um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Clopidogrel is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome -For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel should be administered in conjunction with aspirin. Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel is indicated to reduce the rate of MI and stroke.
1 INDICATIONS AND USAGE
Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of:
hypertension (1.3)
1.3
Hypertension
Carvedilol phosphate extended-release capsules are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
INDICATIONS AND USAGE
For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and
polymyxin B sulfate.
INDICATIONS AND USE
Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin hydrochloride is indicated in patients 10 years of age and older.Metformin hydrochloride may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).
1 INDICATIONS AND USAGE
Budesonide rectal foam
is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
Budesonide rectal foam is a glucocorticosteroid indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. (1)
1 INDICATIONS AND USAGE
AZILECT (rasagiline tablets) is indicated for the treatment of Parkinsons disease (PD).
AZILECT, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinsons disease (1)
1 INDICATIONS AND USAGE
Liothyronine sodium is an L-triiodothyronine (T3) indicated for:
Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism (
1.1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer (
1.2)
Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy (
1.3)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (
1)
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (
1)
1.1 Hypothyroidism
Liothyronine Sodium Tablets, USP are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
1.2 Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
Liothyronine Sodium Tablets, USP are indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.
1.3 Thyroid Suppression Test
Liothyronine Sodium Tablets, USP are indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.
Limitations of Use
Liothyronine Sodium Tablets, USP 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 Liothyronine Sodium Tablets, USP may induce hyperthyroidism
[see
Warnings and Precautions (5.4)].
Liothyronine Sodium Tablets, USP are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
1 INDICATIONS AND USAGE
Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.
Vogelxo is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of Use:
Safety and efficacy of
Vogelxo in men with age-related hypogonadism have not been established (1)
Safety and efficacy of
Vogelxo in males less than 18 years old have not been established (8.4)
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure (1, 12.3)
Limitations of Use:
Safety and efficacy of Vogelxo in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Safety and efficacy of Vogelxo in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration (2) and Clinical Pharmacology (12.3)].
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain where treatment with an opioid is appropriate 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
], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)
Have not provided adequate analgesia, or are not expected to provide adequate analgesia,
Have not been tolerated, or are not expected to be tolerated.
1 INDICATIONS AND USAGE
Sumatriptannasal spray is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan nasal spray, reconsider the diagnosis of migraine before Sumatriptan nasal spray is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache.
Sumatriptan is a serotonin (5-HT
1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. (
1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. (
1)
Not indicated for the prophylactic therapy of migraine attacks. (
1)
Not indicated for the treatment of cluster headache. (
1)
INDICATIONS AND USAGE
When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection, USP, is indicated as follows:
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, serum sickness, transfusion reactions.
Dermatologic diseases
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of 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, nonsuppurative thyroiditis.
Gastrointestinal diseases
To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.
Hematologic disorders
Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia.
Miscellaneous
Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently 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, or craniotomy.
Ophthalmic diseases
Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases
To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to 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, temporal arteritis, polymyositis, and systemic lupus erythematosus.
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia
INDICATIONS AND USAGE
Ticlopidine Hydrochloride Tablets USP are indicated:
to reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced stroke precursors, and in patients who have had a completed thrombotic stroke. Because ticlopidine is associated with a risk of life-threatening blood dyscrasias including thrombotic thrombocytopenic purpura (TTP), neutropenia/agranulocytosis and aplastic anemia (see and ), ticlopidine should be reserved for patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy.
BOXED WARNING
WARNINGS
as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation (see ).
CLINICAL TRIALS
1 INDICATIONS AND USAGE
Montelukast sodium tablets is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 12 months of age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of ageand older (1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
Indications and Usage
Levothyroxine sodium is used for the following indications:
Hypothyroidism
As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Pituitary TSH Suppression
In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic lymphocytic thyroiditis (Hashimotos thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
CONTRAINDICATIONS
Levothyroxine is contraindicated in patients with untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels) or overt thyrotoxicosis of any etiology and in patients with acute myocardial infarction. Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency since thyroid hormones may precipitate an acute adrenal crisis by increasing the metabolic clearance of glucocorticoids (see PRECAUTIONS). Levothyroxine sodium tablets, USP is contraindicated in patients with hypersensitivity to any of the inactive ingredients in Levothyroxine sodium tablets, USP, (see DESCRIPTION, Inactive Ingredients.)
1 INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablet is a proton-pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative
Gastroesophageal Reflux Disease (GERD) (1.1).
Maintenance of Healing of Erosive or
Ulcerative GERD (1.2).
Treatment of Symptomatic GERD (1.3).
Healing of Duodenal Ulcers (1.4).
Helicobacter pylori
Eradication to Reduce Risk of Duodenal Ulcer Recurrence (1.5).
Treatment of Pathological Hypersecretory
Conditions, Including Zollinger-Ellison Syndrome (1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD
(1.7).
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.
1 INDICATIONS AND USAGE
Clobetasol Propionate Shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older (1) .Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Avoid any contact with the eyes and lips. (1.2)
1.1 Indication
Clobetasol Propionate Shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Patients should be instructed to use Clobetasol Propionate Shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1.2 Limitations of Use
Clobetasol Propionate Shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only).
INDICATIONS AND USAGE
Collagenase SantylOintment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21
1 INDICATIONS AND USAGE
Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for:
prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. (1.1)
treatment of acute, uncomplicated P. falciparum malaria. (1.2)
1.1 Prevention of Malaria
Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
1.2 Treatment of Malaria
Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria.
Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
1 INDICATIONS & USAGE
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
Respiratory tract infection (
1.1)
Otitis media (
1.2)
Skin and skin structure infections
(
1.3)
Bone infections (
1 . 4 )
Genitourinary tract infections (
1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be
used only to treat infections that are proven or strongly suspected to be caused
by bacteria. (1.6)
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of
Streptococcus pneumoniae and
Streptococcuspyogenes.
1.2	Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of
Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes, and
Mo raxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus and
Streptococcus pyogenes.
1.4	Bone Infections
Cephalexin is indicated for the treat ment of bone infections caused by susceptible isolates of
Staphylococcusaureus and
Proteus mi rabilis.
1.5	Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of
Escheric hia c oli, Proteus mirabilis, and
Klebsiella pneumonia e.
1.6	Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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
VIAGRA is indicated for the treatment of erectile dysfunction.
VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)