Atazanavir Sulfate

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Overview

What is Atazanavir Sulfate?

The active ingredient in atazanavir sulfate capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor.

The chemical name for atazanavir sulfate is (3 ,8 ,9 ,12 )-3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Atazanavir sulfate has the following structural formula:

C H N O •H SO M.W. 704.9 (free base) 802.9 (sulfuric acid salt)

Atazanavir sulfate is a white to pale yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3° C.

Atazanavir sulfate capsules are available for oral administration in strengths containing the equivalent of 150 mg, 200 mg or 300 mg of atazanavir as atazanavir sulfate and the following inactive ingredients: crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, iron oxide black, lactose monohydrate, magnesium stearate, propylene glycol, shellac, sodium lauryl sulfate, sorbitan monolaurate, and titanium dioxide. Additionally, the 300 mg capsules also contain FD&C red #40.

What does Atazanavir Sulfate look like?

What are the available doses of Atazanavir Sulfate?

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

How should I use Atazanavir Sulfate?

Atazanavir sulfate capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg.

Limitations of Use:

Pretreatment testing:

Treatment-naive adults:

Treatment-experienced adults:

Pediatric patients:

Pregnancy:

Dosing modifications:

What interacts with Atazanavir Sulfate?

Sorry No Records found

What are the warnings of Atazanavir Sulfate?

Sorry No Records found

What are the precautions of Atazanavir Sulfate?

Sorry No Records found

What are the side effects of Atazanavir Sulfate?

Sorry No records found

What should I look out for while using Atazanavir Sulfate?

Atazanavir sulfate capsules are contraindicated:Atazanavir sulfate capsules are contraindicated:

Table 6 displays drugs that are contraindicated with atazanavir sulfate. Table 6 displays drugs that are contraindicated with atazanavir sulfate.

What might happen if I take too much Atazanavir Sulfate?

Human experience of acute overdose with atazanavir sulfate is limited. Single doses up to 1200 mg (three times the 400 mg maximum recommended dose) have been taken by healthy volunteers without symptomatic untoward effects. A single self-administered overdose of 29.2 g of atazanavir sulfate in an HIV-infected patient (73 times the 400-mg recommended dose) was associated with asymptomatic bifascicular block and PR interval prolongation. These events resolved spontaneously. At atazanavir sulfate doses resulting in high atazanavir exposures, jaundice due to indirect (unconjugated) hyperbilirubinemia (without associated liver function test changes) or PR interval prolongation may be observed

Treatment of overdosage with atazanavir sulfate should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patient’s clinical status. If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of unabsorbed drug. There is no specific antidote for overdose with atazanavir sulfate. Since atazanavir is extensively metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicine.

How should I store and handle Atazanavir Sulfate?

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Atazanavir sulfate capsules are available as:150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 0093-5526-06).200 mg – capsules with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body, in bottles of 60 (NDC 0093-5527-06).300 mg – capsules with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body, in bottles of 30 (NDC 0093-5528-56).Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Atazanavir sulfate capsules are available as:150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 0093-5526-06).200 mg – capsules with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body, in bottles of 60 (NDC 0093-5527-06).300 mg – capsules with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body, in bottles of 30 (NDC 0093-5528-56).Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Atazanavir sulfate capsules are available as:150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 0093-5526-06).200 mg – capsules with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body, in bottles of 60 (NDC 0093-5527-06).300 mg – capsules with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body, in bottles of 30 (NDC 0093-5528-56).Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Atazanavir sulfate capsules are available as:150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 0093-5526-06).200 mg – capsules with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body, in bottles of 60 (NDC 0093-5527-06).300 mg – capsules with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body, in bottles of 30 (NDC 0093-5528-56).Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Atazanavir sulfate capsules are available as:150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 0093-5526-06).200 mg – capsules with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body, in bottles of 60 (NDC 0093-5527-06).300 mg – capsules with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body, in bottles of 30 (NDC 0093-5528-56).Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Atazanavir sulfate capsules are available as:150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 0093-5526-06).200 mg – capsules with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body, in bottles of 60 (NDC 0093-5527-06).300 mg – capsules with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body, in bottles of 30 (NDC 0093-5528-56).Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Atazanavir is an HIV-1 antiretroviral drug

Non-Clinical Toxicology

Atazanavir sulfate capsules are contraindicated:Atazanavir sulfate capsules are contraindicated:

Table 6 displays drugs that are contraindicated with atazanavir sulfate. Table 6 displays drugs that are contraindicated with atazanavir sulfate.

Large doses of naloxone are required to antagonize buprenorphine since the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression. The barbiturate methohexital appears to block the acute onset of withdrawal symptoms induced by naloxone in opiate addicts.

Atazanavir sulfate has been shown to prolong the PR interval of the electrocardiogram in some patients. In healthy volunteers and in patients, abnormalities in atrioventricular (AV) conduction were asymptomatic and generally limited to first-degree AV block. There have been reports of second-degree AV block and other conduction abnormalities . In clinical trials that included electrocardiograms, asymptomatic first-degree AV block was observed in 5.9% of atazanavir-treated patients (n = 920), 5.2% of lopinavir/ritonavir-treated patients (n = 252), 10.4% of nelfinavir-treated patients (n = 48), and 3.0% of efavirenz-treated patients (n = 329). In Study AI424-045, asymptomatic first-degree AV block was observed in 5% (6/118) of atazanavir/ritonavir-treated patients and 5% (6/116) of lopinavir/ritonavir-treated patients who had on-study electrocardiogram measurements. Because of limited clinical experience in patients with preexisting conduction system disease (e.g., marked first-degree AV block or second- or third-degree AV block). ECG monitoring should be considered in these patients .

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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Review

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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

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).

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