국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
LOPINAVIR (UNII: 2494G1JF75) (LOPINAVIR - UNII:2494G1JF75), RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825)
Laurus Labs Limited
ORAL
PRESCRIPTION DRUG
Lopinavir and ritonavir 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 lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see Microbiology (12.4)] . - Lopinavir and ritonavir is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir. - Lopinavir and ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)] .
Lopinavir and Ritonavir Tablets, USP are available in the following strengths and package sizes: Lopinavir and Ritonavir Tablets USP, 100 mg/25 mg : Yellow colored, film coated oval shaped biconvex tablets debossed with “LA59” on one side and plain on other side. Bottles of 60 NDC 42385-933-60 Lopinavir and Ritonavir Tablets USP, 200 mg/50 mg : Yellow colored, film coated oval shaped biconvex tablets debossed with “LA58” on one side and plain on other side. Bottles of 120 NDC 42385-934-12 Recommended Storage: Store lopinavir and ritonavir tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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.
Abbreviated New Drug Application
Laurus Labs Limited ---------- MEDICATION GUIDE Lopinavir and Ritonavir (loe-PIN-a-veer and ri-TOE-na-vir) Tablets, USP What is the most important information I should know about lopinavir and ritonavir? Lopinavir and ritonavir may cause serious side effects, including: • Interactions with other medicines. It is important to know the medicines that should not be taken with lopinavir and ritonavir. For more information, see "Who should not take lopinavir and ritonavir?” • Side Effects in babies taking lopinavir and ritonavir oral solution. Lopinavir and ritonavir oral solution contains alcohol (ethanol) and propylene glycol. Call your healthcare provider right away if your baby appears too sleepy or their breathing changes. • Inflammation of your pancreas (pancreatitis). Lopinavir and ritonavir can cause pancreatitis which may be serious and may lead to death. People who have high levels of a certain fat (triglycerides) have a risk for developing pancreatitis. If you have advanced HIV-1 disease, you may have an increased risk of high triglyceride levels in your blood, and pancreatitis. If you have a history of pancreatitis, you may have an increased risk of it coming back again during treatment with lopinavir and ritonavir. Tell your healthcare provider if you have any signs or symptoms of pancreatitis including:◦ nausea ◦ vomiting ◦ stomach-area (abdominal) pain • Liver problems. Liver problems, including death, can happen in people who take lopinavir and ritonavir. Your healthcare provider should do blood tests before and during your treatment with lopinavir and ritonavir to check your liver function. If you have Hepatitis B or Hepatitis C, or other liver problems, you may have an increased risk for developing new or worsening of liver problems during treatment with lopinavir and ritonavir. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including: ◦ loss of appetite ◦ pale colored stools ◦ yellow skin and whites of eyes (jaundice) ◦ itchy ski 전체 문서 읽기
LOPINAVIR AND RITONAVIR - LOPINAVIR AND RITONAVIR TABLET, FILM COATED LAURUS LABS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LOPINAVIR AND RITONAVIR TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOPINAVIR AND RITONAVIR TABLETS. LOPINAVIR AND RITONAVIR TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Contraindications (4) 12/2019 INDICATIONS AND USAGE Lopinavir and ritonavir 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) DOSAGE AND ADMINISTRATION Tablets: May be taken with or without food, swallowed whole and not chewed, broken, or crushed. (2.1) Oral solution: must be taken with food. (2.1) Adults (2.3): Total recommended daily dosage is 800/200 mg given once or twice daily. Lopinavir and ritonavir can be given as once daily or twice daily regimen. See Full Prescribing Information for details. Lopinavir and ritonavir once daily dosing regimen is not recommended in: 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. (12.4) In combination with carbamazepine, phenobarbital, or phenytoin. (7.3) In combination with efavirenz, nevirapine, or nelfinavir. (12.3) In pregnant women. (2.5, 8.1, 12.3) Pediatric Patients (14 days and older) (2.4): Lopinavir and ritonavir once daily dosing regimen is not recommended in pediatric patients. Twice daily dose is based on body weight or body surface area. Concomitant Therapy in Adults and Pediatric Patients: Dose adjustments of lopinavir and ritonavir may be needed when co-administering with efavirenz, nevirapine, or nelfinavir. (2.3, 2.4, 7.3) Lopinavir and ritonavir oral solution should not be administered to neonates before a postmenstrual age (first day of the mother’s last menstrual peri 전체 문서 읽기