um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
ARTICADENT is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
INDICATIONS
Initial Treatment of Advanced Ovarian Carcinoma
Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see
CLINICAL STUDIES
).
There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival ( 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
Secondary Treatment of Advanced Ovarian Carcinoma
Carboplatin injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.
Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
INDICATIONS AND USAGE:
NataChew
is a prescription pre/post-natal multivitamin, multimineral indicated for use in improving the nutritional status of women throughout pregnancy, as well as in the post-natal period for both lactating and non-lactating mothers. This product is also useful in improving the nutritional status of women prior to conception.
1 INDICATIONS AND USAGE
Metformin hydrochloride tablets 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 are 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)
INDICATIONS AND USAGE
Clindamycin Injection, USP is indicated in the treatment of
serious infections caused by susceptible anaerobic bacteria.
Clindamycin Injection, USP is also indicated in the treatment of serious
infections due to susceptible strains of streptococci, pneumococci, and
staphylococci. Its use should be reserved for penicillin-allergic patients or
other patients for whom, in the judgment of the physician, a penicillin is
inappropriate. Because of the risk of antibiotic-associated pseudomembranous
colitis, as described in the WARNING box, before
selecting clindamycin the physician should consider the nature of the infection
and the suitability of less toxic alternatives (e.g., erythromycin).
Bacteriologic studies should be performed to determine the causative
organisms and their susceptibility to clindamycin.
Indicated surgical procedures should be performed in conjunction with
antibiotic therapy.
Clindamycin Injection, USP is indicated in the treatment of serious
infections caused by susceptible strains of the designated organisms in the
conditions listed below:
Lower respiratory tract infections including pneumonia, empyema, and lung
abscess caused by anaerobes, Streptococcus
pneumoniae, other streptococci (except E.
faecalis), and Staphylococcus aureus.
Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus
aureus, and anaerobes.
Gynecological infections including endometritis, nongonococcal tubo-ovarian
abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by
susceptible anaerobes.
Intra-abdominal infections including peritonitis and intra-abdominal abscess
caused by susceptible anaerobic organisms.
Septicemia caused by Staphylococcus aureus,
streptococci (except Enterococcus faecalis), and
susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused
by Staphylococcus aureus and as adjunctive therapy in
the surgical treatment of chronic bone and joint infections due to susceptible
organisms.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin and other antibacterial drugs, clindamycin 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
Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)].
Methylphenidate hydrochloride extended-release tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older (1)
1. Indications and Usage
Pregabalin is 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 Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS & USAGE
Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil for oral suspension, 10 mg/ mL was added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class IIIII symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
Sildenafilfor oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class IIIII symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
1 INDICATIONS AND USAGE
BOSULIF is indicated for the treatment of adult patients with:
Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy.
BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with
Newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML). (1)
Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. (1)
1 INDICATIONS AND USAGE
Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration:
As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
As an analgesic component of monitored anesthesia care in adult patients.
Remifentanil hydrochloride for injection is an opioid agonist indicated for intravenous administration:
As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. (1)
For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. (1)
As an analgesic component of monitored anesthesia care in adult patients. (1)
INDICATION
AND USE:
A topically applied
foaming solution primarily suited for patients with extensive aesthetic
restorations to aid in the prevention of dental caries.
1 INDICATIONS AND USAGE
Evamist is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1)
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause.
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain,where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
WARNINGS
], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Have not been tolerated, or are not expected to be tolerated
1 INDICATIONS AND USAGE
Desmopressin nasal spray 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 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 sprayis 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 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
Heparin Sodium Injection is indicated for:
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease
Atrial fibrillation with embolization
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures
Heparin Sodium Injection is an anticoagulant indicated for (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease
Atrial fibrillation with embolization
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures
INDICATIONS & USAGE SECTION
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (
14.1)].
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (
14.2)].
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and other antibacterial drugs, amoxicillin
should be used only to treat infections that are proven or strongly
suspected to be caused by bacteria. When culture and susceptibility information
are available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin is indicated in the treatment of infections due to
susceptible (ONLY -lactamasenegative) isolates of the designated
bacteria in the conditions listed below:
Amoxicillin is a penicillin-class antibacterial indicated for
treatment of infections due to susceptible strains of designated
microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory tract. (
1.1 -
1.5)
In combination for treatment of
H. pylori infection and
duodenal ulcer disease. (
1.6,
1.7)
1.1 Infections of the ear, nose, and
throat
- due to
Streptococcus species. (- and -hemolytic isolates only),
Streptococcus pneumoniae, Staphylococcus spp., or
Haemophilus
influenzae.
1.2 Infections of the genitourinary
tract
- due to
Escherichia
coli, Proteus mirabilis, or
Enterococcus faecalis.
1.3 Infections of the skin and skin
structure
- due to
Streptococcus spp. (- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the lower respiratory
tract
- due to
Streptococcus spp. (- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
1.5 Gonorrhea, acute uncomplicated (ano-genital and urethral infections in males and females)
- due to
Neisseria gonorrhoeae .
Because of high rates of amoxicillin resistance, amoxicillin is not
recommended for empiric treatment of gonorrhea. Amoxicillin use should be
limited to situations where
N.
gonorrhoeae isolates are known to be susceptible to
amoxicillin.
1.6 Triple therapy for
Helicobacter pylori with
clarithromycin and lansoprazole
Amoxicillin, in combination with
clarithromycin plus lansoprazole as triple therapy, is indicated for the
treatment of patients with
H.
pylori infection and duodenal ulcer disease (active or 1-year
history of a duodenal ulcer) to eradicate
H.
pylori. Eradication of
H.
pylori has been shown to reduce the risk of duodenal ulcer
recurrence.
1.7 Dual therapy for
H. pylori with
lansoprazole
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of
patients with
H. pylori infection
and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to
clarithromycin or in whom resistance to clarithromycin is known or
suspected. (See the clarithromycin package insert,
MICROBIOLOGY.) Eradication of
H.
pylori has been shown to reduce the risk of duodenal ulcer
recurrence.
1 INDICATIONS AND USAGE
ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years and older.
ZONISADE is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older (1).
INDICATIONS AND USAGE
Ampicillin and Sulbactam for Injection, USPis 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 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 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 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.
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 and other antibacterial drugs, ampicillin and sulbactam for injection 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
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 [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Cephalexin for oral suspension is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis
Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes
Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae
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 cephalexin and other antibacterial drugs, cephalexin 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.