EDURANT PACKAGE INSERT PDF

EDURANT PACKAGE INSERT PDF

Drug information on Rilpivirine Tablet (film coated) for health care professionals. Edurant (rilpivirine) Tablets, Package Insert. EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse. For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg .. The interaction between rilpivirine and the medicinal product was evaluated in a clinical study. See package leaflet for further information.

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Where possible, alternatives such as azithromycin should be considered. Immune reactivation syndrome In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms.

If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of EDURANT until the next regularly scheduled dose.

For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy packxge. ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.

The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was Fluconazole Itraconazole Posaconazole Voriconazole.

Store in the original bottle in order to protect from light. No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.

Edurant 25 mg tablets

Rilpivirine should not be used in combination with systemic dexamethasone except as a single dose as co-administration may result in loss of therapeutic effect of rilpivirine see section 4. Healthcare professionals are asked to report any suspected adverse reactions via:. Dose adjustment For patients concomitantly packave rifabutin, the EDURANT ijsert should be increased to 50 mg two tablets of 25 mg each taken once daily.

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Continue typing to refine. In ECHO, randomisation was stratified by screening viral load.

The virologic response was generally preserved throughout the study: HIV PIs — with co-administration of low dose ritonavir. This observation was the same in the efavirenz arm. This information is intended for use inwert health professionals. Renal impairment The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.

The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.

Edurant (rilpivirine) Tablets, Package Insert | DAIDS Regulatory Support Center (RSC)

Typically, such reactions have been packagge within the first weeks or months of initiation of CART. The EK substitution emerged most frequently during rilpivirine treatment, commonly in combination with the MI substitution. However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e.

In patients with severe renal impairment or end-stage renal disease, the combination of rilpivirine with a strong CYP3A inhibitor e. Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to weeks.

No clinically relevant effects on fertility were seen in animal studies see section 5.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5. Absorption After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within hours.

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Other Antiviral Agents Ribavirin Not studied. Only adolescents deemed likely to have good adherence to antiretroviral therapy should pacckage treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.

Edurant (rilpivirine) Tablets, Package Insert

Sign Up Log In Cancel. The greater risk of virologic failure for patients in the rilpivirine arm was observed in the first 48 weeks of these trials see section 5. Renal elimination of rilpivirine is negligible. The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily. It is recommended that the film-coated tablet be swallowed eduurant with water and not be chewed or crushed.

Find out more here. Effects on electrocardiogram The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active moxifloxacin mg once daily controlled crossover study in 60 healthy adults, with 13 measurements over inseft hours at steady-state.

Eeach film-coated tablet contains 56 mg lactose monohydrate. The KN substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of KN and LI exurant in a 7-fold reduced susceptibility to rilpivirine. General disorders and administration site conditions. For the full list of excipients, see section 6.