Atazanavir (Capsules) Instructions for Use
ATC Code
J05AE08 (Atazanavir)
Active Substance
Atazanavir (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antiviral drug active against HIV
Pharmacotherapeutic Group
Systemic antiviral agents; direct-acting antiviral agents; protease inhibitors
Pharmacological Action
Antiviral agent. It is an azapeptide inhibitor of HIV protease.
It selectively inhibits virus-specific processing of viral Gag-Pol proteins in HIV-infected cells, preventing the formation of mature virions and infection of other cells.
Indications
Treatment of HIV infections (in combination with other antiretroviral drugs).
ICD codes
| ICD-10 code | Indication |
| B24 | Human immunodeficiency virus [HIV] disease, unspecified |
| ICD-11 code | Indication |
| 1C62.1 | HIV disease, clinical stage 2, without mention of tuberculosis or malaria |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take orally once daily with food.
For treatment-naive and treatment-experienced adults, the standard dose is 300 mg (two 150 mg capsules) plus ritonavir 100 mg.
When used with efavirenz in treatment-naive patients, administer atazanavir 400 mg (two 200 mg capsules) plus ritonavir 100 mg.
Do not administer as a monotherapy; always use in combination with other antiretroviral agents.
In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose to 300 mg once daily without ritonavir.
Contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).
For patients receiving tenofovir, co-administer atazanavir 300 mg plus ritonavir 100 mg.
Swallow capsules whole; do not open or chew.
If a dose is missed by more than 12 hours, skip it and take the next dose at the regular time. Do not double the dose.
Take antacids or buffered medications at least 2 hours before or 1 hour after atazanavir.
Separate administration from H2-receptor antagonists by at least 10 hours and from proton pump inhibitors by at least 12 hours.
Adverse Reactions
From the central and peripheral nervous systemoften – headache, insomnia, peripheral neurological symptoms; rarely – restless dreams, memory loss, confusion, drowsiness, anxiety, depression, sleep disorders.
From the digestive systemvery often – jaundice; often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting; rarely – taste perversion, flatulence, gastritis, pancreatitis, aphthous stomatitis, dry mouth, anorexia, increased appetite, hepatitis; in isolated cases – hepatosplenomegaly.
From the musculoskeletal systemrarely – arthralgia, muscle atrophy, myalgia; rarely – myopathy.
From the urinary systemrarely – hematuria, frequent urination, proteinuria; in isolated cases – kidney pain, urolithiasis.
Allergic reactionsrarely – urticaria.
Dermatological reactionsoften – rash; rarely – alopecia, itching; rarely – vasodilation, vesiculobullous rash.
From metabolismoften – lipodystrophy; rarely – weight loss, weight gain.
From laboratory parameters increase in total bilirubin (with a predominance of increase in indirect bilirubin), increase in the level of amylase, CPK, ALT, AST, lipase, neutropenia.
Otheroften – general weakness, icterus of the sclera; rarely – chest pain, fatigue, fever, general malaise, gynecomastia.
Contraindications
Severe hepatic insufficiency, children and adolescents under 18 years of age, simultaneous use with rifampicin, hypersensitivity to atazanavir.
Use in Pregnancy and Lactation
Adequate and strictly controlled studies of atazanavir during pregnancy have not been conducted.
Use is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
If it is necessary to use during lactation, breastfeeding should be discontinued.
Use in Hepatic Impairment
Contraindication: severe hepatic insufficiency.
Use with caution in patients with mild and moderate hepatic insufficiency, because Atazanavir is metabolized mainly in the liver, and there is a risk of increasing its plasma concentration.
In patients with viral hepatitis B or C, or with elevated transaminase levels noted before the start of treatment, the risk of further increase in transaminases is increased.
Pediatric Use
Contraindication: children and adolescents under 18 years of age
Special Precautions
It is not recommended to use simultaneously with CYP3A4 inducers (including with St. John’s wort preparations), with drugs that are substrates of CYP3A4 with a narrow therapeutic range (including astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, ergotamine, dihydroergotamine, ergonovine, methylergonovine).
Simultaneous use of the combination Atazanavir+ritonavir with other protease inhibitors is not recommended.
Use with caution in patients with mild and moderate hepatic insufficiency, because Atazanavir is metabolized mainly in the liver, and there is a risk of increasing its plasma concentration.
In patients with viral hepatitis B or C, or with elevated transaminase levels noted before the start of treatment, the risk of further increase in transaminases is increased.
If a severe skin rash appears, the use of atazanavir should be discontinued.
In patients with hemophilia type A and B, bleeding, including spontaneous skin hemorrhages and hemarthrosis, has been described during treatment with protease inhibitors.
Some of these patients required the administration of factor VIII. In more than half of the patients, treatment with protease inhibitors was continued or resumed after a break. A causal relationship between protease inhibitor therapy and these cases has not been established.
If simultaneous use with felodipine, nifedipine, nicardipine and verapamil is necessary, titration of the dose of calcium channel blockers and ECG monitoring are indicated.
Drug Interactions
Since Atazanavir is metabolized in the liver with the participation of the CYP3A4 isoenzyme, when used simultaneously with other drugs metabolized by this isoenzyme (including calcium channel blockers, HMG-CoA reductase inhibitors and PDE5 inhibitors, including sildenafil, tadalafil, vardenafil), an increase in the plasma concentration of one of the components is possible.
This may lead to an increase and prolongation of the therapeutic and side effects of the PDE5 inhibitor.
Simultaneous use of atazanavir with inducers of the CYP3A4 isoenzyme (including with rifampin) may lead to a decrease in the plasma concentration of atazanavir and a decrease in its effectiveness.
Rifampin reduces the activity of most protease inhibitors by approximately 90%.
When atazanavir is used simultaneously with inhibitors of the CYP3A4 isoenzyme, an increase in the plasma concentration of atazanavir is possible.
Efavirenz reduces the effect of atazanavir when used simultaneously.
It is assumed that nevirapine, as an inducer of CYP3A4, is able to reduce the effect of atazanavir (simultaneous use is not recommended).
Indinavir can cause hyperbilirubinemia, so simultaneous use with atazanavir is not recommended.
When used simultaneously with atazanavir, the effectiveness of saquinavir decreases.
When used simultaneously with ritonavir, the plasma concentration of atazanavir increases.
Antacids (and preparations containing antacids) reduce the acidity of gastric juice, so the absorption of atazanavir is reduced.
When used simultaneously with atazanavir, an increase in the plasma concentrations of lidocaine (for systemic use), amiodarone (special caution and monitoring of therapeutic concentrations of these drugs is required), quinidine (use of the combination Atazanavir+ritonavir with quinidine is contraindicated) is possible.
When used simultaneously, an increase in the toxicity of irinotecan is possible due to the slowdown of its metabolism.
Simultaneous use with simvastatin and lovastatin is not recommended.
Atazanavir may enhance the effect of diltiazem and its metabolite deacetyl diltiazem (a 50% reduction in the dose of diltiazem and ECG monitoring is recommended).
When used simultaneously with bepridil, potentiation of the development of severe and/or life-threatening reactions is possible (use of the combination Atazanavir+ritonavir with bepridil is contraindicated).
Under the influence of atazanavir, an enhancement of the effect of atorvastatin, cerivastatin and an increase in the risk of developing myopathy, including rhabdomyolysis, is possible (special caution is required when used simultaneously).
Histamine H2-receptor blockers and proton pump inhibitors reduce the plasma concentration of atazanavir, which may lead to a decrease in its therapeutic effectiveness or the development of resistance.
When used simultaneously with cyclosporine, tacrolimus, sirolimus, an increase in the plasma concentrations of immunosuppressants is possible (monitoring of their therapeutic concentrations is recommended).
When used simultaneously with clarithromycin, an increase in the plasma concentration of the latter is observed, which can cause an increase in the QT interval (a 50% reduction in the antibiotic dose is required).
When used simultaneously with atazanavir, the effectiveness of rifabutin increases (a reduction in the dose of rifabutin to 75% is recommended).
Ketoconazole and itraconazole may increase the plasma concentrations of atazanavir and ritonavir.
When used simultaneously with warfarin, there is a risk of severe and/or life-threatening bleeding due to increased warfarin activity (INR monitoring is recommended).
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 150 mg: 60, 100 pcs.
Capsules 200 mg: 60, 100 pcs.
Capsules 300 mg: 30, 100 pcs.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Manufactured By
Makiz-Pharma, LLC (Russia)
Dosage Forms
 |
Atazanavir | Capsules 150 mg: 60, 100 pcs. |
| Capsules 200 mg: 60, 100 pcs. | ||
| Capsules 300 mg: 30, 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin (size No. 1), opaque light green body with black marking “A6”, opaque green cap with black marking “H”.
The contents of the capsule is a granulated powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 170.854 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients : lactose monohydrate – 81.446 mg, crospovidone – 15 mg, magnesium stearate – 2.7 mg.
Hard gelatin capsule (body : gelatin, water, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), FD&C Blue 1 (Brilliant Blue FCF) (E133), black ink “TekPrintSW9008” (shellac, ethanol, isopropanol, butanol, propylene glycol, ammonia water, potassium hydroxide, purified water, iron oxide black); cap gelatin, water, titanium dioxide (E171), iron oxide yellow (E172), FD&C Blue 1 (Brilliant Blue FCF) (E133), black ink “TekPrintSW9008”)) – 76 mg.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
Capsules hard gelatin (size No. 0), opaque light green body with black marking “A7”, opaque green cap with black marking “H”.
The contents of the capsule is a granulated powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 227.805 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients : lactose monohydrate – 108.595 mg, crospovidone – 20 mg, magnesium stearate – 3.6 mg.
Hard gelatin capsule (body : gelatin, water, titanium dioxide (E171), iron oxide yellow (E172), FD&C Blue 1 (Brilliant Blue FCF) (E133), FD&C Yellow 6 (Sunset Yellow FCF) (E110), black ink “TekPrintSW9008” (shellac, ethanol, isopropanol, butanol, propylene glycol, ammonia water, potassium hydroxide, purified water, iron oxide black); cap gelatin, water, titanium dioxide (E171), iron oxide yellow (E172), FD&C Blue 1 (Brilliant Blue FCF) (E133), black ink “TekPrintSW9008”)) – 96 mg.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
Capsules hard gelatin (size No. 00), opaque green body with black marking “A8”, opaque orange cap with black marking “H”.
The contents of the capsule is a granulated powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 341.708 mg, |
| Equivalent to atazanavir content | 300 mg |
Excipients : lactose monohydrate – 162.892 mg, crospovidone – 30 mg, magnesium stearate – 5.4 mg.
Hard gelatin capsule (body : gelatin, water, titanium dioxide (E171), iron oxide yellow (E172), FD&C Blue 1 (Brilliant Blue FCF) (E133), black ink “TekPrintSW9008” (shellac, ethanol, isopropanol, butanol, propylene glycol, ammonia water, potassium hydroxide, purified water, iron oxide black); cap gelatin, water, titanium dioxide (E171), FD&C Yellow 6 (Sunset Yellow FCF) (E110), FD&C Red 3 (Erythrosine) (E127), black ink “TekPrintSW9008”)) – 119 mg.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
Capsules 150 mg: 60 pcs.
Capsules 200 mg: 60 pcs.
Capsules 300 mg: 60 pcs.
Marketing Authorization Holder
Amedart LLC (Russia)
Manufactured By
Advanced Pharma, LLC (Russia)
Dosage Forms
|
Atazanavir | Capsules 150 mg: 60 pcs. |
| Capsules 200 mg: 60 pcs. | ||
| Capsules 300 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, white, opaque; capsule contents – a mixture of powder and granules from white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 170.85 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients : lactose monohydrate – 82.2 mg, crospovidone – 16.2 mg, magnesium stearate – 1.1 mg.
Hard gelatin capsule: gelatin – 98%, titanium dioxide (E171) – 2%.
60 pcs. – jars – cardboard packs.
Capsules hard gelatin, white, opaque; capsule contents – a mixture of powder and granules from white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 227.8 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients : lactose monohydrate – 109.6 mg, crospovidone – 21.6 mg, magnesium stearate – 1.4 mg.
Hard gelatin capsule: gelatin – 98%, titanium dioxide (E171) – 2%.
60 pcs. – jars – cardboard packs.
Capsules hard gelatin, white, opaque; capsule contents – a mixture of powder and granules from white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 341.6 mg, |
| Equivalent to atazanavir content | 300 mg |
Excipients : lactose monohydrate – 164.36 mg, crospovidone – 32.44 mg, magnesium stearate – 2.16 mg.
Hard gelatin capsule: gelatin – 98%, titanium dioxide (E171) – 2%.
60 pcs. – jars – cardboard packs.
Capsules 150 mg: from 5 to 100 pcs.
Capsules 200 mg: from 5 to 100 pcs.
Capsules 300 mg: from 5 to 100 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Atazanavir | Capsules 150 mg: from 5 to 100 pcs. |
| Capsules 200 mg: from 5 to 100 pcs. | ||
| Capsules 300 mg: from 5 to 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin No. 0, white body, opaque, green cap, opaque; capsule contents – a mixture of powder and granules from white to light yellow; compaction of the contents into lumps in the shape of the capsule is allowed, easily destroyed when pressed.
| 1 caps. | |
| Atazanavir sulfate | 170.87 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients : lactose monohydrate (milk sugar) – 81.85 mg, crospovidone – 16.2 mg, magnesium stearate – 1.08 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition azorubine dye – 0.0016%, brilliant black dye – 0.0958%, patent blue dye – 0.1642%, quinoline yellow dye – 1.1496%, titanium dioxide – 1.3333%, gelatin – up to 100%.
From 5 to 10 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin size #0, with a light blue opaque body and cap; the capsule contents are a mixture of powder and granules from white to light yellow; compaction of the contents into lumps conforming to the capsule shape is allowed, which are easily destroyed when pressed.
| 1 caps. | |
| Atazanavir sulfate | 227.83 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients: lactose monohydrate (milk sugar) – 109.13 mg, crospovidone – 21.6 mg, magnesium stearate – 1.44 mg.
Capsule body composition: dye indigotine – 0.0312%, titanium dioxide – 4%, gelatin – up to 100%.
Capsule cap composition: dye indigotine – 0.0312%, titanium dioxide – 4%, gelatin – up to 100%.
From 5 to 10 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin size #00, with an opaque white body and an opaque bright red cap; the capsule contents are a mixture of powder and granules from white to light yellow; compaction of the contents into lumps conforming to the capsule shape is allowed, which are easily destroyed when pressed.
| 1 caps. | |
| Atazanavir sulfate | 341.74 mg, |
| Equivalent to atazanavir content | 300 mg |
Excipients: lactose monohydrate (milk sugar) – 163.7 mg, crospovidone – 32.4 mg, magnesium stearate – 2.16 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: dye azorubine – 0.568%, dye brilliant black – 0.0019%, dye sunset yellow – 0.1861%, titanium dioxide – 1.3333%, gelatin – up to 100%.
From 5 to 10 pcs. – contour cell packs (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – jars (1) – cardboard packs.
Capsules 150 mg: 30 or 60 pcs.
Capsules 200 mg: 30 or 60 pcs.
Capsules 300 mg: 30 or 60 pcs.
Marketing Authorization Holder
Biocad, JSC (Russia)
Manufactured By
Pharmstandard-Lexredstva OJSC (Russia)
Or
Biocad, JSC (Russia)
Dosage Forms
|
Atazanavir | Capsules 150 mg: 30 or 60 pcs. |
| Capsules 200 mg: 30 or 60 pcs. | ||
| Capsules 300 mg: 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #1, with a pink opaque cap and a white opaque body; the capsule contents are a granulate from white to light yellow; the presence of lumps and rods is allowed, which easily disintegrate upon light pressure with a glass rod.
| 1 caps. | |
| Atazanavir sulfate | 170.84 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients: lactose monohydrate – 82.18 mg, crospovidone – 16.22 mg, magnesium stearate – 1.08 mg.
Composition of hard gelatin capsules:
Body gelatin – sufficient quantity to 100%, titanium dioxide (E171) – 1.41%.
Cap: gelatin – sufficient quantity to 100%, titanium dioxide (E171) – 1.5181%, dye iron oxide red (E172)- 0.0557%.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
Capsules hard gelatin, size #0, with an orange opaque cap and a white opaque body; the capsule contents are a granulate from white to light yellow; the presence of lumps and rods is allowed, which easily disintegrate upon light pressure with a glass rod.
| 1 caps. | |
| Atazanavir sulfate | 227.79 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients: lactose monohydrate – 109.57 mg, crospovidone – 21.63 mg, magnesium stearate – 1.44 mg.
Composition of hard gelatin capsules:
Body: gelatin – sufficient quantity to 100%, titanium dioxide (E171) – 2%.
Cap: gelatin – sufficient quantity to 100%, titanium dioxide (E171) – 2%, dye sunset yellow (E110) – 0.3285%, dye ponceau 4R (E124) – 0.1111%.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
Capsules hard gelatin, size #00, with a white opaque cap and a white opaque body; the capsule contents are a granulate from white to light yellow; the presence of lumps and rods is allowed, which easily disintegrate upon light pressure with a glass rod.
| 1 caps. | |
| Atazanavir sulfate | 341.69 mg, |
| Equivalent to atazanavir content | 300 mg |
Excipients: lactose monohydrate – 164.36 mg, crospovidone – 32.44 mg, magnesium stearate – 2.16 mg.
Composition of hard gelatin capsules:
Body: gelatin – sufficient quantity to 100%, titanium dioxide (E171) – 2%.
Cap: gelatin – sufficient quantity to 100%, titanium dioxide (E171) – 2%.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
Capsules 150 mg: 30 or 60 pcs.
Capsules 200 mg: 30 or 60 pcs.
Capsules 300 mg: 30 or 60 pcs.
Marketing Authorization Holder
Izvarino Pharma LLC (Russia)
Manufactured By
Izvarino Pharma LLC (Russia)
Or
Nanopharma Development, LLC (Russia)
Dosage Forms
|
Atazanavir | Capsules 150 mg: 30 or 60 pcs. |
| Capsules 200 mg: 30 or 60 pcs. | ||
| Capsules 300 mg: 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard, with an opaque body and cap, from white or almost white to white with a yellowish tint.
| 1 caps. | |
| Atazanavir sulfate | 170.84 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients: lactose monohydrate, crospovidone, magnesium stearate.
Composition of capsule shell #1: titanium dioxide, gelatin.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Capsules hard, with an opaque body and cap, from white or almost white to white with a yellowish tint.
| 1 caps. | |
| Atazanavir sulfate | 227.83 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients: lactose monohydrate, crospovidone, magnesium stearate.
Composition of capsule shell #0: titanium dioxide, gelatin.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Capsules hard, with an opaque body and cap, from white or almost white to white with a yellowish tint.
| 1 caps. | |
| Atazanavir sulfate | 341.74 mg, |
| Equivalent to atazanavir content | 300 mg |
Excipients: lactose monohydrate, crospovidone, magnesium stearate.
Composition of capsule shell #00: titanium dioxide, gelatin.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Capsules 150 mg: 60 pcs.
Capsules 200 mg: 30 or 60 pcs.
Capsules 300 mg: 30 pcs.
Marketing Authorization Holder
Irvin 2, LLC (Russia)
Manufactured By
ZiO-Health CJSC (Russia)
Dosage Forms
|
Atazanavir | Capsules 150 mg: 60 pcs. |
| Capsules 200 mg: 30 or 60 pcs. | ||
| Capsules 300 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin #1, with a blue cap and a light blue body; the capsule contents are a granulated powder from white to white with a light yellow tint.
| 1 caps. | |
| Atazanavir sulfate | 170.8 mg, |
| Calculated as Atazanavir | 150 mg |
Excipients: lactose monohydrate – 82.2 mg, crospovidone – 16.2 mg, magnesium stearate – 1.1 mg.
Capsule body composition gelatin – 45.1258 mg, titanium dioxide – 0.456 mg, indigotine – 0.0182 mg.
Capsule cap composition gelatin – 29.716 mg, titanium dioxide – 0.608 mg, indigotine – 0.076 mg.
6 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin #0, with a blue cap and a blue body; the capsule contents are a granulated powder from white to white with a light yellow tint.
| 1 caps. | |
| Atazanavir sulfate | 227.8 mg, |
| Calculated as Atazanavir | 200 mg |
Excipients: lactose monohydrate – 109.6 mg, crospovidone – 21.6 mg, magnesium stearate – 1.4 mg.
Capsule body composition gelatin – 56.304 mg, titanium dioxide – 1.152 mg, indigotine – 0.144 mg.
Capsule cap composition gelatin – 37.536 mg, titanium dioxide – 0.768 mg, indigotine – 0.096 mg.
6 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin #00, with a red cap and a blue body; the capsule contents are a granulated powder from white to white with a light yellow tint.
| 1 caps. | |
| Atazanavir sulfate | 341.69 mg, |
| Calculated as Atazanavir | 300 mg |
Excipients: lactose monohydrate – 164.36 mg, crospovidone – 32.44 mg, magnesium stearate – 2.16 mg.
Capsule body composition gelatin – 69.207 mg, titanium dioxide – 1.416 mg, indigotine – 0.177 mg.
Capsule cap composition gelatin – 46.1341 mg, titanium dioxide – 0.4411 mg, dye iron oxide red – 0.6248 mg.
30 pcs. – jars (1) – cardboard packs.
Capsules 150 mg: 30, 60, or 90 pcs.
Capsules 200 mg: 30, 60, or 90 pcs.
Capsules 300 mg: 30, 60, or 90 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Manufactured By
Canonpharma Production, CJS (Russia)
Or
Academician V.P. Filatov Plant, LLC (Russia)
Dosage Forms
|
Atazanavir Canon | Capsules 150 mg: 30, 60, or 90 pcs. |
| Capsules 200 mg: 30, 60, or 90 pcs. | ||
| Capsules 300 mg: 30, 60, or 90 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin #1, with a blue body and cap; the capsule contents are a mixture of granules and powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 170.86 mg |
| Equivalent to atazanavir content | 150 mg |
Excipients: lactose monohydrate – 51.14 mg, croscarmellose sodium – 9.6 mg, magnesium stearate – 1.2 mg, povidone K30 – 7.2 mg.
Composition of hard gelatin capsule #1:
Capsule body gelatin – 44.561 mg, titanium dioxide – 0.912 mg, dye patent blue V 0.127 mg.
capsule cap: gelatin – 29.7073 mg, titanium dioxide – 0.608 mg, dye patent blue V 0.0847 mg.
10 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (6) – cardboard packs.
15 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
15 pcs. – contour cell packs (aluminum/PVC) (4) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Capsules hard gelatin #0, with a light blue body and cap; the capsule contents are a mixture of granules and powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 227.81 mg |
| Equivalent to atazanavir content | 200 mg |
Excipients: croscarmellose sodium – 12.8 mg, lactose monohydrate – 68.19 mg, magnesium stearate – 1.6 mg, povidone K30 – 9.6 mg.
Composition of hard gelatin capsule #0:
Capsule body gelatin – 55.7965 mg, titanium dioxide – 1.728 mg, dye iron oxide yellow – 0.0408 mg.
capsule cap : gelatin – 37.1977 mg, titanium dioxide – 1.152 mg, dye iron oxide yellow – 0.0272 mg.
10 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (6) – cardboard packs.
15 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
15 pcs. – contour cell packs (aluminum/PVC) (4) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Capsules hard gelatin #00, with a blue body and cap; the capsule contents are a mixture of granules and powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 341.72 mg |
| Equivalent to atazanavir content | 300 mg |
Excipients: croscarmellose sodium – 19.2 mg, lactose monohydrate – 102.28 mg, magnesium stearate – 2.4 mg, povidone K30 – 14.4 mg.
Composition of hard gelatin capsule #00:
Capsule body gelatin – 69.9976 mg, titanium dioxide – 0.708 mg, dye indigotine – 0.0944 mg.
capsule cap : gelatin – 46.6651 mg, titanium dioxide – 0.472 mg, dye indigotine – 0.0629 mg.
10 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (6) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Capsules 150 mg: 60 pcs.
Capsules 200 mg: 60 pcs.
Capsules 300 mg: 30 pcs.
Marketing Authorization Holder
Krka-Rus, LLC (Russia)
Dosage Forms
|
Atazanavir-KRKA | Capsules 150 mg: 60 pcs. |
| Capsules 200 mg: 60 pcs. | ||
| Capsules 300 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, #1, with a white or almost white body and a brownish-orange cap; the capsule cap is imprinted with the inscription “A150” in black ink; the capsule contents: powder from white with a slight yellowish tint to yellowish-white; the presence of lumps is allowed.
| 1 caps. | |
| Atazanavir sulfate | 170.87 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients: lactose monohydrate, crospovidone (type A), magnesium stearate.
Composition of hard gelatin capsule:
Capsule body: titanium dioxide (E171), gelatin .
Capsule cap: titanium dioxide (E171), dye iron oxide yellow (E172), dye iron oxide red (E172).
Composition of black ink shellac (E904), anhydrous ethanol (E1510)*, isopropanol*, butanol*, dye iron oxide black (E172), propylene glycol (E1520)*, concentrated ammonia solution (E527)*, potassium hydroxide (E525), purified water*.
* anhydrous ethanol, isopropanol, butanol, propylene glycol, concentrated ammonia solution, purified water are absent in the finished gelatin capsules, as they evaporate after the printing and drying stage.
60 pcs. – bottlesx – cardboard packs.
x with first-opening control and child-resistant closure.
Capsules hard gelatin, #0, with a brownish-orange body and cap; the capsule cap is imprinted with the inscription “A200” in black ink; the capsule contents: powder from white with a slight yellowish tint to yellowish-white; the presence of lumps is allowed.
| 1 caps. | |
| Atazanavir sulfate | 227.83 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients: lactose monohydrate, crospovidone (type A), magnesium stearate.
Composition of the hard gelatin capsule:
Capsule body: titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), gelatin .
Capsule cap: titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), gelatin.
Composition of black printing ink shellac (E904), anhydrous ethanol (E1510)*, isopropanol*, butanol*, iron oxide black (E172), propylene glycol (E1520)*, concentrated ammonia solution (E527)*, potassium hydroxide (E525), purified water*.
* anhydrous ethanol, isopropanol, butanol, propylene glycol, concentrated ammonia solution, purified water are absent in the finished gelatin capsules as they evaporate after the printing and drying stage.
60 pcs. – bottlesx – carton packs.
x with first-opening control and child-resistant closure.
Capsules hard gelatin, size 00, body white or almost white, cap dark brown; the inscription “A300” is printed in white ink on the capsule cap; capsule contents: powder from white with a slight yellowish tint to yellowish-white; the presence of lumps is allowed.
| 1 caps. | |
| Atazanavir sulfate | 341.74 mg, |
| Equivalent to atazanavir content | 300 mg |
Excipients: lactose monohydrate, crospovidone (type A), magnesium stearate.
Composition of the hard gelatin capsule:
Capsule body: titanium dioxide (E171), gelatin .
Capsule cap: titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), gelatin.
Composition of white printing ink shellac (E904), anhydrous ethanol (E1510)*, isopropanol*, butanol*, titanium dioxide (E171), propylene glycol (E1520)*, concentrated ammonia solution (E527)*, potassium hydroxide (E525), purified water*.
* anhydrous ethanol, isopropanol, butanol, propylene glycol, concentrated ammonia solution, purified water are absent in the finished gelatin capsules as they evaporate after the printing and drying stage.
30 pcs. – bottlesx – carton packs.
x with first-opening control and child-resistant closure.
Capsules 150 mg: 30 or 60 pcs.
Capsules 200 mg: 30 or 60 pcs.
Marketing Authorization Holder
NANOLEK LLC (Russia)
Dosage Forms
|
Atazanavir-Nanolek® | Capsules 150 mg: 30 or 60 pcs. |
| Capsules 200 mg: 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 1, body blue, cap blue; capsule contents – granulated powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 170.854 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients: lactose monohydrate – 82.196 mg, crospovidone – 7.935 mg.
Composition of the granule coating crospovidone – 7.935 mg, magnesium stearate – 1.08 mg.
Composition of the hard gelatin capsule gelatin – 74.4862 mg, indigo carmine (FD&C Blue 2) – 0.0912 mg, titanium dioxide – 1.4226 mg.
30 pcs. – polyethylene jars (1) – carton packs.
60 pcs. – polyethylene jars (1) – carton packs.
Capsules hard gelatin, size 0, body blue, cap blue; capsule contents – granulated powder from almost white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 227.805 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients: lactose monohydrate – 109.595 mg, crospovidone – 10.58 mg.
Composition of the granule coating crospovidone – 10.58 mg, magnesium stearate – 1.44 mg.
Composition of the hard gelatin capsule gelatin – 94.3945 mg, indigo carmine (FD&C Blue 2) – 0.2016 mg, titanium dioxide – 1.4039 mg.
30 pcs. – polyethylene jars (1) – carton packs.
60 pcs. – polyethylene jars (1) – carton packs.
Capsules 150 mg: 60 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
R-Pharm JSC (Russia)
Dosage Form
|
Atazanavir-TL | Capsules 150 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 1, with white body and white cap; capsule contents – mixture of granules and powder from white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 170.86 mg, |
| Equivalent to atazanavir content | 150 mg |
Excipients: lactose monohydrate, crospovidone, magnesium stearate.
Composition of the capsule body titanium dioxide, gelatin.
Composition of the capsule cap titanium dioxide, gelatin.
6 pcs. – blister packs (10) – carton packs.
10 pcs. – blister packs (6) – carton packs.
60 pcs. – polymer jars (1) – carton packs.
Capsules 200 mg: 60 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
R-Pharm JSC (Russia)
Dosage Form
|
Atazanavir-TL | Capsules 200 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 0, with blue body and blue cap; capsule contents – mixture of granules and powder from white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 227.8 mg, |
| Equivalent to atazanavir content | 200 mg |
Excipients: lactose monohydrate, crospovidone, magnesium stearate.
Composition of the capsule body titanium dioxide, brilliant blue, gelatin.
Composition of the capsule cap titanium dioxide, brilliant blue, gelatin.
6 pcs. – blister packs (10) – carton packs.
10 pcs. – blister packs (6) – carton packs.
60 pcs. – polymer jars (1) – carton packs.
Capsules 300 mg: 30 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
R-Pharm JSC (Russia)
Dosage Form
|
Atazanavir-TL | Capsules 300 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 00, with white body and blue cap; capsule contents – mixture of granules and powder from white to light yellow.
| 1 caps. | |
| Atazanavir sulfate | 341.7 mg, |
| Equivalent to atazanavir content | 300 mg |
Excipients: lactose monohydrate, crospovidone, magnesium stearate.
Composition of the capsule body titanium dioxide, gelatin.
Composition of the capsule cap titanium dioxide, indigo carmine, gelatin.
6 pcs. – blister packs (5) – carton packs.
10 pcs. – blister packs (3) – carton packs.
30 pcs. – polymer jars (1) – carton packs.
![Atazanavir [Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Atazanavir [Capsules] 2")