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RENACALCIO
RENACALCIO PLUS
RENACALCIO POLVO
(ELEMENTARY CALCIUM 300mg)
(ELEMENTARY CALCIUM 500mg)
(ELEMENTARY CALCIUM 1000mg)
Calcium Carbonate
RENACALCIO tablet formula: Calcium carbonate 750mg (equal to 300mg of elementary
calcium), corn starch 75mg, glyccholate starch 9mg, microcrystalline cellulose 116mg, magnesium
stearate 9mg.
Fórmula por comprimido de RENACALCIO PLUS: Calcium carbonate 1250mg (equal to
500mg of elementary calcium), corn starch 125mg, glyccholate starch 15mg, microcrystalline
cellulose 194mg, magnesium stearate 15mg.
Fórmula por cada sobre de RENACALCIO POLVO: Calcium carbonate 2500mg (equal to
1000mg of elementary calcium), corn starch 250mg.
Therapeutic action:
Oral calcium therapy (as a calcium supplement or phosphate binder)
Indications:
Calcium supplement for patients who doesn’t consume enough elementary calcium on their diet.
Profilaxys and treatment for osteoporosis.
Treatment for chronic hypocalcemia: chronic hypoparathyroidsm, osteomalacia, raquitism.
Profilaxys of the calcium deficiency: patients with unadequate diet, generally associated with an
increase on their demand (pregnant women and nursing children, elderly people, pre and
postmenopausia, etc.)
Hypocalcemia and hyperphosphatemia of the ESRD (End Stage Renal Disease) - (creatinine
clearence bellow 40 ml/minute).
Antiacid, on the acid indigestion and acidic reflux.
Pharmacokinetics:
The calcium is the fifth among the most abundant elements in the organism and its main part is
present in the bones. It is present also in small amounts in the extracellular fluid, as well as in the
soft tissue cell’s structure and cytoplasma.
The main source of calcium in the diet are the dairy products.
An unadequate diet as well as some diseases such as adbsorption disturbances, hypoparatiroidsm,
osteomalacia and osteoporosis, which comes together with hypocalcemic states, require calcium
supplementation to sustain its adequate equilibrium in the organism.
The hypocalcemia promotes PTH (parathyroid hormone) secretion, which transfers the elementary
calcium from the bones to the plasma to sustain the serum level, increasing its intestinal and renal
reabsorption.
The Calcium Carbonate contents 40% of elementary calcium, of which about a third is absorbed on
the intestine. The absorption takes place on the first part of the small intestine.
A greater calcium absorption can be achieved when it’s taken away from meals.
On the ESRD’s hyperphosphatemia the calcium administered with the meals form insoluble
phosphate complexes with the meal’s phosphate content, which reduces the total intestinal
phosphate absorption.
The Calcium Carbonate possess a gastric acidity neutralizing action by increasing the gastric PH
level (10mEq of acid per 500mg of elementary calcium)
Posology
The treatment doses must be indicated by the physician according to the patient’s condition. The
suggested doses are just for guidance.
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Adults: osteoporosis and calcium deficiencies: 1-2 gr of elementary calcium per day (2 to 4
RENACALCIO PLUS tablets or 1 to 2 RENACALCIO POLVO packets), preferably away from
meals.
Acute hypocalcemia: start with 2 to 4 gr. per day divided in 4 doses, preferably away from meals.
ESRD’s hyperphosphatemia: start with 2 to 4 gr. per day together with the meals.
According to the calcium and phosphate levels of the renal disease patient, the dose will be adjusted
according to the physician’s criteria.
In the stomach acidity it’s suggested to initiate with 1-2 RENACALCIO tablets, which equals to
300 to 600 mg of elementary calcium. If the acidity remains, the dose might be increased to 2-4
tablets, not surpassing the 10 tablets per day and for a maximum period of 10 days. On these cases
an immediate medical consultation should be necessary.
Children: the dose must be adjusted according to weight, age and diet. Generally, in growth stages,
a total daily dose of 1 gr of calcium is recommended.
Rules for its correct administration:
Tablets: The RENACALCIO and RENACALCIO PLUS tablets might be taken with some water,
or could as well be dispersed in water, tea, coffee or milk, both cold or hot. The beverages might be
sweetened with sugar or artificial sweeteners. It’s recommended to avoid the mix with soda
beverages or with fruit juices.
Powder: drop the content of one or two packets, according to the prescription, in half glass of
water (100 ml). Stirr until the dispersion of the powder is complete, and then drink it immediately.
If some of the powder should have precipitated on the glass bottom, add a little more water, stir it
again and complete the ingestion.
It shall also be mixed with tea, coffee, milk, yogurth, caramel custard or cream; but it is not
recommendable to mix it with soda beverages, fruit juices or apple crumble.
The beverages to mix with RENACALCIO POLVO might be sweetened with sugar or artificial
sweeteners, and can be as well cold or hot.
Precautions
On elderly people the calcium absorption could be impaired, because of which a dose adjustment
should be necessary according to the clinical evolution.
Other conditions could also impair the calcium absorption such as the consumption of alcoholic
beverages, caffeine and smoking, because of which it is recommended to avoid the use of them.
In case of concomitant treatments with sodium fluoride it should be taken care of taking both
medications with a difference of at least 2 hs in between, in order to avoid a diminish in the calcium
absorption by interaction of both drugs.
It is recommended to wait for at least 2 hs to take calcium after the previous ingestion of other
medications or high fiber meals (such as cereals).
The digitalics might increase their absorption when are administered together with calcium and
vitamin D, because of which the patients under these circumstances should be surveilled for the
proper dose adjustment.
In case of long treatments, the calcemia and calciuria shall be controlled.
Contraindications
Not to use calcium on vitamin D overdose.
Not to be administered during periods of long convalescence because of the risk of hypercalcemia
and hypercalciuria.
Not to be administered on patients with primary or secondary hypercalcemia, hypercalciuria,
necrocalcinosys, or chronic glomerular nephropaty.
Avoid its use on patients with renal litiasys or in patients that suffers from hypoparatiroidsm,
because thess individuals has strongly increased their calcium absorption.
Undesirable Effects
Even when the calcium carbonate is well tolerated, in long treatments, high doses or in sensitive
persons it might promote gastric intolerance or hypercalcemia associated syndromes, such as
headache, faint, constipation, anorexy and metal taste.
On patients with ESRD or at high doses for long periods there might ocassionally arise symtomps
such as sweat, tremor, skin rash, dizziness, somnolence, paresthesya, which dissappear by reducing
the dose or stopping the treatment.
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Interactions
With sodium fluoride the absorption gets affected (see Precautions), producing hypercalcemia.
With vitamin D and digitalics, the absorption of this gets increased (see Precautions).
The bioavailability of tetracyclines, iron, isoniazide, benzodyazepines and vitamin A, can be
diminished with the concomitant ingestion of calcium, as well as the absorption of this can be
impaired by the before mentioned drugs.
Atenolol and propanalol diminish their absorption by the alkalinizing action of the calcium
carbonate. Because of this effect, the serum rate of levodopa is increased.
Basic drugs or weak acids could have their renal depuration affected. Its alkalinizing action on the
urine increases the absorption of phenobarbital and salicilates, and could impair the excretion of
quinidine, ephedrine, amphetamines and its derivatives.
Diminishs the hepatic metabolism of ranitidine and nitrofurantoine.
Produces a serum decrease of the parathyroid hormone, and a decrease of phosphates by
diminishing its intestinal absorption without promoting hypercalcemia.
The hypercalcemia could be promoted by tiazidic compounds that increases the calcium retention
by reducing its excretion. The estrogens increase the calcium absorption.
Pregnancy and Nursing:
The calcium carbonate can be prescribed during pregnancy and breast-feeding.
Overdose
Has not been described at therapeutic doses.
High doses might produce abdominal distension, meteorism and gastroesofagic reflux.
The accidental ingestion of massive doses of calcium carbonate might promote an acute
hypercalcemic syndrome.
Poisoning and its treatment
The following symtomps could be indicative of hypercalcemia: thirst, nausea, vomits, anorexy,
abdominal pain, bone pain, polyuria, muscular weakness, somnolence or confusion.
Treatment: stopping the administration of calcium and vitamin D, rehydration and, according to
the seriousness of the poisoning, use of diuretics, corticosteroids, calcitonine and/or peritonel
dyalisis.
IN CASE OF OVERDOSE REFER TO THE NEAREST TOXICOLOGICAL CENTER:
Ref. DR. RICARDO GUTIERREZ Children Hospital – Toxicology Unit Tel. (011) 49626666/4962-2247
Presentations:
RENACALCIO 750mg (300mg of elementary calcium) 60, 120 y 240 tablets.
RENACALCIO PLUS 1250mg (500mg of elementary calcium) 60, 120 y 240 tablets.
RENACALCIO POLVO 2500mg (1000mg of elementary calcium) 30, 60 y 120 packets.
Keep out of the reach of children
Store between 10ºC to 30ºC
Protect from light inside the box
BioControl S.A. Laboratorios Fraga 1504 (1427) Buenos Aires – Rep. Argentina
Tel. (54-11) 4555-7585 / 4552-2684 e-mail: biocontrolsa@yahoo.com.ar
Technical Director: María Fernanda Filia – Pharmacist – M.N. 13.747.
Medication authorized by the Ministry of Health. Certified Nº 49.421
Lot and expiry date: see the bottom of the box.
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