kaletra lopinavir and ritonavir tablet film coated kaletra lopinavir and ritonavir solution
1 INDICATIONS AND USAGE KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology ( 12.4 )] . KALETRA is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older). ( 1 )
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16 HOW SUPPLIED/STORAGE AND HANDLING KALETRA ® (
LOPINAVIR AND RITONAVIR) tablets and oral solution are available in the following strengths and package sizes: Formulation and strength Available Presentations Bottle size and NDC codes Tablets: 200 mg lopinavir/ 50 mg ritonavir yellow film-coated ovaloid tablets debossed with the “a” logo and the code KA Bottles of 120 tablets (NDC 0074-6799-22) red film-coated ovaloid tablets debossed with the code AL Bottles of 120 tablets (NDC0074-4014-12) Tablets: 100 mg lopinavir and 25 mg ritonavir Pale yellow film-coated ovaloid tablets debossed with the “a” logo and the code KC Bottles of 60 tablets (NDC 0074-0522-60) pink film-coated ovaloid tablets debossed with the code AC Bottles of 60 tablets (NDC 0074-3008-60) Oral Solution: 80 mg lopinavir and 20 mg ritonavir per mL Light yellow to orange colored liquid supplied in amber-colored multiple-dose bottles containing 400 mg lopinavir and 100 mg ritonavir per 5 mL packaged with a marked dosing cup 160 mL bottle (NDC 0074-3956-46) Recommended Storage: Tablets Store KALETRA tablets at 20°- 25°C (68°- 77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP controlled room temperature]. Dispense in original container or USP equivalent tight container. For patient use: exposure of this product to high humidity outside the original container or USP equivalent tight container for longer than 2 weeks is not recommended. Oral Solution Store KALETRA oral solution at 2°- 8°C (36°- 46°F) until dispensed. Avoid exposure to excessive heat. For patient use: refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 25°C (77°F), oral solution should be used within 2 months.
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