Generic Name: Ritonavir Brand Name(s): Generics only. No brands available.

Uses

What is Ritonavir used for?

Ritonavir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.

Ritonavir belongs to a class of drugs known as protease inhibitors. It increases (“boosts”) the levels of other protease inhibitors, which helps these medications work better.

How should I take Ritonavir?

Take this medication by mouth with a meal as directed by your doctor, usually 1 to 2 times daily. Take ritonavir at the same time(s) as your other HIV protease inhibitor. Swallow the tablet form of this medication whole. Do not crush, chew, or break the tablets.

The dosage is based on your weight, liver function, medical condition, other medications, and response to treatment.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

The tablet and capsule forms of this medication may deliver different amounts of medication. Do not switch between the tablet and capsule forms without your doctor’s permission and directions.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat, or worsen side effects.

How do I store Ritonavir?

Ritonavir is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Ritonavir in the bathroom or the freezer. There may be different brands of Ritonavir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ritonavir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ritonavir?

Before taking ritonavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), hemophilia, high cholesterol/triglycerides, liver problems (such as hepatitis B, hepatitis C), pancreatitis.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

If you have diabetes, this product may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ritonavir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ritonavir. Ritonavir is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ritonavir?

Diarrhea, nausea, vomiting, heartburn, stomach pain, loss of appetite, headache, dizziness, tiredness, weakness, changes in taste, or tingling/numbness of mouth area may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

Tell your doctor right away if you have any serious side effects, including: persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as depression, anxiety), increased urination (especially at night), increased thirst.

Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding, fainting, fast/irregular heartbeat.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ritonavir?

Ritonavir interacts with many medications. Some products that may interact with this drug include: cobicistat, disulfiram, orlistat.

Ritonavir can slow down or speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alfuzosin, antiarrhythmics (such as amiodarone, flecainide, propafenone, quinidine), azole antifungals (such as voriconazole), certain benzodiazepines (midazolam, triazolam), certain “blood thinners” (such as rivaroxaban, warfarin), cisapride, eletriptan, drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), lurasidone, certain narcotic pain medications (such as fentanyl, meperidine), pimozide, ranolazine, salmeterol, simeprevir, “statin” cholesterol drugs (such as simvastatin, lovastatin), among others.

Other medications can affect the removal of ritonavir from your body, which may affect how ritonavir works. Examples include boceprevir, rifampin, St. John’s wort, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.

Ritonavir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ritonavir?

Ritonavir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ritonavir?

Ritonavir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ritonavir.

What is the dose of Ritonavir for an adult?

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

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.

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.

What is the dose of Ritonavir for a child?

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

Precautions

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

How is Ritonavir available?

Ritonavir is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral solution,
  • Oral capsule.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ritonavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 25, 2018 | Last Modified: April 25, 2018

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