um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Bimatoprost ophthalmic solution 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Sertraline hydrochloride tablets are indicated for the treatment of the following [See CLINICAL STUDIES (14)]:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
1 INDICATIONS AND USAGE
MIRAPEX ER tablets are indicated for the treatment of Parkinson's disease.
MIRAPEX ER is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) (1)
INDICATIONS AND USAGE
Hypertension:
Tiadylt ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Chronic Stable Angina:
Tiadylt ER capsules are indicated for the treatment of chronic stable angina.
1 INDICATIONS & USAGE
Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.
Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (1)
1.1 Complicated Skin and Skin Structure Infections
Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis.
1 INDICATIONSAND USAGE
Fenofibrate 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 are 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 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.
1.3
Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet 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)].
1 INDICATIONS AND USAGE
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ACIPHEX is a proton-pump inhibitor indicated for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive or Ulcerative GERD (1.2)
Treatment of Symptomatic GERD (1.3)
Healing of Duodenal Ulcers (1.4)
Helicobacter pylori Eradication to Reduce the
Risk of Duodenal Ulcer Recurrence (1.5)
Treatment of Pathological Hypersecretory Conditions, Including
Zollinger-Ellison Syndrome (1.6)
ACIPHEX is a proton-pump inhibitor indicated for adolescent patients 12 years
of age and above for:
Short-term treatment of Symptomatic GERD (1.3)
1.1 Healing of Erosive or Ulcerative GERD
ACIPHEX is indicated for short-term (4 to 8 weeks) treatment in
the healing and symptomatic relief of erosive or ulcerative gastroesophageal
reflux disease (GERD). For those patients who have not healed after 8 weeks of
treatment, an additional 8-week course of ACIPHEX may be considered.
1.2 Maintenance of Healing of Erosive of Ulcerative GERD
ACIPHEX is indicated for maintaining healing and reduction in
relapse rates of heartburn symptoms in patients with erosive or ulcerative
gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not
extend beyond 12 months.
1.3 Treatment of Symptomatic GERD
ACIPHEX is indicated for the treatment of daytime and nighttime
heartburn and other symptoms associated with GERD in adults and adolescents 12
years of age and above.
1.4 Healing of Duodenal Ulcers
ACIPHEX is indicated for short-term (up to four weeks) treatment
in the healing and symptomatic relief of duodenal ulcers. Most patients heal
within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
ACIPHEX in combination with amoxicillin and clarithromycin as a
three drug regimen, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or
history within the past 5 years) to eradicate H.
pylori. Eradication of H. pylori has been
shown to reduce the risk of duodenal ulcer recurrence. {See CLINICAL STUDIES (
14.5
) and DOSAGE AND
ADMINISTRATION (
2.5
)}
In patients who fail therapy, susceptibility testing should be done. If
resistance to clarithromycin is demonstrated or susceptibility testing is not
possible, alternative antimicrobial therapy should be instituted. {See CLINICAL PHARMACOLOGY, Microbiology (
12.2
) and
the clarithromycin package insert, CLINICAL PHARMACOLOGY,
Microbiology}
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
ACIPHEX is indicated for the long-term treatment of pathological
hypersecretory conditions, including Zollinger-Ellison syndrome.
1 INDICATIONS AND USAGE
Potassium chloride extended-release tablets, USP are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium chloride extended-release tablets, USP are a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
(1)
1 INDICATIONS & USAGE
Lamivudine and Zidovudine tablet, USP a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Lamivudine and Zidovudine tablet, USP a combination of2 nucleoside analogue reverse transcriptase inibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.(
1)
1 INDICATIONS AND USAGE
Silodosin capsules, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsule is not indicated for the treatment of hypertension. (1)
Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. Silodosin capsule is not indicated for the treatment of hypertension.
Diabetic Gastroparesis (Diabetic Gastric Stasis)
Metoclopramide tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.
INDICATIONS AND USAGE
FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing.
1 INDICATIONS AND USAGE
Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.
Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated for in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma (1)
INDICATIONS AND USAGE
Desonate Gel is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonate Gel for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate Gel to suppress the hypothalamic-pituitary-adrenal (HPA) axis (seePRECAUTIONS). Treatment should not exceed 4 consecutive weeks.
1 INDICATIONS AND USAGE
Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1)
INDICATIONS AND USAGE
Edema
Furosemide tablets, USP is indicated in adults and
pediatric patients for the treatment of edema associated with congestive heart
failure, cirrhosis of the liver, and renal disease, including the nephrotic
syndrome. Furosemide is particularly useful when an agent with greater diuretic
potential is desired.
Hypertension
Furosemide tablets, USP may be used in adults for the
treatment of hypertension alone or in combination with other antihypertensive
agents. Hypertensive patients who cannot be adequately controlled with thiazides
will probably also not be adequately controlled with furosemide alone.
1 INDICATIONS AND USAGE
Olmesartan medoxomil tablet is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of
antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with other antihypertensive agents.
Olmesartan medoxomil tablets are angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension
in adult and pediatric patients six years of age and older, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1).
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy
[see
Clinical Studies (14)]
.
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity
[see
Clinical Studies (14)]
.
Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (
1)
Limitation of Use:Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (
1,
14)
Uses
For the temporary relief of pain and itching due to:
minor burns
minor skin irritations
scrapes
minor cuts
sunburn
insect bites
1.3 Social Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was
established in four 12-week and one 26- week, placebo-controlled trials.
1 INDICATIONS AND USAGE
Oxaprozin tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For relief of the signs and symptoms of juvenile rheumatoid arthritis
Oxaprozin is a non-steroidal anti-inflammatory drug indicated for:
Relief of signs and symptoms of Osteoarthritis (OA)
(1)
Relief of signs and symptoms of Rheumatoid Arthritis (RA)
(1)
Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA)
(1)
1.1 Partial Onset Seizures
Levetiracetam tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGECarefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen as naproxen or naproxen sodium tablets are indicated:- For the relief of the signs and symptoms of rheumatoid arthritis- For the relief of the signs and symptoms of osteoarthritis- For the relief of the signs and symptoms of ankylosing spondylitis- For the relief of the signs and symptoms of juvenile arthritisNaproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patients weight.Naproxen as naproxen and naproxen sodium tablets are also indicated:- For relief of the signs and symptoms of tendonitis- For relief of the signs and symptoms of bursitis- For relief of the signs and symptoms of acute gout- For the management of pain- For the management of primary dysmenorrhea
1 INDICATIONS AND USAGE
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 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 AND USAGE
Carefully consider the potential benefits and risks of LOFENA (diclofenac potassium tablets, USP) and other treatment options before deciding to use LOFENA. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation
).
LOFENA is indicated:
For treatment of primary dysmenorrhea
For relief of mild to moderate pain
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
Moxifloxacin Ophthalmic Solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Acinetobacter lwoffii*
Haemophilus influenzae
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
INDICATIONS AND USAGE
Ergotamine
Tartrate
and Caffeine
Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called histaminic cephalalgia.
1.1 Infections of the Ear, Nose, and Throat
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus species. (- and
-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Helicobacter pylori Infection
Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole:
Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by 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.