Hello-D/Hello-D 2000

Each tablet contains Vitamin D₃ (Cholecal­ciferol) 1000 and 2000 IU, respectively.

Pharmacology: Pharmacodynamics: Vitamin D is considered a hormone, although not a natural human hormone. Biologically active vitamin D metabolites control the intestinal absorption of dietary calcium, the tubular reabsorption of calcium by the kidney, and in conjunction with parathyroid hormone (PTH), the mobilization of calcium from the skeleton. They act directly on bone cells (osteoblasts) to stimulate skeletal growth and on the parathyroid glands to suppress PTH synthesis and secretion. Vitamin D is also involved in magnesium metabolism.
Pharmacokinetics: Absorption: Vitamin D₃ is absorbed more rapidly and more completely than vitamin D₂. Bile is essential for adequate absorption. Absorption is reduced in liver or biliary disease. Calcifediol's maximum concentration (C_max) is 4 hours following oral administration.
Distribution: Stored chiefly in the liver, vitamin D is also found in fat, muscle, skin, and bones. In plasma, it is bound to α-globulins and albumin.
Metabolism: Within the liver, cholecalciferol is hydroxy­lated to calcifediol (25-hydroxycholecalciferol) by the enzyme 25-hydroxylase. Within the kidney, calcifediol serves as a substrate for 1-alpha-hydroxylase, yielding calcitriol (1, 25- dihydroxycholecalciferol), the biologically active form of vitamin D.
Excretion: The primary route of vitamin D excretion is in the bile; only a small percentage is found in the urine.

Vitamin D₃ is used as a dietary supplement when vitamin D intake may be inadequate.

Adults: 1 tablet daily.
Children: Individualize pediatric doses and monitor under close medical supervision. (Vitamin D; cholecalciferol 1 mg provides 40,000 units of vitamin D activity.)
Mode of Administration: Swallow whole; do not crush or chew.

Symptoms: Symptoms of overdosage include anorexia, lassitude, nausea and vomiting, diarrhea, constipation, weight loss, polyuria, sweating, headache, thirst, vertigo, and raised concentrations of calcium and phosphate in plasma and urine.
Impairment of renal function may cause polyuria, nocturia, hypercalciuria, polydipsia, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, irreversible renal insufficiency, or proteinuria. Widespread calcification of soft tissue including heart, blood vessels, renal tubules, skin, and lungs may occur.
Treatment: If ingestion is discovered within a short time, emesis or gastric lavage may be beneficial. Treatment of hypervitaminosis D consists of immediately withdrawal of Vitamin D.

Allergy to vitamin D or any other components in the formula. Hypercalcaemia, evidence of vitamin D toxicity, malabsorption syndrome, hypervitaminosis D, abnormal sensitivity to the effects of vitamin D, decreased renal function.

Concomitant calcium administration: Adequate dietary calcium is necessary for a clinical response to vitamin D therapy.
Hypercalcemia: Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis and other soft tissue calcification. Radiographic or slit lamp evaluation of suspect anatomical regions may be useful for early detection.
In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine. While this is usually reversible, it is important to pay careful attention to factors that may lead to hypercalcemia.
Bone lesions: Adynamic bone lesions may develop if PTH levels are suppressed to abnormal levels.
Concomitant vitamin D intake: Evaluate vitamin D ingested in fortified foods, dietary supplements, and other concomitantly administered drugs. It may be necessary to limit dietary vitamin D and its derivatives during treatment.
Hypoparathyroidism: May need calcium, parathyroid hormone, dihydrotachysterol.
Hypersensitivity reaction: Hypersensitivity to vitamin D may be one etiological factor in infants with idiopathic hypercalcemia. In these cases, severely restrict vitamin D intake.
Renal function impairment: The kidneys of uremic patients cannot adequately synthesize calcitriol, the active hormone formed from precursor vitamin D. Resultant hypocalcemia and secondary hyperparathyroidism are a major cause of the metabolic bone disease of renal failure.
Special risk: Use caution in patients, especially in the elderly with coronary disease, renal function impairment, and arteriosclerosis.
Announcement of the Food and Drug Administration: This drug can be accumulated in body's fat tissue therefore do not take excessive doses or long-term supplementation.
Take this drug only as prescribed by the physician.

Pregnancy: Category A - Safety of vitamin D in amounts more than 400 IU/day is not established. Avoid doses greater than the RDA during a normal pregnancy. Animal studies have shown fetal abnormalities associated with hypervitaminosis D.
Lactation: Vitamin D is excreted in breast milk in limited amounts. In a mother given large doses of Vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in the child. Monitoring of infant's serum calcium concentration was required. Do not nurse while taking calcitriol; otherwise, exercise caution when administering to nursing mother.

Early - Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste.
Late - Polyuria, polydipsia, anorexia, irritability, weight loss, nocturia, mild acidosis, hypercalciuria, anemia, reversible azotemia, generalized vascular calcification, nephrocalcinosis, conjunctivitis, pancreatitis, photophobia, rhinorrhoea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated AST and ALT, ectopic calcification, hypertension, cardiac arrhythmias, overt psychosis (rare).

Antacids, magnesium-containing: Hypermagsenemia may develop in patients on chronic renal dialysis.
Digitalis glycoside: Hypercalcemia in patients on digitalis may precipitate cardiac arrhythmias.
Verapamil: Atrial fibrillation has occurred when supplemental calcium and calciferol have induced hypercalcemia.
Cholestyramine: Cholestyramine decreases the concentration of Vitamin D when concurrent use. Intestinal absorption of Vitamin D may be reduced.
Ketoconazole: Ketoconazole may inhibit both synthetic and catabolic enzymes of calcitriol.
Mineral oil: Absorption of Vitamin D is reduced with prolonged use of mineral oil.
Phenytoin, Phenobarbital: Endogenous synthesis of calcitriol will be inhibited. Higher doses of calcitriol may be necessary if these drugs are administered simultaneously.
Thiazide diuretics: Hypoparathyroid patients on Vitamin D may develop hypercalcemia due to thiazide diuretics.

Store below 30°C, protected from light and moisture.

Vitamins A, D & E

A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.

Hello-D: NDD; Hello-D 2000: D