Lasolvan max caps. 10 pcs prolong 75mg

Description

Composition
Active substance:
1 capsule contains: 75 mg of ambroxol hydrochloride ;.
Excipients:
12.55 mg of Crospovidone, 18.31 mg of carnauba wax, stearyl alcohol 110.94 mg Magnesium stearate 1.20 mg; capsule shell composition: gelatin 52.307 mg, 9.135 mg purified water, titanium dioxide (E171) 1.008 mg iron oxide red dye (E172) 0.150 mg Iron oxide yellow dye (E172) 0.398 mg; Ink composition: shellac, titanium dioxide.
Description:
Oblong, hard gelatin capsules consisting of a red opaque cap and orange opaque body; the lid has a printed symbol «MUC 01″ in white, on the case of characters printed Boehringer Ingelheim.
The contents of the capsule: round, yellow-white granules with a smooth, shiny surface, mixed with a small amount of powder.
Product form:
Capsules of 75 mg prolonged action. 5 or 6 capsules in blister made of PVC / PVDC / Al-foil. 1 blister with instructions for use in a cardboard box. 10 capsules in blister made of PVC / PVDC / Al-foil. 1 or 2 blisters with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to ambroxol or other ingredients, pregnancy (I term), lactation, children up to 18 years.
Precautions II – III trimesters of pregnancy, kidney and / or liver failure.
Dosage
75 mg
Indications
Acute and chronic respiratory disease with separation of viscous mucus: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty sputum discharge, bronchiectasis.
Interaction with other drugs
Clinically significant, undesirable interactions with other drugs have not been reported. Ambroxol increases penetration into the bronchial secretions amoxicillin, cefuroxime, erythromycin while the use of them.
Overdose
Specific symptoms of overdose in humans has not been described. There are reports of accidental overdose and / or medical error, which resulted in the observed symptoms known side effects Mucosolvan® MAX: nausea, indigestion, vomiting, diarrhea, abdominal pain. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after ingestion, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Expectorant, mucolytic agent.
Pharmacodynamics:
The studies have shown that Ambroxol – the active ingredient of the drug Mucosolvan® MAX – increases secretion in the airways. It enhances the production of pulmonary surfactant, and stimulates ciliary activity. These effects lead to increased transport current and mucus (mucociliary clearance). Strengthening improves mucociliary clearance of sputum expectoration and eases cough. In patients with chronic obstructive pulmonary disease chronic treatment Mucosolvan® MAX (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 dosage forms immediate release ambroxol is characterized by rapid and nearly complete absorption from the linear dependence on the dose of the therapeutic concentration range. Maximum plasma concentration (Cmax) upon receipt of a sustained-release capsule is achieved at a mean of 6.5 hours. The absolute bioavailability of 30 mg ambroxol tablets is 79%. In the therapeutic concentration range of binding to plasma proteins is approximately 90%. Capsules depot 75 mg ambroxol showed a relative bioavailability of 95% compared with the reception of 60 mg ambroxol hydrochloride per day (30 mg twice daily) in the form of tablets (comparison was made after assimilation doses). Going ambroxol from blood to tissues after oral administration is rapid. The volume of distribution is 552 liters. The highest concentration of active ingredient of the drug are observed in the lungs. Approximately 30% of an oral dose is exposed to the effect of first pass through the liver. Studies in human liver microsomes have shown that CYP3A4 isoenzyme is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilovoy acid. The remainder of ambroxol is metabolized in the liver primarily by glucuronidation and by partial digestion to dibromantranilovoy acid (approximately 10% of the administered dose), and also a small amount of additional metabolites. Terminal half-life period of ambroxol is about 10 hours. The total clearance is in the range 660 ml / min for renal clearance accounting for about 8% of the total clearance. The method of radiolabel was estimated that, after receiving a one-time dose of the drug for a further 5 days with urine is released about 83% of the dose. Not detected clinically significant effect of age and gender on the pharmacokinetics of ambroxol, there is no reason for the selection of dosage on these grounds.
Pregnancy and breast-feeding
Ambroxol crosses the placental barrier. Preclinical studies revealed no direct or indirect adverse effects on pregnancy, embryonic / fetal, postnatal development and delivery. Extensive clinical experience with ambroxol after the 28th week of pregnancy found no evidence of a negative effect of the drug on the fetus. However, you must observe the usual precautions when using the medication during pregnancy. Especially not recommended Mucosolvan® MAX I trimester of pregnancy. In II and III trimester of pregnancy, the use of the drug is possible only if the potential benefit to the mother outweighs the potential risk to the fetus. Ambroxol is excreted in breast milk. Despite the fact that the undesirable effects in children who are breastfed have not been observed in the period of breast-feeding is not recommended Mucosolvan® MAX capsules. Preclinical studies of ambroxol showed no negative effects on fertility.
Conditions of supply of pharmacies
Without recipe.
side effects
Classification of the incidence of side effects (WHO): very common> 1/10; often by> 1/100 to 1/1000 to 1/10000 to
Disorders of the gastrointestinal tract
Often – nausea;
It is not often – indigestion, vomiting, diarrhea, abdominal pain.
Immune system disorders, skin and subcutaneous tissue
Rare – rash, hives;
Frequency unknown – angioneurotic edema, anaphylactic reactions (including anaphylactic shock), itch, hypersensitivity.
special instructions
It should not be combined with antitussive agents that prevent removal of sputum. There are few reports of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which coincided with the appointment expectorant drugs such as Mucosolvan® MAX. In most cases, they can be explained by the severity of the underlying disease and / or concomitant therapy. In patients with Stevens-Johnson syndrome or toxic epidermal necrolysis in the early phase may appear fever, body pain, rhinitis, cough and sore throat. The symptomatic treatment of possible erroneous appointment of “cough” means. When new skin lesions and mucous membranes is recommended to discontinue treatment ambroxol and immediately seek medical attention. In case of violation of renal function the drug should be used only on a doctor’s recommendation. For children under 18 may use other dosage forms Mucosolvan® (syrup, lozenge, solution for oral administration and inhalation).
Effect of the drug on the ability to drive mechanisms and
There were no cases of the influence of the drug on the ability to drive and use machines. Studies on the effect of the drug on the ability to drive and engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions were not carried out.
Storage conditions
Store at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Inside. 1 capsule long acting once a day. Capsules should not be opened or chewed. Swallowed whole with some liquid profusely. “Residues capsules” which are sometimes present in the stool already have released the active ingredient during passage through the digestive tract, therefore they should not impart values. Capsules can be applied regardless of the meal. In the case of preservation of symptoms within 4-5 days from the start of the reception it is recommended to consult a doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist