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Ritonavir Dosage

Applies to the following strength(s): 80 mg/mL ; 100 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

Use as a pharmacokinetic (PK) booster for other protease inhibitors: 100 to 400 mg/day orally in 1 or 2 divided doses

Use as an antiretroviral agent (sole protease inhibitor):
-Initial dose: 300 mg orally twice a day; increase by 100 mg twice a day every 2 to 3 days to the full maintenance dose
-Maintenance dose: 600 mg orally twice a day

Comments:
-This drug is most often used and recommended as a PK enhancer of more potent and better tolerated protease inhibitors.
-Use as a PK enhancer for other protease inhibitors is not specifically approved by the US FDA in the manufacturer product information for ritonavir.
-The manufacturer product information of the boosted protease inhibitor should be consulted for additional information (including dose recommendations).
-According to experts, this drug should not be used as the sole protease inhibitor for initial therapy.

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

Usual Pediatric Dose for HIV Infection

Use as a PK booster for other protease inhibitors: The manufacturer product information of the boosted protease inhibitor should be consulted for dose recommendations.

Use as an antiretroviral agent (sole protease inhibitor):
Greater than 1 month:
-Initial dose: 250 mg/m2 orally twice a day; increase by 50 mg/m2 twice a day every 2 to 3 days to the full maintenance dose
-Maintenance dose: 350 to 400 mg/m2 orally twice a day
Maximum dose: 600 mg/dose

Comments:
-This drug is most often used and recommended as a PK enhancer of more potent and better tolerated protease inhibitors.
-Use as a PK enhancer for other protease inhibitors is not specifically approved by the US FDA in the manufacturer product information for ritonavir.
-If 400 mg/m2 twice a day is intolerable, the highest tolerated dose may be used for maintenance therapy in combination with other antiretrovirals; however, alternative therapy should be considered.
-The oral solution should not be given to neonates before a postmenstrual age of 44 weeks has been reached.
-According to experts, this drug should not be used as the sole protease inhibitor for initial therapy.
-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.
-Total amounts of alcohol and propylene glycol from all medications (including the oral solution) to be given to pediatric patients 1 to 6 months of age should be considered to avoid toxicity from these excipients.

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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Comments:
-Caution and clinical and laboratory monitoring are recommended in patients with preexisting liver disease, hepatitis, or abnormal liver enzymes.

Dose Adjustments

Ritonavir dose reduction needed when used with other protease inhibitors (atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir); the full manufacturer product information and clinical study data of these protease inhibitors should be consulted if they are coadministered with a reduced dose of this drug.

Precautions

US BOXED WARNING:
-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE-THREATENING REACTIONS: Concomitant use of this drug with several drug classes (including sedative hypnotics, antiarrhythmics, ergot alkaloids) may lead to potentially serious and/or life-threatening reactions due to possible effects of this drug on the hepatic metabolism of some agents. Medications taken by patients should be reviewed before starting this drug or when adding medications in patients already taking this drug.

Safety and efficacy have not been established in patients younger than 1 month.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:
-Significant removal via dialysis is not likely (highly protein bound).

Other Comments

Administration advice:
-Use in combination with other antiretroviral agents.
-Administer with meals.
-Do not exceed the maximum dose upon completion of the titration.
-Swallow tablets whole; do not chew, break, or crush.
-Shake the oral solution well before use.
-May improve the taste of the oral solution by mixing it with chocolate milk, Ensure(R), or Advera(R) within 1 hour of dosing.
-Use a calibrated dosing syringe to administer the oral solution.
-Do not administer to neonates before a postmenstrual age of 44 weeks is reached.

Storage requirements:
-Capsules: Store in the refrigerator between 2C to 8C (36F to 46F) until dispensed; refrigeration by the patient recommended, but not required if used within 30 days and stored below 25C (77F); protect from light; avoid exposure to excessive heat; store in original bottle and keep tightly closed.
-Oral solution: Store at 20C to 25C (68F to 77F) in original bottle; do not refrigerate; avoid exposure to excessive heat; keep bottle tightly closed.
-Tablets: Store at or below 30C (86F); exposure up to 50C (122F) for 7 days permitted; do not expose to high humidity outside the original/tight container for more than 2 weeks.

General:
-Current HIV guidelines should be consulted for additional information.
-Dose titration may reduce therapy-emergent side effects while maintaining appropriate plasma drug levels.
-More gastrointestinal side effects (e.g., nausea, vomiting, abdominal pain, diarrhea) may occur when switching from the soft gel capsule to the tablet formulation; these side effects (gastrointestinal or paresthesias) may lessen with continued therapy.
-The oral solution contains 43.2% (v/v) alcohol and 26.57% (w/v) propylene glycol.
-The manufacturer product information for coadministered protease inhibitors should be consulted.

Monitoring:
-Cardiovascular: For PR interval prolongation
-Gastrointestinal: For signs/symptoms of pancreatitis, including serum lipase and amylase
-General: For increases in serum osmolality and for toxicity related to the oral solution in preterm neonates in the immediate postnatal period
-Hepatic: AST, ALT, and GGT (before starting and periodically during therapy); AST/ALT in patients with preexisting liver disease, liver enzyme abnormalities, or hepatitis (especially during first 3 months of therapy)
-Metabolic: Triglycerides, cholesterol, and uric acid (before starting and periodically during therapy)
-Musculoskeletal: Creatine phosphokinase (before starting and periodically during therapy)
-Renal: For increases in serum creatinine in preterm neonates in the immediate postnatal period

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Contact healthcare provider if signs/symptoms of worsening liver disease, pancreatitis, or diabetes mellitus develop or if a rash develops.
-Contact physician if dizziness, lightheadedness, abnormal heart rhythm, or loss of consciousness occurs.
-Pay careful attention to administer the accurate dose.
-If your child's weight changes, contact healthcare provider to ensure the child's dose is correct.

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