um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
Method
Perfect
Use
Typical
Use
Levonorgestrelimplants
0.05
0.05
Malesterilization
0.1
0.15
Femalesterilization
0.5
0.5
Depo-Provera
(injectableprogestogen)
0.3
0.3
Oralcontraceptives
5
Combined
0.1
NA
Progestinonly
0.5
NA
IUD
Progesterone
1.5
2.0
CopperT380A
0.6
0.8
Condom(male)withoutspermicide
3
14
(Female)withoutspermicide
5
21
Cervicalcap
Nulliparouswomen
9
20
Parouswomen
26
40
Vaginalsponge
Nulliparouswomen
9
20
Parouswomen
20
40
Diaphragmwithspermicidalcreamorjelly
6
20
Spermicidesalone(foam,creams,jellies,andvaginalsuppositories)
6
26
Periodicabstinence(allmethods)
1to9Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition.NY, NY: Ardent Media, Inc., 1998.
25
Withdrawal
4
19
Nocontraception(plannedpregnancy)
85
85
NA-notavailable
INDICATIONS AND USAGE
Lorazepamtablets are
indicated for the
management of
anxiety disorders or for
the short-term relief of the
symptoms of
anxiety or
anxiety associated with depressive symptoms. Anxiety or
tension associated with the
stress of
everyday life
usually does not require treatment with an
anxiolytic.
The
effectiveness of lorazepam tabletsin
long-term use, that is, more than 4
months, has not
been assessed by
systematic clinical studies. The
physician should periodically reassess the
usefulness of the drug for the
individual patient.
INDICATIONS AND USAGE
Cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.
Because of the risk of anaphylaxis, cyclosporine injection should be reserved for patients who are unable to take the soft gelatin capsules or oral solution.
INDICATIONS AND USAGE
Alclometasone dipropionate cream USP and alclometasone dipropionate ointment USP are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream USP and alclometasone dipropionate ointment USP may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of alclometasone dipropionate cream USP and alclometasone dipropionate ointment USP have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
INDICATIONS AND USAGE
Droperidol Injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
INDICATIONS AND USAGE
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence)
Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic.
In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see
CLINICAL STUDIES).
Conversion of Atrial Fibrillation/Flutter
Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.
1 INDICATIONS AND USAGE
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Ephedrine sulfate injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (
1)
1 INDICATIONS AND USAGE
HUMULINR U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200units of insulin per day.
HUMULINR U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200units of insulin per day. (1)
Limitation of Use: The safety and efficacy of HUMULINR U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULINR U-500 delivered by continuous subcutaneous infusion has not been determined. (1.1)
1.1 Limitation of Use
The safety and efficacy of HUMULINR U-500 used in combination with other insulins has not been determined.
The safety and efficacy of HUMULINR U-500 delivered by continuous subcutaneous infusion has not been determined.
1 INDICATIONS AND USAGE
TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.
TEPEZZA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease (1)
INDICATIONSAND USAGE
Midazolam Injection is indicated:
intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
1 INDICATIONS AND USAGE
Paroxetine Capsules are indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
Limitation of Use:
Paroxetine Capsules are not indicated for the treatment of any psychiatric condition. Paroxetine Capsules contain a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of paroxetine in Paroxetine Capsules have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue Paroxetine Capsules and initiate a paroxetine-containing medication that is indicated for such use.
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) (1)
Limitation of Use: Paroxetine Capsules are not indicated for the treatment of any psychiatric condition (1)
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim pediatric suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim pediatric suspension 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 empiric selection of therapy.
Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent.
Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis
jirovecii Pneumonia: For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia.
Travelers Diarrhea in Adults: For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic E. coli.
INDICATIONS AND USAGE
Midazolam injection is indicated:
intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
1 INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
Limitations of use (1.8): Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
ZONTIVITYis a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. (
1.1)
1.1
Patients with History of Myocardial Infarction (MI) or with Peripheral Arterial Disease (PAD)
ZONTIVITY
is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
INDICATIONS AND USAGE
Diazepam Tablets USP are indicated for the management of anxiety
disorders or for 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.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief
of acute agitation, tremor, impending or acute delirium tremens and
hallucinosis.
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to
reflex spasm to local pathology (such as inflammation of the muscles or joints,
or secondary to trauma), spasticity caused by upper motor neuron disorders (such
as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it
has not proved useful as the sole therapy.
The effectiveness of diazepam in long-term use, that is, more than 4 months,
has not been assessed by systematic clinical studies. The physician should
periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for:
Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults and adolescents (13 to 17 years) (1, 14.1)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1, 14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (1, 14.2)
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablet has been shown to decrease sleep latency and improve sleep maintenance (
1)
Eszopiclone tablet is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
INDICATIONS & USAGE
Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
1 INDICATIONS AND USAGE
Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older.
Fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 year of age and older. (1)
1 INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.
Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (
1)
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.
Limitations of Use (
1
)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Oral 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
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 Oxycodone Hydrochloride Oral 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
INDICATIONS AND USAGE
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:
a.help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic
b.prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.
Amiloride HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride HCl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes.
1 INDICATIONS AND USAGE
Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a -lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.
Piperacillin and Tazobactam for Injection is a combination penicillin-class antibacterial and -lactamase inhibitor indicated for treatment of:
Intra-abdominal infections (
1.1)
Skin and skin structure infections (
1.2)
Female pelvic infections (
1.3)
Community-acquired pneumonia (
1.4)
Nosocomial pneumonia (
1.5)
1.1 Intra-abdominal Infections
Appendicitis (complicated by rupture or abscess) and peritonitis caused by -lactamase producing isolates of
Escherichia coli or the following members of the
Bacteroides fragilis group:
B. fragilis,
B. ovatus,
B. thetaiotaomicron, or
B. vulgatus. The individual members of this group were studied in fewer than 10 cases.
1.2 Skin and Skin Structure Infections
Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by -lactamase producing isolates of
Staphylococcus aureus.
1.3 Female Pelvic Infections
Postpartum endometritis or pelvic inflammatory disease caused by -lactamase producing isolates of
Escherichia coli.
1.4 Community-acquired Pneumonia
Community-acquired pneumonia (moderate severity only) caused by -lactamase producing isolates of
Haemophilus influenzae.
1.5 Nosocomial Pneumonia
Nosocomial pneumonia (moderate to severe) caused by -lactamase producing isolates of
Staphylococcus aureus and by piperacillin/tazobactam-susceptible
Acinetobacter baumannii,
Haemophilus influenzae,
Klebsiella pneumoniae, and
Pseudomonas aeruginosa (Nosocomial pneumonia caused by
P. aeruginosa should be treated in combination with an aminoglycoside) [
see Dosage and Administration (
2)
].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection 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.