Triozac

Each mL of ampoule of solution for injection contains the following excipients: Polysorbate 20 4 mg, sodium chloride 1.5 mg, sodium ascorbate 10 mg, anhydrous dibasic sodium phosphate 7.6 mg, monobasic sodium phosphate monohydrate 1.8 mg and disodium edetate dihydrate 1.1 mg. It has a pH of 7.2 (6.5-8). Calcitriol (Triozac) does not contain a preservative.

Calcitriol (Triozac) is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol. Its molecular formula is C₂₇H₄₄O₃.

The other names frequently used are 1α,25-dihydroxycholecalciferol; 1α,25-dihydroxy-vitamin D3; 1,25-DHCC; 1,25(OH)₂D3; and 1,25-diOHC.

Calcitriol (Triozac) is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water.

Zinc sulphate monohydrate (Triozac) Capsule: Each capsule contains Zinc sulphate monohydrate (Triozac) 54.93 mg, thiamine nitrate 10 mg, riboflavin 10 mg, pyridoxine hydrochloride 3 mg, vitamin B12 (coated) equivalent to cyanocobalamin 15 mcg, ascorbic acid 150 mg, folic acid 1 mg, nicotinamide 50 mg and calcium pantothenate 12.5 mg.

Zinc sulphate monohydrate (Triozac) Syrup: Each 5 mL contains Zinc sulphate monohydrate (Triozac) gluconate 34.9 mg, thiamine mononitrate 2.5 mg, riboflavin 2.5 mg, pyridoxine hydrochloride 1 mg, cyanocobalamin 3 mcg, ascorbic acid 50 mg, d-panthenol 12.5 mg and niacinamide 25 mg in a flavoured liquid glucose sorbitol syrup base.

Predialysis Patients

Calcitriol (Triozac) (Calcitriol (Triozac)) is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.

Dialysis Patients

Calcitriol (Triozac) (Calcitriol (Triozac)) is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcitriol (Triozac) (Calcitriol (Triozac)) administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.

Hypoparathyroidism Patients

Calcitriol (Triozac) (Calcitriol (Triozac)) is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.

nutritional supplement for pregnant and breast-feeding women

Old age, poor diet, prolonged antibiotic therapy, debilitating diseases & special diets.

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are available in the foods that you eat. Vitamin D is necessary for strong bones and teeth.

Lack of vitamin D may lead to a condition called rickets, especially in children, in which bones and teeth are weak. In adults it may cause a condition called osteomalacia, in which calcium is lost from bones so that they become weak. Your doctor may treat these problems by prescribing vitamin D for you. Vitamin D is also sometimes used to treat other diseases in which calcium is not used properly by the body.

Ergocalciferol is the form of vitamin D used in vitamin supplements.

Some conditions may increase your need for vitamin D. These include:

• Alcoholism
• Intestine diseases
• Kidney disease
• Liver disease
• Overactivity of the parathyroid glands with kidney failure
• Pancreas disease
• Surgical removal of stomach

In addition, individuals and breast-fed infants who lack exposure to sunlight, as well as dark-skinned individuals, may be more likely to have a vitamin D deficiency. Increased need for vitamin D should be determined by your health care professional.

Alfacalcidol, calcifediol, Calcitriol (Triozac), and dihydrotachysterol are forms of vitamin D used to treat hypocalcemia (not enough calcium in the blood). Alfacalcidol, calcifediol, and Calcitriol (Triozac) are also used to treat certain types of bone disease that may occur with kidney disease in patients who are undergoing kidney dialysis.

Claims that vitamin D is effective for treatment of arthritis and prevention of nearsightedness or nerve problems have not been proven. Some psoriasis patients may benefit from vitamin D supplements; however, controlled studies have not been performed.

Injectable vitamin D is given by or under the supervision of a health care professional. Some strengths of ergocalciferol and all strengths of alfacalcidol, calcifediol, Calcitriol (Triozac), and dihydrotachysterol are available only with your doctor's prescription. Other strengths of ergocalciferol are available without a prescription. However, it may be a good idea to check with your health care professional before taking vitamin D on your own. Taking large amounts over long periods may cause serious unwanted effects.

Zinc sulphate monohydrate (Triozac) is a naturally occurring mineral. Zinc sulphate monohydrate (Triozac) is important for growth and for the development and health of body tissues.

Zinc sulphate monohydrate (Triozac) sulfate is used to treat and to prevent Zinc sulphate monohydrate (Triozac) deficiency.

Zinc sulphate monohydrate (Triozac) sulfate may also be used for purposes not listed in this medication guide.

The optimal daily dose of Calcitriol (Triozac) (Calcitriol (Triozac)) must be carefully determined for each patient. Calcitriol (Triozac) (Calcitriol (Triozac)) can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Calcitriol (Triozac) (Calcitriol (Triozac)) therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.

The effectiveness of Calcitriol (Triozac) (Calcitriol (Triozac)) therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

Because of improved calcium absorption from the gastrointestinal tract, some patients on Calcitriol (Triozac) (Calcitriol (Triozac)) may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all.

During the titration period of treatment with Calcitriol (Triozac) (Calcitriol (Triozac)), serum calcium levels should be checked at least twice weekly. When the optimal dosage of Calcitriol (Triozac) (Calcitriol (Triozac)) has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.

Dialysis Patients

The recommended initial dose of Calcitriol (Triozac) (Calcitriol (Triozac)) is 0.25 mcg/day. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease state is not observed, dosage may be increased by 0.25 mcg/day at 4 to 8 week intervals. During this titration period, serum calcium levels should be obtained at least twice weekly, and if hypercalcemia is noted, the drug should be immediately discontinued until normocalcemia ensues. Phosphorus, magnesium, and alkaline phosphatase should be determined periodically.

Patients with normal or only slightly reduced serum calcium levels may respond to Calcitriol (Triozac) (Calcitriol (Triozac)) doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.

Oral Calcitriol (Triozac) (Calcitriol (Triozac)) may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral Calcitriol (Triozac) (Calcitriol (Triozac)) may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.

Hypoparathyroidism

The recommended initial dosage of Calcitriol (Triozac) (Calcitriol (Triozac)) is 0.25 mcg/day given in the morning. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease is not observed, the dose may be increased at 2-to 4-week intervals. During the dosage titration period, serum calcium levels should be obtained at least twice weekly and, if hypercalcemia is noted, Calcitriol (Triozac) (Calcitriol (Triozac)) should be immediately discontinued until normocalcemia ensues. Careful consideration should also be given to lowering the dietary calcium intake. Serum calcium, phosphorus, and 24-hour urinary calcium should be determined periodically.

Most adult patients and pediatric patients age 6 years and older have responded to dosages in the range of 0.5 mcg to 2 mcg daily. Pediatric patients in the 1 to 5 year age group with hypoparathyroidism have usually been given 0.25 mcg to 0.75 mcg daily. The number of treated patients with pseudohypoparathyroidism less than 6 years of age is too small to make dosage recommendations.

Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of Calcitriol (Triozac) (Calcitriol (Triozac)) may be needed.

Predialysis Patients

The recommended initial dosage of Calcitriol (Triozac) (Calcitriol (Triozac)) is 0.25 mcg/day in adults and pediatric patients 3 years of age and older. This dosage may be increased if necessary to 0.5 mcg/day.

For pediatric patients less than 3 years of age, the recommended initial dosage of Calcitriol (Triozac) (Calcitriol (Triozac)) is 10 to 15 ng/kg/day.

How supplied

Capsules: 0.25 mcg Calcitriol (Triozac) in soft gelatin, light orange, oval capsules, imprinted with Calcitriol (Triozac) (Calcitriol (Triozac)) 0.25 ROCHE; bottles of 30 (NDC 0004-0143-23), and bottles of 100 (NDC 0004-0143-01).

Capsules: 0.5 mcg Calcitriol (Triozac) in soft gelatin, dark orange, oblong capsules, imprinted with Calcitriol (Triozac) (Calcitriol (Triozac)) 0.5 ROCHE; bottles of 100 (NDC 0004-0144-01).

Oral Solution

Calcitriol (Triozac) (Calcitriol (Triozac)) Capsules and

Oral Solution should be protected from light.

Store at 59° to 86° F (15° to 30° C).

Distributed by: Roche Laboratories Inc., 340 Nutley Street, New Jersey, NJ 07110-1199. Revised: July 2004. FDA Rev date: 7/7/2004

Adult & child above 12 yrs: 1 tab daily with or after meals.

See also:
What is the most important information I should know about Calcitriol (Triozac)?

You should not use this medication if you have a severe form of psoriasis (with pus, skin peeling, severe redness).

Before using Calcitriol (Triozac) topical, tell your doctor if you have low or high levels of calcium in your blood, a calcium disorder or metabolic imbalance, or if you are receiving UV light treatments (phototherapy) for your psoriasis.

Tell your doctor about all other medicines you are using to treat psoriasis. Also tell your doctor if you are taking a diuretic (water pill) or vitamin or mineral supplements that contain calcium or vitamin D.

Calcitriol (Triozac) topical is for use only on areas of psoriasis. Avoid getting it on healthy skin areas. Calcitriol (Triozac) topical should not be applied to the face or the vaginal area.

Stop using this medication and call your doctor if you have a serious side effect such as blistering or severe redness, itching, or other irritation of treated skin.

Using Calcitriol (Triozac) topical can affect your body's ability to metabolize calcium. This can result in high levels of calcium in your blood (hypercalcemia). Symptoms of this condition include nausea, loss of appetite, constipation, increased thirst and urination, muscle weakness, confusion, and feeling tired or restless. Call your doctor if you have any of these symptoms.

See also:
What is the most important information I should know about Zinc sulphate monohydrate (Triozac)?

Hypersensitivity to any of the ingredients of Zinc sulphate monohydrate (Triozac).

Use Calcitriol (Triozac) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Calcitriol (Triozac) solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Calcitriol (Triozac) solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Calcitriol (Triozac) solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Calcitriol (Triozac) solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Calcitriol (Triozac) solution and you are using 1 dose every other day, use the missed dose if you remember the same day. If you do not remember the dose until the next day, use the missed dose, and then skip a day. Return to your every other day schedule.

Ask your health care provider any questions you may have about how to use Calcitriol (Triozac) solution.

Calcitriol (Triozac) is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones.

Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol (Triozac) is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol (Triozac) is usually used along with specific diet recommendations and sometimes other medications.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat and prevent certain bone diseases (rickets, osteomalacia) when regular vitamin D does not work.

How to use Calcitriol (Triozac)

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. If you are using the liquid form, measure your dose with a special measuring spoon or device. Do not use a normal household spoon since you may not get the correct dose.

Dosage is based on your medical condition and response to therapy. Your doctor may start you on a low dose and adjust the dose slowly to find the best dose for you. Follow your doctor's directions carefully. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.

It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless ordered by your doctor.

Certain medications (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat) can decrease the absorption of vitamin D. Therefore, separate your doses of these medications as far as possible from your doses of Calcitriol (Triozac) (at least 2 hours apart, longer if possible). It may be easiest to take Calcitriol (Triozac) at bedtime if you are also taking these other medications. Ask your doctor or pharmacist about finding a good dosing schedule that will work with all your medications.

Acute hypocalcaemia, hyperphosphataemia, hypocalcaemia, in hypocalcaemic tetany, osteoporosis prophylaxis, osteoporosis, cardiopulmonary resuscitation, severe hyperkalaemia.

It is indicated for the treatment of acute and persistent diarrhoea in infants and children up to 5 years of age.

See also:
What other drugs will affect Calcitriol (Triozac)?

Cholestyramine:

Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of Calcitriol (Triozac).

Phenytoin/Phenobarbital:

The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of Calcitriol (Triozac), but may reduce endogenous plasma levels of 25(OH)D3 by accelerating metabolism. Since blood level of Calcitriol (Triozac) will be reduced, higher doses of Calcitriol (Triozac) may be necessary if these drugs are administered simultaneously.

Thiazides:

Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Some reports have shown that the concomitant administration of thiazides with Calcitriol (Triozac) causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.

Digitalis:

Calcitriol (Triozac) dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias.

Ketoconazole:

Ketoconazole may inhibit both synthetic and catabolic enzymes of Calcitriol (Triozac). Reductions in serum endogenous Calcitriol (Triozac) concentrations have been observed following the administration of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy men. However, in vivo drug interaction studies of ketoconazole with Calcitriol (Triozac) have not been investigated.

Corticosteroids:

A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption.

Phosphate-Binding Agents:

Since Calcitriol (Triozac) also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration.

Vitamin D:

Since Calcitriol (Triozac) is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with Calcitriol (Triozac) to avoid possible additive effects and hypercalcemia.

Calcium Supplements:

Uncontrolled intake of additional calcium-containing preparations should be avoided.

Magnesium:

Magnesium-containing preparations (e.g., antacids) may cause hypermagnesemia and should therefore not be taken during therapy with Calcitriol (Triozac) by patients on chronic renal dialysis.

See also:
What other drugs will affect Zinc sulphate monohydrate (Triozac)?

Pyridoxine reduces the effects of levodopa (but this does not occur if a dopa decarboxylase is also given); decreases serum concentrations of phenobarbitone. Concurrent administration of drugs eg, isoniazid, penicillamine and oral contraceptives increase the requirement for pyridoxine.

Absorption of cyanocobalamin from the GIT may be reduced by neomycin, aminosalicylic acid, histamine H₂-receptor antagonists and colchicine. Serum concentrations may be decreased by concurrent administration of oral contraceptives. Many of these interactions are unlikely to be of clinical significance but should be taken into account when performing assays for blood concentrations.

Parenteral chloramphenicol may attenuate the effect of vitamin B12 in anaemia.

Folate deficiency states may be produced by a number of drugs including antiepileptics, oral contraceptives, antituberculous drugs, alcohol and folic acid antagonists eg, aminopterin, methotrexate, pyrimethamine, trimethoprim and sulphonamides; folic acid may decrease serum-phenytoin concentrations.

There may be an increased risk of myopathy or rhabdomyolysis when nicotinic acid is used concurrently with statins. Nicotinamide may increase the requirements for insulin or oral hypoglycaemics.

Ascorbic acid may increase the absorption of iron-deficiency states.

Ascorbic acid is often given in addition to desferrioxamine to patients with iron overload (thalassemia) to achieve better iron excretion. However, early on in treatment when there is excess tissue iron, there is some evidence that ascorbic acid may worsen the iron toxicity, particularly to the heart. Thus, ascorbic acid should not be given for the first month after starting desferrioxamine treatment.

The absorption of Zinc sulphate monohydrate (Triozac) may be reduced by iron supplements, penicillamine, phosphorus-containing preparations and tetracyclines. Zinc sulphate monohydrate (Triozac) supplements reduce the absorption of copper, ciprofloxacin, iron, norfloxacin, penicillamine and tetracyclines.

See also:
What are the possible side effects of Calcitriol (Triozac)?

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rate observed in practice.

Clinical Studies Experience

Calcitriol (Triozac) Ointment was studied in two vehicle-controlled studies (419 subjects), and in one open label study (324 subjects). The table below describes exposure to Calcitriol (Triozac) Ointment in 743 subjects, including 239 exposed for 6 months and 116 exposed for one year.

Four hundred and nineteen subjects were treated with Calcitriol (Triozac) Ointment twice daily for 8 weeks. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis.

Among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle, however the elevation were less than 10% above the upper limit of normal

The open label study enrolled 324 subjects with psoriasis who were then treated for up to 52 weeks. Adverse events reported at a rate of greater than or equal to 3% of subjects treated with Calcitriol (Triozac) Ointment were lab test abnormality (8%), urine abnormality (4%), psoriasis (4%), hyperciuria (3%), and pruritus (3%). Kidney stones were reported in 3 subjects and confirmed in two.

Postmarketing Experience

The following adverse reactions have been identified during the world-wide post-approval use of Calcitriol (Triozac) Ointment: acute blistering dermatitis, erythema, pruritus, skin burning sensation, and skin discomfort. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nausea, Abdominal pain, Cardiac arrest, Constipation, Dry mouth, Fainting, Headache, Decreased phosphate level in blood, Decreased blood pressure, Loss of appetite, Sinus bradycardia, Vomiting

See also:
What are the possible side effects of Zinc sulphate monohydrate (Triozac)?

Applies to Zinc sulphate monohydrate (Triozac) sulfate: capsules, tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur while taking Zinc sulphate monohydrate (Triozac) sulfate (the active ingredient contained in Zinc sulphate monohydrate (Triozac))

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe vomiting; unusual restlessness; very dry mouth, eyes, or skin.