Recently, certain lot numbers of flu vaccine manufactured by Parke Davis (Fluogen®) were recalled on a national level due to reports of decreased efficacy. The flu vaccine administered at KUMC this year was manufactured by Wyeth-Ayerst (Flushield®) and is not involved in the recall. The FDA is recommending that high risk patients who received the recalled vaccine be revaccinated. The KUMC pharmacy department has sufficient supply of the Wyeth-Ayerst product in stock to provide revaccinations for these patients.
Olanzapine, a thienobenzodiazepine antipsychotic agent, is indicated for the management of psychotic disorders, including schizophrenia. The mechanism of action of olanzapine has not yet been determined. The proposed mechanism is a combination of dopamine and serotonin antagonism. Olanzapine therapy has been shown to be comparable to haloperidol therapy in the reduction of schizophrenic symptoms with one-third fewer episodes of treatment-emergent parkinsonism, one-half as many episodes of akathisia, and no episodes of acute dystonia.
Adverse events associated with olanzapine appear to be due to the agents antagonistic effects at muscarinic, cholinergic, a adrenergic, and histaminic receptors. Treatment emergent adverse events associated with olanzapine therapy at an incidence of greater than 5% and with a greater incidence for olanzapine compared to placebo include: postural hypotension, constipation, weight gain, dizziness, non-aggressive objectionable behavior, and akathisia. As with other antipsychotic agents, serious adverse events that may potentially occur with olanzapine therapy include neuroleptic malignant syndrome and tardive dyskinesia. Seizures, hyperprolactinemia, clinically significant transaminase elevations and dysphagia have also occurred with olanzapine therapy. Unlike clozapine, no indication of a risk of clinically significant neutropenia was associated with olanzapine therapy during controlled clinical trials.
Olanzapine has not been studied extensively in combination with other medications. Because of the CNS effects of olanzapine, its use in combination with other centrally acting agents including alcohol should be undertaken with caution. The potential hypotensive effects of olanzapine may enhance the effects of other blood pressure lowering agents. Olanzapine may antagonize the effects of levodopa and dopamine agonists. Inhibitors of the cytochrome P450 1A2 isoenzymes may inhibit the metabolism of olanzapine. Carbamazepine enhanced the elimination of olanzapine by up to 50%. Administration of olanzapine with cimetidine and antacids did not significantly alter the absorption of olanzapine.
The recommended starting dose of olanzapine is 5-10 mg once daily with a target maintenance dose of 10 mg/day. Dosage adjustments should be made in increments of 5 mg on a weekly basis. Doses up to 15 mg/day were used in clinical trials, but have not been shown to be more efficacious than 10 mg/day.
Olanzapine carries a KUMC cost index of E.
| FOOD/DRUG INTERACTION: Coadministration with food does not interfere with olanzapine dosing. |
Fexofenadine, an active metabolite of terfenadine, is a non-sedating antihistamine indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 12 years of age and older. Fexofenadine will replace terfenadine on the KUMC formulary. The two non-sedating antihistamines on formulary are now loratadine (Claritin®) and fexofenadine Allegra®).
The recommended dose of fexofenadine is 60 mg twice daily. The agent has a half-life of 14.4 hours, an onset of action of 1 hour, and a duration of action of greater than 12 hours. Coadministration of fexofenadine with erythromycin and ketoconazole was shown to increase serum levels of fexofenadine but was not associated with adverse events.
Unlike terfenadine, fexofenadine has not been associated with serious adverse events. Fexofenadine doses considerably higher than the recommended dose of 60 mg twice daily have not been associated with QT interval changes or other cardiovascular adverse events. Adverse events associated with fexofenadine therapy include viral infection, nausea, drowsiness, dysmenorrhea, dyspepsia, fatigue, headache, and throat irritation.
Fexofenadine carries a KUMC cost code index of C.
| FOOD/DRUG INTERACTION: Coadministration with food does not interfere with fexofenadine dosing. |
Colistimethate is currently marketed as an injectable product for the treatment of acute and chronic infections due to sensitive strains of certain gram-negative bacilli. In short-term (up to 3 months) clinical trials, nebulized colistimethate therapy was shown to be effective in eradicating recently acquired Pseudomonas aeruginosa in children and in the prevention and management of chronic infection in adults with cystic fibrosis.
The most important clinical adverse event associated with nebulized colistimethate is chest tightness. Up to 76% of patients enrolled in controlled clinical trials have experienced a bronchoconstrictor response to nebulized colistimethate. Maximum bronchoconstriction usually occurred immediately after colistimethate administration but has been delayed for up to 30 minutes after completion of nebulization.
Uniform dosing recommendations have not been established for nebulized colistimethate. Clinical trials have used nebulized doses 1-2 million units (50-100 mg) daily.
Colistimethate carries a KUMC cost code index of F.
| FOOD/DRUG INTERACTION: Coadministration with food does not interfere with colistimethate dosing. |
Pentosan polysulfate sodium is a low-molecular weight heparin-like compound with anticoagulant and antifibrinolytic effects and is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. This agent has been added to the KUMC formulary with usage restricted to urology. The exact mechanism of action by which pentosan polysulfate sodium works in the treatment of interstitial cystitis is not yet known. It is currently believed that the compound provides artificial restoration of the natural glycosaminoglycans layer of the bladder, which has been shown to be defective in interstitial cystitis. Pentosan polysulfate sodium therapy has resulted in decreased symptom scores compared to baseline in up to 34% of patients after six months of therapy and improved pain scores in a significantly larger percentage of patients (38%) than placebo (18%).
After oral administration, absorption of pentosan polysulfate sodium from the gastrointestinal tract is approximately 3% and the major distribution site is the uroepithelium of the genitourinary tract. Pentosan polysulfate sodium is metabolized via desulfation in the liver and depolymerization in the kidney. The compound has an elimination half-life of approximately 4.8 hours. With multiple dosing, urinary excretion accounts for about 11% of the administered dose with 3% of the dose excreted as unchanged drug. The pharmacokinetics of pentosan polysulfate sodium have not been studied in special populations.
The most commonly reported adverse events associated with pentosan polysulfate
sodium therapy include alopecia, gastrointestinal distress, headache, rash, liver function abnormalities, and dizziness. Bleeding complications, including ecchymosis, epistaxis, gum hemorrhage, and increased prothrombin times have also been reported.
The recommended dose of pentosan polysulfate sodium is 100 mg three times daily. The capsules should be taken with water at least 1 hour before or 2 hours after meals. Patients who do not experience reduction or relief of symptoms after 3 months of therapy should be reassessed and therapy continued for an additional 3 months. The safety and efficacy of courses of therapy longer than 6 months have not been determined.
Pentosan polysulfate sodium carries a KUMC cost code index of D.
| FOOD/DRUG INTERACTION: The effect of food on the absorption of pentosan polysulfate sodium is not known. In clinical trials, the agent was adminstered with water 1 hour before or 2 hours after meals. |
CLARIFICATION: A recent Pharmacy Key indicated that fosphenytoin will replace phenytoin for all adult patients at KUMC. Fosphenytoin has replaced only parenteral forms of phenytoin on the KUMC formulary. Oral phenytoin will remain on formulary.
FORMULARY ADDITIONS
Amoxicillin/ Clavulanic Acid (Augmentin®) [BID Preparations]
Bicalutamide (Casodex®)
Carbamazepine XR (Tegretol XR®)
Cefepime (Maxipime®)
Cefpodoxime (Vantin®) [tablets]
Cefprozil (Cefzil®) Tablets
Ceftriaxone (Rocephin®)
- restriction removed
Colistimethate (Coly-Mycin M®)
Dexfenfluramine (Redux®)
-restricted to obesity clinic
Ethinyl Estradiol + Norgestimate (OrthoCyclen®, OrthoTriCyclen®)
Famciclovir (Famvir®)
Fenfluramine (Pondimin®)
-restricted to obesity clinic
Fexofenadine HCl (Allegra®)
Flunisolide (Aerobid-M) [MDI]
Fosphenytoin (Cerebyx®)
Indinavir (Crixivan®)
Levomethadyl (Orlaam®)
-restricted to methadone clinic
Mebendazole (Vermex®) [Chewable Tabs]
Minocycline (Minocin®)
-restriction removed
Mupirocin Nasal Ointment (Bactroban®)
Olanzapine (Zyprexa®)
Pentosan Polysulfate Sodium (Elmiron®)
- restricted to urology
Phentermine (Adipex-P®,Fastin®)
-restricted to obesity clinic
Piperacillin/ Tazobactam (Zosyn®)
- restriction removed
RSV Immune Globulin (Respigam®)
Ritonavir (Norvir®)
Simvastatin (Zocor®)
Sonicated Albumin 5% (Albunex®)
-restricted to cardiac cath lab
Testosterone Patch (Androderm®)
Terbinafine (Lamisil®)
Topotecan (Hycamtin®)
FORMULARY DELETIONS
Amoxicillin/Clavulanic Acid [TID formulations]
Atracurium Besylate Omeprazole (Prilosec®)
Cefoperazone (Cefobid®)
Cefpodoxime (Vantin®) [suspension]
Ceftizoxime (Cefizox®) [sustained release tablet]
Cefotetan (Cefotan®)
Cefuroxime (Ceftin®) [suspension]
Flunisolide (Aerobid®) [MDI]
Loracarbef (Lorabid®) [suspension]
Phenytoin (Dilantin®) [intravenous]
Procainamide HCl (Procan SR®)
Terfenadine (Seldane®)
Terfenadine + pseudoephedrine (SeldaneD®)
