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

dr. reddy's laboratories inc - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod capsules are contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1) ] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiatio

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

dr. reddy's laboratories inc - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate tablets are indicated for: - narcolepsy - attention deficit disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability , and impulsivity. the diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and othe

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

dr.reddy’s laboratories inc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole tablets are indicated for the treatment of: additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including

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

dr. reddy’s laboratories inc., - vigabatrin (unii: gr120krt6k) (vigabatrin - unii:gr120krt6k) - vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see warnings and precautions ( 5.1 ) ]. vigabatrin for oral solution is not indicated as a first line agent for complex partial seizures. vigabatrin for oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see warnings and precautions ( 5.1 )]. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including vigabatrin, during pregnancy. encourage women who are taking vigabatrin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the

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

dr. reddy's laboratories inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 5 mg - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [ see clinical studies (14.1)].    when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks  when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see  warnings and precautions ( 5.5) ].  oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mixed episode

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

dr reddys laboratories inc - silver sulfadiazine (unii: w46jy43ejr) (sulfadiazine - unii:0n7609k889) - silver sulfadiazine 10 g in 1000 g - silver sulfadiazine cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns. silver sulfadiazine cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. because sulfonamide therapy is known to increase the possibility of kernicterus, silver sulfadiazine cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life. prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain.  the burn wounds are then cleansed and debrided; silver sulfadiazine cream is then applied u

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

dr. reddys laboratories inc - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin 0.3 mg - nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.  nitroglycerin sublingual tablets are contraindicated in patients who are allergic to it.   sublingual nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.  administration of nitroglycerin sublingual tablets are contraindicated in patients who are using a phosphodiesterase-5 (pde-5) inhibitor (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride) since these compounds have been shown to potentiate the hypotensive effects of organic nitrates. do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulator riociguat. concomitant use can cause hypotension.

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

dr. reddy's laboratories inc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole orally disintegrating tablets are indicated for the treatment of: - schizophrenia [ see clinical studies ( 14.1) ] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify ® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [ see adverse reactions ( 6.2) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-8

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

dr.reddys laboratories, inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colchicine tablets, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratoge

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

dr. reddy’s laboratories inc., - vigabatrin (unii: gr120krt6k) (vigabatrin - unii:gr120krt6k) - vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see warnings and precautions ( 5.1 ) ]. vigabatrin tablets are not indicated as a first line agent for complex partial seizures. vigabatrin tablets are indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see warnings and precautions ( 5.1 ) ]. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including vigabatrin, during pregnancy. encourage women who are taking vigabatrin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-