um-ids/dailymed-annotations huggingface dataset:
Indications and Usage
Heparin Sodium Injection is indicated for:
Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and
its extension;
Low-dose regimen for prevention of postoperative deep venous thrombosis and
pulmonary embolism in patients undergoing major abdominothoracic surgery or who,
for other reasons, are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION);
Prophylaxis and treatment of pulmonary embolism;
Atrial fibrillation with embolization;
Diagnosis and treatment of acute and chronic consumptive coagulopathies
(disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism.
Heparin may also be employed as an anticoagulant in blood transfusions,
extracorporeal circulation, and dialysis procedures and in blood samples for
laboratory purposes.
INDICATIONS AND USAGE
Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium level is usually below the lower limit of normal (1.5to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) or elevated.
In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.
1 INDICATIONS AND USAGE
Donepezil hydrochloride tabletsare indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1)
INDICATIONS AND USAGE
Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
Zevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with:
relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) (1.1).
previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy (1.2).
1.1 Relapsed or Refractory, Low-grade or Follicular NHL
Zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
1.2 Previously Untreated Follicular NHL
Zevalin is indicated for the treatment of previously untreated follicular NHL in adult patients who achieve a partial or complete response to first-line chemotherapy.
1 INDICATIONS AND USAGE
Phenylephrine hydrochloride injection, 10 mg/mL is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. (1)
1 INDICATIONSAND USAGE
Rabeprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD). (1.1)
Maintenance of Healing of Erosive or Ulcerative GERD. (1.2)
Treatment of Symptomatic GERD. (1.3)
Healing of Duodenal Ulcers. (1.4)
Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence. (1.5)
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome. (1.6)
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD. (1.7)
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.2)
and the full prescribing information for clarithromycin].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in
Adolescent Patients 12 Years of Age and Older
Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
INDICATIONS
For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.
1 INDICATIONS AND USAGE
Esmolol hydrochloride injection is a beta adrenergic blocker indicated for the short-term treatment of:
Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia
(1.1)
Control of perioperative tachycardia and hypertension
(1.2)
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
Esmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physicians judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride injection is intended for short-term use.
1.2
Intraoperative and Postoperative Tachycardia and Hypertension
Esmolol hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physicians judgment such specific intervention is considered indicated.
Use of esmolol hydrochloride injection to prevent such events is not recommended.
1	INDICATIONS AND USAGE
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with
Metastatic castration-resistant prostate cancer (CRPC)
Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
metastatic castration-resistant prostate cancer (CRPC). (1)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)
1 INDICATIONS AND USAGE
Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1)].
Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [
see Dosage and Administration (1)
].
INDICATIONS AND USAGE
Famotidine tablets are indicated in:
1. Short-term treatment of active duodenal ulcer
Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer
Controlled studies in adults have not extended beyond one year.
3. Short-term treatment of active benign gastric ulcer
Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4. Short-term treatment of gastroesophageal reflux disease (GERD)
Famotidine tablets are indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Famotidine tablets are also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
INDICATIONS AND USAGE
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
1 INDICATIONS AND USAGE
QVAR REDIHALER is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older.
Limitations of Use:
QVAR REDIHALER is not indicated for the relief of acute bronchospasm.
QVAR REDIHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. (1)
Limitations of Use:
Not indicated for the relief of acute bronchospasm. (1)
1 INDICATIONS AND USAGE
Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial-Onset Seizures
Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of primary generalized tonic- clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with
appropriate social and medical services.
NOTE
Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.
INDICATIONS AND USAGE
K-PHOS NEUTRAL increases urinary phosphate and pyrophosphate. As a phosphorus supplement, each tablet supplies 25% of the U.S. Recommended Daily Allowance (U.S.RDA) of phosphorus for adul t s and children over 4 years of age.
1 INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate capsules is a proton pump inhibitor indicated for:
Short-term treatment of active duodenal ulcer (1.1)
Short-term treatment of active benign gastric ulcer (1.2)
Treatment of gastroesophageal reflux disease (GERD) (1.3)
Maintenance of healing of erosive esophagitis (1.4)
The safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. (8.4)
1.1 Duodenal Ulcer
Omeprazole and sodium bicarbonate capsules is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)]
1.2 Gastric Ulcer
Omeprazole and sodium bicarbonate capsules is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2)]
1.3 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
Omeprazole and sodium bicarbonate capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. [See Clinical Studies (14.3)]
Erosive Esophagitis
Omeprazole and sodium bicarbonate capsules is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of omeprazole and sodium bicarbonate capsules may be considered. [See Clinical Studies (14.3)]
1.4 Maintenance of Healing of Erosive Esophagitis
Omeprazole and sodium bicarbonate capsules is indicated to maintain healing of erosive esophagitis. Controlled studies do notextend beyond 12 months. [See Clinical Studies (14.4)]
1. Indications and Usage Section
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain
the effectiveness of Sulfamethoxazole and Trimethoprim Oral Suspension and other
antibacterial drugs, Sulfamethoxazole and Trimethoprim Oral Suspension 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.
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 children due to susceptible
strains of Streptococcus pneumoniae or Haemophilus influenzae when in the
judgment of the physician this combination offers some advantage over the use of
other antimicrobial agents. To date, there are limited data on the safety of
repeated use of sulfamethoxazole and trimethoprim in children under two years of
age. This product 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, this combination 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. For prophylaxis against Pneumocystis
carinii pneumonia in individuals who are immunosuppressed and considered
to be at an increased risk of developing Pneumocystis
carinii pneumonia.
Travelers Diarrhea In Adults:
For the treatment of travelers diarrhea due to susceptible strains of
enterotoxigenic E. coli.
INDICATIONS
& USAGE
Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies (14)]
Maintenance treatment in patients 7 years and older [see Clinical Studies (14)].
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic and mixed episodes in patients 7 years and older (1)
Maintenance treatment in patients 7 years and older (1)
1
INDICATIONS AND USAGE
ARIMIDEX is an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer (1.1)
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer (1.2)
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX (1.3)
1.1
Adjuvant Treatment
ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
1.2
First-Line Treatment
ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
1.3
Second-Line Treatment
ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
INDICATIONS AND USAGE
Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see
WARNINGS
), reserve Levorphanol Tartrate Tablets 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.
INDICATIONS AND USAGE
Adult Patients
Flumazenil injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil injection is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use ).
1 INDICATIONS & USAGE
Amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (
2)].
Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.
INDICATIONS AND USAGE
Lomotil is effective as adjunctive therapy in the management of diarrhea.
INDICATIONS AND USAGE
Ranitidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.