Ambroxol Vramed - instructions for use, dose, side effects, contraindications

Excipients sorbitol (1750.0 mg), citric acid monohydrate (5.0 mg), methyl parahydroxybenzoate (5.0 mg), propyl parahydroxybenzoate (1.0 mg), glycerol (500.0 mg), propylene glycol (100.0 mg) , sodium saccharinate (1.0 mg), raspberry flavor (1.5 mg), purified water (up to 5 ml).

Description:

Transparent viscous liquid from colorless to light yellow with the smell of raspberry.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is an active metabolite of bromhexine, which possesses mucolytic and mukokineticheskim action. Strengthening the production of pulmonary surfactant and stimulation of ciliary activity cause an increase in the current and transport of mucus (mucociliary clearance). Thus, the drug facilitates the production of sputum and cough, improves breathing.

Pharmacokinetics:

Absorption: quickly and almost completely absorbed in the gastrointestinal tract, maximum plasma concentrations are attained from 0.5 to 3 hours after oral administration.

Distribution: It binds to plasma proteins (about 90%). Rapidly distributed in tissues, with the maximum concentration being established in the lungs.

Metabolism: is metabolized mainly in the liver with the formation of dibromantranilic acid and glucuronic conjugates.

Excretion: up to 90% is excreted through the kidneys. Do not cumulate with kidney failure. Excreted in breast milk.

Indications:

In the complex treatment of respiratory diseases with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, asthma with difficulty sputum discharge, bronchiectasis.

Contraindications:

Hypersensitivity to ambroxol or any of the excipients of the drug;

Pregnancy (I trimester);

Lactation period;

Children's age (up to 1 year).

Carefully:

Renal / hepatic insufficiency (should take half the recommended dose for adults and duration of therapy should not exceed 4-5 days), peptic ulcer of stomach and duodenum, pregnancy (II and III trimester).

Pregnancy and lactation:

Pregnancy

Ambroxol penetrates the placental barrier. Data from extensive clinical observations after the 28th week of pregnancy did not reveal fetal lesions. Regardless of this, the usual precautions for the use of the drug during pregnancy is to use under the supervision of the attending physician.

It is not recommended to use the drug in the first trimester.

The drug should be used with caution in the II and III trimester of pregnancy.

Breast-feeding

Ambroxol is excreted in breast milk.

Despite the fact that it is not expected to have an adverse effect on the infant, it is not recommended to use the drug during the breast feeding.

Dosing and Administration:

Ambroxol Vramed syrup is taken orally during meals.

Adults and children over 12 years of age:

For acute diseases or as an initial treatment for chronic diseases: 30 mg (10 ml of syrup) 3 times a day for the first 2-3 days, after which the dose can be reduced - 30 mg (10 ml) 2 times a day.

The maximum daily dose is 120 mg.

Elderly patients

Dosage in elderly patients does not differ from that in adult patients.

Patients with hepatic and renal lesions

In this category of patients, 1/2 of the recommended adult dose is used.

Children

- from 6 to 12 years - 15 mg (5 ml) 2-3 times a day.

- from 2 to 6 years - 7.5 mg 2.5 ml) 3 times a day.

- from 1 year to 2 years - 7.5 mg (2.5 ml) 2 times a day.

- younger than 1 year - not recommended.

In childhood from 1 year to 2 years, the drug is used only as prescribed by the doctor.

Duration of treatment - Do not use the drug for more than 5 days without consulting a doctor.

Side effects:

Side-effects are classified by frequency and system-organ class. Frequency by MedDRA: very frequent (≥ 1/10), frequent (≥ 1/100 and <1/10), infrequent (≥ 1/1 000 and <1/100), rare (≥ 1/10 000 and <1/1 000) , very rare (<1/10 000),with an unknown frequency (based on existing data can not make an estimate).

Immune system disorders

Very rare: anaphylactic reactions, including anaphylactic shock, angioedema, itching and other hypersensitivity reactions.

Disturbances from the nervous system

Infrequent: dysgeusia (for example, taste change).

Respiratory, thoracic and mediastinal disorders

Infrequent: decreased sensitivity in the oral cavity and in the pharynx; dry mouth, rhinorrhea.

With unknown frequency: dryness in the throat.

Gastrointestinal disorders

Infrequent: nausea, vomiting, diarrhea, indigestion and abdominal pain, constipation.

Disturbances from the skin and subcutaneous fabrics

Rare: skin rashes, hives, exanthema.

From the urinary system

Rare: dysuria.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

Treatment: artificial vomiting, gastric lavage in the first 1 to 2 hours after taking the drug; reception of fat-containing products.

Interaction:

Simultaneous use with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) causes an increase in the concentration of antibiotic in the lung tissue.

It is not recommended simultaneous use with drugs that suppress cough.

Clinically significant interactions of ambroxol with other drugs have not been established.

Special instructions:

- In very rare cases, severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) are reported following the use of expectorants as ambroxol. Most of these cases are due to the severity of the underlying disease and / or concomitant medication. In addition, the early phase of Stevens-Johnson syndrome or toxic epidermal necrolysis in the patient can be prodromal with nonspecific flu-like symptoms, such as high fever, pain in the entire body, runny nose, cough and inflammation of the nasopharynx. Nonspecific flu-like symptoms can be misleading, and cause symptomatic treatment with anti-cough and cold medications. That's why in the case of new lesions of the skin or mucous membranes, you should immediately seek medical help and stop ambroxol treatment (as a precaution).

- Ambroxol is administered with caution in cases of severe impairment of liver and kidney function, with a lower dose (half the recommended adult dose) and treatment duration not exceeding 4-5 days.

- If after 5 days of taking the drug, the patient's condition does not change or worsens, the attending physician should review the treatment.

- The preparation contains sorbitol in an amount of 35 g / 100 ml (a dose of 5 ml contains 1.75 g of sorbitol), so it can cause irritation of the stomach and diarrhea in people with congenital intolerance to fructose.

- The drug contains methylparahydroxybenzoate and propyl parahydroxybenzoate as auxiliary substances, which can cause allergic reactions (possibly - delayed).

- The preparation contains glycerol, which, when applied at high doses (10 g / dose), can cause headache, stomach irritation and diarrhea.

- The drug contains less than 1 mmol sodium (23 mg) per dose, i.e. in fact, does not contain sodium.

Under the prescription - for children under 2 years.

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

Ambroxol Vramed syrup does not affect the ability to drive vehicles, work with machines and mechanisms.

Form release / dosage:

Syrup 15 mg / 5 ml.

Packaging:

For 100 ml of the drug in bottles of dark glass, ukuporennyh aluminum caps or caps made of polyethylene type "Pylfer-proof" or in bottles of dark polyethylene terephthalate, sealed with caps of polyethylene type "Pilfer-proof." Each bottle together with a measuring spoon or a measuring cup and instruction for use is placed in a cardboard pack.

Storage conditions:

In a dry and dark place at a temperature of no higher than 25 ° C.

Do not freeze!

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiry date printed on the package! Shelf life after the first opening of the bottle: 1 month.

Terms of leave from pharmacies:Without recipe

Registration number:P N 015626/01

Date of registration:24.04.2009

The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria

Manufacturer: & nbsp

SOPHARMA, AD Bulgaria

Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Ambroxol Vramed (Ambroxol Vramed)