PHYSIOSOL IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PHYSIOSOL IN PLASTIC CONTAINER (PHYSIOSOL IN PLASTIC CONTAINER).
PHYSIOSOL is a sterile, non-pyrogenic isotonic solution of electrolytes (sodium, potassium, calcium, magnesium, chloride, acetate, and gluconate) in water for injection. It serves as a source of water and electrolytes to expand extracellular fluid volume and maintain osmotic balance. The acetate and gluconate ions are metabolized to bicarbonate, providing an alkalinizing effect.
| Metabolism | The acetate and gluconate ions are metabolized in the liver and peripheral tissues, primarily via the tricarboxylic acid cycle, to bicarbonate. Electrolytes (sodium, potassium, calcium, magnesium, chloride) are not metabolized but are excreted or reabsorbed as per physiological needs. |
| Excretion | Renal excretion of water and electrolytes; >95% of administered volume is excreted unchanged by kidneys within 24 hours; minimal (<5%) fecal or biliary elimination. |
| Half-life | Not applicable (physiologic solution); infused electrolytes and water distribute and are eliminated with kinetics dependent on renal function; terminal half-life reflects water turnover (~3-6 days in healthy adults). |
| Protein binding | Negligible (<1%); electrolytes are not bound to plasma proteins. |
| Volume of Distribution | Approximately 0.55 L/kg (total body water); distributes into extracellular fluid (0.2 L/kg) and intracellular water (0.4 L/kg). |
| Bioavailability | Intravenous: 100%; oral: 100% (but not relevant as product is for IV use only). |
| Onset of Action | Immediate upon intravenous infusion; within minutes to restore intravascular volume and correct electrolyte imbalances. |
| Duration of Action | Duration is dependent on infusion rate and renal function; effects persist as long as infusion is maintained; after discontinuation, correction of deficit lasts 1-2 hours before re-distribution. |
Intravenous infusion; dose based on fluid and electrolyte requirements; typical adult dose: 500-1000 mL/h as needed to maintain hydration and electrolyte balance.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required; monitor serum electrolytes and fluid balance closely in renal impairment; adjust infusion rate based on renal function to avoid fluid overload. |
| Liver impairment | No specific dose adjustment required; monitor serum electrolytes and acid-base balance in severe hepatic impairment. |
| Pediatric use | Intravenous infusion; dosing based on body weight; typical dose: 10-20 mL/kg for acute replacement, then adjust based on maintenance requirements; monitor electrolyte levels. |
| Geriatric use | Use with caution; start with lower end of dosing range; monitor for fluid overload, electrolyte disturbances, and renal function due to age-related changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PHYSIOSOL IN PLASTIC CONTAINER (PHYSIOSOL IN PLASTIC CONTAINER).
| Breastfeeding | Safety in breastfeeding has not been established. Since Physiosol is a balanced electrolyte solution, it is unlikely to pose significant risk to the nursing infant. However, caution is advised. The milk-to-plasma (M/P) ratio is not available. |
| Teratogenic Risk | Physiosol in plastic container is a sterile, non-pyrogenic isotonic solution of electrolytes and water. It contains no known teratogenic agents. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with this solution. Therefore, it should be used during pregnancy only if clearly needed. No specific fetal risks have been identified for any trimester when used as directed. |
■ FDA Black Box Warning
Not for injection into the epidural, intrathecal, or intra-arterial spaces. Do not administer if solution contains visible particulate matter or is discolored. Use only if solution is clear and container is undamaged.
| Serious Effects |
["Hypersensitivity to any component of the solution","Hyperkalemia","Hypercalcemia","Severe metabolic alkalosis","Patients with significant fluid overload or pulmonary edema","Concomitant administration with blood products via same IV line"]
| Precautions | ["Monitor serum electrolytes, fluid balance, and renal function during prolonged therapy","Use with caution in patients with heart failure, renal impairment, or conditions predisposing to fluid overload","Avoid rapid administration to prevent hypervolemia and electrolyte disturbances","Contains potassium; use cautiously in patients with hyperkalemia or conditions predisposing to potassium retention","Contains calcium; do not administer simultaneously with blood products through the same IV line due to risk of precipitation"] |
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| Fetal Monitoring | Monitor maternal vital signs, fluid balance, serum electrolytes, and urine output during prolonged administration. Fetal monitoring is not routine but may be considered if maternal fluid overload or electrolyte imbalance occurs. |
| Fertility Effects | No studies have evaluated the effect of Physiosol on fertility. It is not expected to impair fertility since it contains only physiological electrolytes. |