REBON - D3 (VITAMIN D3)
REBON - D3 (VITAMIN D3)
CHOLECALCIFEROL INJECTION BP 300000 IU
COMPOSITION :
- Each 1 ml ampoule contains:
- Cholecalciferol BP300,000 IU (Vitamin D3)
- Ethyl Oleate BPQ.S.
- Overages of vitamin added to compensate for loss on storage.
PHARMACOLOGY
Vitamin D regulates the calcium- and phosphate balance. Cholecalciferol and toan even greater extent its hydroxylation products induce the formation of acalcium transport protein in the mucous membrane of the small intestine. Thisleads to increased absorption of calcium and phosphate from the intestine. In thekidneys vitamin D stimulates the reabsorption of calcium and phosphate. Avitamin D deficiency leads to rickets in the growing organism and osteomalacia inadults.
PHARMACOKINETIC
- Absorption: Cholecalciferol is easily absorbed from the gastrointestinal tract inthe presence of bile. In case of reduced fat absorption, the absorption of vitaminD is also reduced.
- Distribution: Cholecalciferol can be stored in adipose- and muscle tissue for along time. The effect of cholecalciferol starts slowly and is long lasting effect. Itshalf-life is 19-25 hours.
- Metabolism: The active form of Cholecalciferol is 1,25-dihydroxycholecalciferol,which is formed by hydroxylation of cholecalciferol in liver and kidneys.
- Elimination: Cholecalciferol and its metabolites are excreted mainly in the bileand faeces. Small amounts appear in the urine.
INDICATIONS
REBON – D3 Injection is indicated in:
- Prevention and treatment of Vitamin D deficiency.
- Treatment of rickets.
- As an adjunct to a specific therapy for osteoporosis in patients at risk ofVitamin D deficiency.
POSSIBLE SIDE EFFECTS
- Nausea, loss of appetite, weight loss Hypocalcemia, hyperkalemia, Constipation, flatulence, nausea, stomachache, diarrhea.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients. Hypercalcemia and Hypercalciuria
PREGNANCY & LACTATION
- Cholecalciferol should not be used during pregnancy or lactation if necessary.However, it is preferable to consult your doctor before using this drug.
DOSAGE & ROUTE OF ADMINISTRATION
- Rickets: 1 ampoule every 2 weeks for one month then 1 ampoule for every 4months.
- Osteoporosis: 1 ampoule every 2 weeks for 3 months.
- Osteomalacia: 1 ampoule every 2 weeks for 3 months.
- Tetany caused by hypocalcemia: 1 ampoule for every 4 months which may beincreased to 2 ampoules.
- Renal Osteodystrophy: 1 ampoule daily or advised by the physician.
- Menopause: 1 ampoule for every 6 months.
- Preventive measures: Pregnancy: 1 ampoule every at 6th or 7th month
- During breast feeding: 1 ampoule for every 6 month.
- Children upto 6 years: 1 ampoule for every 6 month.
- Adolescent & Elderly: 1 ampoule for every 6 month.
HEPATIC IMPAIRMENT
- No data is available.
METHOD OF ADMINISTRATION
- Cholecalciferol ampoule is used oral and intramuscularly
DRUG INTERACTION
- Mineral oils reduce the absorption of vitamin D, reducing the effect of Cholecalciferol Phenytoin, barbiturates, and rifampicin may reduce the effectiveness of vitaminD3 as they induce hepatic microsomal enzymes.
SPECIAL PRECAUTIONS FOR USE
- Vitamin D should be given with caution in patients with sarcoidosis and othergranulomatous disorders due to the risk of increased metabolization of vitaminD to its active form. These patients should be monitored for the calcium contentin serum and urine.
- Serum calcium levels should be monitored in children with knownhypercalcemia.
- In long-term treatments, renal and urinary calcium levels and serum creatininemeasurement should be checked every 3 to 6 months. These controls areparticularly important in elderly patients and in concomitant treatment withcardiac glycosides or diuretics.
PRESENTATION
- 1 ml Ampoule.
STORAGE INSTRUCTIONS
- Keep in a cool place, Protect from light, Do not freeze.
