um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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 empiric selection of therapy.
Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms:
Escherichia coli,
Klebsiella species,
Enterobacter species,
Morganella morganii,
Proteus mirabilis and
Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent.
Shigellosis: For the treatment of enteritis caused by susceptible strains of
Shigella flexneri and
Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis jiroveci Pneumonia: For the treatment of documented
Pneumocystis jiroveci pneumonia and for prophylaxis against
P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing
P. jiroveci pneumonia.
Travelers Diarrhea in Adults: For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic
E. coli.
INDICATIONS AND USAGE
Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) or elevated.
In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.
1 INDICATIONS AND USAGE
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults (
1)
1 INDICATIONS & USAGE
Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for:
Empirical therapy for presumed fungal infections in febrile, neutropenic patients.
Treatment of candidemia and the following
Candida infections: intra- abdominal abscesses, peritonitis and pleural space infections.
Treatment of esophageal candidiasis.
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients
Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [
see
Clinical Studies (14.1,14.5)
].
1.2 Treatment of Candidemia and Other Candida Infections
Caspofungin acetate for injection is indicated for the treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [
see Clinical Studies (14.2), (14.5)].
Limitations of Use
: Caspofungin acetate for injection has not been studied in endocarditis, osteomyelitis, and meningitis due to
Candida.
1.3 Treatment of Esophageal Candidiasis
Caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [s
ee
Clinical Studies (14.3, 14.5)
]
Limitations of Use:
Caspofungin acetate for injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the treatment of esophageal candidiasis, patients with concomitant OPC had higher relapse rate of the OPC [
see
Clinical Studies (14.3)
]
1.4 Treatment of Invasive Aspergillosis in Patients Who Are Refractory to or Intolerant of Other Therapies
Caspofungin acetate for injection is indicated for the treatment of invasive aspergillosis in adult and pediatric patients (3 months of age and older) who are refractory to or intolerant of other therapies [
see
Clinical Studies
(14.4, 14.5)
].
Limitations of Use
: Caspofungin acetate for injection has not been studied as initial therapy for invasive aspergillosis.
1 INDICATIONS AND USAGE
Baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Limitations of Use
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. (1)
Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. (1)
Limitations of Use
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. (1)
1 INDICATIONS AND USAGE
Pregabalin is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pregabalin is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (
1)
Postherpetic neuralgia (PHN) (
1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older (
1)
Fibromyalgia (
1)
Neuropathic pain associated with spinal cord injury (
1)
1 INDICATIONS AND USAGE
CARNEXIV is indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarilynot feasible, in adults with the following seizure types:
Partial seizures with complex symptomatology
Generalized tonic-clonic seizures
Mixed seizure patterns which include the above, or other partial or generalized seizures
Limitations of Usage
CARNEXIV is not indicated for the treatment of absence seizures (including atypical absence). Carbamazepine has been associated with increased frequency of generalized convulsions in these patients.
CARNEXIV is
indicated as replacement therapy for oral carbamazepine formulations, when oral
administration is temporarily not feasible, in adults with the following
seizure types (1):
Partial seizures
with complex symptomatology
Generalized
tonic-clonic seizures
Mixed seizure
patterns which include the above, or other partial or generalized seizures
INDICATIONS AND USAGE
Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is
indicated for use as a supplement to intravenous solutions given for TPN.
Administration helps to maintain manganese serum levels and to
prevent depletion of endogenous stores and subsequent deficiency
symptoms.
INDICATIONS AND USAGE
REVEX is indicated
for the complete or partial reversal of opioid drug effects, including
respiratory depression, induced by either natural or synthetic opioids.REVEX is indicated
in the management of known or suspected opioid overdose.
INDICATIONS & USAGE
Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
1 INDICATIONS AND USAGE
Ranolazine extended-release tablets are indicated for the treatment of chronic angina.
Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Ranolazine is an antianginal indicated for the treatment of chronic angina. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).
Diclofenac sodium delayed-release tablets, USP are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1).
1 INDICATIONS AND USAGE
PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
PLIAGLIS is a combination of lidocaine, an amide local anesthetic, and tetracaine, an ester local anesthetic, indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. (1)
1 INDICATIONS AND USAGE
Micafungin for injection is indicated for:
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)].
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)].
Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].
Limitations of Use
Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established.
Additional pediatric use information is approved for Astellas Pharma US, Inc.'s Mycamine
(micafungin for injection). However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
Micafungin for injection is an echinocandin indicated in adult and pediatric patients for (1):
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).
Limitations of Use
Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida. (1)
The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established. (1)
1 INDICATIONS AND USAGE
ATORVALIQ is indicated:
To reduce the risk of:
oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
oMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
oNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
oAdults with primary hyperlipidemia.
oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.
ATORVALIQ is an HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of:
oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
oMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
oNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, congestive heart failure (CHF), and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
oAdults with primary hyperlipidemia.
oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
As an adjunct to diet for the treatment of adults with:
oPrimary dysbetaliproteinemia.
oHypertriglyceridemia.
INDICATIONS AND USAGE:
Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see
CLINICAL PHARMACOLOGY , Susceptibility Testing
).
Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to a methicillin-resistant
Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection 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.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for:
treatment of major depressive disorder (MDD) (
1.1)
prevention of seasonal affective disorder (SAD) (
1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment
[see
Clinical Studies (14.1)]
.
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM
[see
Clinical Studies (14.2)]
.
1 INDICATIONS AND USAGE
Tranexamic acid injectionis indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. (1)
INDICATIONS AND USAGE
Fluocinonide Gel USP, 0.05%is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1.3 Hypertension
Carvedilol tablets 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
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
Amelioration of allergic reactions to blood or plasma
Cold urticaria
Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the cute manifestations have been controlled.
1 INDICATIONS AND USAGE
Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimers type.
Galantamine tablets are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimers type (
1)
Use in Pregnancy
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see
PRECAUTIONS
,
Pregnancy
). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia, which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
1 INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see
Clinical Studies (14)]
.
Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults
(
1)
.
1.2Prophylaxis of Influenza
Oseltamivir Phosphate for Oral Suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
INDICATIONS AND USAGE
Famotidine tablets USP are indicated in:
1.
Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine tablets USP at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
3.
Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4.
Short-term treatment of gastroesophageal reflux disease (GERD). Famotidine tablets USP are indicated for short-term treatment of patients with symptoms of GERD (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies).
Famotidine tablets USP are also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies).
5.
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies)
.