um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Testosterone gel1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of testosterone gel1% in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of testosterone gel1% in males less than 18 years old have not been established [see Use in Specific Populations (
8.4
)].
Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure (1, 12.3).
Testosterone gel1% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of use:
Safety and efficacy of testosterone gel1% in men with age-related hypogonadism have not been established. (1)
Safety and efficacy of testosterone gel1% in males less than 18 years old have not been established. (8.4)
Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure. (1, 12.3)
1 INDICATIONS AND USAGE
ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see Clinical Studies (14)].
ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
Depression - For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Childhood Enuresis - May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
INDICATIONS AND USAGE
Diltiazem Hydrochloride Extended-release Capsules (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Diltiazem Hydrochloride Extended-release Capsules (Once-a-Day Dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
INDICATIONS AND USAGE
Ethambutol hydrochloride tablets are indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, i.e., initial treatment, the most freguently used regimens have been the following:
Ethambutol Hydrochloride Tablets plus isoniazid
Ethambutol Hydrochloride Tablets plus isoniazid plus streptomycin.
In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, ethambutol hydrochloride tablets should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculous drugs used with ethambutol hydrochloride tablets have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
INDICATIONS & USAGE
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.
1 INDICATIONS AND USAGE
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of:
Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Prior therapy should have included an anthracycline unless clinically contraindicated. (1.1)
Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. (1.2)
Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. (1.3)
1.1	Metastatic Breast Cancer
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
1.2	Non-Small Cell Lung Cancer
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
1.3	Adenocarcinoma of the Pancreas
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
INDICATIONS AND USAGE
Clindamycin phosphate topical solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).
INDICATIONS AND USAGE
Cardiac Arrhythmias
Intravenous
administration is usually reserved for life-threatening
arrhythmias or those occurring under anesthesia.
Supraventricular arrhythmiasIntravenous propranolol is
indicated for the short-term treatment of supraventricular
tachycardia, including Wolff-Parkinson-White syndrome and
thyrotoxicosis, to decrease ventricular rate. Use in
patients with atrial flutter or atrial fibrillation should
be reserved for arrythmias unresponsive to standard therapy
or when more prolonged control is required. Reversion to
normal sinus rhythm has occasionally been observed,
predominantly in patients with sinus or atrial tachycardia.Ventricular tachycardias With the exception of those
induced by catecholamines or digitalis, propranolol is not
the drug of first choice. In critical situations when
cardioversion techniques or other drugs are not indicated or
are not effective, propranolol may be considered. If, after
consideration of the risks involved, propranolol is used, it
should be given intravenously in low dosage and very slowly,
as the failing heart requires some sympathetic drive for
maintenance of myocardial tone. (See ). Some patients may
respond with complete reversion to normal sinus rhythm, but
reduction in ventricular rate is more likely. Ventricular
arrhythmias do not respond to propranolol as predictably as
do the supraventricular arrhythmias. Intravenous propranolol
is indicated for the treatment of persistent premature
ventricular extrasystoles that impair the well-being of the
patient and do not respond to conventional measures.Tachyarrhythmias of digitalis intoxicationIntravenous
propranolol is indicated to control ventricular rate in
life-threatening digitalis-induced arrhythmias. Severe
bradycardia may occur. (See ).Resistant tachyarrhythmias due to excessive catecholamine
action during anesthesia Intravenous propranolol is
indicated to abolish tachyarrhythmias due to excessive
catecholamine action during anesthesia when other measures
fail. These arrhythmias may arise because of release of
endogenous catecholamines or administration of
catecholamines. All general inhalation anesthetics produce
some degree of myocardial depression. Therefore, when
propranolol is used to treat arrhythmias during anesthesia,
it should be used with extreme caution, usually with
constant monitoring of the ECG and central venous pressure.
(See ).
1 INDICATIONS & USAGE
Warfarin sodium tablets, USP are indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets, USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets, USP are vitamin K antagonist indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement
Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction
Limitation of Use
Warfarin sodium tablets, USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.
INDICATIONS
SSS 10 - 5 Emollient Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Mfd. by: Taro Pharmaceutical Industries, Ltd.Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Revised: December 201820991-1218-2
INDICATIONS AND USAGE
MAXALT is indicated for the acute treatment of migraine attacks with or without aura in adults.
MAXALT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of MAXALT have not been established for cluster headache, which is present in an older, predominantly male population.
INDICATIONS AND USAGE
Lidocaine and prilocaine cream USP, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
normal intact skin for local analgesia.
genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine and prilocaine cream is not recommended in any clinical situation whenpenetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).
1 INDICATIONS AND USAGE
Sotalol hydrochloride is an antiarrhythmic indicated for:
the treatment of life threatening ventricular arrhythmias (1.1)
the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2)
Limitations of Use
Avoid use in patients with asymptomatic ventricular premature contraction (1.1)
Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2)
1.1
Life-Threatening
Ventricular Arrhythmias
Sotalol is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
Limitation of Use:
Sotalol may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of sotalol, including a 1.5 to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions [see Warnings and Precautions (5.2).]
1.2 Delay in
Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)
Sotalol is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.
Limitation of Use:
Because sotalol can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol.
1 INDICATIONS AND USAGE
Valganciclovir hydrochloride is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients (
1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients (
1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk.
1.1 Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir hydrochloride is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)
[see
Clinical Studies (14.1)
].
Prevention of CMV Disease: Valganciclovir hydrochloride is indicated for the prevention of CMV disease in kidney, heart, and kidney- pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
[see
Clinical Studies (14.1)
].
1.2 Pediatric Patients
Prevention of CMV Disease: Valganciclovir hydrochloride is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk
[see
Clinical Studies (14.2)
].
1 INDICATIONS AND USAGE
Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for:
Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses (1.1)
Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses (1.1)
Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1.3)
Palonosetron Hydrochloride Injection is indicated in pediatric patients aged 1 month to less than 17 years for:
Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (1.2)
1.1 Chemotherapy-Induced Nausea and Vomiting in Adults
Palonosetron Hydrochloride Injection is indicated for:
Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses
1.2 Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 1 Month to Less than 17 Years
Palonosetron Hydrochloride Injection is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
1.3 Postoperative Nausea and Vomiting in Adults
Palonosetron Hydrochloride Injection is indicated for prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, Palonosetron Hydrochloride Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS & USAGE
1.1 Hypertension
Lisinopril tablets USP are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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.
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 1 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.
Lisinopril tablets USP may be administered alone or with other antihypertensive agents [see Clinical Studies (14.1)].
1.2 Heart Failure
Lisinopril tablets USP are indicated to reduce signs and symptoms of systolic heart failure [see Clinical Studies (14.2)].
1.3 Reduction of Mortality in Acute Myocardial Infarction
Lisinopril tablets USP are indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see Clinical Studies (14.3)].
INDICATIONSAND USAGE
Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
INDICATIONS AND USAGE:
Lidocaine Hydrochloride Injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
1	INDICATIONS AND USAGE
AXERT is a 5HT1B/1D receptor agonist (triptan) indicated for:
Acute treatment of migraine attacks in adults with a history of migraine with or without aura (1.1)
Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more (1.1)
Important limitations:
Use only after a clear diagnosis of migraine has been established (1.2)
In adolescents age 12 to 17 years, efficacy of AXERT on migraine-associated symptoms was not established (1.2)
Not intended for the prophylactic therapy of migraine (1.2)
Not indicated for the treatment of cluster headache (1.2)
1.1	Acute Treatment of Migraine Attacks
Adults
AXERT (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.
Adolescents Age 12 to 17 Years
AXERT is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
1.2	Important Limitations
AXERT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with AXERT, the diagnosis of migraine should be reconsidered before AXERT is administered to treat any subsequent attacks.
In adolescents age 12 to 17 years, efficacy of AXERT on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. AXERT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see Contraindications (4.7)].
Safety and effectiveness of AXERT have not been established for cluster headache which is present in an older, predominantly male population.