um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin Sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with Gentamicin Sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. If a water-washable preparation is desired, the cream is preferable. Gentamicin Sulfate Cream has been used successfully in infants over one year of age, as well as in adults and children.
1 INDICATIONS AND USAGE
Ondansetron injection is a 5-HT3receptor antagonist indicated for the prevention of:
nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1)
postoperative nausea and/or vomiting. (1.2)
1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron injection is approved for patients aged 6 months and older.
1.2 Prevention of Postoperative Nausea and/or Vomiting
Ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes.
Ondansetron injection is approved for patients aged 1 month and older.
1 INDICATIONS AND USAGE
Sildenafil for Oral Suspensionis indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated whenSildenafil for Oral Suspension was added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class IIIII symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class IIIII symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
Limitation of Use
: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
INDICATIONS AND USAGE
Granisetron hydrochloride tablets USPare indicated for the prevention of:
Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules, USPare indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [ ]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
see Clinical Studies ( )
14
Tamsulosin hydrochloride is an alpha adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia ( )
1
1
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension ( )
1
INDICATIONS AND USAGE
Prednisone tablets and solutions are indicated in the following conditions:
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; hypercalcemia associated with cancer; nonsuppurative thyroiditis.
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.
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Dermatologic Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.
Respiratory Diseases
Symptomatic sarcoidosis; Loefflers syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis.
Hermatologic Disorders
Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases
For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
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.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis.
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
1
I
NDICATIONS AND USAGE
Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients1year of age and older and in adults.
RUFINAMIDE ORAL SUSPENSION isindicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults (
1)
1 INDICATIONS AND USAGE
BENLYSTA (belimumab) is indicated for the treatment of:
patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy, and
patients aged 5 years and older with active lupus nephritis who are receiving standard therapy.
Limitations of Use
The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation.
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of:
patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy; (1)
patients aged 5 years and older with active lupus nephritis who are receiving standard therapy. (1)
Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system lupus. Use of BENLYSTA is not recommended in this situation. (1)
INDICATIONPropoxyphene hydrochloride capsules are indicated for the relief
of mild to moderate pain.
USES:
Use for temporary relief of minor aches and muscle pains associated with arthritis, simple
backache, strains, sprains, muscle soreness and stiffness
1.2 Hyperlipidemia
Pravastatin sodium tablets are indicated:
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).1
as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).
for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
LDL-C remains 190 mg/dL or
LDL-C remains 160 mg/dL and:
there is a positive family history of premature cardiovascular disease (CVD) or
two or more other CVD risk factors are present in the patient.
INDICATIONS AND USAGE
Hyperprolactinemia
-Associated Dysfunctions
Parlodel (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin
-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.
Acromegaly
Parlodel therapy is indicated in the treatment of acromegaly. Parlodel therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately
of patients treated, although not usually to normal levels.
Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with Parlodel offers potential benefit before the effects of irradiation are manifested.
Parkinsons Disease
Parlodel SnapTabs or capsules are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinsons disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), Parlodel therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing end of dose failure on levodopa therapy. Parlodel therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (on-off phenomenon). Continued efficacy of Parlodel therapy during treatment of more than 2 years has not been established.
Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinsons disease with Parlodel. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in Parlodel-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for Parlodel therapy.
INDICATIONS AND USAGE:
Proparacaine Hydrochloride Ophthalmic Solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include
measurement
of
intraocular
pressure
(tonometry),
removal
of
foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical
operations
such
as
cataract
extraction.
1 INDICATIONS AND USAGE
Temozolomide is an alkylating drug indicated for the treatment of adult patients with:
Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1)
Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2)
1.1 Newly Diagnosed Glioblastoma
Temozolomide capsules are indicatedfor the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.
1.2 Refractory Anaplastic Astrocytoma
Temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
1 INDICATIONS AND USAGE
DEXILANT is a proton pump inhibitor (PPI) indicated for:
Healing of all grades of erosive esophagitis (EE). (1.1)
Maintaining healing of EE and relief of heartburn. (1.2)
Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3)
1.1 Healing of Erosive Esophagitis
DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
1.2 Maintenance of Healed Erosive Esophagitis
DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
1.3 Symptomatic Non-Erosive Gastroesophageal Reflux Disease
DEXILANT is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
INDICATIONS AND USAGE
Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder.
The efficacy of Venlafaxine tablets USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see
CLINICAL TRIALS
).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks);it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Tablets USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see
CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP / venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.
Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. (1)
1 INDICATIONS AND USAGE
Lamotrigine extended-release tablets are indicated for:
Adjunctive therapy for primary generalized tonic-clonic
seizures and partial-onset seizures with or without secondary
generalization in patients aged 13 years and older. (1.1)
Conversion to monotherapy in patients aged 13 years and older
with partial-onset seizures who are receiving treatment with a single antiepileptic
drug. (1.2)
Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (1.3)
1.1 Adjunctive Therapy
Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
1.2 Monotherapy
Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine extended-release have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.3 Limitation of Use
Safety and effectiveness of lamotrigine extended-release for use in patients younger than 13 years have not been established.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Salsalate Tablets, USP and other treatment options before deciding to use Salsalate Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, and related rheumatic disorder.
1 INDICATIONSAND USAGE
Amiodarone hydrochloridetablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
Amiodarone hydrochloride is an antiarrhythmic indicated for:
Recurrent ventricular fibrillation. (1)
Recurrent hemodynamically unstable ventricular tachycardia. (1)
1 INDICATIONS AND USAGE
Enstilar (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.
Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 12 years and older. (1)
1 INDICATIONS AND USAGE
Paroxetine extended-release tablets USP are indicated in adults for the treatment of:
Major
depressive disorder (MDD)
Panic
disorder (PD)
Social
anxiety disorder (SAD)
Premenstrual
dysphoric disorder (PMDD)
Paroxetine extended-release tablet USP is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):
Major Depressive Disorder (MDD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Premenstrual Dysphoric Disorder (PMDD)
1 INDICATIONS AND USAGE
Cinacalcet hydrochloride tablets are 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 hydrochloride tablets are 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 undergo parathyroidectomy. (1.3)
1.1 Secondary Hyperparathyroidism
Cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)].
1.3 Primary Hyperparathyroidism
Cinacalcet hydrochloride 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
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
Buprenorphine Sublingual Tablets contain buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. (1)
Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules and cephalexin for 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.
Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci and M. catarrhalis
Skin and skin structure infections caused by staphylococci and/or streptococci
Bone infections caused by staphylococci and/or P. mirabilis
Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae
Note
Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.