um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Risperidone oral solution, USP is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults and adolescents aged 13 to 17 years (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10 to 17 years (1.2)
Treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years (1.3)
1.1
Schizophrenia
Adults
Risperidone oral solution, USP is indicated for the acute and maintenance treatment of schizophrenia .
[see
Clinical Studies (14.1)
]
Adolescents
Risperidone oral solution, USP is indicated for the treatment of schizophrenia in adolescents aged 13 to 17 years .
[see
Clinical Studies (14.1)
]
1.2
Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone oral solution, USP is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10 to 17 years .
[see
Clinical Studies (14.2)
]
Combination Therapy
Adults
The combination of risperidone oral solution, USP with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder
[see
Clinical Studies (14.3)
].
1.3
Irritability Associated with Autistic Disorder
Pediatrics
Risperidone oral solution, USP is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods .
[see
Clinical Studies (14.4)
]
1 INDICATIONS AND USAGE
UCERIS extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
UCERIS (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. (1)
1 INDICATIONS AND USAGE
Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see C
linical Studies (14)].
Clonidine hydrochloride extended-release tablets are a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. (1)
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of:
Major Depressive Disorder (MDD)
Panic Disorder (PD)
1.1 Major Depressive Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.
1.4 Panic Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.
1
INDICATIONS AND USAGE
Memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride extended-release capsulesis a N-methyl-D-aspartate(NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (
1)
1 INDICATIONSAND 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 are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
INDICATIONS AND USAGE
Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see
PRECAUTIONS: Pediatric Use
). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
1 INDICATIONS AND USAGE
Brimonidine Tartrate Ophthalmic Solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The IOP lowering efficacy of Brimonidine Tartrate Ophthalmic Solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.
Brimonidine Tartrate Ophthalmic Solution 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1)
1 INDICATIONS AND USAGE
Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of:
Mild to moderate dementia of the Alzheimers type (1.1)
Mild to moderate dementia associated with Parkinsons disease (1.2)
1.1 Alzheimer's Disease
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
1.2 Parkinson's Disease Dementia
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with Parkinsons disease.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations ofcorticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets are indicated for maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Buprenorphine and naloxone sublingual tablet contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence.
(1)
Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
(1)
1 INDICATIONS AND USAGE
Sildenafil citrate is indicated for the treatment of erectile dysfunction.
Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)
1
INDICATIONS AND USAGE
ACTONELis a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3)
Treatment of Pagets disease (1.4)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.5)
1.1
Postmenopausal Osteoporosis
ACTONELis indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONELreduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see
Clinical Studies (
14.1
,
14.2
)].
1.2
Osteoporosis in Men
ACTONELis indicated for treatment to increase bone mass in men with osteoporosis.
1.3
Glucocorticoid-Induced Osteoporosis
ACTONELis indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
1.4
Pagets Disease
ACTONELis indicated for treatment of Pagets disease of bone in men and women.
1.5
Important Limitations of Use
The optimal duration of use has not been determined.The safety and effectiveness of ACTONELfor the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use.Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONS AND USAGE
Aripiprazole Orally Disintegrating Tablets are indicated for the treatment of: Schizophrenia [see CLINICAL STUDIES (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic indicated as oral formulations for the:
Schizophrenia (14.1)
INDICATIONS AND USAGE
Tretinoin is indicated for topical application in the treatment of acne vulgaris.
The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
1
INDICATIONS AND USAGE
VIBERZIis indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
VIBERZIis a mu-opioid receptoragonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). (1)
1 INDICATIONS AND USAGE
ALBUMINEX 5% is a 5% albumin solution indicated for adults and children:
Hypovolemia (1.1)
Ascites (1.2)
Hypoalbuminemia including from burns (1.3)
Acute Nephrosis (1.4)
Acute Respiratory Distress Syndrome (ARDS) (1.5)
Cardiopulmonary Bypass (1.6)
1.1 Hypovolemia
ALBUMINEX 5% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is required in both adult and pediatric patients. In pediatric patients to reverse hypovolemia and achieve normal capillary refill time. 1, 2, 3, 4, 5, 6, 7, 8
1.2 Ascites
ALBUMINEX 5% is indicated for prevention of central volume depletion and maintenance of cardiovascular function after large volume parencentesis in patients with liver cirrhosis or other chronic liver disease in adults and children. 9, 10, 11, 12
ALBUMINEX 5% infusion plus administration of vasoactive drugs is indicated in the treatment of type I hepatorenal syndrome. 6
For patients with spontaneous bacterial peritonitis, ALBUMINEX 5% is indicated as adjuvant treatment to antibiotic therapy. 9, 10, 13
1.3 Hypoalbuminemia including from burns
ALBUMINEX 5% is indicated in patients with severe burn injury (> 20% total body surface area), but not until at least 12 to 24 hours after the burn, in order to correct protein loss, decrease overall fluid requirements, decrease systemic edema and stabilize cardiovascular hemodynamics without fluid overload (initial resuscitation should be with crystalloids).8, 14 ALBUMINEX 5% is also indicated in patients with pre- or post-operative hypoproteinemia and for third space protein loss due to infection or burns.
1.4 Acute Nephrosis
ALBUMINEX 5% is indicated in patients with acute nephrosis in combination with loop diuretics to reinforce the diuretic therapeutic effect, which is reduced by hypoalbuminemia, and for the correction of reduced oncotic pressure. 15, 16
1.5 Acute Respiratory Distress Syndrome (ARDS)
ALBUMINEX 5% is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS. 17, 18, 19
1.6 Cardiopulmonary Bypass
ALBUMINEX 5% is indicated in cardiopulmonary bypass procedures as part of the priming fluids to passivate the synthetic surfaces of the extracorporeal circuit and maintain the patient's colloid oncotic pressure. 20, 21, 22, 23, 24, 25
INDICATIONS AND USAGE
Promethazine is useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated skin manifestations of urticaria and angioedema.
Amelioration 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.
INDICATIONS AND USAGE
Oxiconazole nitrate cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).
Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12.
1 INDICATIONS AND USAGE
Abacavir and lamivudine tablet, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
1 INDICATIONS AND USAGE
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for:
The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, granisetron hydrochloride injection, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) receptor antagonist indicated for:
Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. (1)
Prevention and treatment of postoperative nausea and vomiting in adults. (1)
1 INDICATIONS AND USAGE
Sumatriptan Injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with Sumatriptan Injection, USP,reconsider the diagnosis beforeSumatriptan Injection, USPis administered to treat any subsequent attacks.
Sumatriptan Injection, USPis not indicated for the prevention of migraine or cluster headacheattacks.
Sumatriptan succinateis a serotonin (5-HT
1B/1D) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults (
1)
Acute treatment of cluster headache in adults (
1)
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established. (
1)
Not indicated for the prophylactic therapy ofmigraine or cluster headache attacks. (
1)
INDICATIONS & USAGE
Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive.
This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components.
When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate.
Treatment may, therefore, be initiated with captopril and hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as captopril and hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION).
In using captopril and hydrochlorothiazide, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).
Captopril and hydrochlorothiazide may be used for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril and hydrochlorothiazide should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations.
ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Captopril: Head and Neck Angioedema and Intestinal Angioedema).
INDICATIONS FOR USETrepadone is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions, particularly those associated with joint pain.
CLINICAL EXPERIENCEAdministration of Trepadone has demonstrated significant reduction in symptoms of pain and inflammation in patients with acute and chronic pain when used for the dietary management of the metabolic processes associated with pain disorders and inflammatory conditions. Administration of Trepadone results in the induction and maintenance of pain relief in patients with pain disorders and inflammatory conditions associated with joint pain.
1
INDICATIONS & USAGE
Donepezil hydrochloride Tablets, USP are indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
Donepezil Hydrochloride Tablets,USP is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (
1).
1 INDICATIONS AND USAGE
ZINPLAVA is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.
ZINPLAVA is a human monoclonal antibody that binds to Clostridioides difficile toxin B, indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. (1)
Limitation of Use:
ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI. (1)
Limitation of Use:
ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI. [See Dosage and Administration (2.1).]
INDICATIONS AND USAGE
Stage I - IV pressure ulcers
Venous stasis ulcers
Ulcerations caused by mixed vascular etiologies
Diabetic skin ulcers
First and second degree burns
Post-surgical incisions, cuts and abrasions.
INDICATIONS AND USAGE
For adjunctive treatment of: edema due to congestive heart failure; drug-induced
edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic
simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute
angle-closure glaucoma where delay of surgery is desired in order to lower
intraocular pressure. AcetaZOLAMIDE is also indicated for the prevention or
amelioration of symptoms associated with acute mountain sickness in climbers
attempting rapid ascent and in those who are very susceptible to acute mountain
sickness despite gradual ascent.
INDICATIONS AND USAGE
Buspirone hydrochloride tablets are indicated for the management of anxiety disorder or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long- term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.