um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of
adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients.
Morphine Sulfate Oral Solution is an opioid agonist.
Morphine Sulfate 2 mg/mL and 4 mg/mL is indicated for the management of:
adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Morphine Sulfate Oral Solution 20 mg/mL is indicated for:
the relief of acute and chronic pain in opioid-tolerant adult patients. (1)
Limitations of Use (1): Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Oral Solution 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.
Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution 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.
INDICATIONS AND USAGE
Dextroamphetamine sulfate tablets, USP are indicated for:
1.
Narcolepsy.
2.
Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
INDICATIONS & USAGE SECTION
Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureusand S. pyogenes.
1 INDICATIONS AND USAGE
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
ORSERDU is an estrogen receptor antagonist indicated for:
treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy (1)
INDICATION AND USAGE
Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
1 INDICATIONS AND USAGE
Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:
Multiple myeloma (MM), in combination with dexamethasone (
1.1).
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (
1.1).
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (
1.2).
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (
1.3).
Previously treated follicular lymphoma (FL), in combination with a rituximab product (
1.4).
Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (
1.5).
Limitations of Use:
Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (
1.4).
1.1
Multiple Myeloma
Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM).
Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).
1.2
Myelodysplastic Syndromes
Lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
1.3
Mantle Cell Lymphoma
Lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
1.4
Follicular Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).
1.5
Marginal Zone Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).
1.6
Limitations of Use
Lenalidomide capsulesare not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials
[see Warnings and Precautions (
5.5)]
.
INDICATIONS & USAGE
Famotidine injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:
1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than 8 weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
3. Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4. Short term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short term treatment of patients with symptoms of GERD (see
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Famotidine is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see
CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
1 INDICATIONS AND USAGE
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine extended-release capsuleis anaminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. (1)
1 INDICATIONS AND USAGE
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated:
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1)
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvantchemotherapy, unless anthracyclines were clinically contraindicated. (1.2)
in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3)
as a single agent for the treatment of pancreatic cancer. (1.4)
1.1 Ovarian Cancer
Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
1.2 Breast Cancer
Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
1.3 Non-Small Cell Lung Cancer
Gemcitabine Injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
1.4 Pancreatic Cancer
Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine Injection is indicated for patients previously treated with fluorouracil.
1 INDICATIONS AND USAGE
Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.
Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir 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.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia
caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see CLINICAL STUDIES).
Acute Exacerbations of Chronic Bronchitis
caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis
caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND
ADMINISTRATION.
Pharyngitis/Tonsillitis
caused by Streptococcus pyogenes (see CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis
caused by Streptococcus pyogenes (see CLINICAL STUDIES).
NOTE
: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
INDICATIONS & USAGE
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis
e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial
e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
Indications and Directions
Indications: A topical anti-caries preparation
Directions:
Following prophylaxis treatment, fill 1/3 of tray with gel
Insert tray in the patients mouth
Have patient bite down lightly for 60 seconds
Remove tray and have patient expectorate excess
Advise patient not to eat, drink or rinse for 30 minutes after application.
Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
INDICATIONS AND USAGE
SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Associations Diagnostic and Statistical Manual, III
1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
1. Motor tension:
Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
2. Autonomic hyperactivity:
Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3. Apprehensive expectation:
Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4. Vigilance and scanning:
Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
DIRECTION
To minimize gastrointestinal irritation, patients must follow direction regarding dilution. Each tablespoonful (15mL) should be diluted with three (3) fluid ounce or more of water or other liquid.
1 INDICATIONS AND USAGE
Sprintec (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraceptive
Sprintec (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies
(14)].
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)].
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
(1)
.
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (generally less than 10 days) management of acute pain. Hydrocodone bitartrate and ibuprofen tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.
INDICATIONS AND USAGE
Keflex is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflex is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Keflex in the subsequent prevention of rheumatic fever are not available at present.)Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalisSkin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenesBone infections caused by Staphylococcus aureus and/or Proteus mirabilisGenitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniaeNote Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Keflex and other antibacterial drugs, Keflex 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.
1
INDICATIONS AND USAGE
Anastrozole is an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer (1.1)
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer (1.2)
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole (1.3)
1.1
Adjuvant Treatment
Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
1.2
First-Line Treatment
Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
1.3
Second-Line Treatment
Anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets.
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol tablets USP reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see
CLINICAL PHARMACOLOGY,
CONTRAINDICATIONS,
WARNINGS, and
PRECAUTIONS).
Allopurinol tablet USP is indicated in:
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets USP should be discontinued when the potential for overproduction of uric acid is no longer present.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.