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sun pharmaceutical industries, inc. - carbidopa (unii: mnx7r8c5vo) (carbidopa anhydrous - unii:kr87b45rgh), levodopa (unii: 46627o600j) (levodopa - unii:46627o600j) - carbidopa anhydrous 25 mg - carbidopa and levodopa extended-release tablets are indicated in the treatment of parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. nonselective monoamine oxidase (mao) inhibitors are contraindicated for use with carbidopa and levodopa extended-release tablets. these inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa extended-release tablets. carbidopa and levodopa extended-release tablets may be administered concomitantly with the manufacturer's recommended dose of an mao inhibitor with selectivity for mao type b (e.g., selegiline hcl) (see precautions, drug interactions). carbidopa and levodopa extended-release tablets are contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.

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

sun pharmaceutical industries, inc. - carbidopa (unii: mnx7r8c5vo) (carbidopa anhydrous - unii:kr87b45rgh), levodopa (unii: 46627o600j) (levodopa - unii:46627o600j) - carbidopa anhydrous 10 mg - carbidopa and levodopa tablets, usp are indicated in the treatment of parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. carbidopa allows patients treated for parkinson's disease to use much lower doses of levodopa. some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets, usp. this is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa. nonselective monoamine oxidase (mao) inhibitors are contraindicated for use with carbidopa and levodopa tablets. these inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa and levodopa tablets. carbidopa and levodo

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

sun pharmaceutical industries ltd - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. caffeine citrate injection and caffeine citrate oral solution are contraindicated in patients who have demonstrated hypersensitivity to any of its components.

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sun pharmaceutical industries, inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets, usp are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to th

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

sun pharmaceutical industries limited - esomeprazole sodium (unii: l2c9gwq43h) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg in 5 ml - esomeprazole sodium for injection is indicated for the short-term treatment of gerd with erosive esophagitis in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral esomeprazole is not possible or appropriate. esomeprazole sodium for injection is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [seeadverse reactions (6)]. risk summary there are no adequate and well-controlled studies with esomeprazole sodium for injection in pregnant women. esomeprazole is the s-isomer of omeprazole. available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at

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

sun pharmaceutical industries, inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 4 ug in 1 ml - hemophilia a: desmopressin acetate injection 4 mcg/ml is indicated for patients with hemophilia a with factor viii coagulant activity levels greater than 5%. desmopressin acetate injection will often maintain hemostasis in patients with hemophilia a during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure. desmopressin acetate injection will also stop bleeding in hemophilia a patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. in certain clinical situations, it may be justified to try desmopressin acetate injection in patients with factor viii levels between 2% to 5%; however, these patients should be carefully monitored. von willebrand’s disease (type i): desmopressin acetate injection 4 mcg/ml is indicated for patients with mild to moderate classic von willebrand’s disease (type i) with factor viii levels greater than 5%. desmopressin acetate injection will often ma

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

sun pharmaceutical industries, inc. - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate 100 mg in 1 ml - testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. primary hypogonadism (congenital or acquired)- testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. hypogonadotropic hypogonadism (congenital or acquired)- gonadotropin or lhrh deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - known hypersensitivity to the drug - males with carcinoma of the breast - males with known or suspected carcinoma of the prostate gland - women who are pregnant (see precautions, pregnancy) - patients with serious cardiac, hepatic or renal disease (see warnings) testosterone cypionate injection contains testosterone, a schedule iii controlled substance in the c

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

sun pharmaceutical industries, inc. - desmopressin acetate (unii: xb13hyu18u) (desmopressin - unii:enr1llb0fp) - desmopressin acetate 0.1 mg in 1 ml - central cranial diabetes insipidus: desmopressin nasal spray solution, usp 0.01% is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. it is ineffective for the treatment of nephrogenic diabetes insipidus.   the use of desmopressin nasal spray solution, usp 0.01% in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. this will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.   there are reports of an occasional change in response with time, usually greater than 6 months. some patients may show a decreased responsiveness, others a shortened duration of effect. there is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the p

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

sun pharmaceutical industries, inc. - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. none teratogenic effects pregnancy category c in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd. in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hydrochloride ophthalmic solution should be used during preg

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

sun pharmaceutical industries, inc. - ganirelix acetate (unii: 56u7906fqw) (ganirelix - unii:ix503l9wn0) - ganirelix acetate injection is indicated for the inhibition of premature lh surges in women undergoing controlled ovarian hyperstimulation. ganirelix acetate injection is contraindicated under the following conditions: - known hypersensitivity to ganirelix acetate or to any of its components. - known hypersensitivity to gnrh or any other gnrh analog. - known or suspected pregnancy (see precautions).