Spojené státy - angličtina - NLM (National Library of Medicine)

dr.reddys laboratories inc - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1) ]. triple therapy: lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori . eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2) ]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole delayed-release orally disintegrating tablets/amoxicillin  lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual thera

Spojené státy - angličtina - NLM (National Library of Medicine)

dr.reddy's laboratories inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine tablets are indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to18 years [see clinical studies (14.1) ].   the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see dosage and administration (2.1) ].   fluoxetine tablets are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (ocd) [see clinical studies (14.2) ].   the effectiveness of fluoxetine tablets in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to use fluoxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see dosage and administration (2.2) ]. fluoxetine tablets are indicate

Spojené státy - angličtina - NLM (National Library of Medicine)

dr.reddys laboratories inc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride extended-release tablets  are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see clinical studies (14)] .   a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; lo

Spojené státy - angličtina - NLM (National Library of Medicine)

dr reddys laboratories inc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies (14.1)]. bupropion hydrochloride extended-release tablets (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets (xl) in the prevention of seasonal major depressive episodes was established in 3 plac

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddys laboratories inc - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for:   • monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)] .   • adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)].   • known  hypersensitivity  to  lurasidone  hcl  or  any  components  in  the  formulation. angioedema has been observed with lurasidone [see adverse reactions ( 6.1)] . • strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions ( 7.1)]. • strong cyp3a4 inducers (e.g., rifampin, avasimibe, st.  john’s wort, phenytoin, carbamazepine, etc.) [see drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddys laboratories inc - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: • treatment of adult and adolescent patients (13 to 17 years) patients with schizophrenia [see clinical studies ( 14.1)] . • monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)]. • adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)]. • known hypersensitivity to lurasidone hcl or any components in the formulation.  angioedema has been observed with lurasidone [see adverse reactions ( 6.1)] . • strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions ( 7.1)]. • stron

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddy’s laboratories inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated f

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddy’s laboratories inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets (sr) is indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies ( 14)] . the efficacy of bupropion hydrochloride extended-release tablets (sr) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies ( 14)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patien

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddy's laboratories inc - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg - adults esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age.  esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of ee in adults. controlled studies do not extend beyond 6 months. adults esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsul

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddy's laboratories inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine tablets are indicated for the treatment of:   - major depressive disorder (mdd). the efficacy of fluoxetine in mdd was established in one 5 week trial, three 6 week trials, and one maintenance study in adults. the efficacy of fluoxetine was also established in two 8 to 9 week trials in pediatric patients 8 to 18 years of age [see clinical studies (14.1)].   - obsessions and compulsions in patients with obsessive compulsive disorder (ocd). the efficacy of fluoxetine in ocd was demonstrated in two 13 week trials in adults and one 13 week trial in pediatric patients 7 to 17 years of age [see clinical studies (14.2)].   - binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. the efficacy of fluoxetine in bulimia nervosa was demonstrated in two 8 week trials and one 16 week trial in adults [see clinical studies (14.3)].   - panic disorder, with or without agoraphobia. the efficacy of fluoxetine in panic disorder was demonstrated in two 12 week trials in adults [see