um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Fluconazole tablets are indicated for the treatment of:
1. Vaginal candidiasis (vaginal yeast infections due to
Candida).
2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablet was also effective for the treatment of
Candida urinary tract infections, peritonitis, and systemic
Candida infections including candidemia, disseminated candidiasis, and pneumonia.
3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis
Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Limitations of Use
FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
FLEQSUVY is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. (1)
FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. (1)
Limitations of Use
FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. (1)
INDICATIONS AND USAGE
Esgic
Capsules (butalbital, acetaminophen and caffeine capsules USP 50 mg/325 mg/40 mg) are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
CLARINEX is a histamine-1 (H1) receptor antagonist indicated for:
Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. (1.1)
Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. (1.2)
Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 6 months of age and older. (1.3)
1.1 Seasonal Allergic Rhinitis
CLARINEX is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.
1.2 Perennial Allergic Rhinitis
CLARINEX is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older.
1.3 Chronic Idiopathic Urticaria
CLARINEX is indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older.
1 INDICATIONS AND USAGE
PROLENSA (bromfenac ophthalmic solution) 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
PROLENSA is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. (1)
1 INDICATIONS & USAGE
Quetiapine is an atypical antipsychotic indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
1.1 Schizophrenia
Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)
].
1.2 Bipolar Disorder
Quetiapine is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see Clinical Studies (14.2)
].
Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2)
].
Quetiapine is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)
].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1 INDICATIONS AND USAGE
Meropenem for Injection is a penem antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1)
Complicated intra-abdominal infections (adult and pediatric patients). (1.2)
Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
1.1Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)
Meropenem for Injection is
indicated for the treatment of
complicated skin and
skin structure infections (cSSSI) due to
Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus
pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis,
and Peptostreptococcus species.
1.2 Complicated Intra-abdominal Infections (Adult and Pediatric Patients)
Meropenem for Injection is
indicated for the treatment of
complicated appendicitis and
peritonitis caused by
viridans group streptococci, Escherichia coli,
Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and
Peptostreptococcus
species.
1.3 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only)
Meropenem for Injection is
indicated for the treatment of
bacterial meningitis caused by
Haemophilus influenzae, Neisseria meningitidis and
penicillin-susceptible isolates of Streptococcus pneumoniae.
Meropenem for Injectionhas
been found to
be effective in
eliminating concurrent bacteremia in
association with bacterial meningitis.
1.4 Usage
To reduce the
development of
drug-resistant bacteria and maintain the effectiveness of
Meropenem for Injection and
other antibacterial drugs, Meropenem for Injection should only be
used 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 & USAGE
Depression
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Childhood Enuresis
May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
1 INDICATIONS AND USAGE
Topiramate extended-release capsules are indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older (1.2)
Preventive treatment of migraine in patients 12 years of age and older (1.3)
1.1 Monotherapy Epilepsy
Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older [see Clinical Studies (14.2)].
1.2 Adjunctive Therapy Epilepsy
Topiramate extended-release capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older [see Clinical Studies (14.3)].
1.3 Migraine
Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies (14.4)].
INDICATIONS AND USAGE
Metronidazole topical gel is indicated for topical application in the treatment
of inflammatory papules and pustules of rosacea.
INDICATIONS AND USAGE
Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
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 (14.2)]
.
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 (XL) are 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)].
Urinary Tract Infections in Adults
Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible
Staphylococcus epidermidis, Staphylococcus saprophyticus, or
Enterococcus faecalis.
1 INDICATIONS AND USAGE
Warfarin sodium tablets areindicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation(AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets are vitamin K antagonist indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism.
(1)
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.
(1)
Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
(1)
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.
(1)
1 INDICATIONS AND USAGE
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for:
treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older (1.1).
treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older (1.2).
1.1	Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML)
MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older.
1.2	Relapsed or Refractory CD33-positive AML
MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older.
1 INDICATIONS AND USAGE
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. (1)
By Intra-articular or Soft Tissue Injection
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Synovitis of osteoarthritis
Rheumatoid arthritis
Acute and subacute bursitis
Acute gouty arthritis
Epicondylitis
Acute nonspecific tenosynovitis
Post-traumatic osteoarthritis
1 INDICATIONS AND USAGE
WYMZYA
TM
Fe is indicated for use by females of reproductive potential to prevent pregnancy.
WYMZYA Fe is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. (1)
INDICATIONS AND USAGE
Benzonatate is indicated for the symptomatic relief of cough.
1 INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets, USP are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 Hypertension
Carvedilol tablets, USP are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
INDICATIONS AND USAGE
Lidocaine 2.5% and prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
normal intact skin for local analgesia.
genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine 2.5% and prilocaine 2.5% cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).
1 INDICATIONS AND USAGE
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Limitations of Use
In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with PROVIGIL for excessive sleepiness.
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). (1)
Limitations of Use
In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
10. Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
INDICATIONS AND USAGE
Levothyroxine sodium is used for the following indications:
Hypothyroidism
As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Pituitary TSH Suppression
In the treatment or prevention of various types of euthyroid goiters (see
WARNINGS
and
PRECAUTIONS
), including thyroid nodules (see
WARNINGS
and
PRECAUTIONS
), subacute or chronic lymphocytic thyroiditis (Hashimotos thyroiditis), multinodular goiter (see
WARNINGS
and
PRECAUTIONS
) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
INDICATIONS AND USAGE
Ciclopirox Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
INDICATIONS AND USAGE:
Amikacin sulfate injection, USP is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella species, Enterobacter species, Serratia species, and Acinetobacter species.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin 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 Section
INDICATIONS AND USAGE
Seizure Disorders:
Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful.
Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS : Loss of Effect).
Panic Disorder:
Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: CLINICAL TRIALS).
Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
INDICATIONS & USAGE SECTION
Glipizide tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.