"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 "...
(Generic versions may still be available.)
In case of overdosage, the patient should be monitored in a suitably equipped medical facility and advised to avoid sun exposure for five days. ECG monitoring is recommended due to the possible prolongation of the QTc interval. There is no known antidote for sparfloxacin overdosage.
It is not known whether sparfloxacin is dialyzable.
Single doses of sparfloxacin were relatively non-toxic via the oral route of administration in mice, rats, and dogs. No deaths occurred within a 14-day posttreatment observation period at the highest oral doses tested, up to 5000 mg/kg in either rodent species, or up to 600 mg/kg in the dog. Clinical signs observed included inactivity in mice and dogs, diarrhea in both rodent species, and vomiting, salivation, and tremors in dogs.
Sparfloxacin is contraindicated for individuals with a history of hypersensitivity or photosensitivity reactions.
Torsade de pointes has been reported in patients receiving sparfloxacin concomitantly with disopyramide and amiodarone. Consequently, sparfloxacin is contraindicated for individuals receiving these drugs as well as other QTc-prolonging antiarrhythmic drugs reported to cause torsade de pointes, such as class Ia antiarrhythmic agents (e.g., quinidine, procainamide), class III antiarrhythmic agents (e.g., sotalol), and bepridil. Sparfloxacin is contraindicated in patients with known QTc prolongation or in patients being treated concomitantly with medications known to produce an increase in the QTc interval and/or torsade de pointes (e.g., terfenadine). (See WARNINGS and PRECAUTIONS.)
It is essential to avoid exposure to the sun, bright natural light, and UV rays throughout the entire duration of treatment and for 5 days after treatment is stopped. Sparfloxacin is contraindicated in patients whose life-style or employment will not permit compliance with required safety precautions concerning phototoxicity. (See WARNINGS and PRECAUTIONS.)This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/7/2009
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