Raltegravir package insert pdf

Store isentress and isentress hd filmcoated tablets at room temperature between 68f to 77f 20c to 25c. What are the raltegravir isentress, isentress hd dosing. Weight at least 40 kg and either therapynaive or virologicallysuppressed on an initial regimen of filmcoated tablets 400 mg twice a day. Isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv1 infection in pediatric patients weighing at least 40 kg1. Several fdaapproved drug labels may be available for raltegravir. Longterm efficacy and safety of raltegravir in the.

Dailymed provides trustworthy information about marketed drugs in the united states. Dosage and administration isentress and isentress hd can be administered with or without food 2. To learn more about possible side effects of raltegravir, read the drug label or package insert or talk to your health. Mepron is a bright yellow, citrusflavored, oral suspension containing 750 mg of atovaquone per 5 ml. Consult the full prescribing information prior to use for potential drug interactions. Isentress raltegravir package insert, in conjunction with safety data from this study, demonstrates a favorable safety pro. Lack of a significant drug interaction between raltegravir. Dolutegravir versus raltegravir in antiretroviralexperienced, integraseinhibitornaive adults with hiv. Keep the drying agent desiccant in the isentress and isentress hd bottle to protect from moisture. You can report side effects to fda at 1800fda1088 18003321088 or online. These are not all the possible side effects of raltegravir. For example, the dose for treating adults who are not taking rifampin is one 400mg tablet, taken.

Not recommended for use during pregnancy because of substantially lower exposures of cobicistat and elvitegravir during pregnancy. Isentress, isentress hd raltegravir dosing, indications. For a complete listing of components, see the dosage forms, composition. Store in the original package at room temperature away from light and moisture. Adults 400 mg filmcoated tablet orally, twice daily 2. Raltegravir ral, sold under the brand name isentress, is an antiretroviral medication used, together with other medication, to treat hivaids.

Raltegravir once daily or twice daily in previously untreated patients with hiv1. Mepron is supplied in 210ml bottles or 5ml foil pouches. Highlights of prescribing information these highlights do not include all the information needed to use isentress safely and effectively. Raltegravir fda label tablet chewable, tablet film. Isentress filmcoated tablets must be swallowed whole. Isentress raltegravir is considered a first choice to be used with other medications for treating hiv, but it can have more side effects than other similar medicines. Raltegravir isentress treatment national hiv curriculum.

See the full prescribing information for lamivudine and raltegravir for postmarketing information. Read all of this leaflet carefully before you start taking this medicine. Keep isentress and all medicines out of the reach of children. Isentress raltegravir twice daily contains the antihiv drug raltegravir. Raltegravir dosing guidelines vary depending on whether you are taking other medications. Isentress contains the active substance raltegravir. Isentress is a prescription hiv medicine used with other antiretroviral medicines to treat human immunodeficiency virus1 hiv1 infection in adults, and in children weighing at least 4. Store isentress for oral suspension at room temperature between 68f to 77f 20c to 25c. Store isentressandisentress hd filmcoatedtablets in the original package with the bottle tightly closed. To learn more about possible side effects of raltegravir, read the drug label or package insert or talk to your health care provider or pharmacist.

Store isentress chewable tablets in the original package with the bottle tightly closed. Similar to tenofovir, raltegravir does not appear to be an inducer or inhibitor of enzymes involved in drug metabolism 11, 18. Information for the user isentress 100 mg granules. Adults during coadministration with rifampin in adults, 800 mg twice daily 2. Coadministration of raltegravir with drugs that inhibit ugt1a1 eg, rifampin may reduce plasma levels of raltegravir see dosage modifications coadministration with other strong inducers.

Aidsinfo provides the following drug label solely as an example of the labels available for raltegravir. Raltegravir isentress is an antiretroviral medicine approved for the treatment of human immunodeficiency virus hiv infection. Learn about isentress raltegravir and isentress hd raltegravir and talk to your doctor to see if isentress or isentress hd is right for you. Drugdrug interactions of ombitasvirparitaprevirr plus.

Isentress 400 mg filmcoated tablets cannot be substituted with isentress 25 mg and 100 mg chewable tablets 2. During coadministration with rifampin in adults, 800 mg twice daily 2. Biktarvy bictegravir, emtricitabine, and tenofovir alafenamide tablets package insert. Effects of omeprazole on plasma levels of raltegravir. These highlights do not include all the information needed to use. Raltegravirresistant hiv strains generally exhibit crossresistance to elvitegravir. Five important things to know about the newly approved. General information about the safe and effective use of isentress and. Isentress can be administered with or without food 2. Highlights of prescribing information these highlights.

To learn more about taking isentress, download a pdf of the instructions for use or watch the video below. The physician prescribing information also is available. Isentress raltegravir film coated tablets, for oral use. Isentress raltegravir and isentress hd raltegravir. Isentress is taken twice daily with or without food. Isentress belongs to the class of drugs called integrase inhibitors. Dailymed is the official provider of fda label information package inserts. Isentress chewable tablets may be chewed or swallowed whole. Kaletra oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. Dutrebis lamivudine and raltegravir tablets label tapermd.

Isentress is an antiviral medicine that works against the human immunodeficiency virus hiv. Keep the drying agent desiccant in the bottle to protect from moisture. What are the pharmacokinetics of integrase strandtransfer. A midazolam drug interaction study confirmed the low propensity of. Raltegravir is used with other hiv medications to help control hiv infection.

1355 1332 960 196 310 501 304 1106 1426 431 483 206 888 401 899 38 755 686 797 889 571 808 994 975 726 921 730 1502 453 341 617 296 593 859 1071 434 1460 845 704 1181