um-ids/dailymed-annotations huggingface dataset:
Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [
see Dosage and Administration (2.2)].
Limitations of Use
Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [
see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].
Bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic. Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2)
Limitations of Use
Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9)
INDICATIONS AND USAGE
Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see
WARNINGS
), reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)
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
Clonidine hydrochloride is indicated in the treatment of
hypertension. Clonidine hydrochloride may be employed alone or concomitantly
with other antihypertensive agents.
INDICATIONS AND USAGE
Hypertension
Atenolol tablets are indicated in the management of hypertension. They may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
Angina Pectoris Due to Coronary Atherosclerosis
Atenolol tablets are indicated for the long-term management of patients with angina pectoris.
Acute Myocardial Infarction
Atenolol tablets are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.
INDICATIONS & USAGE
1.1 Hypertension
Valsartan tablets, USP 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 valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets, USP.
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.
Valsartan tablets, USP may be used alone or in combination with other antihypertensive agents.
1.2 Heart Failure
Valsartan tablets, USP are indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, valsartan tablets, USP significantly reduced hospitalizations for heart failure. There is no evidence that valsartan tablets, USP provide added benefits when it is used with an adequate dose of an ACE inhibitor. [See Clinical Studies (14.2)]
1 INDICATIONS AND USAGE
SKYRIZI is an interleukin-23 antagonist indicated for the treatment of:
moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. (1.1)
active psoriatic arthritis in adults. (1.2)
moderately to severely active Crohn's disease in adults. (1.3)
1.1 Plaque Psoriasis
SKYRIZI is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
1.2 Psoriatic Arthritis
SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
1.3 Crohns Disease
SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g. digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
INDICATIONS AND USAGE
LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions.
LACRISERT is also indicated for patients with:
Exposure keratitisDecreased corneal sensitivityRecurrent corneal erosions
1. INDICATIONS AND USAGE
EXPAREL is indicated:
In patients aged 6 years and older for single-dose infiltration to produce postsurgical local analgesia
In adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia
Limitations of Use
Safety and efficacy have not been established in other nerve blocks.
EXPAREL is indicated:
In patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia (1).
In adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia (1).
Limitations of Use
Safety and efficacy have not been established in other nerve blocks.
INDICATIONS AND USAGE
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.
INDICATIONS AND USAGE
sfROWASA (mesalamine) Rectal Suspension is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
INDICATIONS & USAGE SECTION
Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
1 INDICATIONS AND USAGE
Toreduce the development of drug-resistant bacteria and maintain the effectiveness ofAmoxicillin and Clavulanate PotassiumTabletsand other antibacterial drugs,Amoxicillin and Clavulanate PotassiumTabletsshould be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin and Clavulanate PotassiumTabletsis a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and Clavulanate PotassiumTabletsare a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:
Lowerrespiratory tract infections (
1.1)
Acute bacterial otitis media (
1.2)
Sinusitis (
1.3)
Skin and skin structure infections (
1.4)
Urinary tract infections (
1.5)
1.1 Lower Respiratory Tract Infections
- caused by beta-lactamase-producing isolates of
Haemophilus influenzae and
Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
- caused bybeta-lactamase-producing isolates of
H. influenzaeand M. catarrhalis.
1.3 Sinusitis
- caused by beta-lactamase-producing isolates of
H. influenzae and M. catarrhalis
.
1.4 Skin and Skin Structure Infections
- causedby beta-lactamase-producing isolates of
Staphylococcus aureus,
Escherichia coli, and
Klebsiella species.
1.5 Urinary Tract Infections
- caused by beta-lactamase-producing isolates of
E.
coli,
Klebsiellaspecies, and
Enterobacter species.
1.6 Limitations of Use
- When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production,Amoxicillin and Clavulanate PotassiumTabletsshould not be used.
INDICATIONS AND USAGE
Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/wk because of the potential for the drug to suppress the HPA axis.
This product is not recommended for use in children under 12 years of age.
1 INDICATIONS AND USAGE
Phenylephrine hydrochloride injection, 10 mg/mL, is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. (
1)
1 INDICATIONS AND USAGE
Safyral is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to:
Prevent pregnancy. (1.1)
Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2)
1.1 Oral Contraceptive
Safyral is indicated for use by females of reproductive potential to prevent pregnancy.
1.2 Folate Supplementation
Safyral is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
1 INDICATIONS AND USAGE
Argatroban in sodium chloride injection is a direct thrombin inhibitor indicated:
For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1)
As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2)
1.1 Heparin-Induced Thrombocytopenia
Argatroban in sodium chloride injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
1.2 Percutaneous Coronary Intervention
Argatroban in sodium chloride injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
1. Indications and Usage
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizers LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizers marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Hypothyroidism
Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use
Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism
[see Warnings and Precautions (
5.1)]
.
Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levothyroxine sodium tablet is a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (
1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (
1)
Limitations of Use
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
INDICATION AND USAGE
Phenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.
1 INDICATIONS AND USAGE
Letrozole tablets are an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1)
Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2)
First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3)
1.1 Adjuvant Treatment of Early Breast Cancer
Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. .
1.2 Extended Adjuvant Treatment of Early Breast Cancer
Letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see Clinical Studies (14.2, 14.3)].
1.3 First and Second-Line Treatment of Advanced Breast Cancer
Letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies (14.4, 14.5)].
1 INDICATIONS AND USAGE
Icatibant Injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Icatibant Injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. (
1)
INDICATIONS AND USAGE
Treatment of Acute Malaria Infections
Mefloquine is indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae.
Note: Patients with acute P. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine).
Prevention of Malaria
Mefloquine is indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.
1 INDICATIONSAND USAGE
Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers.
The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:
osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.
juvenile idiopathic arthritis (JIA) in adolescent patients.
The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers.
Limitations of Use:
Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium.
Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products.
Controlled studies do not extend beyond 6 months [see Use in Specific Populations (8.4), Clinical Studies (14)].
Naproxen and esomeprazole magnesium delayed-release tablet is a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers.
The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of:
osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.
juvenile idiopathic arthritis (JIA) in adolescent patients.
The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. (1)
Limitations of Use:
Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium. (1)
Naproxen and esomeprazole magnesium delayed-release tabletsare not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. (1)
Controlled studies do not extend beyond 6 months. (1)
1 INDICATIONS AND USAGE
Arsenic trioxide injection is an arsenical indicated:
For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2)
1.2Relapsed or Refractory APL
Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.