um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Nutrilipid 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Nutrilipid 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated. (1)
1 INDICATIONS AND USAGE
Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD)
Rasagiline tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinsons disease (1)
1 INDICATIONS AND USAGE
Aspirin and extended-release dipyridamole capsule is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
Aspirin and extended-release dipyridamole capsule is a combination of aspirin and dipyridamole, antiplatelet agents, indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis (
1)
INDICATIONS AND USAGE:
Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
INDICATIONS AND USAGE
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules,
USP is indicated for the relief of the symptom complex of tension (or muscle
contraction) headache.
Evidence supporting the efficacy of butalbital, aspirin, caffeine, and
codeine phosphate capsules is derived from 2 multi-clinic trials that compared
patients with tension headache randomly assigned to 4 parallel treatments:
butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine;
Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was
assessed over the course of the first 4 hours of each of 2 distinct headaches,
separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine
phosphate capsules proved statistically significantly superior to each of its
components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to
placebo on measures of pain relief.
Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine,
and Codeine Phosphate Capsules, USP in the treatment of multiple recurrent
headaches is unavailable. Caution in this regard is required because codeine and
butalbital are habit-forming and potentially abusable.
1 INDICATIONS & USAGE
Oxycodone hydrochloride capsule is an opioid analgesic, indicated for the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
Oxycodone hydrochloride is an opioid agonist indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate. (1).
INDICATIONS AND USAGE
Ranitidine tablets, USP is indicated in:
Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Trials available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year.
Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
1 INDICATIONS AND USAGE
Ondansetron Injection USP is a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (
1.1)
postoperative nausea and/or vomiting. (
1.2)
1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron Injection USP is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron Injection USP is approved for patients aged 6 months and older.
1.2 Prevention of Postoperative Nausea and/or Vomiting
Ondansetron Injection USP is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection USP is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection USP and experience nausea and/or vomiting postoperatively, Ondansetron Injection USP may be given to prevent further episodes.
Ondansetron Injection USP
is approved for patients aged 1 month and older.
INDICATIONS & USAGE
Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
INDICATIONS AND USAGE
Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.
Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.
Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
Neoplastic Diseases: For the palliative management of leukemias and lymphomas.
Nervous System: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal Diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
1 INDICATIONS AND USAGE
Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.
Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. (1)
1 INDICATIONS AND USAGE
Fluocinonide cream USP, 0.1%is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1)
Limitation of Use:
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1)
Avoid use on the face, groin, or axillae. (1.2)
Avoid use in perioral dermatitis or rosacea.
1.1 Indication
Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4)].
1.2 Limitation of Use
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Fluocinonide cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
INDICATIONSAND USAGE
Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
It should not be used for longer than two weeks unless directed by a physician.
1 INDICATIONS AND USAGE
Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
The limited usefulness of agents of this class, including phentermine, [see
CLINICAL PHARMACOLOGY (12.1
,
12.2)] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochlorideis a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use.
BMI
INDICATIONS AND USAGE
Mirtazapine Orally Disintegrating Tablets are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders - 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) 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 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The effectiveness of mirtazapine orally disintegrating tablets in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).
1 INDICATIONS & USAGE
Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.
Rizatriptan benzoate is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1) Not indicated for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1)
INDICATIONS AND USAGE
Hypertension
Losartan potassium and hydrochlorothiazide tablets areindicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION).
Hypertensive Patients with Left Ventricular Hypertrophy
Losartan potassium and hydrochlorothiazide tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS,
Race
, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects,
Losartan Potassium, Reduction in the Risk of Stroke, Race, and DOSAGE AND ADMINISTRATION.)
1. INDICATIONS AND 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 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures (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
Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Oxycodone Hydrochloride Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
INDICATIONS AND USAGEBuspirone hydrochloride tablets are indicated for the management
of anxiety disorders 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 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
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 Associations 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:
Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle
aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained
face, fidgeting, restlessness, easy startle.
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.
Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation
of misfortune to self or others.
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 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 for 1 year without ill effect. Therefore, the physician
who elects to use buspirone for extended periods should periodically reassess
the usefulness of the drug for the individual patient.
1	INDICATIONS AND USAGE
Methylphenidate hydrochloride tablets are indicated for the treatment of:
Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
Narcolepsy
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (
1).