um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Glipizide tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with non-insulin-dependent diabetes mellitus (NIDDM; type II), formerly known as maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory.
In initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified, and corrective measures taken where possible.
If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of glipizide must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone also may be transient, thus requiring only short-term administration of glipizide.
During maintenance programs, glipizide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgements should be based on regular clinical and laboratory evaluations.
In considering the use of glipizide in asymptomatic patients, it should be recognized that controlling the blood glucose in non-insulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.
INDICATIONS AND USAGE:
Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcers:Pseudomonas aeruginosa
Serratia marcescens*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)*
Conjunctivitis:Haemophilus influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
*Efficacy for this organism was studied in fewer than 10 infections.
INDICATIONS AND USAGE
LIDODERM is indicated for relief of pain associated with post-herpetic
neuralgia. It should be applied only to intact skin.
1 INDICATIONS & USAGE
Gabapentin is indicated for:
Management of postherpetic neuralgia in adults.
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
1 INDICATIONS AND USAGE
Regadenoson injectionis a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Regadenoson injectionis a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress (1).
INDICATIONS AND USAGE
Hydrochlorothiazide Tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide Tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Hydrochlorothiazide Tablets are 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.
INDICATIONS & USAGE
Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
INDICATIONS AND USAGE
Clindamycin hydrochloride capsules are indicated in the treatment of serious
infections caused by susceptible anaerobic bacteria. Clindamycin
hydrochloride capsules are also indicated in the treatment of serious infections
due to susceptible strains of streptococci, pneumococci, and staphylococci. Its
use should be reserved for penicillin-allergic patients or other patients for
whom, in the judgment of the physician, a penicillin is inappropriate. Because
of the risk of colitis, as described in the
WARNINGbox, before selecting clindamycin the
physician should consider the nature of the infection and the suitability of
less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as
empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue
infections; septicemia; intra-abdominal infections such as peritonitis and
intra-abdominal abscess (typically resulting from anaerobic organisms resident
in the normal gastrointestinal tract); infections of the female pelvis and
genital tract such as endometritis, nongonococcal tuboovarian abscess, pelvic
cellulitis and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious
skin and soft tissue infections.
Staphylococci:
Serious respiratory tract infections; serious skin and soft tissue
infections.
Pneumococci: Serious respiratory
tract infections.Bacteriologic studies should be performed to determine
the causative organisms and their susceptibility to clindamycin.To
reduce the development of drug-resistant bacteria and maintain the effectiveness
of clindamycin hydrochloride and other antibacterial drugs, clindamycin
hydrochloride 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.
INDICATIONS AND USAGE
robaxin and robaxin-750 are
indicated as an adjunct to rest, physical therapy, and other measures for the
relief of discomfort associated with acute, painful musculoskeletal conditions.
The mode of action of methocarbamol has not been clearly identified, but may be
related to its sedative properties. Methocarbamol does not directly relax tense
skeletal muscles in man.
1 INDICATIONS AND USAGE
Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. (1)
1 INDICATIONS AND USAGE
Pediatric use information for patients7 to 17years of ageis approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
Limitations of use( 1.8 ):Rosuvastatintablets has not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatintablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatintablets are indicated as an adjunct to diet for the treatment of adultpatients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatintablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (
1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (
1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (
1.5)
Limitations of use (
1.8): Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin tablets are indicated as anadjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
OPTIRAY is indicated for:
OPTIRAY is a radiographic contrast agent indicated for the following:
Intra-arterial Procedures (1.1)
Adults:
Cerebral Arteriography (300, 320 mg iodine/mL)
Peripheral Arteriography (300, 320, 350 mg iodine/mL )
Visceral and Renal Arteriography, Aortography (320 mg iodine/mL)
Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL)
Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL)
Intravenous Procedures (1.2)
Adults:
Computed tomography (CT) Imaging of Head and Body (300, 320, 350 mg iodine/mL)
Venography (300, 320, 350 mg iodine/mL)
Intravenous Excretory Urography (300, 320, 350 mg iodine/mL)
Intravenous Digital Subtraction Angiography (350 mg iodine/mL)
Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320mg iodine/mL).
1.1 Intra-arterial
In adults
OPTIRAY 300: cerebral arteriography, and peripheral arteriography.
OPTIRAY 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography.
OPTIRAY 350: peripheral arteriography, coronary arteriography, and left ventriculography.
In pediatric patients
OPTIRAY 320 and OPTIRAY 350: angiocardiography.
1.2 Intra-venous
In adults
OPTIRAY 300: CT imaging of the head and body, venography, and intravenous excretory urography.
OPTIRAY 320: CT imaging of the head and body, venography, and intravenous excretory urography.
OPTIRAY 350: CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA).
In pediatric patients
OPTIRAY 320: CT imaging of the head and body, and intravenous excretory urography.
1 INDICATIONS AND USAGE
Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce the risk of hemorrhage during and following tooth extraction.
Tranexamic Acid in Sodium Chloride Injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction (1).
1 INDICATIONSAND USAGE
Clonidine hydrochloride extended-release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].
Clonidine hydrochloride extended-release tablets are a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. (1)
1	INDICATIONS AND USAGE
EMEND for oral suspension, in combination with other antiemetic agents, is indicated in 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.
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
EMEND capsules, in combination with other antiemetic agents, is indicated in patients 12 years 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.
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
EMEND is a substance P/neurokinin 1 (NK1) receptor antagonist.
EMEND for oral suspension is indicated
in combination with other antiemetic agents, in patients 6 months of age and older for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1)
EMEND capsules is indicated
in combination with other antiemetic agents, in patients 12 years of age and older for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1)
Limitations of Use (
1
)
EMEND has not been studied for treatment of established nausea and vomiting.
Chronic continuous administration of EMEND is not recommended.
Limitations of Use
EMEND has not been studied for the treatment of established nausea and vomiting.
Chronic continuous administration of EMEND is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.
INDICATIONS AND 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 tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis and corticosteroid and estrogen therapy.
Chlorthalidone tablets have 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 tablets are 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
Adults
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension
(PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
Pediatric Patients (1 to 17 Years old)
Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14)].
Adults
Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. (1)
Pediatric Patients (1 to 17 years old)
Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise (1, 14)
INDICATIONS AND USAGE
Intraocular use for obtaining miosis during surgery. In addition, Carbastat (Carbachol Intraocular Solution USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.
As a sedative when used as premedication and following general anesthesia, , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
Hydroxyzine may potentiate meperidine (Demerol ) and barbiturates
The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Fluocinonide Gel is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
For patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus infection with compensated liver function.
Adefovir dipivoxil tablets are a nucleotide analogue indicated for the treatment of chronic hepatitis B in patients 12 years of age and older. (1)
INDICATIONS AND USAGE
Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
INDICATIONS AND USAGE
DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.
INDICATIONS AND USAGE
Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder.
The efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.