Viracept
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Questions & Answers
Side Effects & Adverse Reactions
ALERT: Find out about medicines that should not be taken with VIRACEPT. This statement is included on the product's bottle label.
(also see PRECAUTIONS)
Nelfinavir is an inhibitor of the CYP3A enzyme. Coadministration of VIRACEPT and drugs primarily metabolized by CYP3A may result in increased plasma concentrations of the other drug that could increase or prolong its therapeutic and adverse effects. Caution should be exercised when inhibitors of CYP3A, including VIRACEPT, are coadministered with drugs that are metabolized by CYP3A and that prolong the QT interval. (See ADVERSE REACTIONS: Post-Marketing Experience.) Nelfinavir is metabolized by CYP3A and CYP2C19. Coadministration of VIRACEPT and drugs that induce CYP3A or CYP2C19 may decrease nelfinavir plasma concentrations and reduce its therapeutic effect. Coadministration of VIRACEPT and drugs that inhibit CYP3A or CYP2C19 may increase nelfinavir plasma concentrations. (Also see PRECAUTIONS: Table 10: Drugs That Should Not Be Coadministered With VIRACEPT, Table 11: Established and Other Potentially Significant Drug Interactions.)
Concomitant use of VIRACEPT with lovastatin or simvastatin is not recommended. Caution should be exercised if HIV protease inhibitors, including VIRACEPT, are used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A pathway (e.g., atorvastatin). (Also see Tables 6 and 7: Drug Interactions). The risk of myopathy including rhabdomyolysis may be increased when protease inhibitors, including VIRACEPT, are used in combination with these drugs.
Particular caution should be used when prescribing sildenafil, or other PDE5 inhibitors, in patients receiving protease inhibitors, including VIRACEPT. Coadministration of these drugs is expected to substantially increase PDE5 inhibitor concentrations and may result in an increase in PDE5 inhibitor-associated adverse events, including hypotension, visual changes, and priapism. (See PRECAUTIONS, Drug Interactions and Information for Patients, and the complete prescribing information for sildenafil and other PDE5 inhibitors.)
Concomitant use of St. John's wort (hypericum perforatum) or St. John's wort containing products and VIRACEPT is not recommended. Coadministration of St. John's wort with protease inhibitors, including VIRACEPT, is expected to substantially decrease protease inhibitor concentrations and may result in sub-optimal levels of VIRACEPT and lead to loss of virologic response and possible resistance to VIRACEPT or to the class of protease inhibitors.
Patients with Phenylketonuria: VIRACEPT Oral Powder contains 11.2 mg phenylalanine per gram of powder.
New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycemia persisted in some cases. Because these events have been reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between protease inhibitor therapy and these events has not been established.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
In the clinical studies described below, efficacy was evaluated by the percent of patients with plasma HIV RNA < 400 copies/mL (Studies 511 and 542) or < 500 copies/mL (Study ACTG 364), using the Roche RT-PCR (Amplicor) HIV-1 Monitor or < 50 copies/mL, using the Roche HIV-1 Ultrasensitive assay (Study Avanti 3). In the analysis presented in each figure, patients who terminated the study early for any reason, switched therapy due to inadequate efficacy or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 400 copies/mL, above 500 copies/mL, or above 50 copies/mL at subsequent time points, depending on the assay that was used.
Study 511 was a double-blind, randomized, placebo controlled trial comparing treatment with zidovudine (ZDV; 200 mg TID) and lamivudine (3TC; 150 mg BID) plus 2 doses of VIRACEPT (750 mg and 500 mg TID) to zidovudine (200 mg TID) and lamivudine (150 mg BID) alone in 297 antiretroviral naive HIV-1 infected patients (median age 35 years [range 21 to 63], 89% male and 78% Caucasian). Mean baseline CD4 cell count was 288 cells/mm3 and mean baseline plasma HIV RNA was 5.21 log10 copies/mL (160,394 copies/mL). The percent of patients with plasma HIV RNA < 400 copies/mL and mean changes in CD4 cell count are summarized in Figures 1 and 2, respectively.
Study 542 is an ongoing, randomized, open-label trial comparing the HIV RNA suppression achieved by VIRACEPT 1250 mg BID versus VIRACEPT 750 mg TID in patients also receiving stavudine (d4T; 30–40 mg BID) and lamivudine (3TC; 150 mg BID). Patients had a median age of 36 years (range 18 to 83), were 84% male, and were 91% Caucasian. Patients had received less than 6 months of therapy with nucleoside transcriptase inhibitors and were naïve to protease inhibitors. Mean baseline CD4 cell count was 296 cells/mm3 and mean baseline plasma HIV RNA was 5.0 log10 copies/mL (100,706 copies/mL).
Results showed that there was no significant difference in mean CD4 cell count among treatment groups; the mean increases from baseline for the BID and TID arms were 150 cells/mm3 at 24 weeks and approximately 200 cells/mm3 at 48 weeks.
The percent of patients with HIV RNA < 400 copies/mL is summarized in Figure 3. The outcomes of patients through 48 weeks of treatment are summarized in Table 8.
Figure 3
Study 542: Percentage of Patients With HIV RNA Below 400 Copies/mL
| Outcome | VIRACEPT 1250 mg BID Regimen | VIRACEPT 750 mg TID Regimen |
|---|---|---|
|
||
| Number of patients evaluable* | 323 | 192 |
| HIV RNA < 400 copies/mL |
198 (61%) | 111 (58%) |
| HIV RNA ≥ 400 copies/mL |
46 (14%) | 22 (11%) |
| Discontinued due to VIRACEPT toxicity† | 9 (3%) | 2 (1%) |
| Discontinued due to other antiretroviral agents' toxicity† | 3 (1%) | 3 (2%) |
| Others‡ | 67 (21%) | 54 (28%) |
Study Avanti 3 was a placebo-controlled, randomized, double-blind study designed to evaluate the safety and efficacy of VIRACEPT (750 mg TID) in combination with zidovudine (ZDV; 300 mg BID) and lamivudine (3TC; 150 mg BID) (n=53) versus placebo in combination with ZDV and 3TC (n=52) administered to antiretroviral-naive patients with HIV infection and a CD4 cell count between 150 and 500 cells/µL. Patients had a mean age of 35 (range 22–59), were 89% male, and 88% Caucasian. Mean baseline CD4 cell count was 304 cells/mm3 and mean baseline plasma HIV RNA was 4.8 log10 copies/mL (57,887 copies/mL). The percent of patients with plasma HIV RNA < 50 copies/mL at 52 weeks was 54% for the VIRACEPT + ZDV + 3TC treatment group and 13% for the ZDV + 3TC treatment group.
Study ACTG 364 was a randomized, double‑blind study that evaluated the combination of VIRACEPT 750 mg TID and/or efavirenz 600 mg QD with 2 NRTIs (either didanosine [ddI] + d4T, ddI + 3TC, or d4T + 3TC) in patients with prolonged prior nucleoside exposure who had completed 2 previous ACTG studies. Patients had a mean age of 41 years (range 18 to 75), were 88% male, and were 74% Caucasian. Mean baseline CD4 cell count was 389 cells/mm3 and mean baseline plasma HIV RNA was 3.9 log10 copies/mL (7,954 copies/mL).
The percent of patients with plasma HIV RNA < 500 copies/mL at 48 weeks was 42%, 62%, and 72% for the VIRACEPT (n=66), EFV (n=65), and VIRACEPT + EFV (n=64) treatment groups, respectively. The 4-drug combination of VIRACEPT + EFV + 2 NRTIs was more effective in suppressing plasma HIV RNA in these patients than either 3‑drug regimen.
History
There is currently no drug history available for this drug.
Other Information
VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV) protease. VIRACEPT Tablets are available for oral administration as a light blue, capsule-shaped tablet with a clear film coating in 250 mg strength (as nelfinavir free base) and as a white oval tablet with a clear film coating in 625 mg strength (as nelfinavir free base). Each tablet contains the following common inactive ingredients: calcium silicate, crospovidone, magnesium stearate, hypromellose, and triacetin. In addition, the 250 mg tablet contains FD&C blue #2 powder and the 625 mg tablet contains colloidal silicon dioxide. VIRACEPT Oral Powder is available for oral administration in a 50 mg/g strength (as nelfinavir free base) in bottles. The oral powder also contains the following inactive ingredients: microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hypromellose, aspartame, sucrose palmitate, and natural and artificial flavor. The chemical name for nelfinavir mesylate is [3S-[2(2S*,3S*), 3α,4aβ,8aβ]]-N-(1,1-dimethylethyl)decahydro-2-[2-hydroxy-3-[(3-hydroxy-2-methylbenzoyl)amino]-4-(phenylthio)butyl]-3-isoquinoline carboxamide mono-methanesulfonate (salt) and the molecular weight is 663.90 (567.79 as the free base). Nelfinavir mesylate has the following structural formula:
Nelfinavir mesylate is a white to off-white amorphous powder, slightly soluble in water at pH ≤4 and freely soluble in methanol, ethanol, 2-propanol and propylene glycol.
Sources
Viracept Manufacturers
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State Of Florida Doh Central Pharmacy
![Viracept (Nelfinavir Mesylate) Tablet, Film Coated [State Of Florida Doh Central Pharmacy]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Viracept | State Of Florida Doh Central Pharmacy
AdultsThe recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water. Once dissolved, patients should mix the cloudy liquid well, and consume it immediately. The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.
Pediatric Patients (2–13 years)In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children. For children unable to take tablets, VIRACEPT Oral Powder may be administered. The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk or dietary supplements; once mixed, the entire contents must be consumed in order to obtain the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours. Acidic food or juice (e.g., orange juice, apple juice or apple sauce) are not recommended to be used in combination with VIRACEPT, because the combination may result in a bitter taste. VIRACEPT Oral Powder should not be reconstituted with water in its original container.
The healthcare provider should assess appropriate formulation and dosage for each patient. Crushed 250 mg tablets can be used in lieu of powder. Tables 14 and 15 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.
Table 14 Dosing Table for Children ≥ 2 years of age (tablets) Body weight Twice daily (BID)
45 – 55 mg/kg
≥2 years Three times daily (TID)
25 – 35 mg/kg
≥2 years Kg. Lbs. # of tablets
(250 mg) # of tablets
(250 mg) * For BID dosing, the maximum dose per day is 5 tablets BID † For TID dosing, the maximum dose per day is 3 tablets TID 10 – 12 22 –26.4 2 1 13 – 18 28.6 – 39.6 3 2 19 – 20 41.8 – 44 4 2 >21 >46.2 4–5* 3† Table 15 Dosing Table for Children ≥2 years of age (powder) Body weight Twice daily (BID)
45–55 mg/kg Three times daily (TID)
25–35 mg/kg Kg. Lbs. Scoops of powder
(50 mg/1 g) Teaspoons* of Powder Scoops of powder
(50 mg/1 g) Teaspoons* of Powder * If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon) † Use VIRACEPT 250 mg tablet 9.0 to < 10.5 20 to < 23 10 2½ 6 1½ 10.5 to < 12 23 to < 26.5 11 2¾ 7 1¾ 12 to < 14 26.5 to < 31 13 3¼ 8 2 14 to < 16 31 to < 35 15 3¾ 9 2¼ 16 to < 18 35 to < 39.5 Not recommended† Not recommended† 10 2½ 18 to < 23 39.5 to < 50.5 Not recommended† Not recommended† 12 3 ≥23 ≥50.5 Not recommended† Not recommended† 15 3¾ Hepatic ImpairmentViracept can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations).
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Pd-rx Pharmaceuticals, Inc.
Viracept | Pd-rx Pharmaceuticals, Inc.
AdultsThe recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water. Once dissolved, patients should mix the cloudy liquid well, and consume it immediately. The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.
Pediatric Patients (2–13 years)In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children. For children unable to take tablets, VIRACEPT Oral Powder may be administered. The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements; once mixed, the entire contents must be consumed in order to obtain the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours. Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended to be used in combination with VIRACEPT, because the combination may result in a bitter taste. VIRACEPT Oral Powder should not be reconstituted with water in its original container.
The healthcare provider should assess appropriate formulation and dosage for each patient. Crushed 250 mg tablets can be used in lieu of powder. Tables 14 and 15 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.
Table 14 Dosing Table for Children ≥ 2 years of age (tablets) Body weight Twice daily (BID)
45 – 55 mg/kg
≥2 years Three times daily (TID)
25 – 35 mg/kg
≥2 years Kg. Lbs. # of tablets
(250 mg) # of tablets
(250 mg) * For BID dosing, the maximum dose per day is 5 tablets BID † For TID dosing, the maximum dose per day is 3 tablets TID 10 – 12 22 –26.4 2 1 13 – 18 28.6 – 39.6 3 2 19 – 20 41.8 – 44 4 2 ≥21 ≥46.2 4 – 5* 3† Table 15 Dosing Table for Children ≥ 2 years of age (powder) Body weight Twice daily (BID)
45 – 55 mg/kg Three times daily (TID)
25 – 35 mg/kg Kg. Lbs. Scoops of powder
(50 mg/1 g) Teaspoons* of powder Scoops of powder
(50 mg/1 g) Teaspoons* of powder * If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon) † Use VIRACEPT 250 mg tablet 9.0 to < 10.5 20 to < 23 10 2½ 6 1½ 10.5 to < 12 23 to < 26.5 11 2¾ 7 1¾ 12 to < 14 26.5 to < 31 13 3¼ 8 2 14 to < 16 31 to < 35 15 3¾ 9 2¼ 16 to < 18 35 to < 39.5 Not recommended† Not recommended† 10 2½ 18 to < 23 39.5 to < 50.5 Not recommended† Not recommended† 12 3 ≥23 ≥50.5 Not recommended† Not recommended† 15 3¾ Hepatic ImpairmentViracept can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations).
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H.j. Harkins Company, Inc.
Viracept | H.j. Harkins Company, Inc.
AdultsThe recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water. Once dissolved, patients should mix the cloudy liquid well, and consume it immediately. The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.
Pediatric Patients (2–13 years)In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children. For children unable to take tablets, VIRACEPT Oral Powder may be administered. The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements; once mixed, the entire contents must be consumed in order to obtain the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours. Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended to be used in combination with VIRACEPT, because the combination may result in a bitter taste. VIRACEPT Oral Powder should not be reconstituted with water in its original container.
The healthcare provider should assess appropriate formulation and dosage for each patient. Crushed 250 mg tablets can be used in lieu of powder. Tables 14 and 15 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.
Table 14 Dosing Table for Children ≥ 2 years of age (tablets) Body weight Twice daily (BID)
45 – 55 mg/kg
≥2 years Three times daily (TID)
25 – 35 mg/kg
≥2 years Kg. Lbs. # of tablets
(250 mg) # of tablets
(250 mg) * For BID dosing, the maximum dose per day is 5 tablets BID † For TID dosing, the maximum dose per day is 3 tablets TID 10 – 12 22 –26.4 2 1 13 – 18 28.6 – 39.6 3 2 19 – 20 41.8 – 44 4 2 ≥21 ≥46.2 4 – 5* 3† Table 15 Dosing Table for Children ≥ 2 years of age (powder) Body weight Twice daily (BID)
45 – 55 mg/kg Three times daily (TID)
25 – 35 mg/kg Kg. Lbs. Scoops of powder
(50 mg/1 g) Teaspoons* of powder Scoops of powder
(50 mg/1 g) Teaspoons* of powder * If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon) † Use VIRACEPT 250 mg tablet 9.0 to < 10.5 20 to < 23 10 2½ 6 1½ 10.5 to < 12 23 to < 26.5 11 2¾ 7 1¾ 12 to < 14 26.5 to < 31 13 3¼ 8 2 14 to < 16 31 to < 35 15 3¾ 9 2¼ 16 to < 18 35 to < 39.5 Not recommended† Not recommended† 10 2½ 18 to < 23 39.5 to < 50.5 Not recommended† Not recommended† 12 3 ≥23 ≥50.5 Not recommended† Not recommended† 15 3¾ Hepatic ImpairmentViracept can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations).
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Remedyrepack Inc.
Viracept | Remedyrepack Inc.
See full prescribing information for administration instructions (2) Adults and adolescents 13 years and older (tablets): 1250 mg twice daily or 750 mg three times daily with a meal (2.1) Children 2 to less than 13 years (oral powder or 250 mg tablets): 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily with a meal. Refer to Tables 1 and 2 of the full prescribing information for specific dosing guidelines based on age and body weight (2.2)The recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water [see Dosage and Administration (2.3)].
In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children.
For children unable to swallow tablets, VIRACEPT 250 mg tablet(s) may be dissolved in a small amount of water or, VIRACEPT Oral Powder may be administered [see Dosage and Administration (2.3)].
The healthcare provider should assess appropriate formulation and dosage for each patient. Tables 1 and 2 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.
Table 1: Dosing Table for Children 2 to less than 13 years of age (tablets) Body weight Twice daily (BID)
45 – 55 mg/kg
≥2 years Three times daily (TID)
25 – 35 mg/kg
≥2 years Number of tablets
(250 mg) Number of tablets
(250 mg) Kg 10 – 12 2 1 13 – 18 3 2 19 – 20 4 2 ≥21 4 – 5* 3† Table 2: Dosing Table for Children 2 to less than 13 years of age (powder) Body weight Twice daily (BID)
45 – 55 mg/kg Three times daily (TID)
25 – 35 mg/kg Kg Scoops of powder
(50 mg/1 g) Teaspoons* of powder Scoops of powder
(50 mg/1 g) Teaspoons3 of powder 9.0 to <10.5 10 2½ 6 1½ 10.5 to <12 11 2¾ 7 1¾ 12 to <14 13 3¼ 8 2 14 to <16 15 3¾ 9 2¼ 16 to <18 Not recommended† Not recommended4 10 2½ 18 to <23 Not recommended4 Not recommended4 12 3 ≥23 Not recommended4 Not recommended4 15 3¾For Patients Unable to Swallow Viracept Tablets
Place VIRACEPT tablet(s) in small amount of water. Once dissolved, mix the cloudy liquid well, and consume it immediately. The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.Viracept Oral Powder
Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements Once mixed, the entire contents must be consumed in order to obtain the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours. Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended for mixing VIRACEPT Oral Powder because the combination may result in a bitter taste. VIRACEPT Oral Powder should not be reconstituted with water in its original container.VIRACEPT can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment [see Warnings and Precautions (5.4), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
1 For BID dosing, the maximum dose per day is 5 tablets BID 2 For TID dosing, the maximum dose per day is 3 tablets TID 3 If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon) 4 Use VIRACEPT 250 mg tablet -
Agouron
Viracept | Agouron
2.1 Adults and Adolescents (13 years and older)The recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water [see Dosage and Administration (2.3)].
2.2 Pediatric Patients (2 to less than 13 years)In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children.
For children unable to swallow tablets, VIRACEPT 250 mg tablet(s) may be dissolved in a small amount of water or, VIRACEPT Oral Powder may be administered [see Dosage and Administration (2.3)].
The healthcare provider should assess appropriate formulation and dosage for each patient. Tables 1 and 2 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.
Table 1: Dosing Table for Children 2 to less than 13 years of age (tablets) Body weight Twice daily (BID)
45 – 55 mg/kg
≥2 years Three times daily (TID)
25 – 35 mg/kg
≥2 years Number of tablets
(250 mg) Number of tablets
(250 mg) Kg * For BID dosing, the maximum dose per day is 5 tablets BID † For TID dosing, the maximum dose per day is 3 tablets TID 10 – 12 2 1 13 – 18 3 2 19 – 20 4 2 ≥21 4 – 5* 3† Table 2: Dosing Table for Children 2 to less than 13 years of age (powder) Body weight Twice daily (BID)
45 – 55 mg/kg Three times daily (TID)
25 – 35 mg/kg * If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon) † Use VIRACEPT 250 mg tablet Kg Scoops of powder
(50 mg/1 g) Teaspoons* of powder Scoops of powder
(50 mg/1 g) Teaspoons* of powder 9.0 to <10.5 10 2½ 6 1½ 10.5 to <12 11 2¾ 7 1¾ 12 to <14 13 3¼ 8 2 14 to <16 15 3¾ 9 2¼ 16 to <18 Not recommended† Not recommended† 10 2½ 18 to <23 Not recommended† Not recommended† 12 3 ≥23 Not recommended† Not recommended† 15 3¾ 2.3 Method of AdministrationFor Patients Unable to Swallow Viracept Tablets
Place VIRACEPT tablet(s) in small amount of water. Once dissolved, mix the cloudy liquid well, and consume it immediately. The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.Viracept Oral Powder
Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements Once mixed, the entire contents must be consumed in order to obtain the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours. Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended for mixing VIRACEPT Oral Powder because the combination may result in a bitter taste. VIRACEPT Oral Powder should not be reconstituted with water in its original container. 2.4 Hepatic ImpairmentVIRACEPT can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment [see Warnings and Precautions (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
![Viracept (Nelfinavir Mesylate) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=91152af4-a9c8-4b14-acbb-e4b6f2be145a&name=55289477.jpg)
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![Viracept (Nelfinavir Mesylate) Tablet, Film Coated Viracept (Nelfinavir Mesylate) Powder [Agouron]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e72c2bc6-9462-4a2e-8e1d-b97592376cbd&name=viracept-03.jpg)
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