um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Vasospastic Angina
Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.
Chronic Stable Angina (Classical Effort-Associated Angina)
Nifedipine extended-release tablets are indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.
In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete.
Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS.)
Hypertension
Nifedipine extended-release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Metolazone tablets, USP, are indicated for the treatment of salt and water retention including:
edema accompanying congestive heart failure;
edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets..
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 evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see
PRECAUTIONS). 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 be appropriate.
1 INDICATIONS AND USAGE
Piroxicam capsules are indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
Piroxicam capsules are a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA)
Relief of the signs and symptoms of rheumatoid arthritis (RA)
INDICATIONS AND USAGE
In Anesthesia
Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
1 INDICATIONS AND USAGE
Colchicine capsules are indicated for prophylaxis of gout flares in adults.
Limitations of use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.
Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
Colchicine capsules are indicated for prophylaxis of gout flares in adults (1).
Limitations of use:The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied.
Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
1	INDICATIONS AND USAGE
Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium speciesEfficacy for this organism was studied in fewer than 10 infections.
Micrococcus luteus
Staphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneri
Streptococcus pneumoniaeStreptococcus viridans group
Acinetobacter lwoffii
Haemophilus influenzaHaemophilus parainfluenzae
Chlamydia trachomatis
Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti- infective 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. (1)
1. Indications and Usage
Paroxetine tablets are indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive compulsive disorder (OCD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Generalized anxiety disorder (GAD)
Posttraumatic stress disorder (PTSD)
INDICATIONS AND USAGE
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
INDICATIONS AND USAGE
Fluconazole tablets are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to
Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of
Candida urinary tract infections, peritonitis, and systemic
Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
INDICATIONS AND USAGE
Hypertension
Quinapril hydrochloride is indicated for the treatment of hypertension. It may be used alone or incombination with thiazide diuretics.
In using quinapril hydrochloride, consideration should be given to the fact that another angiotensinconvertingenzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renalimpairment or collagen vascular disease. Available data are insufficient to show that quinaprilhydrochloride does not have a similar risk (see WARNINGS).
Angioedema in black patients
Black patients receiving ACE inhibitor monotherapy have beenreported to have a higher incidence of angioedema compared to non-blacks. It should also be notedthat in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in blackpatients than in non-blacks.
1 INDICATIONS AND USAGE
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (
14.1
)], heart [see Clinical Studies (
14.2
)] or liver transplants [see Clinical Studies (
14.3
)], in combination with other immunosuppressants.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
1.2 Bipolar Mania
Monotherapy - Adults and PediatricsRisperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10 to 17 years [see Clinical Studies (14.2)].
Combination Therapy-AdultsThe combination of risperidone tablets with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1 INDICATIONS AND USAGE
Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for:
Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)
1.1 Hypertension
Telmisartan tablets are indicated for the treatment of hypertension, 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.
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 Programs 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.
Telmisartan tablets may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1)].
Use of telmisartan with an ACE inhibitor is not recommended [see Warnings and Precautions (5.6)].
1 INDICATIONS AND USAGE
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (
1.1)
Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (
1.2)
Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (
1.3)
1.1 Secondary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis
[see
Clinical Studies (14.1)].
Limitations of Use:
Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia
[see
Warnings and Precautions (5.1)]
.
1.2 Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma
[see
Clinical Studies (14.2)]
.
1.3
Primary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy
[see
Clinical Studies (14.3)]
.
1
INDICATIONS AND USAGE
VIIBRYDisindicated for the treatment of major depressive disorder (MDD) in adults[see Clinical Studies (
14
)].
VIIBRYD is indicated for the treatment of major depressive disorder (MDD) in adults(1).
Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see USE IN SPECIFIC POPULATIONS (8.4)].
Contraindicated in pediatric patients under 12 years of age [see CONTRAINDICATIONS (4), USE IN SPECIFIC POPULATIONS (8.4)].
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see CONTRAINDICATIONS (4), USE IN SPECIFIC POPULATIONS (8.4)].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)], reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
1 INDICATIONS AND USAGE
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidones greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [seeWarnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]
Schizophrenia
Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)].
Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].
Ziprasidone capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone capsule to prolong the QT interval and may consider the use of other drugs first (1)
Ziprasidone capsule are indicated for the:
treatment of schizophrenia in adults. (1)
acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1)
maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. (1)
1 INDICATIONS AND USAGE
MYXREDLIN is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
MYXREDLIN is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus (1).
INDICATIONS AND USAGE
Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to
Pneumocystis carinii.
1 INDICATIONS AND USAGE
Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
Propafenone hydrochloride extended-release capsules are an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. (1)
Usage Considerations:
Use in patients with permanent atrial fibrillation or with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. (1)
In patients with atrial fibrillation and atrial flutter, use propafenone hydrochloride extended-release capsules with drugs that increase the atrioventricular nodal refractory period. (1)
The effect of propafenone on mortality has not been determined. (1)
Usage Considerations:
The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.
Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
The effect of propafenone on mortality has not been determined [see Boxed Warning].
1 INDICATIONS AND USAGE
Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension:
In patients not adequately
controlled with monotherapy. (1)
As initial therapy in patients
likely to need multiple drugs to achieve their blood pressure goals. (1)
Irbesartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension.
Irbesartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.
Irbesartan and hydrochlorothiazide tablets, USP may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.
*For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).
The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure 140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.
For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone).
The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).
Baseline SBP (mmHg) vs %SBP <140 mmHg
Baseline SBP (mmHg) vs %SBP <130 mmHg
Baseline DBP (mmHg) vs %DBP <90 mmHg
Baseline DBP (mmHg) vs %DBP <80 mmHg