um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Amiodarone Hydrochloride Tablets is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.
Amiodarone Hydrochloride Tablets is an antiarrhythmic indicated for:
Recurrent ventricular fibrillation. (
1)
Recurrent hemodynamically unstable ventricular tachycardia. (
1)
1 INDICATIONS AND USAGE
Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.1 Limitations of Use
Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
INDICATIONS AND USAGE
Epilepsy
Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
1.Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greaterimprovement than those with other types.
2.Generalized tonic-clonic seizures (grand mal).
3.Mixed seizure patterns which include the above, or other partial or generalized seizures.Absence seizures (petit mal) do not appear to be controlled bycarbamazepine(see
PRECAUTIONS,General).
Trigeminal Neuralgia
Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
INDICATIONS AND USAGE
Haloperidol Decanoate Injection is indicated for the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy.
1 INDICATIONS AND USAGE
Famciclovir tablets, a prodrug of penciclovir, is a nucleoside analog DNA polymerase inhibitor indicated for:
Immunocompetent Adult Patients (1.1)
Herpes labialis (cold sores)
Treatment of recurrent episodes
Genital herpes
Treatment of recurrent episodes
Suppressive therapy of recurrent episodes
Herpes zoster (shingles)
HIV-Infected Adult Patients (1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use (1.3)
The efficacy and safety of famciclovir tablets has not been established for:
Patients < 18 years of age
Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1.1 Immunocompetent Adult Patients
Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis.
Genital herpes:
Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established.
Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established.
1.2 HIV-Infected Adult Patients
Recurrent orolabial or genital herpes: Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established.
1.3 Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients < 18 years of age
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1 INDICATIONS AND USAGE
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage orduration [see Warnings and Precautions (5.1)],reserve tramadol hydrochloride and acetaminophen 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 analgesia.
Tramadol hydrochloride and acetaminophen tablets should not be used for an extended period of time.
Tramadol hydrochloride and acetaminophen tablets are a combination of tramadol hydrochloride, an opioid agonist, and acetaminophen, and are 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) Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve tramadol hydrochloride and acetaminophen 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 analgesia
Tramadol hydrochloride and acetaminophen tablets should not be used for an extended period of time.
1 INDICATIONS AND USAGE
Minocycline hydrochloride extended-release capsulesis a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1)
Limitations of Use
Minocycline hydrochloride extended-release capsulesdid not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsuleshas not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14)
1.1 Indication
Minocycline hydrochloride extended-release capsulesis indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release capsulesshould be used only as indicated [see Warnings and Precautions (5.11)].
1.2 Limitations of Use
Minocycline hydrochloride extended-release capsulesdid not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsuleshas not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1) treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years and older (1)
Escitalopram tablets are indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older.
INDICATIONS AND USAGE
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]:
Major
depressive disorder (MDD)
Obsessive-compulsive
disorder (OCD)
Panic disorder
(PD)
Posttraumatic
stress disorder (PTSD)
Social anxiety
disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Sertraline hydrochloride tablet is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
1 INDICATIONS AND USAGE
Dalfampridine extended-release tablet is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed
[see Clinical Studies
(14)].
Dalfampridine extended-release tablet is a potassium channel blocker indicated to improve walking in adultpatients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed
(1,
14).
INDICATIONS AND USAGE
Perennial Allergic Rhinitis: Cetirizine hydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.
Chronic Urticaria: Cetirizine hydrochloride oral solution is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
INDICATIONS AND USAGE
Seasonal Allergic RhinitisFexofenadine Hydrochloride Tablets are indicated for the relief
of symptoms associated with seasonal allergic rhinitis in adults and children 6
years of age and older. Symptoms treated effectively were sneezing, rhinorrhea,
itchy nose/palate/throat, itchy/watery/red eyes.
Chronic Idiopathic UrticariaFexofenadine Hydrochloride Tablets are indicated for treatment of
uncomplicated skin manifestations of chronic idiopathic urticaria in adults and
children 6 years of age and older. It significantly reduces pruritus and the
number of wheals.
INDICATIONS AND USAGE
GLYDO 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).
INDICATIONS AND USAGE
Oxycodone and Acetaminophen 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, even at recommended doses [see
WARNINGS
], reserve Oxycodone and Acetaminophen 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 analgesia
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Upper respiratory tract infections caused by Streptococcus
pyogenes , Streptococcus pneumoniae
andHemophilus influenzae .
Note: Tetracycline should not be used for streptococcal disease unless the
organism has been demonstrated to be susceptible.
Lower respiratory tract infections caused by Streptococcus
pyogenes , Streptococcus pneumoniae , Mycoplasma pneumoniae
(Eaton
agent, and Klebsiella sp .)
Skin and soft tissue infections caused by Streptococcus
pyogenes , Staphylococcus aureaus . (Tetracyclines are not the
drugs of choice in the treatment of any type of staphylococcal
infections.)
Infections caused by rickettsia including Rocky
Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
Psittacosis caused by Chlamydophila psittaci .
Infections caused by Chlamydia trachomatis
such
as uncomplicated urethral, endocervical or rectal infections, inclusion
conjunctivitis, trachoma, and lymphogranuloma venereum.
Granuloma inquinale caused by Klebsiella
granulomatis .
Relapsing fever caused by Borrelia sp.
Bartonellosis caused by Bartonella bacilliformis .
Chancroid caused by Hemophilus ducreyi .
Tularemia caused by Francisella tularensis .
Plaque caused by Yersinia pestis .
Cholera caused by Vibrio cholerae .
Brucellosis caused by Brucella
species
(tetracycline may be used in conjunction with an aminoglycoside).
Infections
due to Campylobacter fetus .
As
adjunctive therapy in intestinal amebiasis caused by Entamoeba
histolytica .
Urinary
tract infections caused by susceptible strains of Escherichia coli , Klebsiella , etc.
Other infections caused by susceptible gram-negative
organisms such as E. coli , Enterobacter aerogenes , Shigella
sp., Acinetobacter sp ., Klebsiella sp ., and Bacteroides sp.
In severe acne, adjunctive therapy with tetracycline
may be useful.
When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:
Syphilis and yaws caused by Treponema
pallidum
and pertenue , respectively,
Vincent's infection caused by Fusobacterium
fusiforme ,
Infections caused by Neisseria
gonorrhoeae,
Anthrax caused by Bacillus
anthracis,
Infections due to Listeria
monocytogenes,
Actinomycosis caused by Actinomyces
species,
Infections due to Clostridium
species.
INDICATIONS FOR USEGABAdone is intended for the clinical dietary management of the metabolic processes in patients with sleep disorders and sleep disorders associated with anxiety.
- Insomnia- Sleep maintenance insomnia- Sleep disorders of circadian origin- Sleep disorders associated with anxiety- Snoring
1 INDICATIONS AND USAGE
Levetiracetam Oral Solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam Oral Solution is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalizedepilepsy (1.3)
1.1 Partial-Onset Seizures
Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures In Patients with Juvenile Myoclonic Epilepsy
Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonicseizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the feeling that you are about to black out in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Droxidopa should be assessed periodically.
Droxidopa Capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the feeling that you are about to black out in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Droxidopa capsules should be assessed periodically(
1).
Interaction with Potassium-Sparing Diuretics
Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.
1 INDICATIONS AND USAGE
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
(1)
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
(1)
1 INDICATIONS AND USAGE
Injectafer is indicated for the treatment of:
iron deficiency anemia (IDA) in:
adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron.
adult patients who have non-dialysis dependent chronic kidney disease.
iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
Injectafer is an iron replacement product indicated for the treatment of:
iron deficiency anemia (IDA) in:
adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. (1)
adult patients who have non-dialysis dependent chronic kidney disease. (1)
iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. (1)
1 INDICATIONS AND USAGE
Lamotrigine extended-release tablets are indicated for:
adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1)
conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. (1.2)
Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (1.3)
1.1 Adjunctive Therapy
Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
1.2 Monotherapy
Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.3 Limitation of Use
Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established.
1 INDICATIONS & USAGE
Darifenacin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Darifenacin extended-release tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. (1)
1	INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see
Clinical Studies (14)].
Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1)
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets, USP are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (
1).
Trazodone hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD) in adults.
1 INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:
Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. (
1.1).
Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. (
1.2).
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
1.1 Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory CLL or SLL after at least two prior therapies.
1.2 Follicular Lymphoma (FL)
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies.
This indication is approved under accelerated approval based on overall response rate (ORR)
[see Clinical Studies (
14.2)];
continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.