um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Carbidopa and levodopa orally disintegrating tablets are indicated in the treatment of the symptoms of idiopathic Parkinsons disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Carbidopa and levodopa orally disintegrating tablets are indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response, and with supplemental pyridoxine (vitamin B6).
In some patients, a somewhat smoother antiparkinsonian effect results from therapy with carbidopa and levodopa than with levodopa. However, patients with markedly irregular (on-off) responses to levodopa have not been shown to benefit from carbidopa and levodopa therapy.
Although the administration of carbidopa permits control of parkinsonism and Parkinsons disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.
Certain patients who responded poorly to levodopa have improved when carbidopa and levodopa was substituted. This is most likely due to decreased peripheral decarboxylation of levodopa which results from administration of carbidopa rather than to a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in parkinsonian syndromes.
In considering whether to give carbidopa and levodopa orally disintegrating tablets to patients already on levodopa who have nausea and/or vomiting, the practitioner should be aware that, while many patients may be expected to improve, some do not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa, about half of the patients with nausea and/or vomiting on levodopa improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate tablet is indicated for the treatment of hypertension.
Enalapril maleate tablet is 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 tablet is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablet 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 tablet 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 tablet does not have a similar risk (see
WARNINGS).
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
).
1 INDICATIONS AND USAGE
Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney or heart transplants, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. (1.1)
1.1Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplant [see Clinical Studies (14.2)] and heart transplant [see Clinical Studies (14.3)], and pediatric patients receiving allogeneic liver transplants [see Clinical Studies (14.2)] in combination with other immunosuppressants.
Additional pediatric use and lung transplant information is approved for Astellas Pharma US, Inc.s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. (
1)
INDICATIONS AND USAGE
Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
Usage in Pregnancy:
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
INDICATIONS AND USAGE
A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4
Sodium Fluoride 5000 ppm 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription should be used once daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
INDICATIONS & USAGE SECTION
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
Indications and Usage
Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
1 INDICATIONS AND USAGE
Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Limitations of Use
Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Roflumilast is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. (1, 14)
Limitations of Use:
Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. (1, 14)
INDICATIONS AND USAGE:
Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
INDICATIONS AND USAGE
Ranitidine oral solution is indicated in:
Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg b.i.d.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg q.i.d.
Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
1 INDICATIONS AND USAGE
Moxifloxacin Ophthalmic Solution USP is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus luteus*, Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*, Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia coli*, Haemophilus influenzae, Klebsiella pneumoniae*, Propionibacterium acnes, Chlamydia trachomatis*
*Efficacy for this organism was studied in fewer than 10 infections. (1)
Moxifloxacin ophthalmic solution USP is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerococcus viridans*
Corynebacterium macginleyi*
Enterococcus faecalis*
Micrococcus luteus*
Staphylococcus arlettae*
Staphylococcus aureus
Staphylococcus capitis
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus saprophyticus*
Staphylococcus warneri*
Streptococcus mitis*
Streptococcus pneumoniae
Streptococcus parasanguinis*
Escherichia coli*
Haemophilus influenza
Klebsiella pneumoniae*
Propionibacterium acnes
Chlamydia trachomatis*
*Efficacy for this organism was studied in fewer than 10 infections.
1 INDICATIONS AND USAGE
Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
Epinephrine injection is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.
Epinephrine injection is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Epinephrine injection is a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis.
INDICATIONS AND USAGE:
Cisatracurium Besylate Injection is an intermediate-onset/intermediate-duration neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU.
1 INDICATIONS AND USAGE
Raloxifene hydrochloride tablet, USP is an estrogen agonist/antagonist indicated for:
Treatmentof osteoporosis in postmenopausal women. (1.1)
1.1 Treatment of Osteoporosis in Postmenopausal Women
Raloxifene hydrochloride tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women [see Clinical Studies (14.1)].
CLINICAL PHARMACOLOGY
Enter section text here
MECHANISM OF ACTION
PharmaPure Rx Lidocaine HCl 3% Cream releases
lidocaine from a mild acidic vehicle to stabilize the neuronal membrane
by inhibiting the ionic fluxes required for initiation and conduction
of impulses, thereby effecting local anesthetic action. A mild acidic
vehicle lowers pH to increase protection against alkaline irritations
and to provide a favorable environment for healing.
PHARMACOKINETICS
Lidocaine may be
absorbed following topical administration to mucous membranes, its rate
and extent of absorption depending upon the specific site of
application, duration of exposure, concentration, and total dosage. In
general, the rate of absorption of local anesthetic agents following
topical application occurs most rapidly after intratracheal
administration. Lidocaine is also well-absorbed from the
gastrointestinal tract, but little intact drug appears in the
circulation because of biotransformation of the liver.
Lidocaine is
metabolized rapidly by the liver, and metabolites and unchanged drug
are excreted by the kidneys. Biotransformation includes oxidative
N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and
conjungation. N-dealkylation, a major pathway of biotransformation,
yields the metabolites monoethylglycinexylidide and glycinexlidide. The
pharmacological/toxicological actions of these metabolites are similar
to, but less potent than, those of lidocaine. Approximately 90% of
lidocaine administered is excreted in the form of various metabolites,
and less than 10% is excreted unchanged. The primary metabolite in
urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The plasma
binding of lidocaine is dependent on drug concentration, and the
fraction bound decreases with increasing concentration. At
concentration of 1 to 4 g of free base per mL, 60 to 80 percent of
lidocaine is protein bound. Binding is also dependent on the plasma
concentration of the alpha-1-acid-glycoprotein. Lidocaine crosses the
blood-brain and placental barriers, presumably by passive diffusion.
Studies of lidocaine metabolism following intravenous bolus injections
have shown that the elimination half-life of this agent is typically
1.5 to 2 hours. Because of the rapid rate at which lidocaine is
metabolized, any condition that affects liver function may alter
lidocaine kinetics. The half-life may be prolonged two-fold or more in
patients with liver dysfunction. Renal dysfunction does not affect
lidocaine kinetics but may increase the accumulation of metabolites.
Factors such as acidosis and the use of CNS stimulants and depressants
affect the CNS levels of lidocaine required to produce overt systemic
effects. Objective adverse manifestations become increasingly apparent
with increasing venous plasma levels above 6 g free base per mL. In the
rhesus monkey arterial blood levels of 18-21 g/mL have been shown to be
threshold for convulsive activity.
INDICATIONS
Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
1 INDICATIONS AND USAGE
Skyla is indicated to prevent pregnancy for up to 3 years.
Replace the system after 3 years if continued use is desired.
Skyla is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 3 years. (1)
1 INDICATIONS AND USAGE
Potassium Chloride in Dextrose Injection is indicated as a source of water, electrolytes and calories.
Potassium Chloride in Dextrose Injection is indicated as a source of water, electrolytes and calories. (1)
INDICATIONS AND USAGE
Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside injection can be minimized.
Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery.
Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.
1 INDICATIONS AND USAGE
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)
Celecoxib is indicated
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [
see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [
see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [
see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [
see Clinical Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [
see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [
see Clinical Studies (14.5)]
1 INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)
1.1 Major Depressive Disorder
Escitalopram Tablets, USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least six months and which the person finds difficult to control. It must be associated with at least three of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1 INDICATIONS AND USAGE
Duloxetinedelayed-release capsules are indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major Depressive Disorder (MDD) in adults (1)
Generalized Anxiety Disorder (GAD) in adults and pediatric patients 7 years of age and older (1)
Diabetic Peripheral Neuropathic Pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults (1)
Chronic musculoskeletal pain in adults (1)
INDICATIONS AND USAGE
The use of metoclopramide tablets is
recommended for adults only. Therapy should not exceed 12 weeks in
duration.
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.
Diabetic Gastroparesis (Diabetic Gastric Stasis)
Metoclopramide tablets, are indicated for the relief of
symptoms associated with acute and recurrent diabetic gastric stasis. The usual
manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn,
persistent fullness after meals, and anorexia) appear to respond to
metoclopramide tablets within different time intervals. Significant relief of
nausea occurs early and continues to improve over a three-week period. Relief of
vomiting and anorexia may precede the relief of abdominal fullness by one week
or more.