um-ids/dailymed-annotations huggingface dataset:
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 pneumoniae and 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
staphylococcalinfections.)
Infections
caused by rickettsia including Rocky Mountain spotted fever, typhus group
infections, Q fever, rickettsialpox.
Psittacosis
caused by Chlamydophila psittaci.
Infections
caused by Chlamydia trachomatis such 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, Shigellasp., 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 pallidum and 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 Actinomyces
species,
Infections
due to Clostridium
species.
INDICATIONS AND USAGE
Intravenous Verapamil HCI is indicated for the following:Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes).In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a fast ventricular rate respond with a decrease in ventricular rate of at least 20%. Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection.Because a small fraction (<1%) of patients treated with verapamil respond with life-threatening adverse responses (rapid ventricular rate In atrial flutter/fibrillation and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole - see Contraindications and Warnings), the initial use of intravenous verapamil should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including DC-cardioversion capability (see Suggested Treatment of Acute Cardiovascular Adverse Reactions). As familiarity with the patient's response is gained, use in an office setting may be acceptable.Cardioversion has been used safely and effectively after intravenous verapamil.
1 INDICATIONS AND USAGE
Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Mesalamine suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. (1)
1 INDICATIONS AND USAGE
AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of POME and anaphylaxis.
Limitations of Use
Safety and efficacy of AVEEDin men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of AVEEDin males less than 18 years old have not been established [see Use in Specific Populations (
8.4
)].
Aveed (testosterone undecanoate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) (1)
Hypogonadotropic hypogonadism (congenital or acquired) (1)
Aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risksofpulmonaryoil microembolism and anaphylaxis (1).
Limitations of Use
Safety and efficacy of Aveed in men with age-related hypogonadism have not been established (1).
Safety and efficacy of Aveed in males less than 18 years old have not been established (1, 8.4).
INDICATIONS AND USAGE
Dacarbazine for Injection, USP is indicated in the treatment of metastatic malignant melanoma. In addition, dacarbazine is also indicated for Hodgkin's disease as a second-line therapy when used in combination with other effective agents.
1 INDICATIONS AND USAGE
Instructions for Use
Clean and dry the affected area.
Gently apply a thin film--1-2 grams, 1-2 times daily or as directed by your physician.
Do not apply over a large area of skin.
Thoroughly wash and dry hands before the next step.
Roll out Soft Silicone to the desired length, tear at the perforated line and then remove adhesive backing.
Place Soft Silicone onto the affected area, and gently apply pressure around the edges for complete coverage.
Use the Soft Silicone tape in conjuction with Fluocinonide Cream 0.1% only as directed by your physician.
Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.
Limitation of Use:
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Avoid use on the face, groin, or axillae.
Avoid use in perioral dermatitis or rosacea.
1.1 Indication
Fluocinonide Cream USP, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [
see Use in Specific Populations (8.4)].
1.2 Limitation of Use
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Fluocinonide Cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
INDICATIONS AND USAGE
Itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis.
(see
CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and
ADVERSE REACTIONS: Post-marketing Experience for more information).
INDICATIONS AND USAGE
Malaria
PLAQUENIL is indicated for the treatment of uncomplicated malaria due to
P. falciparum, P. malariae, P. ovale, and
P. vivax.
PLAQUENIL is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria
PLAQUENIL is not recommended for the treatment of complicated malaria.
PLAQUENIL is not effective against chloroquine or hydroxychloroquine-resistant strains of
Plasmodium species (see
CLINICAL PHARMACOLOGY
Microbiology
). PLAQUENIL is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the
Plasmodium species has not been identified.
PLAQUENIL is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs.
PLAQUENIL does not prevent relapses of
P. vivax or
P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of
P. vivax and
P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see
CLINICAL PHARMACOLOGY
Microbiology
).
Prior to prescribing PLAQUENIL for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (http://www.cdc.gov/malaria).
Lupus Erythematosus
PLAQUENIL is indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis
PLAQUENIL is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
INDICATIONS AND USAGE
Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to
Escherichia coli, Pseudomonas aeruginosa, and
Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to
Proteus mirabilis,
Pseudomonas aeruginosa, and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to
Haemophilus influenzae, Moraxella catarrhalis,
Pseudomonas aeruginosa, Staphylococcus aureus,and
Streptococcus pneumoniae.
INDICATIONS AND USAGE
Lidocaine ointment, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx.
It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
1 INDICATIONS AND USAGE
XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
XEGLYZE should be used in the context of an overall lice management program:
Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels
Wash personal care items such as combs, brushes, and hair clips in hot water
Use a fine-tooth comb or special nit comb to remove dead lice and nits
XEGLYZE is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older.XEGLYZE should be used in the context of an overall lice management program:
Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels
Wash personal care items such as combs, brushes and hair clips in hot water
Use a fine-tooth comb or special nit comb to remove dead lice and nits (1)
1 INDICATIONS AND USAGE
ENDOMETRIN (progesterone) is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
ENDOMETRIN is a progesterone indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women. (1)
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (
1).
1 INDICATIONS AND USAGE
VESIcare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
VESIcare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency (1).
INDICATIONS AND USAGE
Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
WARNINGS
], reserve Hydrocodone Bitartrate and Acetaminophen Tabletsfor use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
have not been tolerated, or are not expected to be tolerated
have not provided adequate analgesia, or are not expected to provide adequate analgesia
1
INDICATIONS AND USAGE
Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to
moderately severe chronic pain inadults who require around-the-clock treatment of their pain for an extended period of time.
Tramadol Hydrochloride Extended-Release is an opioid agonist indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. (
1)
INDICATIONS AND USAGE
Myocardial Infarction
Metoprolol tartrate injection, USP vials are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. Treatment with intravenous metoprolol can be initiated as soon as the patient's clinical condition allows (see
DOSAGE AND ADMINISTRATION,
CONTRAINDICATIONS
, and
WARNINGS
).
1 INDICATIONS AND USAGE
Gemcitabine for injection 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 for injection 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 for injection 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 for injection 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 for injection 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 for injection is indicated for patients previously treated with fluorouracil.
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
1.1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with
2. hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a
3. lower dose of diuretic, which may be sufficient without leading to hypokalemia.
4.2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized
5. patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
Indications & Usage
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis
e.g., insulin in uncomplicated diabetes, blood volumerestoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO 2 content is crucial
e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
1.2 Bipolar Disorder
Lamotrigine tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy
[see
Clinical Studies (14.2)]
. ;
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
1
INDICATIONS AND USAGE
Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see Dosage and Administration (
2)
].
CARISOPRODOL Tablets, USP is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (
1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (
1)
1 INDICATIONS AND USAGE
Adult Patients:
ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1).
Pediatric Patients:
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (1).
ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (1).
Adult Patients:
ISENTRESS and ISENTRESS HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
Pediatric Patients:
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg.
ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg.
1 INDICATIONS AND USAGE
Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.
Limitations of Use:
Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [
see Use in Specific Populations (
8.4)
].
Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [
see Microbiology (
12.4)]
.
Atazanavir capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. (
1)