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dr. reddy's laboratories limited - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - moxifloxacin tablets are indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies (14.3) ]. mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes [see clinical studies (14.4) ].  moxifloxacin tablets are indicated in adult patients f

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dr. reddy's laboratories limited - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg - healing of erosive esophagitis 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 erosive esophagitis. 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.   in infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated gerd.   maintenance of healing of erosive esophagitis esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. controlled studies do not extend beyond 6 months.   symptomatic gastroesophageal reflux disease esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with ger

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dr.reddy's laboratories limited - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 5 mg - adjunctive therapy lamotrigine tablets (chewable, dispersible) are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial seizures - primary generalized tonic-clonic (pgtc) seizures - generalized seizures of lennox-gastaut syndrome  monotherapy lamotrigine tablets (chewable, dispersible)  are indicated for conversion to monotherapy in adults (≥16 years of age) 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 tablets (chewable, dispersible)   are 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 tablets (chewable, dispersible)  are indicated for the maintenance treatment of bipolar i d

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

dr.reddy's laboratories limited - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial seizures - primary generalized tonic-clonic (pgtc) seizures - generalized seizures of lennox-gastaut syndrome  monotherapy lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) 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 tablets are 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 tablets are indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episod

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

dr.reddy's laboratories limited - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (pgtc) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (aed). safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established. lamotrigine extended-release tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed warning, warn

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

dr. reddy's laboratories limited - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - severe recalcitrant nodular acne zenatane is indicated for the treatment of severe recalcitrant nodular acne. nodules are inflammatory lesions with a diameter of 5 mm or greater. the nodules may become suppurative or hemorrhagic. “severe,” by definition,2 means “many” as opposed to “few or several” nodules. because of significant adverse effects associated with its use, zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. in addition, zenatane is indicated only for those patients who are not pregnant, because zenatane can cause life threatening birth defects (see boxed contraindications and warnings ).  a single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 if a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may

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

dr.reddy's laboratories limited - fexofenadine hydrochloride (unii: 2s068b75zu) (fexofenadine - unii:e6582loh6v), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - fexofenadine hydrochloride 180 mg - fexofenadine hcl 180 mg and pseudoephedrine hcl 240 mg extended-release tablets (24 hour formulation) are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.  fexofenadine hcl 180 mg and pseudoephedrine hcl 240 mg extended-release tablets (24 hour formulation) should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see clinical pharmacology ). fexofenadine hcl 180 mg and pseudoephedrine hcl 240 mg extended-release tablets (24 hour formulation) are contraindicated in patients with known hypersensitivity to any of its ingredients. due to its pseudoephedrine component, fexofenadine hcl 180 mg and pseudoephedrine hcl  240 mg extended-release tablets (24 hour formulation) are contrai

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

dr.reddy's laboratories limited - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - divalproex sodium 125 mg - divalproex sodium delayed-release tablet is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.   the efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting dsm-iii-r criteria for bipolar disorder who were hospitalized for acute mania [see clinical studies (14.1) ].   the safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefu

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

dr. reddy's laboratories limited - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies (see clinical studies (14) ). the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. observed reactions include anaphylaxis and angioedema (see warnings and precautions (5.2) ). pregnancy category c. there are no adequate and well-controlled studies  of zolpidem in pregnant women. zolpidem tartrate should be used during pregnancy only if the potential benefit  justifies the potential risk to the fetus.  administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on off

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

dr. reddy's laboratories limited - atomoxetine hydrochloride (unii: 57wvb6i2w0) (atomoxetine - unii:asw034s0b8) - atomoxetine 10 mg - atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (adhd).  the efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with adhd: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see clinical studies (14) ]. a diagnosis of adhd (dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. the symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. the specific etiology of adhd is unknown, and there is no single diagnostic test. ade