um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Therapy
Penicillin G Sodium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Sodium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued.
Clinical Indication
Infecting Organism
Septicemia, empyema,
pneumonia, pericarditis,
endocarditis, meningitis
Streptococcus pyogenes
(group A -hemolytic
streptococcus), other
-hemolytic streptococci
including groups C, H, G, L
and M, Streptococcus
pneumoniae and
Staphylococcus species (non-
penicillinase producing strains)
Anthrax
Bacillus anthracis
Actinomycosis (cervico-
facial disease and
thoracic and abdominal
disease)
Actinomyces Israelil
Botulism (adjunctive
therapy to antitoxin),
gas gangrene, and
tetanus (adjunctive
therapy to human
tetanus immune globulin)
Clostridium species
Diphtheria (adjunctive
therapy to antitoxin and
prevention of the carrier
state)
Corynebacterium
diphtheriae
Erysipelothrix
endocarditis
Erysipelothrix
rhusiopthiae
Fusospirochetosis
(severe infections of the
oropharynx [Vincents],
lower respiratory tract
and genital area)
Fusobacterium species
and spirochetes
Listeria infections
including meningitis and
endocarditis
Listeria monocytogenes
Pasteurella infections
including bacteremia and
meningitis
Pasteurella multocida
Haverhill fever
Streptobacillus
moniliformis
Rat-bite fever
Spirillum minus or
Streptobacillus
moniliformis
Disseminated gonococcal
infections
Neisseria gonorrhoeae
(penicillin-susceptible)
Syphilis (congenital and
neurosyphilis)
Treponema pallidum
Meningococcal
meningitis and/or
septicemia
Neisseria meningitidis
Gram-negative bacillary
infections (bacteremias)
Escherichia coli,
Enterobacter aerogenes,
Alcaligenes faecalis,
salmonella, shigella and
Proteus mirabilis, Penicillin G
is not the drug of choice in the
treatment of gram-negative
bacillary infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin G sodium and other antibacterial drugs, penicillin G sodium 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.
1 INDICATIONS AND USAGE
Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet.
Sapropterin dihydrochloride tablets are a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet. (
1)
1 INDICATIONS AND USAGE
Phentermine Hydrochloride, USP 15 mg and 30 mg is 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 greater than or equal to 30 kg/m2, or greater than or equal to 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.
The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (
12.1
,
12.2
)] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine Hydrochloride is 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 greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including Phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1)
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 Association's Diagnostic and Statistical Manual, III
1 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
DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].
DYANAVEL XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older (1)
INDICATIONS AND USAGE
STROMECTOL is indicated for the treatment of the following infections:
Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite
Strongyloides stercoralis.
This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See
CLINICAL PHARMACOLOGY, Clinical Studies.)
Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite
Onchocerca volvulus.
This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
NOTE: STROMECTOL has no activity against adult
Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites.
INDICATIONS AND USAGE
Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
1.
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
2.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency
or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
INDICATIONS AND USAGE
Nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by
Candida albicans and other susceptible
Candida species.
This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
INDICATIONS AND USAGE
Malathion Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.
1 INDICATIONS AND USAGE
Naproxen tablets are indicated for:
The relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
Polyarticular Juvenile Idiopathic Arthritis
tendonitis
bursitis
acute gout
The management of:
pain
primary dysmenorrhea
Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for:The relief of the signs and symptoms of: rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis bursitis acute gout
The management of: pain primary dysmenorrhea
INDICATIONS & USAGE SECTION
Mupirocin ointment 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.
INDICATIONS AND USAGE
Major Depressive Disorder
Venlafaxine Hydrochloride Extended-Release Capsules USP are indicated for the treatment of major depressive disorder.
The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure 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 efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial (see Clinical Trials). The safety and efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in hospitalized depressed patients have not been adequately studied.
The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Venlafaxine Hydrochloride Tablets USP/Venlafaxine Hydrochloride Extended-Release Capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Edema
Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired.
1 INDICATIONS AND USAGE
ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older.
ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older. (1)
1 INDICATIONS & USAGE
Clopidogrel is a P2Y12 platelet inhibitor indicated for:
Acute coronary syndrome
-For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], Clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)
-For patients with ST-elevation myocardial infarction (STEMI), Clopidogrel has been shown to reduce the rate of MI and stroke. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and strokein patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction(NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel should be administered in conjunction with aspirin.
Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopdiogrel should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopdigorel is indicated to reduce the rate of MI and stroke.
INDICATIONS AND USAGE
Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinsons disease, postencephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
1 INDICATIONS AND USAGE
NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.
NUCYNTA tablets are an opioid analgesic indicated for the management of acute 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 NUCYNTA tablets 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
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 NUCYNTA tablets 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 USAGE Anxiety Disorders XANAX Tablets (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to XANAX. Panic Disorder XANAX is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of XANAX by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Hydromorphone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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 Hydromorphone 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 expectedto be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Hydromorphone Hydrochloride Tablets, USP contain hydromorphone, an opioid agonist, and are 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 Hydromorphone Hydrochloride Tablets, USP for use in patients for whom alternative treatment options [e.g., non-opioid analgesics 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
1 INDICATIONS AND USAGE
Clobazam tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam tablets are a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. (
1)
Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
SPRYCEL (dasatinib) is indicated for the treatment of adults with
newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of SPRYCEL is based on cytogenetic response and major molecular response rates [see Clinical Studies (14.1)]. The trial is ongoing and further data will be required to determine long-term outcome.
chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
SPRYCEL is a kinase inhibitor indicated for the treatment of
newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The trial is ongoing and further data will be required to determine long-term outcome. (1, 14)
adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1, 14)
adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1, 14)
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets 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 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)