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INCIVEK(telaprevir)tablet, film coated(十五)
2013-10-12 22:46:53 来源: 作者: 【 】 浏览:17880次 评论:0
ssant to achieve the desired blood levels should be anticipated. Close monitoring of the immunosuppressant blood levels, and frequent assessments of renal function and immunosuppressant-related side effects are recommended when co-administered with telaprevir. Tacrolimus may prolong the QT interval. The use of telaprevir in organ transplant patients has not been studied.
INHALED BETA AGONIST
salmeterol ↑ salmeterol Concentrations of salmeterol may be increased when co-administered with telaprevir. Concurrent administration of salmeterol and telaprevir is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
NARCOTIC ANALGESIC
methadone* ↓ R-methadone Concentrations of methadone were reduced when co-administered with telaprevir. No adjustment of methadone dose is required when initiating co-administration of telaprevir. However, clinical monitoring is recommended as the dose of methadone during maintenance therapy may need to be adjusted in some patients.
PDE5 INHIBITORS
sildenafil
tadalafil
vardenafil
↑ PDE5 inhibitors Concentrations of PDE5 inhibitors may be increased when co-administered with telaprevir. For the treatment of erectile dysfunction, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg dose in 72 hours, or tadalafil at a single dose not exceeding 10 mg dose in 72 hours can be used with increased monitoring for PDE5 inhibitor-associated adverse events.
QT interval prolongation has been reported with vardenafil. Caution is warranted and clinical monitoring is recommended.
Co-administration of sildenafil and telaprevir in the treatment of pulmonary arterial hypertension is contraindicated [see Contraindications (4)].
Co-administration of tadalafil and telaprevir in the treatment of pulmonary arterial hypertension is not recommended.

In addition to the drugs included in Table 5, the interaction between INCIVEK and the following drug was eva luated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology (12.3)]: esomeprozole.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Because INCIVEK must be used in combination with ribavirin and peginterferon alfa, the contraindications and warnings applicable to those drugs are applicable to combination treatment. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.

INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment

Pregnancy Category X: Animal studies have shown that ribavirin causes birth defects and/or fetal deaths while peginterferon alfa is abortifacient [see Contraindications (4) and Warnings and Precautions (5.1)]. See the prescribing information for ribavirin.

Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin

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