- Email: [email protected]
New Drugs & Devices
break up with their boyfriends and stop the pill, swearing they'll never have sex again. But they do." Compliance problems can also be perpetuated by breaks in pill use, Hillard says. "Breakthrough bleeding, for example, is most common in the first one to three nlonths of pill use. On again, off again use brings the potential for recurrent side effects, which can lead a woman to stop the pill altogether. " Another argument for staying on the pill continuously, Hillard says, is that it brings noncontraceptive benefits, such as relief of dysmenorrhea, shorter periods, and regular periods. "I always tell patients, 'If you're thinking about stopping the pill, call me first so we can talk about it,' " Hillard says. By reinforcing that message to oral contraceptive users, pharmacists can help WOl11en remain compliant and avoid unintended pregnancy. If a woman indicates she is considering taking a rest from the pill, the pharmacist should explain why it's a good idea to continue, Hillard suggests. "If she's having problems with the pill, tell her to discuss them with her physician, " Hillard says. "Sometimes simply switching from one pill preparation to another can solve the problem - we can almost always fllld one that works well. The idea to get across is there are alternatives."
Vol. NS32, No. 12 December 1992/ 939
Health Resources The Pain Relief Video and the newsletter the Pain Relief Papers offer helpful information and guidance about how cancer patients and their families can best cope with physical discomfort. The 1O-minute video and the newsletter, available from] anssen Pharmaceutica, are free to patients and families who call (800) 352-9593. Smoking or Health? It's Your Choice is a 26-page booklet on the adverse effects of smoking on the human body. It covers not only lung cancer and respiratory ailments, but also nlale and female infertility, hearing loss, male impotence, skin wrinkling, peptic ulcer, and other disorders. It is available for $3.85 from the American Council in Science and Health, (212) 362-7044. HIV Negative-lVben Are You Free From HIV? and Positive Living are two new booklets from the American Social Health Association (ASHA) that provide information about HIV. The first discusses what a negative result on the HIV test can mean and how to reduce the risk of future HIV infection. The second discusses, in a positive way, what it means to be infected with HIV, including life decisions and protecting others. ASHA also offers a wide array of educational brochures on other sexually transmitted diseases. For information or a catalog, call (919) 361-8425. Skin Cancer: If You Can
Spot It, You Can Stop It is a new brochure from the Skin Cancer Foundation that explains the warning signs of skin cancer and provides step-by-step instructions for performing skin self-examinations. For a free copy, send a stamped, selfaddressed, business-size envelope to The Skin Cancer Foundation, Dept. SE, Box 561, New York, NY 10156. New treatment guidelines for pregnant women with asthma are now available from the National Heart, Lung, and Blood Institute. While noting that it is desirable to use as few medications as possible during pregnancy, the report emphasizes that the risk of uncontrolled asthma is far greater than risks to the mother or fetus from asthma medications. It recommends preferred medications and selection criteria. Copies may be ordered from the NAEP Information Center, P.O. Box 30105, Bethesda, MD 20814-0105.
Consistency and Quality in Pressure Sore Treatment: A Long Term Care Guide is an in-service training kit and videotape available free from Fujisawa Pharl11aceutical Co., (800) 766-4321.
Health Dates JANUARY National Eye Health Care Month. The Ophthalmic Press and Television Information Center Foundation, Inc. , 5005 Central Ave., St. Petersburg, FL 33710. (813) 323-4999. 26--31, National Glaucoma Awareness Week. National Society to Prevent Blindness, 500 East Remington Rd., Schaumburg, IL 60173. (800) 221-3004 or (708) 843-2020.
FEBRUARY American Heart Month. American Heart Association, 7320 Greenville Ave., Dallas, TX 75231. (800) AHA-USA1.
NEW DRUGS & DEVICES
Cefpodoxime: Nevv Antibiotic Cefpodoxime proxetil (Vantin- The Upjohn Company) is a new broad-spectrum cephalosporin antibiotic for treating mild to moderate infections in adults and children. It is indicated for acute communityacquired pneumonia,
II
pharyngitis, tonsillitis, lmcomplicated skin and skinstructure infections, uncomplicated urinary tract infections, acute uncomplicated urethral and cervical gonorrhea, and acute otitis media. Adverse Effects: Side effects are similar to those for other oral cephalosporins. The l110St common are AMERICAN PHARMACY
PHARMACY NEWS
NEW DRUG & DEVICES
0
Continued.!i-om preuiollspage
diarrhea, nausea, abdolninal pain, and vomiting. Rashes and abnormalities in liverfunction tests have also been observed. The dnlg should be administered with caution to penicillin-sensitive patients because cross-sensitivity may occur in up to 10% of patients with a history of penicillin allergy.
Contraindications: Hypersensitivity to any cephalosporins. Dosage: For most indications the dnlg is taken twice daily. The recommended dosages vary according to the patient's age and site of infection; refer to package insert for complete information. The drug should be administered with food to enhance absorption. The Elderly: Dosage adjustment in elderly patients with nonnal renal function is not necessary. Children: Safety and efficacy in infants younger than six months old have not AMERICANPHARMACY
been established. Pregnancy: CategolY B. Adequate studies have not been conducted in pregnant women. However, studies in anunals have revealed no evidence of harm to the elnbryo or fetus. Nursing Mothers: The dnlg is excreted U1 human milk. Women should either discontinue nursing or discontinue the dnlg. How Supplied: In 100mg and 200-mg tablets, bottles of 20 and 100, and unitdose packages of 100. The product is also available as lemon-flavored granules for reconstitution into an oral suspension in these strengths: 50 mg/5 mL and 100 mg/5 m1. Storage: Tablets and unsuspended granules should be stored tightly closed at roon1 temperature. The suspension should be refrigerated at 2° -8°C (36° -48°F); the unused portion should be discarded after 14 days. For More InfortIlation: (616) 323-4000.
Loracarbef: Ne\N BetaLactam Loracarbef (Lorabid- Eli Lilly), a new broad-spectrum antibiotic, is the first in a new carbacephem class of synthetic oral beta-Iactams. It is approved by the Food and Dnlg Administration for treating patients with mild to moderate infections of the upper- and lower-respiratory tract, including pneumonia,
secondalY infection in acute bronchitis and acute infection in chronic bronchitis, acute otitis media, acute n1axillary sinusitis, pharyngitis, and tonsillitis. It is also u1dicated for treating uncomplicated skin and skin-stnlCture infections, uncOlnplicated urinalY tract infections, and uncolnplicated pyelonephritis caused by Escherichia coli. Adverse Effects: Side effects reported in clinical trials were silnilar to those for other beta-Iactatns and were mostly mild and transient. Gastrointestu1al problems, hypersensitivity reactions, and headache were the tnost common reactions. The drug should be adn1inistered with caution to penicillu1-sensitive patients because cross-sensitivity Inay occur in up to 10% of patients with a history of penicillu1 allergy. Contraindications: Hypersensitivity to any cephalosporins. Dosage: For n10st indications the dnlg is taken twice daily. The recon1n1ended dosages vary according to the patient's age and site of infection; refer to package insert for complete information. The dnlg should be administered at least one hour before eating or two hours after eating. The Elderly: Dosage adjustment in elderly patients with normal renal function is not necessalY. Children: Safety and efficacy in infants younger than six months old have not been established.
Pregnancy: Category B. Adequate studies have not been conducted in pregnant won1en. However, studies in anin1als have revealed no evidence of ilnpaired fertility or harm to the fetus. Nursing Mothers: It is not known whether the dnlg is excreted in hun1an milk. How Supplied: In 200mg capsules, bottles of 30, and as a strawbeny bubblegun1 flavored oral suspension in strengths of 100 n1g/5 n1L and 200 n1g/5 n11. Storage: Store the capsules, dry n1ixture for suspension, and reconstituted suspension at controlled room ten1perature and keep tightly closed. Discard any unused suspension after 14 days. For More InfortIlation: (317) 276-3714.
Enoxacin: Ne\N Quinolone Enoxacin (PenetrexRhone-Poulenc Rorer) is a new broad-spectrum quinolone indicated for treating complicated and December 1992/ 940
Vol. NS32, No. 12
uncomplicated urinary tract infections CUTIs) and uncon1plicated urethral or cervical gonorrhea. Adverse Effects: The n10st common side effects reported in clinical trials were nausea and vomiting. Contraindications: Hypersensitivity to any quinolones. Dosage: For gonorrhea, 400 mg should be administered as a single dose. For uncon1plicated UTIs the dosage is 200 mg every 12 hours for 7 days. For complicated UTIs the dosage is 400 mg every 12 hours for 14 days. Dosage should be adjusted for patients with renal impairment according to instnlCtions in the package insert.
Children: Safety and efficacy have not been established in children under age 18. Enoxacin causes arthropathy in juvenile anin1als. Pregnancy: Category C. Adequate studies have not been conducted in pregnant women. Nursing Mothers: It is not known whether the dnlg is excreted in human milk. However, other quinolones are excreted in Vol. NS3 2, No. 12 December 1992/ 941
human milk and enoxacin is excreted in the milk of lactating rats. How Supplied: In 200mg and 400-mg tablets, bottles of 50. Storage: Store at controlled room temperature. For More Infortllation: (215) 454-8110.
400 mg daily. Dosages above 200 mg per day should be given in two divided doses. Treatment should be continued for a minimum of three months. Itraconazole should be taken with food to ensure n1aximal absorption.
Itraconazole: Antifungal Agent Itraconazole (SporanoxJanssen Pharmaceutic a) is a new systemic antifungal agent for treating the pulmonary infections histoplasmosis and blastomycosis. About 3,000 to 5,000 cases of these diseases occur annually in the United States, many in HIV-positive individuals. Adverse Effects: In clinical trials the most common side effects were nausea, von1iting, rash, headache, edema, and hypertension. Itraconazole should not be coadministered with terfenadine because of the risk of serious cardiovascular events, including ventricular tachycardia, torsades de pointes, and death. Contraindications: Hypersensitivity to the drug or its excipients. Dosage: The recomn1ended dosage is 200 mg once daily. If there is no obvious improvement or there is evidence of progressive fungal disease, the dosage should be increased in 100-mg increments to a maximum of
Children: Safety and efficacy have not been established in children. However, a small number of patients from age three to 16 with systemic fungal infections have been treated with 100 mg per day and no serious adverse effects have been reported. Pregnancy: Category C. Adequate studies have not been conducted in pregnant women. Nursing Mothers: Itraconazole is excreted in human milk and should not be administered to nursing women. How Supplied: In 100mg capsules, bottles of 100 and 250, and unit-dose packages of 30. Storage: Store at controlled room temperature. Protect from light and moisture. For More Infortllation: (800) 253-3682.
Prescription Drug Notes Estrace estradiol tablets (Mead Johnson) have been approved by the Food and Dnlg Administration for preventing postmenopausal osteoporosis. The product has been marketed since 1976 for treating symptoms of menopause such as hot flashes, night sweats, vaginal dryness, and vaginal atrophy. The oral tablets are available in two dosages: 1 mg and 2 mg of 178 estradiol. For more information: (609) 897-2710.
Lorcet 10/650 (Forest Laboratories), a new narcotic analgesic tablet, provides 10 mg of hydrocodone and 650 mg of acetaminophen. Other hydrocodone/acetaminophen combination products on the market contain a maximum of 7.5 mg of
AMERICAN PHARMACY
PHARMACY NEWS
NEW
I)
R II (; S &
I)
E V I (; ES
Continued from page 9
hydrocodone. For more information: (800) 947-5227. Coagulation Factor IX (Human), Mononine
(Armour Pharmaceutical) has been granted orphan status for treating Factor IX deficiency, also known as hemophilia B or Christmas disease. It is supplied in single-dose vials of 250 IU, 500 ill, and 1,000 IU. For more information: (215) 454-8110. Urocit-K (Mission Pharmacal), a formulation of potassium citrate for treating kidney stones, is now available in a double-strength tablet of 1,080 mg. Patients need to take only 4-8 of the tablets each day, as compared with 8-12 of the 540mg strength. The lower-dose tablets will continue to be available. For more information: (800) 531-3333. Cardizem CD by Marion Merrell Dow (diltiazem HCl) is now available in 120-mg capsules for treating hypertension. The product also continues to be available in 180-mg, 240-mg, and 300-mg capsules. For more information: (800) 633-1610. Videx (didanosine, or ddI) by Bristol Myers Squibb has been approved by the Food and Drug Administration for a new indication: treating adult patients with advanced HIV infection who have received prolonged zidovudine (AZD therapy. The original labeling limited the drug's use to adult and pediatric patients with AMERICAN PHARMACY
advanced HIV infection who could not tolerate AZT therapy or had demonstrated significant clinical or immunological deterioration during AZT therapy. For more information: (800) 321-1335.
Nevv OTC Products Tavist-D and Tavist-l, approved by the Food and Drug Administration in August for a switch from prescription to nonprescription status, are now available for self-medication. Both products contain the antihistamine clemastine fumarate ; Tavist-D also contains the decongestant phenylpropanolamine. Tavist-1 and Tavist-D are sold in packages of eight and 16 tablets. Manufacturer: Sandoz Consumer Pharmaceuticals, (800) 4535330. Clear Choice is a new alcohol-free mouthwash that contains domiphen bromide, poloxamer, and cetylpyridinium chloride. Manufacturer: Bausch & Lomb, (800) 553-5340.
Clear, a new cleansing rinse for application after a pediculicide, helps loosen louse nits so they can be combed more easily from the hair. The active ingredient is a natural enzyme complex derived from vegetable materials. Manufacturer: Care Technologies, (800) 783-1919. Extra Strength Tylenol Headache Plus, for relief from stress headaches and accompanying upset stomach, contains a combination of acetaminophen (500 mg) and calcium carbonate (250 mg) in one caplet. Manufacturer: McNeil Consumer Products Company, (215) 233-7730.
Nevv Devices Precise Pregnancy Test, a one-step pregnancy test, can be used day or night and gives results in one minute. After the user puts five drops of urine into the test kit, a blue check mark appears if the test is positive. No check mark means the test is negative. A single blue dash appears as a control in either case to assure the user that the test is working properly. A triangular window turns red to indicate when the test is ready to be read. Manufacturer: Becton Dickinson, (800) 382-4051. E-Z Quit, a device to help smokers break their habit, is a smokeless plastic "cigarette" that comes with a supply of cigarette holders and replaceable menthol flavor cartridges. It may be used
alone or in conjlIDction with transdermal nicotine patches. Manufacturer: E-Z Quit, Inc. , (800) 724-4723.
Approvals Recommended by FDA Panels Following are drug approvals recently recommended by Food and Drug Administration (FDA) advisory panels. Although recommendation by an FDA panel does not guarantee that a product will be approved, it suggests a strong likelihood of approval within the coming months. Paroxetine (PaxilSmithKline Beecham), a serotonin reuptake inhibitor, has been recommended for approval to treat depression by the Psychopharmacologic Drugs AdviSOry Committee. The dnlg is already marketed in several countries, including the United Kingdom, Ireland, Sweden, the Netherlands, and Germany. Rifabutin (MycobutinAdria Laboratories) has been recommended for approval by the Antiviral Drugs Advisory Committee for preventing disseminated mycobacterium avium complex (MAC) in people with AIDS or advanced HIV infection. If approved by FDA, rifabutin would be the first drug available for prophylaxis against MAC. It is now available under an expanded access program (Treatment IND) for AIDS patients whose CD4 counts are 200 or less.
Decembe r 1992/ 944
Vol. NS32, No. 12
Vol. NS32, No. 12 December 1992/ 939
Health Resources The Pain Relief Video and the newsletter the Pain Relief Papers offer helpful information and guidance about how cancer patients and their families can best cope with physical discomfort. The 1O-minute video and the newsletter, available from] anssen Pharmaceutica, are free to patients and families who call (800) 352-9593. Smoking or Health? It's Your Choice is a 26-page booklet on the adverse effects of smoking on the human body. It covers not only lung cancer and respiratory ailments, but also nlale and female infertility, hearing loss, male impotence, skin wrinkling, peptic ulcer, and other disorders. It is available for $3.85 from the American Council in Science and Health, (212) 362-7044. HIV Negative-lVben Are You Free From HIV? and Positive Living are two new booklets from the American Social Health Association (ASHA) that provide information about HIV. The first discusses what a negative result on the HIV test can mean and how to reduce the risk of future HIV infection. The second discusses, in a positive way, what it means to be infected with HIV, including life decisions and protecting others. ASHA also offers a wide array of educational brochures on other sexually transmitted diseases. For information or a catalog, call (919) 361-8425. Skin Cancer: If You Can
Spot It, You Can Stop It is a new brochure from the Skin Cancer Foundation that explains the warning signs of skin cancer and provides step-by-step instructions for performing skin self-examinations. For a free copy, send a stamped, selfaddressed, business-size envelope to The Skin Cancer Foundation, Dept. SE, Box 561, New York, NY 10156. New treatment guidelines for pregnant women with asthma are now available from the National Heart, Lung, and Blood Institute. While noting that it is desirable to use as few medications as possible during pregnancy, the report emphasizes that the risk of uncontrolled asthma is far greater than risks to the mother or fetus from asthma medications. It recommends preferred medications and selection criteria. Copies may be ordered from the NAEP Information Center, P.O. Box 30105, Bethesda, MD 20814-0105.
Consistency and Quality in Pressure Sore Treatment: A Long Term Care Guide is an in-service training kit and videotape available free from Fujisawa Pharl11aceutical Co., (800) 766-4321.
Health Dates JANUARY National Eye Health Care Month. The Ophthalmic Press and Television Information Center Foundation, Inc. , 5005 Central Ave., St. Petersburg, FL 33710. (813) 323-4999. 26--31, National Glaucoma Awareness Week. National Society to Prevent Blindness, 500 East Remington Rd., Schaumburg, IL 60173. (800) 221-3004 or (708) 843-2020.
FEBRUARY American Heart Month. American Heart Association, 7320 Greenville Ave., Dallas, TX 75231. (800) AHA-USA1.
NEW DRUGS & DEVICES
Cefpodoxime: Nevv Antibiotic Cefpodoxime proxetil (Vantin- The Upjohn Company) is a new broad-spectrum cephalosporin antibiotic for treating mild to moderate infections in adults and children. It is indicated for acute communityacquired pneumonia,
II
pharyngitis, tonsillitis, lmcomplicated skin and skinstructure infections, uncomplicated urinary tract infections, acute uncomplicated urethral and cervical gonorrhea, and acute otitis media. Adverse Effects: Side effects are similar to those for other oral cephalosporins. The l110St common are AMERICAN PHARMACY
PHARMACY NEWS
NEW DRUG & DEVICES
0
Continued.!i-om preuiollspage
diarrhea, nausea, abdolninal pain, and vomiting. Rashes and abnormalities in liverfunction tests have also been observed. The dnlg should be administered with caution to penicillin-sensitive patients because cross-sensitivity may occur in up to 10% of patients with a history of penicillin allergy.
Contraindications: Hypersensitivity to any cephalosporins. Dosage: For most indications the dnlg is taken twice daily. The recommended dosages vary according to the patient's age and site of infection; refer to package insert for complete information. The drug should be administered with food to enhance absorption. The Elderly: Dosage adjustment in elderly patients with nonnal renal function is not necessary. Children: Safety and efficacy in infants younger than six months old have not AMERICANPHARMACY
been established. Pregnancy: CategolY B. Adequate studies have not been conducted in pregnant women. However, studies in anunals have revealed no evidence of harm to the elnbryo or fetus. Nursing Mothers: The dnlg is excreted U1 human milk. Women should either discontinue nursing or discontinue the dnlg. How Supplied: In 100mg and 200-mg tablets, bottles of 20 and 100, and unitdose packages of 100. The product is also available as lemon-flavored granules for reconstitution into an oral suspension in these strengths: 50 mg/5 mL and 100 mg/5 m1. Storage: Tablets and unsuspended granules should be stored tightly closed at roon1 temperature. The suspension should be refrigerated at 2° -8°C (36° -48°F); the unused portion should be discarded after 14 days. For More InfortIlation: (616) 323-4000.
Loracarbef: Ne\N BetaLactam Loracarbef (Lorabid- Eli Lilly), a new broad-spectrum antibiotic, is the first in a new carbacephem class of synthetic oral beta-Iactams. It is approved by the Food and Dnlg Administration for treating patients with mild to moderate infections of the upper- and lower-respiratory tract, including pneumonia,
secondalY infection in acute bronchitis and acute infection in chronic bronchitis, acute otitis media, acute n1axillary sinusitis, pharyngitis, and tonsillitis. It is also u1dicated for treating uncomplicated skin and skin-stnlCture infections, uncOlnplicated urinalY tract infections, and uncolnplicated pyelonephritis caused by Escherichia coli. Adverse Effects: Side effects reported in clinical trials were silnilar to those for other beta-Iactatns and were mostly mild and transient. Gastrointestu1al problems, hypersensitivity reactions, and headache were the tnost common reactions. The drug should be adn1inistered with caution to penicillu1-sensitive patients because cross-sensitivity Inay occur in up to 10% of patients with a history of penicillu1 allergy. Contraindications: Hypersensitivity to any cephalosporins. Dosage: For n10st indications the dnlg is taken twice daily. The recon1n1ended dosages vary according to the patient's age and site of infection; refer to package insert for complete information. The dnlg should be administered at least one hour before eating or two hours after eating. The Elderly: Dosage adjustment in elderly patients with normal renal function is not necessalY. Children: Safety and efficacy in infants younger than six months old have not been established.
Pregnancy: Category B. Adequate studies have not been conducted in pregnant won1en. However, studies in anin1als have revealed no evidence of ilnpaired fertility or harm to the fetus. Nursing Mothers: It is not known whether the dnlg is excreted in hun1an milk. How Supplied: In 200mg capsules, bottles of 30, and as a strawbeny bubblegun1 flavored oral suspension in strengths of 100 n1g/5 n1L and 200 n1g/5 n11. Storage: Store the capsules, dry n1ixture for suspension, and reconstituted suspension at controlled room ten1perature and keep tightly closed. Discard any unused suspension after 14 days. For More InfortIlation: (317) 276-3714.
Enoxacin: Ne\N Quinolone Enoxacin (PenetrexRhone-Poulenc Rorer) is a new broad-spectrum quinolone indicated for treating complicated and December 1992/ 940
Vol. NS32, No. 12
uncomplicated urinary tract infections CUTIs) and uncon1plicated urethral or cervical gonorrhea. Adverse Effects: The n10st common side effects reported in clinical trials were nausea and vomiting. Contraindications: Hypersensitivity to any quinolones. Dosage: For gonorrhea, 400 mg should be administered as a single dose. For uncon1plicated UTIs the dosage is 200 mg every 12 hours for 7 days. For complicated UTIs the dosage is 400 mg every 12 hours for 14 days. Dosage should be adjusted for patients with renal impairment according to instnlCtions in the package insert.
Children: Safety and efficacy have not been established in children under age 18. Enoxacin causes arthropathy in juvenile anin1als. Pregnancy: Category C. Adequate studies have not been conducted in pregnant women. Nursing Mothers: It is not known whether the dnlg is excreted in human milk. However, other quinolones are excreted in Vol. NS3 2, No. 12 December 1992/ 941
human milk and enoxacin is excreted in the milk of lactating rats. How Supplied: In 200mg and 400-mg tablets, bottles of 50. Storage: Store at controlled room temperature. For More Infortllation: (215) 454-8110.
400 mg daily. Dosages above 200 mg per day should be given in two divided doses. Treatment should be continued for a minimum of three months. Itraconazole should be taken with food to ensure n1aximal absorption.
Itraconazole: Antifungal Agent Itraconazole (SporanoxJanssen Pharmaceutic a) is a new systemic antifungal agent for treating the pulmonary infections histoplasmosis and blastomycosis. About 3,000 to 5,000 cases of these diseases occur annually in the United States, many in HIV-positive individuals. Adverse Effects: In clinical trials the most common side effects were nausea, von1iting, rash, headache, edema, and hypertension. Itraconazole should not be coadministered with terfenadine because of the risk of serious cardiovascular events, including ventricular tachycardia, torsades de pointes, and death. Contraindications: Hypersensitivity to the drug or its excipients. Dosage: The recomn1ended dosage is 200 mg once daily. If there is no obvious improvement or there is evidence of progressive fungal disease, the dosage should be increased in 100-mg increments to a maximum of
Children: Safety and efficacy have not been established in children. However, a small number of patients from age three to 16 with systemic fungal infections have been treated with 100 mg per day and no serious adverse effects have been reported. Pregnancy: Category C. Adequate studies have not been conducted in pregnant women. Nursing Mothers: Itraconazole is excreted in human milk and should not be administered to nursing women. How Supplied: In 100mg capsules, bottles of 100 and 250, and unit-dose packages of 30. Storage: Store at controlled room temperature. Protect from light and moisture. For More Infortllation: (800) 253-3682.
Prescription Drug Notes Estrace estradiol tablets (Mead Johnson) have been approved by the Food and Dnlg Administration for preventing postmenopausal osteoporosis. The product has been marketed since 1976 for treating symptoms of menopause such as hot flashes, night sweats, vaginal dryness, and vaginal atrophy. The oral tablets are available in two dosages: 1 mg and 2 mg of 178 estradiol. For more information: (609) 897-2710.
Lorcet 10/650 (Forest Laboratories), a new narcotic analgesic tablet, provides 10 mg of hydrocodone and 650 mg of acetaminophen. Other hydrocodone/acetaminophen combination products on the market contain a maximum of 7.5 mg of
AMERICAN PHARMACY
PHARMACY NEWS
NEW
I)
R II (; S &
I)
E V I (; ES
Continued from page 9
hydrocodone. For more information: (800) 947-5227. Coagulation Factor IX (Human), Mononine
(Armour Pharmaceutical) has been granted orphan status for treating Factor IX deficiency, also known as hemophilia B or Christmas disease. It is supplied in single-dose vials of 250 IU, 500 ill, and 1,000 IU. For more information: (215) 454-8110. Urocit-K (Mission Pharmacal), a formulation of potassium citrate for treating kidney stones, is now available in a double-strength tablet of 1,080 mg. Patients need to take only 4-8 of the tablets each day, as compared with 8-12 of the 540mg strength. The lower-dose tablets will continue to be available. For more information: (800) 531-3333. Cardizem CD by Marion Merrell Dow (diltiazem HCl) is now available in 120-mg capsules for treating hypertension. The product also continues to be available in 180-mg, 240-mg, and 300-mg capsules. For more information: (800) 633-1610. Videx (didanosine, or ddI) by Bristol Myers Squibb has been approved by the Food and Drug Administration for a new indication: treating adult patients with advanced HIV infection who have received prolonged zidovudine (AZD therapy. The original labeling limited the drug's use to adult and pediatric patients with AMERICAN PHARMACY
advanced HIV infection who could not tolerate AZT therapy or had demonstrated significant clinical or immunological deterioration during AZT therapy. For more information: (800) 321-1335.
Nevv OTC Products Tavist-D and Tavist-l, approved by the Food and Drug Administration in August for a switch from prescription to nonprescription status, are now available for self-medication. Both products contain the antihistamine clemastine fumarate ; Tavist-D also contains the decongestant phenylpropanolamine. Tavist-1 and Tavist-D are sold in packages of eight and 16 tablets. Manufacturer: Sandoz Consumer Pharmaceuticals, (800) 4535330. Clear Choice is a new alcohol-free mouthwash that contains domiphen bromide, poloxamer, and cetylpyridinium chloride. Manufacturer: Bausch & Lomb, (800) 553-5340.
Clear, a new cleansing rinse for application after a pediculicide, helps loosen louse nits so they can be combed more easily from the hair. The active ingredient is a natural enzyme complex derived from vegetable materials. Manufacturer: Care Technologies, (800) 783-1919. Extra Strength Tylenol Headache Plus, for relief from stress headaches and accompanying upset stomach, contains a combination of acetaminophen (500 mg) and calcium carbonate (250 mg) in one caplet. Manufacturer: McNeil Consumer Products Company, (215) 233-7730.
Nevv Devices Precise Pregnancy Test, a one-step pregnancy test, can be used day or night and gives results in one minute. After the user puts five drops of urine into the test kit, a blue check mark appears if the test is positive. No check mark means the test is negative. A single blue dash appears as a control in either case to assure the user that the test is working properly. A triangular window turns red to indicate when the test is ready to be read. Manufacturer: Becton Dickinson, (800) 382-4051. E-Z Quit, a device to help smokers break their habit, is a smokeless plastic "cigarette" that comes with a supply of cigarette holders and replaceable menthol flavor cartridges. It may be used
alone or in conjlIDction with transdermal nicotine patches. Manufacturer: E-Z Quit, Inc. , (800) 724-4723.
Approvals Recommended by FDA Panels Following are drug approvals recently recommended by Food and Drug Administration (FDA) advisory panels. Although recommendation by an FDA panel does not guarantee that a product will be approved, it suggests a strong likelihood of approval within the coming months. Paroxetine (PaxilSmithKline Beecham), a serotonin reuptake inhibitor, has been recommended for approval to treat depression by the Psychopharmacologic Drugs AdviSOry Committee. The dnlg is already marketed in several countries, including the United Kingdom, Ireland, Sweden, the Netherlands, and Germany. Rifabutin (MycobutinAdria Laboratories) has been recommended for approval by the Antiviral Drugs Advisory Committee for preventing disseminated mycobacterium avium complex (MAC) in people with AIDS or advanced HIV infection. If approved by FDA, rifabutin would be the first drug available for prophylaxis against MAC. It is now available under an expanded access program (Treatment IND) for AIDS patients whose CD4 counts are 200 or less.
Decembe r 1992/ 944
Vol. NS32, No. 12