um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see
CLINICAL PHARMACOLOGY - Susceptibility Test Methods
).
Nafcillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus, therapy should not be continued with Nafcillin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection 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.
INDICATIONS & USAGE SECTION
Hypertension
Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Atrial Fibrillation
Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
Myocardial Infarction
Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Migraine
Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
Essential Tremor
Propranolol hydrochloride tablets are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets, USP causes a reduction in the tremor amplitude but not in the tremor frequency. Propranolol hydrochloride tablets are not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Propranolol hydrochloride tablets improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma
Propranolol hydrochloride tablets are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
INDICATIONS:
This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
INDICATIONS ANDUSAGE
Benzonatate is indicated for the symptomatic relief of cough.
INDICATIONS AND USAGE
Severe Recalcitrant Nodular Acne
Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Severe, by definition,2 means many as opposed to few or several nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane is indicated only for those female patients who are not pregnant, because Zenatane can cause severe birth defects (see
BOXED
CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see
WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure
).
INDICATIONS AND USAGE
Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days).For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules, USP should be used for short periods of time (7 to 10 days).The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
1 INDICATIONS AND USAGE
Roflumilast tablets are 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 tablets are not a bronchodilator and are not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.
Roflumilast tablets are 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 tablets are not a bronchodilator and are not indicated for the relief of acute bronchospasm. (1, 14)
Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. (2, 14)
1 INDICATIONS AND USAGE
BREVIBLOC injection is a beta adrenergic blocker indicated for the short-term treatment of:
Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heartrate in noncompensatory sinus tachycardia (1.1)
Control of perioperative tachycardia and hypertension (1.2)
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
BREVIBLOC (Esmolol Hydrochloride) is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. BREVIBLOC is also indicated in noncompensatory sinus tachycardia where, in the physician's judgment, the rapid heart rate requires specific intervention. BREVIBLOC is intended for short-term use.
1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension
BREVIBLOC (Esmolol Hydrochloride) is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician's judgment such specific intervention is considered indicated.
Use of BREVIBLOC to prevent such events is not recommended.
Chlorhexidine Gluconate Solution, 4%
Drug Facts
Active ingredient
Chlorhexidine Gluconate 4% solution
Purpose
Antiseptic
Uses
surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing
skin wound and general skin cleansing
Warnings
For external use only.
Do not use
if you are allergic to chlorhexidine gluconate or any other ingredients
in contact with meninges
in the genital area
as a preoperative skin preparation of the head or face
When using this product
keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums.
if solution should contact these areas, rinse out promptly and thoroughly with water
wounds which involve more than the superficial layers of the skin should not be routinely treated
repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin
Stop use and ask a doctor
if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
Keep out of reach of children
if swallowed, get medical help or contact a Poison Control Center right away.
Directions
use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.
Surgical hand scrub:
wet hands and forearms with water
scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces
a separate nail cleaner may be used
rinse thoroughly
wash for an additional 3 minutes with 5 ml of product and rinse under running water
dry thoroughly
Healthcare personnel handwash:
wet hands with water
dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
rinse and dry thoroughly
Patient preoperative skin preparation:
apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin wound and general skin cleaning:
thoroughly rinse the area to be cleaned with water
apply the minimum amount of product necessary to cover the skin or wound area and wash gently
rinse again thoroughly
Other information
store at 20-25C (68-77F)
avoid excessive heat above 40C (104F)
Inactive ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Piroxicam Capsules USP and other treatment options before deciding to use Piroxicam Capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Piroxicam Capsules USP is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
1 INDICATIONS AND USAGE
Paroxetine extended-release tablets are indicated in adults for the treatment of:
Major depressive disorder (MDD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):
Major Depressive Disorder (MDD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Premenstrual Dysphoric Disorder (PMDD)
1 INDICATIONS AND USAGE
SUPRAX (cefixime) is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections:
Uncomplicated Urinary Tract Infections (
1.1)
Otitis Media (
1.2)
Pharyngitis and Tonsillitis (
1.3)
Acute Exacerbations of Chronic Bronchitis (
1.4)
Uncomplicated Gonorrhea (cervical/urethral) (
1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SUPRAX and other antibacterial drugs, SUPRAX should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.6)
1.1 Uncomplicated Urinary Tract Infections
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of
Escherichia coli and
Proteus mirabilis.
1.2 Otitis Media
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of
Haemophilus influenzae,
Moraxella catarrhalis, and
Streptococcus pyogenes. (Efficacy for
Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)
Note: For patients with otitis media caused by
Streptococcus pneumoniae, overall response was approximately 10% lower for cefixime than for the comparator
[see Clinical Studies (
14)].
1.3 Pharyngitis and Tonsillitis
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of
Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of
Streptococcus pyogenes infections. SUPRAX is generally effective in the eradication of
Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of SUPRAX in the subsequent prevention of rheumatic fever is not available.)
1.4 Acute Exacerbations of Chronic Bronchitis
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of
Streptococcus pneumoniae and
Haemophilus influenzae.
1.5 Uncomplicated Gonorrhea (cervical/urethral)
SUPRAX is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of
Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).
1.6 Usage
To reduce the development of drug resistant bacteria and maintain the effectiveness of SUPRAX and other antibacterial drugs, SUPRAX should be used only to treat 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.
1. INDICATIONS AND USAGE
Iloperidone tablets are an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. (1,14) In choosing among treatments, prescribers should consider the ability of iloperidone tablets to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate iloperidone tablets slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration. (2,5,14)
Iloperidone tablets are indicated for the treatment of schizophrenia in adults.When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that iloperidone is associated with prolongation of the QTc interval [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether iloperidone tablets will cause torsade de pointes or increase the rate of sudden death is not yet known.
Patients must be titrated to an effective dose of iloperidone tablets. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia [see Dosage and Administration (2.1) and Clinical Studies (14)].
INDICATIONS AND USAGE
Azelastine Hydrochloride Ophthalmic Solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
INDICATIONS AND USAGE
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
Respiratory Tract Infections caused by
S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing),
H. influenzae and Group A beta-hemolytic Streptococci.
Bacterial Meningitis caused by
E. coli, Group B Streptococci, and other Gram-negative bacteria (
Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.
Septicemia and Endocarditis caused by susceptible Gram-positive organisms including
Streptococcus spp., penicillin-G-susceptible staphylococci and enterococci. Gram-negative sepsis caused by
E. coli, Proteus mirabilis and
Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.
Urinary Tract Infections caused by sensitive strains of
E. coli and
Proteus mirabilis.
Gastrointestinal Infections caused by
Salmonella typhi (typhoid fever), other
Salmonella spp. and
Shigella spp. (dysentery) usually respond to oral or intravenous therapy.
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.
It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. Indicated surgical procedures should be performed.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin 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.
INDICATIONS AND 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 hyperlipidemia. Niacin 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.
Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Limitations of Use
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH)
[see
Warnings and Precautions (5.1)]
.
Niacin extended-release tablets contain extended-release niacin (nicotinic acid), and are indicated:
To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. (
1)
To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. (
1)
In combination with a bile acid binding resin:
Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. (
1)
As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. (
1)
To reduce TG in adult patients with severe hypertriglyceridemia. (
1)
Limitations of use:
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (
5.1).
1. INDICATIONS AND USAGE
Warfarin sodium tablets, are indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets are vitamin K antagonist indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (1)
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (1)
Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (1)
Limitation of Use
Warfarin sodium tablets, have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. (1)