Universal reference book for medicines

Active substance: ribavirin

Type: Antiviral drug

Manufacturer: СЕВЕРНАЯ ЗВЕЗДА (Russia)
Composition, form of production and packaging
hard gelatinous, size в„–0, white;
the contents of the capsules are white or white powder with a yellowish tint of color.
1 caps.

ribavirin 200 mg

[PRING] lactose monohydrate (sugar milk) - 96 mg, silicon dioxide colloid (aerosil) - 2 mg, magnesium stearate - 2 mg.

The composition of the capsule body: titanium dioxide, gelatin.

Composition of capsule capsule: titanium dioxide, gelatin.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (6) - packs cardboard.
10 pieces.
- packings cellular planimetric (12) - packs cardboard.
30 pcs.
- polymer cans (1) - packs of cardboard.
30 pcs.
- vials polymeric (1) - packs cardboard.
60 pcs.
- polymer cans (1) - packs of cardboard.
60 pcs.
- vials polymeric (1) - packs cardboard.
120 pcs.
- polymer cans (1) - packs of cardboard.
120 pcs.
- vials polymeric (1) - packs cardboard.

Description of the drug approved by the manufacturer for the printed edition of 2016.


Ribavirin is a synthetic analogue of nucleosides with a pronounced antiviral effect.
Has a wide spectrum of activity against various DNA and RNA-containing viruses.
Ribavirin easily penetrates into the cells affected by the virus and is rapidly phosphorylated by intracellular adenosine kinase to mono-, di- and triphosphate metabolites.
These metabolites, especially ribavirin triphosphate, have a pronounced antiviral activity.
The mechanism of action of ribavirin has not been elucidated.
However, it is known that ribavirin inhibits inosine monophosphate dehydrogenase (IMP), this effect leads to a marked decrease in the level of intracellular guanosine triphosphate (GTP), which in turn is accompanied by suppression of the synthesis of viral RNA and virus-specific proteins. Ribavirin inhibits the replication of new virions, which reduces viral load. Ribavirin selectively inhibits the synthesis of viral RNA, without suppressing the synthesis of RNA in normally functioning cells.
Ribavirin is effective against many DNA and RNA-containing viruses.
The most sensitive to ribavirin DNA viruses are: Nerpes simplex viruses, Poxoviruses, Marek's disease virus. Insensitive to ribavirin DNA viruses are: Varicella zoster, pseudorabies virus, cowpox virus. The most sensitive to Ribavirin RNA viruses are: influenza A, B virus, paramyxovirus (parainfluenza, mumps, Newcastle disease), reoviruses, oncogenic RNA viruses. Insensitive to ribavirin RNA viruses are: enteroviruses, rhinoviruses, encephalitis virus of the Semliki forest.
Ribavirin has activity against the hepatitis C virus (HCV).
The mechanism of action of ribavirin against HCV is not fully elucidated. It is assumed that the ribavirin triphosphate accumulating in the course of phosphorylation competitively suppresses the formation of guanosine triphosphate, thereby reducing the synthesis of viral RNAs. It is also believed that the mechanism of synergistic action of ribavirin and interferon alpha against HCV is due to the increased phosphorylation of ribavirin by interferon.


When taken orally, ribavirin is rapidly absorbed from the digestive tract.
At the same time its bioavailability is more than 45%. The time to reach C max in plasma is from 1 to 1.5 hours. The time to reach a therapeutic concentration in the plasma depends on the value of the minute volume of the blood. The average plasma C maxvalue of about 5 Ојmol / L at the end of 1 week of application at a dose of 200 mg every 8 hours and about 11 Ојmol / L at the end of 1 week of application at a dose of 400 mg every 8 hours. After taking a single dose with food containing fats, the pharmacokinetics of ribavirin varies significantly (AUC and C max increase by 70%).

Ribavirin is distributed in plasma, the secretion of the mucous membrane of the respiratory tract and red blood cells.
A large amount of ribavirin triphosphate accumulates in erythrocytes, reaching a plateau by day 4 and persisting for several weeks after administration. The half-distribution period is 3.7 hours. V d - 647-802 l. With the course application ribavirin accumulates in plasma in large quantities. The ratio of bioavailability indicators (AUC) for repeated and single administration is 6. A significant concentration of ribavirin (more than 67%) can be detected in cerebrospinal fluid after prolonged use. Slightly binds to plasma proteins.

Ribavirin is phosphorylated in the liver cells into active mono-, di- and triphosphate metabolites, which are then metabolized to 1,2,4-triazolecarboxamide (amide hydrolysis to tricarboxylic acid and deribozylation to form the triazole carboxyl metabolite).


Ribavirin is excreted slowly from the body.
T 1/2 after a single dose of 200 mg is from 1 to 2 hours - from the plasma and up to 40 days - from erythrocytes. After stopping the course of use, T 1/2 is about 300 hours. Ribavirin and its metabolites are mainly excreted from the body by the kidneys, only about 10% is excreted through the intestine. In unchanged form, about 7% of ribavirin is excreted in 24 hours and about 10% in 48 hours.
Pharmacokinetics in specific patient groups

In patients with renal insufficiency, AUC and C max of ribavirin increase, which is due to a decrease in true clearance.

In patients with hepatic insufficiency (class A, B and C on the Child-Pugh scale), the pharmacokinetics of ribavirin does not change.


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

- in primary patients previously untreated with interferon alpha-2b or peginterferon alfa-2b;

- with exacerbation after a course of monotherapy with interferon alpha-2b or peginterferon alfa-2b;

- in patients not susceptible to monotherapy with interferon alpha-2b or peginterferon alfa-2b.


The drug is taken orally, along with a meal.
Capsules are swallowed whole, not liquid and squeezed 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-sc administration is prescribed for 3 million IU 3 times a week or peginterferon alfa-2b-1.5 Ојg / kg once a week.
When combined with interferon alpha-2b with a body weight of the patient up to 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). When combined with peginterferon alfa-2b with a body weight of the patient less than 65 kg, the dose of ribavirin is 0.8 g / day (0.4 g in the morning and 0.4 g in the evening), with a body weight of 65-85 kg - 1 g / day (0.4 g in the morning and 0.6 g evening), more than 85 kg - 1.2 g / day (0.6 g in the morning and 0.6 g in the evening).
Duration of treatment - 24 - 48 weeks;
while for previously untreated patients - not less than 24 weeks, in patients with the virus of genotype 1 - 48 weeks. In patients not susceptible to monotherapy with interferon alpha, and also in case of relapse, at least 6 months-1 year (depending on the clinical course of the disease and response to the therapy).

From the side of the nervous system: headache, dizziness, insomnia, depression, irritability, anxiety, emotional lability, nervousness, agitation, aggressive behavior, confused consciousness;
rarely - suicidal tendencies, increased smooth muscle tone, tremor, paresthesia, hyperesthesia, hypoesthesia, fainting.
From the side of the organ of vision: lesion of the lacrimal gland, conjunctivitis, impaired vision.

On the part of the hearing organ: hearing impairment / hearing loss, tinnitus.

From the cardiovascular system: a decrease or increase in blood pressure, bradycardia or tachycardia, a feeling of palpitations, cardiac arrest.

From the hemopoietic system: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia;
extremely rare - aplastic anemia.
On the part of the respiratory system: dyspnoea, cough, pharyngitis, dyspnea, bronchitis, otitis media, sinusitis, rhinitis.

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

On the part of the reproductive system: decreased libido, dysmenorrhea, amenorrhea, menorrhagia, prostatitis.

From the musculoskeletal system: arthralgia, myalgia.

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

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


- chronic heart failure IIb-III st .;

- myocardial infarction;

- renal failure (CC less than 50 ml / min);

- liver failure;

- cirrhosis of the liver in the stage of decompensation;

- severe anemia;

- autoimmune diseases (including autoimmune hepatitis);

- non-treatable thyroid disease;

- severe depression with suicidal intentions;

- children and adolescence under 18;

- Pregnancy;

- lactation period;


With caution should prescribe the drug in decompensated diabetes mellitus (with attacks of ketoacidosis);
chronic obstructive pulmonary disease; thromboembolism of the pulmonary artery; chronic heart failure; diseases of the thyroid gland (including thyrotoxicosis); disorders of blood clotting; thrombophlebitis; myelodepression;hemoglobinopathies (including thalassemia, sickle-cell anemia); depression, suicidal tendencies (including in anamnesis); women of reproductive age (the onset of pregnancy is undesirable); patients of advanced age.

The use of the drug is contraindicated in pregnancy and lactation.


Contraindicated use of the drug in renal failure (KK less than 50 ml / min).


Contraindicated use of the drug in liver failure, decompensated liver cirrhosis, autoimmune hepatitis.


Contraindicated use of the drug in children and adolescents under 18 years.


Caution should be given to elderly patients.


It should take into account the teratogenicity of the drug.
Men and women of reproductive age during treatment and within 7 months after the end of therapy should use effective contraceptives.
Laboratory tests (clinical analysis of blood counting the leukocyte formula and number of platelets, determination of electrolytes, creatinine content, functional liver tests) should be performed before the start of therapy, for 2 and 4 weeks, and then regularly.

During treatment with ribavirin, the maximum reduction in hemoglobin in most cases occurs after 4-8 weeks from the start of treatment.
With a decrease in hemoglobin below 110 mg / ml, the dose of ribavirin should be temporarily reduced by 400 mg / day, with a decrease in hemoglobin below 100 mg / ml, the dose should be reduced to 50% of the initial dose. In most cases, recommended dose changes ensure the recovery of hemoglobin. With a decrease in hemoglobin below 85 mg / ml, the drug should be discontinued.
In acute manifestation of hypersensitivity (hives, angioedema, bronchospasm, anaphylaxis), the drug should be discontinued immediately.
Transient rashes are not grounds for discontinuing treatment.
In connection with the possible deterioration of kidney function in elderly patients, it is necessary to perform a study of the kidney function, in particular QC, before using the drug.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, patients who are tired, drowsy or disoriented should refrain from driving vehicles and practicing potentially dangerous activities that require increased concentration and speed of psychomotor reactions.


Symptoms: may increase the severity of side effects.

Treatment: withdrawal of the drug, symptomatic therapy.


Medicines containing magnesium and aluminum compounds, simethicone reduce the bioavailability of the drug (AUC decreases by 14%, which has no clinical significance).

When combined with interferon alpha-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 can 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 developing lactic acidosis.

Does not affect the enzymatic activity of the liver with the participation of cytochrome P450.

Simultaneous food intake with a high fat content increases the bioavailability of ribavirin (AUC and C max increase by 70%).


The drug is released by prescription.


The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 В° C.
Shelf life - 3 years.
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y

Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!