Cellulose Sodium Phosphate (Systemic)
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VA CLASSIFICATION
Primary: GU900
Commonly used brand name(s): Calcibind.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
†Not commercially available in Canada.
Category:
Antiurolithic (calcium calculi)—
Indications
Accepted
Renal calculi, calcium (prophylaxis)—Cellulose sodium phosphate is indicated for reducing the incidence of new renal stone formation in patients with absorptive hypercalciuria Type I (characterized by recurrent formation or passage of calcium oxalate and/or calcium phosphate renal calculi; evidence of high intestinal calcium absorption, i.e., urinary calcium concentration >0.2 mg per mg creatinine after oral load of 1 gram of calcium; hypercalciuria, i.e., 24-hour urinary calcium >200 mg per day on a diet of 400 mg calcium and 100 mEq sodium per day; normal fasting urinary calcium; no evidence of bone disease; normal serum calcium and phosphorus; normal parathyroid function; and lack of excessive skeletal mobilization of calcium, or renal leak). {01} {04}
—Although some clinicians recommend the use of cellulose sodium phosphate as the primary agent for treatment of absorptive hypercalciuria Type I, others prefer to use dietary restriction of calcium and oxalate, thiazide diuretics, and increased fluid intake as the primary method of treatment. {02} {05}
—Minimal diagnostic tests for different causes of hypercalciuria include serum calcium, phosphorus, and parathyroid hormone (PTH) determinations obtained on an empty stomach; 24-hour urinary calcium on a diet restricted for at least 10 days in calcium and sodium; and a determination of urinary excretion of calcium while fasting for 12 hours. {01}
Unaccepted
Cellulose sodium phosphate is not indicated for causes of hypercalciuria other than hyperabsorption. {01} This medication may be used on a temporary basis for absorptive hypercalciuria Type II (identical to Type I, but the hypercalciuria can usually be eliminated by a calcium-restricted diet alone). Cellulose sodium phosphate should not be used for absorptive hypophosphatemic hypercalciuria Type III because hypercalciuria may result, in part, from an increased skeletal mobilization of calcium. {03}
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Cellulose sodium phosphate exchanges sodium for calcium and other divalent cations. Inorganic phosphate content is approximately 34%; sodium content is approximately 11%. {01}
Mechanism of action/Effect:
Binds dietary and secreted calcium, preventing intestinal calcium absorption. Thus, decreased urinary saturation of calcium, with only slightly increased urinary oxalate and phosphorus, may prevent the spontaneous nucleation of calcium oxalate and calcium phosphate to form stones. {01}
Other actions/effects:
Also binds dietary magnesium and decreases urinary magnesium concentration. Increases urinary oxalate by binding divalent cations, making them unavailable to oxalate, thus increasing oxalate absorption. Increases urinary phosphorus, reflecting hydrolysis of 7 to 30% of cellulose sodium phosphate in the intestinal tract and absorption of released phosphorus. {01}
Absorption:
None. {01}
Elimination:
Fecal, as the complex of calcium and cellulose phosphate. {01}
Precautions to Consider
Carcinogenicity
No long-term studies have been done. {01}
Pregnancy/Reproduction
Pregnancy—
Studies have not been done in either humans or animals. {01}
Because of the increased dietary calcium requirement during pregnancy, cellulose sodium phosphate should not be given to pregnant women unless clearly needed. {01}
FDA Pregnancy Category C. {01}
Breast-feeding
It is not known whether cellulose sodium phosphate is distributed into breast milk. However, problems in humans have not been documented. {01}
Pediatrics
Because growing children have an increased dietary calcium requirement, the use of cellulose sodium phosphate is not recommended in children up to 16 years of age. {01}
Geriatrics
No information is available on the relationship of age to the effects of cellulose sodium phosphate in geriatric patients.
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Ascorbic acid (concurrent use with cellulose sodium phosphate may result in metabolism of ascorbic acid to oxalate {01})
» Calcium-containing medications, including calcium supplements or
» Milk or other dairy products (concurrent use may decrease effectiveness of cellulose sodium phosphate in preventing hypercalciuria {01} {04})
Foods high in oxalate content, such as spinach (and similar dark greens), chocolate, brewed tea, and rhubarb (concurrent use with cellulose sodium phosphate may lead to hyperoxaluria, negating the beneficial effect of hypocalciuria {01})
» Magnesium-containing medications, including magnesium supplements (simultaneous use with cellulose sodium phosphate may result in binding of magnesium; patients should be advised not to take these medications within 1 hour of cellulose sodium phosphate {01} {04})
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problems exist:
» Bone disease, such as osteitis, osteomalacia, and osteoporosis (may further deplete calcium needed to prevent loss of bone mass {01})
» High fasting urinary calcium, unless a high skeletal mobilization of calcium can be excluded or
» Hypophosphatemia (may indicate presence of hyperparathyroidism or renal tubular defects; stimulation of parathyroid hormone [PTH] by drug-induced hypocalcemia may further deplete phosphorus and lead to muscle weakness and osteomalacia {01})
{04}
» Hyperoxaluria, enteric (increases propensity of oxalate stone formation {01} {04})
» Hyperparathyroidism, primary or secondary (increases risk of parathyroid bone disease {01} {04})
» Hypocalcemic states, such as hypoparathyroidism and intestinal malabsorption (further depletion of calcium may lead to osteomalacia {01} {04})
» Hypomagnesemic states—serum magnesium <1.5 mg per deciliter (further depletion of magnesium may lead to generalized tonic-clonic seizures {01} {04})
» Normal or low intestinal absorption and renal excretion of calcium (may cause excessive PTH secretion and possible parathyroid bone disease {01} {02})
Risk-benefit should be considered when the following medical problems exist
Ascites or{01}
Congestive heart failure or{01}
Nephrotic syndrome (sodium content of cellulose sodium phosphate may increase fluid retention)
Sensitivity to cellulose sodium phosphate
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
» Calcium concentrations, serum{01} (determinations recommended every 3 to 6 months during therapy; if borderline values are obtained, determinations should be repeated promptly {01})
» Calcium concentrations, urinary (determinations recommended at periodic intervals during therapy; a reduction in urinary calcium of <30 mg per 5 grams of cellulose sodium phosphate is an inadequate hypocalciuric response to treatment {01})
Magnesium concentrations, serum (determinations recommended every 3 to 6 months during therapy {01})
» Oxalate concentrations, urinary (determinations recommended at periodic intervals during therapy; if urinary oxalate is more than 55 mg per day on moderate dietary oxalate restriction, cessation of treatment should be considered {01})
» PTH concentrations, serum (determinations recommended at least once between the first 2 weeks and 3 months of treatment; if borderline values are obtained, the determinations should be repeated promptly and treatment adjusted or stopped if serum PTH rises above normal {01})
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
With long-term use
Hypomagnesemia{01} (drowsiness; loss of appetite; mood or mental changes; muscle spasms [tetany] or twitching; seizures; nausea or vomiting; trembling; unusual tiredness or weakness)
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Abdominal or stomach discomfort {01}
loose bowel movements or diarrhea {01}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Cellulose Sodium Phosphate (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to cellulose sodium phosphate
Pregnancy—Use not recommended during pregnancy because of increased need for calcium in pregnant women, unless clearly needed
Use in children—Use not recommended in children up to 16 years of age because of increased need for calcium in growing children
Other medications, especially calcium- or magnesium-containing medications
Other medical problems, especially bone disease, high fasting urinary calcium, hypophosphatemia, enteric hyperoxaluria, hypoparathyroidism, hypocalcemia, hypomagnesemia, or normal or low intestinal absorption and renal excretion of calcium
Proper use of this medication
» Taking powder mixed with a full glass (240 mL) of water, soft drink, or fruit juice; rinsing glass and drinking all of liquid to get full dose
» Taking with a meal for optimum calcium binding
» Importance of not taking more medication than the amount prescribed
» Importance of high fluid intake (240 mL hourly while awake) during therapy to dilute urine and help prevent kidney stones
» Proper dosing
Missed dose: Skipping missed dose; not doubling doses
» Proper storage
Precautions while using this medication
» Regular visits to physician to check progress during therapy
Avoiding simultaneous use of magnesium-containing medications; taking at least 1 hour before or after cellulose sodium phosphate
Avoiding concurrent use with vitamin C or high oxalate foods such as spinach (and similar dark greens), chocolate, brewed tea, and rhubarb
Avoiding concurrent use with milk or other dairy products
Avoiding salty foods and use of extra salt to help achieve an intake of <150 mEq of sodium a day
Patients on a sodium-restricted diet: Medication contains sodium
Side/adverse effects
Signs of potential side effects, especially hypomagnesemia
General Dosing Information
Both the initial and maintenance doses of cellulose sodium phosphate are based on measurements of 24-hour urinary calcium excretion. {01}
If there is an inadequate hypocalciuric response (reduction of urinary calcium <30 mg per 5 grams of cellulose sodium phosphate) to treatment while patient is maintained on moderate calcium and sodium restriction, the treatment may be considered ineffective and should be stopped. {01}
Cellulose sodium phosphate is usually administered concomitantly with magnesium supplements to replace dietary magnesium. However, supplemental magnesium should be taken at least 1 hour before or after cellulose sodium phosphate to avoid binding of magnesium. {01}
The dose of oral magnesium supplements, given as magnesium gluconate, depends on the dose of cellulose sodium phosphate. Patients receiving 15 grams of cellulose sodium phosphate a day should take 1.5 grams of magnesium gluconate twice a day. Those taking 10 grams of cellulose sodium phosphate a day should take 1 gram of magnesium gluconate twice a day. {01}
Diet/Nutrition
Cellulose sodium phosphate should be taken with meals because the amount of calcium that is bound is reduced considerably when the medication is administered more than one hour after a meal. The amount of bound calcium depends on actual mixing of medication with food. {01}
High fluid intake (240 mL hourly while awake) should be encouraged to achieve a urinary output of 2 liters a day. This keeps urine diluted and prevents stone formation. {01}
Avoiding the use of salty foods or extra salt will help limit sodium intake to <150 mEq a day. {01}
Ingestion of foods high in oxalate content, such as spinach or similar dark greens, chocolate, brewed tea, and rhubarb, may lead to hyperoxaluria, negating the beneficial effect of hypocalciuria. {01}
Vitamin C supplementation may result in metabolism of ascorbic acid to oxalate. {01}
Milk or other dairy products may decrease the effectiveness of cellulose sodium phosphate by adding more calcium to the diet. {01}
Oral Dosage Forms
CELLULOSE SODIUM PHOSPHATE (FOR ORAL SUSPENSION)
Usual adult dose
Renal calculi
Patients with urinary calcium >300 mg a day:
Oral, initially, 15 grams a day (5 grams three times a day with meals), the dosage being decreased to 10 grams a day (5 grams with main meal, 2.5 grams with each of other two meals) when urinary calcium concentration declines to <200 mg a day. {01} {03}
Patients with controlled urinary calcium (<300 mg but >200 mg a day):
Oral, initially, 10 grams a day with meals, the continuing dosage being determined by the physician. {01} {03}
Usual pediatric dose
Renal calculi—Children up to 16 years of age
Use is not recommended. {01}
Size(s) usually available:
U.S.—
2.5 grams (Rx) [Calcibind]
300 grams (Rx) [Calcibind]
Canada—
Not commercially available.
Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.
Auxiliary labeling:
• Take with meals.
• Drink large amounts of fluids.
Additional information:
Cellulose sodium phosphate contains 25 to 50 mEq of exchangeable sodium per 15 grams.
Interim revision: 05/13/1994
References
- Calcibind product information, rev 11/89, Mission Pharmacal.
- Abraham P, Smith C. Medical evaluation and management of calcium nephrolithiasis. Med Clin N Am March 1984; 68 (2): 281-98.
- Medical Letter. Sodium cellulose phosphate for absorptive hypercalciuria. March 16, 1983.
- Lake K, Brown D. New drug therapy for kidney stones: A review of cellulose sodium phosphate, acetohydroxamic acid, and potassium citrate. DICP 1985; 19: 530-9.
- McEvoy G, ed. AHFS Drug Information. Bethesda: American Society of Hospital Pharmacists 1992.
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