Maximum Strength Acid Reducer

Maximum Strength Acid Reducer Manufacturers

• L.n.k. International, Inc.
  

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  Maximum Strength Acid Reducer | Western Family Foods, Inc.

  

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  mL = milliliter shake well before using measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product adults and children 12 years and over 30 mL (1 dose) every 1 hour as needed do not take more than 4 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years of age: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

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• Family Dollar
  

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  Maximum Strength Acid Reducer | Strides Arcolab Limited

  

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  2.1 Dosage in Adult Kidney and Liver, or Heart Transplant Patients

  The initial oral dosage recommendations for adult patients with kidney, liver, or heart transplants along with recommendations for whole blood trough concentrations are shown in Table 1. The initial dose of tacrolimus should be administered no sooner than 6 hours after transplantation in the liver and heart transplant patients. In kidney transplant patients, the initial dose of tacrolimus may be administered within 24 hours of transplantation, but should be delayed until renal function has recovered. For blood concentration monitoring details see Dosage and Administration (2.6).

  Table 1. Summary of Initial Oral Dosage Recommendations and Observed Whole Blood Trough Concentrations in Adults *  In a second smaller trial, the initial dose of tacrolimus was 0.15 to 0.2 mg/kg/day and observed tacrolimus concentrations were 6 to 16 ng/mL during month 1 to 3 and 5 to 12 ng/mL during month 4 to 12 [see  Clinical Studies (14.1)]. Patient Population
  
  Recommended Tacrolimus 
  Initial Oral Dosage
  Note: daily doses should be
  administered as two divided
  doses, every 12 hours
  Observed  Tacrolimus Whole
   Blood Trough Concentrations
  Adult kidney transplant patients
  In combination with 
  azathioprine 
  
  0.2 mg/kg/day
  
  month 1 to 3 : 7 to 20 ng/mL
  month 4 to 12 : 5 to 15 ng/mL
  In combination with 
  MMF/IL-2 receptor antagonist *
  0.1 mg/kg/day
  month 1 to 12: 4 to 11 ng/mL
  Adult liver transplant patients
  0.10 to 0.15 mg/kg/day
  month 1 to 12 : 5 to 20 ng/mL
  Adult heart transplant patients
  0.075 mg/kg/day
  month 1to 3: 10 to 20 ng/mL
  month ≥4: 5 to 15 ng/mL
  

  Dosing should be titrated based on clinical assessments of rejection and tolerability. Lower tacrolimus dosages than the recommended initial dosage may be sufficient as maintenance therapy. Adjunct therapy with adrenal corticosteroids is recommended early post-transplant.

  The data in kidney transplant patients indicate that the Black patients required a higher dose to attain comparable trough concentrations compared to Caucasian patients (Table 2).

  Table 2. Comparative Dose and Trough Concentrations Based on Race Time After
  Transplant
  Caucasian
  n=114
  Black
  n=56
  
  Dose
  (mg/kg)
  Trough
  Concentrations
  (ng/mL)
  Dose
  (mg/kg)
  Trough
  Concentrations
  (ng/mL)
  Day 7
  0.18
  12.0
  0.23
  10.9
  Month 1
  0.17
  12.8
  0.26
  12.9
  Month 6
  0.14
  11.8
  0.24
  11.5
  Month 12
  0.13
  10.1
  0.19
  11.0
  

  Initial Dose – Injection

  Tacrolimus injection should be used only as a continuous IV infusion and when the patient cannot tolerate oral administration of tacrolimus capsules. Tacrolimus injection should be discontinued as soon as the patient can tolerate oral administration of tacrolimus capsules, usually within 2 to 3 days. In a patient receiving an IV infusion, the first dose of oral therapy should be given 8 to 12 hours after discontinuing the IV infusion.

  The observed trough concentrations described above pertain to oral administration of tacrolimus only; while monitoring tacrolimus concentrations in patients receiving tacrolimus injection as a continuous IV infusion may have some utility, the observed concentrations will not represent comparable exposures to those estimated by the trough concentrations observed in patients on oral therapy.

  The recommended starting dose of tacrolimus injection is 0.03 to 0.05 mg/kg/day in kidney and liver transplant and 0.01 mg/kg/day in heart transplant given as a continuous IV infusion. Adult patients should receive doses at the lower end of the dosing range. Concomitant adrenal corticosteroid therapy is recommended early post-transplantation.

  Anaphylactic reactions have occurred with injectables containing castor oil derivatives, such as tacrolimus injection. [see Warnings and Precautions (5.11)].

  2.2 Dosage in Pediatric Liver Transplant Patients

  The initial oral dosage recommendations for pediatric patients with liver transplants along with recommendations for whole blood trough concentrations are shown in Table 3. For blood concentration monitoring details see Dosage and Administration (2.6). If necessary, pediatric patients may start on an IV dose of 0.03 to 0.05 mg/kg/day.

  Table 3. Summary of Initial Oral Dosage Recommendations and Observed Whole Blood Trough Concentrations in Children Patient Population
  Recommended Tacrolimus Initial
  Oral Dosage
  Note: daily doses should be
  administered as two divided
  doses, every 12 hours
  Observed  Tacrolimus Whole Blood Trough Concentrations
  Pediatric liver transplant patients
  0.15 to 0.20 mg/kg/day
  month 1 to 12 : 5 to 20 ng/mL
  

  Pediatric liver transplantation patients without pre-existing renal or hepatic dysfunction have required and tolerated higher doses than adults to achieve similar blood concentrations.

  Experience in pediatric kidney and heart transplantation patients is limited.

  2.3 Dosage Adjustment in Patients with Renal Impairment

  Due to its potential for nephrotoxicity, consideration should be given to dosing tacrolimus at the lower end of the therapeutic dosing range in patients who have received a liver or heart transplant and have pre-existing renal impairment. Further reductions in dose below the targeted range may be required.

  In kidney transplant patients with post-operative oliguria, the initial dose of tacrolimus should be administered no sooner than 6 hours and within 24 hours of transplantation, but may be delayed until renal function shows evidence of recovery.

  2.4 Dosage Adjustments in Patients with Hepatic Impairment

  Due to the reduced clearance and prolonged half-life, patients with severe hepatic impairment (Child Pugh ≥ 10) may require lower doses of tacrolimus. Close monitoring of blood concentrations is warranted.

  The use of tacrolimus in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood concentrations of tacrolimus. These patients should be monitored closely and dosage adjustments should be considered. Some evidence suggests that lower doses should be used in these patients [see Dosage and Administration (2.1), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.5 Administration Instructions

  It is recommended that patients initiate oral therapy with tacrolimus capsules if possible. Initial dosage and observed tacrolimus whole blood trough concentrations for adults are shown in Table 1 and for pediatrics in Table 3 [seeDosage and Administration (2.1, 2.2)]; for blood concentration monitoring details in kidney transplant patients [see Dosage and Administration (2.1)].

  It is important to take tacrolimus capsules consistently every day either with or without food because the presence and composition of food decreases the bioavailability of tacrolimus [see Clinical Pharmacology (12.3)].

  Patients should not eat grapefruit or drink grapefruit juice in combination with tacrolimus capsules [see Drug Interactions (7.2)].

  Tacrolimus should not be used simultaneously with cyclosporine. Tacrolimus or cyclosporine should be discontinued at least 24 hours before initiating the other. In the presence of elevated tacrolimus or cyclosporine concentrations, dosing with the other drug usually should be further delayed.

  In patients unable to take oral tacrolimus capsules, therapy may be initiated with tacrolimus injection as a continuous IV infusion. If IV therapy is necessary, conversion from IV to oral tacrolimus capsules is recommended as soon as oral therapy can be tolerated. This usually occurs within 2 to 3 days. In patients receiving an IV infusion, the first dose of oral therapy should be given 8 to 12 hours after discontinuing the IV infusion

  2.6 Therapeutic Drug Monitoring

  Monitoring of tacrolimus blood concentrations in conjunction with other laboratory and clinical parameters is considered an essential aid to patient management for the evaluation of rejection, toxicity, dose adjustments and compliance. Observed whole blood trough concentrations can be found in Table 1. Factors influencing frequency of monitoring include but are not limited to hepatic or renal dysfunction, the addition or discontinuation of potentially interacting drugs and the post-transplant time. Blood concentration monitoring is not a replacement for renal and liver function monitoring and tissue biopsies. Data from clinical trials show that tacrolimus whole blood concentrations were most variable during the first week post-transplantation.

  The relative risks of toxicity and efficacy failure are related to tacrolimus whole blood trough concentrations. Therefore, monitoring of whole blood trough concentrations is recommended to assist in the clinical evaluation of toxicity and efficacy failure.

  Methods commonly used for the assay of tacrolimus include high performance liquid chromatography with tandem mass spectrometric detection (HPLC/MS/MS) and immunoassays. Immunoassays may react with metabolites as well as parent compound. Therefore assay results obtained with immunoassays may have a positive bias relative to results of HPLC/MS. The bias may depend upon the specific assay and laboratory. Comparison of the concentrations in published literature to patient concentrations using the current assays must be made with detailed knowledge of the assay methods and biological matrices employed. Whole blood is the matrix of choice and specimens should be collected into tubes containing ethylene diamine tetraacetic acid (EDTA) anti-coagulant. Heparin anti-coagulation is not recommended because of the tendency to form clots on storage. Samples which are not analyzed immediately should be stored at room temperature or in a refrigerator and assayed within 7 days; see assay instructions for specifics. If samples are to be kept longer they should be deep frozen at -20° C. One study showed drug recovery >90% for samples stored at -20° C for 6 months, with reduced recovery observed after 6 months.

  2.7 Preparation for Intravenous Product

  Tacrolimus injection must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a concentration between 0.004 mg/mL and 0.02 mg/mL prior to use. Diluted infusion solution should be stored in glass or polyethylene containers and should be discarded after 24 hours. The diluted infusion solution should not be stored in a PVC container due to decreased stability and the potential for extraction of phthalates. In situations where more dilute solutions are utilized (e.g., pediatric dosing, etc.), PVC-free tubing should likewise be used to minimize the potential for significant drug adsorption onto the tubing.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Due to the chemical instability of tacrolimus in alkaline media, tacrolimus injection should not be mixed or co-infused with solutions of pH 9 or greater (e.g., ganciclovir or acyclovir).

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• L.n.k. International, Inc.
  

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  Maximum Strength Acid Reducer | Rite Aid

  

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  adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor 

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