Renocal Plus Tablet
Calcium Acetate + Heavy Magnesium Carbonate
435 mg + 235 mg
Everest Pharmaceuticals Ltd.
| Pack size | 30's Pack |
|---|---|
| Unite Price | 8.00 BDT |
Indications
Renocal Plus Tablet is used for:
Hyperphosphatemia associated with chronic renal insufficiency
Adult Dose
Oral
Adult
Treatment of hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis)
3 to 10 film-coated tablets per day, depending on the serum phosphate level. The daily dose should be subdivided according to the number of meals per the day (usually 3 a day).
The recommended starting dose is 3 tablets daily.
If necessary, the dosage may be raised to maximally 12 film-coated tablets per day.
Child Dose
Renal Dose
Administration
Must be taken together with the meal
Contra Indications
- Hypophosphataemia
- Hypercalcaemia with or without clinical symptoms, e.g. as a result of an overdose of vitamin D, a paraneoplastic syndrome (bronchial carcinoma, breast cancer, renal cell carcinoma, plasmacytoma), bone metastases, sarcoidosis or immobilisation osteoporosis;
- Elevated serum magnesium levels of more than 2 mmol/l, and/or symptoms of hypermagnesaemia;
- AV-block III degree;
- Myasthenia gravis;
- Hypersensitivity to the active substances or to any of the excipients
Precautions
The use of phosphate binders should be preceded by a dietary consultation with the patient concerning phosphate uptake, and may depend on the kind of dialysis treatment the patient is receiving.
This should only be administered with caution (only with continuous monitoring of serum calcium, magnesium and phosphate) in case of severe hyperphosphataemia with a calcium-phosphate-product of more than 5.3 mmol2/l2 if
• refractory to therapy,
• refractory hyperkalaemia,
• clinical relevant bradycardia or AV-block II degree with bradycardia.
Continuous monitoring of serum phosphate, serum magnesium, serum calcium and the calcium-phosphate-product should be performed, especially in case of simultaneous intake of vitamin D preparations and thiazide diuretics.
High doses and long-term administration of this drug may result in hypermagnesaemia. Hypermagnesaemia is mostly asymptomatic, but in some cases systemic effects may be seen.
Patients should be warned of the possible symptoms of hypercalcaemia.
During a long-term therapy with this attention must be paid to the progression or the appearance of vascular and soft tissue calcifications. The risk decreases by lowering the calcium-phosphate-product to < 4.5 mmol2/l2.
In patients receiving digitalis glycosides, this drug should only be administered under ECG control and monitoring of the serum calcium level.
Increased intake of calcium salts may result in the precipitation of fatty acids and bile acid as calcium soap. This may lead to constipation. In case of diarrhoea the dosage of this drug should be reduced.
It contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
It contains sodium. This has to be taken in consideration by patients on a controlled sodium diet.
Pregnancy-Lactation
Pregnancy
There are no or limited amount of data from the use of this drug in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. This should not be used during pregnancy unless the clinical condition of the woman requires treatment with calcium acetate and magnesium carbonate
Breastfeeding
Calcium acetate and magnesium carbonate are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.
Breast-feeding is not recommended during treatment with this drug.
Fertility
No data available.
Interactions
This drug affects the absorption of antibiotics (such as tetracyclines, doxycycline, norfloxacin, some cephalosporins like cefpodoxime, cefuroxime, and some quinolones (gyrase inhibitors) like ciprofloxacin), biphosphonates, fluorides, ketokonazole, estramustin-preparation, anticholinergics, zinc, urso- and chenodesoxychol acid, halofantrine.
In case of an additional treatment with oral iron preparations, attention has to be paid to the fact that simultaneous intake of magnesium may influence iron absorption.
Magnesium salts may adsorb digoxin in the gastrointestinal tract, decreasing its bioavailability.
Adsorption of nitrofurantoin may occur, decreasing the bioavailability and possibly the anti-infective effect of this medicinal product.
Further, the gastrointestinal absorption of penicillamine may be decreased, possibly decreasing its pharmacological effects.
A combination of magnesium carbonate, hydroxide and aluminium hydroxide with levothyroxine may cause an increased absorption of levothyroxine.
Vitamin D and derivatives increase the absorption of calcium. Thiazide diuretics reduce the renal elimination of calcium. In case of a simultaneous administration of this drug and thiazides or vitamin D derivatives it is therefore necessary to control the serum calcium level.
Concurrent use of oestrogens with this drug may increase calcium absorption.
The sensitivity for glycosides and therefore the risk for arrhythmia is increased by elevated serum calcium levels.
The administration of adrenalin in patients with increased serum calcium levels may lead to severe arrhythmia.
The effect of calcium antagonists may be reduced.
Side Effects
Side effects of Calcium Acetate + Heavy Magnesium Carbonate :
Gastrointestinal disorders:
Common:
Soft stools, gastrointestinal irritation like nausea, anorexia, sensation of fullness, belching and constipation, diarrhoea.
Metabolism and nutrition disorders:
Common:
Hypercalcaemia either asymptomatic or symptomatic, asymptomatic hypermagnesaemia.
Uncommon:
Moderate to severe symptomatic hypercalcaemia, symptomatic hypermagnesaemia.
Very rare:
Hyperkalaemia, magnesium-induced osteal mineralisation disturbances. For symptoms of hypercalcaemia and hypermagnesaemia
Mode of Action
As calcium acetate and magnesium carbonate are phosphate-binding compounds, they lead together with the phosphate contained in food to the formation of low solubility calcium and magnesium phosphate-salts in the gut, which then will be excreted with the faeces. Calcium acetate reaches its maximal phosphate-binding capacity at a pH of 6 – 8. Therefore, this drug is also suitable for phosphate binding in patients with hypo- or anacidity of the stomach.
Note
Renocal Plus 435 mg + 235 mg Tablet generic name is Calcium Acetate + Heavy Magnesium Carbonate. Renocal Plus 435 mg + 235 mg Tablet is manufactured by Everest Pharmaceuticals Ltd.Renocal Plus is availble in all over Bangladesh.
Mes BD drug index information on Renocal Plus Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.