um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See Error! Hyperlink reference not valid.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
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.)
INDICATION AND USAGE
FDA has classified the following indications as possibly effective: For use as adjunctive therapy in the treatment ofirritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful asadjunctive therapy in the treatment of duodenal ulcer.IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ ANTISPASMODIC DRUGS AID IN THEHEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
1 INDICATIONS AND USAGE
Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to:
reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (
1.1).
reduce LDL-C levels in boys and post-menarchal girls, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (
1.1).
Limitations of Use (
1.3):
Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis.
Not studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1	Primary Hyperlipidemia
Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
Colesevelam hydrochloride tablets are indicated to reduce LDL-C levels in boys and post-menarchal girls, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification.
1.3	Limitations of Use
Colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1 INDICATIONS AND USAGE
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings
[see
Clinical Studies (14)]
.
Important Limitations of Use
Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease
[see
Warnings and Precautions (5.3)]
.
Pioglitazone is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (
1,
14)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (
1)
1 INDICATIONS AND USAGE
Voriconazole for oral suspension is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)
1.1 Invasive Aspergillosis
Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus
[see Clinical Studies (14.1, 14.5) and
Microbiology (12.4)].
1.2 Candidemia in
Non-neutropenic Patients and Other Deep Tissue Candida Infections
Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and
Microbiology (12.4)].
1.3 Esophageal Candidiasis
Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3, 14.5) and
Microbiology (12.4)].
1.4 Scedosporiosis and
Fusariosis
Voriconazole for oral suspension is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4)
and
Microbiology (12.4)].
1.5 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14)] .
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
INDICATIONS AND USAGE
Hypertension
COZAAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.
Hypertensive Patients with Left Ventricular Hypertrophy
COZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.)
Nephropathy in Type 2 Diabetic Patients
COZAAR is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio 300mg/g) in patients with type2 diabetes and a history of hypertension. In this population, COZAAR reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects).
1 INDICATIONSAND USAGE
Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
To improve exercise ability and delay clinical worsening.
Studies establishing effectiveness included predominantly patients with WHO Functional Class IIIII symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
Ambrisentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
To improve exercise ability and delay clinical worsening.
Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class IIIII symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
1 INDICATIONS AND USAGE
Midazolam in sodium chloride injection is indicated:
Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
Midazolam in sodium chloride injection is a benzodiazepine indicated for:
continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. (1)
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac Tromethamine Tablets USP are indicated for the short-term ( 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and Ketorolac Tromethamine Tablets USP are to be used only as continuation treatment, if necessary.
The total combined duration of use of Ketorolac Tromethamine Tablets USP and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but Ketorolac Tromethamine Tablet USP therapy is not to exceed 5 days.
INDICATIONS AND USAGE
Azathioprine Sodium for Injection, USP
is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation
Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a five-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody and other variables. The effect of azathioprine on these variables has not been tested in controlled trials.
Rheumatoid Arthritis
Azathioprine is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of azathioprine with these agents cannot be recommended.
INDICATIONS & USAGE SECTION for RadioGenix System 1.2
The RadioGenix System is a technetium Tc-99m generator used to produce sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection. Sodium Pertechnetate Tc 99m Injection is indicated for use in the preparation of FDA-approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc 99m Injection is also indicated in:
Adults for:
Thyroid Imaging
Salivary Gland Imaging
Urinary Bladder Imaging (direct isotopic cystography) for detection of vesicoureteral reflux
Nasolacrimal Drainage System Imaging (dacryoscintigraphy)
Pediatric Patients for:
Thyroid Imaging
Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesicoureteral reflux.
INDICATIONS AND USAGE
Hailey 1.5/30 is 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 1 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 1
LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR
OF CONTINUOUS USE OF A METHOD
% Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
LowestExpected*
Typical**
(No contraception)
(85)
(85)
Oral contraceptives Combined progestin only
0.10.5
3N/A***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
20.80.1
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
0.1
0.15
Adapted from RA Hatcher et al, Reference 7.
INDICATIONS AND USAGE
AYGESTIN (norethindrone acetate tablets USP) is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. AYGESTIN (norethindrone acetate tablets USP) is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol tablets 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 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 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:
Midazolam injection is indicated:
intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
INDICATIONS AND USAGE
Kidney, Liver, and Heart Transplantation
Cyclosporine Oral Solution USP MODIFIED is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine Oral Solution USP MODIFIED has been used in combination with azathioprine and corticosteroids.
Rheumatoid Arthritis
Cyclosporine Oral Solution USP MODIFIED is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine Oral Solution USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
Psoriasis
Cyclosporine Oral Solution USP MODIFIED is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.
While rebound rarely occurs, most patients will experience relapse with Cyclosporine Oral Solution USP MODIFIED as with other therapies upon cessation of treatment.
1 INDICATIONS AND USAGE
Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain
inopioid-tolerant adult patients.
Morphine Sulfate Oral Solution is an opioid agonist.
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.
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.
1 INDICATIONS AND USAGE
Hydrocortisone Butyrate Cream (lipid), 0.1%is indicated for:
Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults.
The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age.
Hydrocortisone Butyrate Cream (lipid), 0.1% is a corticosteroid indicated for:
Relief of the inflammatory and pruritic manifestations ofcorticosteroid-responsive dermatoses in adults. (1)
The treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age. (1)
INDICATIONS & USAGE
Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.
INDICATIONS AND USAGE
ZANOSAR is indicated in the treatment of metastatic islet cell carcinoma of the pancreas. Responses have been obtained with both functional and nonfunctional carcinomas. Because of its inherent renal toxicity, therapy with this drug should be limited to patients with symptomatic or progressive metastatic disease.
Indications and Usage
Renal Caps is indicated in the wasting syndrome of chronic renal failure; uremia and impaired metabolic functions of the kidney. Renal Caps ia also highly effective as a stress vitamin.