ATX code: A12AX
INSTRUCTIONS FOR USE
ZESTCAL
Trade name of the drug: Zestcal
Dosage form: chewable tablets
Composition:
Each chewable tablet contains:
active substances:
milk calcium 1200 mg equivalent
elemental calcium 300 mg
elemental phosphorus 150 mg
colecalciferol (vitamin D 3 ) BF 400 IU
excipients mg/tab: Lactose-92.610 mg, anhydrous dextrose-320.0 mg, mannitol-133.0 mg, sodium methylhydroxybenzoate-2.7 mg, sodium propylhydroxybenzoate-0.77 mg, corn starch-73.91 mg, magnesium stearate – 13.3 mg, purified talc – 10.0 mg, sodium starch glycolate – 50.0 mg, dried peppermint – 22.7 mg, aspartame – 11.0 mg, purified water – a sufficient amount. Appropriate permissible excess vitamins are added to compensate for losses during storage.
Description: Oblong-shaped, biconvex, white chewable tablets with a score on one side.
Pharmacotherapeutic group: mineral supplement
Code ATH: A12AX
Pharmacological properties
Pharmacodynamics
Vitamin D increases calcium absorption in the intestines.
Taking calcium and vitamin D3 prevents the increase in parathyroid hormone (PTH), which is caused by calcium deficiency and which causes increased bone resorption.
A clinical study in hospitalized patients suffering from D 3 deficiency , administration of 2 tablets of calcium 500 mg/vitamin D 400 IU daily for 6 months normalized the value of 25-hydroxylated metabolites of vitamin D 3 and reduced secondary hyperparathyroidism and alkaline phosphatase, increasing calcium absorption in intestinal mucosa.
Pharmacokinetics
Calcium
Suction
Approximately 30% of the calcium dose is absorbed through the gastrointestinal tract.
Distribution and metabolism
99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in intra- and extracellular fluid. About 50% of the total blood calcium is in physiologically active ionized form with about 10% complexed with citrate, phosphate or other anions, the remaining 40% bound to proteins, mainly albumin.
Selection
Calcium is excreted in feces, urine and sweat. Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.
Vitamin D 3
Suction
Vitamin D is easily absorbed in the small intestine.
Distribution and metabolism
Colecalciferol and its metabolites circulate in the blood bound to a certain globulin. Colecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxycholecalciferol. Then it is further converted in the kidneys to 1,25-dihydroxycholecalciferol; 1,25-dihydroxycholecalciferol is a metabolite responsible for increasing calcium absorption. Vitamin D, which is not metabolized, is stored in fat and muscle tissue.
Selection
Vitamin D is excreted in feces and urine.
Indications for use
Prevention and treatment of calcium and vitamin D deficiency in older people.
As a Vitamin D and calcium supplement for patients with osteoporosis who are at risk of vitamin D and calcium deficiency.
Directions for use and doses
Adults and elderly patients:
One chewable tablet 1-2 times a day.
Chew or slowly dissolve the tablet in your mouth.
Dosage for liver failure
No special dose adjustment is required.
Dosage for renal failure
Patients with severe renal impairment should not take Zestcal tablet.
Application method:
Orally
Side effects
Side effects are listed below by organ system class and frequency. Frequencies are defined as: uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000) or very rare (≤1/10000).
From the immune system:
Not known: hypersensitivity reactions such as angioedema or laryngeal edema.
Metabolic and nutritional disorders:
Uncommon: hypercalcemia and hypercalciuria.
Very rare: observed only in case of overdose, see Milk-alkali syndrome.
From the gastrointestinal tract:
Rarely: constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhea.
From the skin and subcutaneous tissue:
Rarely: itching, rash and urticaria.
Other special population:
Patients with renal failure: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis.
Contraindications
Diseases and conditions leading to hypercalcemia or hypercalciuria. Nephrolithiasis. Hypervitaminosis D. High sensitivity to active or any other components of the drug.
Drug interactions
Combinations requiring precautions for use:
Cardiac glycosides:
Risk of cardiac arrhythmia. Clinical observation is necessary and ECG and plasma calcium monitoring are recommended.
Thiazide diuretics:
Thiazide diuretics reduce the renal elimination of calcium. It is recommended to monitor plasma calcium levels regularly.
Tetracycline, etidronate, fluoride and iron:
Calcium may reduce the absorption of tetracycline, etidronate, fluoride and iron. You should maintain a break of at least 3 hours between taking Zestcal chewable tablets and these drugs.
Strontium:
Calcium may reduce the absorption of strontium. The risk of a decrease in the bioavailability of strontium is 60-70% when taking medications containing calcium simultaneously. It is recommended to stop taking Zestcal chewable tablets if you are taking medications containing strontium.
Estramustine and thyroid hormones :
Calcium may reduce the absorption of estramustine and levothyroxine. It is recommended to take these tablets at least 2 hours before or after taking Zestcal chewable tablets.
Orlistat:
Treatment with orlistat may potentially reduce the absorption of Vitamin D.
Food:
Possible interactions with food: foods containing oxalic acid (spinach, rhubarb, sorrel, cocoa, tea), phosphates (pork, sausage, processed cheese) or phytic acid (legumes, whole grain cereals, chocolate). These foods may reduce calcium absorption. Therefore, it is recommended to eat such food with an interval of 2 hours before or after taking the drug.
special instructions
Calculate your total vitamin D intake if you are treated with other medications containing vitamin D.
During long-term therapy, it is recommended to monitor calcium levels in blood plasma and urine. It is recommended to temporarily reduce and interrupt therapy if urinary calcium exceeds 7.5mmol/24h (300mg/24h). This monitoring is especially important in the elderly, in cases of combined treatment with cardiac glycosides or diuretics and in patients who are prone to nephro/urolithiasis. In the presence of hypercalcemia or signs of problems with renal function, the dose should be reduced or treatment interrupted.
The drug should be used with caution in patients with renal failure and the effect of calcium and phosphate on homeostasis should be monitored. The risk of soft tissue calcification must be considered. In patients with severe renal failure, Vitamin D in the form of colicalciferol is not metabolized normally, so other forms of Vitamin D should be used.
The drug is prescribed to be taken with caution in patients with sarcoidosis due to the risk of increased metabolism of Vitamin D in the active form. Calcium levels in blood plasma and urine should be monitored.
Pregnancy and lactation
Pregnancy
During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D. Animal studies have shown reproductive toxicity of high doses of vitamin D. In pregnant women, overdose of calcium and vitamin D should be avoided, since persistent hypercalcemia is associated with adverse effects on the developing fetus. There is no evidence that vitamin D at therapeutic doses is teratogenic in humans. Chewable tablets of Milk calcium and vitamin D 3 can be taken during pregnancy, in cases of calcium and vitamin D deficiency.
Lactation
Chewable tablets of Milk calcium and vitamin D 3 can be taken during breastfeeding. Calcium and vitamin D pass into breast milk. This should be taken into account when prescribing additional vitamin D for a child.
Keep the drug out of the reach of children and should not be used after the expiration date.
Overdose
Overdose can lead to hypervitaminosis D and hypercalcemia. Symptoms of hypercalcemia may include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, joint pain, nephrocalcinosis, nephrolithiasis and in severe cases, cardiac arrhythmia . Persistently high calcium levels can lead to irreversible renal impairment and soft tissue calcification.
Treatment for hypercalcemia: Treatment with calcium and vitamin D should be discontinued.
Treatment with thiazide diuretics, lithium, vitamin A and cardiac glycoside should also be discontinued. Fluid deficiency must be balanced and individual corrective measures must be taken and prescribed by a doctor.
Rehydration and, depending on the severity of hypercalcemia, isolated or combination therapy with loop diuretics, bisphosphonates, calcitonin and corticosteroids are recommended. Serum electrolytes, renal function, and diuresis should be monitored. In severe cases, it is necessary to monitor the ECG and CVP.
The maximum toxic dose of vitamin D is between 40,000 and 100,000 IU/day for 1-2 months in people with normal parathyroid function; for calcium, it exceeds 2000 mg per day. Symptoms of vitamin D toxicity due to hypercalcemia should be treated as above.
The drug should be stored out of the reach of children and not used after the expiration date.
Release form
15 tablets are packed in a blister made of PVC aluminum foil. 1 or 2 blisters with instructions for use in a cardboard box.
Food conditions
Store at temperatures below 30°C in a dry place protected from light.
Best before date
24 months from date of manufacture.
Produced
Coral Laboratories Ltd.
Plot No.57/1 (16), Bhenslore, Dunetha,
Nani Daman-396 210, INDIA.
Email: [email protected]
Website: www.corallab.com
