DV 60K

DV 60K

colecalciferol

Manufacturer:

Indchemie Health Specialities

Distributor:

Royal Distribution

Marketer:

ESTI Pharma
Full Prescribing Info
Contents
Cholecalciferol.
Description
Each soft-gelatin capsule contains: Cholecalciferol USP 1.5 mg ~ 60,000 Units.
Vitamin D is a group of fat-soluble secosteroids, the two major physiologically relevant forms of which are vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol). Vitamin D3 is produced in the skin of vertebrates after exposure to ultraviolet B light from the sun or artificial sources, and occurs naturally in fish and a few other food. Cholecalciferol is a fat soluble vitamin. Vitamin D3 is made in the skin when 7-dehydrocholesterol reacts with ultraviolet light (UVB) at wavelengths between 270 and 300 nm, with peak synthesis occurring between 295 and 297 nm.
Excipients/Inactive Ingredients: q.s.
Action
Pharmacology: Vitamin D3 is produced in the skin from 7-dehydrocholesterol by UV radiation, which breaks the B ring to form pre-D3. Pre-D3 isomerizes to D3 or with continued UV radiation to tachysterol and lumisterol. D3 is preferentially removed from the skin, bound to DBP. The liver and other tissues metabolize vitamin D, whether from the skin or oral ingestion, to 25OHD, the principal hydroxylase. Circulating form of vitamin D, by the enzyme CYP27B1 , the 25OHD-1 25OHD is then further metabolized to 1,25(OH)2D principally in the kidney, although other tissues such as epidermal keratinocytes and macrophages contain this enzymatic activity. 1,25(OH)2D is the principal hormonal form of vitamin D, responsible for most of its biologic actions.
Intestinal calcium absorption, in particular the active component of transcellular calcium absorption, is one of the oldest and best known actions of vitamin D. In addition to its role in promoting bone formation, 1,25(OH)2D also promotes bone resorption by increasing the number and activity of osteoclasts. The vitamin D receptor belongs to the nuclear receptor superfamily of steroid/thyroid hormone receptors, and VDRs are expressed by cells in most organs, including the brain, heart, skin, gonads, prostate, and breast. VDR activation in the intestine, bone, kidney, and parathyroid gland cells leads to the maintenance of calcium and phosphorus levels in the blood (with the assistance of parathyroid hormone and calcitonin) and to the maintenance of bone content. Vitamin D increases expression of the tyrosine hydroxylase gene in adrenal medullary cells. It also is involved in the biosynthesis of neurotrophic factors, synthesis of nitric oxide synthase, and increased glutathione levels.
Indications/Uses
Softgel cholecalciferol 60,000 IU cap is indicated in the following conditions: Treatment of severe vitamin D deficiency; Treatment of osteomalacia; Treatment of osteoporosis along with calcium; Treatment of deficiency during anticonvulsive therapy; Treatment of deficiency due to hepatobiliary disease; Treatment of deficiency due to malabsorption syndrome; Treatment of vitamin D deficiency in pregnant and lactating women.
Dosage/Direction for Use
Softgel cap of 60,000 IU to be given once a week, followed by daily dose of 1,000 IU cap every day for a period of 8-12 weeks.
Contraindications
Hypersensitivity to cholecalciferol, ergocalciferol, or vitamin D metabolites (eg. calcitriol, calcifediol, alfacalcidol, calcipotriol).
Hypercalcemia (exacerbation with enhanced toxicity).
Hypervitaminosis D (worsening of condition; pretherapy 25-hydroxycholecalciferol levels should be considered in selected patients).
Special Precautions
Arteriosclerosis (potential exacerbation related to persistent hypercalcemic effects during therapeutic use).
Cardiac conditions (potential exacerbation related to persistent hypercalcemic effects during therapeutic use).
Concurrent use of calcium-containing preparations, other vitamin D-containing preparations or vitamin D analogs, or thiazide diuretics (enhanced risk of hypercalcemia).
Hyperlipidemia (potential exacerbation of LDL elevation).
Hyperphosphatemia (risk of metastatic calcification; normalization of phosphate levels indicated prior to therapy).
Liver disease (impaired absorption).
Renal impairment (potential exacerbation related to hypercalcemic effects during therapeutic use).
Renal osteodystrophy/other conditions requiring high doses of pure vitamin D (vitamin D metabolites preferred, such as calcitriol).
Sarcoidosis/other granulomatous disease (potential for enhanced sensitivity to vitamin).
Hepatic insufficiency: The intestinal absorption of cholecalciferol may be markedly impaired; conversion to calcifediol may also be reduced significantly, with the requirement of high doses. Agents not requiring hepatic hydroxylation are preferred.
Renal insufficiency: Although only small amounts of a vitamin D dose are recovered in the urine, metabolic conversion to calcitriol is impaired and higher doses are generally required in most conditions. Agents not requiring renal hydroxylation (eg. calcitriol, alfacalcidol) are preferred.
Use In Pregnancy & Lactation
Pregnancy: Nutritional supplement doses of vitamins and minerals are generally considered safe during pregnancy. However fetal risk cannot be ruled out when administered in high doses in pregnancy.
Lactation: Nutritional supplement doses of vitamins and minerals are generally considered safe during lactation. However infant risk as cannot be ruled out when administered in high doses during lactation.
Adverse Reactions
High dose of cholecalciferol can cause weakness, fatigue, sleepiness, headache, loss of appetite, dry mouth, metallic taste, nausea and vomiting.
Vitamin D toxicity, including nephrocalcinosis/renal failure, hypertension, and psychosis, can occur with prolonged use of cholecalciferol; relatively low doses can produce toxicity in hypersensitive infants and children. Hypervitaminosis D is reversible upon discontinuation of treatment unless renal damage is severe.
Drug Interactions
Calcipotriene is a drug that is similar to vitamin D. Taking vitamin D along with calcipotriene might increase the effects and side effects of calcipotriene.
Taking vitamin D along with digoxin might increase the effects of digoxin (Lanoxin) and lead to an irregular heartbeat.
Taking large amounts of vitamin D along with diltiazem might decrease the effectiveness of diltiazem.
When given along with antacids, vitamin D increases the absorption of aluminum salts.
Storage
Store in a dry place below 30°C.
Protected from light.
MIMS Class
ATC Classification
A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Presentation/Packing
Soft-gelatin cap 1.5 mg x 10 x 4's.
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