Lopinavir / Ritonavir Dosage

Medically reviewed by Drugs.com. Last updated on Mar 21, 2024.

Applies to the following strengths: 100 mg-25 mg; 200 mg-50 mg; 400 mg-100 mg/5 mL; 133.3 mg-33.3 mg

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:

This drug can be given in once-daily or twice-daily dosing regimen at dosages recommended above.
Once-daily dosing regimen is not recommended:
In patients with at least 3 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.
In combination with carbamazepine, efavirenz, nelfinavir, nevirapine, phenobarbital, or phenytoin.
In pregnant patients.
The dose of this drug must be increased when coadministered with efavirenz, nelfinavir, or nevirapine.
Twice-daily dosing regimen (lopinavir 400 mg-ritonavir 100 mg orally twice a day) is recommended for pregnant patients with no documented lopinavir-associated resistance substitutions; insufficient data to recommend dosing in those with any documented lopinavir-associated resistance substitutions.
Once-daily dosing is not recommended in pregnancy.
Pregnant patients should avoid using 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 Occupational Exposure

US Public Health Service Working Group Recommendations:

Preferred dosing: Lopinavir 400 mg-ritonavir 100 mg orally twice a day
Alternative dosing: Lopinavir 800 mg-ritonavir 200 mg orally once a day

Duration of therapy: 28 days, if tolerated

Comments:

This drug is recommended as a component in various alternative regimens for HIV postexposure prophylaxis.
Prophylaxis should be started as soon as possible, preferably within hours of exposure.
The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
Current guidelines should be consulted for additional information.

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

Older Than 6 Months to Less Than 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:
Weight less than 15 kg: 12 mg/kg (lopinavir component) orally twice a day
Weight 15 to 40 kg: 10 mg/kg (lopinavir component) orally twice a day
Weight 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:
Weight less than 15 kg: 13 mg/kg (lopinavir component) orally twice a day
Weight 15 to 45 kg: 11 mg/kg (lopinavir component) orally twice a day
Weight greater than 45 kg: Lopinavir 520 mg-ritonavir 130 mg orally twice a day

TABLETS:
Older Than 6 Months to Less Than 18 Years:

Weight 15 to 25 kg or BSA 0.6 to less than 0.9 m2: Lopinavir 200 mg-ritonavir 50 mg orally twice a day
Weight 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
Weight 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:

Weight 15 to 20 kg or BSA 0.6 to less than 0.8 m2: Lopinavir 200 mg-ritonavir 50 mg orally twice a day
Weight 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
Weight 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
Weight 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 or children greater than 12 years: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

Concomitant efavirenz, nelfinavir, or nevirapine:

Weight greater than 45 kg: Lopinavir 533 mg-ritonavir 133 mg orally twice a day

Comments:

Once-daily dosing regimen is not recommended in patients younger than 18 years.
The oral solution is not recommended in neonates before a postmenstrual age of 42 weeks and a postnatal age of at least 14 days has been reached.
Total amounts of ethanol and propylene glycol from all products given to pediatric patients 14 days to 6 months of age should be considered to avoid toxicity from these excipients.
The appropriate dose of this drug should be calculated for each individual pediatric patient based on body weight or BSA to avoid underdosing or exceeding the recommended adult dose.
This drug should not be coadministered with efavirenz, nelfinavir, or nevirapine in patients younger than 6 months.
The oral solution is available for patients with BSA less than 0.6 m2 or those who are unable to reliably swallow a tablet or capsule.
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

Usual Pediatric Dose for Nonoccupational Exposure

US CDC Recommendations:
Children 14 days to 12 months:
Oral suspension: 16 mg/kg or 300 mg/m2 (lopinavir component) orally twice a day

Children older than 12 months to 18 years:
Oral suspension:

Weight less than 15 kg: 12 mg/kg (lopinavir component) orally twice a day
Weight 15 to 40 kg: 10 mg/kg (lopinavir component) orally twice a day
Weight greater than 40 kg: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

Tablets:

Weight 15 to 25 kg: Lopinavir 200 mg-ritonavir 50 mg orally twice a day
Weight greater than 25 to 35 kg: Lopinavir 300 mg-ritonavir 75 mg orally twice a day
Weight greater than 35 kg: Lopinavir 400 mg-ritonavir 100 mg orally twice a day

Duration of Therapy: 28 days

Comments:

Recommended for nonoccupational postexposure prophylaxis of HIV infection
This drug is recommended as a component of a preferred (or alternative) 3-drug regimen in children at least 4 weeks of age (with a postmenstrual age of at least 42 weeks) to less than 2 years.
This drug is recommended as a component of an alternative 3-drug regimen in children 2 to 12 years.
Prophylaxis should be started as soon as possible, within 72 hours of exposure.
Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Liver dysfunction: Caution recommended.

Precautions

CONTRAINDICATIONS:

Previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, urticaria, angioedema) to either active component or to any of the ingredients
Coadministration with drugs highly dependent on CYP450 3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events, including alfuzosin, ranolazine, dronedarone, colchicine (in patients with renal and/or liver dysfunction), lurasidone, pimozide, dihydroergotamine, ergotamine, methylergonovine, cisapride, elbasvir-grazoprevir, lovastatin, simvastatin, lomitapide, oral midazolam, triazolam, sildenafil (for treatment of pulmonary arterial hypertension)
Coadministration with potent CYP450 3A inducers where significantly reduced lopinavir plasma levels may result in loss of virologic response and possible resistance and cross-resistance, including apalutamide, rifampin, St. John's Wort

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

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

This drug is highly protein bound; significant removal via dialysis is unlikely.

Other Comments

Administration advice:

Use in combination with other antiretroviral agents.
Administer the oral solution with food to enhance absorption; administer the capsules with food to enhance bioavailability and lessen pharmacokinetic variability.
May administer the tablets with or without 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; only consider using the lopinavir 100 mg-ritonavir 25 mg tablets in children who have reliably proven the ability to swallow the intact tablet.
Use the calibrated cup (supplied) or oral dosing syringe to administer the oral solution.
Do not use the oral solution in pregnant patients or in neonates before a postmenstrual age of 42 weeks and a postnatal age of at least 14 days has been reached.
Do not use the oral solution (which contains ethanol and propylene glycol) with polyurethane feeding tubes due to potential incompatibility; feeding tubes compatible with ethanol and propylene glycol (e.g., silicone and polyvinyl chloride [PVC] feeding tubes) can be used to administer the oral solution; follow instructions for use of the feeding tube to administer this drug.

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 recommended 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 HIV guidelines should be consulted for additional information.
Limitations of Use: 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 about 42% ethanol (v/v) and about 15% 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
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

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide).
Pay special attention to accurate administration of your dose to reduce the risk of accidental overdose/underdose of this drug.
For the oral solution: Administer using the calibrated dosing cup (supplied) or oral dosing syringe.
Notify healthcare provider if your child's weight changes to ensure the child's dose is adjusted as needed.
Do not alter the dose or discontinue therapy without consulting healthcare provider.
Take this drug on a regular dosing schedule and avoid missing doses.
Contact healthcare provider if symptoms of pancreatitis (e.g., nausea, vomiting, abdominal pain) or symptoms of PR and/or QT prolongation (e.g., dizziness, lightheadedness, abnormal heart rhythm, loss of consciousness) occur.
Notify healthcare provider if a rash develops during therapy or if signs/symptoms of worsening liver disease (including loss of appetite, abdominal pain, jaundice, itchy skin) develop.
Inform healthcare provider if signs/symptoms of diabetes mellitus (including frequent urination, excessive thirst, extreme hunger/unusual weight loss, and/or increased blood sugar) develop during therapy.