NSTRUCTIONS FOR USE

ZESTKAL SUSPENSION

Trade name of the drug: ZESTKAL SUSPENSION

Dosage form: oral suspension

Compound:

Each 5 ml contains:

active substances:

Milk calcium 600 mg equivalent

Elemental calcium 150 mg

Elemental phosphorus 75 mg

Colecalciferol (Vitamin D ₃ ) BF 200 IU

excipients mg/5 ml: propylene glycol-25.0 mg, sodium methylparaben-7.50 mg, sodium propylparaben-0.75 mg, bronopol-2.50 mg, citric acid monohydrate-15.0 mg, liquid sorbitol (non-crystallizing )-4000.0 mg, xanthan gum-15.0 mg, magnesium aluminum silicate-10.0 mg, colloidal anhydrous silicon-10.0 mg, glycerin-666.6 mg, propylene glycol-5.0 mg, ascorbic acid- 0.5 mg, rac-alpha tocopheryl acetate-0.5 mg, liquid strawberry flavor-20.0 mg, peppermint oil 18774-0.5 mg, erythrosine supra dye-0.08 mg, purified water-up to 5 ml.

Appropriate permissible excess vitamins are added to compensate for losses during storage.

Description: Pink suspension with a characteristic odor and taste.

Pharmacological group: Mineral supplement. Calcium, combinations with other drugs.

ATX code: A12AX

Pharmacological properties

Pharmacodynamics

ZESTKAL SUSPENSION is an oral preparation in which calcium phosphate is associated with colecalciferol (Vitamin D ₃ ).

Calcium and Vitamin D have a fundamental effect on the process of “bone repair” and this is the reason for its use in elderly patients characterized by a negative calcium balance with low levels of circulating Vitamin D and elevated levels of parathyroid hormone in the blood serum. This secondary hyperparathyroidism is effectively corrected by the combined effect of tricalcium phosphate and vitamin D ₃ , the active ingredients in ZESTCAL SUSPENSION.

Vitamin D ₃ regulates the metabolism of calcium and phosphate, ensuring the absorption of calcium in the intestinal mucosa.

Pharmacokinetics

Suction

Approximately 30% of the calcium dose is absorbed in the proximal small intestine. Vitamin D is also quickly absorbed in the intestine after oral administration. The role of bile salts in facilitating absorption is well known.

Distribution

Approximately 40% of plasma calcium is bound to proteins, especially about 1/10 of albumin is diffusible but bound to anions (phosphates); the remaining fraction is diffusible ionic calcium, which has a physiological effect.

Vitamin D has a half-life of 19 to 25 hours and circulates in the plasma bound to a specific protein, alpha globulin, and accumulates in the body over a long period of time.

Metabolism

In the liver, vitamin D is converted to a 25-hydroxylase derivative (calcidiol), which is put back into circulation, where it binds to specific alpha globulin and undergoes further hydroxylation in the kidney into a 1-25 hydroxy derivative (calcitriol).

Selection

Vitamin D is excreted mainly in bile. Only a small portion of the administered dose is found in the urine.

Calcium is released in the gastrointestinal tract through saliva, bile and pancreatic secretion. Calcium from these sources, along with calcium that is not absorbed, is excreted in the feces. Approximately 2/3 of the calcium excreted by the renal system is absorbed.

Parathyroid hormone stimulates calcium reabsorption into the distal convoluted tubule, while vitamin D increases proximal reabsorption. Some calcium is also released through sweating.

Indications for use

Correction of calcium, phosphorus and vitamin D deficiency in elderly people.

ZESTKAL SUSPENSION can be taken as an adjunct to specific therapy for osteoporosis in patients either with combined vitamin D and calcium deficiency, or in patients with high risk of needing such therapeutic supplements.

The suspension is used in postmenopausal women, treatment of osteoporosis and after fractures.

Directions for use and doses

For oral administration only.

Adults: Two teaspoons twice a day.

Or as prescribed by a doctor.

Side effects

Side effects are listed according to MedDRA system organ class.

Since the following reactions have been reported in post-marketing experience with ZESTKAL suspension, their frequency is not known (cannot be estimated from the available data).

Immune system disorders

Anaphylactic reaction, allergic dermatitis

Metabolic and nutritional disorders

Hypercalcemia and hypercalciuria

Gastrointestinal disorders

Nausea, constipation, diarrhea, epigastric pain

Diseases of the skin and subcutaneous tissue

Hives

Contraindications

High sensitivity to the active or excipients of the drug.

Hypercalcemia (>10.5 mg/dL), hypercalciuria (300 mg or 7.5 mmol/24 hours), severe renal failure, renal stones, calcium lithiasis, tissue calcification, prolonged immobilization accompanied by hypercalciuria and/or hypercalcemia.

ZESTKAL SUSPENSION is contraindicated for children, pregnant women and lactating women in cases of Hypervitaminosis D.

Drug interactions

Absorption of orally administered tetracycline may be decreased with concomitant calcium intake. These 2 medications should be taken 3 hours apart.

Some diuretics (furosemide, ethacrynic acid), antacids containing aluminum salts and thyroid hormones can interfere with calcium absorption and increase renal and fecal excretion. Thiazide diuretics may reduce urinary calcium excretion and may cause hypercalcemia; some antibiotics such as penicillin, neomycin and chloramphenicol may increase its absorption. It is recommended to monitor serum calcium levels during long-term treatment.

Cholestyramine, corticosteroids and mineral oils interfere with and reduce the absorption of vitamin D, while phenytoin and barbiturates promote its inactivation.

Calcium/digitalis synergism in the heart can cause severe cardiac dysfunction.

In case of simultaneous treatment with a bisphosphonate or with sodium fluoride, it is advisable to allow a minimum period of two hours before taking ZESTCAL SUSPENSION (risk of reduced gastrointestinal absorption of bisphosphonates and sodium fluoride).

Possible interactions may occur with food (eg, foods containing phosphate, oxalic acid or phytic acid) with decreased calcium absorption.

special instructions

ZESTKAL SUSPENSION should be used with caution in patients with renal failure or when there is a clear tendency to form urinary stones. Calcemia and calciuria should be appropriately controlled in these patients to prevent the onset of hypercalcemia. If the calciuria level exceeds 7.5 mmol/24 hours (300 mg/24 hours), treatment should be stopped immediately.

Particular caution is also required when treating patients with cardiovascular diseases. The effect of cardiac glycosides may be enhanced by oral calcium supplementation with vitamin D. Strict medical supervision is necessary and ECG and calcium monitoring is required if required.

You should avoid all vitamin D compounds and derivatives, including foods that are fortified with vitamin D, during treatment with ZESTCAL SUSPENSION.

The drug should be prescribed with caution to patients with sarcoidosis due to the possible increase in the metabolism of vitamin D to its active form. Serum and urinary calcium levels should be monitored in these patients.

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. Excessive hypercalcemia can lead to coma and death. Sustained high calcium levels can lead to irreversible kidney damage 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 stopped. Fluid deficiency must be balanced and individual rescue measures must be prescribed by a doctor.

Rehydration is recommended, and, depending on the severity of hypercalcemia, isolated or combination therapy with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function, and diuresis should be monitored. In severe cases, it is necessary to monitor the ECG and CVP.

The limit of vitamin D toxicity is between 40,000 and 100,000 IU/day for 1-2 months in people with normal parathyroid function, for calcium exceeding 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

200 ml amber plastic bottle, with measuring cup. 1 bottle with measuring cup and instructions for use in a cardboard box.

Storage conditions

Store at temperatures below 30°C. Store in a 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: exports@corallab.com

Website: www.corallab.com

ZESTKAL SUSPENSION

Price on Request

ZESTKAL SUSPENSION

Price on Request