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Ribavirin

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Overview

What is Ribasphere?

RIBASPHERE (ribavirin capsules USP) is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-ß-D-ribofuranosyl-1 -1,2,4-triazole-3-carboxamide and has the following structural formula (see ):

Ribavirin is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The empirical formula is C HNO and the molecular weight is 244.21.

RIBASPHERE (ribavirin capsules USP) consists of white pellets in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients: Croscarmellose Sodium, NF, Lactose Monohydrate, NF, Microcrystalline Cellulose, NF, and Povidone, USP. The capsule shell consists of gelatin and titanium dioxide. The capsule is printed horizontally with "riba 200" on both the body and the cap of the capsule using edible, green pharmaceutical ink which is made of butyl alcohol, NF, Yellow Iron Oxide, NF, dehydrated alcohol, USP, FD&C Blue #2 Aluminum Lake, isopropyl alcohol, USP, propylene glycol, USP, Shellac, NF, strong ammonia solution, NF, and titanium dioxide.



What does Ribasphere look like?



What are the available doses of Ribasphere?

RIBASPHERE Capsules 200 mg ()

What should I talk to my health care provider before I take Ribasphere?

How should I use Ribasphere?

RIBASPHERE (ribavirin capsules USP) is a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. ()

Under no circumstances should RIBASPHERE capsules be opened, crushed, or broken. RIBASPHERE should be taken with food [see ]. RIBASPHERE should not be used in patients with creatinine clearance less than 50 mL/min.


What interacts with Ribasphere?

Sorry No Records found


What are the warnings of Ribasphere?

Sorry No Records found


What are the precautions of Ribasphere?

Sorry No Records found


What are the side effects of Ribasphere?

Sorry No records found


What should I look out for while using Ribasphere?

RIBASPHERE combination therapy is contraindicated in:


What might happen if I take too much Ribasphere?

There is limited experience with overdosage. Acute ingestion of up to 20 g of ribavirin capsules, interferon alfa-2b ingestion of up to 120 million units, and subcutaneous doses of interferon alfa-2b up to 10 times the recommended doses have been reported. Primary effects that have been observed are increased incidence and severity of the adverse reactions related to the therapeutic use of interferon alfa-2b and ribavirin. However, hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with administration of single subcutaneous doses of interferon alfa-2b that exceed dosing recommendations.

There is no specific antidote for interferon alfa-2b or RIBASPHERE overdose, and hemodialysis and peritoneal dialysis are not effective for treatment of overdose of these agents.


How should I store and handle Ribasphere?

RIBASPHERE (ribavirin capsules USP) is available as capsules for oral administration.RIBASPHERE 200 mg capsules are white, opaque, gelatin capsules printed horizontally with "riba 200" on both the body and the cap of the capsule in edible green pharmaceutical ink. RIBASPHERE 200 mg capsules are packaged in HDPE bottles with child-resistant closures containing 84 capsules (NDC 66435-101-84) and 180 capsules (NDC 66435-101-18).The bottle of RIBASPHERE capsules should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].RIBASPHERE (ribavirin capsules USP) is available as capsules for oral administration.RIBASPHERE 200 mg capsules are white, opaque, gelatin capsules printed horizontally with "riba 200" on both the body and the cap of the capsule in edible green pharmaceutical ink. RIBASPHERE 200 mg capsules are packaged in HDPE bottles with child-resistant closures containing 84 capsules (NDC 66435-101-84) and 180 capsules (NDC 66435-101-18).The bottle of RIBASPHERE capsules should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].RIBASPHERE (ribavirin capsules USP) is available as capsules for oral administration.RIBASPHERE 200 mg capsules are white, opaque, gelatin capsules printed horizontally with "riba 200" on both the body and the cap of the capsule in edible green pharmaceutical ink. RIBASPHERE 200 mg capsules are packaged in HDPE bottles with child-resistant closures containing 84 capsules (NDC 66435-101-84) and 180 capsules (NDC 66435-101-18).The bottle of RIBASPHERE capsules should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Ribavirin is an antiviral agent [see ].

Non-Clinical Toxicology
RIBASPHERE combination therapy is contraindicated in:

In vitro

Clinically significant interactions have been reported with inhibitors of CYP3A4 (e.g. erythromycin, ritonavir) causing elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g. rifampin) have caused a lowering of plasma levels of verapamil. Therefore, patients receiving inhibitors or inducers of the cytochrome P450 system should be monitored for drug interactions.

RIBASPHERE (ribavirin capsules) may cause birth defects and death of the unborn child. RIBASPHERE therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two forms of contraception and have monthly pregnancy tests during treatment and during the 6-month period after treatment has been stopped.

Patient Counseling Information ()

Clinical trials with ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b have been conducted in over 7800 subjects from 3 to 76 years of age.

The primary toxicity of ribavirin is hemolytic anemia. Reductions in hemoglobin levels occurred within the first 1 to 2 weeks of oral therapy. Cardiac and pulmonary reactions associated with anemia occurred in approximately 10% of patients [see ].

Greater than 96% of all subjects in clinical trials experienced one or more adverse reactions. The most commonly reported adverse reactions in adult subjects receiving peginterferon alfa-2b or interferon alfa-2b in combination with ribavirin were injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia and anxiety/emotional lability/irritability. The most common adverse reactions in pediatric subjects, ages 3 and older, receiving ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, and vomiting.

The Adverse Reactions section references the following clinical trials:

Serious adverse reactions have occurred in approximately 12% of subjects in clinical trials with peginterferon alfa-2b with or without ribavirin [see ]. The most common serious events occurring in subjects treated with peginterferon alfa-2b and ribavirin were depression and suicidal ideation [see ], each occurring at a frequency of less than 1%. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up [see ]. The most common fatal reaction occurring in subjects treated with peginterferon alfa-2b and ribavirin was cardiac arrest, suicide ideation, and suicide attempt [see ], all occurring in less than 1% of subjects.

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).