Drugplain

Isolyte S pH 7.4 .03 g/100mL

SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE · INJECTION, SOLUTION · B. Braun Medical Inc.

No Recall HistoryCurrently in Shortage
Plain English

Isolyte S pH 7.4 is a injection, solution containing sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium phosphate, dibasic, and potassium phosphate at .03 g/100mL, taken intravenous. Manufactured by B. Braun Medical Inc..

Key Facts

Brand Name
Isolyte S pH 7.4
Generic Name
SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE
NDC Code (Product)
0264-7707
Manufacturer
B. Braun Medical Inc.
Strength
.03 g/100mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA019696
Marketing Start
09/29/1989

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

atrial fibrillation9 reports
bradycardia8 reports
caesarean section1 reports
exposure during pregnancy1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.

Dosage & Administration

DOSAGE AND ADMINISTRATION This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of magnesium and phosphate ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Warnings

WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present. Solutions containing gluconate or acetate should be used with great care in patients with metabolic or respiratory alkalosis and in those conditions in which there is an increased level or an impair

Contraindications

CONTRAINDICATIONS Contraindications: None known. Accurate clinical and laboratory estimation of fluid and electrolyte balance in order to access benefit/risk ratio are essential prior to administration of this solution (see WARNINGS and PRECAUTIONS ).

Drug Interactions

Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect. Parenteral magnesium should be administered with extreme caution to patients receiving digitalis preparations.

Adverse Reactions

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifyin

Frequently Asked Questions

What is Isolyte S pH 7.4 used for?

Isolyte S pH 7.4 contains SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Isolyte S pH 7.4 a controlled substance?

Isolyte S pH 7.4 is not classified as a controlled substance by the DEA.

What is the generic name for Isolyte S pH 7.4?

The generic name for Isolyte S pH 7.4 is SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE. There are no other listed brand versions of SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE.

What is the NDC code for Isolyte S pH 7.4 .03 g/100mL?

The NDC (National Drug Code) for Isolyte S pH 7.4 .03 g/100mL is 0264-7707, listed by B. Braun Medical Inc..

Product NDC

0264-7707

Package NDC

0264-7707-00

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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