"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
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved.
Adult dosage: The maximum recommended initial dose of INAPSINE (droperidol) is 2.5 mg IM or slow IV. Additional 1.25 mg doses of INAPSINE (droperidol) may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.
Children's dosage: For children two to 12 years of age, the maximum recommended initial dose is 0.1 mg/kg, taking into account the patient's age and other clinical factors. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If such abnormalities are observed, the drug should not be administered.
INAPSINE (droperidol) Injection is available as:
NDC 11098-010-01, 2.5 mg/mL, 1 mL ampules in packages of 10
NDC 11098-010-02, 2.5 mg/mL, 2 mL ampules in packages of 10
NDC 11098-531-01, 2.5 mg/mL, 1 mL vials in packages of 25
NDC 11098-531-02, 2.5 mg/mL, 2 mL vials in packages of 25
STORAGE: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
1. Saarnivarra L, Klemola UM, Lindgren L, et al. QT interval of the ECG, heart rate and arterial pressure using propofal, methohexital or midazolam for induction of anesthesia. Acta Anaesthesiol Scand 1990; 34: 276-81.
2. Schmeling WT, Warltier DC, McDonald DJ, et al. Prolongation of the QT interval by enflurane, isoflurane and halothane in humans. Anesth Analg 1991; 72: 137-44.
3. Spath G. Torsade des pointe oder die andere Ursache des plotz-lichen Herztodes. Wien: Ueberreuter, 1998. 4. Riley DC, Schmeling WT, Al-Wathiqui MH, et al. Prolongation of the QT-interval by volatile anesthetics in chronically instrumented dogs. Anesth Analg 1988; 67: 741-9.
5. McConachie I, Keaventy JP, Healy TF, et al. Effects of anaesthesia on the QT-interval. Br J Anaesth 1989; 63: 558-60.
6. Lawrence KR, Nasraway SA. Conduction disturbances associated with administration of butyrophenone antipsychotic in the critically ill: a review of the literature. Pharmacother 1997; 17(3): 531-7.
7. Lischke V, Behne M, Doelken P, et al. Droperidol causes a dose-dependent prolongation of the QT interval.
TAYLOR PHARMACEUTICALS, An Akorn company, Decatur, Illinois 62522. Rev. 04/06. FDA Rev date: 11/26/2001This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/5/2008
Additional Inapsine Information
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