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Lopinavir / Ritonavir Dosage

Applies to the following strength(s): 100 mg-25 mg ; 400 mg-100 mg/5 mL ; 133.3 mg-33.3 mg ; 200 mg-50 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

Once-daily dosing regimen: Lopinavir 800 mg-ritonavir 200 mg orally once a day

Twice-daily dosing regimen: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

Twice-daily dosing regimen in combination with efavirenz, nelfinavir, or nevirapine:
-Tablets: Lopinavir 500 mg-ritonavir 125 mg orally twice a day
-Oral solution: Lopinavir 520 mg-ritonavir 130 mg orally twice a day
-Capsules: Lopinavir 533 mg-ritonavir 133 mg orally twice a day

Comments:
-Patients with less than 3 lopinavir resistance-associated substitutions can use the once-daily or twice-daily dosing regimen.
-Once-daily dosing regimen is not recommended for patients with 3 or more lopinavir resistance-associated substitutions including L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V; twice-daily dosing regimen must be used.
-Once-daily dosing regimen should not be used with concomitant carbamazepine, efavirenz, nelfinavir, nevirapine, phenobarbital, or phenytoin.
-Twice-daily dosing regimen is recommended for pregnant women with no documented lopinavir-associated resistance substitutions; insufficient data to recommend dosing in those with any documented lopinavir-associated resistance substitutions.
-Once-daily dosing regimen is not recommended in pregnancy.
-Pregnant women should not use the oral solution.
-No dose adjustment needed during postpartum period.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: Lopinavir 400 mg-ritonavir 100 mg orally twice a day
Duration of therapy: 28 days

Comments:
-This drug should be used with zidovudine plus (lamivudine or emtricitabine); recommended as the preferred protease inhibitor-based regimen for nonoccupational postexposure prophylaxis of HIV infection.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

Usual Pediatric Dose for HIV Infection

ORAL SOLUTION:
14 days to 6 months: 16 mg/kg or 300 mg/m2 (lopinavir component) orally twice a day

6 months to 18 years:
Based on BSA: 230 mg/m2 (lopinavir component) orally twice a day
Maximum dose: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

Based on weight:
Less than 15 kg: 12 mg/kg (lopinavir component) orally twice a day
15 to 40 kg: 10 mg/kg (lopinavir component) orally twice a day
Greater than 40 kg: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

-Concomitant efavirenz, nelfinavir, or nevirapine:
Based on BSA: 300 mg/m2 (lopinavir component) orally twice a day
Maximum dose: Lopinavir 520 mg-ritonavir 130 mg orally twice a day

Based on weight:
Less than 15 kg: 13 mg/kg (lopinavir component) orally twice a day
Greater than 15 to 45 kg: 11 mg/kg (lopinavir component) orally twice a day
Greater than 45 kg: Lopinavir 520 mg-ritonavir 130 mg orally twice a day

TABLETS:
6 months to 18 years:
15 to 25 kg or BSA 0.6 to less than 0.9 m2: Lopinavir 200 mg-ritonavir 50 mg orally twice a day
Greater than 25 to 35 kg or BSA 0.9 to less than 1.4 m2: Lopinavir 300 mg-ritonavir 75 mg orally twice a day
Greater than 35 kg or BSA at least 1.4 m2: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

-Concomitant efavirenz, nelfinavir, or nevirapine:
15 to 20 kg or BSA 0.6 to less than 0.8 m2: Lopinavir 200 mg-ritonavir 50 mg orally twice a day
Greater than 20 to 30 kg or BSA 0.8 to less than 1.2 m2: Lopinavir 300 mg-ritonavir 75 mg orally twice a day
Greater than 30 to 45 kg or BSA 1.2 to less than 1.7 m2: Lopinavir 400 mg-ritonavir 100 mg orally twice a day
Greater than 45 kg or BSA at least 1.7 m2: Lopinavir 500 mg-ritonavir 125 mg orally twice a day

CAPSULES:
Children less than 12 years weighing greater than 40 kg and children greater than 12 years: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

-Concomitant efavirenz, nelfinavir, or nevirapine:
Greater than 45 kg: Lopinavir 533 mg-ritonavir 133 mg orally twice a day

Comments:
-The oral solution should not be given to neonates before a postmenstrual age of 42 weeks and a postnatal age of at least 14 days has been reached.
-This drug should not be used with efavirenz, nelfinavir, or nevirapine in patients younger than 6 months.
-Pediatric dose should not exceed the usual adult dose.
-Once-daily dosing is not recommended for patients younger than 18 years.
-The oral solution is available for patients with BSA less than 0.6 m2 or those who are unable to reliably swallow tablets or capsules.
-Special attention should be given to accurate calculation of dose, transcription of medication order, dispensing information, and dosing instructions to reduce risk for medication errors and overdose; particularly important for infants and young children.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Caution recommended.

Precautions

Safety and efficacy have not been established in patients younger than 14 days.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments: The components of this drug are highly protein-bound; significant removal via dialysis is not likely.

Other Comments

Administration advice:
-Use in combination with other active antiretroviral agents (associated with increased likelihood of treatment response).
-Administer the oral solution and capsules with food (to improve bioavailability and lessen pharmacokinetic variability).
-May administer tablets without regard to food
-Swallow tablets whole; do not break, crush, or chew.
-If patient is unable to reliably swallow a tablet or capsule, use the oral solution.
-Avoid use of the oral solution in pregnant women.
-Use a calibrated dosing syringe to administer the oral solution.

Storage requirements:
-Tablets: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F); exposure to high humidity outside the original/tight container for more than 2 weeks is not recommended.
-Oral solution and capsules (until dispensed): Store at 2C to 8C (36F to 46F); avoid exposure to excessive heat.
-Oral solution and capsules (patient use): Stable until labeled expiration date if refrigerated; should be used within 2 months if stored at room temperature up to 25C (77F)

General:
-Current guidelines should be consulted for additional information.
-Genotypic or phenotypic testing and/or treatment history should guide use; virologic response affected by number of baseline lopinavir resistance-associated substitutions.
-The oral solution contains 42.4% alcohol (v/v) and 15.3% propylene glycol (w/v).

Monitoring:
-Cardiovascular: For PR interval prolongation
-General: For increases in serum osmolality and for toxicity related to the oral solution in preterm neonates in the immediate postnatal period
-Hematologic: For bleeding in hemophiliacs
-Hepatic: Appropriate laboratory testing (before and during therapy); increased AST/ALT monitoring in patients with underlying chronic hepatitis or cirrhosis (especially during first several months of therapy)
-Metabolic: Triglycerides and total cholesterol (before starting and periodically during therapy); blood glucose levels
-Renal: For increases in serum creatinine in preterm neonates in the immediate postnatal period

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