Nutrilyte

Name: Nutrilyte

Uses of Nutrilyte

  • It is used to give electrolytes to the body when more are needed. This product must be mixed in TPN solution before it is given.

What do I need to tell my doctor BEFORE I take Nutrilyte?

  • If you have an allergy to Nutrilyte (total parenteral nutrition (TPN) electrolytes) or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Very bad swelling caused by heart, kidney, or liver problems; high blood potassium levels; or heart problems like heart block.
  • If you are not able to pass urine.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Nutrilyte with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Nutrilyte) best taken?

Use Nutrilyte as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some other side effects of Nutrilyte?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Nutrilyte?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Warnings

  1. Strongly hypertonic solutions. Must be properly diluted and thoroughly mixed before injection.
  2. Contains no phosphate. Patients receiving TPN solutions containing concentrated dextrose may also require phosphate in addition to Nutrilyte. It is necessary to take into consideration the calcium and magnesium ions in this solution in order to avoid precipitation where phosphate is present in the diluted solution. Phosphate (10-15 mEq/L), calcium (5 mEq/L) and magnesium (5-10 mEq/L) rarely are incompatible when properly mixed. Higher levels must be added cautiously with adequate mixing (avoid layering) and inspection. Additional calcium and phosphate may be added to alternate bottles. If additional phosphate is required, it is essential to consider the salt form because of pre-existing levels of potassium and the final concentration of phosphate in the infusate.
  3. Each 20 mL of Nutrilyte contains 40.5 mEq of potassium. Patient requirements should be carefully evaluated prior to the addition of any potassium salt to a solution containing Nutrilyte.
  4. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

    Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

  1. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration.
  2. Blood levels of sodium, potassium, calcium, magnesium, phosphorus and chloride should be monitored frequently during parenteral nutrition or intravenous therapy, and the daily dosage of electrolytes may require tailoring to meet individual needs. In tissue electrolyte depletion, addition of certain electrolytes may be required to meet individual patient needs.
  3. Care must be exercised administering solutions containing up to 30 mEq of sodium and 40 mEq of potassium per liter to patients with renal or cardiovascular insufficiency, particularly if they are postoperative or elderly. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin or to other salt-retaining patients. Potassium replacement therapy may be guided by serial electrocardiograms since plasma levels are not necessarily indicative of tissue potassium levels.
  4. Administration of barbiturates, narcotics or hypnotics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.
  5. Parenteral magnesium and/or calcium and/or potassium should be administered with extreme caution to patients receiving digitalis preparations.
  6. Extraordinary electrolyte and fluid losses are not necessarily corrected by infusion of solutions containing Nutrilyte. In order to avoid deficits, special consideration must be given to replacement of excessive fluid and electrolyte losses in such conditions as protracted vomiting or diarrhea, nasogastric suction or fistula drainage.
  7. If both phosphate and a Nutrilyte Concentrate are to be added to the solution for TPN administration, add the Nutrilyte Concentrate to one container (either to the amino acids or the concentrated dextrose) and add the phosphate to the other to avoid physical incompatibilities between calcium and phosphorus.

Dosage and administration

For adults, one 20 mL dose of Nutrilyte should be added to each liter of amino acid/dextrose solution (TPN) or other suitable intravenous solution.

Route: Nutrilyte Concentrate is for prescription compounding of intravenous admixtures only. The solution is strongly hypertonic. Not for direct patient injection. Dilute to appropriate strength with suitable intravenous fluid prior to administration.

DIRECTIONS FOR DISPENSING FROM 100 mL PHARMACY BULK PACKAGENOT FOR DIRECT INFUSION

The 100 mL Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. The 100 mL Pharmacy Bulk Package should be suspended (inverted) by its IV hang label in a laminar flow hood or biological safety cabinet. Prior to entering a Pharmacy Bulk Package, remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. Entry into the Pharmacy Bulk Package must be made with a sterile transfer set or other sterile dispensing device and the contents dispensed in aliquots using aseptic technique. Use of a syringe needle is not recommended as it may cause leakage. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS AFTER INITIAL ENTRY. The date and the time initially opened should be recorded in the space provided on the Pharmacy Bulk Package label.

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

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