Full Prescribing Info
Each soft gelatin capsule contains: Colecalciferol (Vitamin D3), USP 800 IU.
Pharmacology: Pharmacodynamics: This product contains Vitamin D. Vitamin D is required for normal bone formation. Vitamin D acts to maintain normal concentrations of calcium and phosphorus in plasma, mainly by facilitating calcium absorption from the small intestines and by enhancing the parathyroid hormone (PTH)-mediated mobilization of calcium and phosphorus from bone. The active form of Vitamin D increases the production of calcium-binding proteins in the lining of the small intestine. Vitamin D deficiency develops when both sunlight exposure and dietary intake are inadequate. Insufficiency is associated with negative calcium balance, bone loss and increased risk of skeletal fracture.
For the prevention and treatment of Vitamin D deficiency.
Dosage/Direction for Use
Adult dose: Orally, one soft gelatin capsule once a day.
Or, as directed by a doctor.
Dosing Instructions: Take each dose with full glass of water.
Doctors should consider the Vitamin D intake of their patients from other sources (i.e., dietary sources, other nutritional supplements) to avoid excessive Vitamin D intake.
Missed dose: If patient miss the dose for the day, take the next dose and the subsequent doses at the usual recommended schedule, i.e., once a day.
Do not double the dose.
Chronic ingestion of 50,000 to 100,000 IU (1.25 to 2.5 mg) of Vitamin D per day may result in hypervitaminosis D. Signs and symptoms include hypercalcemia, hypercalciuria, anorexia (loss of appetite), nausea, vomiting, polyuria (frequent urination), polydipsia (excessive thirst), weakness, lethargy (fatigue), and constipation.
If patient have taken more than the recommended dosage, consult a doctor.
If patient is allergic to any component of the product.
If patient has hypervitaminosis D, nephrolithiasis (kidney stones), diseases or conditions resulting in hypercalcemia (excess calcium in the blood) and/or hypercalciuria (excess calcium in the urine) and severe kidney impairment.
If patient has peanut allergy since this product contains Arachis oil (peanut oil).
Colecalciferol 800 IU soft gelatin capsule is not recommended for children.
Special Precautions
Do not take more than the recommended dose.
Do not use after the expiry date on the label.
If patient is pregnant or breastfeeding, consult a doctor before using this product.
If any undesirable effect occurs.
Adverse Reactions
Vitamin D in doses of 3,800 IU (95 mcg) or greater per day have been reported to cause hypercalcemia.
Drug Interactions
Concomitant use of mineral oils, olestra, orlistat, and bile acid sequestrants (e.g., Cholestyramine, Cholestipol) may reduce the absorption of Vitamin D.
Concomitant use of anticonvulsants, cimetidine and thiazides may decrease the effect of Vitamin D.
Store in a dry place at temperatures not exceeding 30°C.
Protect from light and moisture.
MIMS Class
Vitamins A, D & E
ATC Classification
A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Forti-D softgel cap 800 IU
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