um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE SECTION
1.1 Major Depressive Disorder
Fluoxetine capsules, USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see Dosage and Administration (2.1)].
1.2 Obsessive Compulsive Disorder
Fluoxetine capsules, USP are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
The effectiveness of fluoxetine capsules, USP in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules, USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)].
1.3 Bulimia Nervosa
Fluoxetine capsules, USP are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
The physician who elects to use fluoxetine capsules, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
1.4 Panic Disorder
Fluoxetine capsules, USP are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)].
The effectiveness of fluoxetine capsules, USP in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules, USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)].
1.5 Fluoxetine Capsules, USP and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder
When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for olanzapine and fluoxetine hydrochloride capsules.
Fluoxetine capsules, USP and olanzapine in combination are indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
1 INDICATIONS AND USAGE
EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
EPIDUO gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. (1)
1 INDICATIONS AND USAGE
Hypothyroidism
ERMEZA is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
ERMEZA is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
ERMEZA is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with ERMEZA may induce hyperthyroidism [see
Warnings and Precautions (5.1)
].
ERMEZA is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
ERMEZA is levothyroxine sodium (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
-Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
-Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis
INDICATIONS AND USAGE
For determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography.
INDICATIONS AND USAGE
Lincomycin injection is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the
BOXED WARNING
, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives.
Indicated surgical procedures should be performed in conjunction with antibacterial therapy.
Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated.
Lincomycin injection is not indicated in the treatment of minor bacterial infections or viral infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of lincomycin injection and other antibacterial drugs, lincomycin injection 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:
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the relief of moderate to moderately severe pain.
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 tablets are 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 tablets are indicated for the short-term 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 tablets adjunctive therapy with lithium or valproate is indicated for the short-term 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 tablets are 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)].
INDICATIONS AND USAGE
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see DrugInteractions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).
INDICATIONS AND USAGE
For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
INDICATIONS AND USAGE
Lidocaine Hydrochloride Injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
INDICATIONS AND USAGE
Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
1 INDICATIONS AND USAGE
LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
LUMOXITI is a CD22-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). (1)
Limitations of Use
Not recommended in patients with severe renal impairment (CrCl
29 mL/min). (1)
Limitations of Use
LUMOXITI is not recommended in patients with severe renal impairment (CrCl
29 mL/min)
[see Dosage and Administration (2.3), Warnings and Precautions (5.3), and Use in Specific Populations (8.5)].
1 INDICATIONS AND USAGE
THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). (1.1)
THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (1.2)
1.1
Multiple Myeloma
THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM) [see Clinical Studies (14.1)].
1.2
Erythema Nodosum Leprosum
THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).
THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.
THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (
1.3).
1.1 Asthma
Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2
of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis
,
use for patients who have an inadequate response or intolerance to alternative therapies.
Montelukast sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2
years of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis
[see warnings and precautions (
5.1)]
,
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
INDICATIONS & USAGE
Lidocaine Hydrochloride Jelly USP, 2% 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).
1 INDICATIONS AND USAGE
Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (
12.1
,
12.2
)] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochlorideis a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
The limited usefulness of agents of this class, including Phentermine hydrochloride, should be measured against possible risk factors inherent in their use.
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
Oxybutynin Chloride Syrup is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
INDICATIONS AND USAGE
Hypertension:
Losartan potassium tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.
Hypertensive Patients with Left Ventricular Hypertrophy:
Losartan potassium tablets, USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients (see
PRECAUTIONS,
Race
and
CLINICAL PHARMACOLOGY,
Pharmacodynamics and Clinical Effects
,
Reduction in the Risk of Stroke
,
Race
).
Nephropathy in Type 2 Diabetic Patients
Losartan potassium tablets, USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio
300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects
).
INDICATIONS AND USAGE
FLUOCINONIDE CREAM USP, 0.05%, FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base), FLUOCINONIDE GEL USP, 0.05% and FLUOCINONIDE OINTMENT USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONSAND USAGE
Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Acinetobacter lwoffii*
Haemophilus influenza
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections. (1)
1 INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of age and older
(1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older
(1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies
(1.3).
1.1 Asthma
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients
of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
reserve use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients
15 years of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with
allergic rhinitis
[see warnings and precautions
(5.1)],
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1 INDICATIONS AND USAGE
Gabapentin capsules are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin capsulesare indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
INDICATIONS AND USAGE
Nystatin and Triamcinolone Acetonide Cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
INDICATIONS AND USAGE
Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
Sevoflurane should be administered only by persons trained in the administration of general anesthesia.
Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available.
Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.
1 INDICATIONS AND USAGE
COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).
COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. (1)
1 INDICATIONS AND USAGE
Oxybutynin chloride extended-release tablets are 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)