Darunavir (Tablets) Instructions for Use
ATC Code
J05AE10 (Darunavir)
Active Substance
Darunavir (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
Darunavir is an antiviral agent, an inhibitor of HIV type 1 (HIV-1) protease. Darunavir is an inhibitor of HIV-1 protease dimerization and catalytic activity. It selectively inhibits the cleavage of HIV Gag-Pol polyproteins in virus-infected cells, preventing the formation of mature viral particles.
Darunavir binds strongly to HIV-1 protease (KD 4.5 x 10-12M). Darunavir is resistant to mutations that cause resistance to protease inhibitors.
Darunavir does not inhibit any of the 13 studied human cellular proteases.
Pharmacokinetics
The pharmacokinetic properties of darunavir, used in combination with ritonavir, were studied in healthy volunteers and in HIV-infected patients.
Plasma concentrations of darunavir were higher in HIV-1-infected patients than in healthy individuals. This difference can be explained by higher concentrations of α1-acid glycoprotein in HIV-1-infected patients. Consequently, larger amounts of darunavir bind to plasma α1-acid glycoprotein.
Darunavir is extensively metabolized in the liver primarily by CYP3A isoenzymes. Ritonavir inhibits CYP3A isoenzymes in the liver and thereby significantly increases the plasma concentration of darunavir.
After oral administration, Darunavir is rapidly absorbed from the gastrointestinal tract. The Cmax of darunavir in plasma in the presence of a low dose of ritonavir is achieved within 2.5-4.0 hours. The absolute bioavailability of darunavir after a single oral dose of 600 mg was about 37% and increased to approximately 82% in the presence of ritonavir (100 mg twice daily). The overall pharmacokinetic effect of ritonavir was an approximately 14-fold increase in the plasma concentration of darunavir after a single oral dose of 600 mg darunavir in combination with ritonavir (100 mg twice daily). When taken on an empty stomach, the relative bioavailability of darunavir in the presence of a low dose of ritonavir was 30% lower than when taken with food. The type of food did not affect darunavir plasma concentrations.
The binding of darunavir to plasma proteins (primarily to α1-acid glycoprotein) is about 95%.
In vitro experiments on human liver microsomes showed that Darunavir undergoes predominantly oxidative metabolism. Darunavir is extensively metabolized in the liver by the P450 enzyme system, almost exclusively by the CYP3A4 isoenzyme. A study in which healthy volunteers took 14C-Darunavir showed that the majority of radioactivity in plasma after a single dose of 400 mg darunavir and 100 mg ritonavir was attributable to unchanged darunavir. At least 3 oxidative metabolites of darunavir have been identified in humans; their activity against wild-type HIV was less than 1/10 of the activity of darunavir itself.
After a single dose of 14C-darunavir 400 mg and ritonavir 100 mg, approximately 79.5% and 13.9% of the radioactivity was detected in feces and urine, respectively. Unchanged darunavir accounted for approximately 41.2% and 7.7% of the radioactivity in feces and urine, respectively.
The terminal T1/2 of darunavir was about 15 hours when taken in combination with ritonavir. The clearance of darunavir after intravenous administration of a 150 mg dose was 32.8 L/h without ritonavir and 5.91 L/h in the presence of a low dose of ritonavir.
Indications
Treatment of HIV infection in adult patients (in combination with low-dose ritonavir and 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. |
Tablets
Take orally. Darunavir is always used in combination with low-dose ritonavir (100 mg) as a pharmacokinetic enhancer, as well as in combination with other antiretroviral drugs. The possibility of prescribing ritonavir should be considered before starting therapy with the Darunavir/ritonavir combination.
For patients previously not treated with protease inhibitors, the recommended dose of darunavir is 800 mg once daily in combination with ritonavir 100 mg once daily.
For patients previously treated with protease inhibitors, the recommended dose of darunavir is 600 mg twice daily in combination with ritonavir 100 mg twice daily; the combination should be taken with food.
The Darunavir/ritonavir combination should be used with caution in patients with severe hepatic impairment.
Adverse Reactions
Nervous system disorders headache.
Psychiatric disorders unusual dreams.
Gastrointestinal disorders abdominal pain, acute pancreatitis, diarrhea, dyspepsia, flatulence, nausea, vomiting, increased ALT, AST, ALP activity, acute hepatitis.
Dermatological reactions lipodystrophy (including lipohypertrophy and lipoatrophy), pruritus, rash, Stevens-Johnson syndrome.
Musculoskeletal system disorders: myalgia, in patients receiving protease inhibitors, especially in combination with non-nucleoside reverse transcriptase inhibitors, increased CPK levels, myositis are possible; rarely – rhabdomyolysis.
Metabolism and nutrition disorders anorexia, diabetes mellitus.
Immune system disorders immune reconstitution syndrome.
Investigations increased triglycerides, total cholesterol, LDL cholesterol, glucose, pancreatic lipase, pancreatic amylase.
Infections and infestations in HIV-infected patients with severe immunodeficiency during initial combined antiretroviral therapy, inflammatory reactions to asymptomatic or residual opportunistic infections may occur.
General disorders and administration site conditions asthenia, fatigue.
Contraindications
Concomitant use with drugs whose clearance is primarily determined by the CYP3A4 isoenzyme, and an increase in their plasma concentration is associated with the occurrence of serious and/or life-threatening side effects (narrow therapeutic index) – with astemizole, terfenadine, midazolam, triazolam, cisapride, pimozide, drugs containing ergot alkaloids (ergotamine, dihydroergotamine, ergometrine and methylergometrine); childhood and adolescence under 18 years of age; hypersensitivity to darunavir.
Use in Pregnancy and Lactation
Adequate and strictly controlled clinical studies on the safety of darunavir use during pregnancy have not been conducted. The Darunavir/ritonavir combination can be prescribed to pregnant women only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
It is not known whether Darunavir is excreted in human breast milk. Given the possibility of HIV transmission through breast milk, as well as the risk of serious side effects in infants associated with exposure to darunavir, HIV-infected women receiving Darunavir should refrain from breastfeeding.
Special Precautions
Use with caution in patients with impaired liver function, with allergy to sulfonamides (since Darunavir contains a sulfonamide group).
Patients should be informed that modern antiretroviral drugs do not cure HIV infection and do not prevent the transmission of HIV. Patients should be advised of the need to take appropriate precautions.
Information on the treatment of patients aged 65 years and older with the Darunavir/ritonavir combination is very limited. Caution is required when treating patients in this age group with darunavir, as they more often have liver dysfunction, more often suffer from concomitant diseases, or receive concomitant therapy.
The absolute bioavailability after a single dose of darunavir 600 mg was approximately 37% and increased to approximately 82% after taking darunavir in combination with 100 mg ritonavir twice daily. The overall effect of ritonavir’s pharmacokinetic enhancement of darunavir resulted in an approximately 14-fold increase in darunavir plasma concentration after a single dose of this drug (600 mg) in combination with 100 mg ritonavir twice daily. Therefore, Darunavir should be used only in combination with 100 mg ritonavir to optimize pharmacokinetics.
Increasing the specified dose of ritonavir does not lead to a significant increase in darunavir plasma concentration, and therefore it is not recommended to increase the dose of ritonavir.
In patients with liver disease, including chronic active hepatitis, the frequency of liver function abnormalities may increase during combined antiretroviral therapy, and therefore monitoring of biochemical parameters should be carried out in accordance with standard practice. If such patients show signs of worsening liver function, treatment with the Darunavir/ritonavir combination should be interrupted or completely discontinued.
The kidneys play a minor role in the clearance of darunavir, so in patients with kidney disease, the total clearance of darunavir is practically not reduced. Darunavir and ritonavir are highly bound to plasma proteins, so hemodialysis or peritoneal dialysis does not play a significant role in the elimination of these drugs from the body.
Drug Interactions
Darunavir and ritonavir are inhibitors of the CYP3A isoenzyme. Concomitant use of the Darunavir/ritonavir combination and drugs that are metabolized primarily by the CYP3A isoenzyme may cause an increase in the plasma concentrations of such drugs, which, in turn, may cause an increase or prolongation of the therapeutic effect, as well as side effects.
Darunavir is metabolized by CYP3A isoenzymes. Concomitant use of drugs that induce CYP3A activity may increase the clearance of darunavir, resulting in a decrease in darunavir plasma concentration. Concomitant use of darunavir with CYP3A inhibitors may decrease the clearance of darunavir, resulting in an increase in darunavir plasma concentration.
The Darunavir/ritonavir combination should not be used concomitantly with drugs whose clearance is largely determined by the CYP3A4 isoenzyme and increased plasma concentrations of which may cause serious and/or life-threatening side effects (narrow therapeutic index). Such drugs include astemizole, terfenadine, midazolam, triazolam, cisapride, pimozide and ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergometrine and methylergometrine).
Rifampicin is a strong inducer of CYP450 isoenzymes. The Darunavir/ritonavir combination should not be used concomitantly with rifampicin, as this may lead to a marked decrease in darunavir plasma concentration. As a result, the therapeutic effect of darunavir may be lost.
The Darunavir/ritonavir combination should not be used concomitantly with preparations containing St. John’s wort (Hypericum perforatum) extract, as this may be accompanied by a marked decrease in darunavir plasma concentration, as a result of which the therapeutic effect of darunavir may be lost.
In general, the effect of ritonavir’s pharmacokinetic enhancement of darunavir resulted in darunavir plasma concentrations increasing approximately 14-fold after a single dose of darunavir (600 mg) and 100 mg ritonavir twice daily. Therefore, Darunavir must be used in combination with 100 mg ritonavir to improve the pharmacokinetic characteristics of darunavir.
Results of an interaction study between the Darunavir/ritonavir combination (300 mg/100 mg twice daily) and the lopinavir/ritonavir combination (400 mg/100 mg twice daily) showed that in the presence of the lopinavir/ritonavir combination (with or without an additional 100 mg dose of ritonavir), the plasma concentration of darunavir increased by 53%. In the presence of darunavir alone, the plasma concentration of lopinavir decreased by 19%, and in the presence of the Darunavir/ritonavir combination it increased by 37%. It is not recommended to use the lopinavir/ritonavir combination concomitantly with darunavir, regardless of the intake of a small additional dose of ritonavir.
An interaction study of darunavir (400 mg twice daily), saquinavir (1000 mg twice daily) and ritonavir (100 mg twice daily) showed that the plasma concentration of darunavir increased by 26% in the presence of saquinavir and ritonavir; on the other hand, the Darunavir/ritonavir combination did not affect the plasma concentration of saquinavir. It is not recommended to use saquinavir concomitantly with darunavir, regardless of the use of a small additional dose of ritonavir.
An interaction study between the Darunavir/ritonavir combination (400 mg/100 mg twice daily) and atazanavir (300 mg once daily) showed no significant change in the plasma concentrations of darunavir and atazanavir when used concomitantly. Atazanavir can be used concomitantly with the Darunavir/ritonavir combination.
In an interaction study between the Darunavir/ritonavir combination (400 mg/100 mg twice daily) and indinavir (800 mg twice daily), the plasma concentration of darunavir increased by 24% in the presence of indinavir and ritonavir. In the presence of the Darunavir/ritonavir combination, the plasma concentration of indinavir increased by 23%. When used in combination with the Darunavir/ritonavir combination, the dose of indinavir in patients who do not tolerate it well can be reduced from 800 mg twice daily to 600 mg twice daily.
To date, interactions between the Darunavir/ritonavir combination and protease inhibitors other than lopinavir, saquinavir, atazanavir and indinavir have not been studied, and therefore protease inhibitors not listed here are not recommended for concomitant use with the Darunavir/ritonavir combination.
When the Darunavir/ritonavir combination is used concomitantly, maraviroc should be prescribed at a dose of 150 mg twice daily. In an interaction study between the Darunavir/ritonavir combination (600 mg/100 mg twice daily) and maraviroc (150 mg twice daily), the concentration of maraviroc increased by 305%. No effect of maraviroc on the concentration of darunavir/ritonavir was noted.
The Darunavir/ritonavir combination may increase plasma concentrations of bepridil, lidocaine (with systemic administration), quinidine and amiodarone, flecainide and propafenone. Therefore, caution is required when using the Darunavir/ritonavir combination concomitantly with the listed antiarrhythmics and, if possible, monitoring of their plasma concentrations.
In all studies of the interaction between the Darunavir/ritonavir combination (600/100 mg twice daily) and a single dose of digoxin (400 mcg), an increase in the final plasma concentration of digoxin by 77% was shown. It is recommended to initially prescribe the minimum dose of digoxin and determine its serum concentration to achieve the desired clinical effect when co-administered with this combination.
The Darunavir/ritonavir combination may affect warfarin plasma concentrations. When warfarin and this combination are used concomitantly, monitoring of INR is recommended.
Phenobarbital, phenytoin and carbamazepine are inducers of CYP450 isoenzymes. The Darunavir/ritonavir combination is not recommended for use in combination with these drugs, as this may cause a clinically significant decrease in darunavir plasma concentration and, consequently, a decrease in its therapeutic effect.
An interaction study between the Darunavir/ritonavir combination (600/100 mg twice daily) and carbamazepine (200 mg twice daily) showed that the concentration of darunavir in this case does not change, while the concentration of ritonavir decreases by 49%. The concentration of carbamazepine increases by 45%. No change in the dose of the Darunavir/ritonavir combination is required. If concomitant use of the Darunavir/ritonavir combination and carbamazepine is necessary, patients should be monitored for the possibility of carbamazepine side effects. The plasma concentration of carbamazepine should be monitored and its dose adjusted according to clinical manifestations. Thus, carbamazepine doses may be reduced by 25-50% when co-administered with the Darunavir/ritonavir combination.
When the Darunavir/ritonavir combination is used concomitantly with trazodone and desipramine, an increase in the plasma concentration of trazodone and desipramine is possible. This may cause side effects such as nausea, dizziness, arterial hypotension, fainting. If concomitant use of these drugs and the Darunavir/ritonavir combination is necessary, caution is required, and the possibility of using trazodone and desipramine in lower doses should be considered, especially in the case of long-term therapy.
Concomitant use of the Darunavir/ritonavir combination with parenterally administered midazolam may lead to an increase in midazolam plasma concentration. When used concomitantly, careful clinical monitoring should be carried out and urgent measures should be taken in case of respiratory depression or prolonged sedative effect. The possibility of reducing the dose of midazolam should be considered, especially in the case of long-term therapy.
Use of the Darunavir/ritonavir combination with oral midazolam is contraindicated.
When antipsychotics are used concomitantly with the Darunavir/ritonavir combination, their plasma concentrations may increase. Therefore, when used concomitantly, the doses of antipsychotic drugs (neuroleptics) should be reduced.
Plasma concentrations of calcium channel blockers (e.g., felodipine, nifedipine, nicardipine) may increase when used concomitantly with the Darunavir/ritonavir combination. In such situations, patients should be monitored carefully.
An interaction study between the Darunavir/ritonavir combination (400 mg/100 mg twice daily) and clarithromycin (500 mg twice daily) showed that the plasma concentration of clarithromycin increased by 57%, while the concentration of darunavir remained unchanged. In patients with impaired renal function, it is recommended to reduce the dose of clarithromycin.
Dexamethasone, when entering the bloodstream, induces the CYP3A4 isoenzyme in the liver and consequently reduces darunavir plasma concentrations. This may lead to a decrease in the therapeutic effect of darunavir. Caution is recommended when using dexamethasone and darunavir concomitantly.
Concomitant use of inhaled fluticasone propionate and the Darunavir/ritonavir combination may lead to an increase in fluticasone propionate plasma concentration. A similar interaction may be observed with the use of other corticosteroids metabolized by the CYP3A4 isoenzyme, for example, budesonide. It is advisable to use drugs alternative to fluticasone propionate that are not a substrate of CYP3A4 (for example, beclomethasone).
The isoenzyme CYP3A4 plays a major role in the metabolism of statins such as simvastatin, rosuvastatin, and lovastatin; therefore, their plasma concentrations can significantly increase when used concomitantly with the Darunavir/ritonavir combination. The concomitant use of the Darunavir/ritonavir combination with lovastatin, rosuvastatin, or simvastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis.
An interaction study between atorvastatin (10 mg once daily) and the Darunavir/ritonavir combination (300 mg/100 mg twice daily) showed that in this situation, the plasma concentration of atorvastatin was only 15% lower than with atorvastatin monotherapy (40 mg once daily). If concomitant use of atorvastatin and the Darunavir/ritonavir combination is necessary, it is recommended to start with an atorvastatin dose of 10 mg once daily. The atorvastatin dose can then be gradually increased based on the clinical effect of therapy.
The Darunavir/ritonavir combination (600 mg/100 mg twice daily) increased the plasma concentration of pravastatin after a single dose of this drug (40 mg) by approximately 80%, but only in some patients. If concomitant administration of pravastatin and the Darunavir/ritonavir combination is necessary, it is recommended to start pravastatin at the lowest possible dose and increase the dose until a clinical effect is achieved, while monitoring for the drug’s adverse effects.
The use of omeprazole (20 mg once daily) or ranitidine (150 mg twice daily) concomitantly with the Darunavir/ritonavir combination (400 mg/100 mg twice daily) did not affect the plasma concentration of darunavir. Given this, the Darunavir/ritonavir combination can be used concomitantly with histamine H2-receptor antagonists and proton pump inhibitors without changing the dose of any of the specified drugs.
The plasma concentrations of cyclosporine, tacrolimus, and sirolimus may increase when these drugs are used concomitantly with the Darunavir/ritonavir combination. In these situations, it is recommended to monitor the plasma concentration of the immunosuppressant.
Ketoconazole, itraconazole, and voriconazole are strong inhibitors of the CYP3A4 isoenzyme and are also its substrates. Systemic use of ketoconazole, itraconazole, and voriconazole concomitantly with the Darunavir/ritonavir combination may lead to increased plasma concentrations of darunavir. On the other hand, this combination may increase the plasma concentrations of ketoconazole or itraconazole. This was confirmed by an interaction study between ketoconazole (200 mg twice daily) and the Darunavir/ritonavir combination (400 mg/100 mg twice daily), in which the concentrations of ketoconazole and darunavir increased by 212% and 42%, respectively. If concomitant use of the Darunavir/ritonavir combination with ketoconazole or itraconazole is necessary, the daily dose of the latter should not exceed 200 mg. Plasma concentrations of voriconazole may decrease when co-administered with darunavir/ritonavir. Voriconazole should not be used concomitantly with darunavir/ritonavir; concomitant use is possible only if the potential benefit of voriconazole use outweighs the potential risk.
When the Darunavir/ritonavir combination is used concomitantly with beta-blockers, an increase in the concentration of beta-blockers is possible. Caution should be exercised when using these drugs and the Darunavir/ritonavir combination concomitantly, and careful clinical monitoring should be performed; a dose reduction of the beta-blockers may also be required.
In a study of the effect of the Darunavir/ritonavir combination (600/100 mg twice daily) on stable methadone maintenance therapy, a 16% decrease in the plasma concentration of R-methadone was shown. Based on pharmacokinetic and clinical results, no methadone dose adjustment is required when initiating therapy with the Darunavir/ritonavir combination. However, clinical monitoring is recommended, as some patients may require adjustment of maintenance therapy.
Results of an interaction study between the Darunavir/ritonavir combination and buprenorphine/naloxone showed no effect of the Darunavir/ritonavir combination on the concentration of buprenorphine when used concomitantly. The concentration of the active metabolite of buprenorphine, norbuprenorphine, increased by 46%. No buprenorphine dose adjustment was required. When the Darunavir/ritonavir combination and buprenorphine are co-administered, careful clinical monitoring is recommended.
Results from an interaction study between the Darunavir/ritonavir combination (600/100 mg twice daily) and ethinyl estradiol and norethisterone indicate that the Css in plasma of ethinyl estradiol and norethisterone decreases by 44% and 14%, respectively. When using the Darunavir/ritonavir combination, it is recommended to use alternative non-hormonal methods of contraception.
One study examined sildenafil concentrations after a single 100 mg dose, as well as after taking 25 mg of sildenafil concomitantly with the Darunavir/ritonavir combination (400 mg/100 mg twice daily). Sildenafil concentrations were similar in both situations. Caution is required when using PDE5 inhibitors and the Darunavir/ritonavir combination concomitantly. If concomitant use of the Darunavir/ritonavir combination with sildenafil, vardenafil, or tadalafil is necessary, the single dose of sildenafil should not exceed 25 mg within 48 hours, the single dose of vardenafil should not exceed 2.5 mg within 72 hours, and the single dose of tadalafil should not exceed 10 mg within 72 hours.
Rifabutin is an inducer and substrate of CYP450 isoenzymes. In a study of the interaction between the Darunavir/ritonavir combination (600/100 mg twice daily) and rifabutin (150 mg every other day), an increase in the concentration of darunavir by 57% was observed. Based on the safety profile of the Darunavir/ritonavir combination, the increase in darunavir concentration in the presence of rifabutin does not require a dose adjustment for the Darunavir/ritonavir combination. The interaction study showed comparable concentrations when using rifabutin at a dose of 300 mg once daily and 150 mg every other day in combination with the Darunavir/ritonavir combination (600/100 mg twice daily), as well as an increase in the concentration of the active metabolite 25-O-desacetylrifabutin. When using such a combination, the rifabutin dose should be reduced by 75% from the usual dose of 300 mg/day and increased monitoring for rifabutin adverse effects is required.
An interaction study between paroxetine (20 mg once daily) or sertraline (50 mg once daily) and the Darunavir/ritonavir combination (400 mg/100 mg twice daily) showed that plasma concentrations of darunavir were independent of the presence of sertraline or paroxetine. On the other hand, in the presence of the Darunavir/ritonavir combination, the plasma concentrations of sertraline and paroxetine decreased by 49% and 39%, respectively. If concomitant use with the Darunavir/ritonavir combination is necessary, the doses of selective serotonin reuptake inhibitors should be carefully titrated based on clinical assessment of the antidepressant effect. In addition, in patients receiving a stable dose of sertraline or paroxetine who are starting treatment with the Darunavir/ritonavir combination, the severity of the primary antidepressant effect should be carefully monitored.
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
Film-coated tablets, 400 mg: 60 pcs.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Dosage Form
 |
Darunavir | Film-coated tablets, 400 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval, biconvex; with an engraving “H” on one side and an engraving “189” on the other side; the core on the cross-section is white or almost white.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: microcrystalline cellulose – 389.166 mg, colloidal silicon dioxide – 16.677 mg, crospovidone – 25 mg, magnesium stearate – 2.5 mg.
Film coating composition Opadry II orange 85F530007 – 16.667 mg, including partially hydrolyzed polyvinyl alcohol – 6.6668 mg, macrogol 3350 – 3.667 mg, talc – 2.4667 mg, titanium dioxide – 2.3667 mg, aluminum lake based on sunset yellow dye (15-18%) – 1.55 mg, aluminum lake based on sunset yellow dye (38-42%) – 0.25 mg.
60 pcs. – polyethylene bottles (1) – cardboard packs.
Film-coated tablets, 400 mg: 60 pcs.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Labeled By
MAKIZ-PHARMA, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 400 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval, biconvex; with an engraving “H” on one side and an engraving “189” on the other side; the core on the cross-section is white or almost white.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: microcrystalline cellulose – 389.166 mg, colloidal silicon dioxide – 16.677 mg, crospovidone – 25 mg, magnesium stearate – 2.5 mg.
Film coating composition Opadry II orange 85F530007 – 16.667 mg, including partially hydrolyzed polyvinyl alcohol – 6.6668 mg, macrogol 3350 – 3.667 mg, talc – 2.4667 mg, titanium dioxide – 2.3667 mg, aluminum lake based on sunset yellow dye (15-18%) – 1.55 mg, aluminum lake based on sunset yellow dye (38-42%) – 0.25 mg.
60 pcs. – polyethylene bottles (1) – cardboard packs.
Film-coated tablets, 600 mg: 60 pcs.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Dosage Form
|
Darunavir | Film-coated tablets, 600 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval, biconvex; with an engraving “J” on one side and an engraving “7” on the other side; the core on the cross-section is white or almost white.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: microcrystalline cellulose – 583.75 mg, colloidal silicon dioxide – 25 mg, crospovidone – 37.5 mg, magnesium stearate – 3.75 mg.
Film coating composition Opadry II orange 85F530007 – 25 mg, including partially hydrolyzed polyvinyl alcohol – 10 mg, macrogol 3350 – 5.05 mg, talc – 3.7 mg, titanium dioxide – 3.55 mg, aluminum lake based on sunset yellow dye (15-18%) – 2.325 mg, aluminum lake based on sunset yellow dye (38-42%) – 0.375 mg.
60 pcs. – polyethylene jars (1) – cardboard packs.
Film-coated tablets, 600 mg: 60 pcs.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Labeled By
MAKIZ-PHARMA, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 600 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval, biconvex; with an engraving “J” on one side and an engraving “7” on the other side; the core on the cross-section is white or almost white.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: microcrystalline cellulose – 583.75 mg, colloidal silicon dioxide – 25 mg, crospovidone – 37.5 mg, magnesium stearate – 3.75 mg.
Film coating composition Opadry II orange 85F530007 – 25 mg, including partially hydrolyzed polyvinyl alcohol – 10 mg, macrogol 3350 – 5.05 mg, talc – 3.7 mg, titanium dioxide – 3.55 mg, aluminum lake based on sunset yellow dye (15-18%) – 2.325 mg, aluminum lake based on sunset yellow dye (38-42%) – 0.375 mg.
60 pcs. – polyethylene jars (1) – cardboard packs.
Film-coated tablets, 800 mg: 30 pcs.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Manufactured By
Makiz-Pharma, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 800 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval biconvex, with an engraving “D45” on one side and “H” on the other side; the tablet core on the break is white to almost white.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: silicified microcrystalline cellulose – 761.416 mg, colloidal silicon dioxide – 41.82 mg, crospovidone – 50 mg, magnesium stearate – 13.43 mg.
Coating composition: Opadry II orange 85F530007 – 33.334 mg, contains partially hydrolyzed polyvinyl alcohol – 40%, macrogol 3350 – 20.2%, talc – 14.8%, titanium dioxide -14.2% , aluminum lake based on sunset yellow dye (15-18%) – 9.3%, aluminum lake based on sunset yellow dye (38-42%) – 1.5%.
30 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 60 pcs.
Film-coated tablets, 600 mg: 60 pcs.
Film-coated tablets, 800 mg: 30 pcs.
Marketing Authorization Holder
Amedart LLC (Russia)
Manufactured By
Advanced Pharma, LLC (Russia)
Dosage Forms
|
Darunavir | Film-coated tablets, 400 mg: 60 pcs. |
| Film-coated tablets, 600 mg: 60 pcs. | ||
| Film-coated tablets, 800 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, oval, biconvex.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: low-substituted hypromellose – 80 mg, colloidal silicon dioxide – 21 mg, crospovidone – 110 mg, magnesium stearate – 6 mg.
Film coating composition Opadry® AMB II white 88A180040 – 18 mg (polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%).
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets white, oval, biconvex.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: low-substituted hypromellose – 120 mg, colloidal silicon dioxide – 31.5 mg, crospovidone – 165 mg, magnesium stearate – 9 mg.
Film coating composition Opadry® AMB II white 88A180040 – 27 mg (polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%).
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets white, oval, biconvex.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: low-substituted hypromellose – 160 mg, colloidal silicon dioxide – 42 mg, crospovidone – 220 mg, magnesium stearate – 12 mg.
Film coating composition Opadry® AMB II white 88A180040 – 36 mg (polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%).
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs.
Film-coated tablets, 600 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs.
Film-coated tablets, 800 mg: 30 or 60 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Darunavir | Film-coated tablets, 400 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs. |
| Film-coated tablets, 600 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs. | ||
| Film-coated tablets, 800 mg: 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is almost white; minor roughness of the tablet surface is allowed.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: microcrystalline cellulose (MCC-102) – 135.34 mg, crospovidone – 23.2 mg, colloidal silicon dioxide – 9.86 mg, hypromellose – 4.35 mg, polysorbate 80 – 4.35 mg, magnesium stearate – 2.9 mg.
Film coat composition polyvinyl alcohol – 9 mg; macrogol 4000 – 4.5 mg; titanium dioxide – 3.6 mg; talc – 0.9 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (4) – cardboard packs.
30 pcs. – contour cell blisters (5) – cardboard packs.
30 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – contour cell blisters (10) – cardboard packs.
Film-coated tablets white or almost white, capsule-shaped, biconvex, with a score; the core on the cross-section is almost white; minor roughness of the tablet surface is allowed.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: microcrystalline cellulose (MCC-102) – 203.01 mg, crospovidone – 34.8 mg, colloidal silicon dioxide – 14.79 mg, hypromellose – 6.525 mg, polysorbate 80 – 6.525 mg, magnesium stearate – 4.35 mg.
Film coat composition polyvinyl alcohol – 13.5 mg; macrogol 4000 – 6.75 mg; titanium dioxide – 5.4 mg; talc – 1.35 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (4) – cardboard packs.
30 pcs. – contour cell blisters (5) – cardboard packs.
30 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – contour cell blisters (10) – cardboard packs.
Film-coated tablets white or almost white, oval, biconvex; the core on the cross-section is almost white; minor roughness of the tablet surface is allowed.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: microcrystalline cellulose (MCC-102) – 270.68 mg, crospovidone – 46.4 mg, colloidal silicon dioxide – 19.72 mg, hypromellose – 8.7 mg, polysorbate 80 – 8.7 mg, magnesium stearate – 5.8 mg.
Film coat composition polyvinyl alcohol – 18 mg; macrogol 4000 – 9 mg; titanium dioxide – 7.2 mg; talc – 1.8 mg.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 800 mg: 30 pcs.
Marketing Authorization Holder
Biocad, JSC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 800 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval, biconvex; on the cross-section – from almost white to light brown.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: silicified microcrystalline cellulose – 782.4 mg, croscarmellose sodium – 86 mg, colloidal silicon dioxide – 34.4 mg, magnesium stearate – 17.2 mg.
Coating composition film coating – 70 mg (polyvinyl alcohol – 40%, titanium dioxide (E171) – 11.1%, macrogol – 20.2%, talc – 14.8%, aluminum lake based on sunset yellow FCF (E110) – 8.4%, aluminum lake based on allura red AC (E129) – 5.5%).
10 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
Film-coated tablets, 75 mg: 480 pcs.
Film-coated tablets, 150 mg: 240 pcs.
Film-coated tablets, 300 mg: 120 pcs.
Film-coated tablets, 400 mg: 60 pcs.
Film-coated tablets, 600 mg: 60 pcs.
Marketing Authorization Holder
Biocad, JSC (Russia)
Dosage Forms
|
Darunavir | Film-coated tablets, 75 mg: 480 pcs. |
| Film-coated tablets, 150 mg: 240 pcs. | ||
| Film-coated tablets, 300 mg: 120 pcs. | ||
| Film-coated tablets, 400 mg: 60 pcs. | ||
| Film-coated tablets, 600 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, oval, biconvex; on the cross-section – from almost white to light brown.
| 1 tab. | |
| Darunavir | 75 mg |
Excipients: silicified microcrystalline cellulose – 73.35 mg, croscarmellose sodium – 8.07 mg, colloidal silicon dioxide – 3.23 mg, magnesium stearate – 1.62 mg.
Coating composition film coating – 6.23 mg (polyvinyl alcohol – 40%, titanium dioxide (E171) – 25%, macrogol – 20.2%, talc – 14.8%).
10 pcs. – contour cell blisters (48) – cardboard packs.
Film-coated tablets white, oval, biconvex; on the cross-section – from almost white to light brown.
| 1 tab. | |
| Darunavir | 150 mg |
Excipients: silicified microcrystalline cellulose – 146.7 mg, croscarmellose sodium – 16.13 mg, colloidal silicon dioxide – 6.45 mg, magnesium stearate – 3.23 mg.
Coating composition film coating – 12.49 mg (polyvinyl alcohol – 40%, titanium dioxide (E171) – 25%, macrogol – 20.2%, talc – 14.8%).
10 pcs. – contour cell blisters (24) – cardboard packs.
Film-coated tablets light orange with a brownish tint, oval, biconvex; on the cross-section – from almost white to light brown.
| 1 tab. | |
| Darunavir | 300 mg |
Excipients: silicified microcrystalline cellulose – 293.4 mg, croscarmellose sodium – 32.25 mg, colloidal silicon dioxide – 12.9 mg, magnesium stearate – 6.45 mg.
Coating composition film coating – 26.49 mg (polyvinyl alcohol – 40%, titanium dioxide (E171) – 21.5%, macrogol – 20.2%, talc – 14.8%, aluminum lake based on sunset yellow FCF (E110) – 2.4%, iron oxide yellow – 0.66%, aluminum lake based on indigo carmine (E132) – 0.44%).
10 pcs. – contour cell blisters (12) – cardboard packs.
Film-coated tablets orange, biconvex, capsule-shaped; on the cross-section – white or almost white.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: silicified microcrystalline cellulose – 391.2 mg, croscarmellose sodium – 43 mg, colloidal silicon dioxide – 17.2 mg, magnesium stearate – 8.6 mg.
Coating composition film coating – 35 mg (polyvinyl alcohol – 40%, titanium dioxide (E171) – 11.1%, macrogol – 20.2%, talc – 14.8%, aluminum lake based on sunset yellow FCF (E110) – 8.4%, aluminum lake based on allura red AC (E129) – 5.5%).
10 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
Film-coated tablets light orange, oval, biconvex; on the cross-section – from almost white to light brown.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: silicified microcrystalline cellulose – 586.8 mg, croscarmellose sodium – 64.5 mg, colloidal silicon dioxide – 25.8 mg, magnesium stearate – 12.9 mg.
Coating composition film coating – 52 mg (polyvinyl alcohol – 40%, titanium dioxide (E171) – 21.5%, macrogol – 20.2%, talc – 14.8%, aluminum lake based on sunset yellow FCF (E110) – 2.4%, iron oxide yellow – 0.66%, aluminum lake based on indigo carmine (E123) – 0.44%).
10 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
Film-coated tablets, 400 mg: 60 pcs.
Film-coated tablets, 600 mg: 60 pcs.
Film-coated tablets, 800 mg: 30 pcs.
Marketing Authorization Holder
Geropharm, LLC (Russia)
Dosage Forms
|
Darunavir | Film-coated tablets, 400 mg: 60 pcs. |
| Film-coated tablets, 600 mg: 60 pcs. | ||
| Film-coated tablets, 800 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow, oval, biconvex, with an engraving “400” on one side; the tablet core on the cross-section is white or almost white.
| 1 tab. | |
| Darunavir (as ethanolate) | 400 mg |
Excipients: colloidal anhydrous silicon dioxide – 5.15 mg, crospovidone – 16.5 mg, silicified microcrystalline cellulose – 175.98 mg, magnesium stearate – 4 mg.
Film coating: Opadry® II Yellow 85F32371: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, indigo carmine (E132), iron oxide yellow (E172).
10 pcs. – contour cell blisters (6) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets blue, oval, biconvex, with an engraving “600” on one side; the tablet core on the cross-section is white or almost white.
| 1 tab. | |
| Darunavir (as ethanolate) | 600 mg |
Excipients: colloidal anhydrous silicon dioxide – 7.73 mg, crospovidone – 24.75 mg, silicified microcrystalline cellulose – 263.97 mg, magnesium stearate – 6 mg.
Film coating: Opadry® II Blue 85F20440: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, indigo carmine (E132).
10 pcs. – contour cell blisters (6) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets white, oval, biconvex, with an engraving “800” on one side; the tablet core on the cross-section is white or almost white.
| 1 tab. | |
| Darunavir (as ethanolate) | 800 mg |
Excipients: colloidal anhydrous silicon dioxide – 10.3 mg, crospovidone – 33 mg, silicified microcrystalline cellulose – 351.95 mg, magnesium stearate – 8 mg.
Film coating: Opadry® II White 85F18422: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc.
10 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 150 mg: 240 pcs.
Film-coated tablets, 400 mg: 60 pcs.
Film-coated tablets, 600 mg: 60 pcs.
Film-coated tablets, 800 mg: 30 pcs.
Marketing Authorization Holder
Irvin 2, LLC (Russia)
Manufactured By
ZiO-Health CJSC (Russia)
Dosage Forms
|
Darunavir | Film-coated tablets, 150 mg: 240 pcs. |
| Film-coated tablets, 400 mg: 60 pcs. | ||
| Film-coated tablets, 600 mg: 60 pcs. | ||
| Film-coated tablets, 800 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, oval, biconvex, with a score on both sides.
| 1 tab. | |
| Darunavir | 150 mg |
Excipients: Prosolv® SMCC HD90 (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 42.74 mg, crospovidone – 9.28 mg, polysorbate 80 – 1.96 mg, copovidone – 1.24 mg, sodium stearyl fumarate – 1.03 mg.
Film coat composition Opadry white 85F18422, incl. polyvinyl alcohol – 3.03 mg, macrogol 4000 – 1.67 mg, titanium dioxide – 2.06 mg, talc – 1.22 mg.
240 pcs. – jars (1) – cardboard packs.
Film-coated tablets light orange, oval, with an engraving “Z” on one side.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: Prosolv® SMCC HD90 (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 113.98 mg, crospovidone – 24.75 mg, polysorbate 80 – 5.22 mg, copovidone – 3.3 mg, sodium stearyl fumarate – 2.75 mg.
Film coat composition Opadry orange 85F230079, incl. polyvinyl alcohol – 8.8 mg, macrogol 4000 – 4.44 mg, titanium dioxide – 4.74 mg, talc – 3.26 mg, iron oxide yellow – 0.68 mg, iron oxide red – 0.08 mg.
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets orange, oval, with a score on both sides.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: Prosolv® SMCC HD90 (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 170.97 mg, crospovidone – 37.12 mg, polysorbate 80 – 7.84 mg, copovidone – 4.95 mg, sodium stearyl fumarate – 4.12 mg.
Film coat composition Opadry orange 85F230066, incl. polyvinyl alcohol – 13.2 mg, macrogol 4000 – 6.67 mg, titanium dioxide – 5.07 mg, talc – 4.88 mg, iron oxide yellow – 2.8 mg, iron oxide red – 0.38 mg.
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets red-brown, with a score on both sides, core from white to almost white.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: Prosolv® SMCC HD90 (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 227.95 mg, crospovidone – 49.5 mg, polysorbate 80 – 10.45 mg, copovidone – 6.6 mg, sodium stearyl fumarate – 5.5 mg.
Film coat composition Opadry dark red 85F150004, incl. polyvinyl alcohol – 17.6 mg, macrogol 4000 – 8.89 mg, titanium dioxide – 3.89 mg, talc – 6.51 mg, iron oxide red – 7.11 mg.
30 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 800 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs.
Marketing Authorization Holder
Pharmazashchita SPC, FSUE FMBA of Russia (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 800 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval-shaped, biconvex; the core on the cross-section is almost white.
| 1 tab. | |
| Darunavir (as darunavir ethanolate) | 800 mg |
Excipients: microcrystalline cellulose MS-101 – 139.2 mg, povidone K-30 – 49.5 mg, crospovidone – 33 mg, colloidal silicon dioxide – 5.5 mg, magnesium stearate – 5.5 mg.
Film coat composition Opadry® II 85F13962 Orange (OPADRY ® II 85F13962 Orange) – 44 mg, incl. polyvinyl alcohol – 17.6 mg, macrogol/PEG – 8.9 mg, titanium dioxide – 8.6 mg, talc – 6.5 mg, aluminum lake based on sunset yellow FCF – 2.4 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
240 pcs. – jars (1) – cardboard packs.
360 pcs. – jars (1) – cardboard packs.
480 pcs. – jars (1) – cardboard packs.
30 pcs. – bottles (1) – cardboard packs.
60 pcs. – bottles (1) – cardboard packs.
100 pcs. – bottles (1) – cardboard packs.
120 pcs. – bottles (1) – cardboard packs.
240 pcs. – bottles (1) – cardboard packs.
360 pcs. – bottles (1) – cardboard packs.
480 pcs. – bottles (1) – cardboard packs.
Film-coated tablets 75 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 150 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 300 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 400 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 600 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs.
Marketing Authorization Holder
Pharmazashchita SPC, FSUE FMBA of Russia (Russia)
Dosage Forms
|
Darunavir | Film-coated tablets 75 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs. |
| Film-coated tablets 150 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs. | ||
| Film-coated tablets 300 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs. | ||
| Film-coated tablets 400 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs. | ||
| Film-coated tablets 600 mg: 10, 30, 60, 100, 120, 240, 360, or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange in color, biconvex, round in shape; the core is almost white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir ethanolate) | 75 mg |
Excipients: microcrystalline cellulose MS-101 – 13.05 mg, povidone K-30 – 4.64 mg, crospovidone – 3.09 mg, colloidal silicon dioxide – 0.51 mg, magnesium stearate – 0.51 mg.
Film coating composition Opadry® II 85F13962 Orange film coating (OPADRY® II 85F13962 Orange) – 4.13 mg, including polyvinyl alcohol – 1.65 mg, macrogol/PEG – 0.83 mg, titanium dioxide – 0.81 mg, talc – 0.61 mg, sunset yellow FCF aluminum lake – 0.23 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
240 pcs. – jars (1) – cardboard packs.
360 pcs. – jars (1) – cardboard packs.
480 pcs. – jars (1) – cardboard packs.
Film-coated tablets orange in color, biconvex, round in shape; the core is almost white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir ethanolate) | 150 mg |
Excipients: microcrystalline cellulose MS-101 – 26.11 mg, povidone K-30 – 9.28 mg, crospovidone – 6.18 mg, colloidal silicon dioxide – 1.03 mg, magnesium stearate – 1.03 mg.
Film coating composition Opadry® II 85F13962 Orange film coating (OPADRY® II 85F13962 Orange) – 8.25 mg, including polyvinyl alcohol – 3.3 mg, macrogol/PEG – 1.67 mg, titanium dioxide – 1.61 mg, talc – 1.22 mg, sunset yellow FCF aluminum lake – 0.45 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
240 pcs. – jars (1) – cardboard packs.
360 pcs. – jars (1) – cardboard packs.
480 pcs. – jars (1) – cardboard packs.
Film-coated tablets orange in color, biconvex, round in shape; the core is almost white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir ethanolate) | 300 mg |
Excipients: microcrystalline cellulose MS-101 – 52.21 mg, povidone K-30 – 18.56 mg, crospovidone – 12.37 mg, colloidal silicon dioxide – 2.06 mg, magnesium stearate – 2.06 mg.
Film coating composition Opadry® II 85F13962 Orange film coating (OPADRY® II 85F13962 Orange) – 16.5 mg, including polyvinyl alcohol – 6.6 mg, macrogol/PEG – 3.34 mg, titanium dioxide – 3.22 mg, talc – 2.44 mg, sunset yellow FCF aluminum lake – 0.9 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
240 pcs. – jars (1) – cardboard packs.
360 pcs. – jars (1) – cardboard packs.
480 pcs. – jars (1) – cardboard packs.
Film-coated tablets orange in color, biconvex, round in shape; the core is almost white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir ethanolate) | 400 mg |
Excipients: microcrystalline cellulose MS-101 – 69.6 mg, povidone K-30 – 24.75 mg, crospovidone – 16.5 mg, colloidal silicon dioxide – 2.75 mg, magnesium stearate – 2.75 mg.
Film coating composition Opadry® II 85F13962 Orange film coating (OPADRY® II 85F13962 Orange) – 22 mg, including polyvinyl alcohol – 8.8 mg, macrogol/PEG – 4.45 mg, titanium dioxide – 4.3 mg, talc – 3.25 mg, sunset yellow FCF aluminum lake – 1.2 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
240 pcs. – jars (1) – cardboard packs.
360 pcs. – jars (1) – cardboard packs.
480 pcs. – jars (1) – cardboard packs.
Film-coated tablets orange in color, biconvex, oval in shape; the core is almost white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir ethanolate) | 600 mg |
Excipients: microcrystalline cellulose MS-101 – 104.4 mg, povidone K-30 – 37.13 mg, crospovidone – 24.75 mg, colloidal silicon dioxide – 4.12 mg, magnesium stearate – 4.12 mg.
Film coating composition Opadry® II 85F13962 Orange film coating (OPADRY® II 85F13962 Orange) – 33 mg, including polyvinyl alcohol – 13.2 mg, macrogol/PEG – 6.68 mg, titanium dioxide – 6.45 mg, talc – 4.87 mg, sunset yellow FCF aluminum lake – 1.8 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.
240 pcs. – jars (1) – cardboard packs.
360 pcs. – jars (1) – cardboard packs.
480 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 300 mg: 60 pcs.
Film-coated tablets, 400 mg: 60 pcs.
Film-coated tablets, 600 mg: 60 pcs.
Film-coated tablets, 800 mg: 30 pcs.
Marketing Authorization Holder
R-Pharm JSC (Russia)
Dosage Forms
|
Darunavir | Film-coated tablets, 300 mg: 60 pcs. |
| Film-coated tablets, 400 mg: 60 pcs. | ||
| Film-coated tablets, 600 mg: 60 pcs. | ||
| Film-coated tablets, 800 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the tablet core is white or almost white.
| 1 tab. | |
| Darunavir | 300 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, sodium starch glycolate, polysorbate 80, sodium stearyl fumarate.
Film coating composition Opadry II 85F48105 (white) [polyvinyl alcohol, macrogol, talc, titanium dioxide].
60 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets light orange in color, two layers are visible in cross-section, round, biconvex; the tablet core is white or almost white.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, sodium starch glycolate, polysorbate 80, sodium stearyl fumarate.
Film coating composition Opadry II 85F93377 (orange) [polyvinyl alcohol, titanium dioxide, macrogol, talc, sunset yellow FCF aluminum lake (E110)].
60 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets orange in color, two layers are visible in cross-section, oval, biconvex; the tablet core is white or almost white.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, sodium starch glycolate, polysorbate 80, sodium stearyl fumarate.
Film coating composition Opadry II 85F13962 (orange) [polyvinyl alcohol, macrogol, titanium dioxide, talc, sunset yellow FCF aluminum lake (E110)].
60 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets red-brown in color, two layers are visible in cross-section, oval, biconvex; the tablet core is white or almost white.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, sodium starch glycolate, polysorbate 80, sodium stearyl fumarate.
Film coating composition Opadry II 85F150004 (dark red) [polyvinyl alcohol, macrogol, red iron oxide, talc, titanium dioxide].
30 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 800 mg: 30, 60, 100, 120, 240, 360 or 480 pcs.
Marketing Authorization Holder
Pharmasintez-Tyumen, LLC (Russia)
Manufactured By
Pharmasintez-Tyumen, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 800 mg: 30, 60, 100, 120, 240, 360 or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to dark yellow, biconvex, oval.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: low-substituted hydroxypropyl cellulose – 26.67 mg, polysorbate – 16 mg, crospovidone – 64 mg, colloidal silicon dioxide – 16 mg, Prosolv EasyTab SP – 736 mg.
Film coating composition hypromellose E5 – 28.070 mg, yellow iron oxide – 1.640 mg, macrogol 6000 – 5.410 mg, talc – 0.859 mg, titanium dioxide – 1.344 mg.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – polymer jars.
60 pcs. – polymer jars.
100 pcs. – polymer jars.
120 pcs. – polymer jars.
240 pcs. – polymer jars.
360 pcs. – polymer jars.
480 pcs. – polymer jars.
Film-coated tablets, 75 mg: 30, 60, 100, 120, 240, 360, or 480 pcs.
Marketing Authorization Holder
Pharmasintez-Tyumen, LLC (Russia)
Manufactured By
Pharmasintez-Tyumen, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 75 mg: 30, 60, 100, 120, 240, 360, or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to dark yellow, biconvex, round.
| 1 tab. | |
| Darunavir | 75 mg |
Excipients: low-substituted hydroxypropyl cellulose – 2.5 mg, polysorbate – 1.5 mg, crospovidone – 6 mg, colloidal silicon dioxide – 1.5 mg, Prosolv EasyTab SP – 69 mg.
Film coating composition hypromellose E5 – 2.632 mg, yellow iron oxide – 0.154 mg, macrogol 6000 – 0.5075 mg, talc – 0.0805 mg, titanium dioxide – 0.126 mg.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – polymer jars.
60 pcs. – polymer jars.
100 pcs. – polymer jars.
120 pcs. – polymer jars.
240 pcs. – polymer jars.
360 pcs. – polymer jars.
480 pcs. – polymer jars.
Film-coated tablets, 150 mg: 30, 60, 100, 120, 240, 360, or 480 pcs.
Marketing Authorization Holder
Pharmasintez-Tyumen, LLC (Russia)
Manufactured By
Pharmasintez-Tyumen, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 150 mg: 30, 60, 100, 120, 240, 360, or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to dark yellow, biconvex, round.
| 1 tab. | |
| Darunavir | 150 mg |
Excipients: low-substituted hydroxypropyl cellulose – 5 mg, polysorbate – 3 mg, crospovidone – 12 mg, colloidal silicon dioxide – 3 mg, Prosolv EasyTab SP – 138 mg.
Film coating composition hypromellose E5 – 5.264 mg, yellow iron oxide – 0.308 mg, macrogol 6000 – 1.015 mg, talc – 0.161 mg, titanium dioxide – 0.252 mg.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – polymer jars.
60 pcs. – polymer jars.
100 pcs. – polymer jars.
120 pcs. – polymer jars.
240 pcs. – polymer jars.
360 pcs. – polymer jars.
480 pcs. – polymer jars.
Film-coated tablets, 300 mg: 30, 60, 100, 120, 240, 360, or 480 pcs.
Marketing Authorization Holder
Pharmasintez-Tyumen, LLC (Russia)
Manufactured By
Pharmasintez-Tyumen, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 300 mg: 30, 60, 100, 120, 240, 360, or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to dark yellow, biconvex, oval.
| 1 tab. | |
| Darunavir | 300 mg |
Excipients: low-substituted hydroxypropyl cellulose – 10 mg, polysorbate – 6 mg, crospovidone – 24 mg, colloidal silicon dioxide – 6 mg, Prosolv EasyTab SP – 276 mg.
Film coating composition hypromellose E5 – 10.528 mg, yellow iron oxide – 0.616 mg, macrogol 6000 – 2.030 mg, talc – 0.322 mg, titanium dioxide – 0.504 mg.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – polymer jars.
60 pcs. – polymer jars.
100 pcs. – polymer jars.
120 pcs. – polymer jars.
240 pcs. – polymer jars.
360 pcs. – polymer jars.
480 pcs. – polymer jars.
Film-coated tablets, 400 mg: 30, 60, 100, 120, 240, 360, or 480 pcs.
Marketing Authorization Holder
Pharmasintez-Tyumen, LLC (Russia)
Manufactured By
Pharmasintez-Tyumen, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 400 mg: 30, 60, 100, 120, 240, 360, or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to dark yellow, biconvex, oval.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: low-substituted hypromellose – 13.33 mg, polysorbate – 8 mg, crospovidone – 32 mg, colloidal silicon dioxide – 8 mg, Prosolv EasyTab SP – 368 mg.
Film coating composition: hypromellose E5 – 14.037 mg, yellow iron oxide dye – 0.821 mg, macrogol 6000 – 2.707 mg, talc – 0.429 mg, titanium dioxide – 0.672 mg.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – polymer jars.
60 pcs. – polymer jars.
100 pcs. – polymer jars.
120 pcs. – polymer jars.
240 pcs. – polymer jars.
360 pcs. – polymer jars.
480 pcs. – polymer jars.
Film-coated tablets, 600 mg: 30, 60, 100, 120, 240, 360, or 480 pcs.
Marketing Authorization Holder
Pharmasintez-Tyumen, LLC (Russia)
Manufactured By
Pharmasintez-Tyumen, LLC (Russia)
Dosage Form
|
Darunavir | Film-coated tablets, 600 mg: 30, 60, 100, 120, 240, 360, or 480 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to dark yellow, biconvex, oval.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: low-substituted hypromellose – 20 mg, polysorbate – 12 mg, crospovidone – 48 mg, colloidal silicon dioxide – 12 mg, Prosolv EasyTab SP – 552 mg.
Film coating composition: hypromellose E5 – 21.056 mg, yellow iron oxide dye – 1.232 mg, macrogol 6000 – 4.060 mg, talc – 0.644 mg, titanium dioxide – 1.008 mg.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – polymer jars.
60 pcs. – polymer jars.
100 pcs. – polymer jars.
120 pcs. – polymer jars.
240 pcs. – polymer jars.
360 pcs. – polymer jars.
480 pcs. – polymer jars.
Film-coated tablets, 75 mg: 60 or 90 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Darunavir Canon | Film-coated tablets, 75 mg: 60 or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, round, biconvex, almost white in cross-section.
| 1 tab. | |
| Darunavir | 75 mg |
Excipients: colloidal silicon dioxide – 1.6 mg, croscarmellose sodium – 6.4 mg, magnesium stearate – 1.5 mg, Prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 75.5 mg.
Film coating composition: Opadry II 85F 230087 orange 5 mg, incl.: polyvinyl alcohol – 2 mg, macrogol 3350 (polyethylene glycol) – 1.01 mg, talc – 0.74 mg, titanium dioxide – 0.507 mg, yellow iron oxide dye – 0.046 mg, sunset yellow FCF dye – 0.695 mg, indigo carmine dye 0.002 mg.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 150 mg: 60 or 90 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Darunavir Canon | Film-coated tablets, 150 mg: 60 or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, round, biconvex, almost white in cross-section.
| 1 tab. | |
| Darunavir | 150 mg |
Excipients: colloidal silicon dioxide – 3.2 mg, croscarmellose sodium – 12.8 mg, magnesium stearate – 3 mg, Prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 151 mg.
Film coating composition: Opadry II 85F 230087 orange 10 mg, incl.: polyvinyl alcohol – 4 mg, macrogol 3350 (polyethylene glycol) – 2.02 mg, talc – 1.48 mg, titanium dioxide – 1.014 mg, yellow iron oxide dye – 0.091 mg, sunset yellow FCF dye – 1.391 mg, indigo carmine dye 0.004 mg.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 60 or 90 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Darunavir Canon | Film-coated tablets, 400 mg: 60 or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, round, biconvex, almost white in cross-section.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: colloidal silicon dioxide – 6.5 mg, croscarmellose sodium – 25.2 mg, magnesium stearate – 6 mg, Prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 192.3 mg.
Film coating composition: Opadry II 85F 230087 orange 20 mg, incl.: polyvinyl alcohol – 8 mg, macrogol 3350 (polyethylene glycol) – 4.04 mg, talc – 2.96 mg, titanium dioxide – 2.028 mg, yellow iron oxide dye – 0.182 mg, sunset yellow FCF dye – 2.782 mg, indigo carmine dye 0.008 mg.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 600 mg: 60 or 90 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Darunavir Canon | Film-coated tablets, 600 mg: 60 or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval, biconvex, almost white in cross-section.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: colloidal silicon dioxide – 9.75 mg, croscarmellose sodium – 37.8 mg, magnesium stearate – 9 mg, Prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 288.45 mg.
Film coating composition: Opadry II 85F 230087 orange 30 mg, incl.: polyvinyl alcohol – 12 mg, macrogol 3350 (polyethylene glycol) – 6.06 mg, talc – 4.44 mg, titanium dioxide – 3.042 mg, yellow iron oxide dye – 0.273 mg, sunset yellow FCF dye – 4.173 mg, indigo carmine dye 0.012 mg.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 800 mg: 60 or 90 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Darunavir Canon | Film-coated tablets, 800 mg: 60 or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets orange, oval, biconvex, almost white in cross-section.
| 1 tab. | |
| Darunavir | 800 mg |
Excipients: colloidal silicon dioxide – 13 mg, croscarmellose sodium – 50.4 mg, magnesium stearate – 12 mg, Prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 384.6 mg.
Film coating composition: Opadry II 85F 230087 orange 40 mg, incl.: polyvinyl alcohol – 16 mg, macrogol 3350 (polyethylene glycol) – 8.08 mg, talc – 5.92 mg, titanium dioxide – 4.056 mg, yellow iron oxide dye – 0.364 mg, sunset yellow FCF dye – 5.564 mg, indigo carmine dye 0.016 mg.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 75 mg: 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 150 mg: 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 300 mg: 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 400 mg: 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 600 mg: 60, 100, 120, 240, 360, or 480 pcs.
Film-coated tablets 800 mg: 30, 60, or 120 pcs.
Marketing Authorization Holder
Advanced Pharma, LLC (Russia)
Dosage Forms
|
Darunavir-Advanced | Film-coated tablets, 75 mg: 60, 100, 120, 240, 360, or 480 pcs. |
| Film-coated tablets 150 mg: 60, 100, 120, 240, 360, or 480 pcs. | ||
| Film-coated tablets 300 mg: 60, 100, 120, 240, 360, or 480 pcs. | ||
| Film-coated tablets 400 mg: 60, 100, 120, 240, 360, or 480 pcs. | ||
| Film-coated tablets 600 mg: 60, 100, 120, 240, 360, or 480 pcs. | ||
| Film-coated tablets 800 mg: 30, 60, or 120 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to dark yellow, round biconvex; the core is from almost white to white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir amorphous) | 75 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone XL-10, magnesium stearate, Wincoat WT-18025P yellow coating (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, quinoline yellow aluminum lake (E104)).
10 pcs. – blister pack (6) – cardboard packs.
10 pcs. – blister pack (10) – cardboard packs.
60 pcs. – plastic jars (1) – cardboard packs.
100 pcs. – plastic jars (1) – cardboard packs.
120 pcs. – plastic jars (1) – cardboard packs.
240 pcs. – plastic jars (1) – cardboard packs.
360 pcs. – plastic jars (1) – cardboard packs.
480 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets from light yellow to dark yellow, round biconvex; the core is from almost white to white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir amorphous) | 150 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone XL-10, magnesium stearate, Wincoat WT-18025P yellow coating (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, quinoline yellow aluminum lake (E104)).
10 pcs. – blister pack (6) – cardboard packs.
10 pcs. – blister pack (10) – cardboard packs.
60 pcs. – plastic jars (1) – cardboard packs.
100 pcs. – plastic jars (1) – cardboard packs.
120 pcs. – plastic jars (1) – cardboard packs.
240 pcs. – plastic jars (1) – cardboard packs.
360 pcs. – plastic jars (1) – cardboard packs.
480 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets from light yellow to dark yellow, round biconvex; the core is from almost white to white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir amorphous) | 300 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone XL-10, magnesium stearate, Wincoat WT-18025P yellow coating (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, quinoline yellow aluminum lake (E104)).
10 pcs. – blister pack (6) – cardboard packs.
10 pcs. – blister pack (10) – cardboard packs.
60 pcs. – plastic jars (1) – cardboard packs.
100 pcs. – plastic jars (1) – cardboard packs.
120 pcs. – plastic jars (1) – cardboard packs.
240 pcs. – plastic jars (1) – cardboard packs.
360 pcs. – plastic jars (1) – cardboard packs.
480 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets from light yellow to dark yellow, oval biconvex; the core is from almost white to white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir amorphous) | 400 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone XL-10, magnesium stearate, Wincoat WT-18025P yellow coating (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, quinoline yellow aluminum lake (E104)).
10 pcs. – blister pack (6) – cardboard packs.
10 pcs. – blister pack (10) – cardboard packs.
60 pcs. – plastic jars (1) – cardboard packs.
100 pcs. – plastic jars (1) – cardboard packs.
120 pcs. – plastic jars (1) – cardboard packs.
240 pcs. – plastic jars (1) – cardboard packs.
360 pcs. – plastic jars (1) – cardboard packs.
480 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets from light yellow to dark yellow with a score on one side, oval biconvex; the core is from almost white to white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir amorphous) | 600 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone XL-10, magnesium stearate, Wincoat WT-18025P yellow coating (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, quinoline yellow aluminum lake (E104)).
10 pcs. – blister pack (6) – cardboard packs.
10 pcs. – blister pack (10) – cardboard packs.
60 pcs. – plastic jars (1) – cardboard packs.
100 pcs. – plastic jars (1) – cardboard packs.
120 pcs. – plastic jars (1) – cardboard packs.
240 pcs. – plastic jars (1) – cardboard packs.
360 pcs. – plastic jars (1) – cardboard packs.
480 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets from light yellow to dark yellow, oval biconvex; the core is from almost white to white in cross-section.
| 1 tab. | |
| Darunavir (as darunavir amorphous) | 800 mg |
Excipients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone XL-10, magnesium stearate, Wincoat WT-18025P yellow coating (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, quinoline yellow aluminum lake (E104)).
10 pcs. – blister pack (3) – cardboard packs.
10 pcs. – blister pack (6) – cardboard packs.
30 pcs. – plastic jars (1) – cardboard packs.
60 pcs. – plastic jars (1) – cardboard packs.
120 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 60 pcs.
Film-coated tablets, 600 mg: 60 pcs.
Marketing Authorization Holder
NANOLEK LLC (Russia)
Dosage Forms
|
Darunavir-Nanolek® | Film-coated tablets, 400 mg: 60 pcs. |
| Film-coated tablets, 600 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, oval, biconvex; white or almost white on the cross-section.
| 1 tab. | |
| Darunavir | 400 mg |
Excipients: microcrystalline cellulose (VIVAPUR® 102) – 336.96 mg, crospovidone (Kollidon CL) – 40 mg, colloidal silicon dioxide (aerosil) – 16 mg, magnesium stearate – 7.04 mg.
Film coating composition Opadry white 03F280030 (OPADRY® 03F280030 White) – 24 mg (hypromellose – 65%, macrogol – 13%, talc – 2%, titanium dioxide – 20%).
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets white or almost white, oval, biconvex; white or almost white on the cross-section.
| 1 tab. | |
| Darunavir | 600 mg |
Excipients: microcrystalline cellulose (VIVAPUR® 102) – 505.44 mg, crospovidone (Kollidon CL) – 60 mg, colloidal silicon dioxide (aerosil) – 24 mg, magnesium stearate – 10.56 mg.
Film coating composition Opadry white 03F280030 (OPADRY® 03F280030 White) – 36 mg (hypromellose – 65%, macrogol – 13%, talc – 2%, titanium dioxide – 20%).
60 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 400 mg: 60 pcs.
Film-coated tablets, 600 mg: 60 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Dosage Forms
|
Darunavir-TL | Film-coated tablets, 400 mg: 60 pcs. |
| Film-coated tablets, 600 mg: 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets light orange, oval, biconvex, two layers are visible on the cross-section. The tablet core is white or almost white.
| 1 tab. | |
| Darunavir ethanolate | 433.64 mg |
| Equivalent to darunavir content | 400 mg |
Excipients: microcrystalline cellulose – 310.36 mg, crospovidone – 40 mg, colloidal silicon dioxide – 8 mg, magnesium stearate – 8 mg.
Film coating composition Opadry II 85F93377 (orange) [polyvinyl alcohol – 40%, titanium dioxide – 22.5%, macrogol – 20.2%, talc – 14.8%, aluminum lake based on sunset yellow FCF (E110) – 2.5%] – 32 mg.
60 pcs. – plastic jars (1) – cardboard packs.
Film-coated tablets orange, oval, biconvex, two layers are visible on the cross-section. The tablet core is white or almost white.
| 1 tab. | |
| Darunavir ethanolate | 650.46 mg |
| Equivalent to darunavir content | 600 mg |
Excipients: microcrystalline cellulose – 465.54 mg, crospovidone – 60 mg, colloidal silicon dioxide – 12 mg, magnesium stearate – 12 mg.
Film coating composition Opadry II 85F13962 (orange) [polyvinyl alcohol – 40%, titanium dioxide – 19.5%, macrogol – 20.2%, talc – 14.8%, aluminum lake based on sunset yellow FCF (E110) – 5.5%] – 48 mg.
60 pcs. – plastic jars (1) – cardboard packs.
![Darunavir [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Darunavir [Tablets] 2")