um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see
CLINICAL PHARMACOLOGY
).
Because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.
There is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see
CLINICAL PHARMACOLOGY
).
Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) inMEN ONLY.
Efficacy in bitemporal recession has not been established.
Finasteride tablets are not indicated for use in women.
INDICATIONS & USAGE
Armour Thyroid tablets are indicated:
As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (SeeWARNINGS).As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer.
INDICATIONS AND USAGE
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
INDICATIONS AND USAGE
HypertensionEnalapril 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 FailureEnalapril 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 DysfunctionIn
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.)
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
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated
for the short-term (five days or less) management of acute pain.
1 INDICATIONS AND USAGE
Clopidogrel tablets are P2Y
12platelet inhibitor indicated for:
Acute coronary syndrome
For patients with nonST-segment elevation ACS (unstable angina [UA]/nonST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (
1.1)
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (
1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (
1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with nonST-segment elevation ACS (unstable angina [UA]/nonST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin.
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
Indications and Usage
Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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.
Traveler's Diarrhea in Adults:
For the treatment of travele's diarrhea due to susceptible strains of enterotoxigenic
E. coli
.
1 INDICATIONS AND USAGE
Irinotecan Hydrochloride Injection, USP is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
Irinotecan Hydrochloride Injection, USP is a topoisomerase inhibitor indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
INDICATIONS AND USAGE
Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by
Streptococcus
pneumoniae and
Streptococcus
pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexincapsules aregenerally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsulesin the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to
Streptococcus
pneumoniae,
Haemophilus
influenzae,
Staphylococcus aureus, Streptococcus pyogenes
, and
Moraxella catarrhalis
Skin and skin structure infections caused by
Staphylococcus aureus and/or
Streptococcus pyogenes
Bone infections caused by
Staphylococcus
aureus and/or
Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by
Escherichia coli,
Proteus mirabilis, and
Klebsiella pneumoniae
Note
Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin 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
Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation
).
Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
Naproxen as NAPROXEN Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patients weight.
Naproxen as NAPROXEN, NAPROXEN SODIUM and NAPROXEN SODIUM DS is also indicated:
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dysmenorrhea
EC-NAPROXEN is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see
CLINICAL PHARMACOLOGY
,
DOSAGE AND ADMINISTRATION
).
1	INDICATIONS AND USAGE
Gemcitabine is a nucleoside metabolic inhibitor indicated:
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1)
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2)
in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3)
as a single agent for the treatment of pancreatic cancer. (1.4)
1.1	Ovarian Cancer
Gemcitabine in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
1.2	Breast Cancer
Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
1.3	Non-Small Cell Lung Cancer
Gemcitabine in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
1.4	Pancreatic Cancer
Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with fluorouracil.
1 INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H 1-receptor antagonist indicated for:
The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2)
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3)
1.1 Seasonal Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
1.2 Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older.
1.3 Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
1 INDICATIONS AND USAGE
LEXIVA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
The following points should be considered when initiating therapy with LEXIVA plus ritonavir in protease inhibitor-experienced patients:
The protease inhibitor-experienced patient study was not large enough to reach a definitive conclusion that LEXIVA plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)].
Once-daily administration of LEXIVA plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients.
LEXIVA is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for:
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression)
[see
Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression)
[see
Clinical Studies (14.2)].
Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of:
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy
(1,
14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate
(1,
14.2)
INDICATIONS AND USAGE
Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to
Trichophyton rubrum,
Trichophyton mentagrophytes,
Epidermophyton floccosum, and
Microsporum canis; candidiasis (moniliasis) due to
Candida albicans; and tinea (pityriasis) versicolor due to
Malassezia furfur.
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species,and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.
INDICATIONS AND USAGE
Rifabutin capsules USP are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
1 INDICATIONS ANDUSAGE
Nateglinide Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:Nateglinide Tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Nateglinide Tablets are a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis (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 tablet 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)]
.
INDICATIONS AND USAGE:
Clobetasol propionate cream is a super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Warnings
For external use only
When using this product avoid contact with the eyes.
Directions
Apply to affected area no more than 3 to 4 times daily.
Inactive ingredients
Butylene Glycol, C12-15 Alkyl Benzoate, Carbomer, Glyceryl Stearate, Helianthuus annus (sunflower) Seed Oil, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Ploysorbate 80, Sodium Hydroxide, Sorbitol, Tocopheryl Acetate, Water (Aqua, Eau)
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
INDICATIONS AND USAGE
Nitrofurantoin oral suspension is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
Nitrofurantoin oral suspensionis not indicated for the treatment of pyelonephritis or perinephric abscesses.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin oral suspension are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin oral suspension, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin oral suspension, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.