um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies (14)].
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; on the go; excessive talking; blurting answers; cant wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Methylphenidate hydrochloride extended-release tablets is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.
1.1 Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
1.2 Need for Comprehensive Treatment Program
Methylphenidate hydrochloride extended-release tablets is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patients symptoms.
1 INDICATIONS AND USAGE
Voriconazole for Injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (
1.1)
Candidemia in non-neutropenics and other deep tissue
Candida infections (
1.2)
Esophageal candidiasis (
1.3)
Serious fungal infections caused by
Scedosporium apiospermum and
Fusarium species including
Fusarium solani, in patients intolerant of, or refractory to, other therapy (
1.4)
1.1	Invasive Aspergillosis
Voriconazole for Injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were
Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of
Aspergillus other than
A. fumigatus
[see
Clinical Studies (14.1,
14.5) and
Microbiology (12.4)].
1.2	Candidemia in Non-neutropenic Patients and Other Deep Tissue
Candida Infections
Voriconazole for Injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following
Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds
[see
Clinical Studies (14.2,
14.5) and
Microbiology (12.4)]
.
1.3	Esophageal Candidiasis
Voriconazole for Injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older
[see
Clinical Studies (14.3,
14.5) and
Microbiology (12.4)]
.
1.4	Scedosporiosis and Fusariosis
Voriconazole for Injection is indicated for the treatment of serious fungal infections caused by
Scedosporium apiospermum (asexual form of
Pseudallescheria boydii) and
Fusarium spp. including
Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy
[see
Clinical Studies (14.4) and
Microbiology (12.4)]
.
1.5
Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
1	INDICATIONS AND USAGE
Lazanda (fentanyl) nasal spray is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking Lazanda.
Lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. For this reason, Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, or dental pain. [4]
Lazanda is intended to be prescribed only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Lazanda is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. [1]
Limitations of Use:
Lazanda may be dispensed only to patients enrolled in the TIRF REMS Access program.
Limitations of Use:
As a part of the TIRF REMS Access program, Lazanda may be dispensed only to outpatients enrolled in the program. [see
Warnings and Precautions (5.10)
]. For inpatient administration of Lazanda (e.g. hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient enrollment is not required.
INDICATIONS AND USAGE
Clobetasol propionate creamis a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
1 INDICATIONS & USAGE
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)
].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
1 INDICATIONS AND USAGE
BAQSIMI is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above.
BAQSIMI is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above. (1)
1 INDICATIONS AND USAGE
Carisoprodol tablets, USPare indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodoltablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see
Dosage and Administration (2)
].
Carisoprodol tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults (1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (1)
1. Indications and Usage Section
1 INDICATIONS AND USAGE
Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
INDICATIONS AND USAGE
SALAGEN Tablets areindicated for 1) the treatment of symptoms of drymouth from salivary gland hypofunction caused byradiotherapy for cancer of the head and neck; and2) the treatment of symptoms of dry mouth in patientswith Sjogrens Syndrome.
1 INDICATIONS AND USAGE
Ondansetron oral solution is indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron oral solution is also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron oral solution is a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2.
(1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
(1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
(1)
postoperative nausea and/or vomiting.
(1)
INDICATIONS AND USAGE
Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods).
Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus species, therapy with Nafcillin Injection, USP should be discontinued and alternative therapy provided.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin Injection, USP and other antibacterial drugs, Nafcillin Injection, USP 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.
INDICATIONS AND USAGE
RETIN-A is indicated for topical application in the treatment of acne vulgaris.
The safety and efficacy of the long-term use of this product in the treatment of
other disorders have not been established.
1 INDICATIONS AND USAGE
Fluoxetine is indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder
[see
Clinical Studies (14.1)]
.
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)
[see
Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa
[see
Clinical Studies (14.3)]
.
Acute treatment of Panic Disorder, with or without agoraphobia
[see
Clinical Studies (14.4)].
Fluoxetine and Olanzapine in Combination is indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).
Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax
.
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (
1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (
1)
Acute and maintenance treatment of Bulimia Nervosa (
1)
Acute treatment of Panic Disorder, with or without agoraphobia (
1)
Fluoxetine and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (
1)
Treatment Resistant Depression (
1)
INDICATIONS & USAGE
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
1
INDICATIONS AND USAGE
ABILIFY (aripiprazole) Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for the treatment of:
Schizophrenia
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
Adjunctive Treatment of Major Depressive Disorder
Irritability Associated with Autistic Disorder
Treatment of Tourette's Disorder
ABILIFY Injection is indicated for the treatment of:
Agitation associated with schizophrenia or bipolar mania
ABILIFY is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2)
Adjunctive Treatment of Major Depressive Disorder (14.3)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourette's disorder (14.5)
The injection is indicated for:
Agitation associated with schizophrenia or bipolar mania (14.6)
1 INDICATIONS AND USAGE
Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration.
Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration.
1 INDICATIONS AND USAGE
Potassium chloride is indicated for the treatment and prophylaxis of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are 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 are insufficient (
1)
INDICATIONS AND USAGE:
Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.*4)
(Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.)
(In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment).
It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.
Pyrazinamide should only be used in conjunction with other effective antituberculous agents.
*See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4
INDICATIONS AND USAGE
Central Diabetes Insipidus: Desmopressin Acetate Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus.
Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality.
Primary Nocturnal Enuresis: Desmopressin Acetate Tablets are indicated for the management of primary nocturnal enuresis. Desmopressin Acetate Tablets may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.
1 INDICATIONS AND USAGE
Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.
Anagrelide is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. (1)
1 INDICATIONS AND USAGE
ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
ACANYA Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older. (1)
1 INDICATIONS AND USAGE
OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
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 OLINVYK 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.
The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation. [see Warnings and Precautions (5.5].
OLINVYK is an opioid agonist indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK 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. (1)
The cumulative total daily dose should not exceed 27 mg. (2.2, 5.5).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
INDICATIONS AND USAGE
XOLOX is indicated for the relief of moderate to moderately severe pain.
INDICATIONS AND USAGE
Tramadol hydrochloride tablets, USP are indicated for the management of moderate to
moderately severe pain in adults.
1.2 Parkinsons Disease Dementia
Rivastigmine Transdermal System
is indicated for the treatment of mild-to-moderate dementia associated with Parkinsons disease (PDD).
1 INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablet, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1)
Zolpidem tartrate extended-release tablets are indicated for the 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)].
1 INDICATIONS & USAGE
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)
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 (5.2, 5.3, 5.4)
, Use in Specific Populations (8.1), and Patient Counseling Information (17.3)].
Depakote ER is contraindicated for prophylaxis of migraine headaches in women who are pregnant.