um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Abacavir tablet, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Abacavir tablets USP 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
1.	INDICATIONS AND USAGE
LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Important Limitations of Use:
LANTUS is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition.
LANTUS is a long- acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. ( )
1
Important Limitations of Use:
Not recommended for treating diabetic ketoacidosis. Use intravenous, short-acting insulin instead.
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 INDICATIONS AND USAGE
Glimepiride tablets 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)
].
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1).
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1).
INDICATIONS AND USAGE
Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.
Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use [see
WARNINGS
].
1
INDICATIONS AND USAGE
ZYMAXID is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerobic gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis group*
Streptococcus oralis
*
Streptococcus pneumoniae
Aerobic gram-negative bacteria:
Haemophilus influenzae
*Efficacy for these organisms were studied in fewer than 10 infections.
ZYMAXID
is aquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae (1)
1 INDICATIONS AND USAGE
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. (
1)
1 INDICATIONS AND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia
[see Clinical Studies
(14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY
(aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia
(14.1)
1 INDICATIONS AND USAGE
RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for:
Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7years and older who have been symptomatic for no more than 2days. (1.1)
Prophylaxis of influenza in patients aged 5years and older. (1.2)
Important Limitations of Use:
Not recommended for treatment or prophylaxis of influenza in:
Individuals with underlying airways disease. (5.1)
Not proven effective for:
Treatment in individuals with underlying airways disease. (1.3)
Prophylaxis in nursing home residents. (1.3)
Not a substitute for annual influenza vaccination. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA. (1.3)
1.1 Treatment of Influenza
RELENZA (zanamivir) inhalation powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients aged 7years and older who have been symptomatic for no more than 2days.
1.2 Prophylaxis of Influenza
RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5years and older.
1.3 Important Limitations of Use
RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm [see Warnings and Precautions (5.1)].
RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.
RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting.
RELENZA is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee.
Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA.
There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B.
Patients should be advised that the use of RELENZA for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.
INDICATIONS & 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
MINIVELLE is indicated for:
MINIVELLE is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause (1.1)
Prevention of postmenopausal osteoporosis (1.2)
Limitations of Use
When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1	Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
1.2	Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1 INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C,
Total-C, TG and Apo B, and to increase HDL-C in adult patients with
primary hypercholesterolemia or mixed dyslipidemia (
1.1).
For treatment of adult patients
with severe hypertriglyceridemia (
1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of fenofibrate tablet was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[see Warnings and Precautions (
5.1)].
1 INDICATIONS AND USAGE
Parenteral Phenytoin Sodium Injection, USP is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous Phenytoin Sodium Injection, USP can also be substituted, as short-term use, for oral phenytoin. Parenteral Phenytoin Sodium Injection, USP should be used only when oral phenytoin sodium injection administration is not possible [
see
Dosage and Administration
(
2.1
,
2.3
) and
Warnings and Precautions (5.1)
].
Parenteral phenytoin sodium injection is indicated for the treatment of generalized tonic clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin sodium injection can also be substituted, as short-term use, for oral phenytoin. Parenteral phenytoin sodium injection should be used only when oral phenytoin sodium injection administration is not possible.
INDICATIONS AND USAGE
Hydrochlorothiazide USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Hydrochlorothiazide USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide USP is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy 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 toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
1 INDICATIONS AND USAGE
DOTTIis indicated for:
DOTTI is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause (1.1)
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (1.2)
Limitations of Use
When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products.
Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure (1.3)
Prevention of postmenopausal osteoporosis (1.4)
Limitations of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause
Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.
1.3 Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure
1.4 Prevention of Postmenopausal Osteoporosis
Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dehydrated Alcohol Injection, USP is indicated for therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (tic douloureux), in patients for whom neurosurgical procedures are contraindicated. Relief of trigeminal neuralgia usually is only temporary. Other conditions for which injection of alcohol has been reported include glossopharyngeal neuralgia, angina pectoris and severe claudication due to peripheral vascular insufficiency.
Alcohol concentrations of 40 to 50% (prepared by appropriate dilution of dehydrated alcohol) have been used for epidural or individual motor nerve injections to control certain manifestations of cerebral palsy and spastic paraplegia. Similar concentrations also have been injected for celiac plexus block to relieve pain of inoperable upper abdominal cancer, and have been injected intra-and subcutaneously for relief of intractable pruritus ani.
INDICATIONS AND USAGE
Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.
1INDICATIONS AND USAGE
Coartem (artemether/lumefantrine) Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum in patients of 5 kg bodyweight and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)].
Limitations of Use
:
Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria.
Coartem Tablets are not approved for the prevention of malaria.
Coartem (artemether and lumefantrine) Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum in patients of 5 kg bodyweight and above. (1)
Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported. (1)
Coartem Tablets should not be used to treat severe malaria or to prevent malaria. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of
Ibuprofen tablets and other treatment options before deciding to use
Ibuprofen.Use the lowest effective dose for the shortest duration consistent
with individual patient treatment goals (see
WARNINGS
).
IBU tablets are indicated for relief of the signs and symptoms of rheumatoid
arthritis and osteoarthritis.
IBU tablets are indicated for relief of mild to moderate pain.
IBU tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of IBU
tablets in children have not been conducted.
INDICATIONS AND USAGE
This fixed combination drug is not indicated for the initial therapy of edema or hyper
tension
except in individuals in whom the developme
nt of hypokalemia cannot be ris
ked.
Triamterene and hydrochlorothiazide capsules, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide capsules, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.
Triamterene and hydrochlorothiazide capsules, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary.
Us
age 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 pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. 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 which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which 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 which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
1 INDICATIONS AND USAGE
Fentanyl Citrate Injection is indicated for:
analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
use as an opioid analgesic supplement in general or regional anesthesia.
administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
Fentanyl Citrate Injection is an opioid agonist indicated for:
analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
use as an opioid analgesic supplement in general or regional anesthesia.
administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
1 INDICATIONS AND USAGE
Fluoxetine Capsules are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
Fluoxetine Capsules and Olanzapine in Combination are indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine Capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using Fluoxetine Capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax .
Fluoxetine Capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (1)
Acute and maintenance treatment of Bulimia Nervosa (1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)
Fluoxetine Capsules and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
1 INDICATIONS AND USAGE
CARISOPRODOL is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. CARISOPRODOL should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [
see Dosage and Administration (2)
].
CARISOPRODOL is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.
(1)
Important Limitations:
Should only be used for acute treatment periods up to two or three weeks
(1)
Not recommended in pediatric patients less than 16 years of age
(8.4)
INDICATIONS AND USAGE
Tham Solution (tromethamine injection) is indicated for the
prevention and correction of metabolic acidosis. In the following
conditions it may help to sustain vital functions and thus provide time
for treatment of the primary disease:
Metabolic Acidosis Associated with
Cardiac Bypass Surgery.
Tham Solution has been found to be primarily beneficial
in correcting metabolic acidosis which may occur during or
immediately following cardiac bypass surgical
procedures.
Correction of Acidity of ACD Blood in
Cardiac Bypass Surgery.
It is well known that ACD blood is acidic and becomes
more acidic on storage. Tromethamine effectively corrects this
acidity. Tham Solution may be added directly to the blood used
to prime the pump-oxygenator. When ACD blood is brought to a
normal pH range the patient is spared an initial acid load.
Additional tromethamine may be indicated during cardiac bypass
surgery should metabolic acidosis appear.
Metabolic Acidosis Associated with
Cardiac Arrest.
Acidosis is nearly always one of the consequences of
cardiac arrest and, in some instances, may even be a causative
factor in arrest. It is important therefore, that the correction
of acidosis should be started promptly with other resuscitative
efforts. By correcting acidosis, Tham Solution (tromethamine
injection) has caused the arrested heart to respond to
resuscitative efforts after standard methods alone had failed.
In these cases, tromethamine was given intraventricularly. It is
to be noted, however, that such precariously ill patients often
have died subsequently of causes unrelated to the administration
of tromethamine. With administration by the peripheral venous
route, metabolic acidosis has been corrected in a majority of
patients. The success in reinstitution of cardiac rhythm by this
means probably has not been of the same order of magnitude as
with the intraventricular route.