Viva-D

Viva-D is indicated in adult patients with chronic renal failure for:

• management of hypocalcemia
• secondary hyperparathyroidism
• osteodystrophy

Alfacalcidol stimulates intestinal calcium and phosphorus absorption, the reabsorption of calcium from bone and possibly the renal reabsorption of calcium. In the majority of patients treated with Alfacalcidol, clinical symptoms of bone pain and muscle weakness begin to remit within 2 weeks to 3 months of the start of therapy. Malabsorption of calcium is rapidly corrected. In patients on daily oral therapy, plasma alkaline phosphatase and PTH levels generally begin to fall within 3 months, but plasma calcium levels may not normalize for several months. This delay should not necessarily be construed as a poor response but may indicate that calcium is being utilized for bone mineralization. The decrease in PTH levels may be more rapid in patients on intermittent intravenous therapy, with significant reductions being achieved within 3 months of therapy.

An initial dose of 0.25 mcg/day is recommended for the first 2 months, unless hypercalcemia develops. If hypercalcemia occurs then the dose should be reduced to 0.25 mcg on alternate days. If serum calcium is below the desired range, the dose may be adjusted in increments of 0.25 mcg/day every 2 months.

Maintenance Doses: Most patients will be maintained on a dose of 0.5 mcg/day. However, doses up to 1 mcg/day may be necessary to maintain serum calcium within the desired range. Serum calcium and phosphate levels should be monitored at monthly intervals or as is considered necessary if hypercalcemia develops. If hypercalcemia develops at any time during treatment then the dose of alfacalcidol should be reduced by 50% and all calcium supplements stopped until calcium levels return to normal.

Pediatrics: The safety and efficacy of Alfacalcidol in children has not been established.

Thiazides may increase the risk of hypercalcaemia. Some antiepileptics e.g. carbamazepine, phenobarbital, phenytoin and primidone may increase vitamin D requirements. Rifampicin, isoniazid and corticosteroids may reduce the efficacy of vitamin D.

Alfacalcidol is contraindicated:

• in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
• when there is biochemical evidence of hypercalcemia, hyperphosphatemia, or evidence of vitamin D overdose.

• Elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT), anorexia, weight loss, polydipsia, hyperthermia, dry mouth, metallic taste
• Cardiac arrhythmia, hypertension
• Conjunctivitis, corneal calcification, photophobia
• Rhinorrhea
• Overt psychosis
• Headache, somnolence, vertigo
• Diarrhoea, vomiting, constipation, nausea, pancreatitis
• Pruritus
• Muscle pain, bone pain, ectopic calcification
• Polyuria, nocturia
• Decreased libido
• Fatigue, weakness

Alfacalcidol should not be used in pregnancy unless clearly necessary, as hypercalcemia during pregnancy may produce congenital disorders in the offspring. The safety of Alfacalcidol in pregnant women has not been established. Studies in animals have shown reproductive toxicity, which include reduced pregnancy rates, litter sizes, and birth weights. Alfacalcidol may be excreted in human milk. Therefore, breast feeding during treatment should be avoided.

Pregnancy, lactation, renal impairment, infants, elderly. Monitor serum levels of calcium in patients with renal failure. Caution in hypercalciuria in those with history of renal calculi. Avoid in patients with hypersensitivity to inj. containing propylene glycol.

Vitamin in bone formation, Vitamin-D preparations

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.