um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate is a proton pump inhibitor indicated for:
Short-term treatment of active duodenal ulcer (1.1)
Short-term treatment of active benign gastric ulcer (1.2)
Treatment of gastroesophageal reflux disease (GERD) (1.3)
Maintenance of healing of erosive esophagitis (1.4)
The safety and effectiveness of omeprazole and sodium bicarbonate in pediatric patients (<18 years of age) have not been established (8.4)
1.1 Duodenal Ulcer
Omeprazole and sodium bicarbonate capsules are indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)]
1.2 Gastric Ulcer
Omeprazole and sodium bicarbonate capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer. [See
Clinical Studies (14.2)]
1.3 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
Omeprazole and sodium bicarbonate capsules are indicated for the treatment of heartburn and other symptoms associated with GERD. [See Clinical Studies (14.3)]
Erosive Esophagitis
Omeprazole and sodium bicarbonate capsules are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate may be considered. [See Clinical Studies (14.3)]
1.4 Maintenance of Healing of Erosive Esophagitis
Omeprazole and sodium bicarbonate capsules are indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months.[See
Clinical Studies (14.4)
]
INDICATIONS AND USAGE
I.
Vasospastic Angina
: Nifedipine is indicated for the management of
vasospastic angina confirmed by any of the following criteria: 1) classical
pattern of angina at rest accompanied by ST segment elevation, 2) angina or
coronary artery spasm provoked by ergonovine, or 3) angiographically
demonstrated coronary artery spasm. In those patients who have had angiography,
the presence of significant fixed obstructive disease is not incompatible with
the diagnosis of vasospastic angina, provided that the above criteria are
satisfied. Nifedipine may also be used where the clinical presentation suggests
a possible vasospastic component but where vasospasm has not been confirmed,
e.g., where pain has a variable threshold on exertion or when angina is
refractory to nitrates and/or adequate doses of beta blockers.
ll.
Chronic Stable Angina (Classical
Effort-Associated Angina)
: Nifedipine is indicated for the management of
chronic stable angina (effort-associated angina) without evidence of vasospasm
in patients who remain symptomatic despite adequate doses of beta blockers
and/or organic nitrates or who cannot tolerate those agents.
In chronic stable angina (effort-associated angina) nifedipine has been
effective in controlled trials of up to eight weeks duration in reducing angina
frequency and increasing exercise tolerance, but confirmation of sustained
effectiveness and evaluation of long-term safety in these patients are
incomplete.
Controlled studies in small numbers of patients suggest concomitant use of
nifedipine and beta-blocking agents may be beneficial in patients with chronic
stable angina, but available information is not sufficient to predict with
confidence the effects of concurrent treatment, especially in patients with
compromised left ventricular function or cardiac conduction abnormalities. When
introducing such concomitant therapy, care must be taken to monitor blood
pressure closely since severe hypotension can occur from the combined effects of
the drugs. (See
WARNINGS.)
INDICATIONS AND USAGE
Testosterone cypionate injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired) testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired) idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole Sodium Delayed-Release Tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabeprazole Sodium Delayed-Release Tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole Sodium Delayed-Release Tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole Sodium Delayed-Release Tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole Sodium Delayed-Release Tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole Sodium Delayed-Release Tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.2) and the full prescribing information for clarithromycin].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole Sodium Delayed-Release Tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
INDICATIONS AND USAGE
FML FORTE suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
INDICATIONS AND USAGE
Ranitidine tablets 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 out for 1 year.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg b.i.d.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg q.i.d.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
INDICATIONS AND USAGE
Visudyne (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.
There is insufficient evidence to indicate Visudyne for the treatment of predominantly occult subfoveal choroidal neovascularization.
1INDICATIONS AND USAGE
STRATTERA is a selective norepinephrine reuptake inhibitor indicated for the treatment of AttentionDeficit/Hyperactivity Disorder (ADHD). (1.1)
1.1AttentionDeficit/Hyperactivity Disorder (ADHD)
STRATTERA is
indicated for the treatment of AttentionDeficit/Hyperactivity Disorder
(ADHD).
The efficacy of STRATTERA 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)].
1.2Diagnostic Considerations
A diagnosis of ADHD(DSMIV)
implies the presence of hyperactiveimpulsive or inattentive symptoms
that cause impairment and that were present before age7years.
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 2or 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. Adequate diagnosis requires the use not
only of medical but also of special psychological, educational, and social
resources. Learning may or may not be impaired. The diagnosis must be based
upon a complete history and evaluation of the patient and not solely on the
presence of the required number of DSMIV characteristics.
For the Inattentive Type, at least 6 of the following symptoms must
have persisted for at least 6months: 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, loses things, easily distracted, forgetful. For the HyperactiveImpulsive
Type, at least 6 of the following symptoms must have persisted for at least
6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing,
difficulty with quiet activities, on the go, excessive talking,
blurting answers, cant wait turn, intrusive. For a Combined Type diagnosis,
both inattentive and hyperactiveimpulsive criteria must be met.
1.3Need for Comprehensive Treatment Program
STRATTERA is
indicated as an integral part of a total treatment program for ADHD that may
include other measures (psychological, educational, social) for patients with
this syndrome. Drug treatment may not be indicated for all patients with this
syndrome. Drug treatment is not intended for use in the patient who exhibits
symptoms secondary to environmental factors and/or other primary psychiatric
disorders, including psychosis. Appropriate educational placement is essential
in children and adolescents with this diagnosis and psychosocial intervention
is often helpful. When remedial measures alone are insufficient, the decision
to prescribe drug treatment medication will depend upon the physicians
assessment of the chronicity and severity of the patients symptoms.
1 INDICATIONS AND USAGE
Mannitol Injection is indicated for the reduction of:
intracranial pressure and treatment of cerebral edema;
elevated intraocular pressure.
Mannitol Injection is an osmotic diuretic indicated for the reduction of:
intracranial pressure and treatment of cerebral edema. (1)
elevated intraocular pressure. (1)
INDICATIONS AND USAGE
Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes: Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).
INDICATIONS AND USAGE
Caffeine and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.
INDICATIONS AND USAGE
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders - 3
rd edition (DSM-III) category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest 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.
The effectiveness of mirtazapine tablets, USP in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine tablets, USP in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see
CLINICAL PHARMACOLOGY
).
INDICATIONS AND USAGE
Levocarnitine Oral Solution USP is indicated in the treatment of primary systemic carnitine deficiency.
In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy.
Associated symptoms included hypotonia, muscle weakness and failure to thrive.
A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see
Clinical Pharmacology).
In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms.
Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
Levocarnitine Oral Solution USP is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
CONTRAINDICATIONS
None known.
Hypertension
Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Atrial Fibrillation
Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
Myocardial Infarction
Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Migraine
Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
Essential Tremor
Propranolol hydrochloride tablets, USP are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets, USP cause a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol hydrochloride tablets, USP are not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Propranolol hydrochloride tablets, USP improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma
Propranolol hydrochloride tablets, USP are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
INDICATIONS AND USAGE
ZOVIRAX Cream is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12years of age and older).
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablet, (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1)
1.1 Major Depressive Disorder
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)].
1.2 Seasonal Affective Disorder
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 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
BREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for:
the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1.1)
the maintenance treatment of asthma in patients aged 5 years and older. (1.2)
Limitations of Use: Not indicated for relief of acute bronchospasm. (1.3, 5.2)
1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease
BREO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
1.2 Maintenance Treatment of Asthma
BREO ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and older.
1.3 Limitations of Use
BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.
1 INDICATIONS AND USAGE
Topiramate is indicated for:
Monotherapy epilepsy: Initial monotherapy in patients
2 years of age with partial onset or primary
generalized tonic-clonic seizures (1.1)
Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with
partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age with seizures associated with
Lennox-Gastaut syndrome (LGS) (1.2)
1.1 Monotherapy Epilepsy
Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)].
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Zaleplon capsulesare indicated for the short-term treatment of insomnia. Zaleplon capsuleshave been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see
Clinical Trials
under
CLINICAL PHARMACOLOGY
).They havenot been shown to increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.