"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 the event of overdosage, we recommend close observation in a cardiac care facility for a minimum of 48 hours and use of appropriate supportive measures in addition to gastric lavage. Beta-adrenergic stimulation or parenteral administration of calcium solutions may increase transmembrane calcium ion influx. Clinically significant hypotensive reactions or high-degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Ventricular tachycardia should be handled by cardioversion and, if persistent, by overdrive pacing.
In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropin but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/hour for more than 24 hours) of calcium chloride.
There has been one experience with overdosage in which a patient inadvertently took a single dose of 1600 mg of VASCOR (bepridil hydrochloride). The patient was observed for 72 hours in intensive care, but no significant adverse experiences were noted.
VASCOR (bepridil hydrochloride) is contraindicated in patients with a known sensitivity to bepridil hydrochloride.
VASCOR (bepridil) is contraindicated in (1) patients with a history of serious ventricular arrhythmias (see WARNINGS Induction of New Serious Arrhythmias ), (2) patients with sick sinus syndrome or patients with second- or third-degree AV block, except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients with uncompensated cardiac insufficiency, (5) patients with congenital QT interval prolongation (see WARNINGS), and (6) patients taking other drugs that prolong QT interval (see PRECAUTIONS Drug Interactions ).
This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Vascor Information
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