um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Preservative-free timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Preservative-free timolol maleate ophthalmic solution may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
INDICATIONS AND USAGE
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
1 INDICATIONS AND USAGE
Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
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. (1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2
Prophylaxis of Influenza
Oseltamivir phosphate capsules are indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions 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 oseltamivir phosphate capsules [see Microbiology (12.4)].
Oseltamivir phosphate capsules are not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4)
and
Use in Specific Populations (8.6)].
1 INDICATIONS AND USAGE
Phentermine hydrochloride, USP 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index 30 kg/m2, or27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of Body Mass Index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (
12.1
,
12.2
)] should be measured against possible risk factors inherent in their use such as those described below.
image description
INDICATIONS & USAGE
Dermatitis herpetiformis: (D.H.)
Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
INDICATIONS AND USAGE:
Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
1 INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy (1.1)
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy (1.2)
Important limitation of use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or nontumor-related hypercalcemia. (1.3)
1.1 Hypercalcemia of Malignancy
Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0 mmol/L] using the formula:cCa in mg/dL=Ca in mg/dL + 0.8 (4.0 g/dL - patient albumin [g/dL]).
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Limitations of Use
Thesafety and efficacy of zoledronic acid injection in the treatment ofhypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditionshave not been established.
1 INDICATIONS AND USAGE
Liothyronine sodium is an L-triiodothyronine (T3) indicated for:
Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism (1.1)
Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer (1.2)
Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy (1.3)
Limitations of Use:
- Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1)
- Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1)
1.1	Hypothyroidism
Liothyronine sodium is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
1.2	Pituitary Thyroid-Stimulating Hormone (TSH) Suppression
Liothyronine sodium is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer.
1.3	Thyroid Suppression Test
Liothyronine sodium is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.
Limitations of Use
Liothyronine sodium is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with liothyronine sodium may induce hyperthyroidism [see Warnings and Precautions (5.4)].
Liothyronine sodium is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
INDICATIONS AND USAGE
This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.
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.
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 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
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 and Olanzapine in Combination is indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).
Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
When using fluoxetine 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 and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder
(1)
Treatment Resistant Depression
(1)
1 INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol tablets are an estrogen plus progestin indicated in a woman with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1)
Prevention of Postmenopausal Osteoporosis (1.2)
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, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
1	INDICATIONS AND USAGE
SELZENTRY, in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1.
This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of SELZENTRY in treatment-experienced subjects and one study in treatment-nave subjects. Both studies in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (NRTI, NNRTI, PI, or enfuvirtide) adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with SELZENTRY:
Adult patients infected with only CCR5-tropic HIV-1 should use SELZENTRY.
Tropism testing must be conducted with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for SELZENTRY use. Outgrowth of pre-existing low-level CXCR4- or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on SELZENTRY. [see
Microbiology (12.4)
Clinical Studies (14.3)
] .
Use of SELZENTRY is not recommended in subjects with dual/mixed or CXCR4-tropic HIV-1 as efficacy was not demonstrated in a phase 2 study of this patient group.
The safety and efficacy of SELZENTRY have not been established in pediatric patients.
In treatment-nave subjects, more subjects treated with SELZENTRY experienced virologic failure and developed lamivudine resistance compared to efavirenz. [see
Microbiology (12.4)
Clinical Studies (14.3)
]
SELZENTRY is a CCR5 co-receptor antagonist indicated for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1.
In treatment-nave subjects, more subjects treated with SELZENTRY experienced virologic failure and developed lamivudine resistance compared to efavirenz [see
Microbiology (12.4)
Clinical Studies (14.3)
].
Tropism testing with a highly sensitive tropism assay is required for the appropriate use of SELZENTRY (1).
1 INDICATIONS AND USAGE
GONITRO is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
GONITROis a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. (1)
INDICATIONS AND USAGE
Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma.
In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see
DOSAGE AND ADMINISTRATION
). The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response.
In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium should be given shortly before exposure to the precipitating factor (see
DOSAGE AND ADMINISTRATION
).
INDICATIONS AND USAGE
Hydrocortisone valerate ointment, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
INDICATIONS AND USAGE
Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
1 INDICATIONS AND USAGE
Omidria
is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.
OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for:
Maintaining pupil size by preventing intraoperative miosis (
1)
Reducing postoperative pain (
1)
OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
1 INDICATIONS AND USAGE
Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease (
1
).
INDICATIONS AND USES:
Salicylic Acid, 27.5% Wart Remover is indicated for the topical treatment and removal of common warts and plantar warts.
1 INDICATIONS AND USAGE
Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients.
Limitations of Use
Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Morphine Sulfate Oral Solution is an opioid agonist indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
INDICATIONS & USAGE
Orphengesic Forte (Orphenadrine Citrate, Aspirin and Caffeine 50 mg/ 770 mg/ 60 mg) Tablets are indicated in:
Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.
The orphenadrine component is 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 orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphengesic Forte Tablets do not directly relax tense muscles in man.
1 INDICATIONS AND USAGE
Vardenafil
is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of
erectile dysfunction. (
1)
Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.
Indications & Usage Section
Metaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
Please review the manufacturer's complete drug information available from the FDA at
www.fda.gov
Permanent Link:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb91223e-ffa5-4a3a-b191-fe121250c20c&audience=consumer
INDICATIONS AND USAGE
Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see
DOSAGE AND ADMINISTRATION
and
CLINICAL PHARMACOLOGY
sections).
1 INDICATIONS AND USAGE
Lubiprostone is a chloride channel activator indicated for the treatment of:
chronic idiopathic constipation (CIC) in adults. (
1.1)
opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (
1.2)
Limitations of Use:
Effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (
1.2,
7.1)
irritable bowel syndrome with constipation (IBS-C) in women
18 years old. (
1.3)
1.1 Chronic Idiopathic Constipation in Adults
Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Limitations of Use:
Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
[see
Clinical Studies (14.2)]
1.3 Irritable Bowel Syndrome with Constipation
Lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
1 INDICATIONS AND USAGE
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an antiarrhythmic indicated for:
the treatment of life-threatening ventricular arrhythmias(
1.1)
the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (
1.2)
Limitations of Use
Sotalol hydrochloridehasnotbeenshowntoenhancesurvivalinpatientswithlifethreateningventriculararrhythmias
(1.1)
Avoiduseinpatientswithminimallysymptomaticoreasilyreversible AFIB/AFL(
1.2)
1.1 Life-Threatening Ventricular Arrhythmias
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
Limitation of Use:
Sotalol hydrochloride/Sotalol hydrochloride AF has not been shown to enhance survival in patients with life-threateningventriculararrhythmias.
1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.
Limitation of Use:
Because sotalol hydrochloride/sotalol hydrochloride AF tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride AF tablets.
1	INDICATIONS AND USAGE
Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients.
Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. (1)
INDICATIONS AND USAGE
Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
INDICATIONS AND USAGE
Lidocaine Hydrochloride and Epinephrine Injection, USP is
indicated for production of local or regional anesthesia by infiltration
techniques such as percutaneous injection, by peripheral nerve block
techniques such as brachial plexus and intercostal and by central neural
techniques such as lumbar and caudal epidural blocks, when the accepted
procedures for these techniques as described in standard textbooks are
observed.
DIRECTIONS FOR USE:
To insure full fluorescence and patient comfort, the BioGlo impregnated tip should be moistened before application. One or two drops of sterile irrigating or saline solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.
Grasp tabs between thumbs & index fingers
Gently pull tabs apart
Remove strip taking care to touch only the white portion of the strip
HUB_BioGlo Instructions For Opening Strips