um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP 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, USP 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 musclespasm associated with acute, painful musculoskeletal conditions is generally of short duration and specifictherapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticityassociated with cerebral or spinal cord disease, or in children with cerebral palsy.
INDICATIONS AND USAGE
RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies.
Unlike anti-inflammatory drugs, RIDAURA does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months.
When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage.
In controlled clinical trials comparing RIDAURA with injectable gold, RIDAURA was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findings when deciding on the use of RIDAURA in patients who are candidates for chrysotherapy.
1.3 Second-Line Treatment
Anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole.
INDICATIONS AND USAGE:
Superficial
Dermotophyte
Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton
rubrum
,
Trichophyton
mentagrophytes
,
Epidermophyton
floccosum
. SeborrheicDermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.
INDICATIONS AND USAGE
Vancomycin Hydrochloride for Injection USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin Hydrochloride for Injection USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin Hydrochloride for Injection USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by
S. viridans or
S. bovis. For endocarditis caused by enterococci (e.g.,
E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside.
Vancomycin Hydrochloride for Injection USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by
S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection 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.
The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by
C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.
1 INDICATIONS AND USAGE
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
Doxercalciferol Injection is a synthetic vitamin D2 analog:
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. (1)
DIRECTIONS FOR USE:
For best viewing and patient comfort, the Lissamine Green impregnated tip should be moistened with one or two drops of sterile irrigating or saline solution before application. Apply moistened tip to conjunctiva or fornix as required. It is recommended that the patient blink several times after application.
1. Hold package in middle and tear down toward sterile strip
2. Turn over and tear down from other side, taking care not to tear the sterile strip.
3. Grasp each end of package firmly as shown, without touching the sterile strip, and pull apart.
HUB_GreenGlo Instructions For Opening Strips
INDICATIONS AND USAGE
Cardiac Arrhythmias
Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia.
1. Supraventricular arrhythmiasIntravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including WolffParkinsonWhite syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia.
2. Ventricular tachycardiasWith the exception of those induced by catecholamines or digitalis, propranolol is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, propranolol may be considered. If, after consideration of the risks involved, propranolol is used, it should be given intravenously in low dosage and very slowly, as the failing heart requires some sympathetic drive for maintenance of myocardial tone (see
DOSAGE AND ADMINISTRATION
). Some patients may respond with complete reversion to normal sinus rhythm, but reduction in ventricular rate is more likely. Ventricular arrhythmias do not respond to propranolol as predictably as do the supraventricular arrhythmias.Intravenous propranolol is indicated for the treatment of persistent premature ventricular extrasystoles that impair the wellbeing of the patient and do not respond to conventional measures.
3. Tachyarrhythmias of digitalis intoxicationIntravenous propranolol is indicated to control ventricular rate in life-threatening digitalis-induced arrhythmias. Severe bradycardia may occur (see
OVERDOSAGE
).
4. Resistant tachyarrhythmias due to excessive catecholamine action during anesthesiaIntravenous propranolol is indicated to abolish tachyarrhythmias due to excessive catecholamine action during anesthesia when other measures fail. These arrhythmias may arise because of release of endogenous catecholamines or administration of catecholamines. All general inhalation anesthetics produce some degree of myocardial depression. Therefore, when propranolol is used to treat arrhythmias during anesthesia, it should be used with extreme caution, usually with constant monitoring of the ECG and central venous pressure (see
WARNINGS
).
INDICATIONS AND USAGE
Clobetasol propionate cream USP is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS AND USAGE
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 Cold urticaria Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
1	INDICATIONS AND USAGE
NUCYNTA (tapentadol) is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
NUCYNTA is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1)
1 INDICATIONS AND USAGE
Tetrabenazine is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington's disease (1)
Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease.
1 INDICATIONS AND USAGE
Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (1)
1 INDICATIONS AND USAGE
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for
Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1)
Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (14.1)
Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2)
Efficacy was established in two 6-week trials in adult patients. (14.2)
1.1 Schizophrenia
Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1)].
The efficacy of paliperidone extended-release tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
1.2 Schizoaffective Disorder
Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (14.2)].
The efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults.
INDICATIONS AND USAGE
Metformin hydrochloride extended - release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to:
Reduce TG in patients with severe hypertriglyceridemia (1.1).
Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia (1.2).
Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Treatment of Severe Hypertriglyceridemia
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied.
1.2 Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
1.3 Limitations of Use
Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
1.4 General Considerations for Treatment
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
1 INDICATIONS & USAGE
Efavirenz, emtricitabine and tenofovir disoproxilfumarate tablet is indicated as a complete regimen or in combinationwith other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets is a three-drug combination of efavirenz (EFV), a nonnucleoside reverse transcriptase inhibitor, and emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. (1)
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of Etodolac Tablets and other treatment options before deciding to use Etodolac Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Etodolac Tablets are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
Osteoarthritis
Rheumatoid arthritis
For the management of acute pain
INDICATIONS AND USAGE
ATACAND HCT is indicated for the treatment of hypertension.
This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older.
Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. (
1)
INDICATIONS AND USAGE
Megatope (Iodinated I 131 Albumin Injection) is indicated for use in determinations of
total blood and plasma volumes, cardiac output, cardiac and pulmonary blood
volumes and circulation times, and in protein turnover studies, heart and great vessel
dilineation, localization of the placenta, and localization of celebral neospasms.
1 INDICATIONS AND USAGE
Almotriptan tablets are a 5HT1B/1D receptor agonist (triptan) indicated for:
Acute treatment of migraine attacks in adults with a history of migraine with or without aura (1.1)
Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more (1.1)
Important Limitations:
Use only after a clear diagnosis of migraine has been established (1.2)
In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established (1.2)
Not intended for the prophylactic therapy of migraine (1.2)
Not indicated for the treatment of cluster headache (1.2)
1.1 Acute Treatment of Migraine Attacks
Adults
Almotriptan tablets (almotriptan malate) are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.
Adolescents Age 12 to 17 Years
Almotriptan tablets are indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
1.2 Important Limitations
Almotriptan tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with almotriptan tablets, the diagnosis of migraine should be reconsidered before almotriptan tablets are administered to treat any subsequent attacks.
In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see Contraindications (4.7)].
Safety and effectiveness of almotriptan tablets have not been established for cluster headache which is present in an older, predominantly male population.
1
INDICATIONS AND USAGE
Diclofenac Potassium is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
Limitations of Use:
Diclofenac Potassium is not indicated for the prophylactic therapy of migraine.
The safety and effectiveness ofDiclofenac Potassium have not been established for cluster headache, which is present in an older, predominantly male population.
Diclofenac Potassium is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older (1)
Limitations of Use (
1
):
Diclofenac Potassium is not indicated for the prophylactic therapy of migraine
Safety and effectiveness of Diclofenac Potassium not established for cluster headache, which is present in an older, predominantly male population
INDICATIONS AND USAGE
Clonidine Transdermal System is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
1 INDICATIONS AND USAGE
OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [
see Use in Specific Populations (
8.4)
].
Contraindicated in pediatric patients less than 6 years of age [
see Contraindications (
4)
].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [
see Warnings and Precautions (
5.1)
], reserve OBREDON for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
OBREDON is a combination of hydrocodone, an opioid agonist; and guaifenesin, an expectorant, indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older. (
1)
Important Limitations of Use: (
1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OBREDON for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
INDICATIONS AND USAGE
To reduce the development of drug resistant bacteria and maintain the effectiveness of Suprax (cefixime) chewable tablets and other antibacterial drugs, Suprax (cefixime) chewable tablets 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Suprax (cefixime) chewable tablets are indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis, (most of which are beta-lactamase positive) and S. pyogenes*.
Note: For information on otitis media caused by Streptococcus pneumoniae, see
CLINICAL STUDIES section.
Pharyngitis and Tonsillitis, caused by S. pyogenes.
Note: Penicillin is the usual drug of choice in the treatment of S. pyogenes infections, including the prophylaxis of rheumatic fever. Suprax (cefixime) chewable tablets are generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Suprax (cefixime) chewable tablets in the subsequent prevention of rheumatic fever are not available.
Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains).
Uncomplicated gonorrhea (cervical/urethral), caused by Neisseria gonorrhoeae (penicillinase-and non-penicillinase- producing strains).
Appropriate cultures and susceptibility studies should be performed to determine the causative organism and its susceptibility to cefixime; however, therapy may be started while awaiting the results of these studies. Therapy should be adjusted, if necessary, once these results are known.
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.