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ajanta pharma usa inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (mdd). efficacy of venlafaxine in mdd was shown in both short-term trials and a longer-term trial in mdd [see clinical studies (14.1)]. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. venlafaxine extended-release tablets are indicated for the treatment of social anxiety disorder (sad), also kn

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ajanta pharma usa inc. - entacapone (unii: 4975g9nm6t) (entacapone - unii:4975g9nm6t) - entacapone 200 mg - entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with parkinson’s disease (see clinical pharmacology, clinical studies). entacapone tablet’s effectiveness has not been systematically evaluated in patients with parkinson’s disease who do not experience end-of-dose “wearing-off”. entacapone tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. entacapone tablets are not a controlled substance. animal studies to evaluate the drug abuse and potential dependence have not been conducted. although clinical studies have not revealed any evidence of the potential for abuse, tolerance or physical dependence, systematic studies in humans designed to evaluate these effects have not been performed.

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ajanta pharma usa inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - adjunctive therapy lamotrigine orally disintegrating tablets are 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 orally disintegrating tablets are 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 orally disintegrating tablets are indicated for the maintenance treatment of bipolar i disorder to delay the time to occ

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ajanta pharma usa inc. - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. montelukast sodium tablets and chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium tablets, chewable tablets and oral granules are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. because the benefits of montelukast sodium tablets, chewable tablets and oral granules may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium tablets, chewable tablets and oral granules are not indicated for the treatment of an acute asth

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ajanta pharma usa inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq), esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. the naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: - osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. - juvenile idiopathic arthritis (jia) in adolescent patients. the esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. limitations of use: - do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium. - naproxen and esomeprazo

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ajanta pharma usa inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole 20 mg - omeprazole and sodium bicarbonate for oral suspension is indicated in adults for the: - short-term treatment of active duodenal ulcer. most patients heal within four weeks. some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with gerd for up to 4 weeks. - short-term treatment (4 to 8 weeks) of ee due to acid-mediated gerd which has been diagnosed by endoscopy in adults. the efficacy of omeprazole and sodium bicarbonate for oral suspension used for longer than 8 weeks in patients with ee has not been established. if a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. if there is recurrence of ee or gerd symptoms (e.g., heartburn), additional 4 to 8-week courses of omeprazole and sodium bicarbonate for oral suspension may be considered. - the efficacy of omeprazole and sodium bicarbonate for oral suspension used for longer than 8

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ajanta pharma usa inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 15 mg - lansoprazole delayed-release capsules 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 /amoxicillin /clarithromycin lansoprazole 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 /amoxicillin lansoprazole in combination with amoxicillin as dual therapy is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in

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ajanta pharma usa inc. - ranitidine hydrochloride (unii: bk76465ihm) (ranitidine - unii:884kt10yb7) - ranitidine capsules are indicated in: - short-term treatment of active duodenal ulcer.  most patients heal within 4 weeks.  studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. - maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.  no placebo-controlled comparative studies have been carried out for periods of longer than 1 year. - the treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome and systemic mastocytosis). - short-term treatment of active, benign gastric ulcer.  most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.  studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. - maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers.  placebo-controlled studies have been carried o

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ajanta pharma usa inc. - guanfacine hydrochloride (unii: pml56a160o) (guanfacine - unii:30omy4g3mk) - guanfacine tablets, usp are indicated in the management of hypertension. guanfacine tablets, usp may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. guanfacine tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. no reported abuse or dependence has been associated with the administration of guanfacine hydrochloride. overdosage signs and symptoms   drowsiness, lethargy, bradycardia and hypotension have been observed following overdose with guanfacine. a 25-year-old female intentionally ingested 60 mg. she presented with severe drowsiness and bradycardia of 45 beats/minute. gastric lavage was performed and an infusion of isoproterenol (0.8 mg in 12 hours) was administered. she recovered quickly and without sequelae. a 28-year-old female who ingested 30 mg to 40 mg developed only lethargy, was treated with activated charcoal and a cathartic, was monitored for 24 hours, and was discharged in good health. a 2-year-

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ajanta pharma usa inc. - captopril (unii: 9g64rsx1xd) (captopril - unii:9g64rsx1xd) - hypertension: captopril tablets, usp, are indicated for the treatment of hypertension. in using captopril tablets, usp, consideration should be given to the risk of neutropenia/agranulocytosis (see warnings ). captopril tablets, usp may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. in patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. captopril tablets, usp are effective alone and in combination with other antihypertensive agents, especially thiazidetype diuretics. the blood pressure lowering effects of captopril and thiazides are approximately additive. heart failure: captopril tablets, usp are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. the beneficial effect of captopril i