um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
LUPRON DEPOT 11.25 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for:
Endometriosis
Management of endometriosis, including pain relief and reduction of endometriotic lesions. (1.1)
In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. (1.1)
Limitations of Use:
The total duration of therapy with LUPRON DEPOT 11.25 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density. (1.1, 2.1,5.1)
Uterine Leiomyomata (Fibroids)
Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. (1.2)
Limitations of Use:
LUPRON DEPOT 11.25 mg is not indicated for combination use with norethindrone acetate add-back therapy for the preoperative hematologic improvement of women with anemia caused by heavy menstrual bleeding due to fibroids. (1.2)
1.1 Endometriosis
Monotherapy
LUPRON DEPOT 11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions.
In Combination with Norethindrone Acetate
LUPRON DEPOT 11.25 mg in combination with norethindrone acetate is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with LUPRON DEPOT 11.25 mg is referred to as add-back therapy, and is intended to reduce the loss of bone mineral density (BMD) and reduce vasomotor symptoms associated with use of LUPRON DEPOT 11.25 mg.
Limitations of Use:
The total duration of therapy with LUPRON DEPOT 11.25 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density [see Dosage and Administration
(
2.1
)
and Warnings and Precautions
(
5.1
)
].
1.2 Uterine Lei
omyomata (Fibroids)
LUPRON DEPOT 11.25 mg, used concomitantly with iron therapy, is indicated for the preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary.
Consider a one-month trial period on iron alone, as some women will respond to iron alone [see Clinical Studies (
14.2
)].LUPRON DEPOT 11.25 mg may be added if the response to iron alone is considered inadequate.
Limitations of Use:
LUPRON DEPOT 11.25 mg is not indicated for combination use with norethindrone acetate add-back therapy for the preoperative hematologic improvement of women with anemia caused by heavy menstrual bleeding due to fibroids [see Dosage and Administration (
2.1
)].
INDICATION AND USAGE:
Disulfiram is an aid in the management of selected chronic alcohol patients who to remain in a state of enforced sobriety so that supportive and psychotherapeutic
treatment may be applied to best advantage.
want
Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking
pattern of the chronic alcoholic.
1.1 Complicated Skin and Skin Structure Infections (cSSSI)
Daptomycin for Injection is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).
Pediatric use information is approved for Merck & Co., Inc.s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
Trimipramine Maleate Capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression.
1 INDICATIONS AND USAGE
Desmopressin nasal spray solution is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older.
Limitations of Use:
Desmopressin nasal spray solution is not indicated for:
Treatment of nephrogenic diabetes insipidus, Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1)
], Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)],
Use in patients with an impaired level of consciousness, Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths (3)].
Desmopressin nasal spray solution is a vasopressin analog indicated as antidiuretic replacement therapy in the management of central diabetes insipidus for adults and pediatric patients 4 years of age and older (1)
Limitations of Use:
Desmopressin nasal spray solution is not indicated for:
Treatment of nephrogenic diabetes insipidus (1)
Treatment of primary nocturnal enuresis (1, 5.1)
Use in patients with conditions that compromise intranasal route of administration (1, 5.2)
Use in patients with an impaired level of consciousness (1)
Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg (1, 3)
1 INDICATIONS AND USAGE
Ramipril capsules, USP is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. They may be used alone or in combination with thiazide diuretics (1.1).
1.1 Hypertension
Ramipril Capsules, USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics.
1 INDICATIONS AND USAGE
Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of
adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Morphine Sulfate Oral Solution 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.
Morphine Sulfate Oral Solution is an opioid agonist (1)
Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of: (1)
adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
pediatric patients 2 years of age and older with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for:
treatment of major depressive disorder (MDD) (
1.1)
prevention of seasonal affective disorder (SAD) (
1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment
[see
Clinical Studies (14.1)
].
1.2 Seasonal Affective Disorder (SDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM
[see
Clinical Studies (14.2)
].
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
Warningsand
Precautions (5), Clinical
Pharmacology (12.4) and
ClinicalStudies(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)].
1 INDICATIONS AND USAGE
Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:
Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids. (1.1)
Liver Transplant: Administer no earlier than 30 days post-transplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. (1.2, 5.5)
Limitations of Use(1.3)Safety and efficacy have not been established in the following:
Kidney transplant patients at high immunologic risk (1.3)
Recipients of transplanted organs other than kidney or liver (1.3, 5.7)
Pediatric patients (less than 18 years) (1.3)
1.1 Prophylaxis of Organ Rejection in Kidney Transplantation
Everolimus is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see Clinical Studies (14.1)]. Everolimus is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring (TDM) of everolimus and cyclosporine is recommended for all patients receiving these products [see Dosage and Administration (2.2, 2.3)].
1.2 Prophylaxis of Organ Rejection in Liver Transplantation
Everolimus is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Everolimus is to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see Warnings and Precautions (5.5), Clinical Studies (14.2)]. TDM of everolimus and tacrolimus is recommended for all patients receiving these products [see Dosage and Administration (2.3, 2.5)].
1.3 Limitations of Use
The safety and efficacy of everolimus has not been established in the following populations
Kidney transplant patients at high immunologic risk
Recipients of transplanted organs other than kidney and liver [see Warnings and Precautions (5.7)]
Pediatric patients (less than 18 years).
INDICATIONS AND USAGE
LUPRON INJECTION (leuprolide acetate) is indicated in the palliative treatment of advanced prostatic cancer.
INDICATIONS AND USAGE
Adult Patients
Flumazenil is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil is indicated for the reversal of conscious sedation induced with benzodiazepines. (See
PRECAUTIONSPediatric Use
.)
1 INDICATIONS AND USAGE
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting.
Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.'s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of (1):
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use (1)
Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting.
1 INDICATIONS AND USAGE
Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
not responded adequately to conventional therapy.
Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS.
Because of infrequent but serious gastrointestinal adverse reactions associated withalosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.
Clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men.
Alosetrontablets are a selective serotonin 5-HT3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal tract excluded and
not responded adequately to conventional therapy.(1)
Severe IBS includes diarrhea and 1 or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS.(1)
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
1	INDICATIONS AND USAGE
Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches
0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)
] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1)
Figure
1 INDICATIONS AND USAGE
Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Solifenacin succinate is a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
1 INDICATIONS AND USAGE
Irenka is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
Irenka is indicated for the treatment of:
Major Depressive Disorder[see CLINICAL STUDIES 14.1]
Generalized Anxiety Disorder[see CLINICAL STUDIES 14.2]
Diabetic Peripheral Neuropathy[see CLINICAL STUDIES 14.3]
Chronic Musculoskeletal Pain[see CLINICAL STUDIES 14.5]
1 INDICATIONS AND USAGE
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizers LYRICA (pregabalin) Capsules. However, due to Pfizers marketing exclusivity rights, this drug product is not labeled with that pediatric
information.
Pregabalin capsules are indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN). (1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older. (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury. (1)
1 INDICATIONS AND USAGE
Aripiprazole orally disintegrating tablets are indicated for the treatment of:
Schizophrenia [seeClinical Studies (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole orally disintegrating tablets are an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
INDICATIONS AND USAGE
SPECTRACEF (cefditoren pivoxil) is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.
Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae (including -lactamase-producing strains), Haemophilus parainfluenzae (including -lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), or Moraxella catarrhalis (including -lactamase-producing strains).
Community-Acquired Pneumonia caused by Haemophilus influenzae (including -lactamase-producing strains), Haemophilus parainfluenzae (including -lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: SPECTRACEF is effective in the eradication of Streptococcus pyogenes from the oropharynx. SPECTRACEF has not been studied for the prevention of rheumatic fever following Streptococcus 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) or Streptococcus pyogenes.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF and other antibacterial drugs, SPECTRACEF 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
Ammonia N 13 Injection USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Ammonia N 13 Injection USP is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease (
1).