Компливит® D3 Calcium Forte
Producer: JSC Pharmstandart Russia
Code of automatic telephone exchange: A12AX
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active components:
|
Calcium (in the form of carbonate calcium) |
500 mg 1,25 g |
|
Kolekaltsiferol (D3 vitamin) (in terms of 100% колекальциферол) in the form of the granulate containing cholecalciferol, d, l - alpha tocopherol, triglycerides from the remains of fatty acids of average length, sucrose, acacia gum, corn starch, calcium phosphate (Е 341), water |
0,01 mg (400 ME) |
Excipients: lactose (sugar milk), povidone low-molecular (polyvinylpirrolidone low-molecular), polysorbate-80 (twin-80), starch potato, croscarmellose sodium, citric acid, aspartame (Е 951), magnesium stearate, oil orange either fragrance orange or peppermint of leaves oil or fragrance mint.
Description. Chewable tablets with a rough porous surface of a round biconvex form from color, white to white with a creamy shade. Can have small impregnations of grayish color.
Pharmacological properties:
The combined drug which effect is caused by the components which are its part. Regulates exchange of calcium and phosphates, reduces a resorption and increases density of a bone tissue, compensates for the deficiency of calcium and D3 vitamin of an organism, strengthens absorption of calcium in intestines and a reabsorption of phosphates in kidneys, promotes a mineralization of bones.
Calcium – participates in formation of a bone tissue, a blood coagulation, in maintenance of stable cordial activity, in implementation of processes of transfer of nervous impulses.
D3 vitamin (колекальциферол) – promotes absorption of calcium in intestines, to formation and a mineralization of a bone tissue and tissue of teeth.
Use of calcium and D3 vitamin interferes with increase in production of parathyroid hormone which is a stimulator of the raised bone resorption.
Pharmacokinetics. D3 vitamin is soaked up in a small bowel. Calcium is soaked up in the ionized form in proximal department of a small bowel by means of active, D-vitamin of the dependent transport mechanism.
Indications to use:
- Prevention and complex therapy of osteoporosis (menopauzny, senile, "steroid", idiopathic) and its complications (fractures of bones).
- Completion of deficit of calcium and/or D3 vitamin.
Route of administration and doses:
Inside, chew or swallow entirely, it is preferential during food.
Adult: for treatment of osteoporosis – on 1 tablet 2-3 times a day, for prevention of osteoporosis – on 1 tablet 2 times a day.
For completion of deficit of calcium and/or D3 vitamin:
- To adults and children 12 years – on 1 tablet 1-2 times a day are more senior.
- To children from 3rd to 12 years – on 1 tablet a day or on doctor's orders.
Features of use:
In order to avoid overdose it is necessary to consider additional intake of D3 vitamin from other sources.
Компливит® D3 Calcium Forte contains aspartame which in an organism is transformed to phenylalanine therefore the patients suffering from a fenilketonuriya should not accept drug.
During treatment it is necessary to control constantly removal of calcium with urine and concentration of calcium and creatinine in a blood plasma (in case of the calciuria exceeding 7,5 mmol/days (300 mg/days) it is necessary to reduce a dose or to stop reception).
At elderly people the need for calcium makes 1500 mg/days, in D3 vitamin – 0,5-1 thousand. ME/days.
Side effects:
Allergic reactions. Dispepsichesky frustration from digestive tract (locks, a meteorism, nausea, a stomach ache, diarrhea). A hypercalcemia and a hypercalcuria (the increased content of calcium in blood and urine).
Interaction with other medicines:
Activity of D3 vitamin can decrease at its simultaneous use with Phenytoinum or barbiturates.
At simultaneous treatment by cardiac glycosides control of an ECG and clinical state as drugs of calcium can exponentiate therapeutic and toxic effects of cardiac glycosides is necessary.
Drugs of calcium and D3 vitamin can increase absorption of tetracyclines from digestive tract. Therefore time interval between administrations of drugs has to be not less than three hours.
For prevention of decrease in absorption of drugs of bisfosfonat or sodium fluoride, it is recommended to accept Komplivit® D3 Calcium Forte not earlier than in two hours after their reception.
Glucocorticosteroids reduce absorbability of calcium therefore treatment by glucocorticosteroids can demand increase in a dose of the drug Komplivit® D3 Calcium Forte.
Simultaneous treatment by drugs of Colestyraminum or purgatives on the basis of mineral or vegetable oil can reduce D3 vitamin absorption.
At simultaneous use of diuretics of a thiazide row the risk of emergence of a hypercalcemia as they increase a canalicular reabsorption of calcium increases. Furosemide and other "loopback" diuretics, on the contrary, increase calcium removal by kidneys.
Contraindications:
Hypersensitivity to drug components (including a lactose intolerance, deficit of lactase, glyukozogalaktozny malabsorption), a hypercalcemia, a hypercalcuria, calcic нефроуролитиаз, a hypervitaminosis D, decalcifying tumors (a myeloma, bone metastasises, a sarcoidosis), the osteoporosis caused by an immobilization, a fenilketonuriya (contains aspartame), a pulmonary tuberculosis (an active form), a chronic renal failure, children's age up to 3 years.
Use with care: pregnancy, lactation period.
Use during pregnancy and breastfeeding
The daily dose should not exceed 1500 mg of calcium and 600 ME D3 vitamins. The hypercalcemia developing against the background of overdose during pregnancy can cause defects of intellectual and physical development of the child. Vitamin D and its metabolites can get into breast milk therefore it is necessary to consider intake of calcium and vitamin D from other sources at mother and the child.
Overdose:
In case of detection of signs of overdose see a doctor.
Symptoms: thirst, polyuria, loss of appetite, nausea, vomiting, locks, dizziness, weakness, headache, unconscious states, coma; at prolonged use: calcification of vessels and fabrics.
Treatment: introduction to an organism of a large amount of liquid, use of "loopback" diuretics (for example, furosemide), glucocorticosteroids, calcitonin, bisfosfo-nat.
In case of development of clinical symptoms of overdose it is necessary to define concentration of calcium and creatinine in blood. In case of the increased concentration of calcium or creatinine in blood serum it is necessary to lower a dose of drug or to temporarily stop treatment.
Storage conditions:
In the dry, protected from light place at a temperature not above 25ºС.Хранить in the place, unavailable to children. A period of validity - 2 years. Not to use after a period of validity.
Issue conditions:
Without recipe
Packaging:
Chewable tablets [orange, mint].
On 30, 60, 90, 100 or 120 tablets in banks polymeric.
Banks cork the covers screwed.
On bank, containing 30 tablets, paste the self-adhesive label.
On bank, containing 60, 90, 100 or 120 tablets, paste the self-adhesive label or the multipage self-adhesive label.
Each can is fitted a cap protective thermoshrinkable of a film.
Each can together with the application instruction is placed in the pack from a cardboard or to bank containing 60, 90, 100 or 120 tablets with the multipage label place in a transport container.
