PHYSIOSOL IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | Composite mixture; water 18.02, electrolytes vary (e.g., Na+ 23, Cl- 35.45, etc.) |
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 | PHYSIOSOL is a balanced isotonic crystalloid solution. No evidence of teratogenicity; use only if clearly needed. |
| 2nd trimester | Safe for maternal fluid and electrolyte maintenance; monitor for fluid overload. |
| 3rd trimester | Safe for volume expansion; avoid excessive administration due to risk of maternal edema and potential for neonatal electrolyte disturbances. |
Clinical note
Comprehensive clinical and safety monograph for PHYSIOSOL IN PLASTIC CONTAINER (PHYSIOSOL IN PLASTIC CONTAINER).
| Placental transfer | Electrolytes and water cross placenta freely; no specific binding or accumulation. |
| Breastfeeding | PHYSIOSOL components are normal plasma constituents; excreted in breast milk in small amounts, not expected to cause adverse effects in nursing infants. |
| Lactation Rating | Safe |
| 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. |
| 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. |
■ 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 componentSevere fluid overloadHypernatremiaSevere electrolyte abnormalities uncorrectable by this solution
| 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 |
| Food/Dietary | No specific food interactions. However, consider overall fluid and electrolyte intake from diet, especially sodium and potassium, to avoid imbalances. |
| Clinical Pearls | Physiosol in plastic container is a balanced electrolyte solution for intravenous administration, primarily used for replacement of extracellular fluid losses. Monitor for signs of fluid overload, especially in patients with heart failure or renal impairment. The plastic container may leach phthalates; use with caution in neonates and pregnant women. Do not administer if solution is discolored or contains particulate matter. |
| Patient Advice | This solution is given intravenously to replace fluids and electrolytes. · Report any signs of allergic reaction, such as rash, itching, or difficulty breathing. · Notify your healthcare provider if you experience swelling, shortness of breath, or rapid weight gain. · Do not stop the infusion without consulting your doctor. |
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