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glenmark pharmaceuticals inc., usa - atomoxetine hydrochloride (unii: 57wvb6i2w0) (atomoxetine - unii:asw034s0b8) - atomoxetine 10 mg - pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including atomoxetine, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ . risk summary available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. some animal reproduction studies of atomoxetine had adverse developmental outcomes. one of 3 studies in pregnant rabbits dosed during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery. these effects were observed at plasma levels (auc) 3 times and 0.4 times the human plasma levels in e

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glenmark pharmaceuticals inc., usa - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)]. twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypic

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kvk-tech, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate 17.5 g in 22.7 g - colprep kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with colprep kit. it is also not known whether colprep kit can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. colprep kit should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when colprep kit is administered to a nursing woman. the safety and effectiveness of colprep kit have not been established in pediatric patients. of the 375 patients who received another oral formulation of sodium sulfate (17.5 g), potassium sulfate (3.13 g), and magnesium sulfate (1.6 g)

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aidarex pharmaceuticals llc - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 15 mg - phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. the limited usefulness of agents of this class (see clinical pharmacology ) should be measured against possible risk factors inherent in their use such as those described below. advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. agitated

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torrent pharmaceuticals limited - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - valsartan 40 mg - valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal 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 valsartan principally belongs. there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. 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,

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hikma pharmacuticals usa usa inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65) - clotrimazole 10 mg - clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. the diagnosis should be confirmed by a koh smear and/or culture prior to treatment. clotrimazole is also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. there are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (see dosage and administration.) clotrimazole is contraindicated in patients who are hypersensitive to any of its components. no data available.

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allergan, inc. - triptorelin pamoate (unii: 08an7wa2g0) (triptorelin - unii:9081y98w2v) - triptorelin 3.75 mg in 2 ml - trelstar is indicated for the palliative treatment of advanced prostate cancer [see  clinical studies (14) ]. trelstar is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other gnrh agonists or gnrh [see warnings and precautions (5.1) ]. risk summary based on findings in animal studies and mechanism of action, trelstar can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ] . expected hormonal changes that occur with trelstar treatment increase the risk for pregnancy loss. in animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. advise pregnant patients and females of reproductive potential of the potential risk to the fetus. dat

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janssen pharmaceuticals, 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 0.3%. however, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. table 1 lists the pregnancy rates for users of all major methods of contraception. ortho micronor® 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 - it's best to take your first pop on the first day of your menstrual period (day 1 start). if you use a day 1 start, you are protected from becoming pregnant as soon as you take your first pill. - if you decide to tak

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

bluepoint laboratories - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 38 mg in 1 ml -       gemcitabine for injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.       gemcitabine for injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.       gemcitabine for injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib), or metastatic (stage iv) non-small cell lung cancer.       gemcitabine for injection is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine for injection is indicated for patients previously treated with 5-fu. gemcitabine for injection is

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

validus pharmaceuticals llc - calcitriol (unii: fxc9231jvh) (calcitriol - unii:fxc9231jvh) - calcitriol 0.25 ug - predialysis patients rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (ccr 15 to 55 ml/min) not yet on dialysis. in children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. a serum ipth level of ≥ 100 pg/ml is strongly suggestive of secondary hyperparathyroidism. dialysis patients rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. in these patients, rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. hypoparathyroidism patients rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. rocaltrol should not be given to patients with hypercalcemia or evidence of vitamin d toxicity. use of rocaltrol in patients with known hypersensitivity to rocaltrol (or drugs of the same class) or any of the inactive ingredients is contraindicated.