um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
PHEBURANE is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).
Limitations of Use
Episodes of acute hyperammonemia may occur in patients while on PHEBURANE. PHEBURANE is not indicated for the treatment of acute hyperammonemia, which can be a life-threatening medical emergency that requires rapid acting interventions to reduce plasma ammonia levels.
PHEBURANE is a nitrogen-binding agent indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).(1)
Limitations of Use
PHEBURANE is not indicated for the treatment of acute hyperammonemia. (1)
INDICATIONS AND USAGE
Major Depressive DisorderSertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults.The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (seeClinical Trials under CLINICAL PHARMACOLOGY).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied.The efficacy of sertraline hydrochloride tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically (seeClinical Trials under CLINICAL PHARMACOLOGY).
INDICATIONS AND USAGE
Betaxolol Hydrochloride Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs.
In clinical studies, Betaxolol Hydrochloride Ophthalmic Solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.
1 INDICATIONS AND USAGE
Klor-Con powder (potassium chloride) is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium chloride is a potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. (1)
INDICATIONS AND USAGE
Cytarabine Injection in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection is indicated in the prophylaxis and treatment of meningeal leukemia.
MENINGITIS
MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for Injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia cow. '''Efficacy for this organism in this organ system was studied in fewer than ten infections.
Indications and Usage
KEMSTRO is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Patients should have reversible spasticity so that treatment with KEMSTRO will aid in restoring residual function.KEMSTRO may also be of some value in patients with spinal cord injuries and other spinal cord diseases.KEMSTRO is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of KEMSTRO in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
INDICATIONS AND USAGE
Levorphanol tartrate tablets 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, which can occur at any dosage or duration [see
WARNINGS], reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesiaLevorphanol tartrate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
INDICATIONS AND USAGE
Sodium Phosphates Injection, USP is indicated as a source of phosphate, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
The concomitant amount of sodium (4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
1 INDICATIONS AND USAGE
Tazarotene gel, 0.05% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (
1.1)
Limitations of Use
The safety of tazarotene gel use on more than 20% body surface area has not been established. (
1.3)
1.1 Plaque Psoriasis
Tazarotene gel, 0.05% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.
1.3 Limitations of Use
The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis
[see Warnings and Precautions (
5.1) and Use in Specific Populations (
8.1)].
1INDICATIONS AND USAGE
Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].
Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1)
INDICATIONS AND USAGE
Verapamil Hydrochloride Injection, USP is indicated for the following:
Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.
Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).
In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.
Because a small fraction (<1%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation, and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole
see
CONTRAINDICATIONS
and
WARNINGS
), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see
ADVERSE REACTIONS
, Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable.
Cardioversion has been used safely and effectively after verapamil hydrochloride injection.
1 INDICATIONS AND USAGE
Trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Trospium Chloride Extended-release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
1 INDICATIONS AND USAGE
Divalproex sodium delayed release tablets are an anti-epileptic drug indicated for:
Treatment
of manic episodes associated with bipolar disorder ( )
1.1
Monotherapy
and adjunctive therapy of complex partial seizures and simple and complex
absence seizures; adjunctive therapy in patients with multiple seizure
types that include absence seizures ( )
1.2
Prophylaxis
of migraine headaches ( )
1.3
1.1 Mania
Divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed release tablets were established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania .
[see Clinical Studies ( )]
14.1
The safety and effectiveness of divalproex sodium delayed release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
1.2 Epilepsy
Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.3 Migraine
Divalproex sodium delayed release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed release tablets are useful in the acute treatment of migraine headaches.
1.4 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition
[see Warnings and Precautions ( , , ), Use in Specific Populations ( ), and Patient Counseling Information ( )].
5.2
5.3
5.4
8.1
17
Divalproex sodium delayed release tablets are contraindicated for prophylaxis of migraine headaches in women who are pregnant.
INDICATIONS AND USAGE
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
CONJUNCTIVITIS:
Gram-positive bacteria:
Gram-negative bacteria:
Staphylococcus aureus
Enterobacter cloacae
Staphylococcus epidermidis
Haemophilus influenzae
Streptococcus pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
CORNEAL ULCERS:
Gram-positive bacteria:
Gram-negative bacteria:
Staphylococcus aureus
Pseudomonas aeruginosa
Staphylococcus epidermidis
Serratia marcescens*
Streptococcus pneumoniae
Anaerobic species:
Propionibacterium acnes
*Efficacy for this organism was studied in fewer than 10 infections.
1 INDICATIONS AND USAGE
Ibandronate Sodium Injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women. (
1.1
)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (
1.2
)
1.1 Treatment of Postmenopausal Osteoporosis
Ibandronate Sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures
[see
Clinical Studies(14)
]
.
1.2 Important Limitations of Use
The safety and effectiveness of ibandronate sodium for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONS AND USAGE
Mesalamine delayed-release capsules are an aminosalicylate indicated for:
Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. (1.1)
Maintenance of remission of ulcerative colitis in adults. (1.2)
1.1 Treatment of Mildly to Moderately Active Ulcerative Colitis
Mesalamine delayed-release capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
1.2 Maintenance of Remission of Ulcerative Colitis
Mesalamine delayed-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
1 INDICATIONS AND USAGE
Simvastatin tablets USP are indicated:
To reduce the risk of total
mortality by reducing risk of coronary heart disease death, non-fatal
myocardial infarction and stroke, and the need for coronary and
non-coronary revascularization procedures in adults with established
coronary heart disease, cerebrovascular disease, peripheral vascular
disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce
low-density lipoprotein cholesterol (LDL-C):
oIn adults with primary
hyperlipidemia.
oIn adults and pediatric
patients aged 10 years and older with heterozygous familial
hypercholesterolemia (HeFH).
As an adjunct to other
LDL-C-lowering therapies to reduce LDL-C in adults with homozygous
familial hypercholesterolemia (HoFH).
As an adjunct to diet for the
treatment of adults with:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.
Simvastatin tablets USP are an HMG-CoA reductase inhibitor indicated:
To reduce the risk of total
mortality by reducing risk of coronary heart disease death, non-fatal
myocardial infarction and stroke, and the need for coronary and
non-coronary revascularization procedures in adults with established
coronary heart disease, cerebrovascular disease, peripheral vascular
disease, and/or diabetes, who are at high risk of coronary heart disease
events.
As an adjunct to diet to reduce
low-density lipoprotein cholesterol (LDL-C):
oIn adults with primary
hyperlipidemia.
oIn adults and pediatric
patients aged 10 years and older with heterozygous familial
hypercholesterolemia (HeFH).
As an adjunct to other
LDL-C-lowering therapies to reduce LDL-C in adults with homozygous
familial hypercholesterolemia (HoFH).
As an adjunct to diet for the
treatment of adults with:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.
1
INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H
1-receptor antagonist indicated for:
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (
1.2)
1.2 Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
INDICATIONS & USAGE SECTION
Estradiol Tablets USP 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 500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
INDICATIONS AND USAGE
Junel21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
Lowest Expected*
Typical**
(No contraception)
(85)
(85)
Oral contraceptives
combined
progestin only
0.1 0.5
3 N/A***
N/A***
Diaphragm with spermicidal cream or jelly
6
20
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)
6
26
Vaginal Sponge
nulliparous
parous
9 20
20 40
Implant
0.05
0.05
Injection: depot medroxyprogesterone acetate
0.3
0.3
IUD
progesterone T
copper T 380A
LNg 20
1.5 0.6 0.1
2 0.8 0.1
Condom without spermicides
female
male
5 3
21 14
Cervical Cap with spermicidal cream or jelly
nulliparous
parous
9 26
20 40
Periodic abstinence (all methods)
1 to 9
25
Withdrawal
4
19
Female sterilization
0.5
0.5
Male sterilization
0.10
0.15
Adapted from RA Hatcher et al, Reference 7.
* The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time)
and who use it consistently and correctly during the first year if they do not stop for any other reason.
** This term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do
not stop use for any other reason.
*** N/A-Data not available.
1 INDICATIONS AND USAGE
Succinylcholine Chloride Injection is indicated in adults and pediatric patients:
as an adjunct to general anesthesia
to facilitate tracheal intubation
to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients:
as an adjunct to general anesthesia (
1)
to facilitate tracheal intubation (
1)
to provide skeletal muscle relaxation during surgery or mechanical ventilation. (
1)
INDICATIONS & USAGE
Adult Patients
Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see
PRECAUTIONS, PEDIATRIC USE).