Lorothricin^®-Alium (Tablets) Instructions for Use

Marketing Authorization Holder

Binnopharm JSC (Russia)

Manufactured By

Aliym, JSC (Russia)

Contact Information

BINNOPHARM GROUP LLC (Russia)

ATC Code

R02AB (Antibiotics)

Active Substances

Benzalkonium chloride (Rec.INN registered by WHO)

Benzocaine (Rec.INN registered by WHO)

Tyrothricin (Rec.INN registered by WHO)

Dosage Form

Lorothricin®-Aliym

Lozenges 1 mg+1.5 mg+0.5 mg: 6, 10, 12, or 20 pcs.

Dosage Form, Packaging, and Composition

Lozenges white or almost white, round, biconvex, with a minty odor.

Excipients: sorbitol, povidone (K30), polysorbate 20, mint flavor, magnesium stearate.

6 pcs. – blister packs (1) – cardboard packs.
6 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
12 pcs. – blister packs (1) – cardboard packs.
12 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Drug with antimicrobial and local anesthetic action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antibiotics

Pharmacological Action

A combined drug that has an antiseptic and local anesthetic effect. It reduces irritation and pain in the throat, as well as swelling of the oral mucosa.

Benzocaine is a local anesthetic that reduces pain when swallowing, which often accompanies infectious and inflammatory processes of the mouth and throat.

Benzalkonium chloride is an antiseptic that disrupts the permeability of the microorganism cell membrane and inhibits enzymatic processes. It is active against many pathogenic bacteria, some types of viruses, fungi, and protozoa.

Tyrothricin is a topical antibiotic. It is active against a wide range of gram-positive microorganisms and oral spirochetes. Due to the special mechanism of action of tyrothricin, which is absent in systemic antibiotics, cross-resistance to the drug does not occur.

Pharmacokinetics

Absorption

Benzocaine is poorly soluble in water, which causes its poor absorption in the intestine.

Benzalkonium chloride is practically not absorbed in the intestine and does not have a resorptive effect.

Metabolism

Benzocaine is broken down by enzymes in the blood plasma and is metabolized in the liver to a small extent.

Excretion

It is excreted by the kidneys.

Tyrothricin – due to low systemic absorption, data on pharmacokinetics are not available. It does not affect the intestinal microflora.

Indications

Symptomatic treatment of infectious and inflammatory diseases of the mouth and throat, accompanied by pain syndrome

• Pharyngitis, laryngitis, tonsillitis;
• Inflammation of the gums and oral mucosa (gingivitis, stomatitis).

ICD codes

Dosage Regimen

Topical use. Slowly dissolve in the mouth.

Adults and children over 6 years old – 1 tablet every 3 hours. The maximum daily dose is 6 tablets.

The course of treatment is 7 days. Extension of the course of therapy if necessary – on the recommendation of a doctor.

It is not recommended to eat food and chew chewing gum for 1 hour after using the drug or as long as numbness is felt in the mouth and throat, because there is a risk of aspiration and damage to the oral mucosa.

Adverse Reactions

Allergic reactions, gastrointestinal disorders (nausea, diarrhea) are possible.

Allergic reactions skin itching, skin rash, swelling of the oral and throat mucosa, anaphylactic reactions; burning sensation, tingling in the mouth and throat; convulsions; tachycardia; dermatitis.

Decreased sensitivity of the oral and throat mucosa is possible.

After topical application, in particular, in the presence of large wounds in the mouth and throat, especially in children, the development of methemoglobinemia is possible, which is manifested by shortness of breath, bluish coloration of the lips and fingers.

Tyrothricin, in the presence of fresh wounds, can cause bleeding.

In susceptible patients, allergic reactions caused by substances that are chemically related to benzocaine, such as penicillins, sulfonamides, cosmetic sunscreen, are possible.

Contraindications

• Hypersensitivity to benzalkonium chloride, benzocaine, tyrothricin, para-aminobenzoic acid, quaternary ammonium compounds or to any of the excipients that make up the drug;
• Fresh wounds in the mouth and throat, including immediately after maxillofacial surgery, dental procedures;
• Children under 6 years of age.

Use in Pregnancy and Lactation

Pregnancy

During pregnancy, the drug can be used only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

During breastfeeding, the drug can be used only in cases where the intended benefit to the mother outweighs the potential risk to the child.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Special Precautions

In case of severe sore throat (sore throat accompanied by high body temperature, headache, nausea or vomiting), you should consult a doctor. In case of a known skin hypersensitivity reaction (allergic contact dermatitis), the use of the drug should be avoided due to the possibility of developing a hypersensitivity reaction. It is necessary to observe an interval of 1 hour between the use of the drug and the use of toothpaste, because a decrease in the antibacterial effect of the drug is possible.

Excipients

The drug contains sorbitol. Patients with rare hereditary fructose intolerance should not take this drug.

Information for patients with diabetes in 1 tablet of the drug, the carbohydrate content is approximately 0.07 XE.

Children

For children from 6 to 18 years old, the use of the drug is recommended only for medical reasons.

Effect on the ability to drive vehicles and mechanisms

The drug Lorothricin^®-Aliym does not affect the ability to drive vehicles and work with mechanisms.

Overdose

No cases of overdose have been described at recommended doses.

Symptoms: accidental intake of large doses of the drug Lorothricin^®-Aliym can cause disorders of the digestive system (nausea, vomiting, diarrhea), methemoglobinemia (difficulty breathing and bluish skin color).

Treatment: gastric lavage, intake of sorbents (activated charcoal).

Drug Interactions

No cases of clinically significant interaction of the drug Lorothricin^®-Aliym with other drugs have been described.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed without a prescription.

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.