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DOMNISOL is a brand name for Calcifediol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of vitamin D deficiency in adults. Prevention of vitamin D deficiency in adults with identified risks. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dietary intake of vitamin D and sun exposure vary among patients and should be taken into account when calculating the appropriate dose of vitamin D analogue drugs such as Domnisol. The dose, frequency and duration of the treatment will be determined by the prescriber taking into account the plasma levels of 25(OH)D, type and condition of the patient and other comorbidities such as obesity, malabsorption syndrome, treatment with corticosteroids.
1 for clinical data) although higher doses may be required in certain cases.
Treatment of vitamin D deficiency:
Adults: one capsule (266 micrograms of calcifediol) once a month. Higher doses may be necessary in some patients after analytical verification of the extent of the deficiency. In those cases, the maximum dose administered should not exceed one capsule per week.
Once the plasma levels of 25(OH)D are stabilised within the desired range the treatment frequency of administration should be lowered.
Maintenance therapy following treatment of deficiency:
Adults: one capsule (266 micrograms of calcifediol) once a month. Blood levels of 25(OH)D should be measured approximately 3 to 4 months after beginning maintenance therapy to confirm that target level has been reached. Thereafter, the levels should be measured at 6 monthly intervals to ensure that effective therapeutic levels are maintained.
Prevention of deficiency:
Adults: one capsule (266 micrograms of calcifediol) once a month.
Adjunct to specific therapy for osteoporosis:
Adults: one capsule (266 micrograms of calcifediol) once a month. , anticonvulsants, glucocorticoids) - People with conditions causing malabsorption, including inflammatory bowel disease and coeliac disease. Paediatric population Not recommended for children Dosage in hepatic impairment No dose adjustment is required Dosage in renal impairment Patients with mild or moderate renal impairment: no specific adjustment is required.
Vitamin D must not be used in patients with severe renal impairment. Pregnancy and breastfeeding Not recommended during pregnancy unless the clinical condition of the woman requires treatment. Vitamin D and its metabolites are excreted in breast milk.
Adverse reactions to Domnisol are generally uncommon (≥ 1/1 000 to <1/100) but sometimes they are moderately significant. , they are often associated with overdose or prolonged treatment, especially when associated with high doses of calcium.
The doses of vitamin D analogues required for hypervitaminosis vary considerably from one subject to another. The most common adverse reactions are due to the hypercalcemia which can occur initially or at a later stage: Endocrine disorders: Pancreatitis, among the late symptoms of hypercalcemia Metabolism and nutrition disorders: Elevation of blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, hypercalcemia Nervous system disorders: In case of moderate hypercalcemia, the following symptoms may appear weakness, fatigue, drowsiness, headache, irritability.
Eye disorders:
Rarely (≥1/10 000 to <1/1 000), at very high doses photophobia and conjunctivitis with corneal calcifications may occur.
Cardiac disorders:
In case of hypercalcemia cardiac arrhythmias may occur.
Gastrointestinal disorders:
Nausea, vomiting, dry mouth, constipation, taste disturbances, with a metallic taste, abdominal cramps. If hypercalcemia progresses anorexia may occur.
Hepatobiliary disorders:
High calcemia levels can lead to increased transaminase (SGOT and SGPT).
Musculoskeletal and connective tissue disorders:
Bone and muscle pain may occur in initial stages of hypercalcemia, calcification in soft tissues.
Renal and urinary disorders:
To obtain an adequate clinical response to oral administration of Domnisol, an appropriate dietary calcium intake is also required. Therefore, to control the therapeutic effects, the following parameters should be monitored, in addition to 25(OH)D: serum calcium, phosphorus and alkaline phosphatase as well as urinary calcium and phosphorus in 24 hours.
A decrease in serum levels of alkaline phosphatase normally precedes the onset of hypercalcemia. Once parameters are stabilized and the patient is under maintenance treatment, the above-mentioned determinations should be performed regularly, especially for serum levels of 25(OH)D and calcium.
- Renal impairment: To be administered with caution. Use of this drug in patients with chronic kidney disease should be accompanied by periodic monitoring of serum calcium and phosphorus, and hypercalcemia prevention. Transformation to calcitriol takes place in the kidney; thus, in case of severe renal impairment (creatinine clearance of less than 30 ml/min) a very significant reduction in the pharmacological effects may occur.
- Heart failure: Special caution is required. The patient's serum calcium should be monitored constantly, especially in patients on digitalis, because hypercalcemia may occur, and arrhythmias appear. Twice-a- week determinations are recommended at the beginning of treatment.
- Hypoparathyroidism: 1-alpha-hydroxylase is activated by parathyroid hormone. As a result, in case of parathyroid insufficiency the activity of calcifediol monohydrate may decrease. - Kidney stones: Calcemia should be monitored, since vitamin D increases absorption of calcium and may aggravate the situation.
In these patients supplements of vitamin D should be administered only if the benefits outweigh the risks. - In patients with prolonged immobilization, it may be necessary to reduce the dose to avoid hypercalcemia. - Patients with sarcoidosis, tuberculosis, or other granulomatous diseases: to be administered with caution since these conditions lead to a greater sensitivity to the effect of vitamin D as well as to an increase of the risk of adverse effects at doses lower than the recommended dose.
1. 5 mg/dl) or hypercalciuria - Calcium lithiasis - Hypervitaminosis D
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Calcifediol in United Kingdom.
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Overdose in infants induced by nursing mothers has not been observed but allowance for any maternal dose should be made when prescribing vitamin D products to a breast-fed child.
Other conditions (see above):
Such as obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D metabolism, higher doses might require for the treatment and prevention of vitamin D deficiency. Method of administration This medicine is taken orally.
Domnisol should not be administered with a daily frequency.
Manifestations of hypercalcemia are: nephrocalcinosis and deterioration of kidney function (with polyuria, polydipsia, nocturia and proteinuria).
General disorders and alterations in the place of administration:
Later symptoms of hypercalcemia include: rhinorrhoea, pruritus, hyperthermia, decreased libido. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
It is necessary to monitor serum and urinary calcium concentrations in these patients. - Patients and their families and/or caregivers should be informed of the importance of complying with the prescribed dosage and with recommendations about diet and concomitant intake of calcium supplements in order to prevent overdosing.
- Interference with laboratory tests: Patients should be warned that this drug contains a component that can alter the results of laboratory tests: Determination of cholesterol: calcifediol monohydrate may interfere with Zlatkis-Zak method, leading to false increases in serum cholesterol levels.
98 mg/capsule. This medicine contains 22 mg sorbitol in each capsule. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.