um-ids/dailymed-annotations huggingface dataset:
INDICATIONS
Status Epilepticus
Lorazepam Injection is indicated for the treatment of status epilepticus.
Preanesthetic
Lorazepam Injection is indicated in adult patients for preanesthetic
medication, producing sedation (sleepiness or drowsiness), relief of anxiety,
and a decreased ability to recall events related to the day of surgery. It is
most useful in those patients who are anxious about their surgical procedure and
who would prefer to have diminished recall of the events of the day of surgery
(see PRECAUTIONS- Information for Patients).
1 INDICATIONS AND USAGE
Aripiprazole Oral Solutionis indicated for the treatment of:
Schizophrenia
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
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. The oral formulation is indicated for:
Schizophrenia (14.1)
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2)
1 INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1	Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2	Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3	Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
INDICATIONS AND USAGE
Buspirone hydrochloride tablets, USP 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 hydrochloride tablets, USP 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, USP 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:
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, USP 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, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.
Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.
1INDICATIONS AND USAGE
VARIBAR PUDDING is indicated for modified barium swallow examinations
to evaluate the oral and pharyngeal function and morphology in adult
and pediatric patients 6 months of age and older.
VARIBAR PUDDING is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older (1)
1 INDICATIONS AND USAGE
IC-GREEN is indicated:
IC-GREEN a tricarbocyanine dye, is indicated:
For determining cardiac output, hepatic function and liver blood flow. (1.1)
For ophthalmic angiography. (1.2)
1.1 For Determining Cardiac Output, Hepatic Function and Liver Blood Flow
1.2 For Ophthalmic Angiography
1 INDICATIONS
AND USAGE
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine extended-release capsule is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. (1)
1 INDICATIONS & USAGE
Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.
1 INDICATIONS AND USAGE
Zolmitriptan is serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a 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)
Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Only use zolmitriptan tablets if a clear
diagnosis of migraine has been established. If a patient has no response
to zolmitriptan tablets treatment for the first migraine attack,
reconsider the diagnosis of migraine before zolmitriptan tablets are
administered to treat any subsequent attacks.
Zolmitriptan tablets are not indicated
for the prevention of migraine attacks.
Safety and effectiveness of zolmitriptan tablets
have not been established for cluster headache.
1 INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.
1 INDICATIONS AND USAGE
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glipizide extended-release tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.
1.1 Limitations of Use
Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Indications and Usage Section
INDICATIONS AND USAGE
Sucralfate tablets, USP are 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
MIEBOTM (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease. (1)
INDICATIONS AND USAGE
Triamcinolone Acetonide 0.05% in Absorbase (Triamcinolone Acetonide Ointment, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
1 INDICATIONS AND USAGE
EVKEEZA is indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH).
EVKEEZA is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH). (1)
Limitations of Use:
The safety and effectiveness of EVKEEZA have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). (1)
The effects of EVKEEZA on cardiovascular morbidity and mortality have not been determined. (1)
Limitations of Use:
The safety and effectiveness of EVKEEZA have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
The effects of EVKEEZA on cardiovascular morbidity and mortality have not been determined.
1 INDICATIONS AND USAGE
Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillusanthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. (1.1)
Limitations of Use:
The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. (1.2, 14.1)
There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. (1.2, 8.4)
Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis.
Raxibacumab should be used in combination with appropriate antibacterial drugs. (1.2)
1.1 Inhalational Anthrax
Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillusanthracis in combination with appropriate antibacterial drugs. Raxibacumab is also indicated for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
1.2 Limitations of Use
The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. It is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax [see Clinical Studies (14.1)].
Safety and pharmacokinetics (PK) of raxibacumab have been studied in adult healthy volunteers. There have been no trials of safety or PK of raxibacumab in the pediatric population. An extrapolation approach was used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults [see Use in Specific Populations (8.4)].
Raxibacumab binds to the protective antigen (PA) of B.anthracis; it does not have direct antibacterial activity. Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs.
Indications: Helps prevent dental caries and hypersensitivity
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 INDICATIONS AND USAGE
Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
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 post-operative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1 INDICATIONS AND USAGE
ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60mg of oral morphine daily, or at least 25mcg of transdermal fentanyl/hour, or at least 30mg of oral oxycodone daily, or at least 8mg of oral hydromorphone daily or at least 25mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL.
ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.
ABSTRAL is intended to be prescribed only by healthcare professionals who are knowledgeable of, and skilled in, the use of ScheduleII opioids to treat cancer pain.
Limitations of Use:
As a part of the TIRF REMS Access program, ABSTRAL may be dispensed only to outpatients enrolled in the program [see Warnings and Precautions (5.10)]. For inpatient administration of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.
ABSTRAL is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (1)
Limitations of Use:
ABSTRAL may be dispensed only to patients enrolled in the TIRF REMS Access program.
INDICATIONS AND USAGE
Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.
Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see
PRECAUTIONS
, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.
1 INDICATIONS AND USAGE
Beyaz is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.4)
1.1 Oral Contraceptive
Beyaz is indicated for use by females of reproductive potential to prevent pregnancy.
1.2 Premenstrual Dysphoric Disorder (PMDD)
Beyaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of Beyaz for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Beyaz has not been evaluated for the treatment of premenstrual syndrome (PMS).
1.3 Acne
Beyaz is indicated for the treatment of moderate acne vulgaris in females of reproductive potential at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Beyaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
1.4 Folate Supplementation
Beyaz is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.