um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Glycopyrrolate Injection, USP (0.2 mg/mL) is an anticholinergic indicated for use in:
anesthesia (all ages)
for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,
intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and
for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents.
peptic ulcer (adults)
as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
Glycopyrrolate Injection is an anticholinergic indicated:
in anesthesia (adult and pediatric patients)
for reduction of airway or gastric secretions, and volume and acidity of
gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,
intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and
for protection against peripheral muscarinic effects of cholinergic agents. (1)
in peptic ulcer (adults)
as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated.
INDICATIONS AND USAGE
Hypertension
Lopressor tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Lopressor is indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Lopressor tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous Lopressor. Oral Lopressor therapy can be initiated after intravenous Lopressor therapy or, alternatively, oral treatment can begin within 3 to 10days of the acute event (see
DOSAGE AND ADMINISTRATION
,
CONTRAINDICATIONS
, and
WARNINGS
).
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablet is indicated for:
Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults and adolescents (13 to 17 years)
(1, 14.1)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1, 14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (1, 14.2)
1. INDICATIONS AND USAGE
To reduce the development of drug resistant bacteria and maintain the effectiveness of Cefixime for oral suspension and other antibacterial drugs, Cefixime for oral suspension should be used only to treat 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 antimicrobial therapy. In the absence of such data,local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria:
Cefixime for oral suspension, USP is a cephalosporin antibacterial drug indicated for
Uncomplicated Urinary Tract Infections (
1.1)
Otitis Media (
1.2)
Pharyngitis and Tonsillitis (
1.3)
Acute Exacerbations of Chronic Bronchitis (
1.4)
Uncomplicated Gonorrhea (cervical/urethral)(
1.5)
1.1 Uncomplicated Urinary Tract Infections
Uncomplicated Urinary Tract Infections caused by
Escherichia coli and
Proteus mirabilis
1.2 Otitis Media
Otitis media caused by
Haemophilus influenzae,
Moraxella catarrhalis, and
Streptococcus pyogenes. (Efficacy for
Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)
Note: For patients with otitis media caused by
Streptococcus pneumoniae, overall response was approximately 10% lower for cefixime than for the comparator. [
s
ee CLINICAL STUDIES (
14)
].
1.3 Pharyngitis and Tonsillitis
Pharyngitis and Tonsillitis caused by
Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of
Streptococcus
pyogenes infections. Cefixime for oral suspension is generally effective in the eradication of
Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Cefixime for oral suspension in the subsequent prevention of rheumatic fever is not available.)
1.4 Acute Exacerbations of Chronic Bronchitis
Acute Exacerbations of Chronic Bronchitis caused by
Streptococcus pneumoniae and
Haemophilus influenzae.
1.5 Uncomplicated Gonorrhea (cervical/urethral)
Uncomplicated Gonorrhea (cervical/urethral) caused by
Neisseria gonorrhoeae (penicillinase and non- penicillinase-producing isolates).
1 INDICATIONS 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 hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Limitations of Use
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].
Niacin extended-release tablets contain extended-release niacin (nicotinic acid) and are indicated:
To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. (1)
To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. (1)
In combination with a bile acid binding resin:
Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. (1)
As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. (1)
To reduce TG in adult patients with severe hypertriglyceridemia. (1)
Limitations of use:
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial. (5.1)
1 INDICATIONS AND USAGE
Eletriptan is indicated for the acute treatment of migraine with or without aura in adults.
Eletriptan is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
4.Use only after a clear diagnosis of migraine has been established (1)
5.Not indicated for the prophylactic therapy of migraine (1)
6.Not indicated for the treatment of cluster headache (1)
Limitations of Use:
1.Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan, reconsider the diagnosis of migraine before eletriptan is administered to treat any subsequent attacks.
2.Eletriptan is not intended for the prevention of migraine attacks.
3.Safety and effectiveness of eletriptan have not been established for cluster headache.
1 INDICATIONS AND USAGE
SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see Dosage and Administration (2)
].
SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)
Important Limitations:
Should only be used for acute treatment periods up to two or three weeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
1
INDICATIONS AND USAGE
ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopain patients with Parkinsons disease (PD) experiencing off episodes.
ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopain patients with Parkinsonsdisease (PD) experiencing off episodes.(1)
1 INDICATIONS & USAGE
Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
Efficacy in bitemporal recession has not been established.
Finasteride tablets is not indicated for use in women.
Finasteride tablets is a 5-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY
(1).
Finasteride tablets is not indicated for use in
women
(1, 4, 5.1).
Indications and Usage
INDICATIONS AND USAGE
Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP 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 & USAGE
Finasteride tabletsisindicatedforthetreatmentofmalepatternhairloss(androgeneticalopecia)inMEN ONLY.
Efficacy in bitemporal recession has not been established.
Finasteride tablets is not indicatedfor use in women.
Finasteride tablets isa5-reductaseinhibitorindicatedforthetreatment ofmalepatternhairloss(androgenetic alopecia)inMENONLY
(1).
Finasteride tablets isnotindicatedforusein women (1,4,5.1).
1 INDICATIONS AND USAGE
ORABLOC is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older.
ORABLOC is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older (1).
1	INDICATIONS AND USAGE
Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.
Betamethasone Dipropionate Cream, 0.05% (Augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1)
INDICATIONS AND USAGE
HCG HAS NOT BEEN
DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF
OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS
BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE
ATTRACTIVE OR NORMAL DISTRIBUTION OF FAT, OR THAT
IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH
CALORIE-RESTRICTED DIETS.
Prepubertal cryptorchidism not due to anatomical obstruction. In
general, HCG is thought to induce testicular descent in situations
when descent would have occurred at puberty. HCG thus may help
predict whether or not orchiopexy will be needed in the future.
Although, in some cases, descent following HCG administration is
permanent, in most cases, the response is temporary. Therapy is
usually instituted in children between the ages of 4 and 9.
Selected cases of hypogonadotropic hypogonadism (hypogonadism
secondary to a pituitary deficiency) in males.
Induction of ovulation and pregnancy in the anovulatory, infertile
woman in whom the cause of anovulation is secondary and not due to
primary ovarian failure, and who has been appropriately pretreated
with human menotropins.
1 INDICATIONS AND USAGE
ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
ADUHELM is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see CLINICAL STUDIES
(14)].
The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see CLINICAL STUDIES
(14)].
Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
1 INDICATIONS AND USAGE
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
(1)
Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).
1 INDICATIONS AND USAGE
Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Tolvaptan tablets are selective vasopressin V2-receptor antagonists indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) (1)
Limitations of Use:
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets (1)
It has not been established that tolvaptan tablets provide a symptomatic benefit to patients (1)
Limitations of Use
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets.
It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.
1 INDICATIONS AND USAGE
JAYPIRCA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. (1.1)
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
1.1 Mantle Cell Lymphoma
JAYPIRCA is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
This indication is approved under accelerated approval based on response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
1 INDICATIONS AND USAGE
Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir
phosphate for oral suspension is not a substitute for early influenza
vaccination on an annual basis as recommended by the Centers for Disease
Control and Prevention Advisory Committee on Immunization Practices.
Influenza
viruses change over time. Emergence of resistance substitutions could
decrease drug effectiveness. Other factors (for example, changes in viral
virulence) might also diminish clinical benefit of antiviral drugs.
Prescribers should consider available information on influenza drug
susceptibility patterns and treatment effects when deciding whether to use
oseltamivir phosphate for oral suspension [see
Microbiology (12.4)].
Oseltamivir
phosphate for oral suspension is not recommended for patients with
end-stage renal disease not undergoing dialysis [see
Dosage and Administration (2.4) and Use in Specific Populations (8.6)].
INDICATIONS AND USAGE
Famotidine is indicated in:
Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine 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.
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.
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.
Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, CLINICAL STUDIES).
Famotidine is 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).
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, CLINICAL STUDIES).
Indication and Usage
A once daily topical neutral aqueous solution for the prevention of dental caries.
After brushing with dentifrice, apply a thin ribbon of the formulation to teeth for at least1 minute using a toothbrush.Expectorate and do not eat, drink or rinse for at least 30 minutes.