um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Mixed salts of a single entity amphetamine product are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
Attention Deficit Hyperactivity Disorder (ADHD)
A diagnosis of attention deficit hyperactivity disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The combined type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
Mixed salts of a single entity amphetamine product are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
Long-Term Use
The effectiveness of mixed salts of a single entity amphetamine product for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use mixed salts of a single entity amphetamine product for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
1 INDICATIONS AND USAGE
HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:
Currently use Factor IX prophylaxis therapy, or
Have current or historical life-threatening hemorrhage, or
Have repeated, serious spontaneous bleeding episodes.
HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:
Currently use Factor IX prophylaxis therapy, or
Have current or historical life-threatening hemorrhage, or
Have repeated, serious spontaneous bleeding episodes.
INDICATIONS AND USAGE
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
Respiratory Tract Infections caused by Streptococcus pneumoniae. Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci.
Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.
Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.
Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis.
Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy.
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.
It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP 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 the empiric selection of therapy.
Indicated surgical procedures should be performed.
1 INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (1).
1 INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).
Limitations of Use:
Not indicated to treat an acute asthma attack (5.2).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1.4 Limitations of Use
Montelukast sodium is not indicated for the treatment of an acute asthma attack.
INDICATIONS AND USAGE
Buspirone 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.
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
1 INDICATIONS AND USAGE
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1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
[Enter Generic Section here]
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure
[Enter Generic Section here]
1.4 Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD
[see Clinical Studies (14)].
The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial
[see Clinical Studies (14)].
Bupropion hydrochloride extended-release tablets, (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
INDICATIONS AND USAGE
Cr51 is indicated for use in determining red blood cell volume or mass, studying red blood cell survival time (in conditions such as hemolytic anemia), and evaluating blood loss
Mechanism of Action
The chromium in this agent is present as the dianionic chromate ion in which form it appears to bind to the red blood cell in two steps, initially by a rapid but reversible attachment to the cell membrane followed by a slower nearly irreversible binding to intracellular hemoglobin and reduction to the anionic state. It has been suggested that the slow rate of uptake is dependent on the rate at which chromate can penetrate the cell membrane. Binding is maintained until the red blood cells are sequestered by the spleen or until elution of the chromium occurs into the plasma. The chromium is then readily excreted mainly in the urine. Once liberated by elution or erythrocyte senescence, chromium 51 is not available for relabeling of red cells.
In normal individuals the erythrocyte survival half-time T
as measured by the chromium 51 "random labeling" technique, generally ranges between 25 and 35 days. This apparent short survival time, when compared to the 120 day life span of the red blood cells, is due to the elution of chromium from the cells and to cell damage that probably occurs during the process of withdrawing them from the body and labeling. Subnormal T
may be indicative of blood toss, sequestration of red blood cells by the spleen, or shortened cell viability, as occurs In hemolytic anemia
1 INDICATIONS AND 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 adults and 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).
INDICATIONS AND USAGE
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are effective as adjunctive therapy in the management of diarrhea.
1
INDICATIONS & USAGE
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
Esmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physicians judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride injection is intended for short-term use.
1.2 Intraoperative and Postoperative Tachycardia and Hypertension
Esmolol hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physicians judgment such specific intervention is considered indicated.
Use of esmolol hydrochloride injection to prevent such events is not recommended.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) should be used only to treat 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 the empiric selection of therapy.
Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
1.1 Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta-lactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, USP, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) should not be used.
1 INDICATIONS AND USAGE
Ropivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia:
epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management:
epidural continuous infusion or intermittent bolus; e.g., postoperative or labor; local infiltration
Ropivacaine hydrochloride is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration.
Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, for details and limitations of survival trials).
Heart Failure, Mortality Trials
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure. (See CLINICAL PHARMACOLOGY, for details and limitations of survival trials.) In using enalapril maleate, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate does not have a similar risk. (See WARNINGS.) In considering use of enalapril maleate, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. (See WARNINGS, .)
Heart Failure, Mortality Trials
Head and Neck Angioedema