Rimpin (Capsules) Instructions for Use

Marketing Authorization Holder

Medical Leasing-Consulting, LLC (Russia)

Manufactured By

Rozlex Pharm LLC (Russia)

ATC Code

J04AB02 (Rifampicin)

Active Substance

Rifampicin (Rec.INN WHO registered)

Dosage Forms

	Rimpin	Capsules 150 mg: 8, 20, 40, 80, 100, 200 or 1000 pcs.
		Capsules 300 mg: 8, 20, 40, 80, 100, 200 or 1000 pcs.
		Capsules 450 mg: 8, 20, 40, 80, 100, 200 or 1000 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 3, red in color, with white print “LYKA”; capsule contents – red-brown powder.

Excipients: sodium lauryl sulfate – 1.5 mg, colloidal silicon dioxide – 1 mg, magnesium stearate – 4 mg, sodium carboxymethyl starch – 4.5 mg, lactose monohydrate – 45 mg.

Capsule body composition dye azorubine (E122) – 0.624%, titanium dioxide (E171) – 2%, purified water – 14.5%, gelatin – up to 100%.
Capsule cap composition dye azorubine (E122) – 0.624%, titanium dioxide (E171) – 2%, purified water – 14.5%, gelatin – up to 100%.

4 pcs. – blisters (2) – cardboard packs.
4 pcs. – blisters (10) – cardboard packs.
4 pcs. – blisters (20) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.
100 pcs. – polyethylene bottles (1) – cardboard packs.
1000 pcs. – polyethylene bottles (1) – cardboard packs.

Capsules hard gelatin, size No. 1, red in color, with white print “LYKA”; capsule contents – red-brown powder.

Excipients: magnesium stearate – 8 mg, sodium carboxymethyl starch – 10 mg, corn starch – 4 mg, talc – 2 mg.

Capsule body composition dye azorubine (E122) – 0.624%, titanium dioxide (E171) – 2%, purified water – 14.5%, gelatin – up to 100%.
Capsule cap composition dye azorubine (E122) – 0.624%, titanium dioxide (E171) – 2%, purified water – 14.5%, gelatin – up to 100%.

4 pcs. – blisters (2) – cardboard packs.
4 pcs. – blisters (10) – cardboard packs.
4 pcs. – blisters (20) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.
100 pcs. – polyethylene bottles (1) – cardboard packs.
1000 pcs. – polyethylene bottles (1) – cardboard packs.

Capsules hard gelatin, size No. 0, red in color, with white print “LYKA”; capsule contents – red-brown powder.

Excipients: sodium lauryl sulfate – 4 mg, colloidal silicon dioxide – 2 mg, magnesium stearate – 5 mg, sodium carboxymethyl starch – 10 mg, lactose monohydrate – 29 mg, talc – 10 mg.

Capsule body composition dye azorubine (E122) – 0.624%, titanium dioxide (E171) – 2%, purified water – 14.5%, gelatin – up to 100%.
Capsule cap composition dye azorubine (E122) – 0.624%, titanium dioxide (E171) – 2%, purified water – 14.5%, gelatin – up to 100%.

4 pcs. – blisters (2) – cardboard packs.
4 pcs. – blisters (10) – cardboard packs.
4 pcs. – blisters (20) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.
100 pcs. – polyethylene bottles (1) – cardboard packs.
1000 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic of the rifamycin group. Antituberculosis drug

Pharmacotherapeutic Group

Antibiotic-rifamycin

Pharmacological Action

A broad-spectrum semisynthetic antibiotic of the rifamycin group. It exerts a bactericidal effect. It suppresses the synthesis of bacterial RNA by inhibiting the DNA-dependent RNA polymerase of the pathogen.

It is highly active against Mycobacterium tuberculosis and is a first-line antituberculosis drug.

It is active against gram-positive bacteria: Staphylococcus spp. (including multidrug-resistant strains), Streptococcus spp., Bacillus anthracis, Clostridium spp., as well as against some gram-negative bacteria: Neisseria meningitidis, Haemophilus influenzae, Brucella spp., Legionella pneumophila.

It is active against Rickettsia prowazekii, Mycobacterium leprae, Chlamydia trachomatis.

Resistance to rifampicin develops rapidly. No cross-resistance to other antituberculosis drugs (except for other rifamycins) has been noted.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. It is distributed in most body tissues and fluids. It crosses the placental barrier. Plasma protein binding is high (89%). It is metabolized in the liver. T_1/2 is 3-5 hours. It is excreted in bile, feces, and urine.

Indications

Tuberculosis (including tuberculous meningitis) as part of combination therapy. MAC infection. Infectious and inflammatory diseases caused by pathogens sensitive to rifampicin (including osteomyelitis, pneumonia, pyelonephritis, leprosy; meningococcal carriage).

ICD codes

Dosage Regimen

For oral administration, adults and children – 10 mg/kg once a day or 15 mg/kg 2-3 times a week. It is taken on an empty stomach; the duration of treatment is set individually.

Intravenous for adults – 600 mg once a day or 10 mg/kg 2-3 times a week, for children – 10-20 mg/kg once a day or 2-3 times a week.

Administration into the pathological focus is possible (by inhalation, intracavitary administration, and also into the skin lesion focus) at 125-250 mg.

Maximum doses for oral administration for adults daily dose – 1.2 g, for children 600 mg, for intravenous administration for adults and children – 600 mg.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea, decreased appetite; increased levels of liver transaminases, bilirubin in blood plasma, pseudomembranous colitis, hepatitis.

Allergic reactions urticaria, angioedema, bronchospasm, flu-like syndrome.

From the hematopoietic system rarely – thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, hemolytic anemia.

From the central nervous system headache, ataxia, visual impairment.

From the urinary system renal tubular necrosis, interstitial nephritis, acute renal failure.

From the endocrine system menstrual cycle disorders.

Other red-brown discoloration of urine, feces, saliva, sputum, sweat, tears.

Contraindications

Jaundice, recently (less than 1 year) suffered infectious hepatitis, severe renal impairment, hypersensitivity to rifampicin or other rifamycins.

Use in Pregnancy and Lactation

If it is necessary to use rifampicin during pregnancy, the intended benefit of therapy for the mother and the potential risk to the fetus should be assessed.

It should be borne in mind that the use of rifampicin in the last weeks of pregnancy increases the risk of bleeding in newborns and mothers in the postpartum period.

Rifampicin is excreted in breast milk. If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in jaundice, recently (less than 1 year) suffered infectious hepatitis.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

In newborns and premature infants, Rifampicin is used only in cases of extreme necessity.

Special Precautions

Use with caution in liver diseases, exhaustion. When treating non-tuberculous infections, rapid development of microorganism resistance is possible; this process can be prevented by combining Rifampicin with other chemotherapeutic agents. With daily intake of rifampicin, its tolerability is better than with intermittent treatment. If it is necessary to resume treatment with rifampicin after a break, it should be started with a dose of 75 mg/day, gradually increasing it by 75 mg/day until the desired dose is reached. In this case, renal function should be monitored; additional administration of glucocorticosteroids may be necessary.

With long-term use of rifampicin, systematic monitoring of blood counts and liver function is indicated; the bromsulphthalein loading test should not be used, since Rifampicin competitively inhibits its excretion.

PAS preparations containing bentonite (aluminum hydrosilicate) should be prescribed no earlier than 4 hours after taking rifampicin.

In newborns and premature infants, Rifampicin is used only in cases of extreme necessity.

Drug Interactions

Due to the induction of liver microsomal enzymes (isoenzymes CYP2C9, CYP3A4), Rifampicin accelerates the metabolism of theophylline, oral anticoagulants, oral hypoglycemic drugs, hormonal contraceptives, digitalis preparations, verapamil, phenytoin, quinidine, glucocorticosteroids, chloramphenicol, antifungal drugs, which leads to a decrease in their plasma concentrations and, accordingly, a decrease in their effect.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.