um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE SECTION
1.1 Monotherapy Epilepsy
Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)].
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Dexmedetomidine hydrochloride is a relatively selective alpha2-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.
Administer dexmedetomidine hydrochloride by continuous infusion not to exceed 24 hours (1.1)
Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2)
1.1 Intensive Care Unit Sedation
Dexmedetomidine Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.
Dexmedetomidine Injection should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine Injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine Injection prior to extubation.
1.2 Procedural Sedation
Dexmedetomidine Injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
INDICATIONS AND USAGE
Naloxone Hydrochloride Injection, USP is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage.
Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).
1INDICATIONS AND USAGE
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets are a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2.
(1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
(1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
(1)
postoperative nausea and/or vomiting.
(1)
INDICATIONS AND USAGE
PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.
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.
INDICATIONS & USAGE
Levothyroxine sodium is used for the following indications:
Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
INDICATIONS AND USAGE
MEPHYTON is indicated in the following coagulation disorders which are due to faulty formation of factorsII, VII, IX and X when caused by vitaminK deficiency or interference with vitaminK activity.
MEPHYTON tablets are indicated in:
anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
hypoprothrombinemia secondary to antibacterial therapy;
hypoprothrombinemia secondary to administration of salicylates;
hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitaminK will not be absorbed.
1 INDICATIONSAND USAGE
Erlotinib tablet is a kinase inhibitor indicated for:
The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1)
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2)
Limitations of Use:
Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. (1.1)
Erlotinib tablet is not recommended for use in combination with platinum-based chemotherapy. (1.1)
1.1 Non-Small Cell Lung Cancer (NSCLC)
Erlotinib tablets are indicated for:
The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies (14.1, 14.3)].
Limitations of use:
Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (14.1,
14.2)].
Erlotinib tablet is not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies (14.4)].
1.2 Pancreatic Cancer
Erlotinib tablet in combination with gemcitabineis indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5)].
INDICATIONS AND USAGE:
Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx.
It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
INDICATIONS AND USAGE
Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, 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
Promethazine hydrochloride injection is indicated for the following conditions:
1. Amelioration of allergic reactions to blood or plasma.
2. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
3. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
4. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
5. Active treatment of motion sickness.
6. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
7. As an adjunct to analgesics for the control of postoperative pain.
8. Preoperative, postoperative, and obstetric (during labor) sedation.
9. Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.
Indications and Directions
Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations.
Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit, repeat the rinse procedure with an additional 10mL.
Advise patient not to eat, drink or rinse for 30 minutes after application.
Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls
INDICATIONS AND USAGE
Cevimeline is indicated for the treatment of symptoms of dry mouth in patients
with Sjgrens Syndrome.
1 INDICATIONS & USAGE
Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. (1)
INDICATIONS & USAGE
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.
Edema
Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome.
Furosemide is particularly useful when an agent with greater diuretic potential is desired.
Furosemide is indicated as adjunctive therapy in acute pulmonary edema.
The IV administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.
If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the IM or IV route.
Parenteral use should be replaced with oral furosemide as soon as practical.
INDICATIONS AND USAGE
Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults.
INDICATIONS AND USAGE
Epilepsy
Carbamazepine tablets and carbamazepine tablets (chewable) are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine tablets and carbamazepine tablets (chewable) as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
Generalized tonic-clonic seizures (grand mal).
Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine tablets and carbamazepine tablets (chewable) (see
PRECAUTIONS
,
General
).
Trigeminal Neuralgia
Carbamazepine tablets and carbamazepine tablets (chewable) are indicated in the treatment of the pain associated with true trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
1 INDICATIONS AND USAGE
Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis.
Pediatric use information is approved for Genzyme Corporations RENVELA (sevelamer carbonate) tablets and RENVELA (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporations marketing exclusivity rights, these drug products are not labeled with that pediatric information.
Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis. (1)
Indications and Usage
Bupropion hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion hydrochloride tablets, USP in 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)].
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.
Urinary Tract Infections
For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media
For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim tablets 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 tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are 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 a physician deems that
sulfamethoxazole and trimethoprim tablets could offer 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 jirovecii Pneumonia
For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P.
jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia.
Traveler's Diarrhea in Adults
For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
INDICATIONS AND USAGE
Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
1 INDICATIONS AND USAGE
Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.
Hydrocortisone ButyrateLotion, 0.1%is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. (1)
1 INDICATIONS AND USAGE
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II
III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1)
1.1 Pulmonary Arterial Hypertension
Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II
III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
1 INDICATIONS & USAGE
Acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).
Acetylcysteine injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with an acute ingestion or from repeated supratherapeutic ingestion (RSI).
1 INDICATIONS AND USAGE
Atorvastatin calcium tablets is indicated:
To reduce the risk of:
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia
Hypertriglyceridemia
Atorvastatin calcium tablets is an HMG-CoA reductase inhibitor (statin) indicated:
To reduce the risk of:
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
As an adjunct to diet for the treatment of adults with:
Primary dysbetaliproteinemia.
Hypertriglyceridemia.
INDICATIONS AND USAGE:
Orphenadrine citrate injection is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
PEPCID tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
PEPCID tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
PEPCID is a histamine-2 (H2) receptor antagonist indicated (1):
In adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer.
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
In adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison
syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
INDICATIONSAND USAGE
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.