um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Hypertension
Atenolol tablets, USP are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
Angina Pectoris Due to Coronary Atherosclerosis
Atenolol tablets, USP are indicated for the long-term management of patients with angina pectoris.
Acute Myocardial Infarction
Atenolol tablets, USP are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patients clinical condition allows (see
DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and
WARNINGS). In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta-blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.
INDICATIONS AND USAGE:
DIPRIVAN is an IV general anesthetic and sedation drug that can be used as described in the table below.
Table 3. Indications for DIPRIVAN
Indication
Approved Patient Population
Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation
Adults only
Combined sedation and regional anesthesia
Adults only (seePRECAUTIONS)
Induction of General Anesthesia
Patients greater than or equal to 3 years of age
Maintenance of General Anesthesia
Patients greater than or equal to 2 months of age
Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients
Adults only
Safety, effectiveness and dosing guidelines for DIPRIVAN have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see
PRECAUTIONS, Pediatric Use
).
DIPRIVAN is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.
In the Intensive Care Unit (ICU), DIPRIVAN can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
DIPRIVAN is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see
PRECAUTIONS, Pediatric Use
).
DIPRIVAN is not recommended for obstetrics, including Cesarean section deliveries. DIPRIVAN crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN may be associated with neonatal depression (see PRECAUTIONS).
DIPRIVAN is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (seePRECAUTIONS).
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
Treatment of Anaerobic Infections
Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole.
Metronidazole is effective inBacteroides fragilisinfections resistant to clindamycin, chloramphenicol and penicillin.
Intra-abdominal Infections
,including peritonitis, intra-abdominal abscess and liver abscess, caused by
Bacteroides
species including the
B. fragilis
group(
B. fragilis, B. distasonis, B. ovatus,
B. thetaiotaomicron, B. vulgatus
).
Clostridium
species,
Eubacterium
species,
Peptococcus
species, and
Peptostreptococcus
species.
Skin and Skin Structure Infections
caused by
Bacteroides
species including
B. fragilis
group,
Clostridium
species,
Peptococcus
species,
Peptostreptococcus
species and
Fusobacterium
species.
Gynecologic Infections
,including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by
Bacteroides
species including the
B. fragilis
group,
Clostridium
species,
Peptococcus
species,
Peptostreptococcus
speciesand
Fusobacterium
species.
Bacterial Septicemia
caused by
Bacteroides
species including the
B. fragilis
group and
Clostridium
species.
Bone and Joint Infections
,as adjunctive therapy, caused by
Bacteroides
species including the
B. fragilis
group.
Central Nervous System (CNS) Infections
,including meningitis and brain abscess, caused by
Bacteroides
species including the
B. fragilis
group.
Lower Respiratory Tract Infections
,including pneumonia, empyema, and lung abscess, caused by
Bacteroides
species including the
B. fragilis
group.
Endocarditiscaused byBacteroidesspecies including theB. fragilisgroup.
Prophylaxis
The prophylactic administration of Metronidazole Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated.
Prophylactic use of Metronidazole Injection, USP should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (seeDOSAGE AND ADMINISTRATION).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS & USAGE
Acromegaly
Octreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels (see DOSAGE AND ADMINISTRATION
). In patients with acromegaly, octreotide acetate injection reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested.
Improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with octreotide acetate injection; these trials were not optimally designed to detect such effects.
Carcinoid Tumors
Octreotide acetate injection is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.
Vasoactive Intestinal Peptide Tumors (VIPomas)
Octreotide acetate injection is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.
1 INDICATIONS AND USAGE
Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older.
Fluticasone propionate nasal spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. (
1)
1 INDICATIONS AND USAGE
Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis.
Pediatric use information is approved for Genzyme Corporations Renvela (sevelamer carbonate) tablets and Renvela (sevelamer carbonate) for oral suspension. However, due to Genzyme Corporations marketing exclusivity rights, these drug products are not labeled with that pediatric information.
Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults with chronic kidney disease on dialysis.
(1)
1 INDICATIONS & USAGE
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)
1 INDICATIONS AND USAGE
Arsenic trioxide injection is an arsenical indicated:
For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (1.2)
1.2 Relapsed or Refractory APL
Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with APLwho are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
INDICATIONS AND USAGE
Herpes Zoster Infections
Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes
Acyclovir tabletsare indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox
Acyclovir tabletsare indicated for the treatment of chickenpox (varicella).
1 INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatmentof partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE
Technescan HDP Tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.
For Urologic Irrigation
Mannitol solution, 2.5% is indicated as an irrigation solution in transurethral prostatic resection or other transurethral surgical procedures.
1 INDICATIONS AND USAGE
Aplenzin (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder.
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) [see
CLINICAL STUDIES (14)
].
A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion [see
CLINICAL STUDIES (14)
]. Nevertheless, the physician who elects to use Aplenzin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Aplenzin is an aminoketone antidepressant indicated for the treatment of: Major depressive disorder (1)
Periodically reevaluate long-term usefulness for the individual patient. (1)
INDICATIONS AND USAGE
Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).
1 INDICATIONS AND USAGE
MENOPUR (menotropins for injection) is a gonadotropin indicated for:
Development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1)
Development of Multiple Follicles and Pregnancy in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle
Prior to initiation of treatment with MENOPUR (menotropins for injection):
Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility
Exclude the possibility of pregnancy
Evaluate the fertility status of the male partner
Exclude a diagnosis of primary ovarian failure
1 INDICATIONS AND USAGE
To reduce the development of drugresistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, 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.
Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and clavulanate potassium
tablets, USP are a combination penicillin-class antibacterial and betalactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections
(1.1)
Acute bacterial otitis media
(1.2)
Sinusitis
(1.3)
Skin and skin structure infections
(1.4)
Urinary tract infections
(1.5)
1.1Lower Respiratory Tract Infections
caused by betalactamaseproducing isolates of Haemophilusinfluenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by betalactamaseproducing isolates of E. coli, Klebsiellaspecies, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.
1 INDICATIONS AND USAGE
After consultation with a healthcare professional who has considered and advised the patient of the risks and benefits of rosiglitazone, AVANDAMET is indicated as an adjunct to diet and exercise to improve glycemic control when treatment with both rosiglitazone and metformin is appropriate in adults with type 2 diabetes mellitus who either are:
already taking rosiglitazone, or
not already taking rosiglitazone and unable to achieve glycemic control on other diabetes medications and, in consultation with their healthcare provider, have decided not to take pioglitazone (ACTOS) or pioglitazone-containing products (ACTOPLUS MET, ACTOPLUS MET XR, DUETACT) for medical reasons.
Other Important Limitations of Use:
Due to its mechanism of action, rosiglitazone is active only in the presence of endogenous insulin. Therefore, AVANDAMET should not be used in patients with type 1 diabetes.
Coadministration of AVANDAMET with insulin is not recommended [see Warnings and Precautions (5.2, 5.3)].
AVANDAMET is a combination antidiabetic product containing a thiazolidinedione and a biguanide. After consultation with a healthcare professional who has considered and advised the patient of the risks and benefits of rosiglitazone, this drug is indicated as an adjunct to diet and exercise to improve glycemic control when treatment with both rosiglitazone and metformin is appropriate in adults with type 2 diabetes mellitus who either are:
already taking rosiglitazone, or
not already taking rosiglitazone and are unable to achieve glycemic control on other diabetes medications and, in consultation with their healthcare provider, have decided not to take pioglitazone (ACTOS) or pioglitazone-containing products (ACTOPLUS MET, ACTOPLUS MET XR, DUETACT) for medical reasons. (1)
Other Important Limitations of Use:
Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (1)
Coadministration with insulin is not recommended. (1, 5.2, 5.3)
1 INDICATIONS AND USAGE
Finasteride, is a 5-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1):
Improve symptoms
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score) (1.2).
Limitations of Use: finasteride is not approved for the prevention of prostate cancer (1.3).
1.1 Monotherapy
Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms
- Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score).
1.3 Limitations of Use
Finasteride tablets are not approved for the prevention of prostate cancer.
INDICATIONS AND USAGE
Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura.
Dihydroergotamine mesylate nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate is indicated for the treatment of hypertension.
Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see Error! Hyperlink reference not valid. for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction 35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see Error! Hyperlink reference not valid. for details and limitations of survival trials).
In using enalapril maleate consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate does not have a similar risk (see
WARNINGS, Neutropenia/Agranulocytosis
).
In considering use of enalapril maleate it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see
WARNINGS, Head and Neck Angioedema
).