Lazongin (Tablets) Instructions for Use

Marketing Authorization Holder

Sanofi Russia JSC (Russia)

Manufactured By

Delpharm Reims (France)

ATC Code

R02AD (Local anesthetics)

Active Substance

Ambroxol (Rec.INN registered by WHO)

Dosage Form

Lazongin

Lozenges 20 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Excipients: sodium saccharin (0.5 mg), sorbitol 1373.5 mg, macrogol 6000 30 mg, talc 60 mg, dry peppermint flavor 9/008677 16 mg.

10 pcs. – strips made of aluminum foil (1) – cardboard packs.
10 pcs. – strips made of aluminum foil (2) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
3 pcs. – strips made of aluminum foil (1) – cardboard packs.
3 pcs. – strips made of aluminum foil (2) – cardboard packs.
3 pcs. – blisters (1) – cardboard packs.
3 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Local anesthetic drug for use in ENT practice

Pharmacotherapeutic Group

Local anesthetic agent

Pharmacological Action

The local anesthetic effect of ambroxol (the active component of the drug) is explained by the drug’s property to block sodium channels. An in vitro study showed that Ambroxol blocks cloned neuronal sodium channels; the 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 for inhalation use. When ambroxol was used as a mucolytic agent, a reduction in pain and associated discomfort in the ear, throat, and nose area was noted.

Clinical studies have confirmed that Lazongin shows an analgesic effect in patients with acute pharyngitis of viral etiology. It has a rapid onset of action with a duration of at least 3 hours. Lazongin significantly reduces hyperemia of the pharyngeal mucosa in patients with a sore throat.

Ambroxol has an anti-inflammatory effect. It has been established that in vitro Ambroxol significantly reduces the release of cytokines from mononuclear and polymorphonuclear blood and tissue cells.

Ambroxol increases the production and secretion of surfactant in the lungs and stimulates the activity of ciliated cells. Enhancement of mucociliary clearance improves sputum discharge and alleviates cough.

Pharmacokinetics

Lazongin acts locally on the mucous membrane of the oral cavity and pharynx. When swallowed, it is rapidly and almost completely absorbed from the intestine with a linear dependence on the dose when the drug is used in therapeutic doses. C_max in plasma is reached within 2-25 hours. When the drug is used in therapeutic doses, plasma protein binding is about 90%.

Distribution of ambroxol in tissues upon oral administration occurs rapidly; the highest concentrations of the active substance are found in the lungs. T_1/2 is 10 hours.

About 30% of the orally administered dose of the drug undergoes intensive metabolism due to the first pass through the liver. Ambroxol is metabolized mainly in the liver by conjugation to inactive metabolites.

Indications

• Used as a symptomatic agent to relieve sore throat.

ICD codes

Dosage Regimen

For adults and adolescents over 12 years, dissolve one lozenge in the mouth.

Administer from one to six times per day as needed for symptomatic relief of sore throat.

Allow the lozenge to dissolve slowly; do not chew or swallow it whole.

Take the drug before or after meals; food intake does not affect its local action.

Maintain a minimum interval of two hours between doses to ensure consistent effect.

The maximum daily dose is six lozenges (120 mg ambroxol hydrochloride).

Do not exceed the recommended maximum daily intake.

Treatment duration is typically short-term for acute symptoms.

If high fever, severe pain, or other symptoms persist for more than three days, discontinue use.

Consult a physician for re-evaluation if symptoms worsen or do not improve.

This regimen is not intended for children under 12 years of age.

Adverse Reactions

From the digestive system: common (>1% and < 10 %) – nausea, heartburn, decreased sensitivity in the oral cavity or throat; uncommon (>0.1% and < 1 %) – pain in the upper abdomen, diarrhea, dyspepsia, dry mouth; frequency not established* – vomiting, dry throat.

From the immune system, skin and subcutaneous tissues: frequency not established* – allergic reactions (including anaphylactic shock), angioedema, skin rash, urticaria, pruritus and other allergic reactions.

From the nervous system common (>1% and < 10 %) – dysgeusia (impaired taste sensations).

* – Adverse events were not identified or their connection with drug intake was not proven. The frequency of these rare events is difficult to estimate.

Contraindications

• Children under 12 years of age (no efficacy data);
• Pregnancy (first trimester);
• Hypersensitivity to ambroxol or other components of the drug.

With caution

Pregnancy period (second-third trimester) and lactation period, renal and/or hepatic impairment.

Use in Pregnancy and Lactation

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not revealed any negative effects on pregnancy or fetal development. Extensive clinical experience with the use of ambroxol after the 28th week of pregnancy in women indicates no negative impact on pregnancy.

Use is contraindicated in the first trimester, and should be used with caution in the second and third trimesters of pregnancy.

Ambroxol hydrochloride may be excreted in breast milk. However, an adverse effect on newborns is unlikely. If it is necessary to use Lazongin by nursing mothers, caution should be exercised.

Use in Hepatic Impairment

With caution: hepatic impairment.

Use in Renal Impairment

With caution: renal impairment.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

Lazongin, when used at the maximum recommended dose, contains 8.2 g of sorbitol. Patients with rare hereditary fructose intolerance should not take this drug.

In patients with severe skin lesions – Stevens-Johnson syndrome or toxic epidermal necrolysis – fever, body aches, rhinitis, cough, and sore throat may appear in the early phase. Symptomatic treatment may lead to the erroneous prescription of mucolytic agents such as ambroxol hydrochloride. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis that coincided in time with the prescription of the drug; however, a causal relationship with drug intake is absent. If the above syndromes develop (sudden appearance of rash and spots on the face and torso, which may later spread to other parts of the body), it is recommended to discontinue treatment and seek immediate medical attention.

Lazongin contains less than 1 mg of lactose in the dry peppermint flavor 9/008677. Patients with rare hereditary galactose intolerance or glucose/galactose malabsorption should not take this drug. In case of renal impairment, Lazongin should be used only on the recommendation of a doctor.

Overdose

Specific symptoms of overdose in humans have not been described.

Symptoms nausea, vomiting, diarrhea, dyspepsia.

Treatment symptomatic therapy.

Drug Interactions

Not established.

Storage Conditions

Store the drug in a dry place at a temperature not exceeding 30°C (86°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Do not use the drug after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.