BALANCED SALT Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate

Get an overview of BALANCED SALT (calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in BALANCED SALT can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as BALANCED SALT.

Drug Basics

Brand Name: BALANCED SALT

Generic Name: CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: OPHTHALMIC

Dosage Form: SOLUTION

Data Current As Of: 2018-10-05

Rx only

description

BALANCED SALT SOLUTION is a sterile physiological solution containing calcium chloride (CaCl2·2H2O), magnesium chloride (MgCl2·6H2O), potassium chloride (KCl), sodium acetate (C2H3NaO2·3H2O), sodium chloride (NaCl) and sodium citrate (C6H5Na3O7·2H2O). This solution is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions. Each 1 mL contains:

Calcium Chloride (MW 147.02) 0.48 mg
Magnesium Chloride (MW 203.31) 0.30 mg
Potassium Chloride (MW 74.56) 0.75 mg
Sodium Acetate (MW 136.08) 3.90 mg
Sodium Chloride (MW 58.44) 6.40 mg
Sodium Citrate (MW 294.10) 1.70 mg
Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
Water for Injection
7.0 pH and 300 mosm/kg osmolality.

clinical pharmacology

Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eyes.

indications & usage

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

warnings

  • NOT FOR INJECTION OR INTRAVENOUS INFUSION.
  • Do not use unless product is clear, seal is intact, container is undamaged.
  • Do not use if product is discolored or contains a precipitate.
  • SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
  • This solution contains no preservative; unused contents should be discarded.

precautions

Open under aseptic conditions only.

Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction.

Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution (Sterile Irrigating Solution) was used as an irrigating solution.

adverse reactions

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

dosage & administration

18 mL bottle: The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle.

Method for Using Adaptor Plug for Ophthalmic Irrigating Needle:

  • Aseptically remove bottle from pouch by peeling backing.
  • Snap on surgeon's sterile irrigation needle. Push until firmly in place.
  • Test assembly for proper function before use.

how supplied:

NDC 17478-920-19 18 mL bottle

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.

AKORN
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
BLA0N Rev. 10/16

Principal Display Panel Text for Container Label:

NDC 17478-920-19 Akorn Logo

BALANCED

SALT SOLUTION

Rx only

NOT FOR INJECTION

OR INTRAVENOUS USE.

18 mL Sterile Single Dose Bottle

bal00 0002 01.jpg

Principal Display Panel Text for Carton Label:

NDC 17478-920-19 Akorn Logo

BALANCED SALT SOLUTION

30 Sterile Single Dose Bottles (18 mL each)

NOT FOR INJECTION OR INTRAVENOUS USE.

bal00 0002 02.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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