um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Celecoxib capsules are indicated
Celecoxib capsules are a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3) Ankylosing Spondylitis (AS) (1.4) Acute Pain (AP) (1.5) Primary Dysmenorrhea (PD) (1.6)
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)]
INDICATIONS AND USAGE
Vivacaine (bupivacaine hydrochloride and epinephrine injection, USP) is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults.
Vivacaine (bupivacaine hydrochloride and epinephrine injection, USP) is not recommended for children.
INDICATIONS AND USAGE
Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:
1.
Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
3.
Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4.
Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
). Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
).
5.
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies
).
INDICATIONS AND USAGE
Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients with:
CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. (1.1)
Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). (1.2)
1.1
MRD-positive B-cell Precursor ALL
BLINCYTO is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adult and pediatric patients.
1.2	Relapsed or Refractory B-cell Precursor ALL
BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients.
INDICATIONS AND USAGE
LORTAB 7.5/500 tablets (hydrocodone bitartrate and acetaminophen
tablets, USP, 7.5 mg/500 mg) are indicated for the relief of moderate to
moderately severe pain.
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis
1 INDICATIONS AND USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). (
1)
1 INDICATIONS AND USAGE
Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the relief of the symptoms of:
Seasonal allergic rhinitis in patients 6 years of age and older. (1.1)
Perennial allergic rhinitis in patients 6 years of age and older. (1.1).
1.1 Allergic Rhinitis
Azelastine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older.
INDICATIONS AND USAGE
Verapamil hydrochloride injection, USP is indicated for the following:
Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.
Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).
In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.
Because a small fraction (<1.0%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole-seeCONTRAINDICATIONS and WARNINGS), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.
1 INDICATIONS AND USAGE
TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
TREXIMET is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with TREXIMET, reconsider the diagnosis of migraine before TREXIMET is administered to treat any subsequent attacks.
TREXIMET is not indicated for the prevention of migraine attacks.
Safety and effectiveness of TREXIMET have not been established for cluster headache.
1 INDICATIONS AND USAGE
Esomeprazole Magnesium Delayed-release Capsules is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD). (
1.1)
Risk reduction of NSAID-associated gastric ulcer. (
1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (
1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (
1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-release Capsules is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-release Capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-release Capsules is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole Magnesium Delayed-release Capsules is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole Magnesium Delayed-release Capsules is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Esomeprazole Magnesium Delayed-release Capsules plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-release Capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
[see Dosage and Administration (
2) and Clinical Studies (
14)]
.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted
[see Clinical Pharmacology (
12.4) and the prescribing information for clarithromycin]
.
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole Magnesium Delayed-release Capsules is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS & 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 is 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 has 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 an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatintablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDLC, TotalC, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatintablets has not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
PRECEDEX is a alpha2-adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. (1.1)
Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2)
Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. (1.2)
1.1	Intensive Care Unit Sedation
PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours.
PRECEDEX has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation.
1.2	Procedural Sedation
PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
PRECEDEX is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
INDICATIONS
Sumaxin (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
INDICATIONS AND USAGE
BISOPROLOL FUMARATE is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
1. Indications:Progestin-only oral contraceptives are indicated for the
prevention of pregnancy.
2. Efficacy:If used perfectly, the first-year failure rate for progestin-only
oral contraceptives is 0.5%. However, the typical failure rate is estimated to
be closer to 5%, due to late or omitted pills. The following table lists the
pregnancy rates for users of all major methods of contraception.
Table 1 Comparison of reversible contraceptive methods: Percent of
women experiencing a contraceptive failure (pregnancy) during the first year of
use.
Percent of women experiencing
a pregnancy within the first year of use
Method
Average Use
Perfect Use
No contraception
85
85
Spermicides
21
6
Periodic abstinence
20
1-9
Withdrawal
19
4
Cervical capsGiven birthNever given birth
3618
269
Diaphragms
18
6
CondomsFemaleMale
2112
53
PillsProgestin-onlyCombined
3
0.50.1
IUDsProgesteroneCopper T 380A
20.8
1.50.6
Injectables
0.3
0.3
Implant
0.09
0.09
Adapted with permission.*
*Hatcher RA, Trussel J, Stewart F, Stewart GK, Kowal D, Guest F, Cates W,
Pollcar M. Contraceptive Technology 1994-1996. New York, NY: Irvington
Publishers. 1994.Depending on method (calendar, ovulation, symptom-thermal,
post-ovulation).
1 INDICATIONS AND USAGE
CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.
CELLCEPT is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
1 INDICATIONS AND USAGE
ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. (1)
Lidocaine Ointment 2% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx.
Indications
Spotex is indicated for the treatment of Acne Vulgaris, Acne appears as blackheads and whiteheads which people often refer to as pimples or spots.
Spotex attacks the bacteria that are one of the main causes of acne. The name of these bacteria is Propionibacterium acnes
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets, USP are 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
Donepezil hydrochloride tablets, USP are 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 INDICATIONS AND USAGE
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha2-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.
Administer dexmedetomidine hydrochloride in 0.9% sodium chloride by continuous infusion not to exceed 24 hours. (1.1)
Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2)
1.1 Intensive Care Unit Sedation
Dexmedetomidine hydrochloride in 0.9% sodium chloride is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride in 0.9% sodium chloride should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine hydrochloride in 0.9% sodium chloride has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine hydrochloride in 0.9% sodium chloride prior to extubation.
1.2
Procedural Sedation
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
INDICATIONS AND USAGE
Sucralfate tablets, USPare indicated in:
Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
1 INDICATIONS AND USAGE
Latanoprost Ophthalmic Solution is a prostaglandin F
2 analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Latanoprost Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of testosterone cypionate in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
1 INDICATIONS AND USAGE
Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important
[see
Dosage and Administration
(2.1)].
Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important.
(1)
1. Indications and Usage Section
Pregabalin is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizers LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizers marketing exclusivity rights, this drug product is not labeled with that pediatric information.