Edema Hp

Edema Hp Manufacturers

• Natural Creations, Inc.
  

  ×

  Edema Hp | Natural Creations, Inc.

  

  ---

  DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  Close
  No Recall

  More Info
• Bioactive Nutritional, Inc.
  

  ×

  Edema Hp | Glenmark Pharmaceuticals Inc., Usa

  

  ---

  2.1 Instructions for Use in All Patients

  Voriconazole tablets should be taken at least one hour before or after a meal.

  2.3 Recommended Dosing in Adults

  Invasive Aspergillosis and Serious Fungal Infections due to Fusarium Spp. and Scedosporium Apiospermum

  See Table 1. Therapy must be initiated with the specified loading dose regimen of intravenous voriconazole on Day 1 followed by the recommended maintenance dose regimen. Intravenous treatment should be continued for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized. The recommended oral maintenance dose of 200 mg achieves a voriconazole exposure similar to 3 mg/kg IV; a 300 mg oral dose achieves an exposure similar to 4 mg/kg IV. Switching between the intravenous and oral formulations is appropriate because of the high bioavailability of the oral formulation in adults [see Clinical Pharmacology (12)].

  Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections

  See Table 1. Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.

  Esophageal Candidiasis

  See Table 1. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

  Table 1 Recommended Dosing Regimen

  Infection

  Loading Dose

  Maintenance Dosea,b

  IV

  IV

  Oralc

  Invasive Aspergillosisd

  6 mg/kg q12h for the first 24 hours

  4 mg/kg q12h

  200 mg q12h

  Candidemia in non-neutropenic patients and other deep tissue Candida infections

  6 mg/kg q12h for the first 24 hours

  3 to 4 mg/kg q12he

  200 mg q12h

  Esophageal Candidiasis

  f

  f

  200 mg q12h

  Scedosporiosis and Fusariosis

  6 mg/kg q12h for the first 24 hours

  4 mg/kg q12h

  200 mg q12h

  a Increase dose when voriconazole is co-administered with phenytoin or efavirenz (7); Decrease dose in patients with hepatic impairment (2.7)
  bIn healthy volunteer studies, the 200 mg oral q12h dose provided an exposure (AUCτ) similar to a 3 mg/kg IV q12h dose; the 300 mg oral q12h dose provided an exposure (AUCτ) similar to a 4 mg/kg IV q12h dose [see Clinical Pharmacology (12)].
  c Adult patients who weigh less than 40 kg should receive half of the oral maintenance dose.
  d In a clinical study of invasive aspergillosis, the median duration of intravenous voriconazole therapy was 10 days (range 2 to 85 days). The median duration of oral voriconazole therapy was 76 days (range 2 to 232 days) [see Clinical Studies (14.1)].
  e In clinical trials, patients with candidemia received 3 mg/kg IV q12h as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg q12h as salvage therapy. Appropriate dose should be based on the severity and nature of the infection
  f Not evaluated in patients with esophageal candidiasis.

  2.4 Dosage Adjustment

  If patient response is inadequate, the oral maintenance dose may be increased from 200 mg every 12 hours (similar to 3 mg/kg IV q12h) to 300 mg every 12 hours (similar to 4 mg/kg IV q12h). For adult patients weighing less than 40 kg, the oral maintenance dose may be increased from 100 mg every 12 hours to 150 mg every 12 hours. If patient is unable to tolerate 300 mg orally every 12 hours, reduce the oral maintenance dose by 50 mg steps to a minimum of 200 mg every 12 hours (or to 100 mg every 12 hours for adult patients weighing less than 40 kg).

  The maintenance dose of voriconazole should be increased when co-administered with phenytoin or efavirenz [seeDrug Interactions (7)].

  The maintenance dose of voriconazole should be reduced in patients with mild to moderate hepatic impairment, Child-Pugh Class A and B [see Dosage and Administration (2.7)]. There are no PK data to allow for dosage adjustment recommendations in patients with severe hepatic impairment (Child-Pugh Class C).

  Duration of therapy should be based on the severity of the patient’s underlying disease, recovery from immunosuppression, and clinical response.

  2.7 Use in Patients With Hepatic Impairment

  In the clinical program, patients were included who had baseline liver function tests (ALT, AST) up to 5 times the upper limit of normal. No dose adjustment is necessary in patients with this degree of abnormal liver function, but continued monitoring of liver function tests for further elevations is recommended [see Warnings and Precautions (5.9)].

  It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B) [see Clinical Pharmacology (12.3)].

  Voriconazole tablets have not been studied in patients with severe hepatic cirrhosis (Child-Pugh Class C) or in patients with chronic hepatitis B or chronic hepatitis C disease. Voriconazole has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and should only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk. Patients with hepatic insufficiency must be carefully monitored for drug toxicity.

  2.8 Use in Patients With Renal Impairment

  The pharmacokinetics of orally administered voriconazole tablets are not significantly affected by renal impairment. Therefore, no adjustment is necessary for oral dosing in patients with mild to severe renal impairment [see Clinical Pharmacology (12.3)].

  In patients with moderate or severe renal impairment (creatinine clearance <50 mL/min), accumulation of the intravenous vehicle, SBECD, occurs. Oral voriconazole should be administered to these patients, unless an assessment of the benefit/risk to the patient justifies the use of intravenous voriconazole. Serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral voriconazole therapy [see Warnings and Precautions (5.10)].

  Voriconazole is hemodialyzed with clearance of 121 mL/min. The intravenous vehicle, SBECD, is hemodialyzed with clearance of 55 mL/min. A 4-hour hemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.

  Close
  No Recall

  More Info
• Energique, Inc.
  

  ×

  Edema Hp | Energique, Inc.

  

  ---

  Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

  Close
  No Recall

  More Info