um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli
*, Klebsiella spp.* (including K. pneumoniae
*), Proteus mirabilis
*
, Bacteroides fragilis
*
, Enterobacter spp.*, and Acinetobacter calcoaceticus
*
.
NOTE: For information on use in pediatric patients see
PRECAUTIONS-Pediatric Use
and
CLINICAL STUDIES
sections.
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae
*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli
*, and Bacteroides spp.* (including B. fragilis
*).
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP 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.
INDICATIONS AND USAGE
Terbutaline Sulfate Tablets USP are indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
1 INDICATIONS AND USAGE
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. (1)
1 INDICATIONS AND USAGE
COMPLERA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg:
as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or
to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA [see Microbiology (12.4) and Clinical Studies (14)].
COMPLERA, a combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35 kg (1) as initial therapy in those with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, or (2) or to replace a stable antiretroviral regiment in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA. (1, 14)
Limitations of
Use:
More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA 50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. (1, 14)
Limitations of Use:
More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA 50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14)].
INDICATIONS AND USAGE
Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
1 INDICATIONS AND USAGE
Gabapentin capsules are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin capsules are indicated for:
Postherpetic neuralgia in adults (
1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (
1)
1
INDICATIONS AND USAGE
XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older).
XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older). (1)
1 INDICATIONS AND USAGE
Velphoro is indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
Velphoro is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. (
1)
INDICATIONS AND USAGE
Astringent, Alkaline, for superficial and deep festering wounds. for 1st, 2nd and 3rd ulcers and burns. grade. Ideal for people with diabetes.pply directly without diluting, on the affected area or use an impregnated gauze.
1 INDICATIONS AND USAGE
Fosamprenavir calcium tablets are 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 fosamprenavir plus ritonavir in protease inhibitor-experienced patients:
The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)].
Once-daily administration of fosamprenavir plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration (2.2, 2.3), Clinical Studies (14.2, 14.3)].
Dosing of fosamprenavir plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology (12.3)].
Fosamprenavir calcium tablets are an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
1 INDICATIONS AND USAGE
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve morphine sulfate oral solution 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 oral solution. However, due to Hikma Pharmaceuticals USA Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Morphine sulfate oral solution is an opioid agonist.
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for:
the relief of acute and chronic pain in opioid-tolerant adult patients. (1)
Limitations of Use (1):Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve morphine sulfate oral solution 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.
1 INDICATIONS AND USAGE
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. (1.1)
for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA (1.2, 2.1)
1.1 First-Line Maintenance Treatment of Advanced Ovarian Cancer
ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
1.2 Maintenance Treatment of Recurrent Germline BRCA-mutated Ovarian Cancer
ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAmut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
1 INDICATIONS AND USAGE
NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus.
Limitations of Use:
NOVOLOG MIX 70/30 is not recommended for the treatment of diabetic ketoacidosis.
The proportions of rapid-acting and long-acting insulins in NOVOLOG MIX 70/30 are fixed and do not allow for basal versus prandial dose adjustments.
NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog, indicated to improve glycemic control in adult patients with diabetes mellitus.
Limitations of Use:
Not recommended for the treatment of diabetic ketoacidosis.
The proportions of rapid-acting and long-acting insulins are fixed and do not allow for basal versus prandial dose adjustments (1).
INDICATIONS AND USAGE
CUTIVATE Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CUTIVATE Cream may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of CUTIVATE Cream in pediatric patients below 3 months of age have not been established.
1 INDICATIONS AND USAGE
Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride 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 and Precautions (5.2)],
reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride 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
Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets contain hydromorphone, an opioid agonist, and are indicated for the management of 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 hydromorphone hydrochloride oral solution or hydromorphone hydrochloride 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
1 INDICATIONS AND USAGE
REQUIP XL is an orally administered, non-ergoline dopamine agonist indicated for the treatment of signs and symptoms of idiopathic Parkinsons disease. (1.1)
1.1 Parkinsons Disease
REQUIP XL (ropinirole extended-release tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinsons disease.
1 INDICATIONS AND USAGE
QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. (1)
INDICATIONS AND USAGE
Extended phenytoin sodium capsules are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY).
1 INDICATIONSAND USAGE
Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Azithromycin for injectionis a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Community-acquired pneumonia in adults (1.1) Pelvic inflammatory disease (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness ofazithromycin and other antibacterial drugs,azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
1.1 Community-Acquired Pneumonia
due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.
1.2 Pelvic Inflammatory Disease
due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination withazithromycin for injection.
Azithromycin for injectionshould be followed by azithromycin by the oral route as required [see Dosage and Administration (2)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin 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.
1 INDICATIONS AND USAGE
AGGRENOX is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
AGGRENOX is a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis (1)
Latanoprost Ophthalmic Solution, 0.005% is indicated for the reduction of elevated intraocular pressure in patients with open- angle glaucoma or ocular hypertension.
INDICATIONS AND USAGE
Thisfixedcombinationdrugisnotindicatedfortheinitialtherapyofedemaorhypertensionexceptinindividualsinwhomthedevelopmentofhypokalemiacannotberisked.
Triamterene and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide tablets, USP are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.).
Triamterene and hydrochlorothiazide tablets, USP may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide tablets, USP may enhance the actions of these drugs, dosage adjustments may be necessary.
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 satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of 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 provide relief and may be appropriate.
INDICATIONS & USAGE SECTION
Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.
1
INDICATIONS AND USAGE
Asenapine sublingual Tabletsare indicated for:
Schizophrenia in adults[see Clinical Studies (
14.1
)]
Bipolar I disorder [see Clinical Studies (
14.2
)]
Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age
Adjunctive treatment to lithium or valproate in adults
Maintenance monotherapy treatment in adults
Asenapineis an atypical antipsychotic indicated for (1):
Schizophrenia in adults
Bipolar I disorderAcute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults
1 INDICATIONS AND USAGE
OMECLAMOX-PAK, a co-packaged product containing omeprazole, a proton pump inhibitor, clarithromycin, a macrolide antimicrobial, and amoxicillin, a penicillin class antibacterial, is indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or up to one-year history) to eradicate H. pylori. (1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMECLAMOX-PAK and other antibacterial drugs, OMECLAMOX-PAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2)
1.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease
OMECLAMOX-PAK (Omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules taken together) are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1)].
1.2 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMECLAMOX-PAK and other antibacterial drugs OMECLAMOX-PAK 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
Pantoprazole is a proton pump inhibitor indicated (PPI) for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3)
Pantoprazole sodium delayed-release tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.