um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Bupivacaine Hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration(2.2)].
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration(2.2), Contraindications(4), Warnings and Precautions(5.1, 5.5, 5.7, 5.9)].
Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2)
Limitations of Use
Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use. (1, 2.2, 4, 5.1,5.5, 5.7, 5.9)
1 INDICATIONS AND USAGE
NAMENDA XR (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
NAMENDA XR contains memantine HCl, an NMDA receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( )
1
1 INDICATIONS AND USAGE
Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablets can be continued during acute exacerbations of asthma.
Zileuton extended-release tablets are a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. (1)
Do not use zileuton extended-release tablets to treat an acute asthma attack. (1)
INDICATIONS AND USAGE
Halobetasol propionate cream, 0.05% is a super-high potency
corticosteroid indictated for the relief of the inflammatory and pruritic
manifestations of corticosteroid-responsive dermatoses. Treatment beyond two
consecutive weeks is not recommended, and the total dosage should not exceed 50
g/week because of the potential for the drug to suppress the
hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age
is not recommended. As with other highly active corticosteroid, therapy should
be discontinued when control has been achieved. If no improvement is seen within
2 weeks, reassessment of the diagnosis may be necessary.
1 INDICATIONS AND USAGE
Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol tablets, USP 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 tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (1)
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
DOSAGE AND ADMINISTRATION
,
CONTRAINDICATIONS
, and
WARNINGS
).Alternatively, treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION
).
1 INDICATIONS AND USAGE
Aurovela 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].
The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m2 has not been evaluated.
Aurovela 24 Fe is acombination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen,indicated for use by women to prevent pregnancy. (1) The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m2 has not been evaluated. (1, 8.8)
Indications and Usage
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets USP are indicated for:
Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets USP are indicated in adults for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets USP are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1 INDICATIONS AND USAGE
OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to:
Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1)
Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2)
1.1	CNS (Central Nervous System)
OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1)].
1.2	Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)
OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Topiramate is indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2)
Preventive treatment of migraine in patients 12 years of age and older (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets
are indicated for the preventive treatment of migraine in patients 12 years of age and older.
INDICATIONS
Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS and USAGE
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants.(
1.1)
1.1 Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant
[see
Clinical Studies (14.1)]
, liver transplant
[see
Clinical Studies (14.2)], or
heart transplant
[see
Clinical Studies (14.3)]
and pediatric patients receiving allogeneic liver transplants
[see
Clinical Studies (14.2)]
in combination with other immunosuppressants.
Additional pediatric use information is approved for Astellas Pharma US, Inc.s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
INDICATIONS
For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz Neutral Foam requires a 4-minute application.
Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.
Figure
INDICATIONS AND USAGE
Metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1
INDICATIONS AND USAGE
BENTYL (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
BENTYL is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1).
INDICATIONS AND USAGE
For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris,
or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry,
rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.
Hypertension
Enalapril maleate is indicated for the treatment of hypertension.
Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, HEART FAILURE, MORTALITY TRIALS for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, HEART FAILURE, MORTALITY TRIALS for details and limitations of survival trials).
In using enalapril maleate consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate does not have a similar risk (see WARNINGS).
In considering use of enalapril maleate it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, HEAD AND NECK ANGIOEDEMA).
INDICATIONS AND USAGE
Sucralfate is indicated in:
Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing
with sucralfate may occur during the first week or two, treatment should be
continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or
endoscopic examination.
Maintenance therapy for duodenal ulcer patients at reduced dosage after
healing of acute ulcers.
Indications: To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.
1 INDICATIONS AND USAGE
Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with:
Invasive aspergillosis (
1.1)
Candidemia in non-neutropenics and other deep tissue
Candida infections (
1.2)
Esophageal candidiasis (
1.3)
Serious fungal infections caused by
Scedosporium apiospermum and
Fusarium species including
Fusarium solani, in patients intolerant of, or refractory to, other therapy (
1.4)
1.1 Invasive Aspergillosis
Voriconazole is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were
Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of
Aspergillus other than
A. fumigatus
[see
Clinical Studies (14.1,
14.5) and
Microbiology (12.4)]
.
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue
Candida Infections
Voriconazole is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of candidemia in non-neutropenic patients and the following
Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds
[see
Clinical Studies (14.2,
14.5) and
Microbiology (12.4)]
.
1.3 Esophageal Candidiasis
Voriconazole is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight
[see
Clinical Studies (14.3,
14.5) and
Microbiology (12.4)]
.
1.4 Scedosporiosis and Fusariosis
Voriconazole is indicated for the treatment of serious fungal infections caused by
Scedosporium apiospermum (asexual form of
Pseudallescheria boydii) and
Fusarium spp. including
Fusarium solani, in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) intolerant of, or refractory to, other therapy
[see
Clinical Studies (14.4) and
Microbiology (12.4)]
.
1.5	Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
Additional pediatric use information is approved for PF PRISM C.V.s VFEND (voriconazole). However, due to PF PRISM C.V.s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1)
Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2)
Severe hypercalcemia in adult patients with primary HPT who are unable to parathyroidectomy. (1.3)
1.1 Secondary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis
[see Clinical Studies (14.1)].
Limitations of Use:
Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia
[see Warnings and Precautions (5.1)]
1.2 Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma
[see Clinical Studies (14.2)].
1.3 Primary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy
[see Clinical Studies (14.3)].
1 INDICATIONS AND USAGE
Naftifine Hydrochloride Cream, 2% is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.
Naftifine Hydrochloride Cream, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum. (1)
INDICATIONS & USAGE
Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red celland/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see
CLINICAL PHARMACOLOGY). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
1 INDICATIONS & USAGE
Gabapentin is indicated for:
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
INDICATIONS
ETHAMBUTOL HCI is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following:
ETHAMBUTOL HCI plus isoniazid
ETHAMBUTOL HCI plus isoniazid plus streptomycin.
In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, ETHAMBUTOL HCI should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculous drugs used with ETHAMBUTOL HCI have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
1 INDICATIONS AND USAGE
Piroxicam capsule is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
Piroxicam capsule, is a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA) (
1)
Relief of the signs and symptoms of rheumatoid arthritis (RA) (
1)
1 INDICATIONS AND USAGE
Heparin Sodium Injection is indicated for:
Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
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;
Atrial fibrillation with embolization;
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.
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
HEPARIN SODIUM INJECTION is an anticoagulant indicated for (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
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
Atrial fibrillation with embolization
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
Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures