Ribavirin-SZ capsules 200 mg 120 pcs.

Composition

Active ingredient: 

• ribavirin 200 mg.

• Auxiliary substances: 

• lactose monohydrate (milk sugar) – 96 mg,

• colloidal silicon dioxide (aerosil) – 2 mg,

• magnesium stearate-2 mg.

Capsule body composition: 

• titanium dioxide,

• gelatin.

Capsule cap composition: 

• titanium dioxide,

• gelatin.

Pharmacological action

Ribavirin C3 is an antiviral agent. It quickly penetrates cells and acts inside virus-infected cells. Intracellularly, ribavirin is readily 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 guanylyl transferase of messenger RNA. The latter is manifested by inhibition of the process of covering the messenger RNA envelope.

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 reduces the 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, smallpox viruses, Marek’s disease; RNA viruses – influenza A, B viruses, paramyxoviruses (parainfluenza, mumps, Newcastle disease), reoviruses, arenaviruses (Lassa fever virus, Bolivian hemorrhagic fever), bunyaviruses (Valley fever virus Rift virus, Crimean-Congo hemorrhagic fever virus), hantaviruses (hemorrhagic fever virus with renal or pulmonary syndrome) paramyxoviruses, oncogenic RNA viruses.

When treating hemorrhagic fever with renal syndrome, it reduces the severity of the disease, reduces the duration of symptoms (fever, oliguria, lumbar pain, abdominal pain, headache), improves laboratory indicators of kidney function, reduces the risk of hemorrhagic complications and an unfavorable outcome of the disease.

Ribavirin is insensitive to DNA viruses such as Varicella zoster, pseudoburf virus, and natural cowpox; RNA viruses such as enteroviruses, rhinoviruses, and encephalitis virus of the Semliki forest.

Indications

Chronic viral hepatitis C (in combination with interferon Alfa-2b or peginterferon Alfa-2b):

• from primary patients not previously treated with interferon Alfa-2b or peginterferon Alfa-2b;
• exacerbation after a course of monotherapy with interferon Alfa-2b or peginterferon Alfa-2b;
• in patients unresponsive to monotherapy with interferon Alfa-2b or peginterferon Alfa-2b.

Contraindications

• Chronic heart failure IIB-III. ;
• myocardial infarction;
• renal failure (CC less than 50 ml/min);
• hepatic failure;
• cirrhosis of the liver in the stage of decompensation;
• severe anemia;
• autoimmune diseases (including autoimmune hepatitis);
• not treatable thyroid disease;
• severe depression with suicidal intentions;
• childhood and adolescence to 18 years;
• pregnancy;
• lactation;
• hypersensitivity.

With caution, the drug should be prescribed for decompensated diabetes mellitus (with attacks of ketoacidosis); chronic obstructive pulmonary disease; pulmonary embolism; chronic heart failure; thyroid diseases (including thyrotoxicosis); blood clotting disorders; thrombophlebitis; myelodepression; hemoglobinopathy (including thalassemia, sickle cell anemia); depression, a tendency to suicide (including in the anamnesis); women of reproductive age (pregnancy is undesirable); elderly patients.

Side effects

Nervous system disorders: headache, dizziness, insomnia, depression, irritability, restlessness, emotional lability, nervousness, agitation, aggressive behavior, confusion; rarely-suicidal tendencies, increased smooth muscle tone, tremor, paresthesia, hyperesthesia, hypesthesia, fainting.

From the side of the visual organ: lacrimal gland involvement, conjunctivitis, visual impairment.

From the side of the hearing organ: hearing impairment / loss, tinnitus.

From the cardiovascular system: decrease or increase in blood pressure, bradycardia or tachycardia, palpitation sensation, cardiac arrest.

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

Respiratory system disorders: dyspnoea, 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 distortion, pancreatitis, flatulence, stomatitis, glossitis, gum bleeding, hyperbilirubinemia.

From the side of the reproductive system: decreased libido, dysmenorrhea, amenorrhea, menorrhagia, prostatitis.

Musculoskeletal disorders: arthralgia, myalgia.

Allergic reactions: skin rash, erythema, urticaria, hyperthermia, angioedema, bronchospasm, anaphylaxis, photosensitization, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Other services: general weakness, malaise, asthenia, hair loss, conjunctivitis, alopecia, hair structure disorders, dry skin, hypothyroidism, chest pain, thirst, fungal infection, viral infection, flu-like syndrome, sweating, lymphadenopathy, hot flashes.

Interaction

Drugs containing magnesium and aluminum compounds, simethicone reduce the bioavailability of the drug (AUC decreases by 14%, which is not clinically significant).

When combined with Interferon alfa-2b or pegInterferon alfa-2b – synergism of action.

The use of ribavirin during treatment with zidovudine and / or stavudine is accompanied by a decrease in their phosphorylation, which may lead to HIV viremia and require a change in the treatment regimen.

Increases the concentration of phosphorylated metabolites of purine nucleosides (including didanosine, abacavir) and the associated risk of lactic acidosis.

It does not affect the enzymatic activity of the liver with the participation of cytochrome P 450.

Concomitant intake of high-fat foods increases the bioavailability of ribavirin (AUC and_cmax increase by 70%).

How to take, course of administration and dosage

The drug is taken orally, along with a meal. Capsules are swallowed whole, without chewing and washed down with water.

The recommended dose is 0.8-1.2 g / day in 2 divided doses (morning and evening).

At the same time, Interferon alfa-2b – subcutaneous injection of 3 million IU 3 times a week or peginterferon alpha 2b – subcutaneous injection of 1.5 mcg/kg 1 time a week is prescribed. In combination with Interferon alfa-2b, if the patient’s body weight is less than 75 kg, the dose of ribavirin is 1 g / day (0.4 g in the morning and 0.6 g in the evening); above 75 kg – 1.2 g/day (0.6 g in the morning and 0.6 g in the evening). In combination with peginterferon alfa-2b, if the patient’s body weight is less than 65 kg, the ribavirin dose is 0.8 g/day (0.4 g in the morning and 0.4 g in the evening), if the body weight is 65-85 kg – 1 g/day (0.4 g in the morning and 0.6 g in the evening), and if the patient’s body weight is more than 85 kg – 1.2 g/day (0.6 g in the morning and 0.6 g in the evening).

The duration of treatment is 24-48 weeks; however, for previously untreated patients-at least 24 weeks, in patients with genotype 1 virus-48 weeks. In patients who are immune to interferon alpha monotherapy, as well as in case of relapse – at least 6 months-1 year (depending on the clinical course of the disease and the response to therapy).

Overdose

Symptoms: possible increase in the severity of side effects.

Treatment: discontinuation of the drug, carrying out symptomatic therapy.

Special instructions

The teratogenicity of the drug should be taken into account. Men and women of reproductive age should use effective contraceptives during treatment and for 7 months after the end of therapy.

Laboratory tests (clinical blood analysis with calculation of the leukocyte formula and platelet count, determination of electrolytes, creatinine content, liver function tests) should be performed before starting therapy, for 2 and 4 weeks, and then regularly.

During treatment with ribavirin, the maximum decrease in hemoglobin content in most cases is noted after 4-8 weeks from the start of treatment. With a decrease in hemoglobin below 110 mg/ml, the ribavirin dose should be temporarily reduced by 400 mg / day, and with a decrease in hemoglobin below 100 mg/ml, the dose should be reduced to 50% of the initial one. In most cases, the recommended dose changes ensure that hemoglobin levels are restored. If hemoglobin decreases below 85 mg/ml, the drug should be discontinued.

In case of acute hypersensitivity (urticaria, angioedema, bronchospasm, anaphylaxis), the drug should be discontinued immediately. Transient rashes are not grounds for discontinuing treatment.

Due to possible deterioration of renal function in elderly patients, before using the drug, it is necessary to conduct a study of renal function, in particular creatinine clearance.

Influence on the ability to drive vehicles and mechanisms

During treatment, patients experiencing fatigue, drowsiness or disorientation should refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Ribavirin

Conditions of release from pharmacies

By prescription

Dosage form

of the capsule

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Hepatitis

Weight

Weight: 84 gr.