ALPHAPHORCAL® PLUS
Composition:
Active ingredients: Alphacalcidol, Calcium carbonate;
1 capsule contains Alphacalcidol 0.25 microgram and Calcium carbonate that is equivalent for 200 mg of elementary calcium.
Additional ingredients: corn oil, butylated hydroxyanisole (E 320), butylated hydroxytoluol (E 321), wax.
Gelatine coating of capsule: gelatine, glycerine, sorbitol 70% solution (sorbitol E 420), sodium methylparaben (E 219), sodium propylparaben (E 217), Ponco 4R (E 124), titanium dioxide (E 171), purified water.
Pharmaceutical form: Capsules.
Pharmacotherapeutic group:
Preparation of Vitamin D and its analogues. Code ATC À11Ñ Ñ03.
Indications:
Osteoporosis (postmenopausal, senile, steroid), osteodystrophy in chronic renal insufficiency (ChRI), hypoparathyreosis and pseudohypoparathyreosis (with bones affection), hypophosphatemic (vitamin-D-resistant) rickets and osteomalacia, rickets and osteomalacia associated with malnutrition or malabsorption of vitamin D, Fanconi syndrome (inherited renal acidosis with nephrocalcinosis, late osteomalacia and adiposogenital dystrophy), renal acidosis.
Contraindications:
Hypersensitivity to any drug component; signs of vitamin D intoxication, hypercalcemia, hypermagnesemia, hyperphosphatemia (except hyperphosphatemia caused by hypoparathyreosis), liver diseases, pregnancy and lactation, children age less than 14 years old.
Administration and Dosage:
The preparation is used for adults and children above 14 years old. The duration of the course of the treatment is determined by physician individually and it depends on the character of the disease and the efficacy of the therapy. In isolated cases the drug is used for the rest of life.
It is recommended to start the treatment from the minimal specified dose with control of the level of calcium and phosphorus in blood plasma once a week. The dose of the preparation can be increased on 0.25 or 0.5 microgram/day until biochemical indexes stabilization. On reaching of minimal effective dose it is recommended to control calcium level in plasma every 3–5 weeks.
In adults with rickets and osteomalacia caused by exogenous scarcity of vitamin D, gastro-intestinal tract diseases or prolonged antispasmodic therapy the preparation is prescribed in dosage of 1–3 microgram per day (here and hereinafter the dosage by alphacalcidol is mentioned).
In a case of hypoparathyreosis the daily dosage for adults is 2–4 microgram.
In osteodystrophy and chronic renal insufficiency the daily dosage for adults is up to 2 micrograms.
In Fanconi syndrome and renal acidosis the preparation is prescribed for adults in the daily dosage of 2–6 micrograms.
In hypophosphatemic rickets and osteomalacia the daily dosage for adults is 4–20 micrograms.
In postmenopausal osteoporosis, senile osteoporosis, steroid osteoporosis and other types of it the daily dosage for adults is 0.5–1 microgram.
The dosage for children above 14 years old does not differ from the recommended dosage for adults, but it is necessary to control the level of calcium, phosphorus and alkaline phosphatise every 2–3 weeks of the treatment while the treatment of patients aged from 14 to 16 years old.
Side effects:
Gastro-intestinal tract and liver: anorexia, vomiting, heartburn, stomach pain, nausea, dry mouth, discomfort in epigastrium, constipation, diarrhoea; in rare cases it can be insignificant increasing of alanine aminotransferase and aspartate aminotransferase in plasma.
Central nervous system: rare – weakness, fatigability, headache, dizziness, drowse.
Cardiovascular system: tachycardia is in rare cases.
Allergic reactions: rare – skin rash, itch.
Musculoskeletal system: moderate pain in muscles, bones and joints.
Influence on metabolism: in rare cases – hypercalcinemia; very rare – insignificant increasing of HDL (high-density lipoproteins) in plasma. In patients with serious kidney disorders a development of hyperphosphatemia is possible.
Overdosage:
Possible symptoms: weakness, inertia, dizziness, headache; nausea, dry mouth, constipation, diarrhoea, heartburn, vomiting, pain in epigastrium, bones pain, itch, tachycardia.
Treatment: It is necessary to stop the usage of the drug. On the early stage of the overdosage it can be a positive effect from gastric lavage and/or from the indication of mineral oil (which promotes absorption decrease and increase of the drug excretion with faeces).
In serious cases it can be used isotonic solution of sodium chloride intravenously, loop diuretics, glucocorticoides.
Pregnancy and lactation:
The preparation usage in pregnancy and lactation is contraindicated.
Children:
The preparation is not used in children less than 16 years old.
Special indications:
For patients who are inclined to hypercalcaemia, especially for patients with urolithiasis it is necessary to administer the drug carefully.
During the usage of the preparation it is necessary to control the levels of calcium, phosphorus and alkaline phosphatise in plasma and calcium and phosphorus values in urine regularly (not less than 1 time in 3 months), to observe the development of the therapeutic effect and to adjust the dosage of the preparation if there is a need.
During the usage of Alphaphorcal® Plus it is necessary to keep to a diet. It is necessary also to teach the patients to identify the symptoms of hypercalcaemia. Hypercalcaemia and hypercalcuria can be adjusted by contraindication of the drug usage and decreasing of calcium usage until the normalization of calcium level in blood. As rule this period is 1 week. Then the therapy can be continued, starting from the half of the last dose.
In the presence of biochemical data of normalization of bones structure (normalization of alkaline phosphatases contents in plasma) it is necessary to decrease the dose of Alphaphorcal® Plus that allows to avoid hypercalcaemia.
Influence on velocity reactions in driving motor transport and operating other machines.
If during the treatment by the preparation patients feel dizziness or high fatigability or other symptoms, which were not observed earlier, it is necessary to avoid driving motor transport and other potentially dangerous machines.
Drug interactions:
During the treatment of osteoporosis the preparation can be combined with estrogens and antiresorptive drugs of different groups.
In concurrent usage of Alphaphorcal® Plus and derivations of digitalis the risk of arrhythmia is increased.
In concurrent usage with barbiturates, anticonvulsant drugs or other drugs, which can activate enzymes of microsomal oxidation in liver, efficacy of Alphaphorcal® Plus is decreased.
Absorption of alphacalcidol is decreased in a case of its concurrent usage with mineral oils (during prolonged period), colestyramine, colestipol, sucralfate, antacids and albumin preparations.
In a case of the concurrent usage of alphacalcidol and antacids the risk of hypermagnesemia is increased.
There is an increased risk of hypercalcaemia if the drug is concurrently used with calcium preparations or thiazide diuretics.
During the course of the treatment by Alphaphorcal® Plus vitamin D and its derivates should not be administered because of possibility of additive interaction and increased risk of hypercalcaemia development.
Pharmacological properties:
Pharmacodynamics: Alphacalcidol is the predecessor of active metabolite of vitamin D3. It increases the absorption of calcium and phosphorus in bowels, increases reabsorption of them in kidney, intensifies mineralization of bones and decreases the level of parathyroid hormone in blood.
Alphacalcidol renews a positive balance of calcium during the treatment of calcium malabsorption and in this way it decreases the intensity of bones resorption that promotes decreasing of fractures frequency.
In course treatment of the preparation it is observed decreasing of bones and muscular pain caused by disorders of calcium and phosphorus metabolism and improving of movements’ coordination.
Calcium carbonate inhibits activity of osteoclasts and resorption of bone tissue.
The usage of calcium in combination with alphacalcidol prevents increasing of producing of parathyroid hormone (PTH), which is a stimulator of increased bones resorption.
Pharmacokinetics: After internal usage alphacalcidol is absorbed in gastrointestinal tract quickly. Period of reaching of maximal concentration of the preparation in plasma is 8–18 hours.
In liver alphacalcidol is metabolized into the main active metabolite of vitamin D3 – calcitriol (1-alpha, 25-dihydroxivitamin D3). The less part of the preparation is metabolized in bone tissues. In contrast with natural vitamin D3 biotransformation of the drug is not carried out in kidney. It is allowed to use the preparation in patients with kidney pathology.
Calcium is absorbed in proximal part of small intestine in ionized form using an active, vitamin-D-dependent transport mechanism. After per oral use maximal concentration in plasma is reached in 1.5–2 hours. It is excreted mainly with faeces.
Pharmaceutical characteristics:
General physic-chemical properties: red colored and oblong shaped soft capsules containing oily cream coloured paste with permitted dark impregnations.
Shelf-life: 2 years.
Storage: Store in dry, protected from light place at the temperature not more than 25o C. Keep it out of reach of children.
Package: 10 capsules are in a blister, 3 blisters are in a carton box (¹ 10 x 3).
Conditions of supply: By prescription.
Manufacturer: For KUSUM HEALTHCARE PVT LTD, India, manufactured by OLIVE HEALTHCARE, India.
Information given on this site should not be used for self-diagnosis and treatment and can't be a replacement of doctor's advice.
