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
PRECAUTIONSPediatric 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.
1 INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Buprenorphine and naloxone sublingual tablets contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and
are indicated for the maintenance treatment of opioid dependence. (1).
Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)
1 INDICATIONS & USAGE
VIVIMUSTA is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. (1.1) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (1.2)
1.1 Chronic Lymphocytic Leukemia (CLL)
VIVIMUSTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
1.2 Non-Hodgkin Lymphoma (NHL)
VIVIMUSTA is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
INDICATIONS AND USAGE
IDAMYCIN PFS Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.
INDICATIONS AND USAGE
PROTOPAM Chloride is indicated as an antidote:
1.In the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and
2.In the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis.
The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness.
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride is an
alpha1 adrenoceptor antagonist indicated for treatment of the
signs and symptoms of benign prostatic hyperplasia
(1)
Tamsulosin hydrochloride
capsules are not indicated for the treatment of hypertension
(1)
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)
]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
1 INDICATIONS & USAGE
Gabapentinis 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 is 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)
INDICATIONS AND USAGE
Ciprofloxacin Ophthalmic Solution, USP is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcers:
Pseudomonas aeruginosa
Serratia marcescensEfficacy for this organism was studied in fewer than 10 infections.
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)
Conjunctivitis:
Haemophilus Influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
INDICATIONS AND USAGE
Nystatin and Triamcinolone Acetonide Cream, USP 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.
INDICATIONS & USAGE
Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and -blockers; and for induction of intraoperative hypotension.
INDICATIONS AND USAGE
Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.
1
INDICATIONS AND USAGE
1.1 Alzheimers Disease
ExelonPatch (rivastigminetransdermalsystem) is indicated for
the treatment of mild to moderate dementia of the Alzheimers type.
1.2 Parkinsons Disease
Dementia
ExelonPatch (rivastigminetransdermalsystem) is indicated for
the treatment of mild to moderate dementia associated with Parkinsons
disease.
The dementia of Parkinsons disease is purportedly characterized by
impairments in executive function, memory retrieval, and attention in patients
with an established diagnosis of Parkinsons disease. The diagnosis of dementia
of Parkinsons disease can be made reliably in patients in whom a progressive
dementia syndrome occurs (without the necessity to document the specific
deficits described above) at least 2 years after a diagnosis of Parkinsons
disease has been made, and in whom other causes of dementia have been ruled out.
1 INDICATIONS AND USAGE
Argatroban is a direct thrombin inhibitor indicated:
For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1)
As an anticoagulant in adult patients with or at risk for HIT
undergoing percutaneous coronary intervention (PCI) (1.2)
1.1
Heparin-Induced Thrombocytopenia
Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
1.2
Percutaneous Coronary Interventions
Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT
undergoing percutaneous coronary intervention (PCI).
INDICATIONS & USAGE SECTION
1.1 HypertensionLisinopril tablets USP are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Lisinopril tablets USP may be administered alone or with other antihypertensive agents [see Clinical Studies (14.1)].
1.2 Heart FailureLisinopril tablets USP are indicated to reduce signs and symptoms of systolic heart failure [see Clinical Studies (14.2)].
1.3 Reduction of Mortality in Acute Myocardial InfarctionLisinopril tablets USP are indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see Clinical Studies (14.3)].
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
The use of phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy.
Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection.
Treatment of a urinary tract infection with phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.)
1.	INDICATIONS AND USAGE
LANTUS is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Important Limitations of Use:
LANTUS is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition.
LANTUS is a long- acting human insulin analog indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (1)
Important Limitations of Use:
Not recommended for treating diabetic ketoacidosis. Use intravenous, short-acting insulin instead.
1 INDICATIONSAND USAGE
Brexpiprazole tablets are indicated for:
Adjunctive treatment of major depressive disorder (MDD) in adults.
Treatment of schizophrenia in adults.
Brexpiprazole tablets is an atypical antipsychotic indicated for:
Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults (1, 14.1)
Treatment of schizophrenia in adults
1.2 Hyperlipidemia
Pravastatin sodium tablets are indicated:
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (
Fredrickson Types IIa and IIb).
1
as an adjunct to diet for the treatment of patients with elevated serum TG levels (
Fredrickson Type IV).
for the treatment of patients with primary dysbetalipoproteinemia (
Fredrickson Type III) who do not respond adequately to diet.
as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
LDL-C remains 190 mg/dL or
LDL-C remains 160 mg/dL and:
there is a positive family history of premature cardiovascular disease (CVD) or
two or more other CVD risk factors are present in the patient.
INDICATIONSAND USAGE
Herpes Zoster Infections: Acyclovir oral suspension is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes: Acyclovir oral suspension is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: Acyclovir oral suspension is indicated for the treatment of chickenpox (varicella).
1 INDICATIONS AND USAGE
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 35 kg. (
1.1)
for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. (
1.2)
1.1	HIV-1 Infection
Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 35 kg.
1.2	Chronic Hepatitis B
Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older.
Pediatric use information is approved for Gilead Sciences, Inc.s VIREAD
(tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.s marketing exclusivity rights,this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:
Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)
Important limitations of use:
PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2)
PERFOROMIST Inhalation Solution is not indicated to treat asthma. (1.2)
1.1 Maintenance Treatment of COPD
PERFOROMIST (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
1.2 Important Limitations of Use
PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2)].
PERFOROMIST Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma have not been established.
INDICATIONS AND USAGE
PHENERGAN Injection is indicated for the following conditions:
Amelioration of allergic reactions to blood or plasma.
In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
Active treatment of motion sickness.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
As an adjunct to analgesics for the control of postoperative pain.
Preoperative, postoperative, and obstetric (during labor) sedation.
Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.
1 INDICATIONS AND USAGE
Vagifem is an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause (1).
1.1 Treatment of Atrophic Vaginitis due to Menopause
1 INDICATIONS AND USAGE
Meropenem for injection is a penem antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (
1.1)
Complicated intra-abdominal infections (adult and pediatric patients). (
1.2)
Bacterial meningitis (pediatric patients 3 months of age and older only). (
1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection and other antibacterial drugs, meropenem for injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of age and older only)
Meropenem for injection is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to
Staphylococcus aureus (methicillin-susceptible isolates only),
Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci,
Enterococcus faecalis (vancomycin-susceptible isolates only),
Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species
.
1.2 Complicated Intra-abdominal Infections (Adult and Pediatric Patients)
Meropenem for injection is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci,
Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species
.
1.3 Bacterial Meningitis (Pediatric Patients 3 Months of age and older only)
Meropenem for injection is indicated for the treatment of bacterial meningitis caused by
Haemophilus influenzae, and
Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae.
Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection and other antibacterial drugs, meropenem for injection should only be used 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.
INDICATIONSAND USAGE
Hydrocodone Bitartrate and Ibuprofen Tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Carefully consider the potential benefits and risks of Hydrocodone Bitartrate and Ibuprofen Tablets and other treatment options before deciding to use Hydrocodone Bitartrate and Ibuprofen Tablets Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see
WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation
). Do not use Hydrocodone Bitartrate and Ibuprofen Tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis.Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see
WARNINGS: Addiction, Abuse, and Misuse
), reserve Hydrocodone Bitartrate and Ibuprofen Tablets 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