um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Almotriptan tablets, USPare 5HT1B/1D receptor agonist (triptan) indicated for:
Acute treatment of migraine attacks in adults with a history of migraine with or without aura (1.1)
Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more (1.1)
Important limitations:
Use only after a clear diagnosis of migraine has been established (1.2)
In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established (1.2)
Not intended for the prophylactic therapy of migraine (1.2)
Not indicated for the treatment of cluster headache (1.2)
1.1 Acute Treatment of Migraine Attacks
Adults
Almotriptan tablets, USPare indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.
Adolescents Age 12 to 17 Years
Almotriptan tablets, USPare indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
1.2 Important Limitations
Almotriptan tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with almotriptan tablets, the diagnosis of migraine should be reconsidered before almotriptan tablets are administered to treat any subsequent attacks.
In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see Contraindications (4.7)].
Safety and effectiveness of almotriptan tablets have not been established for cluster headache which is present in an older, predominantly male population.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).
Diclofenac potassium tablets are indicated:
For treatment of primary dysmenorrhea
For relief of mild to moderate pain
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
1 INDICATIONS AND USAGE
Voltaren Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Voltaren Gel has not been evaluated for use on the spine, hip, or shoulder.
Voltaren Gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (1)
Voltaren Gel was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)
INDICATIONS & USAGE SECTION
Metformin Hydrochloride Tablets USP, is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil.
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1).
INDICATIONS AND USAGE
Verapamil hydrochloride tablets, USP are indicated for the treatment of the following:
Angina
1.
Angina at rest including:
Vasospastic (Prinzmetal's variant) angina
Unstable (crescendo, pre-infarction) angina
2. Chronic stable angina (classic effort-associated angina)
Arrhythmias
In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see
WARNINGS: Accessory bypass tract)
Prophylaxis of repetitive paroxysmal supraventricular tachycardia
Essential hypertension
Verapamil hydrochloride is indicated 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug.
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.
1 INDICATIONS AND USAGE
Vasostrict
is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Vasostrict
is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. (
1)
INDICATIONS AND USAGE
Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder.
The efficacy of Venlafaxine tablets USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see
CLINICAL TRIALS
).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks);it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Tablets USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see
CLINICAL TRIALS
). Nevertheless, the physician who elects to use venlafaxine tablets, USP / venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Postherpetic Neuralgia
Gabapentin capsules, USP are indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin capsules, USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin capsules, USPare also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.
1 INDICATIONS AND USAGE
Paroxetine tablets are indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive compulsive disorder (OCD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Generalized anxiety disorder (GAD)
Posttraumatic stress disorder (PTSD)
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (
1):
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Generalized Anxiety Disorder (GAD)
Posttraumatic Stress Disorder (PTSD)
1 INDICATIONS AND USAGE
Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydromorphone hydrochloride oral solution or hydromorphone 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
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone 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
1 INDICATIONS AND USAGE
Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:
Schizophrenia (
1.1
)
Bipolar I disorder manic episodes (
1.2
)
Bipolar disorder, depressive episodes (
1.2
)
1.1 Schizophrenia
Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [
see Clinical Studies
(
14.1)
].
1.2 Bipolar Disorder
Quetiapine tablets are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [
see Clinical Studies
(
14.2)
].
Quetiapine tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [
see Clinical Studies
(
14.2)
].
Quetiapine tablets are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [
see Clinical Studies
(
14.2)
].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions
.
1 INDICATIONS AND USAGE
Deferasirox oral granules are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1)
Deferasirox oral granules are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2)
Limitations of Use:
The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established. (1.3)
1.1 Treatment
of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron
Overload)
Deferasirox oral granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
1.2
Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia
Syndromes
Deferasirox oral granules are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.
1.3
Limitations of Use
The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established.
Idications and Usage
Gabapentin Tablets, 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
INDICATIONS AND USAGE
For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.
INDICATIONS AND USAGE
Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasmin patients 12 years of age and older with asthma and reversible bronchospasm associatedwith bronchitis and emphysema.
1. INDICATIONS AND USAGE
CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of
Stage D2
metastatic carcinoma of the prostate.
CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].
CASODEX 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
CASODEX 150 mg daily is not approved for use alone or with other treatments. (1)
1 INDICATIONS AND USAGE
Hypothyroidism
Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)].
Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levothyroxine sodium tablets are L-thyroxine (T4) indicated for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis
INDICATIONS AND USAGE
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
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
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):
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis or osteoarthritis
Epicondylitis
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Acute rheumatic carditis
Systemic dermatomyositis (polymyositis)
Dermatologic Diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (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 conjunctivitis
Keratitis
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Chorioretinitis
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
Respiratory Disease
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently
with appropriate antituberculosis chemotherapy
Aspiration pneumonitis
Hematologic Disorder
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
Neoplastic Disease
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
INDICATIONS AND USAGE
To reduce the development of drug-resistant
bacteria and maintain the effectiveness of cefdinir for oral suspension
and other antibacterial drugs, cefdinir for oral suspension should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible 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.
Cefdinir for oral suspension is
indicated for the treatment of patients with mild to moderate
infections caused by susceptible strains of the designated
microorganisms in the conditions listed below.
Adults and Adolescents:
Enter section text here
Pediatric Patients:
Enter section text here
INDICATIONS AND USAGE
Parenteral
Sedatives.
Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See "
Clinical Pharmacology
" section).
Preanesthetics.
Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.