um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Topiramate capsules (sprinkle) are 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 capsules (sprinkle) 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 capsules (sprinkle) are indicated as adjunctive therapy 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 capsules (sprinkle) are indicated for the preventive treatment of migraine in patients 12 years of age and older.
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac tromethamine tablets 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 ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets 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 therapy is not to exceed 5 days.
1 INDICATIONS & USAGE
Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
BROMFENAC is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
1 INDICATIONS AND USAGE
1.1 Renal Tubular Acidosis (RTA) with Calcium Stones
Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)].
1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology
Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)].
1.3 Uric Acid Lithiasis with or without Calcium Stones
Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].
Urocit-K is a citrate salt of potassium indicated for the management of:
Renal tubular acidosis (RTA) with calcium stones (1.1)
Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2)
Uric acid lithiasis with or without calcium stones (1.3)
1 INDICATIONS AND USAGE
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Metformin hydrochloride tablets is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
(1)
Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.
INDICATIONS AND USAGE
Predialysis Patients
Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73square meters. A serum iPTH level of 100pg/mL is strongly suggestive of secondary hyperparathyroidism.
Dialysis Patients
Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.
Hypoparathyroidism Patients
Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
1 INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (
1)
1 INDICATIONS AND USAGE
Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimers type.
Galantamine Tables are a cholinesterase inhibitor indicated for thetreatment of mild to moderate dementia of the Alzheimers type(
1)
INDICATIONS AND USAGE
Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by
peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of
patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition
cannot be tolerated, is undesirable, or inadequate.
SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE
ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES.
Aminosyn II can be administered peripherally with dilute (5 to 10%)
dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of
nutritional support can help to preserve protein and reduce catabolism in stress conditions
where oral intake is inadequate.
Aminosyn II is also indicated for central vein infusion to prevent or
reverse negative nitrogen balance in patients where the alimentary tract, by the oral,
gastrostomy or jejunostomy route cannot or should not be used and gastrointestinal absorption
of protein is impaired.
1 INDICATIONS AND USAGE
Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA).
Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (
1)
INDICATIONS AND USAGE
Ocuvel is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation.
1.5
Vancomycin-resistant
Enterococcus faecium Infections
Linezolid is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14)].
INDICATIONS AND USAGE
Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
1 INDICATIONS AND USAGE
CYMBALTA is indicated for the treatment of:
Major Depressive Disorder [see Clinical Studies (14.1
)]
Generalized Anxiety Disorder [see Clinical Studies (14.2
)]
Diabetic Peripheral Neuropathy [see Clinical Studies (14.3
)]
Fibromyalgia [see Clinical Studies (14.4
)]
Chronic Musculoskeletal Pain [see Clinical Studies (14.5
)]
CYMBALTA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Fibromyalgia (FM) (1)
Chronic Musculoskeletal Pain (1)
1 INDICATIONS AND USAGE
Bivalirudin Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
Bivalirudin Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.(1)
INDICATIONS AND USAGE
Foltamin is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation.
Foltamin can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
1 INDICATIONS AND USAGE
Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2 .
initial and repeat courses of moderately emetogenic cancer chemotherapy.
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Ondansetron orally disintegrating tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron orally disintegrating tablets are a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2. (
1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (
1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (
1)
postoperative nausea and/or vomiting. (
1)
INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets 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
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.
%ofWomenExperiencinganUnintendedPregnancy
intheFirstYearofContinuousUse
Method
LowestExpected*
Typical**
(Nocontraception)
(85)
(85)
Oralcontraceptives
3
combined
0.1
N/A***
progestinonly
0.5
N/A***
Diaphragmwithspermicidalcreamorjelly
6
20
Spermicidesalone(foam,creams,gels,vaginalsuppositoriesandvaginalfilm)
6
26
VaginalSponge
nulliparous
9
20
parous
20
40
Implant
0.05
0.05
Injection:depotmedroxyprogesteroneacetate
0.3
0.3
IUD
progesteroneT
1.5
2
copperT380A
0.6
0.8
LNg20
0.1
0.1
Condomwithoutspermicides
female
5
21
male
3
14
CervicalCapwithspermicidalcreamorjelly
nulliparous
9
20
parous
26
40
Periodicabstinence(allmethods)
1to9
25
Withdrawal
4
19
Femalesterilization
0.5
0.5
Malesterilization
0.1
0.15
What testosterone Implants are and what they are used for
Testosterone implants are pellets containing 100mg of the active ingredient testosterone.
These implants are used in hormone replacement therapy in men.
Testosterone is a natural male hormone, known as an androgen, which controls normal sexual development in men.
Testosterone implants are used in testosterone replacement therapy in men with low or no natural testosterone (a condition known as hypogonadism).
INDICATIONS AND USAGE
Parkinson's Disease:
Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
The effectiveness of ropinirole hydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see
CLINICAL PHARMACOLOGY, Clinical Trials
).
Restless Legs Syndrome:
Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
1.2
Community-acquired Pneumonia
Linezolid is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14)].
INDICATIONS AND USAGE:
IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of IMURAN on these variables has not been tested in controlled trials.
Rheumatoid Arthritis: IMURAN is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms.
Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with IMURAN. The combined use of IMURAN with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of IMURAN with these agents cannot be recommended.
1 INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.
Levonorgestrel and ethinyl estradiol tablet is an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1)
1.1	Malaria
Hydroxychloroquine sulfate is indicated in adult and pediatric patients for the:
Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate is not recommended for:
Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology (12.4)] .
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4)] .
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention 1.
1 INDICATIONS AND USAGE
Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum (1.1) Adenocarcinoma of the Breast (1.2) Gastric Adenocarcinoma (1.3) Pancreatic Adenocarcinoma (1.4)
1.1 Adenocarcinoma of the Colon and Rectum
.
1.2 Adenocarcinoma of the Breast
.
1.3 Gastric Adenocarcinoma
.
1.4 Pancreatic Adenocarcinoma
.
1 INDICATIONS AND USAGE
Azithromycin for injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Azithromycinis a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Community-acquired pneumonia in adults (1.1)
Pelvic inflammatory disease (1.2)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
azithromycin
and other antibacterial drugs,
azithromycin
should be used only to treat or prevent infections that
are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
1.1 Community-Acquired Pneumonia
due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.
1.2 Pelvic Inflammatory Disease
due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin.
Azithromycin for injection, USP
should be followed by azithromycin by the oral route as required. [see Dosage and Administration (2)]
1.3	Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS
TriStart DHA is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA can also be beneficial in improving the nutritional status of women prior to conception.This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.
1 INDICATIONS AND USAGE
Gabapentin tablets are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset
seizures, with and without secondary generalization, in adults and
pediatric patients 3 years and older with epilepsy
Gabapentin tablets are indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
INDICATIONS AND USAGE
Postherpetic Neuralgia
Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin tablets USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3
12 years.