um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
To
reduce the development of drug-resistant bacteria and maintain the
effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when
used to treat infection 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.
XIFAXAN is a rifamycin antibacterial indicated
for:
The treatment of patients ( 12 years of age)
with travelers diarrhea (TD) caused by
noninvasive strains of Escherichia coli
(1.1)
Reduction in risk of overt hepatic encephalopathy (HE)
recurrence in patients
18 years of age
(1.2)
Limitations of Use
TD: Do not use in patients with diarrhea complicated by
fever or blood in the stool or diarrhea due to pathogens
other than Escherichia coli
(1.1)
1.1 Travelers Diarrhea
XIFAXAN
200 mg is indicated for the treatment of patients (
12 years of age) with travelers diarrhea caused by
noninvasive strains of Escherichia coli
[
see
Warnings
and
Precautions (5), Clinical
Pharmacology (12.4) and
Clinical
Studies
(14.1)].
Limitations of Use
XIFAXAN
should not be used in patients with diarrhea complicated by
fever or blood in the stool or diarrhea due to pathogens other
than Escherichia coli.
1.2 Hepatic Encephalopathy
XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients
18 years of age.
In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.
XIFAXAN has not been studied in patients with MELD (Model for End-Stage Liver Disease) scores > 25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction [see Warnings and Precautions (5.4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
INDICATIONS AND USAGE
Oxybutynin Chloride Extended Release Tablets are a once-daily
controlled-release tablet indicated for the treatment of overactive bladder with
symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin Chloride Extended Release Tablets are also indicated in the
treatment of pediatric patients aged 6 years and older with symptoms of detrusor
overactivity associated with a neurological condition (e.g., spina bifida).
1INDICATIONS AND USAGE
Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older.
Pediatric use information is approved for Novartis Pharmaceuticals Corporations GILENYA (fingolimod) capsules. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Fingolimod hydrochloride is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. (
1)
1 INDICATIONS AND USAGE
Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged 13 years receiving renal transplants.
Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (
1.1).
Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (
1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (
1.1,
1.2,
14.3).
1.1 Prophylaxis of Organ Rejection in Renal Transplantation
Sirolimus tablets are indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants.
In patients at low- to moderate-immunologic risk, it is recommended that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation
[see
Dosage and Administration (2.2)].
In patients at high-immunologic risk (defined as Black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [PRA; peak PRA level >80%]), it is recommended that sirolimus tablets be used in combination with cyclosporine and corticosteroids for the first year following transplantation
[see
Dosage and Administration (2.3),
Clinical Studies (14.3)].
1.2 Limitations of Use in Renal Transplantation
Cyclosporine withdrawal has not been studied in patients with Banff Grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine >4.5 mg/dL, Black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies
[see
Clinical Studies (14.2)].
In patients at high-immunologic risk, the safety and efficacy of sirolimus tablets used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient
[see
Clinical Studies (14.3)].
In pediatric patients, the safety and efficacy of sirolimus tablets have not been established in patients <13 years old, or in pediatric (<18 years) renal transplant patients considered at high-immunologic risk
[see
Adverse Reactions (6.5),
Clinical Studies (14.6)].
The safety and efficacy of
de novo use of sirolimus tablets without cyclosporine have not been established in renal transplant patients
[see
Warnings and Precautions (5.12)].
The safety and efficacy of
conversion from calcineurin inhibitors to sirolimus tablets in maintenance renal transplant patients have not been established
[see
Clinical Studies (14.4)].
1. INDICATIONS AND USAGE
TEMOZOLOMIDE Capsules, USP are an alkylating drug indicated for the treatment of adult patients with:
Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1)
Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2)
1.1 Newly Diagnosed Glioblastoma
TEMOZOLOMIDE Capsules, USPis indicated for the treatment of adult patients with newly diagnosed glioblastomaconcomitantly with radiotherapy and then as maintenance treatment.
1.2 Refractory Anaplastic Astrocytoma
TEMOZOLOMIDE Capsules, USPis indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
1 INDICATIONS AND USAGE
NATROBA is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. (1.1)
NATROBA is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older, (1.2)
1.1 Head Lice Infestations
NATROBATM is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older.
Adjunctive Measures for Head Lice Infestations
NATROBA should be used in the context of an overall lice management program:
Wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels.
Wash personal care items such as combs, brushes and hair clips in hot water.
A fine-tooth comb or special nit comb may be used to remove dead lice and nits.
1.2 Scabies Infestations
NATROBA is indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older.
Adjunctive Measures for Scabies Infestations
Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies.
INDICATIONS AND USAGE
For use as an adjunct in the therapy of all forms of
parkinsonism.
Useful also in the control of extrapyramidal disorders (except
tardive dyskinesia --- see PRECAUTIONS)
due to neuroleptic drugs (e.g., phenothiazines).
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, Cefdinir capsules 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 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 -lactamasen producing strains),
Streptococcus pneumonia (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 pneumonia (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.
INDICATIONS AND USAGE
Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONSAND USAGE
Triamcinolone Acetonide Ointment 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
1 INDICATIONS AND USAGE
ClobazamTablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam Tablets are benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older (1)
INDICATIONS AND USAGE
Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (See
CLINICAL PHARMACOLOGY
Susceptibility Test Methods
).
Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant
Staphylococcus, therapy should not be continued with oxacillin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin for Injection, USP and other antibacterial drugs, Oxacillin for Injection, USP 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
FOR VAGINAL USE ONLY
Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy.
Etonogestrel and ethinyl estradiol vaginal ring is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. (1)
1. Indications and Usage
Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
Naloxone HCl Nasal Spray is not a substitute for emergency medical care.
Limitations of Use:
Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
1 INDICATIONS AND USAGE
OCALIVA is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
without cirrhosis or
with compensated cirrhosis who do not have evidence of portal hypertension,
either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP) [see Clinical Studies (14)]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
without cirrhosis or
with compensated cirrhosis who do not have evidence of portal hypertension,
either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1)
1 INDICATIONS AND USAGE
Calcitriol Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older (1.1)
Limitations of Use
The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. (1.2)
1.1 Indication
Calcitriol Ointment is indicated for the topical treatment of mild to moderate plaque
psoriasis in adults and pediatric patients 2 years and older.
1.2 Limitations of Use
The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.
1 INDICATIONS AND USAGE
Trimethobenzamide hydrochloride capsules is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
Limitation of Use:
Trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects, and the risk of exacerbation of the underlying disease in pediatric patients with Reye's syndrome or other hepatic impairment.
Trimethobenzamide hydrochloride capsules are an antiemetic indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. (1)
Limitation of Use:
Trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects and the risk of exacerbation of the underlying disease in pediatric patients with Reye's syndrome or other hepatic impairment. (1, 8.4)
Benzonatate capsules, USP are indicated for the symptomatic relief of cough.
Dehydrated Alcohol Injection, USP is indicated for therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (tic douloureux), in patients for whom neurosurgical procedures are contraindicated. Relief of trigeminal neuralgia usually is only temporary. Other conditions for which injection of alcohol has been reported include glossopharyngeal neuralgia angina pectoris and severe claudication due to peripheral vascular insufficiency.
Alcohol concentrations of 40 to 50% (prepared by appropriate dilution of dehydrated alcohol) have been used for epidural or individual motor nerve injections to control certain manifestations of cerebral palsy and spastic paraplegia. Similar concentrations also have been injected for celiac plexus block to relieve pain of inoperable upper abdominal cancer, and have been injected intra- and subcutaneously for relief of intractable pruritus ani.
1 INDICATIONS & USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Ezetimibe and Simvastatin Tablets, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to:
reduce elevated
total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with
primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
(1.1)
reduce elevated
total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH),
as an adjunct to other lipid- lowering treatments. (1.2)
Limitations of Use (1.3)
No incremental
benefit of Ezetimibe and Simvastatin Tablets on cardiovascular morbidity and mortality
over and above that demonstrated for simvastatin has been established.
Ezetimibe
and Simvastatin Tablets has not been studied in Fredrickson Type I, III, IV, and
V dyslipidemias.
1.1 Primary Hyperlipidemia
Ezetimibe and Simvastatin Tablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
1.2 Homozygous Familial Hypercholesterolemia (HoFH)
Ezetimibe and Simvastatin Tablets are indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Limitations of Use
No incremental benefit of Ezetimibe and Simvastatin Tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Ezetimibe and Simvastatin Tablets has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
1INDICATIONS AND USAGE
Mycophenolic Acid Delayed-Release Tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (
1.1)
Use in combination with cyclosporine and corticosteroids. (
1.1)
Limitations of Use:
Mycophenolic Acid Delayed-Release Tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (
1.2)
1.1Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic Acid Delayed-Release Tablets areindicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic Acid Delayed-Release Tablets areindicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic Acid Delayed-Release Tablets areto be used in combination with cyclosporine and corticosteroids.
1.2Limitations of Use
Mycophenolic Acid Delayed-Release Tabletsand mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
INDICATIONS AND USAGE
Perennial Allergic Rhinitis
Cetirizine hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.
Chronic Urticaria
Cetirizine hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
INDICATIONS AND USAGE
Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.