um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
Respiratory tract infection (
1.1)
Otitis media (
1.2)
Skin and skin structure infections (
1.3)
Bone infections (
1.4)
Genitourinary tract infections (
1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets and other antibacterial drugs, cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (
1.6)
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of
Streptococcus pneumoniae and
Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of
Streptococcus pneumoniae,
Haemophilus influenzae,
Staphylococcus aureus,
Streptococcus pyogenes, and
Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus and
Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of
Staphylococcus aureus and
Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of
Escherichia coli,
Proteus mirabilis, and
Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets and other antibacterial drugs, cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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
Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for cariesprophylaxis.
Multivitamin with Fluoride 1.0 mg Chewable Tablets
provide 1.0 mg fluoride in tablet form for children 6-16years of age in areas where the water fluoride level is lessthan 0.3 ppm.
Multivitamin with Fluoride 1.0 mg Chewable Tablets
supply significant amounts of Vitamins A, C, D, E,thiamine, riboflavin, niacin, vitamin B6, vitamin B12, andfolate to supplement the diet, and to help assure thatnutritional deficiencies of these vitamins will not develop.
Thus, in a single easy-to-use preparation, children obtainten essential vitamins and the important mineral, fluoride.The American Academy of Pediatrics recommends thatchildren up to age 16, in areas where drinking watercontains less than optimal levels of fluoride, receive dailyfluoride supplements.
Children using
Multivitamin with Fluoride 1.0 mg
Chewable Tablets regularly should receive semiannualdental examinations. The regular brushing of teeth andattention to good oral hygiene practices are also essential.Multivitamin with Fluoride Chewable Tablets is aprescription product for the clinical dietary management ofthe metabolic processes of caries prophylaxis and providessupplementation of the diet with ten essential vitamins.
INDICATIONS AND USAGE
Glipizide tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Propafenone hydrochloride tablets are indicated to:
prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease.
prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease.
treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.
Usage Considerations:
The use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use propafenone hydrochloride tablets to control ventricular rate during AF.
Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
The use of propafenone hydrochloride tablets in patients with chronic atrial fibrillation has not been evaluated.
Because of the proarrhythmic effects of propafenone hydrochloride tablets, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.
The effect of propafenone on mortality has not been determined [see Boxed Warning].
Propafenone hydrochloride is an antiarrhythmic indicated to:
prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. (1)
prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients who do not have structural heart disease. (1)
treat documented life-threatening ventricular arrhythmias. (1)
Usage Considerations:
Use in patients with permanent atrial fibrillation or with atrial flutter or PSVT has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. (1)
In patients with atrial fibrillation and atrial flutter, use propafenone hydrochloride tablets with drugs that increase the atrioventricular nodal refractory period. (1)
Because of proarrhythmic effects, use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic. (1)
The effect of propafenone on mortality has not been determined. (1)
1
INDICATIONS AND USAGE
Yasmin is indicated for use by females of reproductive potential to prevent pregnancy.
Yasmin is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1)
Chronic Urticaria
Cetirizine hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
1 INDICATIONS AND USAGE
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (1)
INDICATIONS & USAGE
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin
50 mg/m2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
1 INDICATIONS AND USAGE
Palonosetron Hydrochloride Injection is indicated in adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC).
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, Palonosetron Hydrochloride Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Palonosetron Hydrochloride Injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in:
Adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1)
acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1)
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1)
Pediatric patients aged 1 month to less than 17 years for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC). (1)
1 INDICATIONS AND USAGE
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)
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 [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride tablets are indicated for the treatment of:
Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
Narcolepsy
Methylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
Risperidone is an atypical antipsychotic indicated for:
Treatment of schizophrenia. (1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. (1.2)
Treatment of irritability associated with autistic disorder. (1.3)
1.1 Schizophrenia
Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in four short-term trials in adults, two short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)].
1.2 Bipolar Mania
Monotherapy
Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in two short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)].
Adjunctive Therapy
Risperidone tablets adjunctive therapy with lithium or valproate are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums and quickly changing moods. Efficacy was established in three short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4)].
INDICATIONS AND USAGE
RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-release Tablets and other treatment options before deciding to use Diclofenac Sodium Delayed-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diclofenac Sodium Delayed-release Tablets, are indicated:
For relief of signs and symptoms of osteoarthritis
For relief of signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Irinotecan Hydrochloride Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.
Irinotecan Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
Irinotecan Hydrochloride Injectionis a topoisomerase inhibitor indicated for:
First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. (1)
Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. (1)
INDICATIONS AND USAGE
Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Supplementation of the diet with vitamins A, C and D.Tri-Vite Drops with Fluoride 0.5 mg also provides fluoride forcaries prophylaxis.
The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.5 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Dropswith Fluoride 0.5 mg
(See
Dosage and Administration
).
Tri-Vite Drops with Fluoride 0.5 mg supply significant amounts ofvitamins A, C and D to supplement the diet, and to help assure thatnutritional deficiencies of these vitamins will not develop.Thus, in a single easy-to-use preparation, children obtain essentialvitamins and fluoride.
1 INDICATIONS AND USAGE
Desflurane, USP, Liquid for Inhalation a general anesthetic, is an inhalation agent indicated:
for induction and/or maintenance of anesthesia in adults (
1.1)
for maintenance of anesthesia in pediatric patients following induction with agents other than Desflurane, USP, Liquid for Inhalation and intubation.
1.1
Induction of Anesthesia
Desflurane, USP, Liquid for Inhalation is indicated as an inhalational agent for induction of anesthesia for inpatient and outpatient surgery in adults.
Desflurane, USP, Liquid for Inhalation is contraindicated as an inhalational agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.
1.2 Maintenance of Anesthesia
Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.
After induction of anesthesia with agents other than Desflurane, USP, Liquid for Inhalation and tracheal intubation, Desflurane, USP, Liquid for Inhalation is indicated for maintenance of anesthesia in infants and children.
Desflurane, USP, Liquid for Inhalation is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions [
see Warnings and Precautions (
5.3) and Clinical Studies (
14.5)
]
.
Indications
This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
1 INDICATIONS AND USAGE
NEXIUM is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD) (1.1)
Risk reduction of NSAID-associated gastric ulcer (1.2)
H. pylori
eradication to reduce the risk of duodenal ulcer recurrence (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered.
In infants 1 month to less than 1 year, NEXIUM is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.
Maintenance of Healing of Erosive Esophagitis
NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori
Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Dosage and Administration (2) and Clinical Studies (14)
].
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 Clinical Pharmacology (12.4) and the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS AND USAGE
PROMACTA is a thrombopoietin receptor agonist indicated:
for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1)
for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2)
in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3)
for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3)
Limitations of Use:
PROMACTA is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). (1.4)
Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. (1.4)
1.1 Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia
PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
1.2 Treatment of Thrombocytopenia in Patients With Hepatitis C Infection
PROMACTA is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
1.3 Treatment of Severe Aplastic Anemia
PROMACTA is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
1.4 Limitations of Use
PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)].
Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
1 INDICATIONS AND USAGE
Naproxen tablets and naproxen sodium tablets are indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
Polyarticular Juvenile Idiopathic Arthritis
Naproxen tablets and naproxen sodium tablets are also indicated for:
the relief of signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
Naproxen tablets, and naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
Naproxen tablets and naproxen sodium tablets are also indicated for:
the relief of signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea