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astrazeneca pharmaceuticals lp - omeprazole magnesium (unii: 426qfe7xlk) (omeprazole - unii:kg60484qx9) - omeprazole 10 mg - prilosec is indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy prilosec in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy prilosec in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, prilosec with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin is demonstrated or susceptibility testing is not pos

United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - candesartan cilexetil 16 mg - atacand hct is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with atacand hct. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blo

United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx) - candesartan cilexetil 4 mg - atacand is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihy

United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - ticagrelor (unii: glh0314rvc) (ticagrelor - unii:glh0314rvc) - ticagrelor 90 mg - brilinta is indicated to reduce the risk of cardiovascular (cv) death, myocardial infarction (mi), and stroke in patients with acute coronary syndrome (acs) or a history of mi. for at least the first 12 months following acs, it is superior to clopidogrel. brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of acs [see clinical studies (14.1)] . brilinta is indicated to reduce the risk of a first mi or stroke in patients with coronary artery disease (cad) at high risk for such events [see clinical studies (14.2)] . while use is not limited to this setting, the efficacy of brilinta was established in a population with type 2 diabetes mellitus (t2dm). brilinta is indicated to reduce the risk of stroke in patients with acute ischemic stroke (nih stroke scale score ≤5) or high-risk transient ischemic attack (tia) [see clinical studies (14.3)] . brilinta is contraindicated in patients with a history of intracranial hemorrhage (ich) because of a high risk of recurrent i

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mayne pharma inc. - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - desogestrel 0.15 mg - azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets usp) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. table ii: percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, united states. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year * (4) method   (1) typical use † (2) perfect use ‡   (3) chance§   85 85 spermicides¶ 26 6 40 periodi

United States - English - NLM (National Library of Medicine)

mayne pharma inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - because of its life-threatening side effects and the substantial management difficulties associated with its use (see “ warnings ” below), amiodarone is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. - recurrent ventricular fibrillation. - recurrent hemodynamically unstable ventricular tachycardia. as is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone favorably affects survival. amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysio

United States - English - NLM (National Library of Medicine)

mayne pharma inc. - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 10 mg - tamoxifen citrate tablets, usp are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. tamoxifen citrate tablets, usp are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets, usp are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen therapy is likely to b

United States - English - NLM (National Library of Medicine)

mayne pharma - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria. butalbital : barbiturates may be habit-forming : tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. the lethal dose of a barbiturate is far less if alcohol is also ingested. major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. one method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

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mayne pharma inc. - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - norethindrone 0.35 mg - progestin-only oral contraceptives are indicated for the prevention of pregnancy. if used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. however, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. table 1 lists the pregnancy rates for users of all major methods of contraception. norethindrone tablets have not been studied for and are not indicated for use in emergency contraception. progestin-only oral contraceptives (pops) should not be used by women who currently have the following conditions: - known or suspected pregnancy - known or suspected carcinoma of the breast - undiagnosed abnormal genital bleeding - hypersensitivity to any component of this product - benign or malignant liver tumors - acute liver disease

United States - English - NLM (National Library of Medicine)

mayne pharma inc. - vitamin a palmitate (unii: 1d1k0n0vvc) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - vitamin a 1500 [iu] in 1 ml - supplementation of the diet with vitamins a, c, d and fluoride 0.25 mg drops also provides fluoride for caries prophylaxis. the american academy of pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. vitamins a, c, d and fluoride 0.25 mg drops provide fluoride in drop form for infants and young children 6 months to 3 years of age, in areas where the drinking water contains children ages 2-3 years where the drinking water contains less than 0.3 ppm of fluoride and for children over 3 years, in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. each 1.0 ml provides sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron. the american academy of pediatrics recommends that infants and young children under 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and; and for children ages 3-6 years, in areas where the dri