New Drugs & Devices

PHARMACY NEWS

National Eye Donor Month. Eye Bank Association of America, Inc., 1001 Connecticut Ave., NW, Suite 601 , Washington, DC 20036. (202) 775-4999. National Kidney Month. National Kidney Foundation, 30 E. 33rd St., Suite 1100, New York, NY 10016. (800) 622-9010 or (212) 889-2210. National Nutrition Month. American Dietetic Association, 216 W. Jackson Blvd., Suite 800, Chicago, IL 60606-6995. (312) 899-0040. 6-12, National Save Your Vision Week. American Optometric Association, Communications Center, 243 N. Lindbergh Blvd. , St. Louis, MO 63141. (314) 9914100. 20-26, National Poison Prevention Week. Poison Prevention Week Council, PO Box 1543, Washington, DC 20013. (301) 504-0580. 22, American Diabetes Alert. American Diabetes Association, 1660 Duke St. , Alexandria, VA 22314. (800) 232-3472 or (703) 549-1500. APRIL

Alcohol Awareness Month. National Council on Alcoholism and Drug Dependence, 12 W. 21st St. , New York, NY 10010. (212) 2066770. Cancer Control Month. American Cancer Society, 1599 Clifton Rd. , NE, Atlanta, GA 30329-4251. (800) 227-2345 or (404) 3203333. National Child Abuse Prevention Month. National Committee for Prevention AMERICAN PHARMACY

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Suite 200, Washington, DC 20002. (202) 544-7499. National High Blood Pressure Month. National High Blood Pressure Education Program Information Center, National Heart, Lung and Blood Institute-NIH, PO Box 30105, Bethesda, MD 20824-0105. (301) 2511222. National Melanoma/ Skin Cancer Detection and Prevention Month. American Academy of Dermatology, 930 N. Meacham Rd. , PO Box 401 4, Schaumburg, IL 60173. (708) 3300230. National Mental Health Month. National Mental Health Association, 1021 Prince St. , Alexandria, VA 22314-2971. (800) 969-6642 or (703) 684-7722. National Sight Saving Month. National Society to Prevent Blindness, 500 E.

of Child Abuse, 332 S. Michigan Ave., Suite 1600, Chicago, IL 60604. (312) 663-3520. National Youth Sports Injury Prevention Month. National Youth Sports Foundation for Prevention of Athletic Injuries, Inc. , 10 Meredith Circle, Needham, MA 02192. (617) 449-2499. SID Awareness Month. American Social Health Association, PO Box 13827, Research Triangle Park, NC 27709. (919) 361-8400. 7, World Health Day. American Association for World Health, 1129 20th St. , NW, Suite 400, Washington, DC 20036. (202) 466-5883. 18-24, Minority Cancer Awareness Week. National Cancer Institute, Building 31 , Room 3B43, 9000 Rockville Pike, Bethesda, MD 20892. (301) 496-6792 or (800) 422-6237.

Remington Rd., Schaumburg, IL 60173. (800) 3312020 or (708) 843-2020. 8-14, National Hospital Week. American Hospital Association, 840 N. Lake Shore Dr., Chicago, IL 60611. (312) 280-6028 or (800) 621-9212. 8-14, National Medic Alert Week. Medic Alert Foundation U.S. , PO Box 10009, 2323 Colorado Ave. , Turlock, CA 95381-1009. (800) 344-3226. 8-14, National Nursing Home Week. American Health Care Association, 1201 L St. , NW, Washington, DC 20005. (202) 842-4444. 8-14, National Osteoporosis Prevention Week. National Osteoporosis Foundation, 1150 17th St. , NW, Suite 500, 1ashington, DC 20036. (202 \ 223-2226.

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Better Sleep Month. Better Sleep Council, 2233 Wisconsin Ave. , NW, Suite 500, Washington, DC 20007. (202) 333-0700. National Arthritis Month. Artlujtis Foundation, 1314 Spring St., NW, Atlanta, GA 30309. (800) 283-7800 or (404) 872-7100. National Asthma and Allergy Awareness Month. Asthma and Allergy Foundation of America, 1125 15th St., NW, Suite 502, Washington, DC 20005. (800) 727-8462 or (202) 4667643. National Digestive Diseases Awareness Month. Digestive Disease National Coalition, 711 2nd St., NE,

NEW DRUGS & DEVICES

Neurontin Approved for Treating Epilepsy Gabapentin capsules (Neurontin - Parke-Davis) has been approved by the Food and Drug Administration for use in combination with other epilepsy drugs to treat adults with partial epileptic seizures-seizures that originate in a localized area of the brain. Gabapentin is unusual among epilepsy drugs be-

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cause it does not interfere with the metabolism of other antiepilepsy drugs. Therefore, it requires much less laboratory monitoring and fewer dosage adjustments than other products. It has a favorable drug interaction profIle because it is not metabolized in the liver and is excreted by the kidneys unchanged. Gabapentin's mechanism of action is unknown. The drug is structurally related to the neurotransmitter gammaMarch 1994

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aminobutyric acid. Adverse Effects: In clinical studies, the most common side effects were sleepiness, nystagmus, decreased muscular coordination, dizziness, and fatigue. Contraindications: Hypersensitivity to the drug or its ingredients. Dosage: The recommended dosage is 900-1,800 mg per day given in divided doses three times a day using 300- or 400-mg capsules. Titration can take place rapidly by giving 300 mg on day one, 300 mg twice on day two, and 300 mg three times on day three. To minimize potential side effects, the fIrSt dose on day one can be given at bedtime. If necessary, the dosage may be increased using 300- or 400mg capsules three times a day, up to 1,800 mg per day. Dosages up to 2,400 mg per day have been well tolerated in long-term clinical studies. If gabapentin is discontinued or an alternate anticonvulsant is added to the therapy, this should be done gradually over a week or more. The Elderly: No systematic studies have been conVol. NS34, No.3

March 1994

ducted in elderly patients. However, adverse effects reported in patients over age 65 did not differ from those reported for younger patients. Because the drug is eliminated almost totally by renal excretion, the dosage should be adjusted as outlined in the package insert for patients with compromised renal function. Children: Safety and effectiveness have not been established in children under age 12. Pregnancy: Category C. Adequate studies have not been conducted in pregnant women. Nursing Mothers: It is not known if the drug is excreted in human milk, and the effect on the nursing infant is unknown. How Supplied: In 100mg, 3OO-mg , and 400-mg capsules, bottles of 100, and unit-dose packages of 50. Storage: Store at controlled room temperature.

Nevv Cystic Fibrosis Drug: Pulmozyme Dornase alpha, or DNase (Pulmozyme-Genentech, Inc.), a product of recombinant DNA technology, is the fIrSt drug in 30 years to be approved by the Food and Drug Administration specifically to treat cystic fibrosis. Although the drug does not cure the inherited lung disorder, it is the frrst treatment that specifically improves lung function in cystic fibrosis patients. Because the dis-

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ease affects relatively few people-30,000 Americans-DNase has been designated an orphan drug. Cystic fibrosis is characterized by thick mucous secretions in the lungs, which contributes to chronic lung infections and reduced lung function. Patients with cystic fibrosis often do not survive past age 30. When patients inhale DNase alia, which is administered through a jet nebulizer, the drug acts in a scissorslike fashion to cut the excess DNA in the thick secretions lining the airways and transform the secretions into a flowing liquid that can be coughed up. Adverse Effects: Common side effects include throat inflammation, chest pain, voice alteration, and laryngitis. Contraindications: Hypersensitivity to DNase alia, Chinese hamster ovary products, or any component of the drug. Dosage: The recommended dosage for most patients is one 2. 5-mg single-use ampule inhaled daily using a recommended nebulizer: disposable Hudson T Up-draft II, disposable Marquest Acorn II and Pulmo-Aide compressor, or reusable PARI LC]et+ nebulizer in conjunction with the PARI PRO NEB compressor. Some patients may benefit from twice-daily administration. Children: Safety and effectiveness have not been established in children under age five. Pregnancy: Category B.

Adequate studies have not been conducted in pregnant women, but animal studies have shown no evidence of impaired fertility or harm to the fetus. Nursing Mothers: It is not known if the drug is excreted in human milk. How Supplied: In singleuse ampules of 2.5 mL each, which contain 1.0 mg/mL of DNase aifa, 0.15 mg/mL of calcium chloride dihydrate, and 8.77 mg/mL sodium chloride. The ampules are available in cartons of 14 and 30. Storage: Store unused ampules in their protective foil pouches under refrigeration at 2-8°C (39-46°F). Protect the ampules from light. For More Infonnation: (800) 821-8590.

Neutrexin Approved for Treating PCP Trimetrexate glucuronate (Neutrexin-U.S. Bioscience) has been approved by the Food and Drug Administration for concurrent administration with leucovorin as alternative therapy to treat moderate to severe Pneumocystis carinii pneumonia (PCP) in immunocompromised patients who cannot tolerate or are not responding to other treatments. Trimetrexate, a nonclassical folate antagonist, works by inhibiting an enzyme involved in metabolic pathways necessary for the growth and replication of AMERICANPHARMACY

PHARMACY NEWS

the P carinii organism and human cells. Leucovorin is administered concurrently to protect normal cells while trimetrexate attacks the P carinii organism. The drug has been allowed expanded use since 1988 under a "treatment IND," which makes promising drugs available to patients with life-threatening conditions before all clinical trials required for FDA approval have been completed. Adverse Effects: Because the patients participating in clinical studies had advanced AIDS, it was difficult to distinguish drug side effects from problems caused by the underlying medical condition. The principal toxicity associated with the drug was myelosuppression-usually manageable through dosage adjustment -transient elevations of liver enzymes, fever, and rash.

Contraindications: Hypersensitivity to trimetrexate or other quinazolinecontaining compounds, as well as hypersensitivity to leucovorin. Dosage: Trimetrexate is administered at a dosage of 45 mg/m2 once daily by intravenous infusion over 60-90 minutes for 21 days. Leucovorin may be administered daily during trimtrexate administration, and for 72 hours past the last trimetrexate dose. Leucovorin may be administered intravenously at a dose of 20 mg/2 over 5-10 minutes every six hours for a total daily dose of 80 mg/m2, or orally in four doses of 20 mg/m2 spaced evenly throughout the day. Children: Safety and effectiveness have not been established in children. Under a "compassionate use" protocol, however, two

children under age two were treated with the drug and showed no serious or unexpected adverse effects. Pregnancy: Category D. The drug can cause fetal harm when administered to a pregnant woman. Nursing Mothers: It is not known if the drug is excreted in human milk. Because of the potential for harm to the infant, it is recommended that breast-feeding be discontinued while the mother is taking the drug. How Supplied: As a sterile, lyophilized powder in 5mL single-use vials. The drug must be reconstituted with 2 mL of 5% Dextrose or Sterile Water for Injection. The drug is available in packages of 10 vials; 50 vials in two trays; 100 vials in four trays; and a starter pack with 21 vials of trimetrexate and 28 vials of leucovorin.

Storage: Store at controlled room temperature. Protect from light. For More Infonnation: For product information call Dr. Edith Mitchell, (800) 872-4672. For reimbursement assistance, (800) 8872467.

December Approvals The Food and Drug Administration's typical rush of December approvals included the following new drugs, for which complete labeling information was not available at press time. Many of these drugs will not be marketed until later in the year.

Aceon (perindopril erbumine) from RW Johnson is a new angiotensin-converting enzyme inhibitor approved for treating patients with hypertension. It is the ninth drug in its class approved for marketing in the United States and the sixth labeled for once-daily administration. For more information: (908) 218-6116, Clare Cataldo.

Dovonex (calcipotriene ointment) from Bristol-Myers Squibb has been approved for treating moderate plaque psoriasis. For more information: (800) 333-0950, Dr. Epinette.

Effexor (venlafaxine HCI) from Wyeth-Ayerst has been approved for treating depression. It is a bicyclic agent that inhibits neuronal uptake of serotonin and AMERICAN PHARMACY

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norepinephrine. For more information: (800) 950-5099. Kytril (granisetron HCl injection) from SmithKline Beecham has been approved for preventing nausea and vomiting associated with cancer therapy, including high-dose cisplatin. For more information: (215) 751-5231. Lescol (fluvastatin) from Sandoz, an HMG-CoA reductase inhibitor, has been approved as an adjunct to the diet for treating elevated total cholesterol and lowdensity-lipoprotein cholesterol in patients with primary hypercholesterolemia who have not responded to dietary and nonpharmacologic measures. For more information: (800) 526-0175 or (201) 503-7035.

tonin antagonist, has been approved for treating psychotic disorders, including schizophrenia. For more information: (609) 730-3135, Richard Meibach.

FUsperdal(risperidone tablets) from Janssen Pharmaceutica, a dopamine/sero-

Biaxin (clarithromycin) from Abbott Laboratories has been approved by FDA

March 1994

complex, a common systemic infection in patients with AIDS. It is the first drug to be specifically approved for this indication. For more information: (800) 633-9110.

T/Gel Extra Strength Therapeutic Shampoo contains 4.0% Neutar, a solubilized coal tar extract, to reduce the cell proliferation of hyperkeratotic conditions such as psoriasis, seborrhea,

Naproxen: First New OTe Analgesic in 10 Years Despite an advisory panel recommendation en sodium not be switched from prescription counter (OTC) status, the Food and Drug (FDA) gave the go-ahead in January for a ·nnr.....fonn of the drug, to be marketed by ProcteNS1rtltE Products Company under the name Aleve. When the FDA panel decided against recommending approval of the drug last summer, it cited concerns that the proposed 220-mg OTC dose would not be safe and that some consumers, impatient with the drug's slow action, would take more than the rec:OD1l1llc;~,e
Prescription Drug Notes

Lipidil (fenofibrate) from Fournier Research has been approved as an adjunct to the diet for adults with very high elevations of serum triglycerides who are at risk for pancreatitis and have not responded to dietary measures. It has been marketed in Europe since 1975. For more information: (201) 575-1010.

NelN OTC Products

Mycobacterium avium

Trasylol Injection (aprotinin) from Miles has been approved to reduce blood loss and the need for blood transfusions in patients undergoing heart bypass surgery. It will be most useful for patients at high risk for bleeding, such as those undergoing repeat bypass surgery or those with clotting defects, as well as when transfusion is unavailable or unacceptable. For more information: (800) 800-4793.

Septra and Bactrim brands of trimethoprimsulfamethoxazole, manufactured by Burroughs-Wellcome and Roche Laboratories, respectively, have received approval from the Food and Drug Administration (FDA) for the additional indication of preventing Pneumocystis carinii pneumonia (PCP) in immunocompromised patients, including those with AIDS. The only other drug approved for PCP prophylaxis is aerosolized pentamidine. For more information: (919) 248-3000 (Septra) or (800) 526-6367 (Bactrim).

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for the additional indication of treating disseminated

l l h.:iO'1.0

rJ.JlLK

apart. Aleve win be sold with a called "Safety Squease," which .&.&.-." ',.~U~J on adult intelligence and the abilitY once, rather than strength. For more infonnation: (SOQ) 358-8707.

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AMERICAN PHARMACY

PHARMACY NEWS

and dandruff. The extrastrength shampoo has twice as much active ingredient as the original strength T/Gel. Manufacturer: Neutrogena Dermatologics, (310) 642-

ucts Division, Abbott Laboratories: (800) 227-5767.

1150. Isomil DF is a new infant

Personal Best now offers a low-range peak flow meter (50-390 L/minute) for young children or patients with severely restricted airflow. The unit measures 6Y2 inches by 2 inches, weighs 3 oz, and comes in a self-contained carrying case.

formula with added soy fiber, which is designed to shorten the duration of loose stools during mild to severe diarrhea. It should be given under the direction of a physician for up to 10 days. Manufacturer: Rodd Prod-

Nevv Devices

DRUG RESEARCH

Oral Collagen: Treatment for Rheumatoid Arthritis? A recent study using orally ingested type II collagen from chickens to treat rheumatoid arthritis (RA) brings new evidence that oral tolerization can be an effective therapy for autoimmune diseases. (Science, September 24, 1993;261: 1727-30). In oral tolerization thera-

py, patients are fed proteins-in this case collagen-from the site of autoimmune disease in an attempt to reduce autoimmune attacks. This process is antigen-driven bystander suppression. Oral tolerization takes advantage of the body's system for preventing immune reactions to food. Although the specific mechanism of AMERICANPHARMACY

action is not yet understood, scientists believe that foreign proteins entering the body through the digestive system suppress immune responses to those proteins instead of triggering them. In the study, led by David Trentham of Harvard University, 60 patients with severe, active RA were withdrawn from immunosuppressive drugs and randomized to receive either daily doses of type IT collagen from chicken breastbone, taken in orange juice, or placebo. Participants were measured for results at one, two, and three months. At the end of the trial, patients receiving collagen showed a decline in the number of swollen or tender joints. Other measures were not Significant, however. The researchers reported that four of the collagen patients went into remission

during the trial. Four of the patients on placebo showed substantial improvement, as well. Trentham'S fllldings are consistent with earlier studies of oral tolerization, which have shown that feeding collagen to rats triggers production of suppressor T cells. These cells travel to the joints, where they prevent other types of T cells from attacking and causing inflammation. The approach was first tried on humans when patients suffering from multiple sclerosis (MS) were fed preparations of myelin and showed some improvement. Although the recent RA study achieved better results than the MS study, the researchers were cautious about their fllldings. They noted that their study was too small and the results too moderate to signal a new RA treatment. A much larger, multicenter trial is likely to begin in 1995. Paul A. Rochmis, a rheumatologist at Fairfax Hospital in Virginia, has suggested another reason for caution: a flaw in the study design. The researchers, he noted, did not provide a washout period when they took the patients off immunosuppressant drugs. Their results, then, could stem in part from a residual effect of the previous drugs. On the other hand, he said, the collagen might have worked excellently and have overcome an unseen deterioration resulting from removal of the immunosuppressants.

"The study is provocative and should be followed up," Rochmis said. "Their good science will open our understanding of immunology, though it may not lead to treatment of a complex and nonmalignant disease like RA. "

AminophyllineBased Cream Reduces Thigh Fat Women who have longed for a simple way to thin their thighs may have found the answer in a new cosmetic cream made from an overthe-counter asthma remedy. The cream, whose active ingredient is the bronchodilator aminophylline, brought significant results in two small studies led by Frank Greenway, a clinical professor of medicine at the University of California at Los Angeles, and George Bray, a noted obesity researcher and director of Louisiana State University's Pennington Biomedical Research Center. Greenway, who developed the cream, holds the cream's license and shares its patent with Bray. Their studies were presented last fall at the annual meeting of the North American Association for the Study of Obesity. In one study, a group of 12 women had one teaspoon of the cream applied to one thigh every day and a placebo cream to the other. After five weeks, the treated thighs had shrunk in circumMarch 1994

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