Monograph Details
|
|
Infections & Infestations
> Viral infections
|
|
INVIRASE TABLETS |
| Manufacturer |
|
Roche Laboratories |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
HIV protease inhibitor. |
| Generic Name |
|
Saquinavir (as mesylate) 500mg. |
| Also |
|
• INVIRASE CAPSULES
|
| Indications |
|
HIV infection (must use with ritonavir). |
| Children |
|
<16yrs: not recommended. |
| Adults |
|
Take within 2 hours after a meal. ≥16yrs: saquinavir 1g twice daily + ritonavir 100mg twice daily (taken at same time). |
| Contraindications |
|
Severe hepatic impairment. Concomitant amiodarone, bepridil, cisapride, ergots, flecainide, midazolam, pimozide, propafenone, quinidine, rifampin, triazolam. Concomitant lovastatin, simvastatin, St. John's wort, garlic capsules: not recommended. |
| Precautions |
|
Not bioequivalent to soft gel form of saquinavir; do not interchange. Hepatic impairment. Severe renal impairment. Hemophilia (monitor for spontaneous bleeding). Diabetes. Monitor clinical chemistry, triglycerides, and for hyperglycemia. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
|
See Contraindications. Plasma levels reduced by efavirenz, nevirapine, rifabutin, possibly other enzyme inducers. Consider alternatives to CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, dexamethasone): not recommended. Plasma levels increased by clarithromycin (see literature), indinavir, nelfinavir, lopinavir/ritonavir, ritonavir, delavirdine, itraconazole, ketoconazole. Antagonizes methadone, oral contraceptives. Potentiates CYP3A4 substrates (eg, calcium channel blockers, atorvastatin, pravastatin, fluvastatin, rosuvastatin, dapsone, warfarin, cyclosporine, tacrolimus, rapamycin, sildenafil, vardenafil, tadalafil); monitor their effects; may need reduced doses. Caution with antiarrhythmics (eg, systemic lidocaine), tricyclics, benzodiazepines, fentanyl, nefazodone, others (see literature). |
| Adverse Reactions |
|
GI disturbances, headache, fatigue, paresthesia, weakness, lab abnormalities, depression, hyperglycemia, diabetes, fat redistribution, rash, pruritus. |
| Extra Text |
|
Note: Register pregnant patients exposed to saquinavir by calling (800) 258-4263. See Norvir entry in this section for more information on ritonavir. |
| How Supplied |
Caps—270
Tabs—120 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
