um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE SECTION
Seromycin is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, Seromycin should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent.
Seromycin may be effective in the treatment of acute urinary tract infections caused by susceptible strains of grampositive and gramnegative bacteria, especially
Enterobacterspp. and
Escherichia coli. It is generally no more and is usually less effective than other antimicrobial agents in the treatment of urinary tract infections caused by bacteria other than mycobacteria. Use of Seromycin in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug.
INDICATIONS AND USAGE
Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see
WARNINGS: Addiction, Abuse, and Misuse
] reserve buprenorphine hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
1 INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults and adolescents aged 13 to 17 years (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10 to 17 years (1.2)
Treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years (1.3)
1.1 Schizophrenia
AdultsRisperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)].
AdolescentsRisperidone tablets are indiated for the treatment of schizophrenia in adolescents aged 13 to 17 years [see Clinical Studies (14.1)].
1.2 Bipolar Mania
Monotherapy - Adults and PediatricsRisperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10 to 17 years [see Clinical Studies (14.2)].
Combination Therapy-AdultsThe combination of risperidone tablets with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4)].
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)
(1.1)
Maintenance of Healing of Erosive Esophagitis
(1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
(1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium
delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
INDICATIONS AND USAGE
Clobetasol propionate topical solution is indicated for shortterm topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis.
This product is not recommended for use in pediatric patients under 12 years of age.
1 INDICATIONS AND USAGE
SAIZEN is a recombinant human growth hormone indicated for:
Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD) (1.1)
Adult: Treatment of adults with either adult onset or childhood onset GHD. (1.2)
1.1 Pediatric Patients
SAIZEN (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.
1.2 Adult Patients
SAIZEN is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset
Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset
Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.
1 INDICATIONS AND USAGE
Cisatracurium besylate injection is indicated:
as an adjunct to general anesthesia to
facilitate tracheal intubation in adults and in pediatric patients 1 month
to 12 years of age
to provide skeletal muscle relaxation in adults during surgical
procedures or during mechanical ventilation in the ICU
to provide skeletal muscle relaxation during
surgical procedures via infusion in pediatric patients 2 years and older
Limitations of Use
Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Cisatracurium besylate injection is a nondepolarizing neuromuscular blocker indicated:
as an adjunct to general anesthesia to
facilitate tracheal intubation in adults and in pediatric patients 1 month
to 12 years of age (1)
to provide skeletal muscle relaxation during
surgery in adults and in pediatric patients 2 to 12 years of age as a
bolus or infusion maintenance (1)
for mechanical ventilation in the ICU in adults
(1)
Limitations of Use:
Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)
INDICATIONS AND USAGE SECTION
Hyoscyamine sulfate is indicated whenever antispasmodic or anticholinergic therapy is desired. The high degree of purity allows effective action at very low dosage, with a minimal incidence of unwanted side effects.
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see CLINICAL STUDIES (14)] .
Important Limitations of Use
Pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see WARNINGS AND PRECAUTIONS (5.3)] .
These highlights do not include all the information needed to use.
See full prescribing information for Lactulose
Initial U.S. approval
label indications and usage
1 INDICATIONS & USAGE
Adults
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies
(14)].
Adults
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [
see
Clinical Studies (14)
].
1 INDICATIONS AND USAGE
Carvedilol tablets USP are an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets USP are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of
40% (with or without symptomatic heart failure) [see
Clinical Studies (14.2)
].
1.3 Hypertension
Carvedilol tablets USP 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)].
1 INDICATIONS AND USAGE
Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for:
Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery.
(1.1)
Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin. (
1.2,
1.3)
1.1 Prophylaxis of Deep Vein Thrombosis
Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing hip fracture surgery, including extended prophylaxis;
in patients undergoing hip replacement surgery;
in patients undergoing knee replacement surgery;
in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
1.2 Treatment of Acute Deep Vein Thrombosis
Fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
1.3 Treatment of Acute Pulmonary Embolism
Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
1 INDICATIONSAND USAGE
Exemestane is an aromatase inhibitor indicated for:
adjuvant treatment of postmenopausal women with estrogen-receptor
positive
early
breast
cancer
who
have
received
two to
three years of tamoxifen and are switched to
exemestane
tablets for
completion of a
total of five consecutive years of adjuvant hormonal therapy (14.1).
treatment of advanced breast cancer in
postmenopausal women whose
disease has
progressed following
tamoxifen therapy (14.2).
1.1 Adjuvant Treatment of Postmenopausal Women
Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)].
1.2 Advanced Breast Cancer in Postmenopausal Women
Exemestane tablets are indicated for the treatment of advanced breastcancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
INDICATIONS AND USAGE
Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
INDICATIONS AND USAGE
Phenytoin is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATIONand CLINICAL PHARMACOLOGYsections).
INDICATIONS AND USAGE
Lidocaine HCl Injections are indicated for production of local anesthesia by infiltration techniques such as percutaneous injection by peripheral nerve block techniques such as brachial plexus and intercostal, when the accepted procedures for these techniques as described in standard textbooks are observed.
NDICATIONS & USAGE
Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
1 INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
1 INDICATIONS AND USAGE
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the:
Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. (1.1)
Treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. (1.2)
1.1	Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.
1.2	Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture
TYMLOS is indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
1 INDICATIONS AND USAGE
NAYZILAM is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older.
NAYZILAM is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic
episodes of
frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. (1)
1 INDICATIONS AND USAGE
Treprostinil is a prostacyclin vasodilator indicated for:
Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%) (1.1)
Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. (1.2)
1.1 Pulmonary
Arterial Hypertension
Treprostinil is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to -pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%) [see Clinical Studies (14.1)].
1.2 Pulmonary Arterial Hypertension in Patients
Requiring Transition from Epoprostenol
In patients with PAH requiring transition from epoprostenol, treprostinil is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.
1 INDICATIONS AND USAGE
Bupropion hydrochloride tabletsare indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion hydrochloride tabletsin 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)].
Bupropion hydrochloride tablets arean aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
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)]
.
1 INDICATIONS AND USAGE
Gabapentin Capsules, USP are 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 Capsules are 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 INDICATIONSAND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia [seeClinicalStudies(14.1)]
Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)]
Treatment of Tourettes Disorder [see Clinical Studies (14.5)]
Additional pediatric use information is approvedfor OtsukaAmericaPharmaceutical, Inc.sABILIFY(aripiprazole) product.However,due to OtsukaAmericaPharmaceutical,Inc.smarketingexclusivity rights, this drugproduct is not labeledwith that information.
Aripiprazole tablets are an atypical antipsychotic. The oral formulation is indicated for:
Schizophrenia(14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourettes disorder (14.5)
INDICATIONS AND USAGE
VTOL LQ is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
INDICATIONS AND USAGE
Estradiol Tablets USP are indicated in the:
Treatment of moderate to severe vasomotor symptoms associated with the menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the 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 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 PHARMACOLOGY, 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 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.