um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of:
Major Depressive Disorder (
MDD)
Social Anxiety Disorder (
SAD)
Generalized Anxiety Disorder (
GAD)
Panic Disorder (
PD)
1.1 Major Depressive Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.
1.2 Generalized Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.
1.3 Social Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.
1.4 Panic Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.
1 INDICATIONS AND USAGE
Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated in adults for the following:
Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1)
Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2)
1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
Pantoprazole Sodium for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).
Safety and efficacy of Pantoprazole Sodium for Injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome
Pantoprazole Sodium for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
INDICATIONS AND USAGE
IMPORTANT NOTICE
Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.
Antepartum
Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.
Postpartum
Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.
INDICATIONS
AND USAGE:
For use in Computed Tomography to opacify the GI tract.
INDICATIONS AND USAGE
Dobutamine in 5% Dextrose Injection, USP is indicated when
parenteral therapy is necessary for inotropic support in the short-term treatment of cardiac decompensation due to
depressed contractility resulting either from organic heart disease or from
cardiac surgical procedures. Experience with intravenous dobutamine in
controlled trials does not extend beyond 48 hours of repeated boluses and/or
continuous infusions.
Whether given orally, continuously intravenously, or intermittently
intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope
has been shown in controlled trials to be safe or effective in the long-term
treatment of congestive heart failure. In controlled trials of chronic oral
therapy with various such agents, symptoms were not consistently alleviated, and
the cyclic-AMP-dependent inotropes were consistently associated with increased
risks of hospitalization and death. Patients with NYHA Class IV symptoms
appeared to be at particular risk.
1 INDICATIONS & USAGE
Lurasidone hydrochloride 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 (other indication) [see Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (other indication) [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 (other indication) in adults as monotherapy (1, 14.2) Depressive episode associated with Bipolar I Disorder (other indication) in adults as adjunctive therapy with lithium or valproate (1, 14.2)
INDICATIONS AND USAGE
Methenamine mandelate is indicated for thesuppression or elimination of bacteriuria associated withpyelonephritis, cystitis, and other chronic urinary tractinfections; also those neurologic diseases leading to aninfected residual urine. When used as recommended,methenamine mandelate is particularly suitable forlong-term therapy because of its safety and becauseresistance to the nonspecific bactericidal action offormaldehyde does not develop. Pathogens resistant toother antibacterial agents may respond to methenaminemandelate because of the nonspecific effect offormaldehyde formed in an acid urine.
Prophylactic Use Rationale:Urine is a good culturemedium for many urinary pathogens. Inoculation by a feworganisms (relapse or reinfection) may lead to bacteriuriain susceptible individuals. Thus, the rationale ofmanagement in recurring urinary tract infection(bacteriuria) is to change the urine from agrowth-supporting to a growth-inhibiting medium. Thereis a growing body of evidence that long-termadministration of methenamine mandelate canprevent the recurrence of bacteriuria in patients withchronic pyelonephritis.
Therapeutic Use Rationale: Methenamine mandelatehelps to sterilize the urine, and in some situations inwhich underlying pathologic conditions preventsterilization by any means, it can help to suppress thebacteriuria. Methenamine mandelate should not beused alone for acute infections with parenchymalinvolvement causing systemic symptoms such as chillsand fever. A thorough diagnostic investigation as a part ofthe overall management of the urinary tract infectionshould accompany the use of methenamine mandelate.
1 INDICATIONS & USAGE
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Postherpetic neuralgia in adults
(1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (
1)
1 INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
Adjuvant Colon Cancer (1.1)
Patients with Dukes' C colon cancer
Metastatic Colorectal Cancer (1.1)
First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred
Metastatic Breast Cancer (1.2)
In combination with docetaxel after failure of prior anthracycline-containing therapy
As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen
1.1 Colorectal Cancer
Capecitabine tablets USP is
indicated as a single agent for adjuvant treatment in patients with Dukes'
C colon cancer who have undergone complete resection of the primary tumor
when treatment with fluoropyrimidine therapy alone is preferred.
Capecitabine was non-inferior to 5- fluorouracil and leucovorin (5-FU/LV)
for disease-free survival (DFS). Physicians should consider results of
combination chemotherapy trials, which have shown improvement in DFS and
OS, when prescribing single-agent capecitabine in the adjuvant treatment
of Dukes' C colon cancer.
Capecitabine tablets USP are indicated as
first-line treatment of patients with metastatic colorectal carcinoma when
treatment with fluoropyrimidine therapy alone is preferred. Combination
chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A
survival benefit over 5-FU/LV has not been demonstrated with capecitabine
tablets monotherapy. Use of capecitabine tablets USP instead of 5-FU/LV in
combinations has not been adequately studied to assure safety or
preservation of the survival advantage.
1.2 Breast Cancer
Capecitabine tablets USP in combination with docetaxel are indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Capecitabine tablets monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
1 INDICATIONS & USAGE
Atovaquone oral suspension is a quinone antimicrobial drug indicated for:
Prevention of
Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
(1.1)
Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX.
(1.2)
Limitations of Use
(1.3):
Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO
2] >45 mm Hg) with atovaquone oral suspension has not been studied.
The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied.
1.1 Prevention of
Pneumocystis jirovecii Pneumonia
Atovaquone oral suspension is indicated for the prevention of
Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
1.2 Treatment of Mild-to-Moderate
Pneumocystis jirovecii Pneumonia
Atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
1.3 Limitations of Use
Clinical experience with atovaquone for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO
2] 45 mm Hg). Treatment of more severe episodes of PCP with atovaquone has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.
1 INDICATIONS AND USAGE
Calcium Acetate Capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Calcium Acetate Capsules is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)
INDICATIONS AND USAGE
Nifediac CC Extended-release Tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Leucovorin is indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.
1 INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
Buprenorphine sublingual tablets, contain buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction.
Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (
1)
1
INDICATIONS AND USAGE
ELEVIDYS is indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
This indication is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin observed in patients treated with ELEVIDYS [see Clinical Pharmacology (12), Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
ELEVIDYS is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. This indication is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle observed in patients treated with ELEVIDYS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1, 12, 14)
1 INDICATIONS AND USAGE
Quetiapine tablet is an atypical antipsychotic indicated for the treatment of:
Schizophrenia (
1.1)
Bipolar I disorder manic episodes (
1.2)
Bipolar disorder, depressive episodes (
1.2)
1.1 Schizophrenia
Quetiapine tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials
[see
Clinical Studies (14.1)].
1.2 Bipolar Disorder
Quetiapine tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex.
Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years)
[see
Clinical Studies
(14.2)	]
.
Quetiapine tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder
[see
Clinical Studies (14.2)]
.
Quetiapine tablet is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials
[see
Clinical Studies (14.2)]
.
1.3	Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
INDICATIONS FOR USE
Gebauers Pain Ease Mist and Medium Stream Sprays are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Pain Ease controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).
INDICATIONS & USAGE SECTION
Fluconazole Tablets USP are indicated for the treatment of:
1.Vaginal candidiasis (vaginal yeast infections due to Candida).2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.3.Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.Prophylaxis
Fluconazole Tablets USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
INDICATIONS AND USAGE
PREMARIN therapy is indicated in the:
Treatment of moderate to severe vasomotor symptoms due to menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See
CLINICAL STUDIES
.)The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Indications and Usage Section
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Etodolac extended-release tablets are indicated:
*
For relief of signs and symptoms of juvenile arthritis
*
For relief of the signs and symptoms of rheumatoid arthritis
*
For relief of the signs and symptoms of osteoarthritis
1 INDICATIONS AND USAGE
Testosterone gel, 1.62% is indicated for replacement therapy in adult 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 (follicle-stimulating hormone [FSH], luteinizing hormone
[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 gel, 1.62% in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Safety and efficacy of testosterone gel, 1.62% in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Indications and Usage (1), and Clinical Pharmacology (12.3)].
Testosterone gel, 1.62 % 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 gel, 1.62 % in men with "age-related hypogonadism" have not been established. (1)
Safety and efficacy of testosterone gel, 1.62 % in males less than 18 years old have not been established. (1, 8.4)
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)
1	INDICATIONS AND USAGE
TRULANCE is indicated in adults for the treatment of:
chronic idiopathic constipation (CIC).
irritable bowel syndrome with constipation (IBS-C).
TRULANCE is a guanylate cyclase-C agonist indicated in adults for treatment of:
chronic idiopathic constipation (CIC). (1)
irritable bowel syndrome with constipation (IBS-C). (1)