um-ids/dailymed-annotations huggingface dataset:
INDICATIONS
AND USAGE
Carbinoxamine maleate
is effective for the symptomatic treatment of:
Seasonal and perennial allergic rhinitis.
Vasomotor
rhinitis.
Allergic conjunctivitis due to inhalant
allergens and foods.
Mild, uncomplicated allergic
skin manifestations of urticaria and angio-edema.
Dermatographism.
As therapy for anaphylactic
reactions
adjunctiveto epinephrine and other standard
measures after the acute manifestations have been controlled.
Amelioration of the severity of allergic reactions to
blood or plasma.
INDICATIONS AND USAGE
Naftin
Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms
Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans *
Efficacy for this organism in this organ system was studied in fewer than 10 infections.
,
Epidermophyton floccosum *
.
1 INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
Sinusitis
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Urinary Tract Infections
caused by beta-lactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension should not be used.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension 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.
Amoxicillin and clavulanate potassium for oral suspension is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a betalactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension should not be used. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
INDICATIONS AND USAGE
Haloperidol Injection, USP is indicated for the treatment of patients with schizophrenia.
1 INDICATIONS AND USAGE
Diclofenac potassium for oral solution 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 for oral solution is not indicated for the prophylactic therapy of migraine.
The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.
Diclofenac potassium for oral solution 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 for oral solution is not indicated for the prophylactic therapy of migraine
Safety and effectiveness of diclofenac potassium for oral solution not established for cluster headache, which is present in an older, predominantly male population
Indications and Usage
Cortifoam is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.
1 INDICATIONS AND USAGE
Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.
Sufentanil Citrate Injection is indicated for epidural administration:
as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.
Sufentanil Citrate Injection is an opioid agonist indicated:
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.
for epidural administration as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.
INDICATIONS & USAGE
Diltiazem Hydrochloride Injection is indicated for the following:
Atrial Fibrillation or Atrial Flutter
Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome.
Paroxysmal Supraventricular Tachycardia
Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection.
The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.
For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available.
In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours.
A 24-hour continuous infusion of diltiazem injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Hypotension, if it occurs, may be similarly persistent.
In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection.
In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.
Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.
1 INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for:
Treatment of schizophrenia (1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2)
Treatment of irritability associated with autistic disorder (1.3)
1.1 Schizophrenia
Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies
(14.1)].
1.2 Bipolar Mania
Monotherapy
Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years)
[see Clinical Studies (14.2)].
Adjunctive Therapy
Risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults
[see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4)].
1 INDICATIONSAND USAGE
Ranolazine extended-release tablets are indicated for the treatment of chronic angina.
Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Ranolazine is an antianginal indicated for the treatment of chronic angina. (1)
INDICATIONS & USAGE
Butalbital and acetaminophen capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
Oxcarbazepine tablets are indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics:
Monotherapy in the treatment of partial-onset seizures in children 416 years
Adjunctive therapy in the treatment of partial-onset seizures in children 216 years (
1)
INDICATIONS AND USAGE
Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis,
Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform,
Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis,
Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride tablets are indicated for the treatment of:
Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
Narcolepsy
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
1 INDICATIONS AND USAGE
HIV-1 Treatment (
1.1):
Emtricitabine and tenofovir disoproxil fumarate tablet is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 PrEP (
1.2):
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg
[see
Clinical Studies (14)]
.
1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP
[see
Dosage and Administration (2.2),
Warnings and Precautions (5.2)]
.
1 INDICATIONS AND USAGE
HIV-1 Treatment (
1.1)
Emtricitabine and tenofovir disoproxil fumarate tablets are a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
in combination with other antiretroviral agents for the treatment ofHIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 PrEP (
1.2):
Emtricitabine and tenofovir disoproxil fumarate tablets is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg
[see
Clinical Studies (14)]
.
1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)
Emtricitabine and tenofovir disoproxil fumarate tablets are indicatedin at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP
[see
Dosage and Administration (2.2),
Warnings and Precautions (5.2)]
.
1.1 Hypertension
Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Valsartan tablets.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Valsartan tablets may be used alone or in combination with other antihypertensive agents.
Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information.
INDICATIONS AND USAGE
Hydroquinone USP, 4% Time Release Cream is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration (such as chloasma, melasma, freckles, and senile lentigines) resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma.
INDICATIONS & USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
1.1 Prevention of Cardiovascular Disease
In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets, USP are indicated to:
reduce the risk of myocardial infarction (MI).reduce the risk of undergoing myocardial revascularization procedures.reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.
In patients with clinically evident CHD, pravastatin sodium tablet is indicated to:
reduce the risk of total mortality by reducing coronary death.reduce the risk of MI.reduce the risk of undergoing myocardial revascularization procedures.reduce the risk of stroke and stroke/transient ischemic attack (TIA).slow the progression of coronary atherosclerosis.
1.2 Hyperlipidemia
Pravastatin sodium tablet is indicated:
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).1as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
a. LDL-C remains
190 mg/dL or
b. LDL-C remains
160 mg/dL and:
there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors are present in the patient.
1.3 Limitations of Use
Pravastatin sodium has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).