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Purecal

Phillips Pharmaceuticals Limited
Plot 122-132, Apapa-Oshodi Expressway, Afprint Ind. Est., Iyano-Osolo B/stop, Lagos Nigeria.
Email: mktng.phillips@gmail.com, info@phillipsnigeria.com
Tel: 0805-6292409; 0803-6761764
Website: www.phillipspharma.com

Brand Name

Purecal

Manufacturer

Sai Mirra Innopharm Pvt. Ltd, 288, SIDCO Estate, Chennai - 600 098, India.

Therapeutic Class

Calcium, Oral

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Purecal Tablet:

Tablet (NRN: A4-0666): Calcium 320 mg, Phosphorous (Source milk) 137.50 mg

Pack size: presented in a blister of 10 tablets and a carton of 3 blisters.

Purecal Suspension

Suspension (NRN: A4-1022): Calcium 160 mg, Phosphorous (Source milk) 69 mg, Vitamine D3 BP 200 IU

Pack size: presented in a bottle of 200 mL.

Pharmacology

Healthy bones and soft tissues need both calcium and phosphorus to grow and develop throughout life. Vitamin D helps the body maintain healthy levels of calcium and phosphorus and is therefore essential for building and maintaining healthy bones. Calcium, which is the principal element in bone, can be absorbed by the body in a better way when vitamin D is present.

It is a synergistic formula containing calcium and phosphorus in a 2:1 ratio. The absorption and metabolism of calcium and phosphorus are mutually dependent. Therefore, these two elements should always be administered at the same time.

Pregnant women, nursing mothers, children, and adolescents may need more calcium than they normally get from eating calcium-rich foods. Adult women may take calcium supplements to help prevent a bone disease called osteoporosis. A diet low in calcium for many years, especially in the younger adult years, may add to the risk of developing it. Other bone diseases in children and adults are also treated with calcium supplements.

Pharmacokinetics:

Calcium is typically freed from calcium complexes during digestion and is released in a soluble and probably ionized form for absorption. As calcium intakes increase, the active transfer mechanism becomes saturated and an increasing proportion of calcium is absorbed via passive diffusion.

The efficiency of absorption of calcium from a calcium supplement is greatest when calcium is taken at doses of 500 milligrams or lower. Individuals with achlorhydria absorb calcium from calcium carbonate poorly unless the calcium carbonate supplement is taken with food. Calcium that is unabsorbed from the intestine is excreted in the feces. Greater than 98% of calcium from the glomerular filtrate is reabsorbed. Renal reabsorption is primarily regulated by parathyroid hormone or PTH.

The colon plays an important role in calcium absorption after resection of the small intestine. Approximately 40% of calcium in the plasma is bound to proteins, primarily albumin; about 50% of calcium in the plasma is diffusible ionic calcium and about 10% is diffusible, but is complexed with such anions as phosphate and citrate.

Phosphorus supplements are inorganic phosphate salts of sodium, potassium or calcium. Calcium phosphate is a supplement used to supply both calcium and phosphorus. The efficiency of absorption of inorganic forms of phosphorus from the gastrointestinal tract ranges from 55% to 70% in adults. The efficiency of absorption of food phosphorus, which is a mixture of inorganic and organic forms of phosphorus, is similar. Organic forms of phosphorus are hydrolyzed by phosphatases, and therefore most phosphorus absorption occurs as absorption of inorganic phosphate.

Absorption of phosphate occurs by both a saturable, active transport process and by passive diffusion. The saturable, active transport process is stimulated by the active form of vitamin D, 1,25-dihydroxycholecalciferol. The absorption of phosphorus is mainly via the passive, concentration-dependent process.

Phosphorus is transported via the portal circulation to the liver where the hepatocytes extract a fraction of it for their metabolic requirements. Phosphorus is transported via the systemic circulation to the various tissues of the body, where it is used for the metabolic requirements of these tissues.

Excretion of phosphorus is mainly via the kidneys. Phosphorus is freely filtered in the glomerulus. Greater than 80% of the filtered phosphorus is reabsorbed in the proximal tubule and a small amount in the distal tubule. Parathyroid hormone adjusts the renal clearance of phosphorus. In the healthy adult, urine phosphorus is essentially equal to absorbed phosphorus.

It is absorbed well from the intestines in the presence of bile-salts. Absorption of D3 is better than D2. It is bound to a specific alpha-globulin in the circulation and is stored mainly in the adipose tissue for many months. It is hydroxylated in the liver and the metabolites are mainly excreted in the bile.

Indications

Calcium deficiency, supplementation in pregnancy, in pre- and post-menopausal osteoporosis, supplementation in growing children, Bone building in childhood and adolescence and in the event of fractures.

Contra-indications

Calcium supplementation is contraindicated in those with hypercalcemia. Phosphorus supplements are contraindicated in those with hyperphosphatemia and in those with severely impaired renal function (less than 30% of normal).

Vitamin D3 may be contraindicated in cardiac disease.

Precautions/Warnings

Because of the potential for side effects and interactions with medications, dietary supplements should be taken only under the supervision of a knowledgeable healthcare provider.

Total calcium intake, from combined dietary and supplemental sources, should not exceed 2,500 mg per day.

Interactions

Alendronate, Antacids, Aluminum-containing, Blood Pressure Medications, Cholesterol-lowering Medications, Corticosteroids, Digoxin, Diuretics, Estrogens, Gentamicin, Metformin, Antibiotics, Quinolones.

Etidronate use with calcium supplements may decrease the effect of this drug. Etidronate should not be taken within 2 hours of calcium supplementation.

Phenytoin used with calcium decreases the effects of both medicines. Calcium supplements must not be taken within 1-3 hours of phenytoin.

Tetracyclines (oral) used with calcium supplementation may decrease the effects of tetracyclines. Calcium supplements must not be taken within 1-3 hours of tetracyclins.

Adverse Effects

Calcium supplements are generally well tolerated. The most common adverse reaction with use of sodium or potassium phosphate is diarrhea. The salts are less likely to cause diarrhea when they are used by phosphorus-deficient individuals than when used by those with normal phosphorus status.

Common complaints when taking calcium supplements include constipation and stomach upset.

Symptoms that may occur from excessive amounts of calcium in the blood include nausea, vomiting, loss of appetite, increased urination, kidney toxicity, confusion, and irregular heart rhythm. These symptoms resolve when elevated calcium levels are treated and brought back to normal.

Dosage & Administration

Tablet: One tablet to two tablets daily or as directed by the Physician

Suspension: One teaspoonful (5 mL) twice daily or as directed by the Physician.

Storage/Handling Recommendations

Store in a cool dry place and keep out of reach of children.

Review Date

2014-07-02 08:19:15