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    Calcitriol, Calcium Carbonate and Zinc Capsules Calzem Composition

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    Anjali Monga
    This formulation combines calcitriol, calcium, and zinc. Calcitriol is the active form of vitamin D3 and is important for calcium absorption and functioning. Calcium plays a critical role in normal body functioning including nerves, cells, muscle and bone. Zinc is a nutritional supplement important for growth and tissue repair. This formulation is indicated for hypocalcemia, post-menopausal osteoporosis, and other conditions. It should be taken with food once daily and dosage should be carefully monitored to prevent hypercalcemia.

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    Calcitriol, Calcium Carbonate and Zinc Capsules Calzem Composition

    Uploaded by

    Anjali Monga
    112 views5 pages
    This formulation combines calcitriol, calcium, and zinc. Calcitriol is the active form of vitamin D3 and is important for calcium absorption and functioning. Calcium plays a critical role in normal body functioning including nerves, cells, muscle and bone. Zinc is a nutritional supplement important for growth and tissue repair. This formulation is indicated for hypocalcemia, post-menopausal osteoporosis, and other conditions. It should be taken with food once daily and dosage should be carefully monitored to prevent hypercalcemia.

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    This formulation combines calcitriol, calcium, and zinc. Calcitriol is the active form of vitamin D3 and is important for calcium absorption and functioning. Calcium plays a critical role in normal body functioning including nerves, cells, muscle and bone. Zinc is a nutritional supplement important for growth and tissue repair. This formulation is indicated for hypocalcemia, post-menopausal osteoporosis, and other conditions. It should be taken with food once daily and dosage should be carefully monitored to prevent hypercalcemia.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    112 views5 pages

    Calcitriol, Calcium Carbonate and Zinc Capsules Calzem Composition

    Uploaded by

    Anjali Monga
    This formulation combines calcitriol, calcium, and zinc. Calcitriol is the active form of vitamin D3 and is important for calcium absorption and functioning. Calcium plays a critical role in normal body functioning including nerves, cells, muscle and bone. Zinc is a nutritional supplement important for growth and tissue repair. This formulation is indicated for hypocalcemia, post-menopausal osteoporosis, and other conditions. It should be taken with food once daily and dosage should be carefully monitored to prevent hypercalcemia.

    Copyright:

    Attribution Non-Commercial (BY-NC)
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    of 5

    Calcitriol, Calcium Carbonate and Zinc Capsules

    CALZEM

    COMPOSITION
    Each soft gelatin capsule contains:
    Calcium carbonate IP……500 mg
    from an organic source (Oyster shell)
    equivalent to elemental calcium 200 mg
    Calcitriol BP ……………0.25 mcg
    Zinc……………………...7.5 mg
    (as Zinc sulfate monohydrate USP)

    DOSAGE FORM
    Capsules for oral use.

    DESCRIPTION
    This formulation combines calcitriol, calcium and zinc.

    Calcitriol is the active from of vitamin D3 (cholecalciferol). It is produced in the


    kidney from the vitamin D metabolite 25-hydroxyvitamin D3 (calcifediol). Vitamin
    D is important for the absorption of calcium from the stomach and for the
    functioning of calcium in the body.

    The known sites of action of calcitriol are intestine, bone, kidney and parathyroid
    gland. In bone, calcitriol in conjunction with parathyroid hormone stimulates
    resorption of calcium; and in the kidney, calcitriol increases the tubular
    reabsorption of calcium.

    Calcium plays a critical role in the body. It is essential for normal functioning of
    nerves, cells, muscle and bone. Calcium prevents bone loss and is associated
    with a modest reduction in fracture risk. Calcium and vitamin D preparations are
    used to prevent or to treat calcium deficiency. A vitamin D resistant state may
    exist in uremic patients because of the failure of the kidney to adequately
    produce calcitriol.

    Zinc is a nutritional supplement important for normal growth and tissue repair.
    Urinary elimination of zinc is increased in osteoporotic women. Zinc depletion is
    shown to diminish the response of oral calcitriol when administered orally.
    Supplementary zinc not only improves calcitriol response but also helps to arrest
    bone loss in old postmenopausal women.

    INDICATIONS
     Management of hypocalcaemia in patients undergoing dialysis for chronic
    renal failure. It has been shown to significantly reduce elevated
    parathyroid hormone (PTH) levels. Reduction of PTH has been shown to
    result in an improvement in renal osteodystrophy
     Post-menopausal osteoporosis.
     Hypocalcaemia in hypoparathyrodism
     Parathyroidectomy
     Vitamin D dependent rickets
     Renal tubular osteocalcaemia
     Sporadic and oncogenic hypophasphatemic osteomalacia
     X-linked hypophosphatemic osteomalacia
     Osteomalacia in Malabsorption syndrome
     Hypocalcaemia and hypomagnesaemia after small bowel resection
     Osteoporosis in males
     Psoriasis

    DOSAGE AND ADMINISTRATION


    The optimal dose must be carefully determined for each patient. The
    recommended initial dose is one capsule of CALZEM daily. If a satisfactory
    response in the biochemical parameters and clinical manifestations of the
    disease state is not observed, the dose may be increased by an increment of 1-2
    capsules at two to four week intervals. In patients undergoing dialysis, the dose
    may be increased by an increment of 1capsule at 4 to 8 week intervals. During
    this titration period, serum calcium and phosphorus levels should be obtained at
    least twice weekly and if hypercalcaemia is noted, the drug should be
    immediately discontinued until normocalcaemia ensues. In patients undergoing
    dialysis, phosphorus, magnesium and alkaline phosphatase should be
    determined periodically. Patients should be informed of the symptoms of
    hypercalcaemia

    CONTRAINDICATIONS
    CALZEM should not be given to patients with hypercalcaemia or evidence of
    vitamin D toxicity.

    WARNINGS AND PRECAUTIONS


    Since calcitriol is the most potent metabolite of vitamin D available, vitamin D and
    its derivatives should be withheld during treatment.
    In patients undergoing dialysis, who have high serum phosphorus levels,
    appropriate serum phosphate binders should be used.

    Drug Interactions
     Concomitant us of magnesium containing antacids and calcitriol may lead to
    the development of hypermagnesaemia.
     CALZEM should be avoided in patients on digitalis because hypercalcaemia
    in such patients may precipitate cardiac arrhythmias
     Higher doses of calcitriol may be required in patients taking barbiturates or
    anticonvulsants.
     The effect of calcitriol may be counteracted by corticosteroids.
     Cholestyramine may impair intestinal absorption of calcitriol
     Concurrent use of calcium containing formulations may reduce the response
    of verapamil and other calcium channel blockers.
     Oestrogens may increase calcium absorption and calcium may prevent
    absorption of etidronate.
     Calcium carbonate may reduce absorption of fluoroquinolones and the effects
    of gallium may be antagonized.
     Concurrent use with phenytoin decreases the bioavailability of both phenytoin
    and calcium.
     Calcium may also decrease the absorption of tetracyclines.
     Bran products (including brown bread) and some foods (e.g. proteins,
    phytates, some minerals) may decrease zinc absorption.

    Renal impairment
    The elimination half-life of calcitriol increased by at least two fold in chronic renal
    failure and hemodialysis patients compared to healthy subjects.

    Hepatic impairment
    Controlled studies examining the influence of hepatic disease on calcitriol have
    not been conducted.

    Pregnancy
    Category C. There are no adequate and well-controlled studies in pregnant
    women. CALZEM should be used during pregnancy only if the potential benefit
    justifies the potential risk to the fetus.

    Lactation
    Calcitriol may be excreted in human milk. A mother should not nurse while taking
    CALZEM.

    Paediatric use
    Safety and efficacy of this drug has not been established in children.

    Gediatric use
    The dose selection for an elderly patient should be cautious, usually starting at
    the lower end of the dose range, reflecting the greater frequency of decreased
    hepatic, renal or cardiac function and of concomitant disease or other drug
    therapy.

    UNDESIRABLE EFFECTS
    Adverse effects are in general similar to those encountered with excessive
    vitamin D intake.

    The early symptoms of vitamin D intoxication associated with hypercalcaemia


    include weakness, headache, somnolence, nausea, vomiting, dry mouth,
    constipation, muscle pain, bone pain and metallic taste.
    Late signs include polyuria, polydipsia, anorexia, weight loss, nocturia,
    conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus,
    hyperthermia, decreased libido, elevated BUN, albuminuria,
    hypercholesterolaemia, elevated SGOT and SGPT, ectopic calcification,
    hypertension, cardiac arrhythmias and rarely, overt psychosis.

    OVERDOSAGE
    Administration of this formulation to patients in excess of their requirements can
    cause hypercalcaemia, hypercalciuria and hyperphosphataemia.

    Overdosage of any form of vitamin D is dangerous. Progressive hypercalcaemia


    due to overdosage of this formulation may be so severe as to require emergency
    attention. Sometimes hypercalciuria can also occur. Chronic hypercalcaemia
    can lead to generalized vascular calcification, nephrocalcinosis and other soft
    tissue calcification. The serum calcium times phosphate product (Ca x P) should
    not be allowed to exceed 70. Radiographic evaluation of suspect anatomical
    regions may be useful in the early detection of this condition.

    Excessive intake of zinc may lead to overdosage symptoms like nausea, severe
    vomiting, dehydration, restlessness and sideroblastic anaemia (secondary to zinc
    induced copper depletion).

    General treatment of hypercalcaemia (greater than 1 mg/dl above the upper limit
    of normal range) consists of immediate discontinuation of therapy. Serum
    calcium levels should be determined daily until normocalcaemia (8.5 to 10.5
    mg/dl) ensues. Hypercalcaemia usually resolves in two to seven days. When
    serum calcium levels have returned to within normal limits, drug may be
    reinstituted at a dose lower than the prior therapy. Serum calcium levels should
    be obtained at least twice weekly after all dosage changes. Persistent or
    markedly elevated serum calcium levels may be corrected by dialysis against a
    calcium free dialysate.

    The treatment of acute accidental overdosage of the drug should consist of


    general supportive measures. Serial serum electrolyte determinations
    (especially calcium), rate of urinary calcium excretion and assessment of
    electrocardiographic abnormalities due to hypercalcaemia should be obtained.
    Such monitoring is critical in patients receiving digitalis. Due to the
    pharmacological action of calcitriol lasting only 3-5 days, further measures are
    probably unnecessary. However, should persistent and markedly elevated
    serum calcium levels occur, there are a variety of therapeutic alternatives, which
    may be considered, depending on the patient’s underlying condition. These
    include the use of drugs such as phosphates and corticosteroids as well as
    measures to induce an appropriate forced diuresis. The use of peritoneal
    dialysis against a calcium free dialysate has also been reported.
    STORAGE AND HANDLING INSTRUCTION
    Store in a cool dry place. Protect from light.

    PACKAGING INFORMATION
    Blister strip of 10 capsules.

    Last updated: June 2010

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