um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium for oral suspension and
chewable tablets are indicated in the treatment of infections caused by
susceptible strains of the designated organisms in the conditions listed
below:
Lower Respiratory Tract Infections
caused by
-lactamaseproducing strains of H. influenzae and
M. catarrhalis.
Otitis Media
caused by -lactamase-producing
strains of H. influenzae and M.
catarrhalis.
Sinusitis
caused by -lactamase-producing strains
of H. influenzae and M.
catarrhalis.
Skin and Skin Structure Infections
caused by
-lactamaseproducing strains of S. aureus, E. coli
and Klebsiella spp.
Urinary Tract Infections
caused by
-lactamase-producing strains of E. coli, Klebsiella
spp. and Enterobacter spp.
While amoxicillin and clavulanate potassium for oral suspension and chewable
tablets are indicated only for the conditions listed above, infections caused by
ampicillin-susceptible organisms are also amenable to amoxicillin and
clavulanate potassium for oral suspension and chewable tablets treatment due to
its amoxicillin content. Therefore, mixed infections caused by
ampicillin-susceptible organisms and -lactamase-producing organisms susceptible
to amoxicillin and clavulanate potassium for oral suspension and chewable
tablets should not require the addition of another antibiotic. Because
amoxicillin has greater in-vitro activity against
S. pneumoniae than does ampicillin or penicillin, the
majority of S. pneumoniae strains with intermediate
susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin
and amoxicillin and clavulanate potassium for oral suspension and chewable
tablets. (See Microbiology.)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and clavulanate potassium for oral suspension and
chewable tablets and other antibacterial drugs, amoxicillin and clavulanate
potassium for oral suspension and chewable tablets 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.
Bacteriological studies, to determine the causative organisms and their
susceptibility to amoxicillin and clavulanate potassium for oral suspension and
chewable tablets, should be performed together with any indicated surgical
procedures.
1 INDICATIONS AND USAGE
Clopidogrel bisulfate 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 bisulfate has been shown to reduce the rate of myocardial infarction (MI) and stroke. (
1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel bisulfate has been shown to reduce the rate of MI and stroke. (
1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel bisulfate has been shown to reduce the rate of MI and stroke. (
1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in 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 tablets are 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. Clopidogrel bisulfate 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 clopidogrel bisulfate is indicated to reduce the rate of MI and stroke.
1 INDICATIONS AND USAGE
Amlodipine besylate and benazepril hydrochloride capsules are a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1)
1.1 Hypertension
Amlodipine besylate and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Indications and Usage
SSKI (potassium iodide oral solution, USP) is for use as an expectorant in the symptomatic treatment of chronic pulmonary diseases where tenacious mucus complicates the problem, including bronchial asthma, bronchitis and pulmonary emphysema.
1 INDICATIONS AND USAGE
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics):
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
XHANCE is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age or older.
XHANCE is a corticosteroid indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age or older. (1)
1
INDICATIONS AND USAGE
DEMEROL Tabletsand Oral Solution are indicated for the managementof acute painsevere 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 (
5.2
)], reserve DEMEROL TabletsorOral Solution 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.
DEMEROL Tabletsor Oral Solution should not be used for treatment of chronic pain.
Prolonged DEMEROL TabletorOral Solution use may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.
DEMEROL Tablets and Oral Solution are opioid agonistsindicated 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 DEMEROL Tabletsand Oral Solution for use inpatients 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.
1 INDICATIONS AND USAGE
Cinacalcet hydrochloride is a positive modulator of the calcium sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in
adult patients with chronic kidney disease (CKD) on dialysis. (1.1)
Limitations of Use: Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2)
Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3)
1.1 Secondary Hyperparathyroidism
Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)].
Limitations of Use:
Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1)].
1.2 Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)].
1.3 Primary Hyperparathyroidism
Cinacalcet hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. [see Clinical Studies (14.3)].
1 INDICATIONS AND USAGE
Gabapentin tablets are indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
Gabapentin tablets are indicated for:
Management of postherpetic
neuralgia in adults
Adjunctive therapy in the
treatment of partial onset seizures, with and without secondary
generalization, in adults and pediatric patients 3 years and older with
epilepsy
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 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)].
1 INDICATIONS AND USAGE
Cisatracurium Besylate Injection is indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age
to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU
to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older
Cisatracurium Besylate Injection is a nondepolarizing neuromuscular blocker indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age (1)
to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance (1)
for mechanical ventilation in the ICU in adults (1)
Limitations of Use:
Cisatracurium Besylate Injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)
Limitations of Use
Cisatracurium Besylate Injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
INDICATIONS AND USAGE
Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia.
1 INDICATIONS AND USAGE
1.1 Infections of the Ear, Nose, and Throat
Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) isolates of Streptococcus species. (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Helicobacter pylori Infection
Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole:
Amoxicillin tablets, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole:
Amoxicillin tablets, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets and other antibacterial drugs, amoxicillin tablets should be used only to treat infections that are proven or strongly suspected to be caused by 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
Wixela Inhub
is a combination product containing a corticosteroid and a long-acting beta
2-adrenergic agonist (LABA) indicated for:
Twice-daily treatment of asthma in patients aged 4 years and older. (
1.1)
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (
1.2)
Important limitation of use: Not indicated for relief of acute bronchospasm. (
1.1,
1.2)
1.1
Treatment of Asthma
Wixela Inhub
is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub
should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta
2-adrenergic agonist (LABA).
Important Limitation of Use
Wixela Inhub
is NOT indicated for the relief of acute bronchospasm.
1.2
Maintenance Treatment of Chronic Obstructive Pulmonary Disease
Wixela Inhub
250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Wixela Inhub
250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Wixela Inhub
250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength Wixela Inhub
500/50 over Wixela Inhub
250/50 has not been demonstrated.
Important Limitation of Use
Wixela Inhub
is NOT indicated for the relief of acute bronchospasm.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Nabumetone Tablets USP and other treatment options before deciding to use Nabumetone Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
Nabumetone Tablets USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
INDICATIONS AND USAGE
Estradiol tablets are indicated in the:
Treatment of moderate to severe vasomotor symptoms associated with the menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate (See
CLINICAL PHARMACOLOGY, Clinical Studies
).
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
INDICATIONS AND USAGE:
Metronidazole Topical Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
INDICATIONS AND USAGE
Mephyton is indicated in the following coagulation disorders which are due to faulty formation of factors II,VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.
Mephyton tablets are indicated in:
-anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
-hypoprothrombinemia secondary
to antibacterial therapy;
-hypoprothrombinemia secondary to administration of salicylates;
-hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed.
1 INDICATIONS AND USAGE
Savella is indicated for the management of fibromyalgia.
Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia (1).
Savella is not approved for use in pediatric patients (1).
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride (HCl) extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65 [see Clinical Studies (14)].
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; cant wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Methylphenidate HCl extended-release tablets are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults up to the age of 65.(1)
1.1 Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and 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 patient and not solely on the presence of the required number of DSM-IV characteristics.
1.2 Need for Comprehensive Treatment Program
Methylphenidate hydrochloride (HCl) extended-release tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit 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 patients symptoms.
Indications and Usage
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
1 INDICATIONS AND USAGE
EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.
EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.
EpiPen and EpiPen Jr are non-selective alpha and beta-adrenergic receptor agonist indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. (
1)
INDICATIONS AND USAGE
For mydriasis and cycloplegia for
diagnostic procedures.