um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Desonide cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
1 INDICATIONS AND USAGE
Methadone hydrochloride oral solution is indicated for the:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [
see Warnings and Precautions (5.2)
], reserve methadone hydrochloride oral solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride oral solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use:
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)
].
Methadone hydrochloride oral solution is an opioid agonist indicated for the:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long acting opioids, reserve methadone hydrochloride oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride oral solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use:
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12. (2.1)
Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)
Weight
(pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3"
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31
The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
1.1 Heparin-Induced Thrombocytopenia
Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
1 INDICATIONS AND USAGE
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (
1)
Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (
1)
1 INDICATIONS & USAGE
Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the:
short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patientwith EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn),additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate capsules may be considered.
maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months
Omeprazole and Sodium Bicarbonate capsules are a proton pump inhibitor (PPI). Omeprazole and Sodium Bicarbonate capsulesareindicated in adultsfor:
Treatment of active duodenal ulcer
( 1 )
Treatment of active benign gastric ulcer
( 1 )
Treatment of erosive esophagitis
(EE) due to acid-mediated gastroesophageal reflux disease (GERD)
( 1 )
Maintenance of healing of EE
( 1 )
INDICATIONSAND USAGE
Selegiline Hydrochloride Tablets USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.
Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
Acute Pain in Adult Patients
Ketorolac tromethamine is 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 intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral 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 & ADMINISTRATION, and
ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine injection and narcotics should not be administered in the same syringe (see
DOSAGE & ADMINISTRATION
Pharmaceutical Information for Ketorolac Tromethamine Injection).
INDICATIONS AND USAGE
Guanfacine tablets are indicated in the management of hypertension. Guanfacine tablets may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
INDICATIONS AND USAGE
Mometasone Furoate Lotion 0.1% (mometasone furoate topical solution USP) is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since safety and efficacy of Mometasone Furoate Lotion 0.1% have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended, (see PRECAUTIONS
Pediatric Use).
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1 INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis
and chronic treatment of asthma in patients 2 years of age and older
(
1.1).
Acute
prevention of exercise-induced bronchoconstriction (EIB) in patients 6
years of age and older (
1.2).
Relief
of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in
patients 2 years of age and older, and perennial allergic rhinitis (PAR)
in patients 2 years of age and older (
1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older.
INDICATIONS: BP Cleansing Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
INDICATIONS AND USAGE
Ranitidine is indicated in:Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg b.i.d.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg q.i.d.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
INDICATIONS AND USAGE
Tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, E. coli, and S. aureus (penicillinase- and non-penicillinase-producing strains).
Serious central-nervous-system infections (meningitis) caused by susceptible organisms.
Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella sp, and Enterobacter sp.
Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus sp, E. coli, Klebsiella sp, Enterobacter sp
and
S. aureus.
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp, (indole-positive and indole- negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp.
Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram- negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the
WARNINGS
box above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Acute Otitis Media:
For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniaeor Haemophilus influenzaewhen 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.
INDICATIONS AND USAGE
LAZANDA is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least: 60 mg of oral morphine per day, 25 mcg of transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking LAZANDA.
Limitations of Use:
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department
[see Contraindications (
4
)].
As a part of the TIRF REMS, LAZANDA may be dispensed by outpatient pharmacies only to outpatients enrolled in the program.
[see Warnings and Precautions (
5.7
)]. For inpatient administration of LAZANDA, patient and prescriber enrollment are not required.
1 INDICATIONSAND USAGE
Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets, USP are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
1	INDICATIONS AND USAGE
JARDIANCE is indicated:
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:
To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. (1)
To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. (1)
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2 (1)
Limitations of Use
JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)].
JARDIANCE is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
1 INDICATIONS AND USAGE
Fenofibrate tablets is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
INDICATIONS:
Tolcapone tablets is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, Tolcapone tablets should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because Tolcapone tablets, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from Tolcapone tablets.
The effectiveness of Tolcapone tablets was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in patients who did not experience such phenomena (see
CLINICAL PHARMACOLOGY: Clinical Studies
).
INDICATIONS & USAGE SECTION
Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents
INDICATIONS & USAGE SECTION
Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
1 INDICATIONS AND USAGE
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Ephedrine Sulfate Injection, USP is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (1)