Lasoleks

LASOLEKS

Solution for injection 7.5 mg/ml 2 ml in ampoules No.5, No.20 or No.50.

Mucolytic product. It increases lung secretion, increases lung surfactant release and also stimulates ciliary epithelium activity, which results in better mucus release and its excretion and eases  cough.

Marketing Authorization No. UA/12750/01/01

Composition

active ingredient: ambroxol hydrochloride;

1 ml of the solution contains 7.5 mg of ambroxol hydrochloride;

excipients: sodium chloride, citric acid monohydrate (E 330), disodium phosphate dodecahydrate (E 339), water for injections.

Pharmaceutical form

Solution for injection.

Physical and chemical properties: clear colorless or yellowish liquid.

Pharmacotherapeutic group

Products used to treat cough and cold-related diseases. Mucolytic products. ATC Code R05C B06.

Pharmacological properties

Pharmacodynamics.

As it was found during pre-clinical studies, ambroxol hydrochloride, an active ingredient of Lasoleks, can increase lung secretion. It can also increase lung surfactant release and stimulate ciliary epithelium activity. These action result in better mucus release and its clearance (mucociliary clearance). Mucociliary clearance improvement was demonstrated during clinical pharmacological studies. Liquid secretion activation and increase of mucociliary clearance enable mucus excretion and help to ease patient’s cough.

In vitro studies demonstrated that ambroxol hydrochloride reduces the number of cytokines and it also reduces the number or circulating and tissue-bound mononuclear and polymorphnuclear cells.

Anti-oxidant effects of ambroxol were also reported during pre-clinical studies.

Upon ambroxol hydrochloride administration, antibiotics (amoxicillin, cefuroxime, erythromycin) concentration in bronchopulmonary secretion and mucus increases.

Pharmacokynetics.

Ambroxol hydrochloride binds with plasma serum by 90% in  adults and by 60-70% in newborns. The product penetrates though placenta barrier and reaches fetus lungs. A high distribution volume (410 l) evidences about the fact that it accumulates mostly in tissues, rather than in plasma. Concentration in lung tissue is more than that in  plasma having ≥ 17 ratio.

Metabolism and excretion Ambroxol hydrochloride metabolizes mostly in liver through glucuronidation and in some cases it can be metabolized through decomposition to dibromanthranilic acid (almost 10% of the dose); other insignificant metabolites are also formed. Studies dedicated to the human liver microsomes showed that СYР3А4 enzyme contributes in metabolism of ambroxol hydrochloride to dibromanthranilic acid.. 3 days after intravenous injection, 4-6% of dose are excreted unchanged, while 35.6% are excreted in conjugated form with urine.

Ambroxol hydrochloride half-live period in plasma is 10 hours.

When product is administered among newborns, a half-live period upon repeated administration is almost doubled, which demonstrates clearance decrease.

In case of severe liver diseases, ambroxol clearance is decreased  by 20-40%. In case of severe renal dysfunction, ambroxol metabolites (dibromanthranilic acid and glucuronides) accumulation may occur.

Ambroxol penetrates through blood-brain and placenta barriers and is excreted into breastmilk.

 

Clinical performance

Indications.

The product is used to increase lung surfactant release among premature infants and newborns having respiratory distress.

Contraindications

Known hypersensitivity to ambroxol hydrochloride or to any other product components.

Special warnings

Several cases about acute  skin reactions were reported: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) associated with the usage of expectorant drugs, as ambroxol hydrochloride. They could be explained by severe character of the main disease or by simultaneous intake of another product. Therefore, if any dermal or mucous reactions appear, discontinue the use of the product and obtain medical treatment immediately.

Since ambroxol can increase mucus secretion, Lasoleks, solution for injection, should be used with due care in case of bronchial motility disorders or increased mucus secretion (for example, at such rare disease as primary ciliary dyskinesia).

Lasoleks, solution for injection, should be used with due care among the patients having renal disorders or severe liver disorders (either by increasing an interval between administrations or by reducing the dose).

Metabolites accumulation in the liver is likely to happen among the patients having severe renal dysfunction.

Interaction with other medicinal products and other forms of interaction

The simultaneous intake of Lasoleks, solution for injection, and cough-suppressive products may cause excessive mucus accumulation due to cough reflex suppression. Therefore, such combination is possible only upon detailed evaluation by the doctor of the expected benefit and possible risks.

The simulatenous intake with antibiotics (amoxicillin, doxycycline, cefuroxime, erythromycin) results in their increased concentration in lung tissue.

Precautions for use

Since ambroxol can increase mucus secretion, Lasoleks, solution for injection, should be used with due care in case of bronchial motility disorders and increased mucus secretion (for example, at such rare disease as primary ciliary dyskinesia).

Lasoleks should be administered with due care among the patients having renal dysfunction or severe liver disorders. When ambroxol, as any other active ingredient being metabolized in liver and being excreted by kidneys, metabolites accumulation in liver is observed among the patients with the severe renal failure.

The following very rare dermal reactions are observed: Stevens-Johnson syndrome and Lyell's syndrome (toxic epidermal necrolysis (TEN)) associated with the usage of ambroxol hydrochloride. They could be explained by severe character of the main disease or by simultaneous intake of another product. Therefore, if any dermal or mucous reactions appear, discontinue the use of the product and obtain medical treatment immediately.

Lasoleks, solution for injection, contains less than 1 mmol (23 mg) of sodium per ampoule.

Pregnancy and lactation.

The product is prescribed for premature infants and newborns.

Effects on ability to drive and use machines.

The product is prescribed for premature infants and newborns.

Posology and method of administration

It was proven that the most effective daily dose is 30 mg of ambroxol hydrochloride per 1 kg of body weight.

The dose is used in 4 intakes through slow intravenous infusion. It is recommended to use each dose through intravenous infusion with pump for infusion within at least 5 minutes.

Dilute 1-6 ampoules in 250-500 ml of natural saline solution or Ringer solution directly before use. Use the obtained solution within 6 hours after its preparation.

The treatment should last within 5 days.

Instruction for use of  ampule.

1. Separate one ampoule from the block and shake the contents gently, holding the ampoule by its neck.

2. Squeeze the ampoule in your hand (the product leakage shall not occur) and remove the cap by rotating it.

3.Immediately put a syringe in the ampoule through the obtained hole.

4.Turn the ampoule over and slowly suck the liquid in the syringe.

5.Put a needle on the syringe.

Children.

The product is prescribed for premature infants and newborns.

Overdose

No data reported about specific overdose symptoms. The symptoms which are observed at the typical overdose or in case of medical error are similar to the known adverse reactions in recommended doses and may require symptomatic treatment.

Adverse reactions

To evaluate adverse reactions, the following classification was used:

very common > 1/10;
common > 1/100-< 1/10;
uncommon > 1/1000-< 1/100;
rare > 1/10 000-< 1/1000;
very rare < 1/10 000;
unknown not evaluated based on the data available.


Immune
system/skin and subcutaneous tissue:

uncommon ‒ erythema;

unknown ‒ anaphylactic reactions (including anaphylactic shock),  angioedema, skin rash, hives, itching and other hypersensitivity reactions, severe skin reactions: Stevens-Johnson syndrome and Lyell's syndrome.

Gastric intestinal tract:

uncommon ‒ dry mouth, constipation,salivation, dry throat;

unknown ‒ nausea, vomiting, diarrhea,  dyspepsia, stomachache.

Respiratory system, thoracic and mediastinum organs:

uncommon ‒ rhinorrhea, dyspnea (hypersensitivity symptoms).

Renal and urinary system:

uncommon‒ urination disorders.

General disorders and pathological events in the administration site:

uncommon ‒ high temperature and shiver, mucous membrane reactions.

Shelf life

2 years.

Discard the unused ampoule’s contents. Do not store for the further use.

Storage conditions

Store in original package at the temperature not above 25 ºС.

Keep away from children.

Incompatibility

Lasoleks should not be mixed with any medicines, unless specified in section “Posology and method of administration”.

Do not mix with other solutions, since it can result in the mixtures having pH of more than 6.3 and ambroxol hydrochloride precipitate as free base may be formed as the result of high pH.

Packaging

2 ml in ampoules No.5.

Prescription category

Following the doctor’s prescription.

Feedback

Materials on the medicine

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