um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. (1.1
).
Limitations of Use
The optimal duration of use has not been determined. For patients at low -risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.2).
1.1 Treatment and Prevention of Postmenopausal Osteoporosis
Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
1.2 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Vasospastic Angina
Nifedipine capsules, USP (nifedipine) is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine capsules, USP may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta-blockers.
INDICATIONS AND USAGE
INDICATIONS AND USAGE:Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejectionfraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations andemergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensinconvertingenzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation
1 INDICATIONS AND USAGE
Depo-subQ provera 104 is indicated in females of reproductive age for:
Prevention of pregnancy and
Management of endometriosis-associated pain.
Depo-subQ provera 104 is a progestin that is indicated in females of reproductive age for:
Prevention of pregnancy. (1)
Management of endometriosis-associated pain. (1)
Limitations of Use:
Use of depo-subQ provera 104 is not recommended as a long-term (i.e., longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate. (1, 5.1)
Limitations of Use:
The use of depo-subQ provera 104 is not recommended as a long-term (i.e., longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].
INDICATIONS AND USAGE
Olopatadine hydrochloride ophthalmic solution USP, 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
INDICATIONS AND USAGE
Hypertension:
Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.
Hypertensive Patients with Left Ventricular Hypertrophy:
Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients (see PRECAUTIONS, Race
and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race).
Nephropathy in Type 2 Diabetic Patients
Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio
300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects).
1 INDICATIONS AND USAGE
Adenosine, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately (1)
Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
1 INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)
].
Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).
1 INDICATIONS AND USAGE
Ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by
Trichophyton rubrum, Trichophyton mentagrophytes, and
Epidermophyton floccosum in patients 12 years of age and older.
Ecoza is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by
Trichophyton rubrum, Trichophyton mentagrophytes, and
Epidermophyton floccosum in patients 12 years of age and older. (
1)
1 INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
Posaconazole is 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 chemotherap
y
[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
Mupirocin ointment USP, 2% is indicated for the topical treatment of impetigo due to:
S. aureus and
S.
pyogenes.
1 INDICATIONS AND USAGE
Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD)
[see Clinical Studies (
14)].
Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD)(
1).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see Error! Hyperlink reference not valid.).
Etodolac tablets are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
1.2.Osteoarthritis
2.2.Rheumatoid arthritis
For the management of acute pain
INDICATIONS AND USAGE
Phendimetrazine tartrate extended-release capsules are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.
Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches
0.0254 = meters
The usefulness of agents of this class (see
CLINICAL PHARMACOLOGY
) should be measured against possible risk factors inherent in their use such as those described below. Phendimetrazine tartrate is indicated for use as monotherapy only.
bmi-chart
INDICATIONS AND USAGE
Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
1 INDICATIONS & USAGE
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
Rizatriptan benzoate 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 rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
Rizatriptan benzoate is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1) Not indicated for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1)
1 INDICATIONS AND USAGE
Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the:
Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (
1.1)
Treatment of adults with mycosis fungoides. (
1.1)
Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen. (
1.1)
Treatment of adults with rheumatoid arthritis. (
1.2)
Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (
1.3)
Treatment of adults with severe psoriasis. (
1.4)
1.1 Neoplastic Diseases
Methotrexate tablets are indicated for the:
treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen.
1.2 Rheumatoid Arthritis
Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis.
1.3 Polyarticular Juvenile Idiopathic Arthritis
Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
1.4 Psoriasis
Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.
INDICATIONS AND USAGE
Ursodiol capsules are indicated for patients with radiolucent, noncalcified gallbladder stones <20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.
Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
1 INDICATIONS AND USAGE
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs
[see
Warnings and Precautions (5.3)].
Prolongation of the QTc interval is associated in some other drugs with the ability to cause
torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause
torsade de pointes or increase the rate of sudden death is not yet known
[see
Warnings and Precautions (5.3)].
Schizophrenia
Ziprasidone capsules are indicated for the treatment of schizophrenia in adults
[see
Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder
[see
Clinical Studies (14.2)].
Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults
[see
Clinical Studies (14.2)].
Ziprasidone capsules are an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone capsules to prolong the QT interval and may consider the use of other drugs first
(5.3)
Ziprasidone capsules are indicated for the:
treatment of schizophrenia in adults.
(1)
acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder.
(1)
maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.
(1)
INDICATIONS
AND USAGE
Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections;tinea corporis (ringworm of the body), tinea pedis (athletes foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barbers itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi:
Trichophyton rubrum,
Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis,Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and
Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is
not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.
INDICATIONS AND USAGE
Enalapril maleate and hydrochlorothiazide tablets areindicated
for the treatment of hypertension.
These fixed dose combinations are not indicated for initial treatment (see DOSAGE AND ADMINISTRATION).
In using enalapril maleate and hydrochlorothiazide 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 does not have a similar risk (see WARNINGS).
In considering use of enalapril maleate and hydrochlorothiazide tablets, 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:
Angioedema
).
INDICATIONS AND USAGE
Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes
Note: -lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes
Note: -lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cefaclor in the subsequent prevention of rheumatic fever are not available at present.
Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor For Oral Suspension and other antibacterial drugs, Cefaclor 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.
3. Indications and Usage
Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinsons disease has not been established and, therefore, it is not recommended for these conditions.
1 INDICATIONS AND USAGE
Mometasone furoate ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.
Mometasone furoate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age. (1)
1 INDICATIONS AND USAGE
Fenofibrate capsule is a peroxisome proliferator receptor alpha (PPAR) activator indicated as an adjunct to diet:
to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (1.2).
Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia and Mixed Dyslipidemia
Fenofibrate capsules, USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate capsules, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2diabetes mellitus [see
Warnings and Precautions (5.1)
].
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed two days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (See DOSAGE AND ADMINISTRATION section.)
1 INDICATIONS AND USAGE
XENPOZYME is indicated for treatment of noncentral nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.
XENPOZYME is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for treatment of noncentral nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. (1)