"The US Food and Drug Administration (FDA) has approved Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF; 25 mg), the company announced.
DOSAGE AND ADMINISTRATION
VIDEX EC should be administered on an empty stomach. VIDEX EC Delayed-Release Capsules should be swallowed intact.
Recommended Dosage (Adult and Pediatric Patients)
The recommended total daily dose is based on body weight and is administered as one capsule given on a once-daily schedule as outlined in Table 1.
The recommended total daily dose to be administered once daily to pediatric patients weighing at least 20 kg who can swallow capsules is based on body weight (kg), consistent with the recommended adult dosing guidelines (see Table 1). Please consult the complete prescribing information for VIDEX (didanosine) Pediatric Powder for Oral Solution for dosage and administration of didanosine to pediatric patients weighing less than 20 kg or who can not swallow capsules.
Table 1: Recommended Dosage (Adult and Pediatric Patients)
|20 kg to less than 25 kg||200 mg once daily|
|25 kg to less than 60 kg||250 mg once daily|
|at least 60 kg||400 mg once daily|
Dosing recommendations for VIDEX EC and VIDEX Pediatric Powder for Oral Solution are different for patients with renal impairment. Please consult the complete prescribing information on administration of VIDEX (didanosine) Pediatric Powder for Oral Solution to patients with renal impairment.
In adult patients with impaired renal function, the dose of VIDEX EC should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of VIDEX EC in adult patients with renal insufficiency are presented in Table 2.
Table 2: Recommended Dosage in Patients with Renal Impairment
by Body Weighta
|Creatinine Clearance (mL/min)||Dosage (mg)|
|at least 60 kg||less than 60 kg|
|at least 60||400 once daily||250 once daily|
|30-59||200 once daily||125 once daily|
|10-29||125 once daily||125 once daily|
|less than 10||125 once daily||b|
|a Based on studies using a buffered
formulation of didanosine.
b Not suitable for use in patients less than 60 kg with CLcr less than 10 mL/min. An alternate formulation of didanosine should be used.
Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of VIDEX EC in this patient population, a reduction in the dose should be considered (see Table 2).
Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis
For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL/min, shown in Table 2. It is not necessary to administer a supplemental dose of didanosine following hemodialysis.
Concomitant Therapy with Tenofovir Disoproxil Fumarate
In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of VIDEX EC to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL/min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL/min) once daily taken together with tenofovir disoproxil fumarate and a light meal (400 kcalories or less, 20% fat or less) or in the fasted state is recommended. The appropriate dose of VIDEX EC coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL/min has not been established [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
VIDEX EC (didanosine, USP) Delayed-Release Capsules are white, opaque capsules as described below:
- 125 mg capsule imprinted with “BMS 125 mg 6671” in Tan
- 200 mg capsule imprinted with “BMS 200 mg 6672” in Green
- 250 mg capsule imprinted with “BMS 250 mg 6673” in Blue
- 400 mg capsule imprinted with “BMS 400 mg 6674” in Red
Storage And Handling
VIDEX EC (didanosine, USP) Delayed-Release Capsules are white, opaque capsules that are packaged in bottles with child-resistant closures as described in Table 14.
Table 14: VIDEX EC Delayed-Release Capsules
|125 mg capsule imprinted with “BMS 125 mg 6671” in Tan|
|NDC No. 0087-6671-17||30 capsules/bottle|
|200 mg capsule imprinted with “BMS 200 mg 6672” in Green|
|NDC No. 0087-6672-17||30 capsules/bottle|
|250 mg capsule imprinted with “BMS 250 mg 6673” in Blue|
|NDC No. 0087-6673-17||30 capsules/bottle|
|400 mg capsule imprinted with “BMS 400 mg 6674” in Red|
|NDC No. 0087-6674-17||30 capsules/bottle|
The capsules should be stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature).
Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Rev November 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/5/2011
Additional Videx EC Information
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