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New Drugs & Devices
NEW DRUGS & DEVICES
Doxazosin for Treating Hypertension Doxazosin mesylate (Cardura Pfizer) is a new once-daily cardioselective alpha blocker. It has been rated 1-C by the Food and Drug Administration, which means it is a new chemical entity with little or no therapeutic gain over already existing medications. Indicated for treating hypertension, the drug may be used alone or in combination with diuretics or beta-adrenergic blocking agents. However, limited studies have been done with doxazosin mesylate in combination with ACE inhibitors or calcium channel blockers. The drug is contraindicated in patients with a known sensitivity to
The initial dosage is 1 mg once daily in order to minimize the frequency of postural hypotension and first-dose syncope. Dosage should then be adjusted slowly, with increase in dose every two weeks. Because postural effects are most likely to occur between two and six hours after a dose, blood pressure should be measured during this period after the first dose and after each increase in dose. Depending on the patient's standing blood-pressure response, dosage may be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg, and 16 mg. However, increases in dose beyond 4 mg increase the likelihood of excessive postural effects including syncope, dizziness, vertigo, and hypotension. Doxazosin mesylate is administered orally and is available in tablets of 1 mg (white) 2 mg (yellow) 4 mg (orange) and 8 mg (green). The product is provided in bottles of 100.
Lung Surfactant Approved for Premature Infants
quinazolines. The most common side effects reported in clinical trials were dizziness, somnolence, and fatigue. Doxazosin has not been found to adversely affect total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides. In clinical trials involving 300 predominantly normocholesterolemic patients, the drug reduced total serum cholesterol by 2%-3% and LDL by 4% while increasing high-density lipoprotein to total cholesterol ratio by 4%. "The clinical significance of these findings and the impact on coronary heart disease is uncertain," according to the manufacturer. 12
Colfosceril palmitate (Exosurf Neonatal - Burroughs Wellcome), a protein-free synthetic lung surfactant, has been approved for treating respiratory distress syndrome (RDS) in premature infants. It may be used immediately after birth in high-risk infants under 3 lbs and also to treat infants who have developed RDS. The product first became available in 1989 as an investigational drug. The drug is administered directly into the trachea. For prophylactic treatment, 5mUkg should be given as soon as possible after birth. Infants who remain on mechanical ventilation should receive second and third doses approximately 12 and 24 hours later. For rescue treatment, the first dose of 5 mUkg should be given as soon as the diagnosis of RDS is confirmed. A
second dose should be given approximately 12 hours after the first if the infant remains on mechanical ventilation. The drug is supplied as one 10-mL vial with one 10-mL vial of sterile water for injection and five endotracheal tube adapters.
Misoprostal Now in 100-mcg Dose Misoprostal (Cytotec - Searle) is now available in a 100-mcg dose. It was previously available only in 200mcg tablets. According to the manufacturer, the new lower dose reduces the incidence of diarrhea but remains effective in protecting against NSAID-induced gastric ulcer. The new dosage is available free under the Searle Patients in Need program to indigent patients who do not receive Medicaid or other third party assistance. It is also covered under the Searle Patient Promise program, which refunds to patients the amount paid for the most recent prescription of a Searle drug that does not achieve its desired therapeutic benefit. '
Leuprolide Approved for Endometriosis The antineoplastic drug leuprolide acetate (Lupron Depot - TAP Pharmaceuticals) has been approved for treating endometriosis. The drug, previously approved for the palliative treatment of advanced prostate cancer, is a synthetic analog of gonadotropin releasing hormone (GnRH). When taken for six months, the drug causes a sustained decrease in estrogen production and produces a reversible menopause that allows endometrial growths to shrink. The drug is administered as a once-monthly injection of 3.75 mg.
American Pharmacy, Vol. NS31, No.1 January 1991/12
Doxazosin for Treating Hypertension Doxazosin mesylate (Cardura Pfizer) is a new once-daily cardioselective alpha blocker. It has been rated 1-C by the Food and Drug Administration, which means it is a new chemical entity with little or no therapeutic gain over already existing medications. Indicated for treating hypertension, the drug may be used alone or in combination with diuretics or beta-adrenergic blocking agents. However, limited studies have been done with doxazosin mesylate in combination with ACE inhibitors or calcium channel blockers. The drug is contraindicated in patients with a known sensitivity to
The initial dosage is 1 mg once daily in order to minimize the frequency of postural hypotension and first-dose syncope. Dosage should then be adjusted slowly, with increase in dose every two weeks. Because postural effects are most likely to occur between two and six hours after a dose, blood pressure should be measured during this period after the first dose and after each increase in dose. Depending on the patient's standing blood-pressure response, dosage may be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg, and 16 mg. However, increases in dose beyond 4 mg increase the likelihood of excessive postural effects including syncope, dizziness, vertigo, and hypotension. Doxazosin mesylate is administered orally and is available in tablets of 1 mg (white) 2 mg (yellow) 4 mg (orange) and 8 mg (green). The product is provided in bottles of 100.
Lung Surfactant Approved for Premature Infants
quinazolines. The most common side effects reported in clinical trials were dizziness, somnolence, and fatigue. Doxazosin has not been found to adversely affect total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides. In clinical trials involving 300 predominantly normocholesterolemic patients, the drug reduced total serum cholesterol by 2%-3% and LDL by 4% while increasing high-density lipoprotein to total cholesterol ratio by 4%. "The clinical significance of these findings and the impact on coronary heart disease is uncertain," according to the manufacturer. 12
Colfosceril palmitate (Exosurf Neonatal - Burroughs Wellcome), a protein-free synthetic lung surfactant, has been approved for treating respiratory distress syndrome (RDS) in premature infants. It may be used immediately after birth in high-risk infants under 3 lbs and also to treat infants who have developed RDS. The product first became available in 1989 as an investigational drug. The drug is administered directly into the trachea. For prophylactic treatment, 5mUkg should be given as soon as possible after birth. Infants who remain on mechanical ventilation should receive second and third doses approximately 12 and 24 hours later. For rescue treatment, the first dose of 5 mUkg should be given as soon as the diagnosis of RDS is confirmed. A
second dose should be given approximately 12 hours after the first if the infant remains on mechanical ventilation. The drug is supplied as one 10-mL vial with one 10-mL vial of sterile water for injection and five endotracheal tube adapters.
Misoprostal Now in 100-mcg Dose Misoprostal (Cytotec - Searle) is now available in a 100-mcg dose. It was previously available only in 200mcg tablets. According to the manufacturer, the new lower dose reduces the incidence of diarrhea but remains effective in protecting against NSAID-induced gastric ulcer. The new dosage is available free under the Searle Patients in Need program to indigent patients who do not receive Medicaid or other third party assistance. It is also covered under the Searle Patient Promise program, which refunds to patients the amount paid for the most recent prescription of a Searle drug that does not achieve its desired therapeutic benefit. '
Leuprolide Approved for Endometriosis The antineoplastic drug leuprolide acetate (Lupron Depot - TAP Pharmaceuticals) has been approved for treating endometriosis. The drug, previously approved for the palliative treatment of advanced prostate cancer, is a synthetic analog of gonadotropin releasing hormone (GnRH). When taken for six months, the drug causes a sustained decrease in estrogen production and produces a reversible menopause that allows endometrial growths to shrink. The drug is administered as a once-monthly injection of 3.75 mg.
American Pharmacy, Vol. NS31, No.1 January 1991/12