um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Mannitol Injection is indicated for:
Reduction of intracranial pressure and treatment of cerebral edema.
Reduction of elevated intraocular pressure.
Mannitol Injection is an osmotic diuretic, indicated for the reduction of:
intracranial pressure and treatment of cerebral edema.
elevated intraocular pressure.
1.12 Uncomplicated Urinary Tract Infections
Levofloxacin in 5% Dextrose Injection is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to
Escherichia coli, Klebsiella pneumoniae, or
Staphylococcus saprophyticus.
Because fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, have been associated with serious adverse reactions
[see Warnings and Precautions (
5.1-
5.15)]
and for some patients uncomplicated urinary tract infection is self-limiting, reserve Levofloxacin in 5% Dextrose Injection for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.
1 INDICATIONS AND USAGE
RETAVASE is indicated for use in acute ST-elevation myocardial infarction (STEMI) to reduce the risk of death and heart failure.
Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose STEMI puts them at low risk for death or heart failure.
RETAVASE is a tissue plasminogen activator (tPA) indicated for treatment of acute ST-elevation myocardial infarction (STEMI) to reduce the risk of death and heart failure. (1)
Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose STEMI puts them at low risk for death or heart failure. (1)
1 INDICATIONS AND USAGE
Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh
60 kg (1.3)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see
Clinical Studies
(14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [seeClinical Studies
(14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular andPolyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh 60 kg [see Dosage and Administration
(2.4) and Clinical Studies (14.2)].
1
INDICATIONS AND USAGE
SEVENFACT[coagulation factor VIIa (recombinant)-jncw] is indicated forthe treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.
Limitation of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency.
SEVENFACT [coagulation factor VIIa (recombinant)-jncw] is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents(12 years of age and older) with hemophilia A or B with inhibitors (1).
Limitation of Use: SEVENFACT is not indicated for treatment of congenital factor VII deficiency.
1.	INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)
]
CELEBREX is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
Familial Adenomatous Polyposis (FAP)-adjunct to usual care) (1.7)
1.1	Osteoarthritis (OA)
CELEBREX is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)
]
1.2	Rheumatoid Arthritis (RA)
CELEBREX is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)
]
1.3
Juvenile Rheumatoid Arthritis (JRA)
CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)
]
1.4	Ankylosing Spondylitis (AS)
CELEBREX is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)
]
1.5	Acute Pain (AP)
CELEBREX is indicated for the management of AP in adults [see Clinical Studies (14.5)
]
1.6	Primary Dysmenorrhea (PD)
CELEBREX is indicated for the treatment of PD [see Clinical Studies (14.5)
]
1.7	Familial Adenomatous Polyposis (FAP)
CELEBREX is indicated to reduce the number of adenomatous colorectal polyps in FAP, as an adjunct to usual care (e.g., endoscopic surveillance, surgery). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. It is also not known whether the effects of CELEBREX treatment will persist after CELEBREX is discontinued. The efficacy and safety of CELEBREX treatment in patients with FAP beyond six months have not been studied [see Warnings and Precautions (5.15), Clinical Studies (14.6)
]
1 INDICATIONSAND USAGE
Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
Metformin hydrochloride tablets, USP are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (
1)
1 INDICATIONS AND USAGE
BARHEMSYS is indicated in adults for:
prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
BARHEMSYS is a dopamine-2 (D2) antagonist indicated in adults for:
Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. (1)
Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis. (1)
INDICATIONS AND USAGE
Cytarabine in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative-free only) is indicated for the prophylaxis and treatment of meningeal leukemia.
1 INDICATIONS AND USAGE
Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established.
If a patient has no response to the first migraine or cluster headache attack treated with Sumatriptan injection, reconsider the diagnosis before Sumatriptan injection is administered to treat any subsequent attacks.
Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.
Sumatriptan injection is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults (1)
Acute treatment of cluster headache in adults (1)
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established (1)
Not indicated for the prophylactic therapy of migraine or cluster headache attacks (1)
INDICATIONS AND USAGE
Ampicillin and sulbactam for injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli
*, Klebsiella spp.* (including K. pneumoniae*
), Proteus mirabilis
*, Bacteroides fragilis
*, Enterobacter spp.*, and Acinetobacter calcoaceticus
*.
NOTE: For information on use in pediatric patients (see
PRECAUTIONS-Pediatric Use
and
CLINICAL STUDIES
sections).
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae
*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli
*, and Bacteroides spp.* (including B. fragilis
*).
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been
well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride capsules and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride capsules was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.
INDICATIONS AND USAGE
ISOCAINE is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.
1
INDICATIONS AND USAGE
Sensipar is a positive modulator of the calciumsensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.(1.1)
Limitations of Use:Sensipar is not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2)
Hypercalcemia in adult patients withprimary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3)
1.1
Secondary Hyperparathyroidism
Sensipar is indicated for the treatment of secondary hyperparathyroidism (HPT) in adultpatients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (
14.1
)].
Limitations of Use:
Sensipar is not indicated for use in patients with CKD who are not ondialysis because of an increased risk of hypocalcemia[see Warnings and Precautions (
5.1
)]
.
1.2
Parathyroid Carcinoma
Sensipar is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (
14.2
)].
1.3
Primary Hyperparathyroidism
Sensipar is indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see Clinical Studies (
14.3
)].
INDICATIONS AND USAGE
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin.
Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptornegative tumors. (See
CLINICAL STUDIES: Breast Carcinoma
.)
Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
Paclitaxel is indicated for the second-line treatment of AIDS-related Kaposis sarcoma.
1 INDICATIONS AND USAGE
1.1 Duodenal Ulcer (adults)PRILOSEC is indicated for short-term treatment of active duodenal
ulcer in adults. Most patients heal within four weeks. Some patients may require
an additional four weeks of therapy.
PRILOSEC in combination with clarithromycin and amoxicillin, is indicated for
treatment of patients with H. pylori infection and
duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
PRILOSEC, in combination with clarithromycin is indicated for treatment of
patients with H. pylori infection and duodenal ulcer
disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce
the risk of duodenal ulcer recurrence [see
Clinical Studies (14.1) and
Dosage and Administration (2)
].
Among patients who fail therapy, PRILOSEC with clarithromycin is more likely
to be associated with the development of clarithromycin resistance as compared
with triple therapy. In patients who fail therapy, susceptibility testing should
be done. If resistance to clarithromycin is demonstrated or susceptibility
testing is not possible, alternative antimicrobial therapy should be instituted.
[See
Microbiology
section (12.4)], and the clarithromycin package insert, Microbiology
section.)
1.2 Gastric Ulcer (adults)PRILOSEC is indicated for short-term treatment (4-8 weeks) of
active benign gastric ulcer in adults. [See
Clinical Studies (14.2) ]
1.3 Treatment of Gastroesophageal Reflux Disease
(GERD) (adults and pediatric patients)
Symptomatic GERD
PRILOSEC is indicated for the treatment of heartburn and other symptoms
associated with GERD in pediatric patients and adults.
Erosive Esophagitis
PRILOSEC is indicated for the short-term treatment (4-8 weeks) of erosive
esophagitis that has been diagnosed by endoscopy in pediatric patients and
adults. [See
Clinical
Studies (14.4) ]
The efficacy of PRILOSEC used for longer than 8 weeks in these patients has
not been established. If a patient does not respond to 8 weeks of treatment, an
additional 4 weeks of treatment may be given. If there is recurrence of erosive
esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of
omeprazole may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis
(adults and pediatric patients)PRILOSEC is indicated to maintain healing of erosive esophagitis
in pediatric patients and adults.
Controlled studies do not extend beyond 12 months. [See
Clinical Studies (14.4) ]
1.5 Pathological Hypersecretory Conditions
(adults)PRILOSEC is indicated for the long-term treatment of pathological
hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine
adenomas and systemic mastocytosis) in adults.
INDICATIONS AND USAGE
Cefadroxil is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E.
coli, P.
mirabilis, and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.
Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil and other antibacterial drugs, cefadroxil 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 AND USAGE
Fluocinonide Cream USP, 0.05% (Emulsified Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Enter section text here
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1)
1 INDICATIONS & USAGE
Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. (1)
1 INDICATIONS AND USAGE
OPZELURA is a Janus kinase (JAK) inhibitor indicated for:
the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatricpatients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. (1.1)
the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. (1.2)
Limitations of Use
Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended. (1.3)
1.1 Atopic Dermatitis
OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatricpatients 12years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
1.2Nonsegmental Vitiligo
OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
1.3Limitations of Use
Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
Indications and Usage
Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.1.1 Important Limitations of Use
Alfuzosin hydrochloride extended-release tabletsare not indicated for the treatment of hypertension.
Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.
Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
1 INDICATIONS AND USAGE
Lamotrigine extended-release tablets are indicated for:
adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
(
1.1)
conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. (
1.2)
Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. (
1.3)
1.1 Adjunctive Therapy
Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
1.2 Monotherapy
Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.3 Limitation of Use
Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established.
1 INDICATIONS AND USAGE
PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. (1)
1
INDICATIONS AND USAGE
XTANDI is indicated for the treatment of patients with:
castration-resistant prostate cancer (CRPC)
metastatic castration-sensitive prostate cancer (mCSPC)
XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with:
castration-resistant prostate cancer. (1)
metastatic castration-sensitive prostate cancer. (1)