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Norvir 100mg Tablet
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Indications & Clinical Uses
- Norvir 100 mg (ritonavir), a protease inhibitor and potent CYP3A4 inhibitor, is used in combination with other antiretroviral medicines for the treatment of HIV-1 infection in adults and pediatric patients.
- At full antiretroviral doses it directly treats HIV, but ritonavir is also very widely used at low, 'booster' doses simply to raise and prolong the blood levels of other HIV protease inhibitors in the same regimen, rather than for its own antiviral effect; the prescriber's regimen determines which role Norvir is playing.
- It is not a cure for HIV infection and does not prevent transmission to others.
- Norvir tablets are taken by mouth, with food, as part of a combination regimen prescribed and monitored by a specialist in HIV care; children are dosed according to body surface area under the same specialist supervision.
Side Effects
- Common side effects, some affecting more than half of patients in trials, include diarrhea, nausea, tingling or numbness around the mouth or in the hands and feet, fatigue and skin rash.
- Norvir carries a boxed warning for drug-drug interactions: because ritonavir strongly affects how the liver breaks down many other medicines, combining it with certain sedatives, heart-rhythm medicines (antiarrhythmics) or ergot-derived migraine medicines can cause dangerously high levels of those drugs, leading to potentially fatal reactions; these combinations must be avoided.
- Other serious effects include liver inflammation and abnormal liver blood tests, pancreatitis, which can be fatal and may cause severe abdominal pain, changes in heart rhythm shown on ECG (PR interval prolongation), and severe allergic reactions including Stevens-Johnson syndrome.
- Patients should seek urgent care for severe abdominal pain, yellowing of the skin or eyes, irregular heartbeat, or signs of severe allergic reaction such as facial swelling or difficulty breathing.
Precautions & Warnings
- Norvir must not be combined with a defined list of drugs highly dependent on the liver enzyme it inhibits, including certain sedative-hypnotics (oral midazolam, triazolam), heart-rhythm medicines (amiodarone, flecainide, propafenone, quinidine), ergot medicines (dihydroergotamine, ergotamine) and some cholesterol-lowering statins (lovastatin, simvastatin), because of the boxed-warning risk of life-threatening reactions; a full medicine review is essential before starting.
- It should be used with caution in people with existing liver disease, since ritonavir can worsen liver function, and liver blood tests are monitored during treatment.
- Caution is also needed in hemophilia, since bleeding events have been reported with protease inhibitors, and in patients with pre-existing heart conduction problems because of the PR-interval effect.
- Norvir can be used in pregnancy under specialist HIV care as part of an approved regimen.
- Immune reconstitution syndrome, a flare of inflammation as the immune system recovers, can occur after starting therapy and should be reported promptly.
Avoid Interactions
- Norvir is a strong inhibitor of the liver enzyme CYP3A4 and also affects CYP2D6, so it interacts with a very wide range of medicines; the manufacturer provides a specific list of drugs that must never be combined with Norvir, including certain sedative-hypnotics, antiarrhythmics, ergot alkaloids, and the statins lovastatin and simvastatin, because of the risk of life-threatening toxicity described in the boxed warning.
- Other interactions requiring dose adjustment or close monitoring include some hormonal contraceptives, which may become less effective, other HIV medicines, certain anticonvulsants, corticosteroids such as fluticasone (risk of Cushing's syndrome with prolonged use), and erectile-dysfunction medicines such as sildenafil, which may need dose reduction.
- St John's Wort should be avoided, as it can reduce ritonavir levels and risk treatment failure.
- Patients should tell their healthcare provider and pharmacist about every prescription, over-the-counter, herbal and recreational substance used, given the breadth of possible interactions.
References
Frequently Asked Questions
Norvir (ritonavir) is used with other antiretroviral medicines to treat HIV-1 infection in adults and children. It is also commonly used at a lower 'booster' dose simply to raise blood levels of other HIV protease inhibitors in the same regimen.
Norvir tablets are taken by mouth with food, usually as 600 mg twice daily for direct antiviral treatment, or a lower dose when used only to boost another protease inhibitor; children are dosed by body size. Take it exactly as your HIV specialist prescribes.
Common Norvir side effects include diarrhea, nausea, tingling around the mouth or in the hands and feet, tiredness and rash. Serious risks include liver problems, pancreatitis and irregular heart rhythm. Report severe stomach pain, yellowing skin or a fast, uneven heartbeat urgently.
Norvir has a boxed warning: combining it with certain sedatives such as oral midazolam, heart-rhythm drugs like amiodarone or quinidine, ergot migraine medicines, or the statins lovastatin and simvastatin can cause life-threatening reactions. Tell every prescriber and pharmacist you take Norvir before starting any new medicine.
If you miss a Norvir dose, take it as soon as you remember with food, then continue your normal schedule; do not double up. Store tablets at or below 30°C, in the original container, protected from excess heat.
Norvir's boxed warning covers dangerous drug interactions: because it strongly affects how the liver processes other drugs, certain sedatives, heart-rhythm medicines, ergot medicines and some statins must never be combined with it, due to the risk of life-threatening reactions.
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