um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Gemcitabine 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 adjuvant chemotherapy, 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 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 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 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 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 is indicated for patients previously treated with fluorouracil.
1. Indications and Usage Section
INDICATIONS AND USAGE
Celecoxib capsules are indicated
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)]
INDICATIONS AND USAGE
ANASPAZ is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), acute entercolitis and other functional gastrointestinal disorders. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. ANASPAZ is indicated (along with appropriate analgesics) in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis.
1 INDICATIONS AND USAGE
Entecavir
is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating therapy with entecavir:
In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-nave and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease.
[see
Clinical Studies (14.1)
].
Pediatric use information is approved for Bristol-Myers Squibb Companys Baraclude (entecavir) tablets.
However, due to Bristol-Myers Squibb Companys marketing exclusivity rights, this drug product is not labeled with that information.
Entecavir is a Hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
(1)
INDICATIONS AND USAGE
Hypertension
Quinapril hydrochloride tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
In using quinapril hydrochloride tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril hydrochloride tablets do not have a similar risk (see WARNINGS).
Angioedema in Black Patients
Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac Tromethamine Tablets USP are indicated for the short-term ( 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and Ketorolac Tromethamine Tablets USP are to be used only as continuation treatment, if necessary.
The total combined duration of use of Ketorolac Tromethamine Tablets USP and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see
WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and
ADVERSE REACTIONS
). Patients should be switched to alternative analgesics as soon as possible, but Ketorolac Tromethamine Tablet USP therapy is not to exceed 5 days.
1 INDICATIONS & USAGE
Phentermine hydrochloride tablets USPare 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 greater than or equal to 30 kg/m2, or greater than or equal to 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 patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)
Weight(pounds)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
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 hydrochloride is 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 greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including phentermine hydrochloride tablets USP, should be measured against possible risk factors inherent in their use. (1)
1 INDICATIONS AND USAGE
Morphine Sulfate Tablets are indicated for the management of acute and chronic 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 and Precautions (5.1)], reserve Morphine Sulfate Tablets 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.
Morphine Sulfate Tablets are indicated for the management of:
adults and pediatric patients weighing at least 50 kg with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
(1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Morphine Sulfate Tablets 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
Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin is indicated in patients 10 years of age and older.Metformin may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age nd older).
1 INDICATIONS AND USAGE
Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for:
Treatment of hypertension in adults and pediatric patients 6 years of age and older (
1.1)
Adjunct therapy for heart failure (
1.2)
Treatment of Acute Myocardial Infarction (
1.3)
Indications and Usage
FludrocortisoneAcetate Tablets, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addisons disease and for the treatment of salt-losing adrenogenital syndrome.
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	INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows (1.2)
Posaconazole delayed-release tablets: Adults and pediatric patients 13 years of age and older.
1.2 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus- host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see Clinical Studies (14.2)]as follows
Posaconazole delayed-release tablets: Adults and pediatric patients 13 years of age and older.
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.s NOXAFIL (posaconazole delayed-release tablets). However, due to Merck Sharp & Dohme Corp.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (
1.1,
1.2)
1.1 Parkinson's Disease
Ropinirole tablets are indicated for the treatment of Parkinsons disease.
1.2 Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for: Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2) Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3) and maintenance of healing of erosive esophagitis (1.4) Pathologic Hypersecretory Conditions (1.5)
The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. (8.4)
1.7 Plaque Psoriasis
HYRIMOZ is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HYRIMOZ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5)].
INDICATIONS AND USAGE
Cancer Patients Receiving
Myelosuppressive Chemotherapy
NEUPOGEN is indicated to decrease the
incidence of infection as manifested by febrile neutropenia in patients with
nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated
with a significant incidence of severe neutropenia with fever (see
CLINICAL
EXPERIENCE
). A complete blood count (CBC) and platelet count should
be obtained prior to chemotherapy and twice per week (see
LABORATORY
MONITORING
) during NEUPOGEN therapy to avoid
leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies
NEUPOGEN therapy was discontinued when the ANC was
10000/mm3 after the expected chemotherapy-induced
nadir.
Patients With Acute Myeloid
Leukemia Receiving Induction or Consolidation Chemotherapy
NEUPOGEN is indicated for reducing the
time to neutrophil recovery and the duration of fever, following induction or
consolidation chemotherapy treatment of adults with AML.
Cancer Patients Receiving Bone
Marrow Transplant
NEUPOGEN is indicated to reduce the
duration of neutropenia and neutropenia-related clinical sequelae eg febrile
neutropenia in patients with nonmyeloid malignancies undergoing myeloablative
chemotherapy followed by marrow transplantation (see
CLINICAL
EXPERIENCE
). It is recommended that CBCs and platelet counts be
obtained at a minimum of 3 times per week (see
LABORATORY
MONITORING
) following marrow infusion to monitor the recovery of
marrow reconstitution.
Patients Undergoing Peripheral
Blood Progenitor Cell Collection and Therapy
NEUPOGEN is indicated for the
mobilization of hematopoietic progenitor cells into the peripheral blood for
collection by leukapheresis. Mobilization allows for the collection of increased
numbers of progenitor cells capable of engraftment compared with collection by
leukapheresis without mobilization or bone marrow harvest. After myeloablative
chemotherapy the transplantation of an increased number of progenitor cells can
lead to more rapid engraftment which may result in a decreased need for
supportive care (see
CLINICAL
EXPERIENCE
).
Patients With Severe Chronic
Neutropenia
NEUPOGEN is indicated for chronic
administration to reduce the incidence and duration of sequelae of neutropenia
(eg fever infections oropharyngeal ulcers) in symptomatic patients with
congenital neutropenia cyclic neutropenia or idiopathic neutropenia (see
CLINICAL
EXPERIENCE
). It is essential that serial CBCs with differential and
platelet counts and an evaluation of bone marrow morphology and karyotype be
performed prior to initiation of NEUPOGEN therapy (see
WARNINGS
).
The use of NEUPOGEN prior to confirmation of SCN may
impair diagnostic efforts and may thus impair or delay evaluation and treatment
of an underlying condition other than SCN causing the neutropenia.
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 tablets were 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
Fyavolv is an estrogen plus progestin indicated in a woman with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to
Menopause (1.1)
Prevention of Postmenopausal Osteoporosis (1.2)
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
1 INDICATIONS AND USAGE
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.
1
INDICATIONS AND USAGE
Carvedilol Table t is an alpha/be ta-adrenergic blocking agent indicate d for the treatment of: Mild
to severe chronic heart failure (1.1)
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.1
Heart Failure
Carvedilol Tablets is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to
increase survival and, also, to reduce the risk of hospitalization [see Clinical Studies(14.1)].
1.2
Left
Ventricular Dys
function Following Myocardial Infarction
Carvedilol Tablet is 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 less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (
14.2
)].
1.3
Hypertension
Carvedilol Tablet is 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: Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including
S. aureus and
S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some
Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most
Proteus vulgaris strains,
Haemophilus influenzae and
H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some
Neisseria species.
INDICATIONS:
This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
1 INDICATIONSAND USAGE
VIGAMOX 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 influenzae
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
VIGAMOX 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)
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of moderate to moderately severe 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 [seeWARNINGS], 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