um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Lamotrigine is indicated for:
Epilepsy
adjunctive therapy in patients aged 2 years and older:
Partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome.
(1.1)
Epilepsymonotherapy in patients aged 16 years and older:
Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.
(1.1)
Bipolar disorder:
Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
(1.2)
Limitations of Use:
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy
[see
Clinical Studies (14.2)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
INDICATIONS & USAGE SECTION
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus,Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, Pseudomonas aeruginosa.
This product does not provide adequate coverage against Serratia marcescens, and Streptococci, including Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults (1)
INDICATIONS AND USAGE
Purified Cortrophin Gel is indicated in the following disorders:
1.
Rheumatic disorders:
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).Ankylosing spondylitis.Acute gouty arthritis.
2.
Collagen diseases:
During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis).
3.
Dermatologic diseases:
Severe erythema multiforme (Stevens-Johnson syndrome).Severe psoriasis.
4.
Allergic states:
Atopic dermatitisSerum sickness.
5.
Ophthalmic diseases:
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitis.Keratitis. Iritis and iridocyclitis.Diffuse posterior uveitis and choroiditis.Optic neuritis.Chorioretinitis. Anterior segment inflammation.
6.
Respiratory diseases:
Symptomatic sarcoidosis.
7.
Edematous states:
To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
8.
Nervous system:
Acute exacerbations of multiple sclerosis.
INDICATIONS AND USAGE
Baclofen tablets are 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 baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinsons disease has not been established and, therefore, it is not recommended for these conditions.
1 INDICATIONS AND USAGE
Deferoxamine mesylate is an iron-chelating agent indicated:
As an adjunct to standard measures for the treatment of acute iron intoxication. (1.1)
For the treatment of transfusional iron overload in patients with chronic anemia. (1.2)
Limitations of Use
Deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
1.1	Acute Iron Intoxication
Deferoxamine Mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication.
1.2	Chronic Iron Overload
Deferoxamine mesylate is indicated for the treatment of transfusional iron overload in patients with chronic anemia.
1.3	Limitations of Use
Deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder).
1 INDICATIONS AND USAGE
Trimethobenzamide hydrochloride capsules are indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
Limitation of Use:
Trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects, and the risk of exacerbation of the underlying disease in pediatric patients with Reyes syndrome or other hepatic impairment.
Trimethobenzamide hydrochloride capsules are an antiemetic indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. (1)
Limitation of Use:
Trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects and the risk of exacerbation of the underlying disease in pediatric patients with Reyes syndrome or other hepatic impairment. (1, 8.4)
INDICATIONS AND USAGE
TOBREX (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated
in the treatment of external infections of the eye and its adnexa caused by
susceptible bacteria. Appropriate monitoring of bacterial response to topical
antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic
ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective
for use in children.
1 INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see
Clinical Studies (14)].
Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults
(
1).
INDICATIONS AND USAGE
Angina Pectoris
Nadolol tablets are indicated for the long-term management of patients with angina pectoris.
Hypertension
Nadolol tablets are indicated in the management of hypertension; they may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
INDICATIONS AND USAGE
For mydriasis and cycloplegia for diagnostic procedures.
1	INDICATIONS AND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile dysfunction (ED) (
1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (
1.2)
ED and the signs and symptoms of BPH (ED/BPH) (
1.3)
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (
1.4).
1.1	Erectile Dysfunction
Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED).
1.2	Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3	Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4	Limitation of Use
If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown
[see Clinical Studies (
14.3)]
.
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, Cefdinir capsules 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.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia
Caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitis
Caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis
Caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumonia (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Use
and
DOSAGE AND ADMINISTRATION
.
Pharyngitis/Tonsillitis
Caused by
Streptococcus pyogenes
(see CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media
Caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumonia (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis
Caused by Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
1INDICATIONS AND USAGE
Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
Triazolam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.(1)
INDICATIONS & USAGE
Propofol injectable emulsion is an IV general anesthetic and sedation drug that can be used as described in the table below.
TABLE 3. INDICATIONS FOR PROPOFOL INJECTABLE EMULSION
Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see
PRECAUTIONS, Pediatric Use).
Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.
In the Intensive Care Unit (ICU), propofol injectable emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see
PRECAUTIONS, Pediatric Use).
Propofol injectable emulsion is not recommended for obstetrics, including Cesarean section deliveries. Propofol injectable emulsion crosses the placenta, and as with other general anesthetic agents, the administration of propofol injectable emulsion may be associated with neonatal depression (see
PRECAUTIONS).
Propofol is not recommended for use in nursing mothers because propofol injectable emulsion has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (see
PRECAUTIONS).
INDICATIONS AND USAGE
INDICATIONS AND USAGE
Temazepam capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days).
For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules, USP should be used for short periods of time (7 to 10 days).
The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
INDICATIONS AND USAGE
Terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
INDICTIONS AND USAGE
For routine management after delivery of the placenta; postpartum atony and
hemorrhage; subinvolution. Under full obstetric supervision, it may be given in
the second stage of labor following delivery of the anterior shoulder.
INDICATIONS & USAGE
Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. It is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine sulfate given with morphine may be indicated. Atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography.
Atropine is used as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases. Large doses relieve the muscarine-like symptoms and some of the central nervous system manifestations.
INDICATIONS
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
Hydroxyzine may potentiate meperidine (Demerol) and barbiturates
1 INDICATIONS AND USAGE
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Dicyclomine is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)
1 INDICATIONS AND USAGE
Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting.
Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Fosaprepitant for Injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of (1):
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use (
1
)
Fosaprepitant for Injection has not been studied for treatment of established nausea and vomiting
1 INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for:
Treatment
of schizophrenia (1.1)
As
monotherapy or adjunctive therapy with lithium or valproate, for the
treatment of acute manic or mixed episodes associated with Bipolar I
Disorder (1.2)
Treatment
of irritability associated with autistic disorder (1.3)
1.1 Schizophrenia
Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)].
1.2 Bipolar Mania
Monotherapy
Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)].
Adjunctive Therapy
Risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4)].
1 INDICATIONS AND USAGE
Bupropion hydrochloride is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (
1)
Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD
[see Clinical Studies (
14)].
1 INDICATIONS AND USAGE
Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Injection, for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Morphine Sulfate Injection 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
Carefully consider the potential benefits and risks of Indomethacin and other treatment options before deciding to use Indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin has been found effective in active stages of the following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
Moderate to severe ankylosing spondylitis.
Moderate to severe osteoarthritis.
Acute painful shoulder (bursitis and/or tendinitis).
Acute gouty arthritis.
INDICATIONS AND USAGE
PROVENTIL HFA Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.