um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
UKONIQ is a kinase inhibitor indicated for the treatment of adult patients with:
Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen (
1.1).
Relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy (
1.2).
These indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.
1.1 Marginal Zone Lymphoma
UKONIQ is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen.
This indication is approved under accelerated approval based on overall response rate
[see Clinical Studies (
14.1)]
. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
1.2 Follicular Lymphoma
UKONIQ is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
This indication is approved under accelerated approval based on overall response rate
[see Clinical Studies (
14.2)]
. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
1. INDICATIONS AND USAGE
ARICEPT is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
ARICEPT is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (
1.0
).
1 INDICATIONS AND USAGE
Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (
1)
CLINICAL STUDIES
In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:
Lesions
Clindamycin Phosphate Topical Gel QD
N=162
Vehicle Gel QD
N=82
Inflammatory
51%
40%P<0.05
Noninflammatory
25%
12%
Total
38%
27%
There was a trend in the investigators global assessment of the results, which favored Clindamycin Phosphate Topical GelQD over the vehicle QD.
In a contactsensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to Clindamycin Phosphate Topical Gel. There was no signal for contact sensitization in the clinical trials under normal use conditions.
INDICATIONS AND USAGE
Dextroamphetamine sulfate tablets, USPare indicated for:
Narcolepsy
.
Attention Deficit Disorder with Hyperactivity
, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
1 INDICATIONS AND USAGE
ZEGERID is a proton pump inhibitor indicated for:
Short-term treatment of active duodenal ulcer (1.1)
Short-term treatment of active benign gastric ulcer (1.2)
Treatment of gastroesophageal reflux disease (GERD) (1.3)
Maintenance of healing of erosive esophagitis (1.4)
Reduction of risk of upperGI bleeding in critically ill patients (1.5)
The safety and effectiveness of ZEGERID in pediatric patients (<18 years of age) have not been established.
(8.4)
1.1 Duodenal Ulcer
ZEGERID (omeprazole/sodium bicarbonate) is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)]
1.2 Gastric Ulcer
ZEGERID is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2)]
1.3 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
ZEGERID is indicated for the treatment of heartburn and other symptoms associated with GERD. [See Clinical Studies (14.3)]
Erosive Esophagitis
ZEGERID is indicated for the short-term treatment (4-8weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of ZEGERID used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of ZEGERID
may be considered. [See Clinical Studies (14.3)]
1.4 Maintenance of Healing of Erosive Esophagitis
ZEGERID is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)]
1.5 Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40mg oral suspension only)
ZEGERID Powder for Oral Suspension 40 mg/1680mg is indicated for the reduction of risk of upperGI bleeding in critically ill patients. [See
CLINICAL STUDIES
, Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (14.5)]
INDICATIONSAND USAGE
Desipramine hydrochloride tablets, USP are indicated for the treatment of depression.
INDICATIONS AND USAGE
Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.2 mEq/L) or elevated. In total parental nutrition (TPN), magnesium sulfate may be added to the nutriend admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.
INDICATIONS AND USAGE
Severe Recalcitrant Nodular Acne
Amnesteem is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Severe, by definition,2 means many as opposed to few or several nodules. Because of significant adverse effects associated with its use, Amnesteem should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Amnesteem is indicated only for those patients who are not pregnant, because Amnesteem can cause life threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Amnesteem. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).
INDICATIONS AND USAGE
Trazodone Hydrochloride Tablets USP are indicated for the treatment of depression. The efficacy of Trazodone Hydrochloride Tablets USP has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Associations Diagnostic and Statistical Manual, lll.a
Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.
1 INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1).
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients withcoronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
1 INDICATIONS AND USAGE
Olopatadine hydrochloride nasal solution is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.
Olopatadine hydrochloride nasal solution is an H1receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older (1).
INDICATIONS AND USAGE
Moexipril hydrochloride is indicated for treatment of patients
with hypertension. It may be used alone or in combination with thiazide
diuretics.
In using moexipril hydrochloride, consideration should be given to the fact
that another ACE inhibitor, captopril, has caused agranulocytosis, particularly
in patients with renal impairment or collagen-vascular disease. Available data
are insufficient to show that moexipril hydrochloride does not have a similar
risk (see WARNINGS).
In considering use of moexipril hydrochloride, it should be noted that in
controlled trials ACE inhibitors have an effect on blood pressure that is less
in black patients than in non-blacks. In addition, ACE inhibitors (for which
adequate data are available) cause a higher rate of angioedema in black than in
non-black patients (see WARNINGS , Angioedema ).
INDICATIONS AND USAGE
Chlorhexidine Gluconate Oral Rinse, 0.12% is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine Gluconate Oral Rinse, 0.12% has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see
PRECAUTIONS
.
1 INDICATIONSAND USAGE
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatingreater than or equal to 50 mg/m2.
initial and repeat courses of moderately emetogenic cancer chemotherapy.
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2.(1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1)
postoperative nausea and/or vomiting. (1)
1 INDICATIONS AND USAGE
Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older (1).
1 INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for:
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2)
1.2 Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
INDICATIONS AND USAGE
Promethazine HCl Suppositories are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amerlioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1 INDICATIONS AND USAGE
Rufinamide tablets USP are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults (1)
Rufinamide tablets USP are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
INDICATIONS AND USAGE
Midazolam hydrochloride injection, USP is indicated:
intramuscularly or intravenously for preoperative
sedation/anxiolysis/amnesia;
intravenously as an agent for sedation/anxiolysis/amnesia
prior to or during diagnostic, therapeutic or endoscopic procedures, such
as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac
catheterization, oncology procedures, radiologic procedures, suture of
lacerations and other procedures either alone or in combination with other
CNS depressants;
intravenously for induction of general anesthesia, before
administration of other anesthetic agents. With the use of narcotic
premedication, induction of anesthesia can be attained within a relatively
narrow dose range and in a short period of time. Intravenous midazolam
hydrochloride can also be used as a component of intravenous
supplementation of nitrous oxide and oxygen (balanced anesthesia);
continuous intravenous infusion for sedation of intubated
and mechanically ventilated patients as a component of anesthesia or
during treatment in a critical care setting.
1 INDICATIONS AND USAGE
Temozolomide capsules are an alkylating drug indicated for the treatment of adult patients with:
Newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment.
(1.1)
Refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
(1.2)
1.1
Newly Diagnosed Glioblastoma Multiforme
Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
1.2
Refractory Anaplastic Astrocytoma
Temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
INDICATIONS AND USAGE
Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or lump in throat); (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or mind going blank because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam tablets. Alprazolam tablets are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam tablets by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
Anxiety Disorders
Motor Tension
Autonomic Hyperactivity
Vigilance and Scanning
Panic Disorder
1 INDICATIONS AND USAGE
TREXALL is a dihydrofolate reductase inhibitor indicated for the:
Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1)
Treatment of adults with mycosis fungoides (1.1)
Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1)
Treatment of adults with rheumatoid arthritis (1.2)
Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3)
Treatment of adults with severe psoriasis (1.4)
1.1
Neoplastic Diseases
TREXALL is indicated for the:
treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen
treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen
treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen.
1.2
Rheumatoid Arthritis
TREXALL is indicated for the treatment of adults with rheumatoid arthritis.
1.3 Polyarticular Juvenile Idiopathic Arthritis
TREXALL is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
1.4 Psoriasis
TREXALL is indicated for the treatment of adults with severe psoriasis.
1. Indications and Usage
Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Acinetobacter lwoffii*
Haemophilus influenza
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
INDICATIONS AND USAGE
This solution is indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories.
INDICATIONS AND USAGE:
Hydrocortisone suppositories are indicated for use in:
inflamed hemorrhoids
post-irradiation (factitial) proctitis
as an adjunct in the treatment of chronic ulcerative colitis
cryptitis
other inflammatory conditions of anorectum and pruritus ani.
INDICATIONS AND USAGE
KADIAN Capsules are an extended-release oral formulation of
morphine sulfate indicated for the management of moderate to severe pain when a
continuous, around-the-clock opioid analgesic is needed for an extended period
of time (see CLINICAL
PHARMACOLOGY).
KADIAN Capsules are NOT intended for use as a prn
analgesic.
KADIAN is not indicated for pain in the immediate postoperative period (the
first 12-24 hours following surgery), or if the pain is mild or not expected to
persist for an extended period of time. KADIAN is only indicated for
postoperative use if the patient is already receiving the drug prior to surgery
or if the postoperative pain is expected to be moderate to severe and persist
for an extended period of time. Physicians should individualize treatment,
moving from parenteral to oral analgesics as appropriate. (See American Pain
Society guidelines.)