Doxerol IV Injection
Doxercalciferol
4 mcg/2 ml
ACI Limited
| Pack size | 4 mcg vial |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 700.00 AED |
Available as:
Indications
Doxerol IV Injection is used for:
Secondary hyperparathyroidism, with chronic kidney disease (CKD) on dialysis
Adult Dose
Dialysis
Injection
Initiate dosing at 4 mcg by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day).
The maximum dose is 18 mcg weekly.
Target the maintenance dose of Doxercalciferol Injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
Child Dose
Renal Dose
Administration
IV Administration
Administer by IV bolus at end of dialysis session
Contra Indications
Hypercalcemia.
Vitamin D toxicity.
Known hypersensitivity to doxercalciferol or any of the inactive
ingredients of Doxercalciferol Injection
Precautions
Hypercalcemia: Can occur during treatment with Doxercalciferol Injection and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds.
Digitalis Toxicity: Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of Doxercalciferol Injection.
Serious Hypersensitivity Reactions: Anaphylaxis, with symptoms of angioedema, hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest, has been reported in hemodialysis patients after administration of Doxercalciferol Injection. Monitor patients upon treatment initiation for hypersensitivity reactions. Should a
reaction occur, discontinue and treat.
Adynamic Bone Disease: May develop and increase risk of fractures if intact PTH levels are suppressed to abnormally low levels. Monitor intact PTH levels to avoid over suppression and adjust dose if needed.
Monitoring Parameter
Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly.
Monitor intact PTH and serum calcium concentrations closely.
Monitor patients upon treatment initiation for hypersensitivity reactions.
Pregnancy-Lactation
Pregnancy
Limited available data in pregnant women are insufficient to identify drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with chronic kidney disease in pregnancy as it increases risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery polyhydramnios, stillbirth, and low-birth-weight infants
Animal data
In reproduction studies in rats and rabbits treated during organogenesis at up to 20 mcg/kg/day and 0.1 mcg/kg/day, respectively (approximately 25 times (rats) and less than (rabbits) maximum recommended human oral dose of 60 mcg/week based on mcg/m2 body surface area), no adverse developmental effects observed
Lactation
There is no information available on presence of doxercalciferol in human milk, effects of drug on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Infants exposed to drug through breast milk should be monitored for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation and weight loss; consider monitoring of serum calcium in infant
Interactions
Cytochrome P450 inhibitors: Formation of the active doxercalciferol moiety may be hindered and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely.
Enzyme inducers: Formation of the active doxercalciferol moiety may be affected and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely.
Magnesium-containing products: Combined use may cause hypermagnesemia. Monitor serum magnesium concentrations more frequently and adjust dose as needed.
Adverse Effects
Side effects of Doxercalciferol :
Frequency Not Defined
Edema
Palpitation
Chills
Dizziness
Headache
Malaise
Nausea
Vomiting
Hypercalcemia
Hypercalciuria
Anorexia
Constipation
Dyspepsia
Arthralgia
Edema
Weight increase
Sleep disorder
Dyspnea Pruritus
Mechanism of Action
Doxercalciferol is metabolized to the active form of vitamin D, which in turn controls the reabsorption of calcium by the kidneys, controls the intestinal absorption of dietary calcium, and along with parathyroid hormone controls the mobilization of calcium from the skeleton.
Note
Doxerol 4 mcg/2 ml IV Injection manufactured by ACI Limited. Its generic name is Doxercalciferol. Doxerol is availble in Bangladesh.
Farmaco BD drug index information on Doxerol IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.