um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Etodolac Capsules and Tablets, USP 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
Skin Repair Complex (Dimethicone Cream 5%)
Drug Facts
Active ingredient
Dimethicone 5.0%
Purpose
Skin Protectant
Uses
for the treatment and/or prevention of diaper rash
temporarily protects and helps relieve chapped or cracked skin
Warnings
For external use only
Do not use on
deep or puncture wounds
animal bites
serious burns
When using this product
do not get into eyes
Stop use and ask a doctor if
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
apply cream liberally as needed
Other information
protect from freezing
avoid excessive heat
Inactive ingredients
Aleurites moluccana seed oil,
Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, caprylyl glycol,
Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethiconecrosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex
[consisting of: bisabolol, calcium pantothenate (vitamin B
5),
Carthamus tinctorius (safflower)oleosomes, maltodextrin, niacinamide (vitamin B
3), pyridoxine HCl (vitamin B
6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate(vitamin E),
Zingiber officinale (ginger) root extract], PEG100stearate, pentaerythrityl tetraditbutylhydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate,stearic acid, triethanolamine.
1 INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (
1)
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
1 INDICATIONS AND USAGE
Gadobutrol injectionis a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates (1.1)
To assess the presence and extent of malignant breast disease in adult patients (1.2)
To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates (1.3)
To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary arterydisease (CAD). (1.4).
1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)
Gadobutrol injectionis indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
1.2 MRI of the Breast
Gadobutrol injectionis indicated for use with MRI in adult patients to assess the presence and extent of malignant breast disease.
1.3 Magnetic Resonance Angiography (MRA)
Gadobutrol injection is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease.
1.4 Cardiac MRI
Gadobutrol injection is indicated for use in cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim 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 empiric selection of therapy.
Urinary Tract Infections
For the treatment of urinary tract infections due to susceptible strains of the following organisms:
Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and
Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media
For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent.
Shigellosis
For the treatment of enteritis caused by susceptible strains of
Shigella flexneri and
Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis Carinii Pneumonia
For the treatment of documented
Pneumocystis carinii pneumonia and for prophylaxis against
Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing
Pneumocystis carinii pneumonia.
Travelers' Diarrhea in Adults
For the treatment of travelers' diarrhea due to susceptible strains of enterotoxigenic
E. coli.
INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders
3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY).
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.
The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).
1 INDICATIONS AND USAGE
Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam oral suspension is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. (1)
INDICATIONS AND USAGE
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) strains of the designated microorganisms in the conditions listed below:
Infections of the ear, nose, and throat - due to
Streptococcus spp. (- and - hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or H. influenzae.
Infections of the genitourinary tract - due to
E. coli, P. mirabilis, or
E. faecalis.
Infections of the skin and skin structure - due to
Streptococcus spp. (- and -hemolytic strains only),
Staphylococcus spp., or
E. coli.
Infections of the lower respiratory tract - due to
Streptococcus spp. (- and -hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to
N. gonorrhoeae (males and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Amoxicillin/Clarithromycin/Lansoprazole
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION
sections.)
Dual Therapy
Amoxicillin/Lansoprazole
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert,
MICROBIOLOGY
section.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION
sections.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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.
Indicated surgical procedures should be performed.
1 INDICATIONS AND USAGE
BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
BARACLUDE is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
1 INDICATIONS AND USAGE
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
INDICATIONS AND USAGE
Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
POVIDONE IODINE
Povidone-Iodine Swabsticks
For External Use Only
NDC# 67777-130-02
ACTIVE INGREDIENT
Active Ingredient.............................. Purpose
Povidone Iodine 10% v/v.................. Antiseptic
Purpose
First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
For preparation of the skin prior to surgery.
Helps reduce bacteria that can potentially cause skin infections.
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
As a first aid antiseptic for more than 1 week.
In the eyes.
Over large areas of the body.
ASK A DOCTOR BEFORE USE IF YOU HAVE
Deep puncture wounds
Animal bites
Serious burns
STOP USE
If irritation and redness develop
If condition persists for more than 72 hours, consult a physician.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center.
DIRECTIONS POVIDONE IODINE
Tear at notch, remove applicator, use only once.
As a first aid antiseptic
clean affected area
apply 1 to 3 times daily
may be covered with a sterile bandage, if bandaged let dry.
For preoperative patient skin preparation
clean area
apply to operative site prior to surgery using the applicator
OTHER INFORMATION
Store at room temperature.
Avoid excessive heat.
INDICATIONS & USAGE
For use as an
first aid antiseptic
pre-operative skin preperation
INACTIVE INGREDIENTS
Inactive ingredients: nonoxynol-9, water
PRINCIPAL DISPLAY PANEL
Povidone Iodine Swabsticks 1201 & 1202
povidone-iodine swabs
Indications and Usage Section
NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity
1 INDICATIONS AND USAGE
Fenofibrate tablets are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (
1.1).
For treatment of adult patients with severe hypertriglyceridemia (
1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[see
Warnings and Precautions (5.1)
].
INDICATIONS AND USAGE
Lac-Hydrin Cream is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.
1	INDICATIONS AND USAGE
Bivalirudin is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
Bivalirudin is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).(1)
1 INDICATIONS & USAGE
Quetiapineis an atypical antipsychotic indicated forthetreatmentof:
Schizophrenia(1.1)
BipolarIdisordermanicepisodes(1.2)
Bipolardisorder,depressiveepisodes(1.2)
1.1 Schizophrenia
Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)
].
1.2 Bipolar Disorder
Quetiapineis indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see
Clinical Studies
(14.2)
].
Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see
Clinical Studies
(14.2)
].
Quetiapineis indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see
Clinical Studies
(14.2)
].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1.1 Schizophrenia
Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.1)].
1.2 Bipolar Disorder
Quetiapine tablets are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see CLINICAL STUDIES (14.2)].
Quetiapine tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see CLINICAL STUDIES (14.2)].
Quetiapine tablets are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.2)].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
INDICATIONS & USAGE SECTION
Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows:
Effective: Management of nausea and vomiting, and dizziness associated with motion sickness.
Final classification of the less than effective indications requires further investigation.
1	INDICATIONS AND USAGE
ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system [See Dosage and Administration (2).]
Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1
106/L for up to 5 days at 20-24 C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)] [See Clinical Studies (14).]
ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system. Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% Isoplate and 35% plasma.
Platelets in ISOPLATE SOLUTION can be stored at a concentration range of 0.7 to 2.1
106/L for up to 5 days at 20-24 C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)]. (1)
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 PreviDent 5000 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste 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
Guanfacine tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.