Clinical medicine profile
Calcium Lactate Gluconate 1000mg + Calcium Carbonate 327 mg + Vit C 500mg
Vitamin / mineral / nutritional supplement
- Route
- ORAL / IM / IV (selected)
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
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A traceable source link is not attached to this profile. Confirm prescribing decisions against the current SmPC and Kenya STG/EML.
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [Calcium Lactate Gluconate] Hypervitaminosis risk states (hypercalcaemia for vitamin D/A).
- Iron: avoid in iron overload.
- Potassium: severe hyperkalaemia / untreated Addison's. [Calcium Carbonate] [Calcium carbonate] Hypervitaminosis risk states (hypercalcaemia for vitamin D/A).
- Iron: avoid in iron overload.
- Potassium: severe hyperkalaemia / untreated Addison's. [Vit C] [From component Calcitriol 0.25mcg, Calcium Carbonate 500mg, Methylcobalamin 1500mcg plus others] CONTRAINDICATIONS Calcitriol Oral Solution should not be given to patients with hypercalcemia or evidence of vitamin D toxicity.
- Use of Calcitriol Oral Solution in patients with known hypersensitivity to Calcitriol Oral Solution (or drugs of the same class) or any of the inactive ingredients is contraindicated.
Precautions
- [From component Calcium] 5 WARNINGS AND PRECAUTIONS Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D.
- Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules.
- ( 5.1 ) Hypercalcemia may aggravate digitalis toxicity.
- ( 5.2 ) 5.1 Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate.
- Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with calcium acetate.
- An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures.
- Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly.
- Should hypercalcemia develop, reduce the calcium acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia.
- More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma.
- Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy.
- Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting.
- Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Above 7yrs: I tab OD. Children 2-7 yrs: 1/2 tab OD
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Fat-soluble vitamins and potassium need care in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Vitamin A toxicity hepatic; niacin hepatotoxicity at high dose.
Use, effects & interactions
Indications
- Increased demand for Calcium and Vitamin-C, e.g. pregnancy, lactation, periods of rapid growth (childhood, adolescence), in old age, During infectious disease and convalescence, Treatment of calcium and vitamin-C deficiency, Osteoporosis, Premenstrual syndrome, Postmenopausal problems and an Adjuvant in colds and influenza.
- (Supplement).
Adverse effects
- [From component Calcium] 6 ADVERSE REACTIONS Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ].
- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting.
- ( 6.1 ) In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy.
- ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- In clinical studies, calcium acetate has been generally well tolerated.
- Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients.
- Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
- Table 1: Adverse Reactions in Patients with End-Stage Renal Disease Undergoing Hemodialysis Preferred Term Total adverse reactions reported for calcium acetate n=167 n (%) 3-month, open-label study of calcium acetate n=98 n (%) Double blind, placebo-controlled, cross-over study of liquid calcium acetate n=69 Calcium acetate n (%) Placebo n (%) Nausea 6 (3.6) 6 (6.1) 0(0.0) 0(0.0) Vomiting 4 (2.4) 4 (4.1) 0(0.0) 0(0.0) Hypercalcemia 21 (12.6) 16 (16.3) 5 (7.2) 0(0.0) Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting.
- More severe hypercalcemia is associated with confusion, delirium, stupor, and coma.
- Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate - induced hypercalcemia.
- Isolated cases of pruritus have been reported, which may represent allergic reactions. 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
- The following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Calcium, Calcium.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Combination product.
Read complete mechanism
Combination product. Component mechanism (Calcium): 12.1 Mechanism of Action Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
Days–weeks for repletion
Depends on stores and ongoing intake
ORAL / IM / IV (selected)
depends on GI integrity, food matrix and binders (e.g. calcium/iron interactions). Fat-soluble vitamins (A,D,E,K) accumulate; water-soluble generally renally cleared.
Pregnancy, lactation & diet
[From component Calcium] 8.1 Pregnancy Pregnancy Category C Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1) ] . Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.
[From component Calcium] 8.3 Nursing Mothers A calcium acetate capsule contains calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.