um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].
The efficacy of bupropion hydrochloride extended-release tablet (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].
Bupropion hydrochloride extended-release tablets, (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
INDICATIONS & USAGE
Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
INDICATIONS AND USAGE
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 USAGEOxazepam is 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.
Anxiety associated with depression is also responsive to Oxazepam
therapy.
This product has been found particularly useful in the management of anxiety,
tension, agitation, and irritability in older patients.
Alcoholics with acute tremulousness, inebriation, or with anxiety, associated
with alcohol withdrawal are responsive to therapy.
The effectiveness of Oxazepam 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.
INDICATIONS AND USAGE
Baclofen tablets are 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 tablets 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 tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
1 INDICATIONS AND USAGE
Micafungin for injection is indicated for:
Treatment of Candidemia, Acute Disseminated Candidiasis, CandidaPeritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)].
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses
without
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)].
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)].
Prophylaxis of CandidaInfections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].
Limitations of Use
The safety and effectiveness of Micafungin have
not
been established for the treatment of candidemia
with
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific Populations (8.4)].
Micafungin has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
The efficacy of micafungin against infections caused by fungi other than Candidahas not been established.
Micafungin for injection is an echinocandin indicated in adult and pediatric patients for (1):
Treatment of Candidemia, Acute Disseminated Candidiasis, CandidaPeritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses
without
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
Prophylaxis of CandidaInfections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).
Limitations of Use
The safety and effectiveness of Micafungin have not been established for the treatment of candidemia
with
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed. (1, 2.3, 8.4)
Micafungin has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida.(1)
The efficacy of micafungin against infections caused by fungi other than Candidahas not been established. (1)
1 INDICATIONS AND USAGE
Doxycycline 40 mg is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. (1.1)
Limitations of Use
This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use Doxycycline 40 mg for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. (1.2) Doxycycline 40 mg has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. (1.2)
1.1 Indication
Doxycycline 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.
1.2 Limitations of Use
This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use Doxycycline 40 mg for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Doxycycline 40 mg should be used only as indicated.
Doxycycline 40 mg has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.
1 INDICATIONS AND USAGE
Febuxostat tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. (1)
For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. (1)
1 INDICATIONS AND USAGE
Paricalcitol injection
is indicated for the
prevention and treatment
of secondary hyperparathyroidism
in patients 5
years of age and older with chronic kidney
disease (CKD) on dialysis.
Paricalcitol injection is a vitamin D analog
indicated for the prevention
and treatment
of secondary hyperparathyroidism
in patients 5 years
of age and older with chronic kidney disease
on dialysis
(1).
1 INDICATIONS AND USAGE
Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.
Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. (1)
1 INDICATIONS AND USAGE
Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
Limitations of Use
Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.
Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
Limitations of Use
Safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established.
Uses
surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
patient preoperative skin preparation: preparation of the patient's skin prior to surgery
skin wound and general skin cleansing
INDICATIONS AND USAGE:
Vasopressin Injection, USP is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows and in diabetes insipidus.
1. INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major Depressive Disorder
[see
Clinical Studies (14.1)]
Generalized Anxiety Disorder
[see
Clinical Studies (14.2)]
Diabetic Peripheral Neuropathy
[see
Clinical Studies (14.3)]
Chronic Musculoskeletal Pain
[see
Clinical Studies (14.5)]
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (
1)
Generalized Anxiety Disorder (GAD) (
1)
Diabetic Peripheral Neuropathic Pain (DPNP) (
1)
Chronic Musculoskeletal Pain (
1)
INDICATIONS AND USAGE
Status Epilepticus
Lorazepam Injection is indicated for the treatment of status epilepticus.
Preanesthetic
Lorazepam Injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (see ).
PRECAUTIONS, Information for Patients
INDICATIONS AND USAGE
Thisfixedcombinationdrugisnotindicatedfortheinitialtherapyofedemaorhypertensionexceptinindividualsinwhomthedevelopmentofhypokalemiacannotberisked.
Triamterene and hydrochlorothiazide capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.
Triamterene and hydrochlorothiazide capsules may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules may enhance the action of these agents, dosage adjustments may be necessary.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
INDICATIONS AND USAGE
Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.
1 INDICATIONS AND USAGE
Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of
adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative
treatments are inadequate.
Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Morphine Sulfate Oral Solution is an opioid agonist.
Morphine Sulfate 2 mg/mL and 4 mg/mL is indicated for the management of
adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Morphine Sulfate Oral Solution 20 mg/mL is indicated for:
the relief of acute and chronic pain in opioid-tolerant adult patients. (1)
Limitations of Use (1):
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
INDICATIONS & USAGE
For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.
INDICATIONS AND USAGE
Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside.
Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP 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.
The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.
1 INDICATIONS AND USAGE
TOPAMAX 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)
Migraine: Treatment for adults for prophylaxis of migraine headache (1.3)
1.1	Monotherapy Epilepsy
TOPAMAX (topiramate) Tablets and TOPAMAX (topiramate capsules) Sprinkle Capsules 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
TOPAMAX Tablets and TOPAMAX Sprinkle Capsules are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].
1.3	Migraine
TOPAMAX Tablets and TOPAMAX Sprinkle Capsules are indicated for adults for the prophylaxis of migraine headache [see Clinical Studies (14.3)]. The usefulness of TOPAMAX in the acute treatment of migraine headache has not been studied.
INDICATIONS AND USAGE
When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11
THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.