Cephalon, Incorporated
Manufacturer Details
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Cephalon, Incorporated Drugs
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![Amrix (Cyclobenzaprine Hydrochloride) Capsule, Extended Release [Cephalon, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3902123b-1365-ac3c-0934-afff9eeeb1bd&name=image-02.jpg)
Amrix
The recommended adult dose for most patients is one (1) AMRIX 15 mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) AMRIX 30 mg capsule taken once daily or as two (2) AMRIX 15 mg capsules taken once daily.
• It is recommended that doses be taken at approximately the same time each day. • Use of AMRIX for periods longer than two or three weeks is not recommended. [ See Indications and Usage (1) ] -
![Trisenox (Arsenic Trioxide) Injection, Solution [Cephalon, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dec51fab-3784-deb7-752f-2d4d5692a20f&name=image-02.jpg)
Trisenox
2.1 Recommended Dosage
Induction Treatment Schedule: Administer TRISENOX intravenously at a dose of 0.15 mg/kg daily until bone marrow remission. Do not exceed 60 doses for induction.
Consolidation Treatment Schedule: Begin consolidation treatment 3 to 6 weeks after completion of induction therapy. Administer TRISENOX intravenously at a dose of 0.15 mg/kg daily for 25 doses over a period up to 5 weeks.
2.2 Dose Adjustment for Non-Hematologic Adverse Reactions
If a severe non-hematologic adverse reaction occurs (such as neurologic or dermatologic toxicity), consider delaying TRISENOX infusion until the event has resolved (≤ Grade 1).
2.3 Instructions for Preparation and Intravenous Administration
Administration
Administer TRISENOX intravenously over 1-2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. A central venous catheter is not required.
The TRISENOX ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Do not mix TRISENOX with other medications.
Reconstitution
Dilute TRISENOX with 100 to 250 mL 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. Do not save any unused portions for later administration.
Safe Handling Procedures
TRISENOX is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
2.4 Stability
After dilution, TRISENOX is chemically and physically stable when stored for 24 hours at room temperature and 48 hours when refrigerated.
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![Nuvigil (Armodafinil) Tablet [Cephalon, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d878aed0-ddbf-8fa1-abf7-d3e480260845&name=image-10.jpg)
Nuvigil
2.1 Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy
The recommended dosage of NUVIGIL for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.
In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].
2.2 Dosage in Shift Work Disorder (SWD)
The recommended dosage of NUVIGIL for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
2.3 Dosage Modification in Patients with Severe Hepatic Impairment
In patients with severe hepatic impairment, the dosage of NUVIGIL should be reduced [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.4 Use in Geriatric Patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
2.1 Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy
The recommended dosage of NUVIGIL for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.
In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].
2.2 Dosage in Shift Work Disorder (SWD)
The recommended dosage of NUVIGIL for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
2.3 Dosage Modification in Patients with Severe Hepatic Impairment
In patients with severe hepatic impairment, the dosage of NUVIGIL should be reduced [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.4 Use in Geriatric Patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
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