August                                                                                        2002

 

FORMULARY ADDITIONS

 

Levetiracetam (Keppra®)

250 mg, 500 mg, and 750 mg tablets

UCB Labs

 

Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The mechanism of action of levetiracetam is currently unknown. Adverse effects emerging during levetiracetam therapy included headache, infection, somnolence, anorexia, and nervousness.

 

Levetiracetam is contraindicated in patients who have demonstrated hypersensitivity to levetiracetam or to any of the product ingredients. Levetiracetam therapy is associated with somnolence and fatigue, coordination difficulties, and behavioral abnormalities. Most of these events occurred during the first four weeks of therapy. The incidence of somnolence is higher when no titration phase is used during the initial phase of therapy, especially when the dose is greater than 3000 mg/day. Psychotic symptoms were reported in a small number of patients (0.7%).

 

Hematologic changes have been observed during levetiracetam therapy.  Small reductions in red blood cell count, mean hemoglobin, mean hematocrit, and neutrophil and white blood cell counts occurred in some levetiracetam-treated patients.  Discontinuation of therapy was not necessary.

 

An advantage with levetiracetam therapy is a lack of drug interactions with other antiepileptic agents, which require close monitoring and potential dosage adjustments.

 

DRUG AND FOOD INTERACTIONS: There are no known food/drug interactions with levetiracetam. 

 

 

DOSAGE AND ADMINISTRATION: Levetiracetam therapy should be initiated with a dose of 500 mg twice daily.  The dose may be increased by 1000 mg/day every 2 weeks to a maximum dose of 3000 mg/day. Patients should be monitored for a change in seizure frequency and side effects. Dosage reductions are recommended in patients with impaired renal function. Levetiracetam therapy should be gradually withdrawn to minimize the risk of increased seizure frequency.

 

 

Fenofibrate

(TricorÒ)

54 mg, 160 mg tablets

 

Fenofibrate (TricorÒ) is an analogue of clofibrate and may be classified as a third-generation fibric acid derivative.  Fenofibrate inhibits the synthesis of fatty acids in the liver, stimulates fatty acid beta-oxidation, inhibits adipose tissue lipolysis and inhibits triglyceride synthesis.  Fenofibrate is approved as an adjunct to diet for the treatment of adults with very high serum triglyceride levels (Types IV and V hyperlipidemia) not controlled by diet alone and who are at risk of pancreatitis.

 

Fenofibrate is contraindicated in patients with known hypersensitivity to fenofibrate.  In addition, patients with hepatic and severe renal dysfunction, gallbladder disease or primary biliary cirrhosis should not be treated with fenofibrate therapy.  The product labeling contains a fibric acid class warning regarding the risk of cholelithiasis, cholecystitis, elevated serum transaminases, gallbladder surgery or death.  This warning is based on the information reported with clofibrate and gemfibrozil. A baseline serum transaminase should be obtained prior to the start of therapy and repeated at 3-month intervals during the first year of treatment.  Routine monitoring of lipoprotein levels is also recommended.

 

The most common adverse reactions reported with fenofibrate therapy were gastrointestinal (diarrhea, constipation, dyspepsia, flatulence), muscle pain, and skin reactions.  In placebo-controlled trials, the incidence of adverse reactions with fenofibrate and placebo are similar, with the exception of dermatologic reactions.  Fenofibrate, like other fibric acid derivatives, increases bile cholesterol saturation, which predisposes the patient to gallstone formation.  This incidence rate is estimated to be 0.3%.   Consult TricorÒ prescribing information for a complete list of side effects observed in clinical trials.

 

Use caution when given concomitantly with HMG-CoA reductase inhibitors.  Oral anticoagulant therapy may be enhanced with concurrent use.  Women of childbearing potential should exercise strict birth control procedures. If pregnancy occurs, fenofibrate should be discontinued.

 

DRUG AND FOOD INTERACTIONS

Tablets should be administered with food. The hypolipidemic effect of fenofibrate is increased when used with cholestyramine or colestipol.  Fenofibrate may increase the effect of chlorpropamide and warfarin.  Concurrent use with HMG-CoA reductase inhibitors may increase the risk of myopathy and rhabdomyolysis. 

 

 

DOSAGE AND ADMINISTRATION

The initial dose of the tablet formulation is 54 mg once daily for the treatment of hypertriglyceridemia.  If an inadequate effect is achieved, the dose of fenofibrate can be increased at 4- to 8-week intervals.  The maximum recommended dose is 160 mg per day.

 

Formulary Additions and Deletions Not Listed in 2002-2003 Formulary Publication

Generic Name

Trade Name

Therapeutic Class

Action

Date

Comments

Alendronate  35 mg once-weekly

Fosamax

Bisphosphonate

Added

6/25/02

 

Colchicine 0.5 mg

Colchicine

Antigout

Deleted

1/22/02

 

Colchicine 0.6 mg

Colchicine

Antigout

Added

1/2202

 

Dexamethasone-Neomycin Sulfate-Polymyxin B Sulfate Ophthalmic Solution

Dexacidin

Ophthalmic anti-inflammatory/antibiotic

Added

3/26/02

 

Ertapenem

Invanz

Antibiotic

Added

3/26/02

Restricted to complicated/severe intra-abdominal infections and diabetic foot ulcers

Ethosuximide

Zarontin

Anticonvulsant

Deleted

6/25/02

 

Felbamate

Felbatol

Anticonvulsant

Deleted

6/25/02

 

Fenofibrate

Tricor

Antilipemic

Added

6/25/02

 

Fondaparin

Arixtra

Anticoagulant

Added

3/26/02

Restricted to Orthopedics

Insulin Lispro Mix

Humalog Mix 75/25

Insulin

Added

6/25/02

 

Ketoprofen

Orudis

Nonsteroidal anti-inflammatory

Deleted

6/25/02

 

Ketorolac Oral

Toradol

Nonsteroidal anti-inflammatory

Deleted

6/25/02

60 mg IV  restricted to pharmacy compound use only

Lactobacillus GG

Culturelle

Dietary Supplement

Added

9/25/01

 

Levetiracetam

Keppra

Anticonvulsant

Added

6/25/02

 

Mefenamic Acid

Ponstel

Nonsteroidal anti-inflammatory

Deleted

6/25/02

 

Mephenytoin

Methoin

Anticonvulsant

Deleted

6/25/02

 

Nesiritide

Natrecor

Natriuretic peptide for acutely decompensated congestive heart failure

Added

3/26/02

Restricted to cardiology consult

Oxaprozin

Daypro

Nonsteroidal anti-inflammatory

Deleted

6/25/02

 

Papain-Urea-Chlorophyllin Copper Complex Debriding Ointment

Panafil

Wound debridement

Added

3/26/02

 

Sirolimus 1 mg/mL Solution

Rapamune

Immunosuppressant Agent

Deleted

3/4/02

Discontinued by manufacturer

Theophylline IR (100 mg & 200 mg)

Slophyllin

Antiasthmatic

Deleted

3/4/02

Discontinued by manufacturer

Thioridazine

Mellaril-S

Antipsychotic

Deleted

9/20/01

 

Thymocyte Globulin (rabbit)

Thymoglobulin

Immunosuppressant

Added

3/28/01

 

 

Prepared by

Brandi Littles, Pharm.D.

Kara Johnson, Pharm.D.

Drug Information Residents (7/24/02)