1. COMPOSITION: 

     Active ingredient:

    Calcium Lactate Pentahydrate   

Excipients:

Povidone, Microcrystalline Cellulose, Sodium Starch Glycolate, Colloidal Silicon     Dioxide, Magnesium Stearate, Talc, Spearmint Flavour.

 

2. PRODUCT DESCRITION:

White, round, N.C. tablets.

 

3. DOSAGE FORM:

Tablets

 

4. PACKING:

100 tablets packed in blisters

 

5. INDICATION:

Calcium Lactate tablets are indicated for use in the treatment of calcium deficiency. It is an ideal calcium dietary supplement during pregnancy and breast-feeding and is beneficial for the formation of healthy bones and teeth in growing children.

 

6. CONTRAINDICATION:

Hypersensitivity to one of the excipients, hypercalcaemia, severe renal impairment, increased renal excretion of calcium.

 

7. DOSAGE AND ADMINISTRATION:

Adults: 1000 mg daily.

Children: 500-1000 mg daily

 

8. Pharmacodynamic / PHARMACOKINETICS:

9. Pharmacodynamic properties:

      Pharmacotherapeutic group: Mineral supplements

      ATC Code: A12AA (Calcium)

Calcium salts are used to treat or prevent calcium depletion. Calcium is now recognized as an important agent in preventing osteoporosis, especially in postmenopausal women. Calcium is the fifth most abundant element in the body. Calcium is a divalent metal essential for the maintenance of the nervous, muscular, and skeletal systems, and for cell membrane and capillary permeability. Its role in bone structure and muscle contraction is well known, but calcium is also important for blood coagulation, nerve conduction, and electrical conduction in the heart. Calcium stimulates gastrin secretion, which offsets the utility of oral calcium carbonate as a treatment of peptic ulcer disease, calcium and magnesium are, in some ways, physiological opposites, and calcium can be used for the temporary control of cardiac arrhythmias associated with hypokalaemia.

Parathyroid hormone (PTH), vitamin D, and, to a lesser extent, calcitonin, glucocorticoids, and magnesium influence calcium balance.

 

10. Pharmacokinetics:

Absorption

Calcium is actively absorbed in the duodenum and proximal jejunum and, to a lesser extent, in the more distal segments of the small intestine. The degree of absorption depends on a number of factors; calcium is never completely absorbed from the intestine. For absorption to occur, calcium must be in a soluble, ionized form. The efficiency of intestinal calcium absorption may be increased when calcium intake is reduced and during pregnancy and lactation when calcium

requirements are higher than normal. However, when hypocalcemia is caused by deficiency of either parathyroid hormone or vitamin D, calcium absorption decreases.

Calcium absorption is decreased in geriatric patients and in patients with certain disease states such as achlorydria, renal osteodystrophy, steatorrhea or uremia.

Distribution

Following absorption, calcium first enters the extracellular fluid and is then rapidly incorporated into skeletal tissue. Bone formation, however, is not stimulated by administration of calcium. Bone contains 99% of the body’s calcium; the remaining 1% is distributed equally between the intracellular and extracellular fluids.

Normal total serum calcium concentrations range from 9-10.4mg/dL (4.5-5.2mEq/L), but only ionized calcium is physiologically active.

CSF concentrations of calcium are about 50% of serum calcium concentrations and tend to reflect ionised serum calcium concentrations. Calcium crosses the placenta and reaches higher concentrations in fetal blood than in maternal blood. Calcium is distributed into milk.

Elimination

Calcium is excreted mainly in the feces and consists of unabsorbed calcium and that secreted via bile and pancreatic juice into the lumen of the GI tract. Most of the calcium filtered by renal glomeruli is reabsorbed in the ascending limb of the loop of Henle and proximal and distal convoluted tubules. Only small amounts of the cation are excreted in urine. Parathyroid hormone, vitamin D, and thiazide diuretics decrease urinary excretion of calcium, whereas other diuretics, calcitonin, and growth hormone promote renal excretion of the cation. Urinary excretion of calcium decreases with reduction of ionic serum calcium concentrations but is proportionately increased as serum ionized calcium concentrations increase. In healthy adults on a regular diet, urinary excretion of calcium may be as high as 250—300mg daily. With low calcium diets, urinary excretion usually does not exceed 150mg daily. Urinary excretion of calcium decreases during pregnancy and in the early stages of renal failure. Calcium is also excreted by the sweat glands.

 

11. Warnings and Precautions:

Calcium Lactate Tablets should be given cautiously to patients with impaired renal function, cardiac disease, a history of renal stone formation, diabetes or low sodium diet. Calcium appears to add to the effects of digitalis on the heart and may precipitate digitalis toxicity.

 

• Pregnancy:

It is especially important that pregnant women receive enough calcium and that they continue to receive the right amount of calcium throughout their pregnancy. However, taking large amounts of calcium during pregnancy may be harmful to the mother and/or foetus and should be avoided.

• Lactation:

It is especially important that lactating women receive the right amount of calcium so that their baby will also get the calcium needed to grow properly. However, taking large amounts of calcium while breast-feeding may be harmful to the mother and/or baby and should be avoided.

• Use in pediatric:

None

• Renal and hepatic impairment:

None

• Operating machine and driving vehicles:.

      Calcium salts do not affect the ability to drive and use machines

 

12. INTERACTION:

Calcium salts reduce the absorption of tetracyclines, phenytoin, ferrous, spinach, biphosphonates thyroxine. Vitamin D increases the absorption of calcium salts. Thiazide diuretics increase renal absorption of calcium, so the risk of hypercalcaemia should be considered.

 

13. Undesirable Effects:

None

 

14. Overdose and treatment:

In the event of overdosage, supportive and symptomatic therapy is indicated. Symptoms: Gastrointestinal disturbances. Treatment: Symptomatic and supportive therapy.

 

15. Storage Condition:

Calcium lactate tablets should be stored below 25^oC, protected from light and moisture.

 

16. Shelf life:

       5 years

 

17. Name and Address of Manufacturer:

Remedica Ltd

Aharnon Str.,Limassol Industrial Estate,

3056 Limassol

Cyprus