um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Hydroxychloroquine sulfate tablets are antimalarial and antirheumatic indicated for the:
Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1)
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1)
Treatment of rheumatoid arthritis in adults. (1.2)
Treatment of systemic lupus erythematosus in adults. (1.3)
Treatment of chronic discoid lupus erythematosus in adults. (1.4)
Limitations of Use (
1.1
):
Hydroxychloroquine sulfate tablets are not recommended for the:
Treatment of complicated malaria.
Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species.
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.
1.1 Malaria
Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patients for the:
Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate tablets are not recommended for:
Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodiumspecies [see Microbiology (12.4)].
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4)].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1.
1.2 Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults.
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 (Hashimoto's 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.
1 INDICATIONS AND USAGE
Sodium Iodide I-131 Solution is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.
Sodium Iodide I-131 is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
INDICATIONS: FeRiva FA
is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
INDICATIONS AND USAGE
Hypertension
Enalapril Maleate Tablets are indicated for the treatment of hypertension.
Enalapril Maleate Tablets are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of Enalapril Maleate Tablets and thiazides are approximately additive.
Heart Failure
Enalapril Maleate Tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients Enalapril Maleate Tablets improve symptoms, increases survival, and decreases the frequency of hospitalization (see
CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials
for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), Enalapril Maleate Tablets decrease the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see
CLINICAL PHARMACOLOGY
,
Heart Failure
,
Mortality Trials for details and limitations of survival trials).
In using Enalapril Maleate Tablets 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, and that available data are insufficient to show that Enalapril Maleate Tablets do not have a similar risk (see
WARNINGS, Neutropenia/Agranulocytosis
).
In considering use of Enalapril Maleate Tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see
WARNINGS
,
Head and Neck Angioedema).
1
INDICATIONS AND USAGE
EXSERVAN is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
EXSERVAN is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (1)
INDICATIONS AND USAGE
Flurazepam Hydrochloride Capsules are a hypnotic agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Flurazepam Hydrochloride Capsules can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have objectively determined that Flurazepam Hydrochloride Capsules are effective for at least 28 consecutive nights of drug administration. Since insomnia is often transient and intermittent short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient.
1 INDICATIONS AND USAGE
Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. (1)
Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)
1 INDICATIONSAND USAGE
Roflumilast tablet is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Limitations of Use
Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Roumilast 250 mcg is a starting dose, for the rst 4 weeks of treatment only and is not the effective (therapeutic) dose.
Roflumilast tablet is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
(1,
14)
Limitations of Use:
Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
(1,
14)
Roumilast tablet 250 mcg is a starting dose, for the rst 4 weeks of treatment only and is not the effective (therapeutic) dose. (
2,
14)
1	INDICATIONS AND USAGE
Posaconazole delayed-release tablets are an azole antifungal indicated as follows:
Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (
1.2)
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
1.2 Prophylaxis of Invasive
Aspergillus and
Candida Infections
Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive
Aspergillus and
Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy
[see
Clinical Studies (14.2)]
as follows:
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.s NOXAFIL
(posaconazole)
delayed-release tablets. However, due to Merck Sharp & Dohme Corp.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
Hydrocortisone valerate cream USP, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles,
senile lentigines, and other unwanted areas of melanin hyperpigmentation.
INDICATIONS AND USAGE
Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics.
Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see
DOSAGE AND ADMINISTRATION)
.
In using fosinopril sodium tablets, 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 sodium tablets do not have a similar risk (see
WARNINGS
).
In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see
WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema)
.
1 INDICATIONSAND USAGE
Levofloxacin ophthalmic solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:
Gram-positive bacteria:
Corynebacterium species
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumonia
Viridans group streptococci*
Gram-negative bacteria:
Pseudomonas aeruginosa
Serratia marcescens*
*Efficacy for this organism was studied in fewer than 10 infections
Levofloxacin ophthalmic solution is a topical quinolone anti-microbial indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:
Corynebacterium species
*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumonia
Viridans group streptococci*
Pseudomonas aeruginosa
Serratia marcescens*
*Efficacy for this organism was studied in fewer than 10 infections.
(1)
1 INDICATIONS AND USAGE
Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Solifenacinsuccinate tabletsare a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
INDICATIONS AND USAGE
AVITA Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established.
INDICATIONS AND USAGE:
Propylthiouracil is indicated:
in patients with Graves' disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option.
to ameliorate symptoms of hyperthyroidism in preparation forthyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole.
1 INDICATIONS AND USAGE
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS) (1.1, 1.2)
1.1 Parkinsons Disease
Ropinirole tablets are indicated for the treatment of Parkinsons disease.
1.2 Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
1 INDICATIONS AND USAGE
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].
Important Limitations of Use
Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see Warnings and Precautions (5.3)].
Pioglitazone is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1,
14)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
1 INDICATIONS AND USAGE
Fluoxetine Tablets USP are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2)
Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4)
1.1 Major Depressive Disorder
Fluoxetine tablets USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see Dosage and Administration (2.1)].
1.2 Obsessive Compulsive Disorder
Fluoxetine tablets USP are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
The effectiveness of fluoxetine tablets USP in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine tablets USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)].
1.3 Bulimia Nervosa
Fluoxetine tablets USP are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
The physician who elects to use fluoxetine tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
1.4 Panic Disorder
Fluoxetine tablets USP are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)].
The effectiveness of fluoxetine tablets USP in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine tablets USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)].
INDICATIONS AND USAGE
10% calcium chloride injection is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
INDICATION AND USAGE
VIAGRA is indicated for the treatment of erectile dysfunction.
1INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
LESCOL XL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia (1.1)
Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.1)
Reduce the risk of undergoing revascularization procedures in patients with clinically evident Coronary Heart Disease (CHD) (1.2)
Slow the progression of atherosclerosis in patients with CHD (1.2)
Limitations of Use:
LESCOL XL has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V) (1.3)
1.1Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia
LESCOL XL is indicated
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:
LDL-C remains 190 mg/dL or
LDL-C remains
160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other cardiovascular disease risk factors are present
The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.
Category
Total-C (mg/
dL
)
LDL-C (mg/
dL
)
Acceptable
< 170
< 110
Borderline
170-199
110-129
High
200
130
Children treated with fluvastatin in adolescence should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals.
1.2Secondary Prevention of Cardiovascular Disease
In patients with clinically evident Coronary Heart Disease (CHD), LESCOL XL is indicated to:
reduce the risk of undergoing coronary revascularization procedures
slow the progression of coronary atherosclerosis
1.3Limitations of Use
LESCOL XL has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of CATAFLAM
(diclofenac potassium tablets, USP) and other treatment options before deciding to use CATAFLAM. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation
).
CATAFLAM is 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
INDICATIONS AND USAGE
Verapamil Hydrochloride Injection, USP is indicated for the following:
Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.
Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W- P-W) and Lown-Ganong-Levine (L-G-L) syndromes).
In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride.Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.
Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole
see CONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.