Composition, form of production and packaging
? Tablets for resorption mint 1 tab.
Ambroxol hydrochloride 20 mg
Excipients: sodium saccharinate (0.5 mg), sorbitol 1373.5 mg, macrogol 6000 30 mg, talc 60 mg, peppermint flavoring powder 9/008677 16 mg.
10 pieces. - strips of aluminum foil (1) - packs of cardboard.
10 pieces. - strips of aluminum foil (2) - packs of cardboard.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
3 pcs. - strips of aluminum foil (1) - packs of cardboard.
3 pcs. - strips of aluminum foil (2) - packs of cardboard.
3 pcs. - blisters (1) - packs of cardboard.
3 pcs. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Local anesthetic effect of ambroxol (the active component of the drug) is explained by the property of the drug to block sodium channels. An in vitro study showed that ambroxol blocks cloned neuronal sodium channels; binding is reversible and depends on the concentration of ambroxol.
These pharmacological properties correspond to additional observations obtained in clinical studies evaluating the efficacy of ambroxol in inhalation. With the use of ambroxol as a mucolytic agent, pain and associated discomfort in the ear, throat and nose were noted.
In clinical studies it was confirmed that Lazognin shows an analgesic effect in patients with acute pharyngitis of viral etiology. Has a rapid onset of action with a duration of at least 3 hours. Lazognin significantly reduces hyperemia of the mucous membrane of the throat in patients with sore throat.
Ambroxol has an anti-inflammatory effect. It is established that in vitro ambroxol significantly reduces the release of cytokines from mononuclear and polynucleated cells of blood and tissues.
Ambroxol increases the production and secretion of surfactant in the lungs and stimulates the activity of ciliated cells. Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.
Lazognin acts locally on the mucous membrane of the mouth and throat. If swallowed, it is quickly and almost completely absorbed from the intestine with a linear dependence on the dose value when the drug is used in therapeutic doses. C max plasma is reached within 2-25 hours. When using the drug in therapeutic doses, binding to plasma proteins is about 90%.
Distribution ambroksola in the tissues when taking the drug inside is fast; the highest concentrations of the active substance are found in the lungs. T 1/2 is 10 hours.
About 30% of the dose taken internally undergoes intensive metabolism due to primary passage through the liver. Ambroxol is metabolized mainly in the liver by conjugation to inactive metabolites.
- is used as a symptomatic tool to relieve sore throats.
In adults and adolescents over 12 years of age: dissolve 1 tablet. from 1 to 6 times / day. The drug can be used before or after a meal.
In the event that the high temperature and symptoms persist for 3 days, the advisability of further taking the drug is determined by the attending physician.
On the part of the digestive system: often (> 1% and <10%) - nausea, heartburn, decreased sensitivity in the oral cavity or throat; infrequently (> 0.1% and <1%) - pain in the upper abdomen, diarrhea, indigestion, dry mouth; frequency not established * - vomiting, dryness in the throat.
On the part of the immune system, skin and subcutaneous tissues: frequency is not established * - allergic reactions (including anaphylactic shock), angioedema, skin rash, urticaria, pruritis and other allergic reactions.
From the nervous system: often (> 1% and <10%) - dysgeusia (a violation of taste sensations).
* - Adverse events were not identified or their relationship with the drug was not proven. The frequency of these rare phenomena is difficult to assess.
- Children under 12 years of age (no data on effectiveness);
- Pregnancy (I trimester);
- Hypersensitivity to ambroxol or other components of the drug.
Pregnancy period (II-III trimester) and lactation period, renal and / or hepatic insufficiency.
PREGNANCY AND LACTATION
Ambroxol hydrochloride penetrates the placental barrier. In animal studies, there was no adverse effect on either pregnancy or fetal development. The extensive clinical experience of using ambroxol after the 28th week of pregnancy in women indicates that there is no adverse effect on pregnancy.
In the first trimester, use is contraindicated, in the second and third trimester of pregnancy - with caution.
Ambroxol hydrochloride may be excreted in human milk. However, the adverse effect in newborns is unlikely. Care should be taken when lazogin is used by nursing mothers.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: liver failure.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
Lazognin, when used at the recommended maximum dose, contains 8.2 g of sorbitol. Patients with a rare hereditary intolerance to fructose should not take this drug.
In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - temperature, body pain, rhinitis, cough and sore throat may appear in the early phase. With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol hydrochloride. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of the drug; but there is no causal relationship with taking the drug. With the development of the above syndromes (the sudden appearance of rashes and spots on the face and trunk, which can later spread to other parts of the body), it is recommended to stop treatment and seek medical help immediately.
Lazognin contains less than 1 mg of lactose in the dry flavor of peppermint 9/008677. Patients with a rare hereditary intolerance to galactose or a violation of glucose / galactose adsorption should not take this drug. If the kidneys are abnormal, Lazognin should be used only on the advice of a doctor.
Specific symptoms of an overdose in humans are not described.
Symptoms: nausea, vomiting, diarrhea, indigestion.
Treatment: symptomatic therapy.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Store the drug in a dry place at a temperature of no higher than 30 В° C. Keep out of the reach of children. Shelf life - 3 years.
Do not use the drug after the expiration date.