um-ids/dailymed-annotations huggingface dataset:
1INDICATIONS AND USAGE
COSENTYX is a human interleukin-17A antagonist indicated for the treatment of:
moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy (1.1)
active psoriatic arthritis (PsA) in patients 2 years of age and older (1.2)
adults with active ankylosing spondylitis (AS) (1.3)
adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (1.4)
active enthesitis-related arthritis (ERA) in patients 4 years of age and older (1.5)
1.1Plaque Psoriasis
COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.
1.2Psoriatic Arthritis
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.
1.3Ankylosing Spondylitis
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
1.4Non-Radiographic Axial Spondyloarthritis
COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
1.5Enthesitis-Related Arthritis
COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
Indications
Aquax-H
Cream can be used for the treatment of superficial skin conditions where itching, redness and scaling are often present.
INDICATIONS & USAGE
Intravenous adenosine injection is indicated for the following:
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration.
It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see
DOSAGE & ADMINISTRATION.
Adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.
1 INDICATIONS AND USAGE
Epoprostenol sodium for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Trials establishing effectiveness included predominantly (97%) patients with New York Heart Association (NYHA) Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%).
Epoprostenol sodium for injection is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Studies establishing effectiveness included predominantly (97%) patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%). (1)
INDICATION: Chlorhexidine gluconate oral rinse 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 has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG).
For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS.
1
INDICATIONS AND USAGE
Guanfacine extended-releasetablets areindicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications
[see Clinical Studies (
14
)].
Guanfacine extended-release is a central alpha
2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications (
1,
14).
1 INDICATIONS AND USAGE
Mitosol is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery.
Mitosol is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. (1)
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.
Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent.
Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis CariniiPneumonia: For the treatment of documented Pneumocystis cariniipneumonia and for prophylaxis against Pneumocystis cariniipneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis cariniipneumonia.
Travelers' Diarrhea In Adults: For the treatment of travelers' diarrhea due to susceptible strains of enterotoxigenic E. coli.
1 INDICATIONS AND USAGE
FLECTOR
is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.
FLECTOR is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. (
1)
INDICATIONS
Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of baclofen in stroke, cerebral palsy, and Parkinsons disease has not been established and, therefore, it is not recommended for these conditions.
1 INDICATIONS AND USAGE
Pregabalin capsule 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.
Pregabalin capsule is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older (1) Fibromyalgia (1) Neuropathic pain associated with spinal cord injury (1)
1 INDICATIONS AND USAGE
AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1)
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)
Limitations of Use: AVODART is not approved for the prevention of prostate cancer. (1.3)
1.1 Monotherapy
AVODART (dutasteride) soft gelatin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
improve symptoms,
reduce the risk of acute urinary retention (AUR), and
reduce the risk of the need for BPH-related surgery.
1.2 Combination with Alpha-adrenergic Antagonist
AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3 Limitations of Use
AVODART is not approved for the prevention of prostate cancer.
1 INDICATIONS & USAGE
Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m2 or greater [see Clinical Studies (14.1, 14.2)].
Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4+ cell counts greater than 250 cells/mm3 or
adult males with CD4+ cell counts greater than 400 cells/mm3
[see Warnings and Precautions (5.1)].
Nevirapine extended-release tablets are an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adultsand pediatric patients 6 years of age or older with a BSA of 1.17 m2 or greater. (1)
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+ cell counts greater than 250 cells/mm3
adult males with CD4+ cell counts greater than 400 cells/mm3 (1, 5.1)
1 INDICATIONS AND USAGE
Risperidone tabletsare anatypical antipsychotic indicated for:
Treatment of schizophrenia (
1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (
1.2)
Treatment of irritability associated with autistic disorder (
1.3)
1.1 Schizophrenia
Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults
[see
Clinical Studies (14.1)]
.
1.2 Bipolar Mania
Monotherapy
Risperidone tabletsare indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years)
[see
Clinical Studies (14.2)]
.
Adjunctive Therapy
Risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults
[see
Clinical Studies (14.3)]
.
1.3 Irritability Associated with Autistic Disorder
Risperidone tabletsare indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years)
[see
Clinical Studies (14.4)]
.
INDICATIONS AND USAGE
Morphine sulfate is indicated for the relief of severe pain. It is used preoperatively to sedate the patient and allay apprehension, facilitate anesthesia induction and reduce anesthetic dosage. It is likewise effective in the control of postoperative pain.
The use of morphine for the relief of pain should be reserved for the more severe manifestations of pain, as in myocardial infarction,severe injuries, or in severe chronic pain associated with terminal cancer after all non-narcotic analgesics have failed.
Effective analgesic therapy of severe chronic pain associated with terminal cancer continues to be a difficult problem. Intermittent administration of intramuscular morphine may be effective; however, the mode of therapy has significant limitations. Morphine has a short plasma half-life of 2.5 to 3.0 hours; therefore, frequent administration (every 1 to 2 hours) often becomes necessary to control severe pain associated with cancer. Tolerance develops to the analgesic effects and increasingly higher doses of morphine are required to produce analgesia. The higher morphine doses produce significant and often life-threatening side effects (see ADVERSE REACTIONS). The peak and trough effects produced by intermittent administration cause fluctuations in pain control. Repeated I.M. injections are frequently unacceptable due to the lack of muscle mass in the debilitated patient, the tendency for bruising and bleeding at the injection site, and the anxiety and pain associated with the injection.
Continuous I.V. infusion of morphine (see DOSAGE AND ADMINISTRATION) has been employed as an alternative to the traditional modes of administration. Lower doses of morphine produce uniform pain control because a steady morphine concentration is maintained. Titration of the dosage to the patients needs is easily achieved by adjusting the infusion rate. The lag time between the patients request for pain medication and administration of the dose and the amount of nursing time necessary for preparation and administration of frequent doses are reduced. The degree of respiratory depression and sedation may be decreased, and the anxiety experienced by the patient in anticipation of I.M. administration is avoided. Some investigators feel that tolerance to the analgesic effects may develop more slowly with continuous I.V. infusion.
In addition to analgesia, the drug may relieve anxiety and reduce left ventricular work by reducing preload pressure. Morphine is also used in the therapy of dyspnea associated with acute left ventricular failure and pulmonary edema. Care must be taken to avoid inducing respiratory depression in such patients.
For open-heart surgery, especially in high risk patients with cardiac disease, some anesthesiologists use morphine to produce anesthesia.
1 INDICATIONS & USAGE
Lamotrigine is indicated for:
Epilepsyadjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. (
1.1)
Epilepsymonotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (
1.1)
Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (
1.2)
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2years and older:
partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy
[see
Clinical Studies (14.2)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1. Indications and Usage
Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
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 sumatriptan, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.
1 INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablet is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (
1)
INDICATIONS AND USAGE
Estradiol Tablets USP are indicated in the:
1.Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
4.Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
5.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
6.Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
1 INDICATIONS AND USAGE
Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency .
[see
CLINICAL STUDIES (14)
]
Tolterodine tartrate extended-release capsules is an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( )
1
1INDICATIONS AND USAGE
VuewayTM is indicated
in adult and pediatric patients aged 2 years and older for use with
magnetic resonance imaging (MRI) to detect and visualize lesions with
abnormal vascularity in:
the central nervous system (brain, spine, and associated
tissues),
the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal
system).
Vueway is a gadolinium-based contrast agent indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:
the central nervous system (brain, spine, and associated tissues),
the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). (1)
INDICATIONS & USAGE
Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.
INDICATIONS & USAGE
Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including:
Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil 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 [WPW] and Lown-Ganong-Levine [LGL] syndromes).
In controlled studies in the U.S., 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 fast ventricular rate respond with a decrease in heart 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. The effect of a single injection lasts for 3060 minutes when conversion to sinus rhythm does not occur.
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 with an accessory bypass tract, marked hypotension, or extreme bradycardia/asystolesee Contraindications and Warnings), the initial use of intravenous Verapamil hydrochloride should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including DC-cardioversion capability (see Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patients response is gained, an office setting may be acceptable.
Cardioversion has been used safely and effectively after intravenous Verapamil.