um-ids/dailymed-annotations huggingface dataset:
Indications and 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)]
INDICATIONS AND USAGE
Diphenoxylate HCl and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
INDICATIONS AND USAGE
Butalbital, acetaminophen, and caffeine tablets USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Refractory Testicular Tumors
Etoposide Injection, USP in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.
Adequate data on the use of etoposide capsules in the treatment of testicular cancer are not available.
Indications and Directions
Indications: topical anti-caries preparation
Directions:
Following prophylaxis treatment, fill
of tray with foam
To dispense, shake bottle vigorously then invert applicator 180 downward to the bottom of the tray
Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes
Remove tray and have patient expectorate excess
Advise patient not to eat, drink or rinse for 30 minutes after the treatment
Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
1 INDICATIONS AND USAGE
Valproic Acid Capsules, USP are an anti-epileptic 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 Capsules, USP are 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 Capsules, USP are 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, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17.3)].
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets(SR)are indicated as an aid to smoking cessation treatment.
Bupropion hydrochloride extended-release tablets (SR)are an aminoketone agent indicated as an aid to smoking cessation treatment. (1)
INDICATIONS AND USAGE:
Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years
1 INDICATIONS AND USAGE
Colchicine Tablets, USP are an alkaloid indicated for:
Prophylaxis and treatment of gout flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).
Colchicine Tablets, USP are not an analgesic medication and should not be used to treat pain from other causes.
1.1	Gout Flares
Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares.
Prophylaxis of Gout Flares:
Colchicine Tablets, USP are indicated for prophylaxis of gout flares.
Treatment of Gout Flares:
Colchicine Tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2	Familial Mediterranean Fever (FMF)
Colchicine Tablets, USP are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
1 INDICATIONS AND USAGE
Heparin sodium is indicated for:
Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
Heparin sodium is indicated for: (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
INDICATIONS AND USAGE
Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.
1 INDICATIONS AND USAGE
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney
[see
Clinical Studies (14.1)], heart [see Clinical Studies (14.2)]
or liver transplants
[see Clinical Studies (14.3)],
in combination with other immunosuppressants.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. (1)
1 INDICATIONS AND USAGE
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
Celecoxib is indicated
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)].
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)].
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)].
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)].
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)].
INDICATIONS & USAGE
Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration
INDICATIONS AND USAGE
LIORESAL INTRATHECAL (baclofen injection) is indicated for use in the management of
severe spasticity. Patients should first respond to a screening dose of
intrathecal baclofen prior to consideration for long term infusion via an
implantable pump. For spasticity of spinal cord origin, chronic infusion of
LIORESAL INTRATHECAL via an implantable pump should be reserved for patients
unresponsive to oral baclofen therapy, or those who experience intolerable CNS
side effects at effective doses. Patients with spasticity due to traumatic brain
injury should wait at least one year after the injury before consideration of
long term intrathecal baclofen therapy. LIORESAL INTRATHECAL is intended for use by the intrathecal route in single bolus test
doses (via spinal catheter or lumbar puncture) and, for chronic use, only in
implantable pumps approved by the FDA specifically for the administration of
LIORESAL INTRATHECAL into the intrathecal space.
Spasticity of Spinal Cord Origin: Evidence supporting
the efficacy of LIORESAL INTRATHECAL was obtained in randomized, controlled
investigations that compared the effects of either a single intrathecal dose or
a three day intrathecal infusion of LIORESAL INTRATHECAL to placebo in patients
with severe spasticity and spasms due to either spinal cord trauma or multiple
sclerosis. LIORESAL INTRATHECAL was superior to placebo on both principal
outcome measures employed: change from baseline in the Ashworth rating of
spasticity and the frequency of spasms.
Spasticity of Cerebral Origin: The efficacy of
LIORESAL INTRATHECAL was investigated in three controlled clinical trials; two
enrolled patients with cerebral palsy and one enrolled patients with spasticity
due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically
significant results; LIORESAL INTRATHECAL was superior to placebo in reducing
spasticity as measured by the Ashworth Scale. A second cross-over study was
conducted in 11 patients with spasticity arising from brain injury. Despite the
small sample size, the study yielded a nearly significant test statistic (p=0.066) and provided directionally favorable results. The last study, however,
did not provide data that could be reliably analyzed.
LIORESAL INTRATHECAL therapy may be considered an alternative to destructive
neurosurgical procedures. Prior to implantation of a device for chronic
intrathecal infusion of LIORESAL INTRATHECAL, patients must show a response to
LIORESAL INTRATHECAL in a screening trial (see Dosage and Administration).
1 INDICATIONS AND USAGE
Mometasone furoate nasal spray is a corticosteroid indicated for:
Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult and pediatric patients 12 years of age and older (1.1)
Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult patients 18 years of age and older (1.2)
1.1 Prophylaxis of Seasonal Allergic Rhinitis
Mometasone furoate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older.
1.2 Treatment of Chronic Rhinosinusitis with Nasal Polyps
Mometasone furoate nasal spray is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older.
1 INDICATIONS AND USAGE
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). (1)
1. INDICATIONS AND USAGE
Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:
Atropine is an anti-muscarinic agent indicated for:
cycloplegia (1.1)
mydriasis (1.2)
penalization of the healthy eye in the treatment of amblyopia (1.3)
1.1 Cycloplegia
1.2 Mydriasis
1.3 Penalization of the healthy eye in the treatment of amblyopia
INDICATIONS & USAGE
Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.
1 INDICATIONS AND USAGE
Valproic Acid Oral Solution is 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)
].
Migraine
Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should 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 Potassium Extended Release Tablets is indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected -lactamaseproducing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL). Amoxicillin and Clavulanate Potassium Extended Release Tablet is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs
4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs
4 mcg/ml [see Clinical Studies (14)].
In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablet is prescribed.
Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S. pneumoniae plus a -lactamaseproducing pathogen can be treated with another amoxicillin/clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin.
Amoxicillin and Clavulanate Potassium Extended Release Tabletsare a combination of a penicillin-class antibacterial drug and a beta-lactamase inhibitor indicated for treatment of community-acquired pneumonia and acute bacterial sinusitis (1).
Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1	INDICATIONS AND USAGE
Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
1 INDICATIONS AND USAGE
PENNSAID is indicated for the treatment of the pain of osteoarthritis of the knee(s).
PENNSAID is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). (1)