Alfadol-Ca (Alphadol-Ca)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAlfacalcidol + Calcium carbonateAlfacalcidol + Calcium carbonate
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  • Alfadol-Ca
    capsules inwards 
    Panacea Biotech Co., Ltd.     India
    • Dosage form: & nbspcapsules
    Composition:

    Each capsule contains:

    Active substances:

    Alfacalcidol 0.25 μg,

    Calcium carbonate in an amount of 500.00 mg corresponding to elemental calcium 200 mg

    Excipients: castor oil hydrogenated 6.00 mg, vegetable hydrogenated oil 29.00 mg, mixture LTG: corn oil 314.937 mg, butyl hydroxy anisole 0.063 mg.

    The dark blue part of the capsule shell contains: gelatin 46.14 mg, glycerol 13.84 mg, sorbitol 70 % solution 2.31 mg, methyl parahydroxybenzoate 0.22 mg, propyl parahydroxybenzoate 0.13 mg, water 36.91 mg, brilliant blue gum 0.13 mg, titanium dioxide 0.32 mg.

    The light blue part of the capsule shell contains: gelatin 46.19 mg, glycerol 13.86 mg, sorbitol 70 % solution of 2.31 mg, methyl parahydroxybenzoate 0.22 mg, propyl parahydroxybenzoate 0.13 mg, water 36.95 mg, brilliant blue dye 0.02 mg, titanium dioxide 0.32 mg. Dihydrogenated ethanol, soybean oil - removed during production.

    Description:

    Soft gelatin capsules of oblong form of double coloration (light blue / dark blue). The contents of the capsules are almost white pasty mass.

    Pharmacotherapeutic group:Vitamin - calcium-phosphorus exchange regulator
    ATX: & nbsp

    A.11.C.C   Vitamin D and its derivatives

    Pharmacodynamics:

    Combined drug regulating the exchange of calcium and phosphorus. Replenishes lack of calcium and vitamin D3 in organism.

    The main therapeutic effects of alfacalcidol are an increase in the concentration of 1,25-hydroxycolecalciferol in the blood and, as a consequence, an increase in the absorption of calcium and phosphate; improvement of mineralization and reduction of bone resorption, normalization of parathyroid hormone in the plasma, reduction of bone and muscle pain.

    Calcium is involved in the formation of bone tissue, the process of blood clotting, the transmission of nerve impulses, the contractions of skeletal muscles, the regulation of the heart.

    The rationale for the combination of alfacalcidol and calcium

    Alfacalcidol enhances the absorption of calcium from the gastrointestinal tract and causes a therapeutic effect in osteoporosis. The content of elemental calcium in calcium carbonate is 40%, i.e. in 500 mg of calcium carbonate contains 200 mg of elemental calcium, which corresponds to the minimum physiological needs.

    Pharmacokinetics:

    Absorption - high, TCmax - 8-18 hours. In the blood it binds to specific alpha globulins.

    Metabolised in the liver with the formation of an active metabolite of calcitriol (1,25-dihydroxycolecalciferol); The smaller part is metabolized in bone tissue. Unlike natural vitamin D, It is not metabolized in the kidneys, which allows prescribing with vitamin deficiency D in patients with renal insufficiency (the effect does not depend on the hydroxylation in the kidneys). It is excreted by the kidneys and with bile in approximately the same amount.

    Indications:

    Osteoporosis (menopausal, senile, steroid, idiopathic, etc.) and its complications (fractures of bones);

    renal osteodystrophy;

    Hypoparathyroidism and hyperparathyroidism (with bone damage);

    chronic renal failure.

    Contraindications:

    Hypersensitivity to vitamin A D3. Urolithiasis (education calcium stones). Elevated levels of calcium in the blood (in individuals with strengthened parathyroid function, hypervitaminosis D, osteochondrosis, metastases of tumors in the bone). Hyperphosphatemia (except when the latter develops against a background of hypoparathyroidism), hypermagnesia, Zollinger's syndrome. Intolerance to peanuts or soy. Children under 18 years.

    Carefully:Take care with persons suffering from kidney failure, as well as patients on hemodialysis. In the case of long-term treatment, it is necessary to check the amount of calcium secreted by the kidneys.
    Pregnancy and lactation:Studies have not been conducted, so the drug is contraindicated during pregnancy and lactation. In pregnancy, the drug is prescribed only for absolute indications and only if the potential benefit of its use exceeds the possible risk to the fetus. Hypercalcemia during pregnancy can affect fetal development. The daily dose should not exceed 1500 mg of calcium carbonate.
    Dosing and Administration:

    When osteoporosis - 1-2 capsules per day.

    When osteodystrophy with chronic renal failure - 2 capsules per day.

    When hypoparathyroidism and hyperparathyroidism (with damage to the bones) - 1-2 capsules per day.

    Chronic Renal Failure - 1-2 capsules per day.

    The duration of the drug is determined by the doctor.

    Side effects:

    From the side of metabolic processes: hypercalcemia. Patients with severe renal dysfunction may develophyperphosphatemia.

    From the digestive system: constipation, diarrhea.

    urinary system: nephrocalcinosis.

    Allergic reactions: itching, rash, hives.

    Overdose:

    In the development of hypercalcemia should stop taking the drug.

    Hypercalcemia manifests as malaise, fatigue, weakness, dizziness, drowsiness, headache, nausea, dry mouth, constipation, diarrhea, heartburn, vomiting, abdominal pain, gastrointestinal disorders, muscle pain, bone pain, joint pain , itching.

    Treatment: should cancel the drug. Severe form of hypercalcemia requires supportive treatment measures - hydration with the introduction of infusion saline solutions, in some cases - the appointment of "loop" diuretics, corticosteroids.

    In cases of acute overdosage, it is necessary to perform a preliminary treatment with gastric lavage and / or the administration of mineral oil, which helps to reduce absorption and increase the excretion of the drug through the intestine.

    Interaction:

    Alphacalcidol / digitalis glycosides

    Hypercalcemia in patients who take cardiac glycosides may increase cardiac arrhythmia,in this connection, they should be avoided joint application.

    Alfacalcidol / barbiturates / anticonvulsants, which are inducers of microsomal liver enzymes

    Patients who are systematically receiving barbiturates or other anticonvulsants need increased doses of alfacalcidol to achieve a therapeutic effect.

    Alfacalcidol / drugs that affect absorption

    Absorption of alfacalcidol can disrupt concurrently taken mineral oils (with long-term admission), colestramine, Colestipol, sucralfate, as well as large amounts of aluminum containing antacids.

    With the combined use of alfacalcidol with antacids and laxatives containing magnesium in patients on hemodialysis, the possibility of developing hypermagnesia should be considered.

    Alfacalcidol / Thiazide Diuretics

    The interaction of alfacalcidol with thiazide diuretics increases the risk of hypercalcemia.

    Calcium carbonate may interfere with the absorption of concomitant tetracycline and ciprofloxacin.

    Special instructions:

    Alfacalcidol is an active derivative of the vitamin D3. During treatment, do not prescribe therapeutic doses of vitamin A D3 and its derivatives due to the possibility of additive effects and an increased risk of hypercalcemia:

    The drug enhances the intestinal absorption of calcium and phosphate, the concentration of which must be controlled, especially in patients with renal insufficiency. It is necessary to monitor the concentrations of calcium, phosphate, alkaline phosphatase, magnesium and creatinine.

    If hypercalcemia or hypercalciuria occur, they can be quickly eliminated by lifting the drug to normalize the calcium concentration in the plasma. The drug should be used with caution in patients with hypercalciuria, in particular in patients with urolithiasis.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the driving of motor vehicles and employment by other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Capsules.
    Packaging:

    Primary packaging:

    For 10 capsules in a blister of PVC / aluminum foil.

    Secondary packaging:

    3 blisters for 10 capsules with instructions for medical use in a cardboard box.10 blisters for 10 capsules with instructions for medical use in a cardboard box.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013997 / 01-2002
    Date of registration:09.02.2009 / 25.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Panacea Biotech Co., Ltd.Panacea Biotech Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspKORAL-MED, CJSCKORAL-MED, CJSC
    Information update date: & nbsp17.07.2017
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