Generic Name: Norvir
What is Norvir?
No dose adjustment of ritonavir is necessary for patients with either mild Child-Pugh Class A or moderate Child-Pugh Class B hepatic impairment. Acute Overdosage - Human Overdose ExperienceHuman experience of acute overdose with NORVIR is limited. One patient in clinical trials took NORVIR 1500 mg per day for two days. The patient reported paresthesias which resolved after the dose was decreased. A post-marketing case of renal failure with eosinophilia has been reported with ritonavir overdose.
The approximate lethal dose was found to be greater than 20 times the related human dose in rats and 10 times the related human dose in mice. Ingestion of the product over the recommended dose by a young child could result in significant toxicity and could potentially be lethal. Treatment of overdose with NORVIR consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
There is no specific antidote for overdose with NORVIR. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug.
Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children. Talk to your doctor or other health care provider if you have any questions about this medicine or your condition. If you have any concerns about this medicine, ask your doctor. Your doctor or pharmacist can give you information about this medicine that was written for health care professionals. Indinavir C min was also increased 4-fold.
Saquinavir C min was 0. Alterations in concentrations are noted when reduced doses of indinavir are co-administered with NORVIR. Appropriate doses for this combination, with respect to efficacy and safety, have not been established When used in combination therapy for up to 24 weeks, doses of 400 mg b. Dosing of didanosine and ritonavir should be separated by 2. Further dosage reduction may be necessary May lead to loss of virologic response. John's wort hypericum perforatum May lead to loss of virologic response and possible resistance to NORVIR or to the class of protease inhibitors.
HMG-CoA Reductase Inhibitors: lovastatin, simvastatin Potential for serious reactions such as risk of myopathy including rhabdomyolysis. Further dosage reduction may be necessary Antimycobacterial: rifampin May lead to loss of virologic response.
How should I take Norvir?
Tablet: Copovidone Sorbitan laurate Calcium hydrogen phosphate, anhydrous Silica, colloidal anhydrous Sodium stearyl fumarate Film-coating: Hypromellose Titanium dioxide E171 Macrogols Hydroxypropyl cellulose Talc Silica, colloidal anhydrous Polysorbate 80 This medicinal product does not require any special temperature storage conditions. Increased plasma concentrations of norpethidine, piroxicam and propoxyphene.
Amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine Increased plasma concentrations of amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine. Increased plasma concentrations of fusidic acid and ritonavir. Concomitant use of ritonavir 400 mg twice daily and more and voriconazole is contraindicated due to a reduction in voriconazole plasma concentrations and possible loss of effect see section 4.
Increased plasma concentrations of astemizole and terfenadine. Concomitant use of ritonavir 500 mg twice daily dosed as an antiretroviral agent and rifabutin due to an increase of rifabutin serum concentrations and risk of adverse reactions including uveitis see section 4. Increased plasma concentrations of clozapine and pimozide.
What should I avoid while taking Norvir?
Bedaquiline Strong CYP3A4 inhibitors such as protease inhibitors may increase bedaquiline exposure which could potentially increase the risk of bedaquiline-related adverse reactions.
Therefore, combination of bedaquiline with ritonavir should be avoided. However, if the benefit outweighs the risk, co-administration of bedaquiline with ritonavir must be done with caution. More frequent electrocardiogram monitoring and monitoring of transaminases is recommended see section 4. Delamanid Co-administration of delamanid with a strong inhibitor of CYP3A ritonavir may increase exposure to delamanid metabolite, which has been associated with QTc prolongation.
Norvir side effects
Common Norvir ide effects may include:
Amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine Increased plasma concentrations of amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine.
The isopropylthiazole oxidation metabolite M-2 is the major metabolite and has antiviral activity similar to that of parent compound.
When used with ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent, the lowest doses of atorvastatin or rosuvastatin should be administered.
If you have any concerns about this medicine, ask your doctor.
Talk to your healthcare provider if you have any questions. Important information For more information about NORVIR oral powder see the Patient Information section of the Prescribing Information.
Be sure to prepare your dose exactly as your healthcare provider tells you. You will also need the following items to prepare your dose of NORVIR oral powder with food not included in the NORVIR oral powder carton : If you are preparing a dose of NORVIR oral powder in liquid, you will also need the following items not included in your NORVIR oral powder carton : The instructions below show the dose being prepared with food, but if you are using liquid you can swap the food for a liquid.
This Instructions for Use has been approved by the U.
Where can I get more information?
Ritonavir with indinavir Crixivan The dose of ritonavir used may be 100 or 200 mg, twice daily with 800 mg of indinavir Crixivanalso twice daily.
The median duration of follow-up through the end of the open-label phase was 13.