um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
MYKROX Tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.
MYKROX TABLETS HAVE
NOT
BEEN EVALUATED FOR THE TREATMENT OF CONGESTIVE HEART FAILURE OR FLUID RETENTION DUE TO RENAL OR HEPATIC DISEASE AND THE CORRECT DOSAGE FOR THESE CONDITIONS AND OTHER EDEMA STATES HAS NOT BEEN ESTABLISHED.
SINCE A SAFE AND EFFECTIVE
DIURETIC
DOSE HAS NOT BEEN ESTABLISHED, MYKROX TABLETS SHOULD
NOT
BE USED WHEN DIURESIS IS DESIRED.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia (see PRECAUTIONS).
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. MYKROX is not indicated for the treatment of edema in pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.
1 INDICATIONS AND USAGE
Morphine sulfate tablets are indicated for the management of:
adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Morphine sulfate tablets are an opioid agonist indicated for the management of:
adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Pediatric use information is approved for Hikma Pharmaceuticals USA Inc.'s morphine sulfate tablets.
However, due to Hikma Pharmaceuticals USA Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Tramadol hydrochloride tablets are indicated in adults 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 and Precautions (5.1)], reserve tramadol hydrochloride 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.
INDICATIONS AND USAGE
Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since safety and efficacy of Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. (see
PRECAUTIONS - Pediatric Use
).
1 INDICATIONS AND USAGE
Evamist (estradiol transdermal spray) is an estrogen indicated for the treatment
of moderate to severe vasomotor symptoms due to menopause.
Evamist is an estrogen indicated for the treatment of moderate to
severe vasomotor symptoms due to menopause (1)
INDICATIONS & USAGE SECTION
Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
1INDICATIONS AND USAGE
Pravastatin sodium tablets are indicated:
To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.
As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.
As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
INDICATIONS AND USAGE
Renal, Cardiac, and Hepatic Transplant
CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication.
Indications and Usage:
This is a prescription fluoride treatment gel used to help prevent dental decay.
1 INDICATIONS AND USAGE
SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients (1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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.
Cefdinir capsules, USP are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains) (see CLINICAL STUDIES).
Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including -lactamase producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION.
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media caused by Haemophilus influenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including -lactamase producing strains) and Streptococcus pyogenes.
1 INDICATIONS AND USAGE
Rasagiline tablets are indicated for the treatment of Parkinsons disease (PD).
Rasagiline tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), are indicated for the treatment of Parkinsons disease (1)
INDICATIONS AND USAGE:
Possibly effective for use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer.
IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
INDICATIONS AND USAGE
Cefprozil for oral suspension is indicated for the treatment of
patients with mild to moderate infections caused by susceptible strains of the
designated microorganisms in the conditions listed below:
Upper Respiratory Tract:
Pharyngitis/Tonsillitis:Caused by Streptococcus pyogenes.
NOTE: The usual drug of choice in the treatment and prevention of
streptococcal infections, including the prophylaxis of rheumatic fever, is
penicillin given by the intramuscular route. Cefprozil is generally effective in
the eradication of Streptococcus pyogenes from the
nasopharynx; however, substantial data establishing the efficacy of cefprozil in
the subsequent prevention of rheumatic fever are not available at present.
Otitis Media:Caused by Streptococcus pneumoniae,
Haemophilus influenzae (including -lactamase-producing strains), and
Moraxella (Branhamella) catarrhalis (including
-lactamase-producing strains). (See
CLINICAL STUDIES
.)
NOTE: In the treatment of otitis media due to -lactamase producing
organisms, cefprozil had bacteriologic eradication rates somewhat lower than
those observed with a product containing a specific -lactamase inhibitor. In
considering the use of cefprozil, lower overall eradication rates should be
balanced against the susceptibility patterns of the common microbes in a given
geographic area and the increased potential for toxicity with products
containing -lactamase inhibitors.
Acute Sinusitis:Caused by Streptococcus pneumoniae,
Haemophilus influenzae (including -lactamase producing strains), and
Moraxella (Branhamella) catarrhalis (including
-lactamase-producing strains).
Lower Respiratory Tract:
Secondary Bacterial Infection of Acute Bronchitis and Acute
Bacterial Exacerbation of Chronic Bronchitis:Caused by Streptococcus pneumoniae,
Haemophilus influenzae (including
-lactamase-producing strains), and Moraxella (Branhamella)
catarrhalis (including -lactamase-producing strains).
Skin And Skin Structure:
Uncomplicated Skin and Skin-Structure Infections:Caused by Staphylococcus aureus
(including penicillinase producing strains) and Streptococcus pyogenes. Abscesses usually require surgical
drainage.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefprozil for oral suspension and other antibacterial drugs,
cefprozil for oral suspension should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible bacteria. When
culture and susceptibility information are available, they should be considered
in selecting or modifying antibacterial therapy. In the absence of such data,
local epidemiology and susceptibility patterns may contribute to the empiric
selection of therapy.
1.
INDICATIONS AND USAGE
Corlanor (ivabradine) isa hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated:
To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.(
1.1)
For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. (
1.2)
1.1
Heart Failure in Adult Patients
Corlanor is indicated to reduce the risk of hospitalization for worsening heart failure inadult patients with stable, symptomaticchronic heart failurewithleft ventricular ejection fraction
35%, who arein sinus rhythm with resting heart rate
70beats per minuteand either are on maximally tolerated doses of beta-blockers or have a contraindication tobeta-blocker use.
1.2
Heart Failure in Pediatric Patients
Corlanor is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.
1 INDICATIONS AND USAGE
Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated
influenza A and B in patients 2 weeks of age and
older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
Not a substitute for annual influenza
vaccination. (1.3)
Consider available information on
influenza drug susceptibility patterns and treatment effects when deciding
whether to use. (1.3)
Not recommended for patients with end-stage renal disease
not undergoing dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir phosphate for oral suspension
is not a substitute for early influenza vaccination on an annual basis as
recommended by the Centers for Disease Control and Prevention Advisory
Committee on Immunization Practices.
Influenza viruses change over time.
Emergence of resistance substitutions could decrease drug effectiveness.
Other factors (for example, changes in viral virulence) might also
diminish clinical benefit of antiviral drugs. Prescribers should consider
available information on influenza drug susceptibility patterns and
treatment effects when deciding whether to use oseltamivir phosphate for oral suspension [see
Microbiology (12.4)] .
Oseltamivir phosphate for oral suspension is not
recommended for patients with end-stage renal disease not undergoing
dialysis [see Dosage and Administration (2.4)
and Use in Specific Populations (8.6)] .
INDICATIONSAND USAGE
Trientine hydrochloride capsules USP 250 mg is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules USP 250 mg is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride capsules USP 250 mg and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules USP 250 mg should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride capsules USP 250 mg is not recommended in cystinuria or rheumatoid arthritis. The absence ofa sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride capsules USP 250 mg was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride capsules USP 250 mg is not indicated for treatment of biliary cirrhosis.
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 is 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 is 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)
1 INDICATIONS AND USAGE
Sumatriptan Injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established.If a patient has no response to the first migraine attack treated with Sumatriptan Injection reconsider the diagnosis before Sumatriptan Injection is administered to treat any subsequent attacks.
Sumatriptan Injection is not indicated for the prevention of migraine attacks or cluster headache attacks.
Sumatriptan injection, USP is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults (1) Acute treatment of cluster headache in adults (1)
Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established (1) Not indicated for the prophylactic therapy of migraine or cluster headache attacks (1)
INDICATIONS:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
1.1 Infections of the Ear, Nose, and Throat
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamasenegative) isolates of Streptococcus species. (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamasenegative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Helicobacter pylori Infection
Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly 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.
INDICATIONS AND USAGE
4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.