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KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV1 infection in adults and pediatric patients (14 days and older).
The following points should be considered when initiating therapy with KALETRA:
- The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Microbiology and Clinical Studies].
- Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Microbiology]. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology].
DOSAGE AND ADMINISTRATION
KALETRA Capsules must be taken with food.
- KALETRA Capsules 400/100 mg (given as three 133/33 mg capsules) twice daily.
- KALETRA Capsules 800/200 mg (given as six 133/33 mg capsules) once daily in patients with less than three lopinavir resistance-associated substitutions.
Once daily administration of KALETRA is not recommended for adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Microbiology].
KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin [see DRUG INTERACTIONS].
Concomitant therapy: Efavirenz, Nevirapine, or Nelfinavir
KALETRA capsules should not be administered as a once-daily regimen in combination with efavirenz, nevirapine, or nelfinavir.
- A dose increase is recommended for all patients who use KALETRA capsules. The recommended dose of KALETRA Capsules is 533/133 mg twice daily (given as four 133/33 mg capsules twice daily taken with food) when used in combination with efavirenz, nevirapine, or nelfinavir.
KALETRA Capsules should not be administered once daily in pediatric patients less than 18 years of age.
For children less than 12 years of age who weigh greater than 40 kg or for children greater than 12 years of age, the maximum dose of 400/100 mg twice daily (given as three 133/33 mg capsules twice daily taken with food) is recommended.
The use of KALETRA oral solution is recommended for children 14 days to 12 years of age who weigh less than 40 kg and in those children who cannot swallow capsules. Please refer to the KALETRA oral solution full prescribing information for pediatric dosage and administration and other important information for these children.
Concomitant Therapy: Efavirenz, Nevirapine, or Nelfinavir
A dose increase is recommended for all pediatric patients who use KALETRA capsules. For children weighing more than 45 kg, the recommended dose of KALETRA capsules is 533/133 mg twice daily (given as four 133/33 mg capsules twice daily taken with food) when used in combination with efavirenz, nevirapine, or nelfinavir.
Dosage Forms And Strengths
KALETRA (lopinavir/ritonavir) Capsules are orange soft gelatin capsules imprinted with the corporate Abbott “A” logo and the Abbo-Code PK. KALETRA is available as 133.3 mg lopinavir/33.3 mg ritonavir capsules.
Storage And Handling
KALETRA (lopinavir/ritonavir) Capsules are orange soft gelatin capsules imprinted with the corporate Abbott “A” logo and the Abbo-Code PK. KALETRA is available as 133.3 mg lopinavir/33.3 mg ritonavir capsules in the following package sizes:
Bottles of 180 capsules each . (NDC 0074-3959-77)
Recommended storage: Store KALETRA Soft Gelatin Capsules at 36 - 46°F (2 - 8°C) until dispensed. Avoid exposure to excessive heat. For patient use, refrigerated KALETRA Capsules remain stable until the expiration date printed on the label. If stored at room temperature up to 77°F (25°C), capsules should be used within 2 months.
Rev. 01/2013. Abbott Laboratories North Chicago, IL 60064 USA
Last reviewed on RxList: 2/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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