ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - tranylcypromine sulfate (unii: 7zat6es870) (tranylcypromine - unii:3e3v44j4z9) - tranylcypromine sulfate is indicated for the treatment of major depressive disorder (mdd) in adult patients who have not responded adequately to other antidepressants. tranylcypromine sulfate is not indicated for the initial treatment of mdd due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see contraindications (4), warnings and precautions (5), and drug interactions (7)] . concomitant use of tranylcypromine sulfate or use in rapid succession with the products in table 1 is contraindicated. such use may cause severe or life-threatening reactions such as hypertensive crises or serotonin syndrome [see drug interactions (7.1)]. medication-free periods between administration of tranylcypromine sulfate and contraindicated agents are recommended [see dosage and administration (2.2) and drug interactions (7.1)]. - other monoamine oxidase inhibitors (maois) - selective serotonin reuptake inhibitors (ssris) and serotonin and norepinephrine reuptake inhi

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - imipramine hydrochloride (unii: bke5q1j60u) (imipramine - unii:ogg85sx4e4) - depression: for the relief of symptoms of depression. endogenous depression is more likely to be alleviated than other depressive states. one to three weeks of treatment may be needed before optimal therapeutic effects are evident. childhood enuresis: may be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. in patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. the effectiveness of treatment may decrease with continued drug administration. the concomitant use of monoamine oxidase inhibiting compounds is contraindicated. hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. the potentiation of adverse effects can be serious, or even fatal. when it is desired to substitute imipramine hydrochloride in patients receiving a monoamine oxidase inhibitor, as long an

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone gel 1% in men with "age-

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. the clinical trials performed in support of efficacy were up to 3 months in duration. doxepin tablets are contraindicated in individuals who have shown hypersensitivity to doxepin hcl, any of its inactive ingredients, or other dibenzoxepines. serious side effects and even death have been reported following the concomitant use of certain drugs with mao inhibitors. do not administer doxepin if patient is currently on maois or has used maois within the past two weeks. the exact length of time may vary depending on the particular maoi dosage and duration of treatment. doxepin tablets are contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention. risk summary available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see data) . there are risks of poor neonatal adaptation

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir 300 - abacavir tablets in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir tablets are contraindicated in patients: - who have the hla-b*5701 allele [see warnings and precautions (5.1)]. - with prior hypersensitivity reaction to abacavir [see warnings and precautions (5.1)]. - with moderate or severe hepatic impairment [see use in specific populations (8.6)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir tablets during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data). the apr uses the macdp as

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)] , heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil (mmf) during pregnancy is associated with

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - polyethylene glycol 3350 420 g in 4 l - polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is contraindicated in the following conditions: - gastrointestinal (gi) obstruction, ileus, or gastric retention - bowel perforation - toxic colitis or toxic megacolon - known allergy or hypersensitivity to any component of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [see how supplied/storage and handling (16)] animal reproduction studies have not been conducted with polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. it is also not known whether polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered t

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - ergocalciferol (unii: vs041h42xc) (ergocalciferol - unii:vs041h42xc) - ergocalciferol 1.25 - ergocalciferol capsules, usp are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin d resistant rickets, and familial hypophosphatemia. ergocalciferol capsules, usp are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin d, and hypervitaminosis d.

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e), triamcinolone acetonide (unii: f446c597ka) (triamcinolone acetonide - unii:f446c597ka) - nystatin and triamcinolone acetonide ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment. these preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

ABD - İngilizce - NLM (National Library of Medicine)

strides pharma science limited - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam capsules are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of cabg surgery [see warnings and precautions (5.1)] risk summary use of nsaids, including piroxicam capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of piroxic