DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER (DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER).
DIANEAL LOW CALCIUM W/DEXTROSE 3.5% provides a hyperosmotic solution for peritoneal dialysis. Dextrose generates an osmotic gradient across the peritoneal membrane, promoting fluid and solute removal (ultrafiltration). Low calcium content helps manage hypercalcemia in patients requiring peritoneal dialysis.
| Metabolism | Dextrose is metabolized systemically via glycolysis and oxidative phosphorylation; approximately 60-80% absorbed across peritoneum. Calcium is absorbed and regulated by renal and bone homeostasis. |
| Excretion | Primarily removed via peritoneal dialysis; negligible renal excretion due to local administration. Dextrose is metabolized systemically; dialysate is drained as waste. |
| Half-life | Not applicable; drug is not systematically absorbed. Dextrose has half-life of ~1.5-2 hours after absorption. |
| Protein binding | Not applicable; dextrose does not bind to proteins. Calcium in dialysate binds partially to albumin (~50% bound). |
| Volume of Distribution | Not applicable; remains in peritoneal cavity. Dextrose distributes into total body water (~0.6 L/kg) after absorption, but clinically irrelevant. |
| Bioavailability | Not applicable; administered intraperitoneally as a dialysis solution; not absorbed as a drug. |
| Onset of Action | Immediate upon instillation into peritoneal cavity for ultrafiltration and solute removal. |
| Duration of Action | Dwell time of 4-6 hours for standard exchanges; longer dwells (8-12 hours) for nocturnal cycling. Clinical effect persists until dialysate drainage. |
Intraperitoneal: 2-3 L per exchange, 4-5 exchanges daily, as prescribed by physician based on body size and residual renal function.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required; drug is indicated for peritoneal dialysis in ESRD. Dose titrated to achieve adequate dialysis adequacy (Kt/V). |
| Liver impairment | No dose adjustment required for Child-Pugh class A, B, or C; peritoneal dialysis solution does not undergo hepatic metabolism. |
| Pediatric use | Intraperitoneal: 800-1400 mL/m² per exchange, 4-5 exchanges daily, adjusted to achieve target ultrafiltration and solute clearance. |
| Geriatric use | Use standard adult dose; monitor for fluid and electrolyte balance due to potential comorbidities; consider lower fill volumes if tolerated poorly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER (DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER).
| Breastfeeding | No data on excretion into breast milk. Low molecular weight of dextrose suggests excretion, but minimal oral bioavailability. Caution advised. M/P ratio not established. |
| Teratogenic Risk | Insufficient data in pregnant women. Animal reproduction studies not conducted. Dextrose solutions administered intravenously are not associated with teratogenic risk; however, effects of intraperitoneal glucose and potential electrolyte shifts are unknown. Risk cannot be excluded. |
■ FDA Black Box Warning
Not for intravenous use. Only for intraperitoneal administration.
| Serious Effects |
["Hypersensitivity to dextrose or any component","Pre-existing severe hyperglycemia or hyperosmolar state","Severe hypocalcemia (uncorrected)","Documented loss of peritoneal function or extensive adhesions","Acute abdomen or bowel perforation"]
| Precautions | ["Monitor serum electrolytes, glucose, calcium, and phosphorus regularly.","Risk of peritonitis; strict aseptic technique required.","Monitor fluid balance; risk of hyperglycemia in diabetic patients.","Avoid in patients with severe hypokalemia or hypocalcemia.","May cause peritoneal fibrosis or encapsulating peritoneal sclerosis with long-term use."] |
Loading safety data…
| Fetal Monitoring |
| Monitor serum electrolytes, glucose, renal function, fluid balance, and signs of peritonitis. In pregnancy, additional fetal monitoring including heart rate and growth assessments due to potential metabolic disturbances. |
| Fertility Effects | No studies on fertility. No known adverse effects on fertility from intraperitoneal dextrose or low calcium dialysate. |