um-ids/dailymed-annotations huggingface dataset:
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 volume
restoration 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.
INDICATIONS AND USAGE:
Melphalan hydrochloride for injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
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 tablets for HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and Tenofovir disoproxil fumarate tablet 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 [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)].
1 INDICATIONS AND USAGE
Efavirenz tablets in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.
Efavirenz is a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. (
1)
1 INDICATIONS AND USAGE
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults
Indications and Usage Section
Tramadol Hydrochloride Tablets, USP are indicated for the management of pain in adults that is 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 tramadol for 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.
Please review the manufacturer's complete drug information available from the FDA at www.fda.gov
Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee7179b7-6a08-4eeb-a787-5d697b02c4a2
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin andother antibacterial drugs, Amoxicillin Tablets should be used only to treat infections that are proven orstrongly suspected to be caused by 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.
Amoxicillin Tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin Tablets are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1
1.5) In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
1.1 Infections of the ear, nose, and throat
due to Streptococcus species.(- and -hemolytic isolates only), Streptococcus pneumoniae,
Staphylococcus spp., or Haemophilus
influenzae.
1.2 Infections of the genitourinary tract
due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the skin and skin structure
due to Streptococcus spp.(- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the lower respiratory tract
due to Streptococcus spp.(- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Gonorrhea, acute uncomplicated (ano-genital and urethral infections)
due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, Amoxicillin Tablets are not recommended for empiric treatment of gonorrhea. Amoxicillin Tablets use should be limited to situations where N. gonorrhoeaeisolates are known to be susceptible to amoxicillin.
1.6 Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole
Amoxicillin Tablets, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year historyof a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk ofduodenal ulcer recurrence.
1.7 Dual therapy for H. pylori with lansoprazole
Amoxicillin Tablets, in combination with lansoprazoledelayed-release capsules as dual therapy, are indicated for the treatment of patients with H. pyloriinfection 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 orsuspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has beenshown to reduce the risk of duodenal ulcer recurrence.
1.3 Neurology
For the identification of regions of abnormal
glucose metabolism associated with foci of epileptic seizures.
Venlafaxine Tablets, USP are indicated for the treatment of major depressive disorder.
The efficacy of Venlafaxine Tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Venlafaxine Tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Venlafaxine Tablets, USP / venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Uses
helps prevent sunburn
if used as directed wiht other sun protection measures (see
Directions
), decreases the risk of skin cancer and early skin aging caused by the sun.
1 INDICATIONS AND USAGE
Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) are indicated for the treatment of Parkinson's disease.
Carbidopa, levodopa and entacapone tablets can be used:
To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.
To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose wearing-off and when they have been taking a total daily dose of levodopa of 600mg or less and have not been experiencing dyskinesias.
Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aromatic amino acid decarboxylation inhibitor), and entacapone (catechol-O-methyltransferase (COMT) inhibitor) are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets are to be used:
To substitute (with equivalent strengths of each of the three components) for carbidopa/levodopa and entacapone previously administered as individual products (1)
To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose wearing-off and when they have been taking a total daily dose of levodopa of 600mg or less and have not been experiencing dyskinesias (1)
INDICATIONS AND USAGE
Lidocaine Viscous (Lidocaine Hydrochloride Oral Topical Solution USP) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
INDICATIONS AND USAGE
DITROPAN XL (oxybutynin chloride) is a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
DITROPAN XL is also indicated in the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
1
INDICATIONS AND USAGE
GLOPERBA
(colchicine) Oral Solution is indicated for prophylaxis of gout flares in adults.
Limitations of use: The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied. GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.
GLOPERBA is indicated for prophylaxis of gout flares in adults.
Limitations of use:The safety and effectiveness of GLOPERBA for acute treatment of gout flares during prophylaxis has not been studied.
GLOPERBA is not an analgesic medication and should not be used to treat pain from other causes.
INDICATIONS AND USAGE
Bromfed DM (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Oral Syrup) is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
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 tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are 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 a physician deems that sulfamethoxazole and trimethoprim could offer 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
jirovecii Pneumonia
For the treatment of documented Pneumocystis
jirovecii pneumonia and for prophylaxis against P.
jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P.
jirovecii pneumonia.
Travelers Diarrhea in Adults
For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic E. coli.
INDICATIONS AND USAGE
June
l
21 and Junel
Fe 28
are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
Adapted from RA Hatcher et al, Reference 7.
% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
LowestExpectedThe authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.
TypicalThis term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(No contraception)
(85)
(85)
Oral contraceptives combined progestin only
0.10.5
3N/AN/A--Data not available
N/A
Diaphragm with spermicidal cream or jelly
6
20
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)
6
26
Vaginal Sponge nulliparous parous
920
2040
Implant
0.05
0.05
Injection: depot medroxyprogesterone acetate
0.3
0.3
IUD progesterone T copper T 380A LNg 20
1.50.60.1
2.00.80.1
Condom without spermicides female male
53
2114
Cervical Cap with spermicidal cream or jelly nulliparous parous
926
2040
Periodic abstinence (all methods)
1 to 9
25
Withdrawal
4
19
Female sterilization
0.5
0.5
Male sterilization
0.10
0.15
INDICATIONS AND USAGE
Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease.
Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.
INDICATIONS AND USAGE
Cimetidine tablets are indicated in:
Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION, Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg at bedtime for periods of up to five years.
Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.
Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established [see DOSAGE AND ADMINISTRATION, Erosive Gastroesophageal Reflux (GERD)].
The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
1 INDICATIONS AND USAGE
NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
Limitations of Use
In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.
NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). (1)
Limitations of Use
In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
INDICATIONS AND USAGE
Diethylpropion hydrochloride tablets are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regiment of weight reduction based on caloric restriction.
The usefulness of agents of this class should be measured against possible risk factors inherent in their use such as those described (see CLINICAL PHARMACOLOGY).
INDICATIONS AND USAGE
Haloperidol decanoate injection, 50 mg (base)/mL and haloperidol decanoate injection, 100 mg (base)/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
INDICATIONS AND USAGE
Griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:
Tinea corporis
Tinea pedis
Tinea cruris
Tinea barbae
Tinea capitis
Tinea unguium when caused by one or more of the following species of fungi:
Epidermophyton floccosum
Microsporum audouinii
Microsporum canis
Microsporum gypseum
Trichophyton crateriform
Trichophyton gallinae
Trichophyton interdigitalis
Trichophyton megnini
Trichophyton mentagrophytes
Trichophyton rubrum
Trichophyton schoenleini
Trichophyton sulphureum
Trichophyton tonsurans
Trichophyton verrucosum
Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection.
Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.
Griseofulvin is not effective in the following:
Bacterial infections
Candidiasis (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
Nocardiosis
The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.
INDICATIONS AND USAGE
For control of severe nausea and vomiting.
For the treatment of schizophrenia.
Prochlorperazine maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).
When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see
WARNINGS
).
The effectiveness of prochlorperazine maleate tablets as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine maleate tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).
Prochlorperazine maleate tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.