Ribamidil (Tablets) Instructions for Use

Marketing Authorization Holder

Biopharma, CJS (Russia)

ATC Code

J05AP01 (Ribavirin)

Active Substance

Ribavirin (Rec.INN WHO registered)

Dosage Form

Ribamidil

Tablets 200 mg: 20, 50, 100, 25000, or 50000 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – non-cell contour packs (10) – cardboard packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
25000 pcs. – polyethylene bags (1) – combined material bags.
50000 pcs. – polyethylene bags (1) – combined material bags.

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Antiviral agent

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 guanyltransferase, 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), bunyaviruses (Rift Valley fever virus, Crimean-Congo hemorrhagic fever virus), hantaviruses (hemorrhagic fever with renal or pulmonary syndrome virus) 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 developing hemorrhagic complications and an unfavorable outcome of the disease.

DNA viruses – Varicella zoster, pseudorabies virus, natural cowpox; 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 use: 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

Dosage Regimen

Determine the dosage regimen individually based on the indication, route of administration, and patient factors.

For chronic hepatitis C in adults, administer orally in combination with interferon alfa-2b or peginterferon alfa-2b. The dose is weight-based. For patients weighing <75 kg (165 lbs), prescribe 1000 mg per day orally in two divided doses. For patients weighing ≥75 kg, prescribe 1200 mg per day orally in two divided doses.

Adjust the dose in cases of hemolytic anemia or other significant adverse reactions. Do not reduce the dose below 600 mg per day. If hemoglobin levels fall below 10 g/dL, reduce the dose by 200 mg. If hemoglobin levels fall below 8.5 g/dL, discontinue therapy permanently.

For the treatment of hemorrhagic fever with renal syndrome, administer parenterally in a hospital setting. The initial dose is 33 mg/kg IV, followed by 16 mg/kg IV every 6 hours for 4 days, then 8 mg/kg IV every 8 hours for 3 days. The total course duration is 7 days.

For topical application in herpes simplex virus infections or herpes zoster, apply a thin layer to affected skin and mucous membranes several times a day. Use as monotherapy or as an adjunct to systemic antiviral treatment.

For all indications, initiate therapy as early as possible following diagnosis. The duration of treatment for chronic hepatitis C is typically 24 to 48 weeks, depending on the viral genotype and treatment response.

Monitor complete blood count with differential, blood chemistry, and thyroid function tests before therapy and regularly during treatment. Perform pregnancy tests in women of reproductive potential before, during, and for 4 months after therapy cessation.

Adverse Reactions

From the CNS 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 BP, 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, multiforme erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis; with IV 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 insufficiency, decompensated liver cirrhosis, autoimmune diseases (including autoimmune hepatitis), treatment-resistant thyroid diseases, severe depression with suicidal tendencies, children and adolescents 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 insufficiency, 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.

When used concomitantly with interferons, therapeutic efficacy increases.

When used concomitantly 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.