um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Albuterol Inhalation Aerosol is indicated for the prevention and relief of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exercise induced bronchospasm in patients 4 years of age and older.
Albuterol Inhalation Aerosol can be used with or without concomitant steroid therapy.
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 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 tablets are 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 tablets are 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). 1
as 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:
LDL-C remains 190 mg/dL or
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 tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson Types I and V).
INDICATIONS AND USAGE
I. Stable Angina:
Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers.
II. Hypertension:
Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Bexarotene capsule is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. (1)
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Upper respiratory tract infections caused by
Streptococcus pyogenes,Streptococcus pneumoniaeand
Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.
Lower respiratory tract infections caused by
Streptococcus pyogenes,Streptococcus pneumoniae,Mycoplasma pneumoniae(Eaton agent, and
Klebsiella sp
.)
Skin and soft tissue infections caused by
Streptococcus pyogenes,Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)
Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
Psittacosis caused by
Chlamydophila psittaci.
Infections caused by
Chlamydia trachomatissuch as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.
Granuloma inquinale caused by
Klebsiella granulomatis.
Relapsing fever caused by
Borrelia sp.
Bartonellosis caused by
Bartonella bacilliformis.
Chancroid caused by
Hemophilus ducreyi.
Tularemia caused by
Francisella tularensis.
Plaque caused by
Yersinia pestis.
Cholera caused by
Vibrio cholerae.
Brucellosis caused by
Brucellaspecies (tetracycline may be used in conjunction with an aminoglycoside).
Infections due to
Campylobacter fetus.
As adjunctive therapy in intestinal amebiasis caused by
Entamoeba histolytica.
Urinary tract infections caused by susceptible strains of
Escherichia coli,Klebsiella, etc.
Other infections caused by susceptible gram-negative organisms such as
E. coli,Enterobacter aerogenes,Shigella sp
.,Acinetobacter sp
.,Klebsiella sp.
, and
Bacteroides sp.
In severe acne, adjunctive therapy with tetracycline may be useful.
When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:
Syphilis and yaws caused by
Treponema pallidumand
pertenue, respectively,
Vincent's infection caused by
Fusobacterium fusiforme,
Infections caused by
Neisseria gonorrhoeae,
Anthrax caused by
Bacillus anthracis,
Infections due to
Listeria monocytogenes,
Actinomycosis caused by
Actinomycesspecies,
Infections due to
Clostridiumspecies.
INDICATIONS AND USAGE
Lotensin is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
In using Lotensin, 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. Available data are insufficient to show that Lotensin does not have a similar risk (see WARNINGS).
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.
1 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 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.
Ezetimibe tablets are an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to:
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (
1.1)
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (
1.1)
Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (
1.2)
Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (
1.3)
Limitations of Use (
1.4)
The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1 Primary Hyperlipidemia
Monotherapy
Ezetimibe tablets, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with HMG-CoA Reductase Inhibitors (Statins)
Ezetimibe tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with Fenofibrate
Ezetimibe tablets, administered in combination with fenofibrate, are indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.
1.2 Homozygous Familial Hypercholesterolemia (HoFH)
The combination of ezetimibe tablets and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Homozygous Sitosterolemia
Ezetimibe tablets are indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
1.4 Limitations of Use
The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
INDICATIONS AND USAGE
Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
1 INDICATIONS AND USAGE
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
RAVICTI is a nitrogen-binding agent indicated for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements. (1)
Limitations of Use:
RAVICTI is not indicated for treatment of acute hyperammonemia in patients with UCDs. (1)
Safety and efficacy for treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established. (1)
Limitations of Use:
RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels.
The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.
1 INDICATIONS AND USAGE
Yaz is an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
1.1 Oral Contraceptive
Yaz is indicated for use by women to prevent pregnancy.
1.2 Premenstrual Dysphoric Disorder (PMDD)
Yaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Yaz for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Yaz has not been evaluated for the treatment of premenstrual syndrome (PMS).
1.3 Acne
Yaz is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Yaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
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
For the treatment of moderate to severe pain not responsive to non-narcotic
analgesics.
For detoxification treatment of opioid addiction (heroin or other
morphine-like drugs).
For maintenance treatment of opioid addiction (heroin or other morphine-like
drugs), in conjunction with appropriate social and medical services.
NOTE
Outpatient maintenance and outpatient detoxification treatment may be
provided only by Opioid Treatment Programs (OTPs) certified by the Federal
Substance Abuse and Mental Health Services Administration (SAMHSA) and
registered by the Drug Enforcement Administration (DEA). This does not preclude
the maintenance treatment of a patient with concurrent opioid addiction who is
hospitalized for conditions other than opioid addiction and who requires
temporary maintenance during the critical period of his/her stay, or of a
patient whose enrollment has been verified in a program which has been certified
for maintenance treatment with methadone.
1 INDICATIONS AND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia [see CLINICAL STUDIES (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for:
Schizophrenia (14.1)
INDICATIONS AND USAGE
GYNAZOLE
1 Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES).
Note: GYNAZOLE
1 Butoconazole Nitrate Vaginal Cream USP, 2% is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established (see PRECAUTIONS - Pregnancy).
INDICATIONSAND USAGE
Fluticasone Propionate Cream, USP 0.05%is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate Cream, USP 0.05%may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of Fluticasone Propionate Cream, USP 0.05%in pediatric patients below 3 months of age have not been established.
Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
Postherpetic neuralgia in adults
(
1)
Adjunctive therapy in the treatment of
partial onset seizures, with and without secondary generalization, in
adults and pediatric patients 3 years and older with epilepsy
(
1)
Gabapentin Tablets, USP is indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset
seizures, with and without secondary generalization, in adults and
pediatric patients 3 years and older with epilepsy
1 INDICATIONS AND USAGE
Dichlorphenamideis indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
Dichlorphenamideis an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants (1)
1 INDICATIONS AND USAGE
PANDEL (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.
PANDEL (hydrocortisone probutate) Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older. (1)
Hypertension
Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate 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 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 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 does not have a similar risk (see WARNINGS, NEUTROPENIA/AGRANULOCYTOSIS).
In considering use of enalapril maleate, 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).
INDICATIONS AND USAGE
Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management:
epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration
Pediatric and Adolescent Patients
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients (see WARNINGS). For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.