CAL D3® TABLETS Calcium with Vitamin D3 Tablets
Dosage and strength, History of active ingredients, Net content, Clinical pharmacology, Pharmacodynamics, Pharmacokinetics, Indication and usage, Contraindication, Interactions, Warnings, Pregnancy and lactation, Precautions, Adverse reaction, Drug abuse and dependence, Symptoms of overdose and antidote, Dosage and administration, The preparation for use, Presentation, Storage condition, NAFDAC Registration number, Sole agent and Manufacturer of Cal D3 Tablet Medicine for Food Supplements.
DOSAGE FORM & STRENGTH
Oral Solid Dosage Form-Tablets
Vitamin D3 250 I.U.
HISTORY OF ACTIVE INGREDIENTS
Calcium Carbonate is commonly used medicinally as a calcium supplement or as an antacid, but excessive consumption can be hazardous.
Vitamin D is a group of fat-soluble seco-steroids responsible for enhancing intestinal absorption of calcium and phosphate. In humans, the most important compounds in this group are vitamin D (also known as cholecalciferol) and vitamin D (ergocalciferol).
Each film coated tablet contains:
Calcium Carbonate B.P. 1250mg
equ. to Elemental Calcium 500mg
Colecalciferol B.P. 250 I.U.
Colour: Ponceau 4R & Titanium Dioxide B.P.
Calcium Carbonate: A02AC01
Vitamin D3: A11CC
Calcium is used in deficiency states and as an adjunct in the prevention and treatment of osteoporosis. Vit D may have antiosteoporotic, immunomodulatory, anticarcinogenic, antipsoriatic, antioxidant & mood-modulatory activities. Along with parathyroid hormone and catcitonin, regulate serum calcium conc.
The amount of calcium absorbed through the gastrointestinal tract in approximately 30% of the swallowed dose. 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra and extra cellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin. Calcium is eliminated through faeces, urine and sweat Renal excretion depends on glomerular filtration and cekdum tubular reabsorption.
Well absorbed from the GI tract. Presence of bile in essential for adequate intestinal absorption. Bound to a specific globulin. Can be stored in adipose & muscle tissue for long periods of time. Slowly released from storage sites & skin where it is formed in the presence of sunlight or uv light. May distribute into breast milk. Hydroxylated in the liver by the enzyme vitamin D 25-hydroxylane to form 25-hydroxycholecalciferol (calcifiediol). Further hydroxylated in the kidneys by the enzyme vitamin D1-hydroxylase to form the active metabolites 1, 25-dihydroxycholecalciferol (calcitriol). Further metabolism also occurr in the kidneys, including the formation of the 1, 24, 25-trihydroxy derivatives. Mainly in the bile & faeces with only small amounts appearing in urine.
INDICATION AND USAGE
Cal D3 Tablets is indicated for the following conditions:
• As a nutritional supplement for teen, young adult and post menopausal women.
• Helps build strong bones and teeth.
• May reduce the risk of osteoporosis.
• Helps support healthy muscle contraction.
Hypersensitivity to any of the component in the preparation.
No serious interaction.
Increased risk of hypercalcaemie and hypercalciuria in hypoparathyroid patients receiving high doses of vitamin D.
PREGNANCY AND LACTATION
Routine supplementation during pregnancy is not recommended.
Excreted in breast milk.
Keep out of reach of children.
Caution should be exercised while using in patients with history of kidney stones and renal impairment.
Pruritus, rash and urticaria.
DRUG ABUSE AND DEPENDENCE
SYMPTOMS OF OVERDOSE AND ANTIDOTE
The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to
vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of calcium and vitamin D and rehydration.
DOSAGE AND ADMINISTRATION
Adults and Elderly and children above 12 years of age:
2 tablets per day, preferably one tablet each morning and evening.
Not recommended for children under 12 years.
Or as directed by the physician.
THE PREPARATION FOR USE
2 x 15 tablets packed in a unit carton along with Patient information leaflet
Store in a cool, dry & dark place at a temperature not exceeding 25oC.
To be dispensed on medical prescription only.
NAFDAC Reg. No.: 04-5497
Manufactured in India by
LABORATE PHARMACEUTICALS INDIA LTD.
51, Indl. Area, Paonta Sahib (H.P)
H.O.: IND. AREA, PANIPAT-132103
EMBASSY PHARMACEUTICAL & CHEMICAL LTD.