-: First Apradil I.V. MUST be reconstituted with Sterile Water for Injection, USP.
-: Inject 5 mL of ONLY Sterile Water for Injection, USP into a 30 mg vial of Apradil I.V. for Injection. The resulting solution will contain Apradil 6 mg/mL (30 mg/5 mL).
-: Failure to reconstitute with Sterile Water may result in formation of precipitation/particulates.
-: Mix gently until the powder is dissolved.

The pH of this reconstituted solution is approximately 11. The reconstituted solution can be held for 1 hour when stored at 25°C (77°F) prior to further dilution.

STEP TWO - Preparation of Admixture

-: Dilute the reconstituted solution in either 50 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP, or 5% Dextrose Injection, USP.
-: The admixture should be stored at 25°C (77°F) and should be administered within the designated time period as listed in Table 5. No refrigeration is required.

Table 5
Diluent	pH	Administer within:
0.9% Sodium Chloride Injection, USP	Approximately 10.2	24 hours
Lactated Ringer's Injection, USP	Approximately 10.0	24 hours
5% Dextrose Injection, USP	Approximately 9.5	12 hours

-: Once the admixture is prepared, proceed toInstructions for Priming and Use of Filter.

Reconstitution with Baxter's MINI-BAG Plus Container

-: Apradil I.V. for Injection can be reconstituted directly into 50 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP utilizing Baxter's MINI-BAG Plus Container.
-: Refer to separate instructions that are provided with Baxter's MINI-BAG Plus Container.
-: Once the admixture is prepared, proceed to Instructions for Priming and Use of Filter.

The admixture should be stored at 25°C (77°F) and should be administered within the designated time period as listed in Table 6. No refrigeration is required.

Table 6
Diluent	pH	Administer within:
0.9% Sodium Chloride Injection, USP	Approximately 10.2	24 hours
5% Dextrose Injection, USP	Approximately 9.5	8 hours

Instructions for Priming and Use of Filter

TO PRIME FILTER

-: Prime administration set in usual manner and close administration set clamp.
-: Connect luer adapter of administration set to filter inlet using a twisting motion. Over-tightening should be avoided.
-: Hold filter below the level of solution container.
-: Open administration set clamp and slowly prime filter.
-: Close administration set clamp. Verify no air bubbles are present on patient side of filter.
-: If air bubbles are observed, open set clamp slightly to re-establish flow then gently tap filter housing. Observe that no air bubbles are present and close clamp.
-: Connect to patient and regulate flow. Filter may be primed using a syringe and saline.
-: The administration set can then be connected to inlet of filter.

PRECAUTIONS WITH USE OF FILTER

Follow instructions carefully:

-: Use Aseptic technique. For single use only. Do not resterilize or reuse. Do not use if package is damaged.
-: If repositioning of filter is required, loosen luer locking collar, reposition, then retighten locking collar firmly.
-: Maximum working pressure is 1500 mmHg (30 psi, 2 bar). When the working limits of the filter are exceeded, causes of the added resistance should be investigated and corrected.
-: The internal volume of the filter is approx. 0.7 mL.
-: The administration set clamp should be closed during solution container change.
-: Pumps should not be used downstream of filter.

Administration

Do not administer with other drugs or diluents as this may cause incompatibilities.

IN-LINE FILTER THAT IS PROVIDED MUST BE USED when administering Apradil I.V. for Injection via an administration set.

Follow these steps:

Flush the Apradil I.V. for Injection administration port before administration of Apradil I.V. for Injection with at least 5 cc of either:
- 0.9% Sodium Chloride Injection, USP,
- Lactated Ringer’s Injection, USP, or
- 5% Dextrose Injection, USP.
Attach the filter and administration set.
Administer Apradil I.V. for Injection over 30 minutes.
Remove and discard the administration set, including the filter, used for Apradil I.V. for Injection.
Flush the administration port with at least 5 cc of above mentioned solutions.

If the administration port is not flushed and the administration set is not removed, Apradil degradation may occur with time, and black or brown particulate may be observed in the tubing or on the filter.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Treatment of Erosive Esophagitis

The recommended adult dose (when patients are unable to take the oral therapy) is 30 mg of Apradil (1 vial of Apradil I.V. for Injection) per day administered by I.V. infusion over 30 minutes for up to 7 days. Once the patient is able to take medications orally, therapy can be switched to an oral Apradil formulation for a total of 6 to 8 weeks. Refer to full prescribing information for the oral formulations of Apradil.

No dosage adjustment is necessary in patients with renal insufficiency or the elderly. For patients with severe liver disease, dosage adjustment should be considered.

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What other drugs will affect Apradil?

Ask a doctor or pharmacist if it is safe for you to use Apradil if you are also using any of the following drugs:

ampicillin;
atazanavir;
clarithromycin;
digoxin;
iron-containing medicines (ferrous fumarate, ferrous gluconate, ferrous sulfate, and others);
ketoconazole;
methotrexate;
mycophenolate mofetil;
nelfinavir;
tacrolimus;
theophylline; or
warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may interact with Apradil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Apradil interactions

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Drugs With pH-Dependent Absorption

Due to its effects on gastric acid secretion, Apradil can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. As with other drugs that decrease the intragastric acidity, the absorption of drugs such as ampicillin esters, ketoconazole, atazanavir, nelfinavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease, while the absorption of drugs such as digoxin can increase during treatment with Apradil.

Apradil is likely to substantially decrease the systemic concentrations of HIV protease inhibitors, such as atazanavir and nelfinavir, which are dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir or nelfinavir and the development of HIV resistance. Therefore, Apradil should not be co-administered with atazanavir or nelfinavir.

Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving PPIs and MMF. Use Apradil with caution in transplant patients receiving MMF.

Warfarin

In a study of healthy subjects, co-administration of single or multiple 60 mg doses of Apradil and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

Tacrolimus

Concomitant administration of Apradil and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

Theophylline

A minor increase (10%) in the clearance of theophylline was observed following the administration of Apradil concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when Apradil is started or stopped to ensure clinically effective blood levels.

Clopidogrel

Concomitant administration of Apradil and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition. No dose adjustment of clopidogrel is necessary when administered with an approved dose of Apradil.

Methotrexate

Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of high dose methotrexate with PPIs have been conducted.

In a study of rheumatoid arthritis patients receiving low-dose methotrexate, Apradil and naproxen, no effect on pharmacokinetics of methotrexate was observed.

Combination Therapy With Clarithromycin

Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions. Because of these drug interactions, clarithromycin is contraindicated for co-administration with certain drugs.

For information about drug interactions of antibacterial agents (amoxicillin and clarithromycin) indicated in combination with Apradil, refer to the DRUG INTERACTIONS section of their package inserts.

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References

DailyMed. "LANSOPRAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
MeSH. "Proton Pump Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "2-({[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl}sulfinyl)-1H-benzimidazole: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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