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Ribavirin (Tablets, Capsules, Lyophilisate) Instructions for Use

ATC Code

J05AP01 (Ribavirin)

Active Substance

Ribavirin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; antiviral agents for the treatment of hepatitis C

Pharmacological Action

Antiviral agent. It quickly penetrates cells and acts inside virus-infected cells. Intracellularly, Ribavirin is easily phosphorylated by adenosine kinase to mono-, di-, and triphosphate metabolites. Ribavirin triphosphate is a strong competitive inhibitor of inosine monophosphate dehydrogenase, influenza virus RNA polymerase, and messenger RNA guanylyl transferase, the latter manifested by inhibition of the messenger RNA capping process.

These diverse effects lead to a significant decrease in the amount of intracellular guanosine triphosphate, as well as suppression of viral RNA and protein synthesis. Ribavirin inhibits the replication of new virions, which ensures a reduction in viral load, selectively inhibits the synthesis of viral RNA without suppressing RNA synthesis in normally functioning cells.

It is most active against DNA viruses – respiratory syncytial virus, Herpes simplex virus types 1 and 2, adenoviruses, CMV, poxvirus group viruses, Marek’s disease virus; RNA viruses – influenza A, B viruses, paramyxoviruses (parainfluenza, mumps, Newcastle disease), reoviruses, arenaviruses (Lassa fever virus, Bolivian hemorrhagic fever virus), bunyaviruses (Rift Valley fever virus, Crimean-Congo hemorrhagic fever virus), hantaviruses (hemorrhagic fever virus with renal or pulmonary syndrome), paramyxoviruses, oncogenic RNA viruses.

In the treatment of hemorrhagic fever with renal syndrome, it reduces the severity of the disease, shortens the duration of symptoms (fever, oliguria, pain in the lumbar region, abdomen, headache), improves laboratory parameters of kidney function, reduces the risk of hemorrhagic complications and unfavorable outcome of the disease.

DNA viruses – Varicella zoster, pseudorabies virus, natural cowpox virus; RNA viruses – enteroviruses, rhinoviruses, Semliki forest encephalitis virus are not sensitive to ribavirin.

Indications

For oral administration: treatment of chronic hepatitis C in adults (in combination with interferon alfa-2b or peginterferon alfa-2b).

Parenterally: hemorrhagic fever with renal syndrome.

Topically as monotherapy or in combination with other dosage forms of ribavirin for oral and parenteral administration: infections of the skin and mucous membranes caused by Herpes simplex viruses types 1 and 2, of various localizations, including in the genital area; herpes zoster (as part of complex therapy).

ICD codes

ICD-10 code Indication
A60 Anogenital herpesviral infection [herpes simplex]
A98.5 Hemorrhagic fever with renal syndrome
B00 Herpesviral [herpes simplex] infections
B02 Zoster [herpes zoster]
B18.2 Chronic viral hepatitis C
ICD-11 code Indication
1A94.Z Anogenital herpes simplex virus infection without further specification
1D62.0 Hemorrhagic fever with renal syndrome
1E51.1 Chronic viral hepatitis C
1E91.Z Herpes zoster, unspecified
1F00.Z Infections due to herpes simplex virus, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Determine the dosage regimen individually based on the indication, patient age, and specific pharmaceutical form (tablets, capsules, lyophilisate).

For chronic hepatitis C in adults, administer orally in combination with interferon alfa-2b or peginterferon alfa-2b. The typical dose for patients weighing 75 kg or less is 1000 mg per day, administered as two 200 mg capsules in the morning and three 200 mg capsules in the evening. For patients weighing more than 75 kg, the dose is 1200 mg per day, administered as three 200 mg capsules in the morning and three 200 mg capsules in the evening.

For the treatment of hemorrhagic fever with renal syndrome, administer parenterally. The initial intravenous dose is 33 mg/kg, followed by 16 mg/kg every 6 hours for 4 days, then 8 mg/kg every 8 hours for 3 days. The total duration of intravenous therapy is 7 to 10 days, depending on the clinical response and tolerance.

For topical application to treat Herpes simplex infections or herpes zoster, apply the formulation to affected skin and mucous membranes several times daily. Use topically as monotherapy or as an adjunct to systemic ribavirin therapy.

Adjust the dose or discontinue treatment in case of severe adverse reactions, particularly a significant decrease in hemoglobin concentration. Monitor hematological parameters, including hemoglobin, hematocrit, leukocyte, neutrophil, and platelet counts, before therapy and at weeks 2 and 4 of treatment, and periodically thereafter.

For all indications, the total duration of therapy should not exceed the recommended course. Complete the full prescribed course unless otherwise directed by a physician due to intolerance or lack of efficacy.

Adverse Reactions

From the central and peripheral nervous system: headache, dizziness, general weakness, malaise, insomnia, asthenia, depression, irritability, anxiety, emotional lability, nervousness, agitation, aggressive behavior, confusion; rarely – suicidal tendency, increased smooth muscle tone, tremor, paresthesia, hyperesthesia, hypoesthesia, fainting.

From the cardiovascular system: decrease or increase in blood pressure, brady- or tachycardia, palpitations, cardiac arrest.

From the hematopoietic organs: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia; extremely rarely – aplastic anemia.

From the respiratory system: dyspnea, cough, pharyngitis, shortness of breath, bronchitis, otitis media, sinusitis, rhinitis.

From the digestive system: dry mouth, decreased appetite, nausea, vomiting, diarrhea, abdominal pain, constipation, taste perversion, pancreatitis, flatulence, stomatitis, glossitis, gum bleeding, hyperbilirubinemia.

From the sensory organs: lacrimal gland lesion, conjunctivitis, visual impairment, hearing impairment/loss, tinnitus.

From the musculoskeletal system: arthralgia, myalgia.

From the genitourinary system: hot flashes, decreased libido, dysmenorrhea, amenorrhea, menorrhagia, prostatitis.

Allergic reactions: skin rash, erythema, urticaria, hyperthermia, angioedema, bronchospasm, anaphylaxis, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; with intravenous administration – chills.

Local reactions: pain at the injection site.

Other: hair loss, alopecia, impaired hair structure, dry skin, hypothyroidism, chest pain, thirst, fungal infection, viral infection (including herpes), flu-like syndrome, sweating, lymphadenopathy. In healthcare workers performing inhalation administration, headache, itching, redness of the eyes or swelling of the eyelids are possible.

Contraindications

Chronic heart failure stage IIB-III, myocardial infarction, renal failure (creatinine clearance less than 50 ml/min), severe anemia, severe hepatic failure, decompensated liver cirrhosis, autoimmune diseases (including autoimmune hepatitis), treatment-resistant thyroid diseases, severe depression with suicidal tendencies, childhood and adolescence under 18 years of age, pregnancy, lactation period, hypersensitivity to ribavirin.

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

Contraindicated in severe hepatic failure, decompensated liver cirrhosis, autoimmune hepatitis.

Use in Renal Impairment

Contraindicated in renal failure (creatinine clearance less than 50 ml/min).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Use only in a hospital setting with a specialized intensive care unit. The use of ribavirin in patients requiring mechanical ventilation is possible only by specialists with experience in resuscitation measures.

Use with caution in women of reproductive age (pregnancy is undesirable), in patients with decompensated diabetes mellitus (with ketoacidosis attacks), with COPD, pulmonary embolism, chronic heart failure, with thyroid diseases (including thyrotoxicosis), with blood clotting disorders, with thrombophlebitis, myelodepression, hemoglobinopathy (including thalassemia, sickle cell anemia), depression, suicidal tendency (including in history), concomitant HIV infection (against the background of combined highly active antiretroviral therapy – risk of lactic acidosis), in elderly patients.

Medical personnel using Ribavirin should take into account its teratogenicity.

Drug Interactions

The possibility of drug or other type of interaction with ribavirin may persist for up to two months (5 half-lives of ribavirin) after its discontinuation due to slow elimination.

With simultaneous use with interferons, therapeutic efficacy increases.

With simultaneous use with ribavirin, the effectiveness of stavudine and zidovudine may decrease.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin Tablets 200 mg: 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Ribavirin 200 mg

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin Capsules 200 mg: blisters of 5, 6, or 10 pcs., containers of 10, 12, 14, 18, 20, 30, 40, 50, 60, 100, 120, 140, 180, or 200 pcs.

Dosage Form, Packaging, and Composition

Capsules 1 caps.
Ribavirin 100 mg

5 pcs. – blisters (2) – cardboard packs.
5 pcs. – blisters (4) – cardboard packs.
5 pcs. – blisters (6) – cardboard packs.
60 pcs. – polymer containers (1) – cardboard packs.
6 pcs. – blisters (2) – cardboard packs.
10 pcs. – polymer containers (1) – cardboard packs.
10 pcs. – polymer containers (5) – cardboard packs.
10 pcs. – polymer containers (10) – cardboard boxes.
10 pcs. – polymer containers (20) – cardboard boxes.
10 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (100) – cardboard boxes.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (20) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (40) – cardboard boxes.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (60) – cardboard boxes.
10 pcs. – blisters (7) – cardboard boxes.
10 pcs. – blisters (80) – cardboard boxes.
10 pcs. – blisters (800) – cardboard boxes.
10 pcs. – blisters (9) – cardboard boxes.
10 pcs. – bottles (1) – cardboard packs.
10 pcs. – bottles (10) – cardboard boxes.
10 pcs. – bottles (20) – cardboard boxes.
10 pcs. – bottles (5) – cardboard boxes.
100 pcs. – polymer containers (1) – cardboard packs.
100 pcs. – polymer containers (10) – cardboard boxes.
100 pcs. – polymer containers (20) – cardboard boxes.
12 pcs. – polymer containers (1) – cardboard packs.
12 pcs. – polymer containers (10) – cardboard boxes.
12 pcs. – polymer containers (20) – cardboard boxes.
120 pcs. – polymer containers (1) – cardboard packs.
120 pcs. – polymer containers (10) – cardboard boxes.
120 pcs. – polymer containers (20) – cardboard boxes.
140 pcs. – polymer containers (1) – cardboard packs.
140 pcs. – polymer containers (10) – cardboard boxes.
140 pcs. – polymer containers (20) – cardboard boxes.
140 pcs. – polymer containers (5) – cardboard boxes.
18 pcs. – polymer containers (1) – cardboard packs.
18 pcs. – polymer containers (10) – cardboard boxes.
18 pcs. – polymer containers (20) – cardboard boxes.
18 pcs. – polymer containers (5) – cardboard boxes.
180 pcs. – polymer containers (1) – cardboard packs.
180 pcs. – polymer containers (10) – cardboard packs.
180 pcs. – polymer containers (20) – cardboard packs.
180 pcs. – polymer containers (5) – cardboard packs.
20 pcs. – polymer containers (1) – cardboard packs.
20 pcs. – polymer containers (10) – cardboard boxes.
20 pcs. – polymer containers (20) – cardboard boxes.
20 pcs. – polymer containers (5) – cardboard boxes.
200 pcs. – polymer containers (10) – cardboard boxes.
200 pcs. – polymer containers (20) – cardboard boxes.
30 pcs. – polymer containers (1) – cardboard packs.
30 pcs. – polymer containers (10) – cardboard boxes.
30 pcs. – polymer containers (20) – cardboard boxes.
30 pcs. – polymer containers (5) – cardboard boxes.
36 pcs. – polymer containers (5) – cardboard boxes.
36 pcs. – polymer containers (10) – cardboard boxes.
36 pcs. – polymer containers (20) – cardboard boxes.
36 pcs. – polymer containers (1) – cardboard packs.
40 pcs. – polymer containers (1) – cardboard packs.
40 pcs. – polymer containers (10) – cardboard boxes.
40 pcs. – polymer containers (20) – cardboard boxes.
40 pcs. – polymer containers (5) – cardboard boxes.
45 pcs. – polymer containers (5) – cardboard boxes.
45 pcs. – polymer containers (10) – cardboard boxes.
45 pcs. – polymer containers (20) – cardboard boxes.
45 pcs. – polymer containers (1) – cardboard packs.
5 pcs. – blisters (1) – cardboard packs.
5 pcs. – blisters (3) – cardboard packs.
5 pcs. – blisters (5) – cardboard packs.
5 pcs. – blisters (7) – cardboard packs.
5 pcs. – blisters (8) – cardboard packs.
5 pcs. – blisters (9) – cardboard packs.
5 pcs. – blisters (10) – cardboard packs.
5 pcs. – blisters (20) – cardboard boxes.
5 pcs. – blisters (40) – cardboard boxes.
5 pcs. – blisters (60) – cardboard boxes.
5 pcs. – blisters (80) – cardboard boxes.
5 pcs. – blisters (100) – cardboard boxes.
5 pcs. – blisters (800) – cardboard boxes.
60 pcs. – polymer containers (10) – cardboard boxes.
60 pcs. – polymer containers (20) – cardboard boxes.
60 pcs. – polymer containers (5) – cardboard boxes.
50 pcs. – polymer containers (5) – cardboard boxes.
50 pcs. – polymer containers (10) – cardboard boxes.
50 pcs. – polymer containers (20) – cardboard boxes.
50 pcs. – polymer containers (1) – cardboard packs.
6 pcs. – blisters (1) – cardboard packs.
6 pcs. – blisters (3) – cardboard packs.
6 pcs. – blisters (4) – cardboard packs.
6 pcs. – blisters (5) – cardboard packs.
6 pcs. – blisters (6) – cardboard packs.
6 pcs. – blisters (7) – cardboard packs.
6 pcs. – blisters (8) – cardboard packs.
6 pcs. – blisters (9) – cardboard packs.
6 pcs. – blisters (10) – cardboard packs.
6 pcs. – blisters (20) – cardboard boxes.
6 pcs. – blisters (40) – cardboard boxes.
6 pcs. – blisters (60) – cardboard boxes.
6 pcs. – blisters (80) – cardboard boxes.
6 pcs. – blisters (100) – cardboard boxes.
6 pcs. – blisters (800) – cardboard boxes.
200 pcs. – polymer containers (5) – cardboard boxes.
200 pcs. – polymer containers (1) – cardboard packs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin Tablets 200 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a bevel and a score.

1 tab.
Ribavirin 200 mg

Excipients : lactose monohydrate, potato starch, methylcellulose, magnesium stearate.

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

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin Capsules 200 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules 1 caps.
Ribavirin 200 mg

10 pcs. – blister packs (3) – cardboard packs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Bottle Rx Icon Ribavirin Canon Tablets 200 mg: 20, 30, 60, 90 or 120 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line; slight marbling is allowed.

1 tab.
Ribavirin 200 mg

Excipients: calcium hydrogen phosphate dihydrate – 42.45 mg, calcium stearate – 1.55 mg, pregelatinized starch – 26 mg, magnesium stearate – 3 mg, talc – 3 mg, microcrystalline cellulose – 34 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (12) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (4) – cardboard packs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Bottle Rx Icon Ribavirin Canon Capsules 200 mg: 30, 40, 60, 90, or 140 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size #0, white body, green cap; capsule contents – a mixture of granules and powder, white or almost white in color.

1 caps.
Ribavirin 200 mg

Excipients: calcium hydrogen phosphate dihydrate – 50.1 mg, colloidal silicon dioxide – 0.9 mg, croscarmellose sodium – 6 mg, lactose monohydrate – 30 mg, magnesium stearate – 3 mg, povidone – 10 mg.

Capsule body composition: gelatin – 57.82 mg, titanium dioxide – 1.18 mg.
Capsule cap composition: gelatin – 35.885 mg, iron oxide yellow – 0.634 mg, indigo carmine – 0.111 mg, titanium dioxide – 0.37 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (14) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.

Marketing Authorization Holder

Meduna Arzneimittel GmbH (Germany)

Dosage Form

Bottle Rx Icon Ribavirin Meduna Capsules 200 mg: 100 pcs.

Dosage Form, Packaging, and Composition

Capsules 1 caps.
Ribavirin 200 mg

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

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin-FPO Tablets 200 mg: 20, 30, 60, 100, or 140 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Ribavirin 200 mg

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (14) – cardboard packs.

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin-FPO Capsules 200 mg: 10, 20, 30, 40, 50, 60, 70, 80, or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules 1 caps.
Ribavirin 200 mg

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.

Marketing Authorization Holder

Vector-Medica, JSC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin-Lipint® Lyophilisate for the preparation of suspension for oral administration 200 mg: vial 1 or 6 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of suspension for oral administration in the form of a powder or porous mass from white to light yellow; delamination, complete or partial, from the surface of the vial glass with the formation of a tablet-like structure is allowed, hygroscopic.

1 vial
Ribavirin 200 mg

Excipients: sodium chloride – 12 mg, Lipoid S100 (phospholipids (mixture with a phosphatidylcholine content of at least 94%)) – 360 mg, cholesterol – 40 mg, alpha-tocopherol acetate (vitamin E acetate) – 3.6 mg, methylparaben (nipagin) – 2.8 mg, lactose monohydrate – 348 mg.

200 mg – vials (1) – cardboard packs.
200 mg – vials (6) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle Rx Icon Ribavirin-Vertex Capsules 200 mg: 20, 30, 40, 60, 80, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size #0, yellow; capsule contents – powder or compacted mass from white to white with a yellowish tint, disintegrating upon pressure.

1 caps.
Ribavirin 200 mg

Excipients: lactose monohydrate, corn starch, povidone (low molecular weight polyvinylpyrrolidone), colloidal silicon dioxide, calcium stearate.

Composition of hard gelatin capsules: titanium dioxide, iron oxide yellow (iron oxide), gelatin.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (12) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (8) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (4) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
90 pcs. – polyethylene jars (1) – cardboard packs.
120 pcs. – polyethylene jars (1) – cardboard packs.

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