um-ids/dailymed-annotations huggingface dataset:
1. INDICATIONS AND USAGE
LEVAMLODIPINE TABLETS is calcium channel blocker and may be used alone or in combination with other antihypertensive agents for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
1.1 Hypertension
LEVAMLODIPINE TABLETS is indicated for the treatment of hypertension in adults and pediatric patients 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including levamlodipine.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Levamlodipine may be used alone or in combination with other antihypertensive agents.
1 INDICATIONS AND USAGE
Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use:
Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations (
8.4)].
Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. (1)
Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. (1)
Limitations of Use:
Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. (1, 8.4)
INDICATIONS AND USAGE
Prednisone tablets are indicated in the following conditions:
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurativethyroiditis.
Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosingspondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis.
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Dermatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythemamultiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.
Respiratory Diseases
Symptomatic sarcoidosis; Loefflers syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis.
Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases
For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis.
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
1. INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults and adolescents aged 13-17 years (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10-17 years (1.2)
Treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years (1.3)
1.1 Schizophrenia
Adults
Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)].
Adolescents
Risperidone tablets are indicated for the treatment of schizophrenia in adolescents aged 13-17 years [see Clinical Studies (14.1)].
1.2 Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10-17 years [see Clinical Studies (14.2)].
Combination Therapy
Adults
The combination of risperidone with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics
Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4)].
INDICATIONS AND USAGE:
Diphenhydramine hydrochloride in the oral form is effective for the following indications:
Antihistaminic:
For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
Motion Sickness:
For active and prophylactic treatment of motion sickness.
Antiparkinsonism:
For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents.
Nighttime sleep-aid.
1 INDICATIONS AND USAGE
LUMIGAN
0.01% and 0.03% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
LUMIGAN
is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. (1)
1INDICATIONS AND USAGE
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 (1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen (1)
postoperative nausea and/or vomiting (1)
INDICATIONS AND USAGE
Ustell
capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
1 INDICATIONS AND USAGE
1.1 Duodenal Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Omeprazole delayed-release capsules, USP in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Omeprazole delayed-release capsules, USP in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see CLINICAL STUDIES (14.1) and DOSAGE AND ADMINISTRATION (2)].
Among patients who fail therapy, omeprazole delayed-release capsules, USP with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. 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 MICROBIOLOGY SECTION (12.4)], and the clarithromycin package insert, Microbiology section.
1.2 Gastric Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults [see CLINICAL STUDIES (14.2)].
1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)
Symptomatic GERD
Omeprazole delayed-release capsules, USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults for up to 4 weeks.
Erosive Esophagitis
Omeprazole delayed-release capsules, USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults [see CLINICAL STUDIES (14.4)].
The efficacy of omeprazole delayed-release capsules, USP used for longer than 8 weeks in these patients 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 erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)
Omeprazole delayed-release capsules, USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.
Controlled studies do not extend beyond 12 months [see CLINICAL STUDIES (14.4)].
1.5 Pathological Hypersecretory Conditions (adults)
Omeprazole delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
INDICATIONS AND USAGE
Morphine sulfate extended-release tablets are a controlled release oral morphine formulation indicated for the relief of moderate to severe pain. They are intended for use in patients who require repeated dosing with potent opioid analgesics over periods of more than a few days.
1	INDICATIONS AND USAGE
Teriflunomide tablet is 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 adults.
Teriflunomide is a pyrimidine synthesis inhibitor 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 adults. (1)
INDICATIONS AND USAGE:
Nystatin and triamcinolone acetonide cream is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
1.1 Osteoarthritis (OA)
1.2 Rheumatoid Arthritis (RA)
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
1INDICATIONS AND USAGE
1.1Osteoarthritis (OA)
MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies
(14.1)].
1.2Rheumatoid Arthritis (RA)
MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies
(14.1)].
1.3Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
MOBIC is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies
(14.2)].
INDICATIONS AND USAGE
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. Please Note: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. It is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with Gentamicin Sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Cream USP, 0.1% is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. Gentamicin sulfate ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. If a water-washable preparation is desired, the cream is preferable. Gentamicin Sulfate Cream USP, 0.1% has been used successfully in infants over one year of age, as well as in adults and children.
1 INDICATIONS AND USAGE
Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with
opioids, even at recommended doses, and because of the greater risks of
overdose and death with extended-release opioid formulations, reserve
morphine sulfate extended-release tablets for use in patients for whom
alternative treatment options (e.g., non-opioid analgesics or
immediate-release opioids) are ineffective, not tolerated, or would be
otherwise inadequate to provide sufficient management of pain. (1)
Morphine sulfate extended-release tablets is not indicated
as an as-needed (prn) analgesic. (1)
Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with
opioids, even at recommended doses, and because of the greater risks of
overdose and death with extended-release opioid formulations [see Warnings
and Precautions (5.1)] , reserve morphine sulfate
extended-release tablets for use in patients for whom alternative
treatment options (e.g., non- opioid analgesics or immediate-release
opioids) are ineffective, not tolerated, or would be otherwise inadequate
to provide sufficient management of pain.
Morphine sulfate extended-release tablets is not indicated
as an as-needed (prn) analgesic.
INDICATIONS AND USAGE
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.
1 INDICATIONS AND USAGE
Adapalene and Benzoyl Peroxide
gel is indicated for the topical treatment of acne vulgaris.
Adapalene and Benzoyl Peroxide gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris.
INDICATIONS & USAGE
These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
INDICATIONS AND USAGE
Volumex (Iodinated I 131 Allbumin injection) is indicated for use in determinations of total blood and plasma volumes and in protein turnover studies
INDICATIONS AND USAGE
Doxycycline hyclate tablets, USP are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture susceptibility information is available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Escitalopram oral solution is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years(1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)
1.1 Major Depressive Disorder
Escitalopram oral solution is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [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 or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine 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.
1.2 Generalized Anxiety Disorder
Escitalopram oral solution is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine 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 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 tablets 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.
1
INDICATIONS AND USAGE
ACUVAIL
ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery.
ACUVAILophthalmic solution is a nonsteroidal, anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery. (1)