um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
ACIPHEX delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1).
Maintenance of Healing of Erosive or Ulcerative GERD (1.2).
Treatment of Symptomatic GERD (1.3).
Healing of Duodenal Ulcers (1.4).
Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence (1.5).
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD (1.7).
1.1 Healing of Erosive or Ulcerative GERD in Adults
ACIPHEX delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD).
For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
ACIPHEX delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance).
Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
ACIPHEX delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
ACIPHEX delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers.
Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
ACIPHEX delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
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 (12.2)
and the full prescribing information for clarithromycin].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
ACIPHEX delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
ACIPHEX delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.
Urinary Tract Infections:
For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media:
For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets USP in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets USP are not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults:
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim tablets USP offers some advantage over the use of a single antimicrobial agent.
Shigellosis:
For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis Carinii Pneumonia:
For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
Travelers Diarrhea in Adults:
For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
Zolpidem tartrate extended-release tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES (14)].
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 epidemology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE:
Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
Surgical Anesthesia:
epidural block for surgery including cesarean section; major nerve block; local infiltration
Acute Pain Management:
epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration
1 INDICATIONS AND USAGE
Ondansetron is indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron is a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2. (
1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (
1)
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. (
1)
postoperative nausea and/or vomiting. (
1)
1 INDICATIONS AND USAGE
Testosterone topical gel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired)
testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelters syndrome, chemotherapy, or toxic damage from alcohol, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [FSH] and luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired)
gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range.
Limitations of Use
Safety and efficacy of testosterone topical gel in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of testosterone topical gel in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
Testosterone topical gel is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of Use
Safety and efficacy of testosterone topical gel in men with age-related hypogonadism have not been established. (1)
Safety and efficacy of testosterone topical gel in males less than 18 years old have not been established. (8.4)
INDICATIONS
Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo-skeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.
INDICATIONS AND USAGE
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets are indicated for the relief of symptoms associated
with seasonal allergic rhinitis in adults and children 12 years of age and
older. Symptoms treated effectively include sneezing, rhinorrhea, itchy
nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release
Tablets should be administered when both the antihistaminic properties of
fexofenadine hydrochloride and the nasal decongestant properties of
pseudoephedrine hydrochloride are desired (see CLINICAL
PHARMACOLOGY).
INDICATIONS AND USAGE
Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletalconditions.Themodeofactionofmethocarbamolhasnotbeenclearlyidentified, butmay berelatedtoitssedativeproperties.Methocarbamoldoesnotdirectlyrelaxtenseskeletal musclesinman.
INDICATIONS AND USAGE
Cromolyn sodium inhalation solution, USP is a prophylactic agent indicated in the management of patients with bronchial asthma.
In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution, USP is given by inhalation on a regular daily basis (see
DOSAGE AND ADMINISTRATION). The effect of cromolyn sodium inhalation solution is usually evident after several weeks of treatment, although some patients show an almost immediate response.
In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium inhalation solution should be given shortly before exposure to the precipitating factor (see
DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
TYLENOL with Codeine (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 TYLENOL with Codeine 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 & USAGE
Risperidone is an atypical antipsychotic agent 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 oral solution, USP is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 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 oral solution, USP is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 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 oral solution, USP adjunctive therapy with lithium or valproate is 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 oral solution, USP is 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 3 short-term trials in children and adolescents (ages 5 to 17 years) [see
Clinical Studies (14.4)
].
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution (preservative free) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution (preservative free) is a carbonic anhydrase inhibitor with a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
INDICATIONS AND USAGE
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
Methylphenidate HCl Oral Solution is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
1 INDICATIONS AND USAGE
Levetiracetam injectionis indicated for adjunctive therapy, as an alternative when oral administration is temporarily not feasible, in the treatment of:
Partial onset seizures in patients 1 month of age and older with epilepsy (1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial Onset Seizures
Levetiracetam injection, USP is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Levetiracetam injection, USP is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam injection, USP is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam injection, USP is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam injection, USP is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Levetiracetam injection, USP is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
1 INDICATIONS AND USAGE
Voriconazole is an azole antifungal drug indicated for use in the treatment of:
Invasive aspergillosis (1.1)
Candidemia (non-neutropenics) and disseminated candidiasis
in skin, abdomen, kidney, bladder wall and wounds (1.2)
Esophageal candidiasis (1.3)
Serious infections caused by Scedosporium apiospermum
and Fusarium
species including Fusarium solani , in patients
intolerant of, or refractory to, other therapy (1.4)
Voriconazole is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections:
1.1 Invasive Aspergillosis
In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1) and Clinical Pharmacology (12.4)].
1.2 Candidemia in Non-neutropenic Patients and the Following Candida Infections: Disseminated Infections in Skin and Infections in Abdomen, Kidney, Bladder Wall, and Wounds
[See Clinical Studies (14.2) and Clinical Pharmacology (12.4).]
1.3 Esophageal Candidiasis
[See Clinical Studies (14.3) and Clinical Pharmacology (12.4).]
1.4 Serious Fungal Infections Caused by Scedosporium apiospermum (Asexual Form of Pseudallescheria boydii) and Fusarium spp. Including Fusarium solani, in Patients Intolerant of, or Refractory to, Other Therapy
[See Clinical Studies (14.4) and Clinical Pharmacology (12.4).]
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
INDICATIONS AND USAGE
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life-threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.
INDICATIONS AND USAGE
Trihexyphenidyl HCl tablets are indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.
INDICATIONS AND USAGE
Atracurium besylate injection is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
INDICATIONS AND USAGE
Mycelex Troches are indicated for the local treatment of oropharyngeal candidiasis.The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.Mycelex Troches are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION.)