"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 "...
Nimotop® (nimodipine) is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).
DOSAGE AND ADMINISTRATION
DO NOT ADMINISTER NIMOTOP (nimodipine) CAPSULES INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES (see WARNINGS). If Nimotop (nimodipine) is inadvertently administered intravenously, clinically significant hypotension may require cardiovascular support with pressor agents. Specific treatments for calcium channel blocker overdose should also be given promptly.
Nimotop (nimodipine) is given orally in the form of ivory colored, soft gelatin 30 mg capsules for subarachnoid hemorrhage.
The oral dose is 60 mg (two 30 mg capsules) every 4 hours for 21 consecutive days, preferably not less than one hour before or two hours after meals. Oral Nimotop® (nimodipine) therapy should commence within 96 hours of the subarachnoid hemorrhage.
If the capsule cannot be swallowed, e.g., at the time of surgery, or if the patient is unconscious, a hole should be made in both ends of the capsule with an 18 gauge needle, and the contents of the capsule extracted into a syringe. A parenteral syringe can be used to extract the liquid inside the capsule, but the liquid should always be transferred to a syringe that cannot accept a needle and that is designed for administration orally or via a naso-gastric tube or PEG. To help minimize administration errors, it is recommended that the syringe used for administration be labeled “Not for IV Use”. The contents should then be emptied into the patient's in situnaso-gastric tube and washed down the tube with 30 mL of normal saline (0.9%). The efficacy and safety of this method of administration has not been demonstrated in clinical trials.
Patients with hepatic cirrhosis have substantially reduced clearance and approximately doubled Cmax. Dosage should be reduced to 30 mg every 4 hours, with close monitoring of blood pressure and heart rate.
Each ivory colored, soft gelatin NIMOTOP® (nimodipine) capsule is imprinted with the word Nimotop and contains 30 mg of nimodipine. The 30 mg capsules are packaged in unit dose foil pouches and supplied in cartons containing 100 capsules. The product is also available in child resistant unit dose safety pak foil pouches containing 30 capsules per carton. The capsules should be stored in the manufacturer's original foil package at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [See USP controlled Room Temperature.]
Capsules should be protected from light and freezing.
|Strength||NDC Code||Capsule Identification|
Package of 100:
Package of 30:
Distributed by: Bayer Pharmaceuticals Corporation, 400 Morgan Lane, West Haven, CT 06516. Manufactured by: Catalent Pharma Solutions St. Petersburg, FL 33716. FDA revision date: 1/20/2006
Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.
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