um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Cephalexin for oral suspension, USPis a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
Respiratory tract infection (1.1)
Otitis media (1.2)
Skin and skin structure infections (1.3)
Bone infections (1.4)
Genitourinary tract infections (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for oral suspension, USPand other antibacterial drugs, Cephalexin for oral suspension, USPshould be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for oral suspension, USPand other antibacterial drugs, Cephalexin for oral suspension, USPshould be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac potassium tablets are 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
INDICATIONS AND USAGE
Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsiveinflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of theglobe.
1 INDICATIONS AND USAGE
Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].
Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
INDICATIONS AND USAGE
Flurandrenolide Lotion USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE
Intradermal skin tests with Trichophyton extract are indicated for use in persons who are suspected of having Type I hypersensitivity (i.e. allergy) to the fungus.
1 INDICATIONS AND USAGE
1.1 Partial Onset Seizures
Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
[see Clinical Studies (
14)].
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
Tamsulosin hydrochloride capsules are an alpha
1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (
1)
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (
1)
1 INDICATIONS AND USAGE
ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimers type.
ADLARITY is an acetylcholinesterase inhibitor indicated for the treatment of mild, moderate, and severe dementia of the Alzheimers type. (1)
INDICATIONS AND USAGE
PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Cefazolin for Injection is a cephalosporin antibacterial indicated for perioperative prophylaxis in adult patients (1.1).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2)
1.1 Perioperative Prophylaxis
Cefazolin for Injection is indicated for perioperative prophylaxis in adult patients [see Dosage and Administration (2.1, 2.2, 2.3, 2.4).
The perioperative use of Cefazolin for Injection is indicated in adult surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty).
The prophylactic administration of Cefazolin for Injection preoperatively, intraoperatively and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice or common duct bile stones).
Pediatric use information is approved for B. Braun Medicals Cefazolin for Injection and Dextrose for Injection. However, due to B. Braun Medicals marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection USP and other antibacterial drugs, Cefazolin for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
Pantoprazole sodium delayed-release tablet is a proton pump inhibitor indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.Pediatric indication and usage information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only).
FULL PRESCRIBING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].
1. INDICATIONS AND USAGE
1.1. Read these instructions carefully before use.1.2.
Rx ONLY.1.3.
Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.
For the collection of 450 mL 10% or 500 mL 10% Whole Blood.1.5.
Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6.
For further processing, use standard component processing techniques.
Image of Figure Sealing with tape
Image of Fig. 1 (attach luer adapter to tube holder)
Image of Fig. 2 (attach adapter/holder to Blood Sampling Arm)
1
INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Ezetimibe and simvastatin tablets, which contain a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to:
reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. (1.1)
reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. (1.2)
Limitations of Use (1.3)
Noincrementalbenefitofezetimibe and simvastatintablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Ezetimibe and simvastatin tablets have not been studied in Fredrickson Type I, III, IV, and Vdyslipidemias.
1.1
Primary Hyperlipidemia
Ezetimibe and simvastatintablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol(LDL-C),apolipoproteinB(Apo B),triglycerides(TG),andnon-high-densitylipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
1.2
Homozygous Familial Hypercholesterolemia (HoFH)
Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3
Limitations of Use
No incremental benefit of ezetimibe and simvastatintablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Ezetimibe and simvastatintablets have not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
INDICATIONS AND USAGE
MOTOFEN is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
1
INDICATIONS AND USAGE
VYVGART HYTRULO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. (1)
1 INDICATIONS AND USAGE
VIAGRA is indicated for the treatment of erectile dysfunction.
VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)
1 INDICATIONS AND USAGE
RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushings syndrome for whom surgery is not an option or has not been curative.
Limitations of Use
RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established.
RECORLEV is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushings syndrome for whom surgery is not an option or has not been curative (1)
Limitations of Use
RECORLEV is not approved for the treatment of fungal infections (1)
Topiramate tablets are indicated for:
Epilepsy:
initial monotherapy in patients
2 years of age with partial onset
or primary generalized tonic-clonic seizures (1.1);
adjunctive therapy for adults and pediatric patients (2 to 16 years of
age) with partial onset seizures or primary generalized tonic-clonic
seizures, and for patients 2 years of age with seizures associated
with Lennox-Gastaut syndrome (1.2)
Prophylaxis
of migraine in patients 12 years of age and other (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1.3 Migraine
Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache.
1 INDICATIONS AND USAGE
Carvedilol tablets USP are an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Mild to severe chronic heart failure (1.1)
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.1 Heart Failure
Carvedilol tablets USP are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4) and Clinical Studies (14.1)].
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets USP are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of
40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 Hypertension
Carvedilol tablets USP are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. They can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
1 INDICATIONS AND USAGE
Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
[see
Clinical Studies (
14.1)].
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1.1)
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis
(
1.1)
1.1
Important Limitations of Use
Glimepiride tablets USP should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
INDICATIONS AND USAGE
In Chronic Spasticity
Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis).
It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity.
Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function.
Dantrolene sodium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
If improvement occurs, it will ordinarily occur within the dosage titration (see
DOSAGE AND ADMINISTRATION
), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolene sodium.
Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy.
In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him.
Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.
A decision to continue the administration of dantrolene sodium on a long-term basis is justified if introduction of the drug into the patient's regimen:
produces a significant reduction in painful and/or disabling spasticity such as clonus, or
permits a significant reduction in the intensity and/or degree of nursing care required, or
rids the patient of any annoying manifestation of spasticity considered important by the patient himself.
In Malignant Hyperthermia
Oral dantrolene sodium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery.
Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene Sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium
(dantrolene sodium) Intravenous.
Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
1 INDICATIONS AND USAGE
Eptifibatide injection is a platelet aggregation inhibitor indicated for:
Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (1.1)
Treatment of patients undergoing PCI (including intracoronary stenting) (1.2)
1.1 Acute Coronary Syndrome (ACS)
Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST- elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
1.2 Percutaneous Coronary Intervention (PCI)
Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting [see Clinical Studies (14.1, 14.2)].
1 INDICATIONS AND USAGE
Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting.
Fosaprepitant for Injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of (1):
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use (1)
Fosaprepitant for Injection has not been studied for treatment of established nausea and vomiting.
1 INDICATIONS AND USAGE
Pregabalin is 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.
Pregabalin is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (
1)
Postherpetic neuralgia (PHN) (
1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older (
1)
Fibromyalgia (
1)
Neuropathic pain associated with spinal cord injury (
1)
INDICATIONS AND USAGE
Methimazole is indicated in the medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease.
Methimazole may be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy.
Methimazole is also used when thyroidectomy is contraindicated or not advisable.