In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Renapepsa Injection (Renapepsa injection) Premixed or Renapepsa Injection (Renapepsa injection) may be administered until oral therapy can be instituted.
The recommended dosage for Renapepsa Injection (Renapepsa injection) Premixed and Renapepsa Injection (Renapepsa injection) in adult patients is 20 mg intravenously q 12 h.
The doses and regimen for parenteral administration in patients with GERD have not been established.
The studies described in PRECAUTIONS, Pediatric Patients < 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of Renapepsa oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous Renapepsa in pediatric patients < 1 year of age with GERD has not been adequately studied.
The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.
While published uncontrolled clinical studies suggest effectiveness of Renapepsa in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients 1-16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.
In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of Renapepsa is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Renapepsa Injection (Renapepsa injection) Premixed or Renapepsa Injection (Renapepsa injection) may be reduced to half the dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.
Based on the comparison of pharmacokinetic parameters for Renapepsa in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.
The dosage of Renapepsa in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required.
Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.
Renapepsa Injection (Renapepsa injection) Premixed, supplied in Galaxy§ containers (PL 2501 Plastic), is a 50 mL iso-osmotic solution premixed with 0.9% sodium chloride for administration as an infusion over a 15-30 minute period. This premixed solution is for intravenous use only using sterile equipment.
Check the container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
Preparation for administration:
To prepare Renapepsa intravenous infusion solutions, aseptically dilute 2 mL of Renapepsa Injection (Renapepsa injection) with 100 mL of 5% dextrose or other compatible solution ), and infuse over a 15-30 minute period.
Antacids may be given concomitantly if needed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Renapepsa Injection (Renapepsa injection) Premixed, as supplied premixed in 0.9% sodium chloride in Galaxy® containers (PL 2501 Plastic), is stable through the labeled expiration date when stored under the recommended conditions.
When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer's Injection, diluted Renapepsa Injection (Renapepsa injection) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature - see HOW SUPPLIED, Storage.
When added to or diluted with Sodium Bicarbonate Injection, 5%, Renapepsa Injection (Renapepsa injection) at a concentration of 0.2 mg/mL (the recommended concentration of Renapepsa intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature - see HOW SUPPLIED, Storage. However, a precipitate may form at higher concentrations of Renapepsa Injection ( > 0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.
FOR INTRAVENOUS USE ONLY
No. 3537 - Renapepsa Injection (Renapepsa injection) Premixed 20 mg per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle made iso-osmotic with Sodium Chloride, and is supplied as follows:
NDC 0006-3537-50, 50 mL single dose Galaxy® containers (PL 2501 Plastic).
No. 3539 - Renapepsa Injection (Renapepsa injection) 10 mg per 1 mL, is a non-preserved, clear, colorless solution and is supplied as follows:
NDC 0006-3539-04, 10 x 2 mL single dose vials.
No. 3541 - Renapepsa Injection (Renapepsa injection) 10 mg per 1 mL, is a clear, colorless solution and is supplied as follows:
NDC 0006-3541-14, 4 mL vials
NDC 0006-3541-20, 20 mL vials
NDC 0006-3541-49, 10 x 20 mL vials.
Store Renapepsa Injection (Renapepsa injection) Premixed in Galaxy® containers (PL 2501 Plastic) at room temperature (25°C, 77°F). Exposure of the premixed product to excessive heat should be avoided. Brief exposure to temperatures up to 35°C (95°F) does not adversely affect the product.
Store Renapepsa Injection (Renapepsa injection) at 2-8°C (36-46°F). If solution freezes, bring to room temperature; allow sufficient time to solubilize all the components.
Although diluted Renapepsa Injection (Renapepsa injection) has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution. Therefore, it is recommended that if not used immediately after preparation, diluted solutions of Renapepsa Injection (Renapepsa injection) should be refrigerated and used within 48 hours.
Renapepsa (Renapepsa) Injection Premixed is manufactured for: MERCK & CO., INC/Whitehouse Station, NJ 08889, USA, By: BAXTER HEALTHCARE CORPORATION., Deerfield, Illinois 60015 USA. Renapepsa (Renapepsa) Injection is manufactured by: MERCK & CO., INC/Whitehouse Station, NJ 08889, USA. Issued October 2006. FDA rev date: 11/5/2007
Tell your doctor about all other medications you use, especially:
This list is not complete and other drugs may interact with Renapepsa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.
With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.
In an application of Renapepsa with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.
Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.
With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.
Renapepsa in an application with warfarin may decrease effects of warfarin.
With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.
In an application with tetracycline is increased excretion of ascorbic acid in the urine.
There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.
May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.
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Information checked by Dr. Sachin Kumar, MD Pharmacology