Carbamazepine- CARNEXIV™ injection |
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Usual Diluents |
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NS, D5W, LR | ||||||||||||||||||||||||||||||||||||||||||||||
Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate] |
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[Prescribed dose ] [0 - 280mg] [100 ml] [30 minutes] Storage and Handling Stability: Determination of Total Daily Dose for CARNEXIV Infusion
CARNEXIV injection vials are for single-dose only. Discard any unused portion.
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WARNINGS |
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DESCRIPTION |
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Description: CARNEXIV (carbamazepine) injection is available as a clear, colorless, sterile solution for intravenous infusion. The chemical name of carbamazepine, an anticonvulsant, is 5H-dibenz[b,f]azepine-5-carboxamide, and its molecular weight is 236.27. CARNEXIV injection is supplied in single-dose 20 mL vials containing 200 mg carbamazepine. Each mL contains 10 mg of carbamazepine, 250 mg of betadex sulfobutyl ether sodium, and 0.78 mg of sodium phosphate monobasic dihydrate in water for injection. The product may contain sodium hydroxide and/or hydrochloric acid for pH adjustment to pH 6.2. |
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CLINICAL PHARMACOLOGY: |
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Mechanism of Action: The mechanism by which carbamazepine exerts its anticonvulsant activity is unknown. The principal metabolite of carbamazepine, carbamazepine-10,11-epoxide, has demonstrated anticonvulsant activity in in vivo animal models of seizures. However, its contribution to the therapeutic effect of carbamazepine is unknown. |
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INDICATIONS AND USAGE |
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INDICATIONS AND USAGE: CARNEXIV is indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure types (1): -Partial seizures with complex symptomatology -Generalized tonic-clonic seizures -Mixed seizure patterns which include the above, or other partial or generalized seizures |
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CONTRAINDICATIONS |
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Contraindications: Bone marrow depression (4, 5.2) Hypersensitivity to carbamazepine (4, 5.4) Hypersensitivity to tricyclic antidepressants (4, 7.1) Concomitant use of boceprevir (4, 7.1). Use of MAOIs within the past 14 days (4,7.3) Concomitant use of nefazodone (4, 7.1) Concomitant use with delavirdine or other non-nucleoside reverse transcriptase inhibitors (4, 7.1) |
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PRECAUTIONS |
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WARNINGS AND PRECAUTIONS: | ||||||||||||||||||||||||||||||||||||||||||||||
ADVERSE REACTIONS |
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ADVERSE REACTIONS:
Most common adverse reactions with CARNEXIV (incidence greater than or equal to 2%) were dizziness, somnolence, blurred vision, diplopia, headache, infusion-related reaction, infusion site pain, and anemia (6.1) The most common adverse reactions with oral carbamazepine were dizziness, drowsiness, unsteadiness, nausea, and vomiting (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. |
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DOSAGE AND ADMINISTRATION |
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DOSAGE AND ADMINISTRATION: 2.1 Dosage Information CARNEXIV is a replacement therapy for oral carbamazepine. Carbamazepine treatment should generally be initiated with an oral carbamazepine formulation. The total daily dose of CARNEXIV is 70% of the total daily oral carbamazepine dose from which patients are being switched (see Table 1). The total daily dose of CARNEXIV should be equally divided in four 30-minute infusions, separated by 6 hours. Patients should be switched back to oral carbamazepine administration at their previous total daily oral dose and frequency of administration as soon as clinically appropriate. The use of CARNEXIV for periods of more than 7 days has not been studied. Table 1. Determination of Total Daily Dose for CARNEXIV Infusion
2.2 Administration Information Using Table 2 as a guide, prepare the solution for each infusion by transferring the single dose volume of CARNEXIV to 100 mL of diluent solution (0.9% sodium chloride, lactated Ringer's solution, or 5% dextrose) and mixing gently. Before administration, the prepared solution for infusion may be stored for a maximum of 4 hours at 20°C to 25°C (68°F to 77°F) or a maximum of 24 hours if refrigerated at 2°C to 8°C (36°F to 46°F). Parenteral drug products should be inspected visually for particulate matter, cloudiness, or discoloration prior to administration, whenever solution and container permit. If any of these are present, discard the solution. Administer each infusion intravenously over 30 minutes. CARNEXIV injection vials are for single-dose only. Discard any unused portion.
2.3 Renal Function Monitoring 2.4 Serum Level Monitoring 2.5 Laboratory Testing Prior to Carbamazepine Initiation Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with carbamazepine because liver damage may occur. Discontinue CARNEXIV in cases of aggravated liver dysfunction or active liver disease. |
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HOW SUPPLIED |
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DOSAGE FORMS AND STRENGTHS: CARNEXIV (carbamazepine) 200 mg/20 mL (10 mg/mL) injection is a clear, colorless, sterile solution. It is supplied in single-dose 20 mL glass vials, available in cartons of one vial (NDC 67386-621-52). Not made with natural rubber latex. |
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Storage and Stability |
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Storage and Handling Vials: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Stability:
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