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Lopinavir / Ritonavir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

Lopinavir 400 mg-ritonavir 100 mg orally twice a day
-If less than 3 lopinavir resistance-associated substitutions: May use lopinavir 800 mg-ritonavir 200 mg orally once a day

Concomitant efavirenz, nelfinavir, or nevirapine therapy:
Tablets: Lopinavir 500 mg-ritonavir 125 mg orally twice a day
Oral solution and capsules: Lopinavir 533 mg-ritonavir 133 mg orally twice a day

Comments:
-Once-daily dosing 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.
-The once-daily regimen should not be used with concomitant carbamazepine, efavirenz, nelfinavir, nevirapine, phenobarbital, or phenytoin.

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

Usual Adult Dose for Nonoccupational Exposure

(Not approved by FDA)

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

Comments:
-Lopinavir-ritonavir should be used in combination with zidovudine plus (lamivudine or emtricitabine); one of the preferred regimens recommended for nonoccupational HIV postexposure prophylaxis.
-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

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.
-Lopinavir-ritonavir should not be used with concomitant efavirenz, nelfinavir, or nevirapine in patients younger than 6 months.

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

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 533 mg-ritonavir 133 mg per dose

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 533 mg-ritonavir 133 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 1.4 m2 or greater: 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 1.7 m2 or greater: 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:
-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.

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

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Caution recommended in patients with liver dysfunction.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Comments:
-Not significantly removed by hemodialysis.

Other Comments

Administration advice:
-The oral solution and capsules must be taken with food (to improve bioavailability and lessen pharmacokinetic variability).
-The tablets may be taken without regard to food.
-The tablets should be swallowed whole and not broken, crushed, or chewed.
-If a patient is unable to reliably swallow a lopinavir-ritonavir tablet or capsule, then the oral solution should be used.
-The oral solution should be administered using a calibrated dosing syringe.

Storage requirements:
-Tablets: Should 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): Should store at 2C to 8C (36F to 46F); exposure to excessive heat should be avoided.
-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:
-Lopinavir-ritonavir should always be used in combination with other antiretroviral agents.
-Genotypic or phenotypic testing and/or treatment history should guide use; virologic response affected by number of baseline lopinavir resistance-associated substitutions.

Monitoring:
-Cardiovascular: For PR interval prolongation
-General: Preterm neonates in the immediate postnatal period for increases in serum osmolality and serum creatinine, and for toxicity related to the oral solution
-Hematologic: Hemophiliacs for bleeding
-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

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