um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
evothyroxine sodium is used for the following indications:
Hypothyroidism
As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Pituitary TSH Suppression
In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic lymphocytic thyroiditis (Hashimotos thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
INDICATIONS AND USAGEAcetaminophen and codeine phosphate oral solution is indicated
for the relief of mild to moderate pain.
1 INDICATIONS AND USAGE
Flector Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
Flector Patch contains diclofenac epolamine, a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. (1)
INDICATIONS AND USAGE:
Triamcinolone Acetonide Cream 0.025%, 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE:
Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcers:
Pseudomonas aeruginosa
Serratia marcescens*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)*
Conjunctivitis:
Haemophilus influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
*Efficacy for this organism was studied in fewer than 10 infections.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate tablets are indicated for the treatment of hypertension.
Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.
Heart Failure
Enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets improves symptoms, increases survival, and decreases the frequency of hospitalization (see
CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials
for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), enalapril maleate tablets decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see
CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials
for details and limitations of survival trials).
In using enalapril maleate tablets consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets does not have a similar risk (see
WARNINGS, Neutropenia/Agranulocytosis).
In considering use of enalapril maleate tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see
WARNINGS, Head and Neck Angioedema
).
Symptomatic Gastroesophageal Reflux
Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.
The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d.
As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.
INDICATIONS:
Podocon-25 (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata)(4).
INDICATIONS AND USAGE
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets are indicated
for the relief of moderate to moderately severe pain.
INDICATIONS AND USAGE
Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see
WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding,
Ulceration, and Perforation
). Do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see
WARNINGS: Addiction, Abuse, and Misuse
), reserve hydrocodone bitartrate and ibuprofen 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
Metformin hydrochloride extended - release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
DICLOFENAC SODIUM TOPICAL 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.
DICLOFENAC SODIUM TOPICAL GEL has not been evaluated for use on the spine, hip, or shoulder.
DICLOFENAC SODIUM TOPICAL GEL is a nonsteroidal 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)
DICLOFENAC SODIUM TOPICAL GEL was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat
1.	INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [
see
Warnings and Precautions (5)
]
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (
1.3)
Ankylosing Spondylitis (AS) (
1.4)
Acute Pain (AP) (
1.5)
Primary Dysmenorrhea (PD) (
1.6)
1.1	Osteoarthritis (OA)
Celecoxib capsules are indicated for relief of the signs and symptoms of OA [
see
Clinical Studies (14.1)
]
1.2	Rheumatoid Arthritis (RA)
Celecoxib capsules are indicated for relief of the signs and symptoms of RA [
see
Clinical Studies (14.2)
]
1.3
Juvenile Rheumatoid Arthritis (JRA)
Celecoxib capsules are indicated for relief of the signs and symptoms of JRA in patients 2 years and older [
see
Clinical Studies (14.3)
]
1.4	Ankylosing Spondylitis (AS)
Celecoxib capsules are indicated for the relief of signs and symptoms of AS [
see
Clinical Studies (14.4)
]
1.5	Acute Pain (AP)
Celecoxib capsules are indicated for the management of AP in adults [
see
Clinical Studies (14.5)
]
1.6	Primary Dysmenorrhea (PD)
Celecoxib capsules are indicated for the treatment of PD [
see
Clinical Studies (14.5)
]
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, Cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia
Caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitis
Caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis
Caused by Haemophilus influenzae (including -lactamasen producing strains), Streptococcus pneumonia (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Use
and
DOSAGE AND ADMINISTRATION
.
Pharyngitis/Tonsillitis
Caused by
Streptococcus pyogenes
(see CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media
Caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumonia (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis
Caused by Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
1 INDICATIONS AND USAGE
Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitation of Use:
Repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Repaglinide tablets are a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
(1)
Limitation of Use:
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis
(1)
INDICATIONS AND USAGEClotrimazole and betamethasone dipropionate cream is indicated in
patients 17 years and older for the topical treatment of symptomatic
inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum, Trichophyton
mentagrophytes, and Trichophyton rubrum.
Effective treatment without the risks associated with topical corticosteroid use
may be obtained using a topical antifungal agent that does not contain a
corticosteroid, especially for noninflammatory tinea infections. The efficacy of
clotrimazole and betamethasone dipropionate cream for the treatment of
infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established. Several cases
of treatment failure of clotrimazole and betamethasone dipropionate cream in the
treatment of infections caused by Microsporum canis
have been reported.
1 INDICATIONS AND USAGE
Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam tablet is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older (1)
INDICATIONS AND USAGE
Cyclobenzaprine Hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine Hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine Hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
1 INDICATIONS AND USAGE
Capecitabine tablets is a nucleoside metabolic inhibitor indicated for:
Colorectal Cancer
adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1)
perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (1.1)
treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (1.1)
Breast Cancer
treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline-or taxane-containing chemotherapy is not indicated. (1.2)
treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. (1.2)
Gastric, Esophageal, or Gastroesophageal Junction Cancer
treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (1.3)
treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. (1.3)
Pancreatic Cancer
adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. (1.4)
1.1 Colorectal Cancer
Capecitabine tablets are indicated forthe:
adjuvanttreatmentofpatientswithStageIIIcoloncancerasasingleagentorasa component of a combination chemotherapy regimen.
perioperativetreatmentofadultswithlocallyadvancedrectalcancerasacomponentof chemoradiotherapy.
treatmentofpatientswithunresectableormetastaticcolorectalcancerasasingleagentor as a component of a combination chemotherapy regimen.
1.2 Breast Cancer
Capecitabine tablets are indicated for the:
treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxanecontaining chemotherapy is not indicated.
treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy.
1.3 Gastric, Esophageal, or Gastroesophageal Junction Cancer
Capecitabine tablets are indicated for the:
treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen.
treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.
1.4 PancreaticCancer
Capecitabine tablets areindicatedfortheadjuvanttreatmentofadultswithpancreaticadenocarcinomaasa component of a combination chemotherapy regimen.
INDICATIONS AND USAGE
For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
INDICATIONS AND USAGE
Ergomar is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia".
INDICATIONSAND USAGE
14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
1 INDICATIONS AND USAGE
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/dL) hypertriglyceridemia.
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 TG-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.
Omega-3-acid ethyl esters, USP is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia. (1)
Limitations of Use:
3.The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. (1)
4.The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined. (1)
1 INDICATIONS AND USAGE
AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [see Clinical Studies (14)].
Limitations of Use
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [see Warnings and Precautions (5.14)].
AMZEEQ is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. (1)
Limitations of Use
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated. (5.14)
1 INDICATIONS AND USAGE
Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Gram-positive bacteria
Corynebacterium species*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumonia
Streptococcus (Groups C/F)
Streptococcus (Group G)
Viridans group streptococci*
Gram-negative bacteria
Acinetobacter lwoffii*
Haemophilus influenzae
Serratia marcescens*
* Efficacy for this organism was studied in fewer than 10 infections.
Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Gram-positive bacteria
Corynebacterium species*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumonia
Streptococcus (Groups C/F)
Streptococcus (Group G)
Viridans group streptococci*
Gram-negative bacteria
Acinetobacter lwoffii*
Haemophilus influenzae
Serratia marcescens*
* Efficacy for this organism was studied in fewer than 10 infections (1)
INDICATIONS & USAGE SECTION
Metaxalone tabletsare indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.