Peteha (Tablets) Instructions for Use

Marketing Authorization Holder

Riemser Arzneimittel, AG (Germany)

Manufactured By

Fatol Arzneimittel subsidiary of Riemser Arzneimittel, AG (Germany)

Promotion

SVICH, LLC (Russia)

ATC Code

J04AD01 (Protionamide)

Active Substance

Protionamide (Rec.INN registered by WHO)

Dosage Form

Peteha

Film-coated tablets, 250 mg: 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow-orange in color, with a score on one side.

Excipients: microcrystalline cellulose – 81.4 mg, copovidone – 4.3 mg, hypromellose (hydroxypropyl methylcellulose) – 4.3 mg, crospovidone – 8.6 mg, magnesium stearate – 1.4 mg.

Shell composition: hypromellose (hydroxypropyl methylcellulose) – 5.4 mg, titanium dioxide – 1.3 mg, yellow-orange S – 1.1 mg, macrogol 6000 (polyethylene glycol 6000) – 2.4 mg.

100 pcs. – plastic containers (1) – cardboard packs.

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Antitubercular agent

Pharmacological Action

[I] – Instructions for medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation on 06/27/2000

Second-line antituberculosis agent, acts bacteriostatically, blocks the synthesis of mycolic acids, which are the most important structural component of the cell wall of Mycobacterium tuberculosis. It has the properties of a nicotinic acid antagonist. In high concentrations, it disrupts the synthesis of the microbial cell protein and acts bactericidally. Effective against Mycobacterium tuberculosis resistant to first-line drugs. Use in combination with other antituberculosis drugs reduces the likelihood of developing tuberculosis resistance.

Pharmacokinetics

Protionamide is rapidly absorbed from the gastrointestinal tract, achieving a C_max in blood plasma 2-3 hours after oral administration. It penetrates into healthy and pathologically altered tissues (tuberculous foci and cavities in the lungs, serous and purulent pleural effusion, cerebrospinal fluid in meningitis). In the body, it is partially converted into a sulfoxide, which has tuberculostatic activity. It is partially excreted unchanged (up to 15-20% of the administered dose) in urine and feces.

Indications

• Treatment of all forms of tuberculosis, including cases with pathogen resistance to other antituberculosis drugs (first-line) or intolerance to them.

ICD codes

Dosage Regimen

Administer the drug orally, after meals to improve gastrointestinal tolerance.

For adult patients, initiate therapy with 250 mg three times daily.

With good tolerance, transition to a regimen of 500 mg twice daily to enhance patient compliance.

For patients over 60 years of age and those with a body weight under 50 kg, the maximum daily dose is 750 mg.

In this population, administer 250 mg twice daily as the standard regimen.

For the pediatric population, calculate the daily dose based on 10-20 mg per kg of body weight.

Divide the total daily dose into two or three administrations.

Always use protionamide as part of a multidrug antituberculosis regimen to prevent the development of resistance.

Adjust dosing carefully in patients with risk factors for hepatotoxicity.

Monitor for gastrointestinal adverse effects, which may necessitate dose adjustment or administration with food.

Adverse Reactions

Adverse effects of protionamide manifest from the gastrointestinal tract, liver, skin, endocrine and nervous systems.

From the digestive system: loss of appetite, nausea, vomiting, dryness and metallic taste in the mouth. After drug withdrawal, these phenomena, as a rule, quickly disappear.

Often during treatment, an increase in transaminase levels in the blood is noted. Rarely, pronounced liver function disorders with signs of hepatitis and jaundice are observed. The hepatotoxicity of the drug depends on existing liver function impairments, such as liver damage due to alcoholism or after surgical interventions. These side effects are noted especially during combination therapy with isoniazid, rifampicin, and pyrazinamide.

Skin reactions are rarely noted; in isolated cases, pellagra-like reactions have been described, correspondingly with a combination of skin manifestations and CNS disorders.

From the endocrine system, sometimes along with the development of hypoglycemia (blood sugar decrease below 50 mg%) in patients with diabetes mellitus, the development of gynecomastia (enlargement of mammary glands in men) has been described. Rarely, menstrual cycle disorders and impotence are noted, as well as hypothyroidism (decreased thyroid function).

From the CNS and peripheral nervous system, sometimes in combination with isoniazid, cases of polyneuropathy have been described. Taking protionamide can cause dizziness, headaches, concentration disorders, and mental disorders. Simultaneous administration of other antituberculosis drugs, such as isoniazid or cycloserine, can lead to an increase in CNS side effects. The same effect can be caused by simultaneous alcohol intake. In isolated cases, allergic reactions and bone marrow disorders have been described.

Contraindications

• Individual hypersensitivity to the drug components;
• Pregnancy;
• Lactation period;
• Acute gastritis;
• Gastric and duodenal ulcer;
• Erosive-ulcerative colitis;
• Acute hepatitis;
• Liver cirrhosis;
• Chronic alcoholism.

Use in Pregnancy and Lactation

Protionamide should not be used during pregnancy and lactation.

Use in Renal Impairment

The drug is contraindicated in cirrhosis, hepatitis.

Pediatric Use

Children are prescribed at a rate of 10-20 mg/kg of body weight per day.

Geriatric Use

For patients over 60 years of age and with a body weight less than 50 kg, the daily dose should not exceed 0.75 g (more often prescribed as 0.25 g 2 times/day).

Special Precautions

Concomitant use of protionamide and alcohol should be avoided due to the risk of CNS excitation states (associated with increased toxic effect of alcohol).

With combined use of protionamide with isoniazid and cycloserine, special attention should be paid to the possibility of mental disorders.

Since the drug is constantly used in combination with other antituberculosis medications, regular monitoring of serum transaminases, gamma-glutamyltransferase, and alkaline phosphatase is necessary. In diabetics, blood sugar level control is necessary.

Skin and especially mucous membrane reactions may be the first signs of pellagra-like side effects. This should be regarded as a precursor to the necessary drug withdrawal.

Drug Interactions

During combination therapy for tuberculosis, the additive hepatotoxic effect of individual drugs should be taken into account. This especially applies to the combination of protionamide with isoniazid, rifampicin, and pyrazinamide. An additive effect on the CNS is noted with the combined use of isoniazid and cycloserine.

Simultaneous alcohol intake leads to an increase in the excitatory effect on the central nervous system.

In certain cases when taking protionamide, it is necessary to reduce the dose of insulin or oral antidiabetic drugs.

Due to metabolic competition, the breakdown of other drugs in the body is slowed down, for example, isoniazid or barbiturates.

Storage Conditions

List B.

Store at a temperature not exceeding 25°C (77°F). Protect from moisture and light. Keep out of reach of children.

Shelf Life

The shelf life is 5 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by 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.