um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is
indicated for the treatment of pediatric patients with recurrent or persistent
acute otitis media due to S. pneumoniae
(penicillin MICs
2 mcg/mL), H.
influenzae (including -lactamaseproducing strains), or
M. catarrhalis (including
-lactamaseproducing strains) characterized by the following risk
factors:
antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
age
2 years
daycare attendance
[See CLINICAL PHARMACOLOGY, Microbiology.]
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with
amoxicillin. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is not
indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC
4 mcg/mL.
Therapy may be instituted prior to obtaining the results from
bacteriological studies when there is reason to believe the infection may
involve both S. pneumoniae (penicillin
MIC
2 mcg/mL) and the -lactamaseproducing organisms listed
above.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL
and other antibacterial drugs, Amoxicillin and Clavulanate Potassium 600
mg/42.9 mg per 5 mL 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
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer(DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcerrecurrence.
Famotidine is a histamine-2 (H
2) receptor antagonist indicated (
1):
In adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer(DU).
active gastriculcer.
symptomatic nonerosive gastroesophageal reflux disease(GERD).
erosive esophagitis due to GERD, diagnosed bybiopsy.
In adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrineneoplasias).
reduction of the risk of DUrecurrence.
1. Indications and Usage
Fludeoxyglucose F18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F18 Injection USP is indicated for positron
emission tomography (PET) imaging in the following
settings:
Oncology: For assessment of abnormal glucose
metabolism to assist in the evaluation of malignancy in
patients with known or suspected abnormalities found by
other testing modalities, or in patients with an existing
diagnosis of cancer.
Cardiology: For the identification of left ventricular
myocardium with residual glucose metabolism and
reversible loss of systolic function in patients with
coronary artery disease and left ventricular dysfunction,
when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal
glucose metabolism associated with foci of epileptic
seizures (
1).
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
INDICATIONS AND USAGE
Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin hydrochloride capsules, USP are
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 hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., 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, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP 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
Cyclobenzaprine Hydrochloride Tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine Hydrochloride Tablets USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine Hydrochloride Tablets USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
INDICATIONS & USAGE SECTION
Ofloxacin Otic Solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae.
INDICATIONS AND USAGE
MICROGESTIN and MICROGESTIN Fe are 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 I 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.
TABLE I:
LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Lowest
Method
Expected*
Typical**
(No contraception) ......................
(85)
(85)
Oral contraceptives ....................
3
combined ................................
0.1
N/A***
progestin only ........................
0.5
N/A***
Diaphragm with spermicidal cream or jelly ..........................
6
20
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) ................................
6
26
Vaginal Sponge
nulliparous ..............................
9
20
parous ....................................
20
40
Implant........................................
0.05
0.05
Injection: depot medroxyprogesterone acetate ......................
0.3
0.3
IUD
progesterone T ........................
1.5
2.0
copper T 380A ........................
0.6
0.8
LNg 20 ....................................
0.1
0.1
Condom without spermicides
female......................................
5
21
male ........................................
3
14
Cervical Cap with spermicidal cream or jelly
nulliparous ..............................
9
20
parous ....................................
26
40
Periodic abstinence (all methods) ..............................
1-9
25
Withdrawal..................................
4
19
Female sterilization......................
0.5
0.5
Male sterilization ........................
0.10
0.15
Adapted from RA Hatcher et al, Reference 7.
*The authors best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
**This term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
***N/A - Data not available.
INDICATIONS AND USAGE
Severe Recalcitrant Nodular Acne
Sotret is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Severe, by definition,2 means many as opposed to few or several nodules. Because of significant adverse effects associated with its use, Sotret should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Sotret is indicated only for those female patients who are not pregnant, because Sotret can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS).A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).
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 capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5)].
1 INDICATIONS AND USAGE
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated 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 are 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 Drug Interactions (7.4) and Clinical Studies (14.1)].
1.2 Left Ventricular Dysfunction following Myocardial Infarction
Carvedilol tablets 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 less than or equal to 40% (with or without symptomatic heart failure) [seeClinical Studies (14.2)].
1.3 Hypertension
Carvedilol tablets are indicated for the management of essential hypertension [seeClinical 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 & USAGE SECTION
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
1 INDICATIONS AND USAGE
Sodium nitroprusside is a direct acting vasodilator indicated for:
Immediate reduction of blood pressure (1.1)
Producing controlled hypotension to reduce bleeding during surgery. (1.2)
Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. (1.3)
1.1 Immediate Reduction of Blood Pressure
Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises.
1.2 Induction and Maintenance of Controlled Hypotension
Sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding.
1.3 Treatment of Acute Heart Failure
Sodium nitroprusside is indicated for the treatment of acute heart failure to reduce, left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure.
INDICATIONS AND USAGE
Gastrografin (Diatrizoate Meglumine and
Diatrizoate Sodium Solution) is indicated for radiographic examination
of segments of the gastrointestinal tract (esophagus, stomach, proximal
small intestine, and colon). The preparation is particularly indicated
when a more viscous agent such as barium sulfate, which is not water-soluble,
is not feasible or is potentially dangerous.
Gastrografin may also be used as an adjunct to contrast
enhancement in computed tomography of the torso (body imaging); the
preparation is indicated, in conjunction with intravenous administration
of a radiopaque contrast agent, when unenhanced imaging may not provide
sufficient definition in distinguishing normal loops of bowel from
adjacent organs or areas of suspected pathology.
1 INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets USP are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (
1.1)
1.1 Oral Contraceptive
Norgestimate and ethinyl estradiol tablets USP are indicated for use by females of reproductive potential to prevent pregnancy
[see CLINICAL STUDIES (
14)].
1 INDICATIONS AND USAGE
Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1)
1.	INDICATIONS AND USAGE
Celecoxib is indicated
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
1.1	Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)
].
1.2	Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)
].
1.3 Juvenile Rheumatoid Arthritis (JRA)
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 (AS)
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
VASERETIC is indicated for the treatment of hypertension.
This fixed dose combination is not indicated for initial treatment (see
DOSAGE AND ADMINISTRATION
).
In using VASERETIC, 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, and that available data are insufficient to show that enalapril does not have a similar risk (see
WARNINGS
).
In considering use of VASERETIC, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see
WARNINGS, Head and Neck Angioedema
).
1 INDICATIONSAND USAGE
Ifosfamide for Injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
Ifosfamide for Injection is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. (1)
INDICATIONS AND USAGE
4% Lidocaine Hydrochloride Injection, USP is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract or the genito-urinary tract. It may be injected trans-tracheally to anesthetize the larynx and trachea, and it may be administered by retrobulbar injection to provide anesthesia for ophthalmic surgery.
1 INDICATIONS AND USAGE
Topiramate is indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 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 tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.
1 INDICATIONS AND USAGE
LAMICTALXR is indicated for:
adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1)
conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. (1.2)
Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (1.3)
1.1 Adjunctive Therapy
LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
1.2 Monotherapy
LAMICTAL XR is indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).
Safety and effectiveness of LAMICTAL XR have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.3 Limitation of Use
Safety and effectiveness of LAMICTAL XR for use in patients younger than 13 years have not been established.
INDICATIONS & USAGE
Doxepin Hydrochloride is recommended for the treatment of:
Psychoneurotic patients with depression and/or anxiety
Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that Doxepin Hydrochloride is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, Doxepin Hydrochloride is not recommended for use in children under 12 years of age.