"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 "...
Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. (See WARNINGS.) In case of overdose, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for DDAVP (desmopressin acetate tablets) . The patient should be observed and treated with appropriate symptomatic therapy.
An oral LD50 has not been established. Oral doses up to 0.2 mg/kg/day have been administered to dogs and rats for 6 months without any significant drug-related toxicities reported. An intravenous dose of 2 mg/kg in mice demonstrated no effect.
DDAVP (desmopressin acetate tablets) Tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP (desmopressin acetate tablets) Tablets.
DDAVP (desmopressin acetate tablets) is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).
DDAVP (desmopressin acetate tablets) is contraindicated in patients with hyponatremia or a history of hyponatremia.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/18/2008
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