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RETROVIR

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Overview

What is RETROVIR?

RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3′-azido-3′-deoxythymidine; it has the following structural formula:

Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg per mL in water at 25°C. The molecular formula is CHNO.

RETROVIR capsules are for oral administration. Each capsule contains 100 mg of zidovudine and the inactive ingredients corn starch, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 100-mg empty hard gelatin capsule, printed with edible black ink, consists of black iron oxide, dimethylpolysiloxane, gelatin, pharmaceutical shellac, soya lecithin, and titanium dioxide.

RETROVIR syrup is for oral administration. Each mL of RETROVIR syrup contains 10 mg of zidovudine and the inactive ingredients sodium benzoate 0.2% (added as a preservative), citric acid, flavors, glycerin, and liquid sucrose. Sodium hydroxide may be added to adjust pH.

RETROVIR injection is a sterile solution for IV infusion only. Each mL contains 10 mg zidovudine in water for injection. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH to approximately 5.5. RETROVIR injection contains no preservatives. The vial stoppers for RETROVIR injection contain dry natural rubber latex.



What does RETROVIR look like?



What are the available doses of RETROVIR?

Capsules: 100 mg ()

Syrup: 10 mg per mL ()

Injection: (10 mg per mL) 20-mL single-use vial ()

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

How should I use RETROVIR?

RETROVIR, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Oral Dosing

The recommended oral dose of RETROVIR is 300 mg twice daily in combination with other antiretroviral agents.

Intravenous (IV) Dosing

The recommended intravenous dose is 1 mg per kg infused at a constant rate over 1 hour every 4 hours. Patients should receive RETROVIR injection only until oral therapy can be administered.


What interacts with RETROVIR?

Sorry No Records found


What are the warnings of RETROVIR?

Sorry No Records found


What are the precautions of RETROVIR?

Sorry No Records found


What are the side effects of RETROVIR?

Sorry No records found


What should I look out for while using RETROVIR?

RETROVIR is contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations.


What might happen if I take too much RETROVIR?

Acute overdoses of zidovudine have been reported in pediatric patients and adults. These involved exposures up to 50 grams. No specific symptoms or signs have been identified following acute overdosage with zidovudine apart from those listed as adverse events such as fatigue, headache, vomiting, and occasional reports of hematological disturbances. Patients recovered without permanent sequelae. Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of zidovudine while elimination of its primary metabolite, 3′-azido-3′-deoxy-5′--β--glucopyranuronosylthymidine (GZDV), is enhanced. If overdose occurs, the patient should be monitored for evidence of toxicity and given standard supportive treatment as required.


How should I store and handle RETROVIR?

Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F).[see USP Controlled Room Temperature].Keep tube tightly closed.Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F).[see USP Controlled Room Temperature].Keep tube tightly closed.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.RETROVIR 100-mg capsules are supplied as white, opaque cap and body capsules containing 100 mg zidovudine per capsule. Each capsule is printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body. The vial stoppers for RETROVIR injection contain dry natural rubber latex.Bottles of 100 (NDC 49702-211-20).Store at 15° to 25°C (59° to 77°F) and protect from moisture.RETROVIR syrup is supplied as a colorless to pale yellow, strawberry-flavored syrup containing 10 mg zidovudine in each mL.Bottle of 240 mL (NDC 49702-212-48) with child-resistant cap.Store at 15° to 25°C (59° to 77°F).RETROVIR injection, 10 mg zidovudine in each mL.20‑mL Single‑use Vial (NDC 49702-213-01), Carton of 5 (NDC 49702-213-26).Store vials at 15° to 25°C (59° to 77°F) and protect from light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Zidovudine is an antiretroviral agent .

Non-Clinical Toxicology
RETROVIR is contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations.

No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.

RETROVIR should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells per mm or hemoglobin less than 9.5 g per dL. Hematologic toxicities appear to be related to pretreatment bone marrow reserve and to dose and duration of therapy. In patients with advanced symptomatic HIV-1 disease, anemia and neutropenia were the most significant adverse events observed. In patients who experience hematologic toxicity, a reduction in hemoglobin may occur as early as 2 to 4 weeks, and neutropenia usually occurs after 6 to 8 weeks. There have been reports of pancytopenia associated with the use of RETROVIR, which was reversible in most instances after discontinuance of the drug. However, significant anemia, in many cases requiring dose adjustment, discontinuation of RETROVIR, and/or blood transfusions, has occurred during treatment with RETROVIR alone or in combination with other antiretrovirals.

Frequent blood counts are strongly recommended to detect severe anemia or neutropenia in patients with poor bone marrow reserve, particularly in patients with advanced HIV-1 disease who are treated with RETROVIR. For HIV-1-infected individuals and patients with asymptomatic or early HIV-1 disease, periodic blood counts are recommended. If anemia or neutropenia develops, dosage interruption may be needed .

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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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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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

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