um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Lamotrigine tablets, USP are indicated for:
Epilepsyadjunctive 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 tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
Monotherapy
Lamotrigine tablets are 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 tablets 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 tablets are 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 (14.1)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, USP (SR)are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion 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)].
The efficacy of bupropion hydrochloride extended-release tablets, USP (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].
Bupropion hydrochloride extended-release tablets, USP (SR) are aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD).(1)
INDICATIONS AND USAGE
Herpes Zoster Infections
Acyclovir oral suspension, USP is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes
Acyclovir oral suspension, USP is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox
Acyclovir oral suspension, USP is indicated for the treatment of chickenpox (varicella).
INDICATIONS & USAGE
Carefully consider the potential benefits and risks ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. (see DOSAGE AND ADMINISTRATION -Pharmaceutical Information for Ketorolac Tromethamine Injection).
INDICATIONS AND USAGE
Hypertension
Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
Angina Pectoris Due to Coronary Atherosclerosis
Atenolol is indicated for the long-term management of patients with angina pectoris.
Acute Myocardial Infarction
Atenolol is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows (see
DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.
1. INDICATIONS AND USAGE
Alfuzosin HCl extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1)
Important Limitations of Use:
Alfuzosin HCl extended-release tablets are not indicated for treatment of hypertension. (1.1)
Alfuzosin HCl extended-release tablets are not indicated for use in the pediatric population. (1.1, 8.4, 12.3)
Alfuzosin HCl extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
1.1 Important Limitations of Use
Alfuzosin HCl extended-release tablets are not indicated for the treatment of hypertension.
Alfuzosin HCl extended-release tablets are not indicated for use in the pediatric population.
1. Indications and Usage
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of:
Major Depressive Disorder (MDD) [see CLINICAL STUDIES (14.1)]
Generalized Anxiety Disorder (GAD) [see CLINICAL STUDIES (14.2)]
Social Anxiety Disorder (SAD) [see CLINICAL STUDIES (14.3)]
Panic Disorder (PD) [see CLINICAL STUDIES (14.4)]
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of:
Major Depressive Disorder (MDD)
Generalized Anxiety Disorder (GAD)
Social Anxiety Disorder (SAD)
Panic Disorder (PD)
1.1 Major Depressive Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.
1.2 Generalized Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.
1.3 Social Anxiety Disorder
Venlafaxine hydrochloride extended-release capsules, USP are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.
1.4 Panic Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.
1 INDICATIONS AND USAGE
Paricalcitol is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with:
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysis or peritoneal dialysis (1.2).
1.1 Chronic Kidney Disease Stages 3 and 4
Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Chronic Kidney Disease Stage 5
Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
Topex Fluoride Foams are indicated for topical application to teeth to aid in the prevention of dental caries.
The non-acidic nature of Neutral pH (NaF) is recommended for patients with ceramic or composite restorations.
INDICATION
AND USE:
A once daily topical
neutral aqueous solution for the prevention of dental caries.
1 INDICATIONS & USAGE
Fluorouracil is indicated for the treatment of patients with:
1.1Adenocarcinoma of the Colon and Rectum
1.2Adenocarcinoma of the Breast
1.3Gastric Adenocarcinoma
1.4Pancreatic Adenocarcinoma
Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with
Adenocarcinoma of the Colon and Rectum (1.1)
Adenocarcinoma of the Breast (1.2)
Gastric Adenocarcinoma (1.3)
Pancreatic Adenocarcinoma (1.4)
1 INDICATIONS AND USAGE
CIALIS is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).
1.1 Erectile Dysfunction
CIALIS is indicated for the treatment of erectile dysfunction.
INDICATIONS AND USAGE
Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernickes encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure.
Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.
Paroxetine tablets are indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive compulsive disorder (OCD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Generalized anxiety disorder (GAD)
Posttraumatic stress disorder (PTSD)
1 INDICATIONS AND USAGE
Caspofungin acetate for Injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for:
Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1)
Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1)
Treatment of esophageal candidiasis. (1)
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1)
1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients
Caspofungin acetate for Injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.1,14.5)].
1.2 Treatment of Candidemia and Other Candida Infections
Caspofungin acetate for Injection is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.2, 14.5)].
Limitations of Use: Caspofungin acetate for Injection has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.
1.3 Treatment of Esophageal Candidiasis
Caspofungin acetate for Injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.3, 14.5)].
Limitations of Use: Caspofungin acetate for Injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the treatment of esophageal candidiasis, patients with concomitant OPC had higher relapse rate of the OPC [see Clinical Studies (14.3)].
1.4 Treatment of Invasive Aspergillosis in Patients Who Are Refractory to or Intolerant of Other Therapies
Caspofungin acetate for Injection is indicated for the treatment of invasive aspergillosis in adult and pediatric patients (3 months of age and older) who are refractory to or intolerant of other therapies [see Clinical Studies (14.4,14.5)].
Limitations of Use: Caspofungin acetate for Injection has not been studied as initial therapy for invasive aspergillosis.
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate is indicated for the treatment of systemic lupus erythematosus in adults.
Indications and Usage Section
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
1 INDICATIONS AND USAGE
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years
and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
Celecoxib capsules are indicated
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see CLINICAL STUDIES (14.1)]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [seeCLINICAL STUDIES (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients 10 kg to 25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.
For patients who have difficulty swallowing capsules, the contents of a celecoxib capsules can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2 C to 8 C/ 35 F to 45 F).
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see CLINICAL STUDIES (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [seeCLINICAL STUDIES (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see CLINICAL STUDIES (14.5)]
INDICATION
AND USE:
A topically-applied
foaming solution to aid in the prevention of dental caries.
INDICATIONS & USAGE
In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action.
In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon.
To relieve hypertonicity of the uterine muscle.
To relax the spasm of biliary and uretered colic and bronchial spasm.
To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders.
To control the crying and laughing episodes in patients with brain lesions.
In cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal EEG patterns, stupor and neurological signs.
In the management of peptic ulcer.
In anesthesia to control excessive salivation and bronchial secretions.
To control rhinorrhea of acute rhinitis or hay fever.
As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of Aminata and in cases of anticholinesterase insecticide poisoning.
In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central-nervous-system manifestations. Adults suspected of contact with organic phosphorus insecticides of the parathion type should be given atropine sulfate, 0.8 mg, intramuscularly. If an atropine effect is not apparent within thirty minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements, and excessive sweating, salivation, and bronchial secretion), atropine sulfate, 2 mg, should be given intramuscularly at hourly intervals until signs of atropinization are observed. Up to two or three times this dose (4 to 6 mg) may be required in severe cases. Removing contaminated clothing, washing the skin, and commencing artificial respiration and supportive therapy are also indicated.
1 INDICATIONS AND USAGE
Argatroban is a direct thrombin inhibitor indicated:
For prophylaxis or treatment of thrombosis in adult patients with heparin induced thrombocytopenia (HIT). (1.1)
As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). (1.2)
1.1 Heparin-Induced Thrombocytopenia
Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
1.2 Percutaneous Coronary Intervention
Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
INDICATIONS AND USAGE
Dextroamphetamine sulfate oral solution is indicated in:
Narcolepsy
Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for
treatment of major depressive disorder (MDD) (
1.1)
prevention of seasonal affective disorder (SAD) (
1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment
[see
Clinical Studies (14.1)].
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM
[see
Clinical Studies (14.2)].
INDICATIONS
Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose wearing-off in patients with Parkinsons disease (see CLINICAL PHARMACOLOGY, Clinical Studies).
Entacapone tablets effectiveness has not been systematically evaluated in patients with Parkinsons disease who do not experience end-of-dose wearing-off.