um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to 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 offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim 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.
Travelers Diarrhea in Adults
For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic E. coli.
INDICATIONS AND USAGE
Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Indications and Usage
ANGELIQ
is indicated in women who have a uterus for the:
1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
INDICATIONS:
For
the
treatment
of superficial
ocular
infections
involving
the conjunctiva
and/or
cornea
caused
by Bacitracin susceptible organisms.
INDICATIONS AND USAGE
Sulfasalazine tablets are indicated:
a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; andb) for the prolongation of the remission period between acute attacks of ulcerative colitis.
1 INDICATIONS AND USAGE
PRADAXA is a direct thrombin inhibitor indicated:
To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (1.1)
For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2)
To reduce the risk of recurrence of DVT and PE in patients who have been previously treated (1.3)
For the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery (1.4)
1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation
PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
1.2 Treatment of Deep Venous Thrombosis and Pulmonary Embolism
PRADAXA is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days.
1.3 Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism
PRADAXA is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.
1.4 Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery
PRADAXA is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism, in patients who have undergone hip replacement surgery.
INDICATIONS AND USAGE
IMPORTANT NOTICE
Oxytocin is indicated for the medical rather than the
elective induction of labor. Available data and information are
inadequate to define the benefits-to-risks considerations in the
use of the drug product for elective induction. Elective
induction of labor is defined as the initiation of labor for
convenience in an individual with a term pregnancy who is free
of medical indications.
Antepartum
Oxytocin is indicated for the initiation or improvement
of uterine contractions, where this is desirable and considered
suitable for reasons of fetal or maternal concern, in order to
achieve early vaginal delivery. It is indicated for (1)
induction of labor in patients with a medical indication for the
initiation of labor, such as Rh problems, maternal diabetes,
preeclampsia at or near term, when delivery is in the best
interests of mother and fetus or when membranes are prematurely
ruptured and delivery is indicated; (2) stimulation or
reinforcement of labor, as in selected cases of uterine inertia;
(3) as adjunctive therapy in the management of incomplete or
inevitable abortion. In the first trimester, curettage is
generally considered primary therapy. In second trimester
abortion, oxytocin infusion will often be successful in emptying
the uterus. Other means of therapy, however, may be required in
such cases.
Postpartum
Oxytocin is indicated to produce uterine contractions
during the third stage of labor and to control postpartum
bleeding or hemorrhage.
INDICATIONS AND USAGE
Ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).
1. INDICATIONS AND USAGE
Carticel is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft).
Carticel should be used only in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown.
Carticel is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis.
Carticel is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel implantation.
Carticel is an autologous cellular product indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). (1)
Carticel should be used only in conjunction with debridement, placement of a periosteal flap and rehabilitation. (1)
Carticel is not indicated for:
treatment of cartilage damage associated with generalized osteoarthritis. (1)
patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel implantation. (1)
INDICATIONS
For testing tear film stability by determining the fluorescein break-up time (FBUT).
1 INDICATIONS AND USAGE
Amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)].
Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary.
Amiodarone hydrochloride injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. (1)
1 INDICATIONS AND USAGE
LoJaimiess is indicated for use by females of reproductive potential to prevent pregnancy.
LoJaimiess is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1)
INDICATIONS AND USAGE
Fluconazole Tablets USP are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to
Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole Tablets USP were also effective for the treatment of
Candida urinary tract infections, peritonitis, and systemic
Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole Tablets USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen (
1).
1.1 Intrathecal Administration
Adults
OMNIPAQUE 180, 240, and 300
Myelography (lumbar, thoracic, cervical, total columnar)
Computerized Tomography (CT) (myelography, cisternography, ventriculography)
Pediatrics
OMNIPAQUE 180
Myelography (lumbar, thoracic, cervical, total columnar)
CT (myelography, cisternography)
1.2 Intravascular Administration
Adults
OMNIPAQUE 140
Intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels
OMNIPAQUE 240
CT head imaging
Peripheral venography (phlebography)
OMNIPAQUE 300
Aortography including studies of the aortic arch, abdominal aorta and its branches
CT head and body imaging
Cerebral arteriography
Peripheral venography (phlebography)
Peripheral arteriography
Excretory urography
OMNIPAQUE 350
Angiocardiography (ventriculography, selective coronary arteriography)
Aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches
CT head and body imaging
Intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels
Peripheral arteriography
Excretory urography
Pediatrics
OMNIPAQUE 240
CT head and body imaging
OMNIPAQUE 300
Angiocardiography (ventriculography)
Excretory urography
CT head and body imaging
OMNIPAQUE 350
Angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries)
Aortography including the aortic root, aortic arch, ascending and descending aorta
1.3 Oral or Rectal Administration
Adults
OMNIPAQUE 350
Oral radiographic examination of the gastrointestinal tract
Pediatrics
OMNIPAQUE 180, 240 and 300
Oral and rectal radiographic examination of the gastrointestinal tract
1.4 Oral Administration in Conjunction with Intravenous Administration
Diluted OMNIPAQUE Injection
Adults
OMNIPAQUE 240, 300 and 350 diluted and administered orally in conjunction with OMNIPAQUE 300 administered intravenously
CT of the abdomen
Pediatrics
OMNIPAQUE 240, 300 and 350 diluted and administered orally in conjunction with OMNIPAQUE 240 or OMNIPAQUE 300 administered intravenously
CT of the abdomen
OMNIPAQUE Oral Solution
Adults
OMNIPAQUE oral solution 9 and 12 administered orally in conjunction with OMNIPAQUE 300 administered intravenously
CT of the abdomen
Pediatrics
OMNIPAQUE oral solution 9 and 12 administered orally in conjunction with OMNIPAQUE 240 or OMNIPAQUE 300 administered intravenously
CT of the abdomen
1.5 Intraarticular Administration
Adults
OMNIPAQUE 240, 300, and 350
Arthrography
1.6 Body Cavity Administration
Adults
OMNIPAQUE 240
Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP)
Herniography
Hysterosalpingography
OMNIPAQUE 300
Hysterosalpingography
Pediatrics
OMNIPAQUE 240, 300 and 350 diluted
Voiding cystourethrography (VCU)
INDICATIONS AND USAGE
Junel
21 and Junel
Fe 28
are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
Adapted from RA Hatcher et al, Reference 7.
% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
LowestExpectedThe authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
TypicalThis term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(No contraception)
(85)
(85)
Oral contraceptives combined progestin only
0.10.5
3N/AN/A--Data not available
N/A
Diaphragm with spermicidal cream or jelly
6
20
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)
6
26
Vaginal Sponge nulliparous parous
920
2040
Implant
0.05
0.05
Injection: depot medroxyprogesterone acetate
0.3
0.3
IUD progesterone T copper T 380A LNg 20
1.50.60.1
2.00.80.1
Condom without spermicides female male
53
2114
Cervical Cap with spermicidal cream or jelly nulliparous parous
926
2040
Periodic abstinence (all methods)
1 to 9
25
Withdrawal
4
19
Female sterilization
0.5
0.5
Male sterilization
0.10
0.15
INDICATIONS AND USAGE:
Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dematoses: seborrheic dermatitis and sebonthea sicca (dandruff).
It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
1 INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy (1.1)
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)
Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
1.1 Hypercalcemia of Malignancy
Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL - patient albumin [g/dL]).
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Limitations of Use
The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
INDICATIONS AND USAGE
These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.
1 INDICATIONS AND USAGE
Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
Limitations of Use
Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
Glycopyrrolate tablets are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1)
Limitations of Use:
Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)
1 INDICATIONS AND USAGE
Adapalene and benzoyl peroxide swab 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Adapalene and benzoyl peroxide swab 0.1% / 2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)
1 INDICATIONS AND USAGE
Bimatoprost ophthalmic solution 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
Bimatoprost ophthalmic solution is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. (1)
INDICATIONS
SulfaCleanse 8/4 (sodium sulfacetamide 8% & sulfur 4%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
INDICATIONS AND USAGE
Naphazoline Hydrochloride Ophthalmic Solution is indicated for use as a topical ocular vasoconstrictor.
INDICATIONS AND USAGE
Nystatin and Triamcinolone Acetonide Cream and Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
1 INDICATIONS AND USAGE
BELRAPZO is an alkylating drug indicated for treatment of patients with:
Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. (1.1)
Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (1.2)
1.1 Chronic Lymphocytic Leukemia (CLL)
BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
1.2 Non-Hodgkin Lymphoma (NHL)
BELRAPZO is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
INDICATIONS AND USAGE
Nisoldipineis indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
1 INDICATIONS AND USAGE
Morphine sulfate oral solution (10 mg per 5 mL and 20 mg per 5 mL) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer.
Morphine sulfate is an opioid agonist indicated for the relief of moderate to severe acute and chronic pain where an opioid analgesic is appropriate. (1)
Morphine sulfate 100 mg per 5 mL (20 mg/mL) solution is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. (1)
1 INDICATIONS AND USAGE
NUVESSA is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.
NUVESSA is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older. (
1)
1 INDICATIONS AND USAGE
Topiramate tablets USP is an antiepileptic (AED) agent indicated for:
Monotherapy
epilepsy: Initial monotherapy in patients
2 years of age with
partial onset or primary generalized tonic-clonic seizures (
1.1)
Adjunctive
therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2
to 16 years of age) with partial onset seizures or primary generalized
tonic-clonic seizures, and in patients 2 years of age with seizures
associated with Lennox-Gastaut syndrome (LGS) (
1.2)
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)]
.