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Ribavirin
RTC · LEVOVIRIN · Ribavirine · VIRAZOLE · RIBAVARIN · REBETOL · Copegus · tribavirin
Identifikatoren & physikalische Daten
| CAS No. | 36791-04-5 |
|---|---|
| Summenformel | C8H12N4O5 |
| Durchschnittliche Molmasse | 244,2 g/mol |
| Monoisotopische Masse | 244,0807695 g/mol |
| SMILES | NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1 |
| InChIKey | IWUCXVSUMQZMFG-AFCXAGJDSA-N |
| PubChem CID | 37542 |
| ChEMBL | CHEMBL1643 |
| ChEBI | CHEBI:63580 |
| EC No. | 636-825-3 |
| DTXSID | DTXSID8023557 |
Chemische & physikalische Eigenschaften
| XLogP | -1,8 |
|---|---|
| Polarare Oberfläche (TPSA) | 144 |
| H-Brücken-Donoren | 4 |
| H-Brücken-Akzeptoren | 7 |
| Frei drehbare Bindungen | 3 |
| Schwere Atome | 17 |
| Formalladung | 0 |
| Komplexität | 304 |
| LogP (Verteilungskoeffizient) | -1.85log Kow = -1.85-2.6 |
| Geruch | Odorless |
| Geschmack | Tasteless |
| Color/Form | ColorlessWhite crystalline powder |
| Löslichkeit | greater than or equal to 100 mg/mL at 66 °F (NTP, 1992)SolubleWater-solubleSlightly soluble in alcohol.In water, 142 mg/mL at 25 °C3.32e+01 g/LFreely soluble in water, slightly soluble in ethanol (96 per cent), slightly soluble or very slightly soluble in methylene chloride. It shows polymorphism (5.9).>=10 g/100 mL at 19 ºC |
| Decomposition | When heated to decomposition it emits toxic fumes of /nitrogen oxides/. |
| Schmelzpunkt | 345 to 349 °F (NTP, 1992)174-176 °C166-168 °C (aq ethanol)174-176 °C (ethanol).174 - 176 °C174-176°C |
| Optical Rotation | Specific optical rotation: -36.5 deg at 25 °C/D |
| Physical Description | Ribavirin is a white powder. Exists in two polymorphic forms. (NTP, 1992)Solid |
| Stability/Shelf Life | Ribavirin solutions contain no preservatives and are stable for 24 hr when stored under sterile conditions at a room temperature of 20-30 °C. Following addition of the reconstituted solution to the reservoir of the SPAG-2 and further dilution with sterile water for injection or inhalation (additive free), the ribavirin solution for nebulization should be discarded within 24 hr. |
| Collision Cross Section | 152.15 Ų [M+Na]+ [CCS Type: TWMethod: calibrated with polyalanine and drug standards]149.81 Ų [M+H]+ [CCS Type: TW153.31 Ų [M+K]+ [CCS Type: TW142.23 Ų [M+H-H2O]+ [CCS Type: TW |
| Other Experimental Properties | Exists in two polymorphic forms |
| Siedepunkt | 387.12°C (rough estimate) |
| Dichte | 1.4287 (rough estimate) |
| Brechungsindex | -36 ° (C=1, H2O) |
| Lagerbedingungen | 2-8°C |
| Aggregatzustand | White solid |
| pKa (Säurekonstante) | 12.95±0.70(Predicted) |
| Farbe | White |
| Merck | 14,8198 |
| BCS Class | 3 |
| Stabilität | Stable for 1 year from date of purchase as supplied. Solutions in DMSO or distilled water may be stored at -20°C for up to 3 months. |
| Hauptanwendungen | pharmaceutical (small molecule) |
| InChI | 1S/C8H12N4O5/c9-6(16)7-10-2-12(11-7)8-5(15)4(14)3(1-13)17-8/h2-5,8,13-15H,1H2,(H2,9,16)/t3-,4-,5-,8-/m1/s1 |
| InChIKey | IWUCXVSUMQZMFG-AFCXAGJDSA-N |
| SMILES | NC(=O)c1ncn(n1)[C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O |
| LogP (Verteilungskoeffizient) | -2.260 (est) |
| CAS Datenbank | 36791-04-5 |
| EPA chemische Informationen | Ribavirin (36791-04-5) |
Sicherheit & Vorschriften
| GHS-Einstufung | DangerH317 (47.4%): May cause an allergic skin reaction [Warning Sensitization, Skin]H319 (49.1%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]H335 (57.9%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposureRespiratory tract irritation]H341 (58.8%): Suspected of causing genetic defects [Warning Germ cell mutagenicity]H360 (51.8%): May damage fertility or the unborn child [Danger Reproductive toxicity]H361 (48.2%): Suspected of damaging fertility or the unborn child [Warning Reproductive toxicity]H373 (48.2%): May causes damage to organs through prolonged or repeated exposure [Warning Specific target organ toxicity, repeated exposure]H412 (47.4%): Harmful to aquatic life with long lasting effects [Hazardous to the aquatic environment, long-term hazard]P203, P260, P261, P264+P265, P271, P272, P273, P280, P302+P352, P304+P340, P305+P351+P338, P318, P319, P321, P333+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 114 reports by companies from 11 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. |
|---|---|
| Regulatorische Informationen | Hazard Traits - Developmental ToxicityReproductive ToxicityAuthoritative List - Prop 65Report - regardless of intended function of ingredient in the product1H-1,2,4-Triazole-3-carboxamide, 1-.beta.-D-ribofuranosyl-: Does not have an individual approval but may be used as a component in a product covered by a group standard. It is not approved for use as a chemical in its own right. |
| Brandgefahren | Flash point data for this chemical are not availablehowever, it is probably combustible. (NTP, 1992) |
| Gesundheitsgefahren | SYMPTOMS: Symptoms of exposure to this compound may include headache, abdominal cramps, fatigue, reversible anemia and elevation of bilirubin concentrations. In infants, it may cause deterioration of respiratory function. In adults, it may cause chronic obstructive lung disease or asthma, dyspnea, chest soreness, pulmonary function deterioration, bacterial pneumonia, pneumothorax, apnea, ventilator dependence, cardiac arrest, hypotension, digitalis toxicity, reticulocytosis, rash and conjunctivitis.ACUTE/CHRONIC HAZARDS: When heated to decomposition this compound emits toxic fumes of nitrogen oxides. (NTP, 1992) |
| FDA-Anforderungen | Manufacturers, packers, and distributors of drug and drug products for human use are responsible for complying with the labeling, certification, and usage requirements as prescribed by the Federal Food, Drug, and Cosmetic Act, as amended (secs 201-902, 52 Stat. 1040 et seq., as amended21 U.S.C. 321-392).The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl ribavirin, approved on the basis of safety and effectiveness by FDA under sections 505 and 507 of the Federal Food, Drug, and Cosmetic Act. |
| Reaktive Gruppe | Alcohols and PolyolsAmides and ImidesAmines, Phosphines, and Pyridines |
| Reactivity Profile | RIBAVIRIN may be sensitive to prolonged exposure to light. |
| Air and Water Reactions | Water soluble. |
| Hazard Classes and Categories | Skin Sens. 1 (47.4%)Eye Irrit. 2 (49.1%)STOT SE 3 (57.9%)Muta. 2 (58.8%)Repr. 1B (51.8%)Repr. 2 (48.2%)STOT RE 2 (48.2%)Aquatic Chronic 3 (47.4%) |
| Brandbekämpfung | Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. (NTP, 1992) |
| Erste Hilfe | EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. If symptoms (such as redness or irritation) develop, immediately transport the victim to a hospital.SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment.INHALATION: IMMEDIATELY leave the contaminated areatake deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be usedif not available, use a level of protection greater than or equal to that advised under Protective Clothing.INGESTION: DO NOT INDUCE VOMITING. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. (NTP, 1992) |
| Lagerbedingungen | Commercially available ribavirin powder for inhalation solution should be stored in tight containers in a dry place at 15-25 °C. ... Ribavirin inhalation solutions contain no preservatives and are stable for 24 hours when stored under sterile conditions at a room temperature of 20-30 °C. ... Ribavirin capsules or tablets should be stored at 25 °C, but may be exposed temperatures ranging from 15-30 °C. Ribavirin oral solution should be stored at 2-8 °C or at 25 °C, but may be exposed to temperatures ranging from 15-30 °C. |
| Freisetung ohne Brand | SMALL SPILLS AND LEAKAGE: If you spill this chemical, you should dampen the solid spill material with water, then transfer the dampened material to a suitable container. Use absorbent paper dampened with water to pick up any remaining material. Seal your contaminated clothing and the absorbent paper in a vapor-tight plastic bag for eventual disposal. Wash all contaminated surfaces with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned.STORAGE PRECAUTIONS: You should protect this material from exposure to light, and store it in a refrigerator. (NTP, 1992) |
| Entsorgungsverfahren | SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational exposure or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air qualitypotential migration in soil or watereffects on animal, aquatic, and plant lifeand conformance with environmental and public health regulations. |
| Preventive Measures | Ribavirin can precipitate on contact lenses of health-care personnel exposed to aerosolized drug, and such precipitation may be associated with conjunctivitis. Therefore, it has been suggested that contact lens wearers use eyeglasses rather than contact lenses or, alternatively, use protective goggles while potentially in contact with aerosolized ribavirin.Because of uncertainties about potential risk, procedures to minimize environmental exposure to aerosolized ribavirin generally should be developed. Whenever possible, patients receiving ribavirin inhalation therapy should be located in rooms where potential exposure of personnel and other patients is minimized (e.g., private rooms with adequate ventilation or, preferably, the National Institute for Occupational Safety and Health [NIOSH] recommends isolation rooms that are under negative pressure and have adequate air exchange and exhaust to the outside).In deciding the method of administration of ribavirin inhalation therapy, current data on associated exposure levels should be considered, and, whenever possible, methods associated with the lowest levels of exposure employed. Except when immediate care is necessary, the small-particle aerosol generator should be turned off (using a remote switch) temporarily, but for at least 5-10 minutes before entering the room, when attending to the patient and when handling the respiratory apparatus. In addition, the air pressure of the ribavirin treatment room should be evaluated (e.g., using tissue paper at the ajar doorway) and ideally be negative relative to the hallway prior to initiation of a treatment session. An aerosol delivery hood intended for use in administering oxygen and aerosolized ribavirin and that includes a vacuum exhaust filtration system has recently become available from the manufacturer of ribavirin (Valeant) and reportedly can substantially reduce the risk of aerosol emission into the environment during ribavirin inhalation therapy. |
| Personal Protective Equipment (PPE) | RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with an organic vapor/acid gas cartridge (specific for organic vapors, HCl, acid gas and SO2) with a dust/mist filter. (NTP, 1992)Use of gowns, gloves, goggles, and masks, which already may be part of the usual procedures for minimizing nosocomial spread of RSV when in contact with infected patients, has been suggested, although the level of protection provided is not known. Some experts, including NIOSH, state that use of surgical masks by health-care personnel caring for ribavirin-treated patients probably is unlikely to provide an effective means for reducing environmental exposure to the drug, and therefore currently is not recommended by these experts as a primary protective measure. However, use of alternative, appropriately designed (e.g., for adequate particle-size filtration) and well-fitted face masks ... or powered air-purifying respirators may provide protection. |
| Wechselwirkungen | In vitro and in vivo antiviral activity of ribavirin against some viruses (eg, influenza virus) may be enhanced by other antiviral agents (eg, amantadine, rimantadine).Ribavirin may antagonize the in vitro antiviral activity of stavudine and zidovudine against HIVconcomitant use of ribavirin with either of these drugs should be avoided.Coadministration /of didanosine/ with oral ribavirin is not recommendedcases of fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.Results of in vitro tests in various cell cultures and peripheral blood lymphocytes indicate that ribavirin may potentiate the antiretroviral activity of didanosine against human immunodeficiency virus (HIVformerly HTLV-III/LAV) and Moloney murine sarcoma virus. Conversely, results of in vitro tests indicate that ribavirin antagonizes the antiviral activity of zidovudine and zalcitabine against HIV. Ribavirin appears to potentiate the antiretroviral effects of didanosine by promoting formation of didanosine-S'-triphosphate, the metabolically active metabolite of didanosine with antiviral activity. The mechanism by which ribavirin antagonizes the antiretroviral effects of zidovudine or zalcitabine has not been elucidated to date but it has been suggested that ribavirin may interfere with phosphorylation steps that convert the drugs to their active triphosphate metabolites, deoxythymidine triphosphate or dideoxycytidine-S'-triphosphate, respectively. |
| Hepatotoxicity | Oral therapy with ribavirin alone is rarely used and has not been associated with serum aminotransferase elevations. Because ribavirin is usually used in patients with underlying liver disease (hepatitis C), it is difficult to interpret increases in serum ALT levels during therapy, and typically ribavirin decreases serum ALT levels in patients with hepatitis C. Ribavirin does cause a dose dependent red cell hemolysis which can be severe. The onset of hemolysis is usually after 2 to 3 weeks of therapy and can present with symptoms of anemia and sudden decreases in hematocrit levels by 5% to 10%. The hemolysis is accompanied by a mild increase in indirect bilirubin, which may result in total bilirubin concentrations of 1.5 to 2.5 mg/dL. This indirect hyperbilirubinemia is generally benign and resolves rapidly once therapy is stopped. Patients with underlying Gilbert syndrome or with advanced liver disease may become visibly jaundiced. Patients with deficiencies in inosine triphosphatase activity (ITPA variants) are relatively protected against the hemolysis of ribavirin, probably because the increased levels of intracellular ITP provide an alternate source for intracellular guanosine and adenosine triphosphate which are depleted in red cells by ribavirin-triphosphate.Rare instances of fatty liver with lactic acidosis and hepatic dysfunction have been reported in patients with HIV infection receiving antiretroviral therapy as well as ribavirin in combination with interferon or oral direct acting antiviral agents against hepatitis C. This complication has not been reported with use of ribavirin alone and drug-drug interactions are likely the cause, ribavirin increasing the risk of lactic acidosis from other nucleoside analogues used in the treatment of HIV infection (particularly stavudine, didanosine and zidovudine).Treatment of patients with advanced cirrhosis with chronic hepatitis C using potent direct acting antiviral agents has resulted in several instances of acute hepatic decompensation, typically arising during the first few weeks of treatment. Many of these patients were also receiving ribavirin, but sudden decompensation has also been described in non-ribavirin containing regimens and no single antiviral agent appears to be responsible. Because ribavirin is generally used in combination with other antiviral agents its contribution to adverse events and particularly liver associated adverse events is difficult to assess. If ribavirin is capable of causing significant liver injury, this must be quite rare.Likelihood score: E* (unproven although suspected rare cause of clinically apparent liver injury) |
| Human Toxicity Excerpts | /SIGNS AND SYMPTOMS/ Rash, erythema of the eyelids, and conjunctivitis have occurred in patients receiving ribavirin inhalation therapy. These effects usually resolve within hours after ribavirin therapy is discontinued. In addition, hearing disorders (e.g., hearing loss, tinnitus), vertigo, hypertriglyceridemia, and fatal and nonfatal pancreatitis have been observed in patients receiving ribavirin in conjunction with interferon alfa-2b./SIGNS AND SYMPTOMS/ Coadministration /of didanosine/ with oral ribavirin is not recommendedcases of fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials./SIGNS AND SYMPTOMS/ Worsening of respiratory function has occurred, sometimes suddenly, during ribavirin inhalation therapy in infants with RSV infections or in adults with chronic obstructive pulmonary disease (COPD) or asthma. In infants with underlying life-threatening conditions, inhalation of the drug has been associated with aggravation and worsening of respiratory function, apnea, and physical dependence on assisted respiration. In adults with COPD or asthma, therapy with the drug frequently has been associated with deterioration in pulmonary function, and dyspnea and chest soreness have occurred in several adults with asthma. Minor pulmonary function abnormalities have also been observed in healthy adults receiving ribavirin inhalation. Bronchospasm, pulmonary edema, hypoventilation, cyanosis, dyspnea, bacterial pneumonia, pneumothorax, apnea, atelectasis, and ventilator dependence also have been associated with ribavirin inhalation therapy. Several deaths that were characterized as possibly related to ribavirin inhalation therapy by the treating physician occurred in infants who experienced worsening respiratory status related to bronchospasm while receiving the drug./SIGNS AND SYMPTOMS/ Ribavirin inhalation therapy in patients who require assisted respiration has resulted in mechanical problems caused by precipitation of the drug in the respiratory apparatus, including the endotracheal tube and other tubing, and may result in inadequate assisted respiration and gas exchange in these patients. Increases in positive inspiratory and end-expiratory pressures have occurred in these patients as a result of drug precipitation and subsequent malfunction or obstruction of valves in the respiratory apparatus, and pneumothorax can result from such alterations in the pressures of the apparatus. Accumulation of fluid in tubing of the apparatus ("rain out") has also occurred. There have been several deaths reported in infants with RSV who were undergoing assisted respiration while receiving ribavirin inhalation therapy. In these cases, death was attributed to mechanical ventilator malfunction caused by precipitation of the drug within the ventilator apparatus that led to excessively high pulmonary pressures and diminished oxygenation. Whenever ribavirin inhalation therapy is used in a patient requiring mechanical ventilator assistance, strict attention must be paid to procedures that have been shown to minimize the accumulation of drug precipitate.For more Human Toxicity Excerpts (Complete) data for RIBAVIRIN (8 total), please visit the HSDB record page. |
| Drug Induced Liver Injury | Drug Induced Liver Injury Rank (DILIrank 2.0)RibavirinvLess-DILI-concern7Adverse reactionsDOI:10.1016/j.drudis.2016.02.015 |
| Non-Human Toxicity Excerpts | /LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Cardiac lesions were observed in mice and rats receiving ribavirin inhalation dosages of 30 and 36 mg/kg daily, respectively, for 4 wk, and in monkeys and rats receiving oral dosages of 120 and 154-200 mg/kg daily, respectively, for 1-6 mon./LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Results of a chronic feeding study in rats receiving 16-100 mg/kg daily (estimated human equivalent of 2.3-14.3 mg/kg daily based on body surface area adjustment for the adult) suggest that ribavirin may induce benign mammary, pancreatic, pituitary, and adrenal tumors. Preliminary results of 2 oral gavage oncogenicity studies in mice and rats receiving 18-24 months of ribavirin are inconclusive as to the carcinogenic potential of the drug but demonstrate a relationship between chronic ribavirin exposure and increased incidences of vascular lesions (microscopic hemorrhages) in mice and retinal degeneration in rats. The mice and rats in these studies received 20-75 and 10-40 mg/kg, respectively, of ribavirin daily (estimated human equivalent of 1.67-6.25 and 1.43-5.71 mg/kg, respectively, daily based on body surface area adjustment for the adult)./LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ Ribavirin has been shown to produce testicular lesions (e.g., tubular atrophy) in adult rats receiving oral dosages of 16 mg/kg daily (estimated human equivalent of 2.29 mg/kg daily based on body surface area adjustment for the adult)lower dosages were not tested./LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ In studies in mice, ribavirin dosages of 35-150 mg/kg daily (estimated human equivalent of 2.92-12.5 mg/kg daily based on body surface area adjustment for the adult) resulted in seminiferous tubule atrophy, decreased sperm concentrations, and increased numbers of sperm with abnormal morphologypartial recovery of sperm production was apparent 3-6 months after the drug was discontinued. ... In addition, sperm abnormalities have occurred in mice following oral ribavirin doses of 15-150 mg/kg daily (estimated human equivalent of 1.25-12.5 mg/kg/day, based on body surface area adjustment for a 60-kg adult0.1-0.8 times the maximum human 24-hour dose of ribavirin) administered for 3 or 6 months. Essentially total recovery from ribavirin-induced testicular toxicity was apparent within 1 or 2 spermatogenesis cycles following discontinuance of the drug. However, ribavirin is known to accumulate in intracellular components of cells from which the drug is cleared very slowly, and it is not yet known whether ribavirin contained in sperm will exert a potential teratogenic effect upon fertilization of the ova.For more Non-Human Toxicity Excerpts (Complete) data for RIBAVIRIN (11 total), please visit the HSDB record page. |
| Probable Routes of Human Exposure | ... Health care personnel in contact with patients undergoing ribavirin inhalation therapy. |
| Environmental Water Concentrations | While data specific to ribavirin were not located(SRC, 2006), the literature suggests that some pharmaceutically active compounds originating from human and veterinary therapy are not eliminated completely in municipal sewage treatment plants and are therefore discharged into receiving waters(1). Wastewater treatment processes often were not designed to remove them from the effluent(2). Selected organic waste compounds may be degrading to new and more persistent compounds that may be released instead of or in addition to the parent compound(2). Studies have indicated that several polar pharmaceutically active compounds can leach through subsoils into aquifers(1). |
| Antidote and Emergency Treatment | /SRP:/ Basic treatment: Establish a patent airway. Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with normal saline during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poison A and B//SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in respiratory arrest. Positive pressure ventilation techniques with a bag valve mask device may be beneficial. Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start an IV with D5W /SRP: "To keep open", minimal flow rate/. Use lactated Ringer's if signs of hypovolemia are present. Watch for signs of fluid overload. Consider drug therapy for pulmonary edema ... . For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam (Valium) ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poison A and B/ |
| National Toxicology Program Studies | ... This study was performed to determine the potential effects of ribavirin on the immune system of mice. ... Ribavirin ... was administered to female C57BL/6 mice by oral gavage at dosages of 0, 75, 150, or 300 mg/kg body weight at a volume of 0.1 ml/10 g body weight. Each animal received the test compound for ten days over a 14 day period. For each of the assays examined, 7-8 mice per group were employed. No positive control groups were included. ... There were no drug-related mortalities or overt signs of toxicity from ribavirin exposure. Likewise, there were no consistent treatment-related effects on body weight, measured organ weights, or lymphoid histology except for a decrease in thymus weights at the 150 mg/kg dose level. Serum chemistries examined included SGPT, BUN, glucose, total protein, albumin, globulin and albumin/globulin ratios. There was a dose-related decrease in albumin and albumin/globulin ratios after ribavirin treatment. Hematological values in ribavirin-treated mice were similar to controls, except for a slight decrease in hematocrit at the high dose level. ... The major immunological effect observed from ribavirin treatment was a dose-dependent decrease in the antibody response to sheep erythrocytes and DNP-Ficoll, the latter being a T-independent antigen. Antibody suppression was associated with only a slight decrease in splenic B cell numbers and no (i.e., LPS) or a slight (anti-Ig/IL-4) increase in lymphocyte blastogenesis. There were no effects on T lymphocyte functions as evidenced by normal CTL activity, lymphocyte mitogenesis, mixed leukocyte responsiveness and T cell numbers. Natural killer cell activity was apparently not altered by drug treatment, although the control response was well below historical control values making it difficult to interpret this response. Bone marrow cellularity and DNA synthesis were unaffected by ribavirin treatment but there was a dose-related increase in CFU- C1 and CFU-C2 progenitor cell formation. . |
| Effects During Pregnancy and Lactation | ◉ Summary of Use during LactationRibavirin has not been studied in nursing mothers being treated for hepatitis C infection. However, ribavirin is given directly to infants by inhalation to treat respiratory syncytial virus (RSV) infection. The amount in milk is likely to be lower than the doses received by infants treated with ribavirin for RSV infection.Hepatitis C is not transmitted through breastmilk and breastmilk has been shown to inactivate hepatitis C virus (HCV). However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C.Infants born to mothers with HCV infection should be tested for HCV infectionbecause maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.◉ Effects in Breastfed InfantsRelevant published information was not found as of the revision date.◉ Effects on Lactation and Breastmilk |
| Non-Human Toxicity Values | LD50 Rat oral 5.3 g/kgLD50 Mouse oral 2 g/kgLD50 Mouse ip 0.9-1.3 g/kgLD50 Rat ip 2 g/kg |
| Wassergefährdungsklasse (WGK) | 3 |
| Zollcode | 29349990 |
| RTECS-Nr. | XZ4250000 |
| R-Sätze (R) | 61-36/38 |
| Toxizität | LD50 i.p. in mice: 1.3 g/kgorally in rats: 5.3 g/kg (Witkowski, 1972) |
| Gefahrensymbole | T,Xi |
| Sicherheitshinweise (S) | 53-22-45-37/39-26 |
| Lagerklasse | 6.1C - Combustible acute toxic Cat.3toxic compounds or compounds which causing chronic effects |
| Gefahrstoffdaten | 36791-04-5(Hazardous Substances Data) |
| Gefahrenklasse | Muta. 2Repr. 1B |
Anwendungen & Verwendung
Verwenden
Ribavirin is a guanosine analog with antiviral properties against DNA and RNA viruses, including respiratory syncytial virus, hepatitis C, and influenza. It acts as a prodrug that can be activated by either mono- or tri-phosphorylation by cellular kinases. These phosphorylated derivatives of ribavirin have diverse effects on both cellular and viral enzymes, resulting in suppression of viral replication.