Composition
D-BalanceTM
2000 Licap: Each Liquid filled hard gelatin capsule contains Cholecalciferol EP 2000 IU.
D-BalanceTM
20000 Licap: Each Liquid filled hard gelatin capsule contains Cholecalciferol EP 20000 IU.
D-BalanceTM 40000 Licap: Each Liquid filled hard gelatin capsule contains Cholecalciferol EP 40000 IU.
D-BalanceTM 50000 Licap: Each Liquid filled hard gelatin capsule contains Cholecalciferol EP 50000 IU.
Description
D-BalanceTM
is a preparation of Cholecalciferol,a synthetic form of Vitamin D3.It is essential for normal bone growth and development
and to maintain bone density.Cholecalciferol helps our body to utilize both Calcium and Phosphorus.
Indication and Usage
Prevention and Treatment of Cholecalciferol deficiency states.
Dosage and Administration
Adults: Treatment of Cholecalciferol deficiency: 40,000-50,000 lU/week for 7 weeks, followed by maintenance therapy (1,400-2,000
lU/day). Follow-up 25 (OH)D measurements should be made approximately 3 to 4 months after initiating maintenance therapy to
confirm that the target level has been achieved. Prevention of Vitamin D deficiency: 20,000 lU/month.
Children: Treatment of Vitamin D deficiency,12-18 years:20,000 IU,once every 2 weeksfor 6 weeks.Prevention of Vitamin D deficiency,
12-18 years: 20,000 IU, once every 6 weeks.
Contraindication
.Hypersensitivity to Cholecalciferol or any of the excipients in the product
.Hypervitaminosis D
.Nephrolithiasis
.Diseases or conditions resulting in hypercalcemia and/or hypercalciuria
.Severe renal impairment
Precaution
Cholecalciferol should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate
levels should be monitored. Caution is required in patients receiving treatment for cardiovascular disease as the administration of
Cholecalciferol may increase the risk of digitalis toxicity (arrhythmia). Cholecalciferol should also be prescribed with caution in
patients with sarcoidosis.
There is no clear evidence for causation between Cholecalciferolsupplementation and renalstones,but the risk is plausible,especially
in the context of concomitant calcium supplementation. Medical supervision is required whilst on treatment to prevent hypercalcemia.
Drug Interaction
Cholecalciferol is known to interact with Carbamazepine, Dactinomycin, Diuretics, Fosphenytoin, Miconazole, Phenobarbital,
Phenytoin, Primidone.
Side Effect
Metabolism and nutrition disorders: Uncommon (a 1/1000 to <1/100): Hypercalcemia and hypercalciuria. Gastrointestinal disorders:
Rare (a 1/10,000 to <1/1000):Constipation, flatulence, bloating, abdominal distension, nausea, abdominal pain and diarrhea.
Skin and subcutaneous tissue disorders: Rare (a 1/10,000 to < 1/1,000): Pruritus,rash and urticaria.
Use in Pregnancy and Lactation
Studies have shown safe use of doses up to 4000 IU during pregnancy.The recommended daily intake for pregnant women is 400 IU,
however, in women who are considered to be Cholecalciferol deficient a higher dose may be required. During pregnancy women
should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and
their response to treatment.
Cholecalciferol and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been
observed; however, when prescribing additional Cholecalciferol to a breast-fed child the practitioner should consider the dose of any
additional Cholecalciferol given to the mother.
Storage
Store below 30ÂșC, protect from light & moisture. Keep all medicines out of the reach of children.
How supplied
D-BalanceTM
2000 Licap: Each Box containing 30 Licap in 30s Alu-Alu blister pack.
D-BalanceTM
20000 Licap: Each Box containing 10 Licap in 10s Alu-Alu blister pack.
D-BalanceTM 40000 Licap: Each Box containing 10 Licap in 10s Alu-Alu blister pack.
D-BalanceTM 50000 Licap: Each Box containing 10 Licap in 10s Alu-Alu blister pack.
Salgaria,
Brand: Square Pharmaceuticals Ltd
