um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:
have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
are metastatic or where surgical resection is likely to result in severe morbidity, and
have no satisfactory alternative treatments or that have progressed following treatment.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that:
have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
are metastatic or where surgical resection is likely to result in severe morbidity, and
have no satisfactory alternative treatments or that have progressed following treatment.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials (1,14).
1 INDICATIONS AND USAGE
Mercaptopurine tablets are a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (1.1)
1.1	Acute Lymphoblastic Leukemia
Mercaptopurine tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
1 INDICATIONS AND USAGE
Campral is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.
The efficacy of Campral in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning Campral treatment.
The efficacy of Campral in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
Campral is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( , ).
1
14
Treatment with Campral should be part of a comprehensive management program that includes psychosocial support ( ).
1
INDICATIONS AND USAGE
Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials
under
CLINICAL PHARMACOLOGY
). It has not been shown to increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
INDICATIONS AND USAGE
Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcers:
Pseudomonas aeruginosa
Serratia marcescens *
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group) *
Conjunctivitis:
Haemophilus influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
*Efficacy for this organism was studied in fewer than 10 infections.
INDICATIONS AND USAGE
For control of severe nausea and vomiting. For the treatment of schizophrenia.
Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).
When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see
WARNINGS
).
The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).
Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
INDICATIONS & USAGE
Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation: Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials.
Rheumatoid Arthritis: Azathioprine is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of azathioprine with these agents cannot be recommended.
1 INDICATIONS AND USAGE
Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)].
Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [seeClinical Studies (14)].
Gefitinib tablets are tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. (1) Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. (1)
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (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 BACTRIM in pediatric patients under two years of age. BACTRIM is 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 in the judgment of the physician BACTRIM offers 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 Carinii Pneumonia:
For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
Traveler's Diarrhea in Adults:
For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
1 INDICATIONS & USAGE
Fluoxetine is 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 adults 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 is 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 is 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 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 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 is 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 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 is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)].
The effectiveness of fluoxetine 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 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:
Adapalene Topical Solution 0.1% is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS & USAGE
Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution, 0.2% diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.
Brimonidine Tartrate Ophthalmic Solution, 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1)
1 INDICATIONS AND USAGE
Desmopressin acetate injection is a vasopressin analog used for:
Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. (1.1)
Hemophilia A- for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.2)
von Willebrands disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. (1.3)
Limitations of Use
Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. (1.3)
von Willebrands disease (severe Type I) - not indicated for the treatment of patients with severe Type I von Willebrands disease and when there is evidence of an abnormal molecular form of factor VIII antigen. (1.3)
1.1 Central Diabetes Insipidus
Desmopressin acetate injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.
Limitations of Use:
Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.
1.2 Hemophilia A
Desmopressin acetate injection is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to:
Maintain hemostasis during surgical procedures and postoperatively
Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.
1.3 von Willebrands Disease (Type I)
Desmopressin acetate injection is indicated for patients with mild to moderate von Willebrands disease (Type I) with factor VIII levels greater than 5% to:
Maintain hemostasis during surgical procedures and postoperatively
Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.
Limitations of Use
Desmopressin acetate is not indicated for the treatment of severe von Willebrands disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen [see Warnings and Precautions (5.2)].
INDICATIONS AND USAGE
Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia colior Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
INDICATIONS AND USAGE
Ferric Subsulfate, Aqueous, is a stypic agent used for achieving local hemostasis. In punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.
1
One method of applying ferric subsulfate solution for dermal use consists of the physician placing fingers at the opposite edge of the wound and stretching the skin. The wound is then wiped with gauze, the ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds.
2
INDICATIONS AND USAGE
Normosol-R is indicated for
replacement
of acute extracellular fluid volume losses in
surgery, trauma, burns or shock. Normosol-R also can be used as an
adjunct to restore a decrease in circulatory volume in patients with
moderate blood loss. Normosol-R is not intended to supplant transfusion
of whole blood or packed red cells in the presence of uncontrolled
hemorrhage or severe reductions of red cell volume.
1.1 Alzheimers Disease
Rivastigmine transdermal system is indicated for the treatment of dementia of the Alzheimers type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
INDICATIONS AND USAGE
A. Benign Prostatic Hyperplasia (BPH)Doxazosin mesylate tablets are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning).
Doxazosin mesylate tablets may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin mesylate tablet monotherapy.
Doxazosin mesylate tablets provides rapid improvement in symptoms and urinary flow rate in 66-71% of patients.
Sustained improvements with doxazosin mesylate tablets were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.B. HypertensionDoxazosin mesylate tablets are also indicated for the treatment of hypertension.
Doxazosin mesylate tablets may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors.
Juvenile idiopathic arthritis
Relief of the signs and symptoms of pauciarticular or polyarticular course juvenile idiopathic arthritis in patients 2 years and older (suspension) and in pediatric patients weighing at least 60 kg (orally-disintegrating tablet).
Osteoarthritis
Relief of the signs and symptoms of osteoarthritis (OA); management of OA pain.
Rheumatoid arthritis (orally-disintegrating tablet, tablet, and suspension only)
Relief of the signs and symptoms of rheumatoid arthritis.
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 has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
1 INDICATIONS & USAGE
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcuspyogenes.
1.2 Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes,and Mo raxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin is indicated for the treat ment of bone infections caused by susceptible isolates of Staphylococcusaureus and Proteus mi rabilis.
1.5 Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escheric hia c oli, Proteus mirabilis, and Klebsiella pneumonia e.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired):
testicular
failure due to conditions such as cryptorchidism, bilateral torsion,
orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's
syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
These men usually have low serum testosterone concentrations and
gonadotropins (FSH, LH) above the normal range.
Hypogonadotropic
hypogonadism (congenital or acquired): gonadotropin or luteinizing
hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic
injury from tumors, trauma, or radiation. These men have low testosterone
serum concentrations but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of
testosterone topical solution in men with "age-related hypogonadism"
(also referred to as "late-onset hypogonadism") have not been
established.
Safety and efficacy
of testosterone topical solution in males <18 years old have not been
established [see Use in Specific Populations (8.4)].
Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Limitations of use:
Safety and efficacy of testosterone topical solution in men with "age-related hypogonadism" have not been established. (1)
Safety and efficacy of testosterone topical solution in males <18 years old have not been established. (8.4)