um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Palonosetron Hydrochloride Injectionis a serotonin-3 (5-HT
3) 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)
Palonosetron Hydrochloride Injectionis 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 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 Injectionis 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.
1 INDICATIONS AND USAGE
Voriconazole for injection is an azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)
1.1 Invasive Aspergillosis
Voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of invasive aspergillosis (IA). 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, 14.5) and Microbiology (12.4)].
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
Voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of 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, 14.5) and Microbiology (12.4)].
1.3 Esophageal Candidiasis
Voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of esophageal candidiasis (EC) in adults [see Clinical Studies (14.3, 14.5) and Microbiology (12.4)].
1.4 Scedosporiosis and Fusariosis
Voriconazole for injection is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4)].
1.5 Usage
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.
Additional pediatric use information is approved for PF PRISM C.V.'s VFEND (voriconazole). However, due to PF PRISM C.V.'s marketing exclusivity rights, this drug product is not labeled with that information.
INDICATIONS AND USAGE
Haloperidol decanoate injection 50 mg/mL and haloperidol decanoate injection 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
1 INDICATIONS AND USAGE
Hydroxyurea capsules, USP is indicated for the treatment of:
Resistant chronic myeloid leukemia.
Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination withchemoradiation.
Hydroxyurea capsules, USP is an antimetabolite indicated for the treatment of:
Resistant chronic myeloid leukemia.
(1)
Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation.
(1)
1 INDICATIONS AND USAGE
Paricalcitol capsules are a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism associated with
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD) (1.2).
Renal osteodystrophy in CKD Stage 5 patients (with prevention of hyperphosphatemia).
1.1 Chronic Kidney Disease Stages 3 and 4
Paricalictol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
1.2 Chronic Kidney Disease Stage 5
Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
1 INDICATIONS AND USAGE
Succinylcholine chloride injection is indicated in adults and pediatric patients:
as an adjunct to general anesthesia
to facilitate tracheal intubation
to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Succinylcholine chloride is a depolarizing neuromuscular blocker indicated in adults and pediatric patients:
as an adjunct to general anesthesia (1)
to facilitate tracheal intubation (1)
to provide skeletal muscle relaxation during surgery or mechanical ventilation. (1)
1 INDICATIONSAND USAGE
Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Decitabine for injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocyticleukemia)and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring Systemgroups.(1)
INDICATIONS AND USAGE
Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.
1 INDICATIONS AND USAGE
Celecoxib capsules are indicated
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)]
1 INDICATIONS AND USAGE
JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
JANUMET should not be used in patients with type 1 diabetes mellitus.
JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET. [See Warnings and Precautions (5.2).]
JANUMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
JANUMET should not be used in patients with type 1 diabetes. (1)
JANUMET has not been studied in patients with a history of pancreatitis. (1, 5.2)
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules 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.
Dicloxacillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug (see
CLINICAL PHARMACOLOGY
Susceptibility Testing
).
Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.
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 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.
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) strains of the designated microorganisms in the conditions listed below:
Infections of the ear, nose, and throat due to Streptococcus spp. (- and -hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae.
Infections of the genitourinary tract
due to E. coli, P. mirabilis, or E. faecalis.
Infections of the skin and skin structure
due to Streptococcus spp. (- and -hemolytic strains only), Staphylococcus spp., or E. coli.
Infections of the lower respiratory tract due to Streptococcus spp. (- and -hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to N. gonorrhoeae (males and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence
Triple therapy: Amoxicillin /clarithromycin/lansoprazoleAmoxicillin, 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. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION.)
Dual therapy: Amoxicillin/lansoprazoleAmoxicillin, 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. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION.)
Indicated surgical procedures should be performed.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketorolac tromethamine tablets are indicated for the short-term ( 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see
WARNINGS
,
PRECAUTIONS
,
DOSAGE AND ADMINISTRATION
, and
ADVERSE REACTIONS
). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days.
1 INDICATIONS AND USAGE
ASCOMP with CODEINE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve ASCOMP with CODEINE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
1.1 Erectile Dysfunction
Tadalafil tablets, USP are indicated for the treatment of erectile dysfunction (ED).
1.2 Benign Prostatic Hyperplasia
Tadalafil tablets, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets, USP are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4 Limitation of Use
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies (14.3)].
INDICATIONS & USAGE
Diabetic Gastroparesis (Diabetic Gastric Stasis)
Metoclopramide Injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.
The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy
Metoclopramide Injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.
The Prevention of Postoperative Nausea and Vomiting
Metoclopramide Injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.
Small Bowel Intubation
Metoclopramide Injection may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.
Radiological Examination
Metoclopramide Injection may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.
INDICATIONS AND USAGE
Lindane Shampoo is indicated for the treatment of head lice (infestations of Pediculosis humanis capitis), crab lice (infestations of Pthirus pubis), and their ova only in patients who
cannot tolerate other approved therapies, or
have failed treatment with other approved therapies.
Lindane Shampoo should be used in the context of an overall lice management program that includes:
Visual inspection to ensure that the patient is currently infested with live lice (empty egg casings or "nits" can remain on hair shaft long after true infestation).
Manual removal of nits using a comb designed for this purpose and/or individual removal with tweezers followed by close examination of the hair and scalp.
Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Shampoo only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
Caregivers applying this product to patients should wear gloves less permeable to Lindane such as nitrile, latex with neoprene or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Lindane.
Lindane Shampoo does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.
INDICATIONS AND USAGE
Lithium carbonate extended-release tablets, USP is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets, USP is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.
Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
1 INDICATIONS AND USAGE
Isoproterenol hydrochloride injection is indicated:
To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output
For bronchospasm occurring during anesthesia
Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated:
To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output. (
1)
For treatment of bronchospasm occurring during anesthesia. (
1)
1 INDICATIONS AND USAGE
Epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
Epinastine hydrochloride ophthalmic solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. (1)
1 INDICATIONS AND USAGE
Gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerobic gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis group*
Streptococcus oralis*
Streptococcus pneumoniae
Aerobic gram-negative bacteria:
Haemophilus influenzae
*Efficacy for these organisms were studied in fewer than 10 infections.
Gatifloxacin ophthalmic solution is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae (1)
INDICATIONS & USAGE
Propofol injectable emulsion is an IV general anesthetic and sedation drug that can be used as described in the table below.
TABLE 3. INDICATIONS FOR PROPOFOL INJECTABLE EMULSION
Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see
PRECAUTIONS, Pediatric Use).
Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.
In the Intensive Care Unit (ICU), propofol injectable emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see
PRECAUTIONS, Pediatric Use).
Propofol injectable emulsion is not recommended for obstetrics, including Cesarean section deliveries. Propofol injectable emulsion crosses the placenta, and as with other general anesthetic agents, the administration of propofol injectable emulsion may be associated with neonatal depression (see
PRECAUTIONS).
Propofol is not recommended for use in nursing mothers because propofol injectable emulsion has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (see
PRECAUTIONS).
INDICATIONS & USAGE