um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Anxiety Disorders
ALPRAZOLAM Tablets (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients:
Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability);
Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or lump in throat);
Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or mind going blank because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to alprazolam.
Panic Disorders
ALPRAZOLAM is also indicated for the treatment of panic disorder, with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see
CLINICAL STUDIES).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization
(feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of ALPRAZOLAM by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Albuterol sulfate inhalation aerosol is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
1.1 Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
INDICATIONS AND USAGE
Ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis.
The safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USPand other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are 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.
Amoxicillin capsules, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin capsules, USP are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1, 1.2, 1.3, 1.4, 1.5)
In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
1.1 Infections of the Ear, Nose, and Throat
Due to
Streptococcus
species (- and -hemolytic isolates only),
Streptococcus pneumoniae
,
Staphylococcus
spp., or
Haemophilus influenzae
.
1.2 Infections of the Genitourinary Tract
Due to
Escherichia coli, Proteus mirabilis
, or
Enterococcus faecalis
.
1.3 Infections of the Skin and Skin Structure
Due to
Streptococcus
spp. (- and -hemolytic isolates only),
Staphylococcus
spp., or
E. coli
.
1.4 Infections of the Lower Respiratory Tract
Due to
Streptococcus
spp. (- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus
spp., or
H. influenzae
.
1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections in males and females)
Due to
Neisseria gonorrhoeae
.
Because of high rates of amoxicillin resistance, amoxicillin capsules, USPare not recommended for empiric treatment of gonorrhea. Amoxicillin capsules, USP use should be limited to situations where
N. gonorrhoeae
isolates are known to be susceptible to amoxicillin.
1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
Amoxicillin capsules, USP, in combination with clarithromycin plus lansoprazole as triple therapy,are indicated for the treatment of patients with
H. pylori
infection and duodenal ulcer disease (active or 1-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.
1.7 Dual Therapy for H. pylori with Lansoprazole
Amoxicillin capsules, USP, in combination with lansoprazole delayed-release capsules as dual therapy,are indicated for the treatment of patients with
H. pylori
infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected
. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori
has been shown to reduce the risk of duodenal ulcer recurrence.
INDICATIONS AND USAGE
Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see
WARNINGS
). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate tablets, USP can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following:
Mild to moderate pain
Osteoarthritis
Rheumatoid arthritis
INDICATIONS AND USAGE
Fosinopril sodium and hydrochlorothiazide tablets, USP is indicated for the treatment of hypertension.
These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION.)
In using fosinopril sodium and hydrochlorothiazide tablets, USP, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis
).
ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).
1 INDICATIONS AND USAGE
Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)], reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Etodolac Capsules and Tablets are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
Osteoarthritis
Rheumatoid arthritis
For the management of acute pain
1 INDICATIONS AND USAGE
BETHKIS is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of sixyears, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia[see ClinicalStudies (
14
)].
BETHKIS is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonasaeruginosa. (1) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume inone second (FEV1) less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia. (1)
1INDICATIONS AND USAGE
BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.
BETOPTIC S is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. (1)
1 INDICATIONS & USAGE
Vardenafil hydrochloride orally disintegrating tablet is indicated for the treatment of erectile dysfunction.
Vardenafil hydrochloride is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1)
INDICATIONS AND USAGE
Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.
For prolonged control of blood pressure, patients should be transferred to oral medication as soon as their clinical condition permits (see DOSAGE AND ADMINISTRATION).
1. Indications and Usage Section
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1
INDICATIONS & USAGE
Heparin Sodium Injection is indicated for:
Prophylaxis and treatment of venous thrombosis and, pulmonary embolism;
Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease;
Atrial fibrillation with embolization;
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
1 INDICATIONS AND USAGE
Dexlansoprazole delayed-release capsules are proton pump inhibitor (PPI) indicated in patients 12 years of age and older for:
Healing of all grades of erosive esophagitis (EE). (1.1)
Maintenance of healed EE and relief of heartburn. (1.2)
Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3)
1.1	Healing of Erosive Esophagitis
Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks.
1.2	Maintenance of Healed Erosive Esophagitis and Relief of Heartburn
Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age.
1.3	Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
1 INDICATIONS AND USAGE
Sertraline hydrochloride tablets are indicated for the treatment of the following
[See Clinical Studies (
14)]
:
Major
depressive disorder (MDD)
Obsessive-compulsive
disorder (OCD)
Panic disorder
(PD)
Posttraumatic
stress disorder (PTSD)
Social anxiety
disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Sertraline hydrochloride tablet is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (
1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
1 INDICATIONS AND USAGE
Gabapentin capsules, USP are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin capsules are indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
INDICATIONS AND USAGE
Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
INDICATIONS AND USAGE
Clobetasol propionate cream is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS AND USAGE
ERYGEL Topical Gel is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS & USAGE
Lithium is a mood-stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder.
Lithium is a mood stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder (
1)
INDICATIONS AND USAGE
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.
Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond- Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic diseases: For the palliative management of leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that are due to systemic lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
1
INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets are an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
1.1
Oral Contraceptive
Drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy.
1.2 Premenstrual Dysphoric Disorder (PMDD)
Drospirenone and ethinyl estradiol tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone and ethinyl estradiol tablets for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Drospirenone and ethinyl estradiol tablets has not been evaluated for the treatment of premenstrual syndrome (PMS).
1.3
Acne
Drospirenone and ethinyl estradiol tablets are indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone and ethinyl estradiol tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
1
INDICATIONS AND USAGE
GLOPERBA(colchicine) Oral Solution is indicated for prophylaxis of gout flares in adults.
Limitations of use:The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.
GLOPERBA is indicated for prophylaxis of gout flares in adults (1).
Limitations of use:
The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes (1).