um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see
CLINICAL PHARMACOLOGY
Susceptibility Testing
).
The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also 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 colitis, as described in the
WARNING
box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (eg, erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Divalproex Sodium Delayed-Release Tablets, USP are an anti-epileptic drug indicated for:
Treatment of manic episodes associated with bipolar disorder (1.1)
Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2)
Prophylaxis of migraine headaches (1.3)
1.1	Mania
Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].
The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
1.2	Epilepsy
Divalproex Sodium Delayed-Release Tablets, USP are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex Sodium Delayed-Release Tablets, USP are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.3	Migraine
Divalproex Sodium Delayed-Release Tablets, USP are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets are useful in the acute treatment of migraine headaches.
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)].
Divalproex Sodium Delayed-Release Tablets, USP are contraindicated for prophylaxis of migraine headaches in women who are pregnant.
1 INDICATIONS AND USAGE
OCREVUS is indicated for the treatment of:
Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
Primary progressive MS, in adults
OCREVUS is a CD20-directed cytolytic antibody indicated for the treatment of:
Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults (1)
Primary progressive MS, in adults (1)
Indications
Prenatrix is indicated to provide vitamins and minerals to women
throughout pregnancy and during the postnatal period for both lactating and non-lactating
mothers, and throughout the childbearing years.
Prenatrix may be beneficial in improving the nutritional status of women prior to conception.
INDICATIONS AND USAGE
Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require 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 Hydrocodone Bitartrate 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
1 INDICATIONS AND USAGE
ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)]
1.1	Adult Patients
Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis. or Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
1.2	Pediatric Patients
[see Use in Specific Populations (8.4) and Clinical Studies (14.2)]
Acute otitis media (>6 months of age)
caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Community-acquired pneumonia (>6 months of age)
due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis (>2 years of age)
caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
1.3	Limitations of Use
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomial infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat 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.
1 INDICATIONS AND USAGE
Cyclophosphamide is an alkylating drug indicated for treatment of:
Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1)
1.1 Malignant Diseases
Cyclophosphamide is indicated for the treatment of:
malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
multiple myeloma
leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
mycosis fungoides (advanced disease)
neuroblastoma (disseminated disease)
adenocarcinoma of the ovary
retinoblastoma
carcinoma of the breast
Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
1 INDICATIONS AND USAGE
Thiotepa for injection is an alkylating drug indicated:
For treatment of adenocarcinoma of the breast or ovary. (1.2)
Forcontrollingintracavitaryeffusionssecondarytodiffuseorlocalized neoplastic diseases of various serosal cavities.(1.3)
Fortreatmentofsuperficialpapillarycarcinomaoftheurinarybladder. (1.4)
1.2 Adenocarcinoma of the Breast or Ovary
Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.
1.3 Malignant Effusions
Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
1.4 Superficial Papillary Carcinoma of the Urinary Bladder
Thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection. However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Meloxicam is a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA)
(1.1)
Rheumatoid Arthritis (RA)
(1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older
(1.3)
1.1 Osteoarthritis (OA)
Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [
see Clinical Studies
(14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [
see Clinical Studies
(14.1)
].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [
see Clinical Studies
(14.2)].
1INDICATIONS AND USAGE
FANAPTtablets are indicated for the treatment of adults with schizophrenia. Efficacy was established in two short-term (4- and 6-week) placebo-and active-controlled studies of adult patients with schizophrenia [see Clinical Studies (14)].
When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that FANAPTis associated with prolongation of the QTc interval [see Warnings and Precautions (5.2)].Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death.In many cases this would lead to the conclusion that other drugs should be tried first.Whether FANAPTwill cause torsade de pointes or increase the rate of sudden death is not yet known.
Patients must be titrated to an effective dose of FANAPT.Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration.Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia [see Dosage and Administration (2.1) and Clinical Studies (14)].
The effectiveness of FANAPTin long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.Therefore, the physician who elects to use FANAPTfor extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
FANAPT is anatypical antipsychotic agent indicated for the treatment of schizophreniain adults. (1) Efficacy was established in two short-term (4- and 6-week) placebo- and active-controlled studies of adult patients with schizophrenia. (14) In choosing among treatments, prescribers should consider the ability of FANAPT to prolong the QT interval and theuse of other drugs first.Prescribers should also consider the need to titrate FANAPT slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for:
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of:
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy. (1, 14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate. (1, 14.2)
1 INDICATIONS AND USAGE
Neostigmine Methylsulfate Injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. (
1)
1 INDICATIONS AND USAGE
Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated in adults for the following:
Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (
1.1)
Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (
1.2)
1.1	Gastroesophageal Reflux Disease Associated with a History of
Erosive Esophagitis
Pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of pantoprazole sodium for injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
1.2	Pathological Hypersecretion Including Zollinger-Ellison Syndrome
Pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
1 INDICATIONS AND USAGE
Escitalopram oral solution is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (
1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (
1.2)
1.1 Major Depressive Disorder
Escitalopram oral solution is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age
[see Clinical Studies (
14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram oral solution is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults
[see Clinical Studies (
14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1 INDICATIONS AND USAGE
Technetium Tc 99m Sulfur Colloid Injection is indicated:
In adults, to assist in the:
localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter.
evaluation of peritoneo-venous (LeVeen) shunt patency.
In adults and pediatric patients, for imaging:
areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow.
studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated (1):
In adults, to assist in the:
localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter.
evaluation of peritoneo-venous (LeVeen) shunt patency in adults.
In adults and pediatric patients, for:
imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow.
studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.
INDICATIONS AND USAGE
LARIN 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
2
1 INDICATIONS AND USAGE
Dexmedetomidine hydrochloride injection is a relatively selective alpha2-adrenergic agonist indicated for:
Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2)
1.2 Procedural Sedation
Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
INDICATIONS AND USAGE
Halobetasol propionate cream, 0.05% is a super-high potency corticosteroid indictated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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 hypothalamic-pituitary-adrenal (HPA) axis.
Use in children under 12 years of age is not recommended. As with other highly active corticosteroid, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS AND USAGE
Augmented Betamethasone Dipropionate Ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE
Administration of Sodium Iodide I-123 is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology