwanted reactions: in order to obtain new information on the safety of the drug Vix Active AmbroMed, medical workers are advised to report every case of an undesirable reaction that occurred when using the drug Vix Active AmbroMed. This allows you to constantly monitor the benefit / risk ratio of the drug.

Overdose:

Specific symptoms of an overdose in humans are not described.

There are reports of accidental overdose and / or medical error, which resulted in symptoms of known adverse reactions: nausea, indigestion, vomiting, diarrhea, abdominal pain.

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

Interaction:

Ambroxol should not be taken concomitantly with antitussive agents, including with codeine, because of the possible suppression of cough reflex and delay of secretion in the airways.

Ambroxol Do not take concomitantly with bronchial secretion suppressants.

Ambroxol increases the penetration of certain antibiotics (eg, amoxicillin, cefuroxime, erythromycin, doxycycline) into the lung tissue and, consequently, increases their concentration in the pulmonary parenchyma.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

Children and patients with reduced cough reflex (elderly patients, patients unconscious or immobilized) should ensure the evacuation of bronchial secretions.

At the beginning of ambroxol therapy, coughing in patients with bronchial asthma may be increased.

There are isolated reports of severe skin lesions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of expectorants such as ambroxol hydrochloride. In patients with Stevens-Johnson syndrome or toxic epidermal necrolysis, fever, rhinitis, cough and sore throat may appear in the early phase. With symptomatic treatment, it is possible to erroneously prescribe anti-cold remedies.When new lesions of the skin and mucous membranes appear, it is recommended to stop ambroxol treatment and immediately seek medical help.

Vix Active AmbroMed may cause allergic reactions (possibly delayed type) due to the content of methyl parahydroxybenzoate, propyl parahydroxybenzoate and propylene glycol.

Vix Active AmbroMed can be prescribed to patients with diabetes mellitus (5 ml of syrup contain 2.25 g of sorbitol).

Taking Vix Active AmbroMed can be accompanied by a slight laxative effect.

If the kidney function is impaired or liver function is disrupted, the drug should be used only on the advice of a doctor.

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

There were no cases of drug effects on the ability to drive vehicles and mechanisms. Studies on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been carried out.

Form release / dosage:

Syrup, 15 mg / 5 ml and 30 mg / 5 ml.

Packaging:

120 ml or 200 ml of syrup is placed in a glass bottle of brown color with an aluminum or polypropylene screw cap with the control of the first opening.

1 A bottle together with the instruction for use and a measuring spoon for dosing is put in a cardboard box.

Storage conditions:

Store at a temperature of no higher than 25 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

2 of the year.

After the first opening of the vial, the drug is suitable for use for 28 days.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001318

Date of registration:02.12.2011 / 05.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Operations Poland, Sp. z o.o. Poland

Representation: & nbspTeva Teva Israel

Information update date: & nbsp11.03.2017

Illustrated instructions

Instructions

Wicks Active AmbroMed (Vicks Active AmbroMed)