"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
DOSAGE AND ADMINISTRATION
Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m²). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
Patients with Renal Impairment
In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m²), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).
Capsules, 300 mg
Usual Adult Dosage
Store at 25°C (77°F). Excursions permitted to 15–30°C (59–86°F).
[See USP Controlled Room Temperature]
Capsules, 300 mg trimethobenzamide hydrochloride each, bottles of 100 NDC 61570-079-01 300 mg 100's
Prescribing Information as of April 2008. Distributed By: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured By: King Pharmaceuticals, Inc., Bristol, TN 37620. FDA revision date: 12/2/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/23/2009
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