Niatira^® (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

S02AA12 (Rifamycin)

Active Substance

Rifamycin (Rec.INN registered by WHO)

Dosage Form

Niatira®

Ear drops 2.6%

Dosage Form, Packaging, and Composition

Ear drops

10 ml – bottles – cardboard packs – By prescription

Clinical-Pharmacological Group

Antibacterial drug for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of ear diseases; antimicrobial agents

Pharmacological Action

An antibiotic of the rifamycin group, obtained from the actinomycete Streptomyces mediterranei. It has a bactericidal effect. The mechanism of action is associated with the suppression of RNA synthesis by forming a complex with DNA-dependent RNA polymerase.

At low concentrations, it is active against Mycobacterium tuberculosis, Staphylococcus spp., Streptococcus spp. (including Streptococcus pneumoniae), Neisseria gonorrhoeae, Neisseria meningitidis; at higher concentrations, it is active against Escherichia coli, Proteus spp.

It is active against strains of microorganisms resistant to semi-synthetic penicillins and cephalosporins. It does not interact crosswise with other antibiotics (except for rifampicin).

Pharmacokinetics

It is rapidly absorbed after intramuscular administration. C_max is reached after 30 minutes, the therapeutic concentration is maintained for 6-8 hours. With a 4-fold increase in dose, C_max increases by 1.5-3 times and after intravenous administration is higher than after intramuscular administration, but decreases faster. Does not cumulate. Plasma protein binding is 60-70%. Distribution: the maximum concentration is in the liver, less in the kidneys, lungs, ascitic and pleural fluids. It is retained for a long time in the foci of inflammation. Does not penetrate the blood-brain barrier. Penetrates the placental barrier. Metabolized to form an active metabolite. T_1/2 is 2 hours. Excreted in bile (60-90% within 8-24 hours), in small amounts by the kidneys. Partial reabsorption occurs in the intestine, causing prolonged circulation in the body. In cholestasis, the plasma concentration increases.

When used topically in the form of ear drops, it is characterized by low absorption into the systemic circulation.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to rifamycin, including gonorrhea, tuberculosis.

ICD codes

Dosage Regimen

Intramuscularly for adults and children over 6 years of age weighing more than 25 kg – 500-750 mg every 8 and 12 hours, respectively; for children under 6 years of age – 125 mg every 12 hours.

Intravenously for adults and children weighing more than 25 kg – 500 mg per day; for children weighing less than 25 kg – the daily dose is 10-30 mg/kg, the frequency of administration is 2-4 times/day.

For ear diseases in adults and children, apply topically 2 times/day.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea, anorexia, erosive gastritis, pseudomembranous enterocolitis, increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis.

Allergic reactions urticaria, eosinophilia, angioedema, bronchospasm, arthralgia, fever.

From the hematopoietic system leukopenia.

From the reproductive system dysmenorrhea.

From the central and peripheral nervous system headache, visual impairment, ataxia, disorientation, muscle weakness.

From the urinary system nephron necrosis, interstitial nephritis.

Other herpes, phlebitis (with intravenous administration), induction of porphyria.

With topical use in the form of ear drops allergic reactions, staining of the eardrum pink (visible during otoscopy).

Contraindications

Jaundice, recently suffered (less than 1 year) infectious hepatitis, severe renal impairment, pregnancy, lactation period, hypersensitivity to rifamycins.

Use in Pregnancy and Lactation

Rifamycin is contraindicated for use during pregnancy and during the lactation period (breastfeeding).

No clinical studies on the safety of topical use of rifamycin in the form of ear drops during pregnancy and lactation have been conducted.

Use in Hepatic Impairment

Contraindicated in jaundice, recently suffered (less than 1 year) infectious hepatitis. Use with caution in patients with impaired liver function due to the risk of developing jaundice.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Use with caution in patients with impaired liver function due to the risk of developing jaundice.

During treatment, the skin, sputum, sweat, feces, tear fluid, and urine of patients may acquire an orange-red color. It may permanently stain soft contact lenses. Contains sulfites, which must be taken into account when prescribing to patients with hypersensitivity to sulfur.

Drug Interactions

Antacids, opioids, anticholinergic agents and ketoconazole reduce (in case of simultaneous oral administration) the bioavailability of rifamycin.

With simultaneous use, isoniazid and/or pyrazinamide increase the frequency and severity of liver function disorders to a greater extent (in patients with pre-existing liver disease).

With simultaneous use, Rifamycin reduces the activity of oral anticoagulants, oral hypoglycemic drugs, hormonal contraceptives, digitalis preparations, antiarrhythmic agents (disopyramide, quinidine, mexiletine, tocainide), corticosteroids, dapsone, hydantoins (phenytoin), hexobarbital, nortriptyline, benzodiazepines, sex hormones, theophylline, chloramphenicol, ketoconazole, itraconazole, cyclosporine A, azathioprine, beta-blockers, slow calcium channel blockers, enalapril, cimetidine (Rifamycin causes induction of some liver enzyme systems, accelerates metabolism).

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.