um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Clarithromycin Extended-release Tablets, USP is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following:
Acute Bacterial Exacerbation of Chronic Bronchitis in Adults
(1.1)
Acute Maxillary Sinusitis
(1.2)
Community-Acquired Pneumonia
(1.3)
Limitations of Use
Clarithromycin Extended-release Tablets, USP is indicated only for acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, and community-acquired pneumonia in adults.
(1.4)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clarithromycin Extended-release Tablets, USP and other antibacterial drugs, Clarithromycin Extended-release Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
(1.4)
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis
Clarithromycin Extended-release Tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,
Haemophilus parainfluenzae,
Moraxella catarrhalis, or
Streptococcus pneumoniae
[see Indications and Usage
(1.4)]
.
1.2 Acute Maxillary Sinusitis
Clarithromycin Extended-release Tablets, USP (in adults)
are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,
Moraxella catarrhalis, or
Streptococcus pneumoniae [see Indications and Usage
(1.4)]
.
1.3 Community-Acquired Pneumonia
Clarithromycin Extended-release Tablets, USP are indicated
[see Indications and Usage
(1.4)]
for the treatment of mild to moderate infections caused by susceptible isolates due to:
Haemophilus influenzae (in adults)
Haemophilus parainfluenzae (in adults)
Moraxella catarrhalis (in adults)
Mycoplasma pneumoniae,
Streptococcus pneumoniae,
Chlamydophila pneumoniae (in adults)
1.4 Limitations of Use
Clarithromycin Extended-release Tablets, USP are indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of Clarithromycin Extended-release Tablets, USP in treating other infections for which other formulations of clarothromycin are approved have not been established.
There is resistance to macrolides in certain bacterial infections caused by
Streptococcus pneumoniae and
Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.
1.5 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clarithromycin Extended-release Tablets, USP
and other antibacterial drugs, Clarithromycin Extended-release Tablets, 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
Carefully consider the potential benefits and risks of Fenoprofen Calcium and other treatment options before deciding to use Fenoprofen Calcium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Fenoprofen Calcium is indicated:
For relief of mild to moderate pain in adults.
For relief of the signs and symptoms of rheumatoid arthritis.
For relief of the signs and symptoms of osteoarthritis.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Piroxicam capsules are indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
INDICATIONS AND USAGE
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
INDICATIONS AND USAGE
EXUBERA is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. EXUBERA has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. In patients with type 1 diabetes, EXUBERA should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, EXUBERA can be used as monotherapy or in combination with oral agents or longer-acting insulins.
1 INDICATIONS AND USAGE
Levetiracetam is indicated forthe treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial-onset seizures inpatients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures inpatients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures inpatients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be one component of multiple risk factor intervention in individuals who require modifications of their lipid profile. Drug therapy is recommended as an adjunct to a diet restricted in saturated fat and cholesterol only when the response to diet and other non-pharmacological measures has been inadequate.
Altoprev is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of MI, revascularization procedures, and angina in patients without CHD, but with multiple risk factors. (1.1)
Slow the progression of coronary atherosclerosis in patients with CHD as part of a treatment strategy to lower Total-C and LDL-C. (1.1)
Reduce elevated Total-C, LDL-C, Apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2)
Limitations of Use
Altoprevhas not been studied in FredricksonTypes I, III, and V dyslipidemias. (1.3)
1.1 Prevention of Coronary Heart Disease
In patients without symptomatic coronary heart disease (CHD), but at high risk,Altoprev isindicated to reduce the risk of:
Myocardial infarction
Unstable angina
Coronary revascularization procedures
Coronary Heart Disease
Altoprev is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower Total-C and LDL-C to target levels.
1.2 Hyperlipidemia
Altoprev is indicated as an adjunct to diet for the reduction of elevated Total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson types IIa and IIb).
1.3 Limitations of Use
Altoprevhas not been studied in Fredrickson Types I, III, and V.
1 INDICATIONS AND USAGE
Celecoxib is indicated
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
Methadone hydrochloride oral concentratecontains methadone, an opioid agonist indicated for the:
detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8[see Dosage and Administration (2.1)].
Methadone hydrochloride oral concentrateis an opioid agonist indicated for the:
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). (1)
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec. 8. (2.1)
1 INDICATIONS AND USAGE
Monotherapy and Combination Therapy
Pioglitazone tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].
Important Limitations of Use
Pioglitazone hydrochloride exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone hydrochloride should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see Warnings and Precautions (5.3)].
Pioglitazone tablets, USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.
(1, 14)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
INDICATIONS AND USAGE
Oxycodone and acetaminophen tablets is indicated for the management of 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], reserve oxycodone 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
INDICATIONS AND USAGE
STRATOL Ophthalmic Solution is indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria.
Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis, acute meibomianitis and dacryocystitis.
INDICATIONS AND USAGE
In Anesthesia:
Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug - induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer:
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
1 INDICATIONS AND USAGE
Nutropin AQ is a recombinant human growth hormone indicated for:
Pediatric Patients:
Treatment of children with growth failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome (TS), and chronic kidney disease (CKD) up to the time of renal transplantation (1.1).
Adult Patients: Treatment of adults with either childhood-onset or adult-onset GHD (1.2).
1.1
Pediatric Patients
Growth Hormone Deficiency (GHD) - Nutropin AQ is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
Growth Failure Secondary to Chronic Kidney Disease (CKD) - Nutropin AQ is indicated for the treatment of growth failure associated with CKD up to the time of renal transplantation.
Nutropin AQ therapy should be used in conjunction with optimal management of CKD.
Idiopathic Short Stature (ISS) - Nutropin AQ is indicated for the treatment of ISS, also called non-GHD short stature, defined by height SDS
2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.
Short Stature Associated with Turner Syndrome (TS) - Nutropin AQ is indicated for the treatment of short stature associated with TS.
1.2
Adult Patients
Nutropin AQ is indicated for the replacement of endogenous GH in adults with GHD who meet either of the following two criteria:
Adult Onset:
Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset:
Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients who were treated with somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults.
According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate GH provocative test with two exceptions: (1) patients with multiple pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic GHD.
1 INDICATIONS AND USAGE
Varenicline tablets are indicated for use as an aid to smoking cessation treatment.
Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. (1 and 2.1)
INDICATIONS AND USAGE
Flucytosine capsules are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
Flucytosine capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine capsules (see MICROBIOLOGY).
1 INDICATIONS AND USAGE
Aripiprazole is indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder
Treatment of Tourettes Disorder
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourettes disorder (14.5)
INDICATIONS AND USAGE
Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.
Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
1 INDICATIONS AND USAGE
ONZETRA Xsail is indicated for the acute treatment of migraine with or without aura in adults.
ONZETRA Xsail 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 if a clear diagnosis of migraine headache has been established (1)
Not indicated for the prophylactic therapy of migraine attacks (1)
Not indicated for the treatment of cluster headache (1)
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 ONZETRA Xsail, reconsider the diagnosis of migraine before treatment of subsequent attacks with ONZETRA Xsail.
ONZETRA Xsail is not indicated for the prevention of migraine attacks.
Safety and effectiveness of ONZETRA Xsail have not been established for the treatment of cluster headache.
INDICATIONS AND USAGE
June
l
21 and Junel
Fe 28
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.
% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
LowestExpected
Typical
(No contraception)
(85)
(85)
Oral contraceptives combined progestin only
0.10.5
3N/AN/A--Data not available
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 parous
920
2040
Implant
0.05
0.05
Injection: depot medroxyprogesterone acetate
0.3
0.3
IUD progesterone T copper T 380A LNg 20
1.50.60.1
2.00.80.1
Condom without spermicides female male
53
2114
Cervical Cap with spermicidal cream or jelly nulliparous parous
926
2040
Periodic abstinence (all methods)
1 to 9
25
Withdrawal
4
19
Female sterilization
0.5
0.5
Male sterilization
0.10
0.15
INDICATIONS AND USAGE:
Midazolam hydrochloride syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.
Midazolam hydrochloride syrup is intended for use in monitored settings only and not for chronic or home use (see WARNINGS). MIDAZOLAM HYDROCHLORIDE SYRUP MUST BE USED AS SPECIFIED IN THE LABEL.
Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours (see CLINICAL PHARMACOLOGY).
INDICATIONS AND USAGE
Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.
INDICATIONS & USAGE
Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp.
Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis.
This product is not recommended for use in pediatric patients under 12 years of age.
1 INDICATIONS AND USAGE
Ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
Limitations of Use
Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established.
Ketoconazole foam is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older (1).
Limitations of Use
Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established.
1 INDICATIONS AND USAGE
GLUCAGON for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated:
for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. (1.1)
as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. (1.2)
1.1 Severe Hypoglycemia
Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus.
1.2 Diagnostic Aid
Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
INDICATIONS AND USAGE
Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis.
The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less
than optimal levels of fluoride, receive daily fluoride supplementation.
Multivitamin with Fluoride 0.5 mg Chewable Tablets provide 0.5 mg fluoride in tablet form for children 4-6 years of
age in areas where the drinking water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the
drinking water contains 0.3 through 0.6 ppm of fluoride.
Multivitamin with Fluoride 0.5 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.
Children using
Multivitamin with Fluoride 0.5 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.