um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.
Temsirolimus injection is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (
1)
1
INDICATIONS AND USAGE
Amiodarone hydrochloride is indicated for thetreatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot betolerated.
Amiodarone hydrochloride is an antiarrhythmic indicated for:
Recurrent ventricular fibrillation. (
1)
Recurrent hemodynamically unstable ventricular tachycardia. (
1)
1 INDICATIONS AND USAGE
Diclofenac Potassium Capsules is indicated for relief of mild to moderate acute pain in adult patients.
Pediatric use information is approved for Assertio Therapeutics Inc's ZIPSOR (diclofenac potassium) Capsules. However, due to Assertio Therapeutics Inc's marketing exclusivity rights, this drug product is not labeled with that information.
Diclofenac Potassium Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult patients (1)
1 INDICATIONS AND USAGE
Levomilnacipran is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].
Limitation of Use: Levomilnacipran extended-release capsules are not approved for the management of fibromyalgia. The efficacy and safety of levomilnacipran extended-release capsules for the management of fibromyalgia have not been established.
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults (1).
Limitation of Use: Levomilnacipran extended-release capsules are not approved for the management of fibromyalgia. The efficacy and safety of levomilnacipran extended-release capsules for the management of fibromyalgia have not been established (1).
1 INDICATIONS & USAGE
Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. (1)
INDICATIONS
Sulfacetamide Sodium and Sulfur cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
1 INDICATIONS AND USAGE
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile dysfunction (ED) (
1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (
1.2)
ED and the signs and symptoms of BPH (ED/BPH) (
1.3)
If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (
1.4).
1.1 Erectile Dysfunction
Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED).
1.2 Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4 Limitation of Use
If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decrease from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown
[see Clinical Studies (
14.3)].
INDICATIONS AND USAGE
Prednisolone acetate ophthalmic suspension 1% is indicated for the treatment of steroid-responsiveinflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segmentof the globe.
1 INDICATIONS AND USAGE
Ammonia N 13 Injection, USPis indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Ammonia N 13 Injection, USPis a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease
(1).
INDICATIONS AND USAGE
SYNALAR Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
1 INDICATIONS AND USAGE
Desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (MDD)
[see
Clinical Studies (14)].
Desvenlafaxine extended-release tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (
1).
INDICATIONS AND USAGE
Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Orally Disintegrating Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a drying agent in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.
1 INDICATIONS AND USAGE
COSOPT PF is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1)].
COSOPT PF is a carbonic anhydrase inhibitor with a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of COSOPT twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
INDICATIONS AND USAGE
Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively.
Sodium Citrate and Citric Acid Oral Solution USP is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patients clinical condition allows (see , , and ). Alternatively, treatment can begin within 3 to 10 days of the acute event (see ).
DOSAGE AND ADMINISTRATION
CONTRAINDICATIONS
WARNINGS
DOSAGE AND ADMINISTRATION
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets
are indicated for:
Pantoprazole sodium is 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 Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
1 INDICATIONS AND USAGE
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
INDICATIONS AND USAGE
Perphenazine tablets, USP are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults.
Perphenazine tablets, USP have not been shown effective for the management of behavioral complications in patients with mental retardation.
1 INDICATIONS AND USAGE
1.1 Treatment of HIV-1 Infection
TRUVADA, a combination of EMTRIVA and VIREAD, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see DOSAGE AND ADMINISTRATION (2) and CLINICAL STUDIES (14)].
The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:
It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen.
TRUVADA should not be coadministered with ATRIPLA, COMPLERA, DESCOVY, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, VEMLIDY, VIREAD, or lamivudine-containing products [see WARNINGS AND PRECAUTIONS (5.4)].
In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history [see MICROBIOLOGY (12.4)].
1.2 Pre-Exposure Prophylaxis
TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples [see CLINICAL STUDIES (14.2, 14.3)].
When considering TRUVADA for pre-exposure prophylaxis the following factors may help to identify individuals at high risk:
has partner(s) known to be HIV-1 infected, or
engages in sexual activity within a high prevalence area or social network and one or more of the following:
inconsistent or no condom use
diagnosis of sexually transmitted infections
exchange of sex for commodities (such as money, food, shelter, or drugs)
use of illicit drugs or alcohol dependence
incarceration
partner(s) of unknown HIV-1 status with any of the factors listed above
When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:
prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [see WARNINGS AND PRECAUTIONS (5.8)];
counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [see WARNINGS AND PRECAUTIONS (5.8)];
confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection [see WARNINGS AND PRECAUTIONS (5.8)]; and
screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP.
1 INDICATIONS AND USAGE
Carmustine for injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following:
Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
Multiple myeloma in combination with prednisone.
Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs.
Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.
Carmustine for injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors
glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma,
and metastatic brain tumors (1)
Multiple
myeloma-in combination with prednisone (1)
Relapsed or
refractory Hodgkin's lymphoma in combination with other approved drugs
(1)
Relapsed or
refractory Non-Hodgkin's lymphomas in combination with other approved
drugs (1)
1 INDICATIONS & USAGE
Montelukast sodium tablet is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older (
1.3). Reserve use for patients
who have an inadequate response or intolerance to alternative therapies (1.3).
1.1 Asthma
Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see
Warnings and Precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies.
INDICATIONS AND USAGE
Clomipramine hydrochloride capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of clomipramine hydrochloride capsulesfor long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsulesfor extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (
see
DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Gabapentin capsules 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 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)
INDICATIONS AND USAGE
Acyclovir ointment USP 5% is indicated in the management of initial genital herpes and in limited non- life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
INDICATIONS AND USAGE
Guanfacine tablets are indicated in the management of
hypertension. Guanfacine may be given alone or in combination with other
antihypertensive agents, especially thiazide-type diuretics.
INDICATIONS AND USAGE
To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.
INDICATIONS AND USAGE
Luxiq is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
1 INDICATIONS AND USAGE
CARISOPRODOL is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
CARISOPRODOL 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)].
CARISOPRODOL is a muscle relaxant indicated for the relief of discomfort associated withacute, painful musculoskeletal conditions in adults. (1)
Limitation of Use
Should only be used for acute treatment periods up to two or three weeks(1)
INDICATIONS & USAGE
Diazoxide Oral Suspension, USP is useful in the management of hypoglycemia due to hyperinsulinism associated with the following conditions:
Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy.
Infants and Children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide Oral Suspension, USP may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.
Diazoxide Oral Suspension, USP should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with Diazoxide Oral Suspension, USP should be considered.
1 INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
EZALLOR Sprinkleis an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.1)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.2)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.3)
Limitations of use (1.4):
EZALLOR Sprinkle has not been studied in Fredrickson Type I and V dyslipidemias
1.1 Hypertriglyceridemia
EZALLOR Sprinkle is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.2 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
EZALLOR Sprinkle is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.3 Adult Patients with Homozygous Familial Hypercholesterolemia
EZALLOR Sprinkle is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.4 Limitations of Use
EZALLOR Sprinkle has not been studied in Fredrickson Type I and V dyslipidemias.
INDICATIONS AND USAGE
Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life- threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.