um-ids/dailymed-annotations huggingface dataset:
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
Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Adapalene and Benzoyl Peroxide gel, is a combination of adapalene, a retinoid, and benzoyl peroxide and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. (1)
1 INDICATIONS AND USAGE
UPNEEQis indicated for the treatment of acquired blepharoptosis in adults.
UPNEEQ is indicated for the treatment of acquired blepharoptosis in adults. (1)
INSTRUCTIONS FOR USE
Purpose and Indications
Phocal disks are topical delivery vehicles designed to fluoridate interproximal tooth surfaces. This action aids in the prevention of dental caries on intact surfaces, arrests progress on surfaces with incipient carious lesions and enhances remineralization. Phocal disks are also effective at tooth restoration margins and furcations.
Phocal disks are to be applied only by dental professionals at selected sites to achieve the desired benefits.
1 INDICATIONS AND USAGE
Naproxen Tablets are indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
INDICATIONS AND USAGE
Management of nausea and vomiting, and dizziness associated with motion sickness.
1 INDICATIONS AND USAGE
RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)].
RELEXXII is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older (1)
INDICATIONS AND USAGE
Malaria
Hydroxychloroquine sulfate tablets is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.
Hydroxychloroquine sulfate tablets is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria
Hydroxychloroquine sulfate tablets is not
recommended for the treatment of complicated malaria.
Hydroxychloroquine sulfate tablets is not
effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see
CLINICAL PHARMACOLOGY
Microbiology
). Hydroxychloroquine sulfate
tablets is not recommended for the treatment of malaria acquired in
geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Hydroxychloroquine sulfate tablets is not
recommended for malaria prophylaxis in geographic areas where chloroquine
resistance occurs.
Hydroxychloroquine sulfate tablets does not
prevent relapses of P. vivax or P. ovale because it is not
active against the hypnozoite forms of these parasites. For radical cure
of P. vivax and P. ovale infections, concomitant therapy
with an 8-aminoquinoline compound is necessary (see
CLINICAL PHARMACOLOGY
Microbiology
).
Prior to prescribing Hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (http://www.cdc.gov/malaria).
Lupus Erythematosus
Hydroxychloroquine sulfate tablets is indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1 INDICATIONS AND USAGE
ZEGALOGUE is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
ZEGALOGUE is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. (1)
INDICATIONS & USAGE
Promethazine Hydrochloride, is useful orally 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.
INDICATIONS AND USAGE
Hypertension
Acebutolol HCl capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Ventricular Arrhythmias
Acebutolol HCl capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.
Tramadol hydrochloride tablets, USP are indicated in adults 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 AND PRECAUTIONS (5.1)] , reserve tramadol hydrochloride 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.
INDICATIONSAND USAGE
Clomipramine hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Angeliq 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) is an estrogen/progestin indicated in women with an intact uterus for the treatment of:
Vasomotor symptoms due to menopause. (1.1)
Angeliq 0.5 mg DRSP/1 mg E2 is an estrogen/progestin indicated in women with an intact uterus for the treatment of:
Vasomotor symptoms due to menopause. (1.1)
Vulvar and vaginal atrophy symptoms due to menopause. (1.2
)
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Angeliq 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause in women who have a uterus.
Angeliq 0.5 mg DRSP/1 mg E2 is indicated for the treatment of moderate to severe vasomotor symptoms associated due to menopause in women who have a uterus.
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Angeliq 0.5 mg DRSP/1 mg E2 is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause in women who have a uterus.
1 INDICATIONS AND USAGE
Everolimus tablets are a kinase inhibitor indicated for the treatment of:
Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1)
Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.
Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. (1.2)
Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. (1.3)
Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4)
Everolimus tablets are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5)
1.1 Hormone Receptor-Positive,
HER2-Negative Breast Cancer
Everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone
receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.
1.2 Neuroendocrine Tumors (NET)
Everolimus tablets are indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.
Everolimus tablets are indicated for the treatment of adult patients with progressive, well-differentiated,
non-functional NET of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.
Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors [see Clinical Studies (14.2)].
1.3 Renal Cell Carcinoma (RCC)
Everolimus tablets are indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib.
1.4 Tuberous Sclerosis Complex
(TSC)-Associated Renal Angiomyolipoma
Everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.
1.5 Tuberous Sclerosis Complex
(TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
Everolimus tablets are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected.
Hydrocodone bitartrate and acetaminophen tablets are 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 hydrocodone bitartrate 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
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)
INDICATIONS AND USAGE
Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective.
Table II 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 these methods can result in lower failure rates.
TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use
% of Women
Continuing Use at
One Year
a
Method
(1)
Typical Use
b
(2)
Perfect Use
c
(3)
(4)
Chance
d
85
85
Spermicides
e
26
6
40
Periodic Abstinence
25
63
Calendar
9
Ovulation Method
3
Sympto-Thermal
f
2
Post-Ovulation
1
Withdrawal
19
4
Cap
g
Parous Women
40
26
42
Nulliparous Women
20
9
56
Sponge
Parous Women
40
20
42
Nulliparous Women
20
9
56
Diaphragm
g
20
6
56
Condom
h
Female (Reality)
21
5
56
Male
14
3
61
Pill
5
71
Progestin Only
0.5
Combined
0.1
IUD
Progesterone T
2
1.5
81
Copper T 380A
0.8
0.6
78
LNg 20
0.1
0.1
81
Depo-Provera
0.3
0.3
70
Norplant and Norplant-2
0.05
0.05
88
Female Sterilization
0.5
0.5
100
Male Sterilization
0.15
0.10
100
Adapted from Hatcher et al., 1998, ref #1.
a)Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
b)Among
typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
c) Among couples who initiate use of a method (not necessarily for the first time) and who use it
perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
d)The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
e) Foams, creams, gels, vaginal suppositories, and vaginal film.
f)Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
g) With spermicidal cream or jelly.
h)Without spermicides.
INDICATIONS AND USAGE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Attention Deficit Hyperactivity Disorder (ADHD)
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; on the go; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Uses
Helps prevent sunburn.
If used as directed, with other sun protection measures (see
Directions
), decreases the risk of skin cancer and early skin aging caused by the sun.
1 INDICATIONS AND USAGE
1.1 Duodenal Ulcer (adults)
Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Omeprazole delayed-release capsules, in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2) ].
Among patients who fail therapy, Omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. [
See Microbiology section (12.4)
], and the clarithromycin package insert, Microbiology section.)
1.2 Gastric Ulcer (adults)
Omeprazole delayed-release capsules are indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults. [See Clinical Studies (14.2) ]
1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)
Symptomatic GERD
Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.
Erosive Esophagitis
Omeprazole delayed-release capsules are indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies (14.4) ]
The efficacy of Omeprazole delayed-release capsules used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of omeprazole may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)
Omeprazole delayed-release capsules are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.
Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4) ]
1.5 Pathological Hypersecretory Conditions (adults)
Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
1 INDICATIONS AND USAGE
Minocycline hydrochloride extended-release tablets is tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1)
1.1 Indication
Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
1.2 Limitations of Use
Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see CLINICAL STUDIES (14)].
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets should be used only as indicated [see WARNINGS AND PRECAUTIONS (5.11)].
1 INDICATIONS AND USAGE
Topiramate tablets USP is indicated for:
Monotherapy
epilepsy: Initial monotherapy in patients
2 years of age with
partial onset or primary generalized tonic-clonic seizures (1.1)
Adjunctive therapy
epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16
years of age) with partial onset seizures or primary generalized
tonic-clonic seizures, and in patients 2 years of age with seizures
associated with Lennox-Gastaut syndrome (LGS) (1.2)
Prophylaxis of
migraine in patients 12 years of age and older (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1.3 Migraine
Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache.
1 INDICATIONS AND USAGE
VOLTAREN GEL is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment,such as the knees and those of the hands.
VOLTAREN GEL has not been evaluated for use on the spine, hip, or shoulder.
VOLTAREN GEL is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (1)
VOLTAREN GEL was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)