um-ids/dailymed-annotations huggingface dataset:
STERILE ALCOHOL PREP PAD
ACTIVE INGREDIENT
Active Ingredient..........................................Purpose
Isopropyl Alcohol 70% v/v..........................Antiseptic
USE: ALCOHOL_PREP
For preparation of the skin prior to injection.
WARNINGS
For external use only
Flammable, keep away from flame or fire
Not for use with electrocautinary devices or procedures
Do not use in eyes
Sterile unless package is damaged or open.
INDICATIONS AND USAGE
Stop use and ask a doctor if:
Irritation or redness develops
condition persists for more than 72 hours
Cleansing of an injection site
KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
DIRECTIONS
Wipe injection site vigorously and discard
OTHER INFORMATION
Store at room temperature: 15 deg C to 30 deg C
59 deg F to 86 deg F
avoid excessive heat
INACTIVE INGREDIENT
Inactive Ingredient
Water
PRINCIPAL DISPLAY PANEL
Dynarex Sterile Alcohol Prep Pad
dynarex alcohol prep pad
INDICATIONS & USAGE SECTION
1. INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to:
Reduce the risk of total mortality by reducing CHD deaths.
Reduce the risk of non-fatal myocardial infarction and stroke.
Reduce the need for coronary and non-coronary revascularization procedures.
1.2 Hyperlipidemia
Simvastatin tablets are indicated to:
Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson typeIIb).
Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson typelV hyperlipidemia).
Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson typeIII hyperlipidemia).
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)
Simvastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
LDL cholesterol remains 190mg/dL; or
LDL cholesterol remains 160mg/dL and
There is a positive family history of premature cardiovascular disease (CVD) or
Two or more other CVD risk factors are present in the adolescent patient.
The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.
1.4 Limitations of Use
Simvastatin tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson typesI andV).
1
INDICATIONS AND USAGE
INDOCIN Oral Suspension is 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
INDOCIN 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)
1 INDICATIONS AND USAGE
Vinorelbine injection is indicated:
In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
As a single agent for the treatment of patients with metastatic NSCLC
Vinorelbine injection is a vinca alkaloid indicated:
In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) (1)
As a single agent for first-line treatment of patients with metastatic NSCLC (1)
1 INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)].
The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are an estrogen/progestin COC indicated for use by women to prevent pregnancy (1)
The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated (1,8.8)
1 INDICATIONS AND USAGE
Ondansetron 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron 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)
1 INDICATIONS AND USAGE
TRULICITY is indicated:
As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type2 diabetes mellitus.
To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
TRULICITY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated (1):
As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type2 diabetes mellitus.
To reduce the risk of major adverse cardiovascular events in adults with type2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
Limitations of Use:
Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients (1, 5.2).
Not for treatment of type1 diabetes mellitus (1).
Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis (1, 5.6).
Limitations of Use
TRULICITY:
Has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. Consider other antidiabetic therapies in patients with a history of pancreatitis.
Should not be used in patients with type1 diabetes mellitus.
Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see Warnings and Precautions (5.6)].
1 INDICATIONSAND USAGE
Fluoxetine tablets are indicated for the treatment of:
Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)].
Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)].
Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies (14.3)].
Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies (14.4)].
Fluoxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of:
Major Depressive Disorder (MDD)(1)
Adults: Efficacy was established in one 5-week trial, three 6- week trials, and one maintenance study (14.1)
Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age (14.1)
Obsessive Compulsive Disorder (OCD) (1)
Adults: Efficacy was established in two 13-week trials (14.2)
Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age (14.2)
Bulimia Nervosa (1)
Adults: Efficacy was established in two 8-week trials and one 16-week trial (14.3)
Panic Disorder, with or without agoraphobia(1)
Adults: Efficacy was established in two 12-week trials (14.4)
INDICATIONS
Ethambutol Hydrochloride Tablets, USP are indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, i.e., initial treatment, the most frequently used regimens have been the following:
Ethambutol hydrochloride, USP plus isoniazid
Ethambutol hydrochloride, USP plus isoniazid plus streptomycin
In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, ethambutol hydrochloride should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculous drugs used with ethambutol hydrochloride have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
INDICATIONS AND USAGE
Ergotamine Tartrate and Caffeine
Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called histaminic cephalalgia.
1 INDICATIONS AND USAGE
Estradiol and norethindrone acetate tablets are indicated for:
Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1)
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2)
Limitations of Use:
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
Prevention of Postmenopausal Osteoporosis (1.3)
Limitations of Use:
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
1.3 Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1 INDICATIONS AND USAGE
Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants.
(1.1)
1.1 Prophylaxis of Organ Rejection in Kidney, Liver, and Heart Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplants [see Clinical Studies (14.2)] and heart transplant [see Clinical Studies (14.3)], in combination with other immunosuppressants.
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (
1)
INDICATIONS & USAGE SECTION
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1 INDICATIONS AND USAGE
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with:
Metastatic castration-resistant prostate cancer (CRPC)
Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Abiraterone acetate is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with:
metastatic castration-resistant prostate cancer (CRPC). (
1)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (
1)
INDICATIONS AND USAGE
Phentermine hydrochloride is 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.,
hypertension, diabetes, hyperlipidemia).
Below is a chart of Body Mass Index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches
0.0254 = meters.
The limited usefulness of agents of this class (see
CLINICAL PHARMACOLOGY
) should be measured against possible risk factors inherent in their use such as those described below.
BMI Table
INDICATIONS AND USAGE
Podofilox 0.5% solution is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated in the treatment of perianal or mucous membrane warts (see PRECAUTIONS).
Diagnosis
Although genital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called Bowenoid papulosis) is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with podofilox 0.5% solution.
1 INDICATIONS AND USAGE
NitroMist is indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
NitroMist
is a nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease (
1).
1
INDICATIONS AND USAGE
1.1 Monotherapy and
Combination TherapyAVANDIA is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type2 diabetes mellitus.
1.2 Important Limitations of
Use
Due to its mechanism of action, AVANDIA is active only in the presence of
endogenous insulin. Therefore, AVANDIA should not be used in patients with type
1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
The coadministration of AVANDIA and insulin is not recommended.
The use of AVANDIA with nitrates is not recommended.
INDICATIONS AND USAGE
1. Males
Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenita or acquired)
Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired)
Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
Safety and efficacy of methyltestosterone in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every 6 months to assess the effect of treatment on the epiphyseal centers (see
WARNINGS
).
2. Females
Androgens may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefitted from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of nabumetone and other treatment options before deciding to use nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
1 INDICATIONS AND USAGE
Levetiracetam is
indicated for
adjunctive therapy
in
the treatment of:
Partial
onset
seizures
in
patients
one month
of
age
and
older
with epilepsy
(1.1)
Myoclonic seizures in patients 12 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 as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
UROXATRAL is indicated for the treatment of signs and symptoms of
benign prostatic hyperplasia. UROXATRAL is not indicated for the treatment of
hypertension.
2 DOSAGE AND ADMINISTRATION
The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl)
extended-release tablet once daily. The extent of absorption of Uroxatral is 50%
lower under fasting conditions. Therefore, Uroxatral should be taken immediately
after the same meal each day. The tablets should not be chewed or crushed.
3 DOSAGE FORMS AND STRENGTHS
UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is
available as a round, three-layer tablet: one white layer between two yellow
layers, debossed with X10.
4 CONTRAINDICATIONS
UROXATRAL is contraindicated for use in patients with moderate or
severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin
blood levels are increased in these patients. [see
Clinical Pharmacology (12.3)].
UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as
ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are
increased. [see
Clinical Pharmacology
(12.3)].
UROXATRAL is contraindicated in patients known to be hypersensitive to
alfuzosin hydrochloride or any component of UROXATRAL tablets.