um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE
Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as possibly effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
1 INDICATIONS AND USAGE
Phentermine resin extended-release capsules are 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
30 kg/m2, or
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 patients weight, in kilograms (kg), divided by the patients 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)
50
53
56
59
60
63
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 resin extended-release capsules are 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
30 kg/m2, or
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, should be measured against possible risk factors inherent in their use. (1)
INDICATIONS AND USAGE
ISOVUE-M (lopamidol Injection)
is indicated for intrathecal administration in adult neuroradiology
including myelography (lumbar, thoracic, cervical, total columnar),
and for contrast enhancement of computed tomographic (CECT) cisternography
and ventriculography. ISOVUE-M 200 (lopamidol Injection) is indicated
for thoraco-lumbar myelography in children over the age of two years.
Ketorolac tromethamine ophthalmic solution 0.5% is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution 0.5% is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
1. INDICATIONS AND USAGE
FENOPROFEN CALCIUM is indicated for:
Relief of mild to moderate pain in adults.
Relief of the signs and symptoms of rheumatoid arthrites.
Relief of the signs and symptoms of osteoarthritis.
FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug indicated for:
Relief of mild to moderate pain in adults. (
1)
Relief of the signs and symptoms of rheumatoid arthritis. (
1)
Relief of the signs and symptoms of osteoarthritis. (
1)
INDlCATlONS AND USAGE:
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
INDICATIONS AND USAGE
Terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium)
(see
DOSAGE AND ADMINISTRATION
and
CLINICAL STUDIES
).
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
1 INDICATIONS AND USAGE
Mycophenolic Acid Delayed-Release Tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (
1.1)
Use in combination with cyclosporine and corticosteroids. (
1.1)
Limitations of Use:
Mycophenolic Acid Delayed-Release Tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (
1.2)
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic Acid Delayed-Release Tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic Acid Delayed-Release Tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic Acid Delayed-Release Tablets are to be used in combination with cyclosporine and corticosteroids.
1.2 Limitations of Use
Mycophenolic Acid Delayed-Release Tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
1 INDICATIONS AND USAGE
Dimethyl fumarate delayed-release capsules are 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.
Dimethyl fumarate delayed-release capsules are 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)
1 INDICATIONS AND USAGE
Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks.
Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks.
Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.
Eletriptan hydrobromide tablets is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
1
INDICATIONS & USAGE
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. BREVIBLOC injection is also indicated in noncompensatory sinus tachycardia where, in the physicians judgment, the rapid heart rate requires specific intervention. BREVIBLOC injection is intended for short-term use.
1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension
BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physicians judgment such specific intervention is considered indicated.
Use of BREVIBLOC injection to prevent such events is not recommended.
1 INDICATIONS AND USAGE
Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:
Schizophrenia
(1.1)
Bipolar I disorder manic episodes
(1.2)
Bipolar disorder, depressive episodes
(1.2)
1.1 Schizophrenia
Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials
[see
Clinical Studies (14.1)]
.
1.2 Bipolar Disorder
Quetiapine tablets are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years)
[see
Clinical Studies (14.2)]
.
Quetiapine tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder
[see
Clinical Studies (14.2)]
.
Quetiapine tablets are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials
[see
Clinical Studies (14.2)]
.
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1 INDICATIONS AND USAGE
Fingolimod capsule is a sphingosine 1-phosphate receptor modulator 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 patients 18 years of age and older. (1)
Fingolimod capsule 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 patients 18 years of age and older.
Pediatric use information is approved for Novartis Pharmaceuticals Corporation's GILENYA (fingolimod) capsules. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension USP and other antibacterial drugs, cefdinir for oral suspension 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.
Cefdinir for oral suspension USP is 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 AND USAGE
OVIDE Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and
their
ova) of the scalp hair.
1 INDICATIONS AND USAGE
Esmolol hydrochloride injection is a beta adrenergic blocker indicated for the short-term treatment of:
Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia (1.1)
Control of perioperative tachycardia and hypertension (1.2)
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
Esmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short-term control of ventricular rate with a short-acting agent is desirable. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physicians judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride is intended for short-term use.
1.2 Intraoperative and Postoperative Tachycardia and Hypertension
Esmolol hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physicians judgment such specific intervention is considered indicated.
Use of esmolol hydrochloride to prevent such events is not recommended.
1 INDICATIONS AND USAGE
Bimatoprost ophthalmic solution, 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. (1)
Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
1 INDICATIONS AND USAGE
Plan B
One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.
Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.
Plan B One-Step is not indicated for routine use as a contraceptive.
Plan B One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Plan B One-Step is not intended for routine use as a contraceptive. (1)
1 INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy. (1.1)
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)
Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
1.1 Hypercalcemia of Malignancy
Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL + 0.8 (4.0 g/dL - patient albumin [g/dL]).
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Limitations
of Use
The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
1 INDICATIONS AND USAGE
Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. (1.1)
1.1 Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)] or heart transplant [see Clinical Studies (14.3)] and pediatric patients receiving allogeneic liver transplant [see Clinical Studies (14.2)] in combination with other immunosuppressants.
INDICATIONS AND USAGE
Temazepam is indicated for the short-term treatment of insomnia
(generally 7 to 10 days).
For patients with short-term insomnia, instructions in the prescription
should indicate that temazepam should be used for short periods of time (7 to 10
days).
The clinical trials performed in support of efficacy were 2 weeks in duration
with the final formal assessment of sleep latency performed at the end of
treatment.
1 INDICATIONS AND USAGE
Celecoxib capsules are 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)
]
1 INDICATIONS AND USAGE
Midazolam in Sodium Chloride Injection is indicated:
Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
Midazolam in Sodium Chloride Injection is a benzodiazepine indicated for:
continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. (1)
1 INDICATIONS AND USAGE
MILPROSA is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women up to and including 34 years of age.
MILPROSA is a progesterone indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. (1)
Limitation of Use
Efficacy in women 35 years of age and older has not been established.
1 INDICATIONS & USAGE
Indomethacin Capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis
Indomethacin Capsule is a nonsteroidal anti-inflammatory drug indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis (1)
Parkinson's Disease / Syndrome
Amantadine Hydrochloride is indicated in the treatment of idiopathic Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson's disease, Amantadine Hydrochloride is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established.
INDICATIONS AND USAGE
Atracurium Besylate Injection, USP is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.