um-ids/dailymed-annotations huggingface dataset:
SURGICAL PROPHYLAXIS:
SURGICAL PROPHYLAXIS: The preoperative administration of a single 1g dose of Ceftriaxone for Injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in highrisk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Ceftriaxone for Injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1g dose of Ceftriaxone for Injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure.
INDICATIONS AND USAGE
Aminocaproic Acid Tablets is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See
WARNINGS
.)
INDICATIONS AND USAGE
Eulexin capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.
Stage B2-C Prostatic Carcinoma
Treatment with Eulexin capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy.
Stage D2 Metastatic Carcinoma
To achieve benefit from treatment, Eulexin capsules should be initiated with the LHRH-agonist and continued until progression.
INDICATIONS AND USAGE
Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures(See
WARNINGS
).
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus.
Diazepam injection is a useful adjunct in status epilepticus.
Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.
INDICATIONS AND USAGE
Ovidrel PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.
Selection of Patients
Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel PreFilled Syringe only if enrolled in an in vitro fertilization program.
Primary ovarian failure should be excluded by the determination of gonadotropin levels.
Appropriate evaluation should be performed to exclude pregnancy.
Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel PreFilled Syringe therapy.
Evaluation of the partner's fertility potential should be included in the initial evaluation.
1 INDICATIONSAND USAGE
Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor
(PPAR) alpha agonist indicated as adjunctive therapy to diet to:
Reduce
TG in patients
with severe hypertriglyceridemia
(1.1).
Reduce elevated
LDL-C, Total-C, TG and Apo B, and to increase
HDL-C in patients
with primary hypercholesterolemia or mixed dyslipidemia
(1.2).
Limitations of Use: Fenofibrate at a
dose equivalent to
135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in patients
with type 2 diabetes mellitus (5.1).
1.1 Treatment of Severe Hypertriglyceridemia
Fenofibric acid delayed-release capsules are
indicated as adjunctive therapy to
diet to
reduce triglycerides (TG) in
patients with severe hypertriglyceridemia. Improving glycemic
control in
diabetic patients
showing fasting
chylomicronemia will usually
obviate the
need
for pharmacological intervention. Markedly elevated levels of
serum triglycerides
(e.g., > 2,000
mg/dL)
may increase the
risk of developing
pancreatitis. The effect of
fenofibric acid delayed-release capsules therapy on
reducing this
risk has not been adequately
studied.
1.2 Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibric acid delayed-release capsules are
indicated as adjunctive therapy to
diet to
reduce elevated low-density lipoprotein
cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B
(Apo B), and to increase high-density
lipoprotein cholesterol (HDL-C) in patients
with primary hypercholesterolemia or mixed
dyslipidemia.
1.3 Limitations of Use
Fenofibrate ata dose
equivalent to 135 mg of fenofibric acid delayed-release capsules did
not reduce coronary
heart disease morbidity
and mortality
in 2
large, randomized
controlled trials of
patients with type 2
diabetes mellitus [see Warnings and Precautions (5.1)].
1.4 General Considerations for Treatment
Laboratory
studies should be
performed to establish
that lipid
levels are abnormal before instituting
fenofibric acid delayed-release capsules therapy.
Every
reasonable attempt should be
made to control
serum lipids
with non-drug methods including appropriate diet,
exercise, weight loss in
obese patients, and control of any
medical problems such as diabetes
mellitus and hypothyroidism that may be contributing to the lipid
abnormalities. Medications known to
exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or
changed if possible,
and excessive alcohol
intake should be
addressed before
triglyceride-lowering drug therapy is
considered. If the decision is
made to use
lipid-altering drugs, the patient should be
instructed that this
does not
reduce the
importance
of
adhering to
diet.
Drug therapy is not
indicated for patients
who have
elevations of
chylomicrons and plasma triglycerides, but
who have
normal levels of
VLDL.
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily.
1 INDICATIONS AND USAGE
Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
Levalbuterol inhalation solution (concentrate) is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. (1)
1 INDICATIONS AND USAGE
Valproic acid is an antiepileptic drug indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1)
1.1 Epilepsy
Valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
See
Warnings and Precaution (5.1)
for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see
Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1),
and
Patient Counseling Information (17)
].
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see
Contraindications (4)
].
INDICATIONS & uSAGE
10% Calcium Chloride Injection, USP is indicated (1) for the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, (2) in the treatment of magnesium intoxication due to overdosage of magnesium sulfate and (3) to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid.
10% Calcium Chloride Injection, USP also may be used in cardiac resuscitation when weak or inadequate contractions return following defibrillation or when epinephrine injection has failed to strengthen myocardial contractions.
1 INDICATIONS AND USAGE
Tadalafil
is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile dysfunction (ED) (
1.1)
the signs and symptoms of benign
prostatic hyperplasia (BPH) (
1.2)
ED and the signs and symptoms of BPH
(ED/BPH) (
1.3)
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (
1.4).
1.1 Erectile Dysfunction
Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED).
1.2 Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4 Limitation of Use
If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown
[see Clinical Studies (
14.3)]
.
1. Indications and Usage
Pantoprazole Sodium Delayed-Release Tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). 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.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole Sodium Delayed-Release Tablets are indicated for maintenance of healing of EE 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 (ZE) Syndrome.
1 INDICATIONS AND USAGE
Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation (1).
1 INDICATIONS AND USAGE
Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important. (1)
Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
1 INDICATIONS AND USAGE
Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
INDICATIONS AND USAGE :
Drug-induced methemoglobinemia
1 INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis
and chronic treatment of asthma in patients 12 months of age and older (
1.1).
Acute
prevention of exercise-induced bronchoconstriction (EIB) in patients 6
years of age and older (
1.2).
Relief
of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in
patients 2 years of age and older, and perennial allergic rhinitis (PAR)
in patients 6 months of age and older (
1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
INDICATIONS AND USAGE
Postherpetic Neuralgia
Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin Capsules, USP is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules, USP is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.
1 INDICATIONS AND USAGE
Topiramate tablets are indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (
1.1);adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (
1.2)
Preventive treatment of migraine in patients 12 years of age and older (
1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.
1 INDICATIONS AND USAGE
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.s Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.
Limitations of Use
Rizatriptan benzoate tablets 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 rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
Rizatriptan benzoate tablets are a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
INDICATIONS & USAGE SECTION
Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
1 INDICATIONS AND USAGE
Brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Brimonidine tartrate ophthalmic solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1)
1. INDICATIONS AND USAGE
Warfarin sodium tablets 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 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 are vitamin K antagonist indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (1)
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (1)
Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (1)
Limitation of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. (1)
1 INDICATIONS AND USAGE
Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of:
Renal tubular acidosis (RTA) with calcium stones (1.1)
Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2)
Uric acid lithiasis with or without calcium stones (1.3)
1.1 Renal Tubular Acidosis
(RTA) with Calcium Stones
Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)].
1.2 Hypocitraturic Calcium Oxalate
Nephrolithiasis of any Etiology
Potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)].
1.3 Uric Acid Lithiasis with
or without Calcium Stones
Potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].