Copegus
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
COPEGUS in combination with PEGASYS (peginterferon alfa-2a) is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
The following points should be considered when initiating COPEGUS combination therapy with PEGASYS:
- This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm3.
- This indication is based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks, based on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose.
- Safety and efficacy data are not available for treatment longer than 48 weeks.
- The safety and efficacy of COPEGUS and PEGASYS therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy.
- The safety and efficacy of COPEGUS therapy for the treatment of adenovirus, RSV, parainfluenza or influenza infections have not been established. COPEGUS should not be used for these indications. Ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered.
History
There is currently no drug history available for this drug.
Other Information
COPEGUS, ribavirin, is a nucleoside analogue with antiviral activity. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula:
The empirical formula of ribavirin is C8H12N4O5 and the molecular weight is 244.2. Ribavirin is a white to off-white powder. It is freely soluble in water and slightly soluble in anhydrous alcohol.
COPEGUS (ribavirin) is available as a light pink to pink colored, flat, oval-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin and the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, cornstarch, and magnesium stearate. The coating of the tablet contains Chromatone-P® or Opadry® Pink (made by using hydroxypropyl methyl cellulose, talc, titanium dioxide, synthetic yellow iron oxide, and synthetic red iron oxide), ethyl cellulose (ECD-30), and triacetin.
Sources
Copegus Manufacturers
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Genentech, Inc.
![Copegus (Ribavirin) Tablet, Film Coated [Genentech, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Copegus | Avpak
Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Delayed-Release Capsules.
Patients should be informed that the Omeprazole Delayed-Release Capsules should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].
2.1 Short-Term Treatment of Active Duodenal UlcerThe recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer RecurrenceTriple Therapy (Omeprazole Delayed-Release Capsules/clarithromycin/amoxicillin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy (Omeprazole Delayed-Release Capsules /clarithromycin) — The recommended adult oral regimen is Omeprazole Delayed-Release Capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Delayed-Release Capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
2.3 Gastric UlcerThe recommended adult oral dose is 40 mg once daily for 4-8 weeks.
2.4 Gastroesophageal Reflux Disease (GERD)The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
2.5 Maintenance of Healing of Erosive EsophagitisThe recommended adult oral dose is 20 mg daily Controlled studies do not extend beyond 12 months[See Clinical Studies ( 14.4 )].
2.6 Pathological Hypersecretory ConditionsThe dosage of Omeprazole Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Delayed-Release Capsules for more than 5 years.
2.7 Pediatric PatientsFor the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:
Patient Weight Omeprazole Daily Dose 10 < 20 kg 10 mg ≥ 20 kg 20 mgOn a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].
2.8 Alternative Administration OptionsOmeprazole Delayed-Release Capsule is available as a delayed-release capsule.
For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.
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