New Drugs and Devices

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Ddl for AIDS Patients Intolerant to AZT Didanosine (VIDEXBristol-Myers Squibb Company), also called ddI, has been approved by the Food and Drug Administration for treating patients at advanced stages of AIDS infection. It may be used in adult and pediatric patients who are intolerant to AZT or whose health has significantly dete-

riorated while on AZT. The drug is rated l-AA: new chemical entity with significant therapeutic gain, approved through an expedited review process. Adverse Effects: The major adverse effects seen in clinical trials were pancreatitis, peripheral neuropathy, and diarrhea. Contraindications: Clinically significant hypersensitivity to the drug. Also, \

AMERICAN PHARMACY

patients with a previous history of pancreatitis or heavy alcohol consumption are not considered candidates for the drug because they are at highest risk for developing serious side effects. Dosage: For adults, the dosage depends on body weight; for children, the dosage depends on body surface. Refer to package insert for dosing tables. Patients with renal or hepatic impairment may be at greater risk of toxicity and may require a reduction in dose. When tablets are administered, they should be chewed, crushed, or dispersed in at least 1 oz of water. Children: May be used in children over the age of six months. Pregnancy: Category B. No evidence of risk to the human fetus based on animal reproductive studies, but adequate studies have not been conducted in pregnant women. Nursing Mothers: It is not known whether the drug is excreted in human milk. How Supplied: As buffered tablets in 25-mg, 50-mg, 100-mg, or 150-mg strengths; as a buffered powder for oral solution in Single-dose packets of 100 mg, 167 mg, 250 mg, or 375 mg; as a pediatric powder for oral solution in HZ and 8-oz glass bottles.

Storage: Store at room temperature. Tablets should be stored in tightly closed bottles; if dispersed in water the dose may be held at ambient temperature up to 1 hour. After dissolving in water the buffered powder may be stored at ambient temperature up to 4 hours. The constituted pediatric solution may be stored up to 30 days in a refrigerator at 36°F-46°F (2°C-8°C). For More Infonnation: Call (800) 622-7999.

Foscarnet for CMV Retinitis Foscamet sodium injection (Foscavir-Astra Pharmaceutical Products, Inc.) is the second drug approved by the Food and Drug Administration for treating AIDS patients with cytomegalovirus (CMV) retinitis. Although it does not cure the disease, it can significantly delay its progression. Up to 300/0 of AIDS patients develop CMV retinitis. The drug is rated l-AA: new chemical entity with significant therapeutic gain, approved through an expedited review process. Adverse Effects: The major side effect is renal impairment. Physicians are asked to measure the patient's renal function before starting treatment a~d to monitor serum creatinine frequently throughout therapy. Electrolyte and mineral imbalances can also occur and may be associated with seizures. December 1991/850

VoL NS31, No. 12

Contraindications: Clinically significant hypersensitivity to the drug. Dosage: For patients with normal renal function the recommended initial dosage is 60 mg/kg, adjusted for individual patients' renal function. The drug should be given intravenously at a constant rate over a minimum of 1 hour every 8 hours for 2-3 weeks depending on clinical response. The recommended maintenance dosage is 90 mg/kg per day to 120 mg/kg per day (individualized for renal function) infused over 2 hours. See package insert for a table of dosage adjustments according to renal function. Children: Safety and effectiveness have not been established. The Elderly: Safety and effectiveness have not been established. Since persons over age 65 often have reduced glomerular filtration, renal function must be carefully assessed before and during administration of the drug. Pregnancy: Category C. Use only if clearly needed; potential benefits may justify the potential risk to the fetus. Nursing Mothers: It is not known whether the drug is excreted in human milk. How Supplied: In 250mL and 500-mL glass bottles, cases of 12. Storage: At controlled room temperature, protect from excessive heat and from freezing. Vol. NS31, No. 12 December 1991/851

NewOTC Products

For More Information: For details about the drug or related medical issues, call (800) 388-4148. For answers to insurance questions and help with filing claims, health care providers may call the Foscavir Reimbursement Hotline at (800) 488-3247.

Dermoxyl acne gel, containing benzoyl peroxide, is being targeted specifically for adult use. It is available in strengths of 2.5%,5%, and 100/0, in either an acetone base for oily skin or a water base for normal skin. Manufacturer: SPI Pharmaceuticals, Inc. (714) 556-0131. DuoFilm wart removers in patch and liquid form and DuoPIant gel for plantar warts are now available over the counter. Each contains 17% salicylic acid. Manufacturer: ScheringPlough HealthCare Products. (908) 604-1640.

Prescription Drug Notes Minoxidil 20/0 topical solution (Ragaine--The Upjohn Company) has been approved by the Food and Drug Administration for treating hereditary hair loss in women (androgenetic alopecia). The dosage for women is the same as for men: Once in the morning and once at night, 1 mL each time. For more information: (616) 323-4000. Atenolol is now available as a multisource product from Geneva Pharmaceuticals. It was approved by the Food and Drug Administration as equivalent to the brand name (Tenarmin-ICI Pharmaceuticals) and is available in 50--mg and 100--mg tablets, bottles of 100. For more information: (303) 466-2400.

Lipisorb powder is a new nutritional product designed for patients with fat malabsorption, such as AIDS patients. It is vanilla flavored and contains 86% medium-chain triglycerides oil and 140/0 com oil. It may be administered orally or enterally. Manufacturer: Bristol-Myers Squibb. (812) 429-5000. Nasal Moist is a new saline nasal moisturizing spray. Manufacturer: Blairex Laboratories. (800) 252-4739. Soothe & Clean personal

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cleansing foam is useful for treating external hemorrhoids and other minor external irritation of the rectum or vagina. It contains lanolin and is free of alcohol. Manufacturer: Blair Laboratories, Inc. (203) 853-0123. AK-301 Dermaseel Antimicrobial Cream con-

tains chloroxylenol, nonoxynol-9, and emollients. It is intended for use on the hands of dentists and other health care workers who come in contact with infectious agents susceptible to its active ingredients. Manufacturer: Medarave, Inc. (201) 836-1999. Painbust-Rll, a new cream for treating arthritis symptoms, contains methyl salicylate 170/0 and menthol. Manufacturer: Continental Quest Corporation. (800) 451-5773. Preparation H Cleansing Tissues are premoistened, alcohol-free wipes for cleansing the sensitive skin of external hemorrhoids. They can be used alone or with Preparation H ointment, suppositories, or cream. Manufacturer: Whitehall Laboratories. (212) 878-6923. Pin-Rid for eliminating AMERICAN PHARMACY

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pinworms is now available in a soft-gel capsule. Manufacturer: Apothecary Products Inc. (800) 328-2742.

Extra Strength Tylenol PM, indicated for relieving aches and pains that interfere with sleep, is nowavailable. Each tablet or caplet contains 500 mg of aceta'minophen and 25 mg of diphenhydramine hydrochloride. Manufacturer: McNeil Consumer Products Company. (215) 233-7730. Bayer Plus Aspirin with Stomach Guard contains 325-1ng tablets and buffering agents. Manufacturer: Sterling

Engineered Livestock May Become Drug ·Factories' Researchers in different parts of the world are making significant progress toward producing important human proteins in the milk of transgenic livestock, AMERICAN PHARMACY

Winthrop Consumer_Health Group. (800) 446-6267.

New Devices Counter Cap fits over the cap of any medicine container and displays, through a window indicator, the number of times the container has been opened. Manufacturer: Senetics, Inc. (303) 494-2825. The Q.E.D. Total Cholesterol Test is a hand-held device that uses blood from a fingerstick to give cholesterol readings in five minutes. Manufacturer: Enzymatics, Inc. (215) 674-3288. Tactylon Gloves are made without latex and meet federal standards for surgical gloves. Manufacturer: Tactyl Technologies, Inc., distribu':ed by SmartPractice. (800) 822-8956. Kiss of Life is a new barrier mask for use when conducting cardiopulmonary resuscitation. Manufacturer: Brunswick Biomedical Technologies, Inc. (508) 291-1830.

according to a recent issue of Bio/J'echnology (1991; 9:830-9). In the United States, researchers at Genzyme, in collaboration with Tufts University School of Veterinary Medicine, succeeded in breeding goats that secrete tissue plasminogen activator

(tPA) into their milk, although at a very low level. Scientists devised a simple purification method that allows them to recover 980/0 electrophoretically pure protein, with an overall yield of 25%. However, the tPA produced by this method is not structurally identical to that produced by the more conventional mouse-cell tissue-culture system. Still, the research holds promise for developing a way to mass produce this thrombolytic agent and thus reduce its cost. In the Netherlands, a transgenic dairy calf that carries a gene to produce human lactoferrin (hLF) in cow milk is the result of a collaboration between GenPharm International and the Research Institute for Animal Production of the Dutch Ministry of Agriculture. The antibacterial and iron transport properties of hLF make it an important ingredient for infant formula and enteral formulations for immunocompromised patients. According to GenPharm, hLF's structure makes it "difficult to impossible" to produce efficiently in other production systems. A third report, from Scotland's Institute of Animal Physiology and the company Pharmaceutical Proteins Ltd., demonstrated that genetically engineered sheep can produce the human protein alpha-I-antitrypsin at a concentration thousands of times higher than is possible through current methods. The drug,

which is used as replacement therapy for genetically deficient patients at risk for emphysema, is normally produced by purification from plasma. Development of the transgenic calf was hailed by biotechnology experts as a special breakthrough because the approach was much less expensive than the traditional method used in smaller animals (and which was used in the sheep and goat studies). Normally, artificially inseminated eggs are collected from the animal, injected with the new genetic material, and reimplanted, requiring surgery at least twice. The transgenic cow was produced by harvesting eggs from cows killed in a slaughterhouse, fertiliZing them in vitro, injecting them with the new genes, and implanting the resulting embryo into the surrogate cow's uterus by syringe through the vagina.

Step Up Malaria Research. Committee Advises Malaria, a tropical disease that is rare in this country, is spreading at unprecedented levels worldwide and must be targeted for research and prevention, according to a 17-member committee of experts convened by the Institute of Medicine. Malaria, which infects about 300 million people December 1991/852 Vol. NS31, No. 12