um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
ZYLOPRIM reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
ZYLOPRIM is indicated in:
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with ZYLOPRIM should be discontinued when the potential for overproduction of uric acid is no longer present.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
INDICATIONS AND USAGE:
BenzePrOTM Creamy Wash is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ILUMYA is an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1)
INDICATIONS AND USAGE
Jeanatope I-125 is indicated for use in the determination of total blood and plasma volume.
INDICATIONS AND USAGE
Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and
as a source of essential fatty acids for prevention of EFAD.
1 INDICATIONS AND USAGE
Atovaquone oral suspension is a quinone antimicrobial drug indicated for:
Prevention of
Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX). (1.1)
Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. (1.2)
Limitations of Use (1.3):
Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO
2] >45 mm Hg) with atovaquone oral suspension has not been studied.
The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied.
1.1 Prevention of
Pneumocystis jirovecii Pneumonia
Atovaquone oral suspension is indicated for the prevention of
Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
1.2 Treatment of Mild-to-Moderate
Pneumocystis jirovecii Pneumonia
Atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
1.3 Limitations of Use
Clinical experience with atovaquone oral suspension for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO
2] 45 mm Hg). Treatment of more severe episodes of PCP with atovaquone oral suspension has not been studied. The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied.
INDICATIONS AND USAGE
Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics.
Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).
In using fosinopril sodium, 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. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS).
In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS,
Head and Neck Angioedema
and
Intestinal Angioedema
).
1 INDICATIONS AND USAGE
Hypothyroidism
THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
THYQUIDITYis indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
THYQUIDITYis not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with THYQUIDITYmay induce hyperthyroidism [see
Warnings and Precautions (5.4)
].
THYQUIDITYis not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
THYQUIDITYis levothyroxine sodium (T4) indicated for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis
1 INDICATIONS AND USAGE
Everolimus is a kinase inhibitor indicated for the treatment of:
Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. (1.3)
Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)
1.3 Renal Cell Carcinoma (RCC)
Everolimus is indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib.
1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma
Everolimus is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.
INDICATIONS AND USAGE
Benzamycin Topical Gel is indicated for the topical treatment of acne vulgaris.
1.2 Treatment to Increase
Bone Mass in Men With Osteoporosis
BINOSTO is indicated for treatment to increase bone
mass in men with osteoporosis
[see Clinical Studies (
14.2)]
.
1
INDICATIONS AND USAGE
VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). (1)
Limitation of Use:
VOWST is not indicated for treatment of CDI.
Limitation of Use:
VOWST is not indicated for treatment of CDI.
INDICATIONS AND USAGE
Estradiol Vaginal Cream 0.01%
is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
INDICATIONS AND USAGE
Attention Deficit Disorder with Hyperactivity
Methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)].
INDICATIONS AND USAGE
Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone
acetate ophthalmic ointment is indicated for steroid-responsive inflammatory
ocular conditions for which a corticosteroid is indicated and where bacterial
infection or a risk of bacterial infection exists. Ocular corticosteroids are
indicated in inflammatory conditions of the palpebral and bulbar conjunctiva,
cornea, and anterior segment of the globe where the inherent risk of
corticosteroid use in certain infective conjunctivitides is accepted to obtain a
diminution in edema and inflammation. They are also indicated in chronic
anterior uveitis and corneal injury from chemical, radiation, or thermal burns,
or penetration of foreign bodies. The use of a combination drug with an
anti-infective component is indicated where the risk of infection is high or
where there is an expectation that potentially dangerous numbers of bacteria
will be present in the eye (see
CLINICAL
PHARMACOLOGY: Microbiology
). The particular anti-infective drugs in
this product are active against the following common bacterial eye pathogens:
Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus
influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas
aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
1 INDICATIONS AND USAGE
Buprenorphine sublingual tabletis indicated for the treatment of opioid dependence andis preferred for induction. Buprenorphine sublingual tablet should be used as part of a complete treatment plan to include counseling and psychosocial support.
Buprenorphine sublingual tablet, contains buprenorphine, a partial opioid agonist, andis indicated for the treatment of opioid dependence and ispreferred for induction. (1)
Buprenorphine sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)
INDICATIONS AND USAGE
1. Endocrine disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. Rheumatic disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis
Rheumatoid arthritis; including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Epicondylitis
3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Acute rheumatic carditis
Systemic dermatomyositis (polymyositis)
4. Dermatologic diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic states. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Serum sickness
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Drug hypersensitivity reactions
6. Ophthalmic diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis
Keratitis
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Chorioretinitis
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
7. Respiratory diseases
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic diseases. For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous states. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11. Gastrointestinal diseases. To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Nervous system. Acute exacerbations of multiple sclerosis
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement
INDICATIONS AND USAGE
Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.
Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
INDICATIONS AND USAGE
In Anesthesia
Glycopyrrolate injectionis indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
INDICATIONS AND USAGE
Epilepsy
Carbamazepine extended-release tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablets 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 othertypes.
Generalized tonic-clonic seizures (grandmal).
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 extended-release tablets (see PRECAUTIONS, General).
Trigeminal Neuralgia
Carbamazepine extended-release tablets 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.
1INDICATIONS AND USAGE
NETSPOT, after radiolabeling with Ga 68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
NETSPOT, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. (1)
INDICATIONS AND USAGE
Ergomar is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia".
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol tablets, USP reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see
CLINICAL PHARMACOLOGY,
CONTRAINDICATIONS,
WARNINGS, and
PRECAUTIONS).
Allopurinol tablets, USP are indicated in:
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets, USP should be discontinued when the potential for overproduction of uric acid is no longer present.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
INDICATIONS AND USAGE
Angina Pectoris
Nadolol Tablets are indicated for the long-term management of patients with angina pectoris.
Hypertension
Nadolol Tablets are indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol Tablets.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Nadolol Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
INDICATIONS AND USAGE
Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection (intrathecal) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of baclofen injection (intrathecal) into the intrathecal space.
Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of baclofen injection (intrathecal) was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of baclofen injection (intrathecal) to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Baclofen injection (intrathecal) was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.
Spasticity of Cerebral Origin: The efficacy of baclofen injection (intrathecal) was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; baclofen injection (intrathecal) was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross-over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p= 0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed.
Baclofen injection (intrathecal) therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of baclofen injection (intrathecal), patients must show a response to baclofen injection (intrathecal) in a screening trial (see Dosage and Administration).