Celol-D3

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 (Celol-D3) does not contain a preservative.

Calcitriol (Celol-D3) 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 (Celol-D3) is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water.

A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (poaceae). Folic acid (Celol-D3) is used in the treatment and prevention of folate deficiencies and megaloblastic anemia. [PubChem]

Each ampoule also contains D-mannitol 50 mg as an additive. pH 5.3-7.3. Osmotic Pressure (to physiological saline): Approximately 1.

Mecobalamin is α-(5,6-dimethylbenzimidazolyl)-Co-methyl-cobamide.

Molecular Formula: C₆₃H₉₁CoN₁₃O₁₄P.

Molecular Weight: 1344.4.

Mecobalamin occurs as a dark red, odorless and almost tasteless crystal or crystalline powder. It is sparingly soluble in water, methanol and ethanol and practically insoluble in acetone, ether and chloroform. Mecobalamin is hygroscopic and decomposes upon exposure to light.

Predialysis Patients

Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.

Oral

Nutritional supplementation

Adult: Usual dose range: 125-250 mg 1-2 times daily. Dosing instruction may vary according to the product used.

dietary supplement

nutritional supplement for pregnant and breast-feeding women

Folic acid (Celol-D3) is used in the treatment and prevention of the folate deficiency state. It does not correct folate deficiency due to dihydrofolate reductase inhibitors. Folic acid (Celol-D3) is also used in women of child-bearing potential and pregnant women to protect against neural tube defects in their offspring. It is also used for the treatment of folate-deficient megaloblastic anaemia, chronic haemolytic states such as thalassaemia major or sickle-cell anaemia.

Tab: Treatment of peripheral neuropathies. Inj: Megaloblastic anemia due to vit B₁₂ deficiency, peripheral neuropathies.

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 (Celol-D3), and dihydrotachysterol are forms of vitamin D used to treat hypocalcemia (not enough calcium in the blood). Alfacalcidol, calcifediol, and Calcitriol (Celol-D3) 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 (Celol-D3), 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.

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Folic acid (Celol-D3) (vitamin B 9) is necessary for strong blood.

Lack of Folic acid (Celol-D3) may lead to anemia (weak blood). Your health care professional may treat this by prescribing Folic acid (Celol-D3) for you.

Some conditions may increase your need for Folic acid (Celol-D3). These include:

• Alcoholism
• Anemia, hemolytic
• Diarrhea (continuing)
• Fever (prolonged)
• Hemodialysis
• Illness (prolonged)
• Intestinal diseases
• Liver disease
• Stress (continuing)
• Surgical removal of stomach

In addition, infants smaller than normal, breast-fed infants, or those receiving unfortified formulas (such as evaporated milk or goat's milk) may need additional Folic acid (Celol-D3).

Increased need for Folic acid (Celol-D3) should be determined by your health care professional.

Some studies have found that Folic acid (Celol-D3) taken by women before they become pregnant and during early pregnancy may reduce the chances of certain birth defects (neural tube defects).

Claims that Folic acid (Celol-D3) and other B vitamins are effective for preventing mental problems have not been proven. Many of these treatments involve large and expensive amounts of vitamins.

Injectable Folic acid (Celol-D3) is given by or under the direction of your health care professional. Another form of Folic acid (Celol-D3) is available without a prescription.

Methylcobalamin (Celol-D3) is a form of vitamin B12. Vitamin B12 is important for the brain and nerves, and for the production of red blood cells.

Methylcobalamin (Celol-D3) is used to treat vitamin B12 deficiency. Methylcobalamin (Celol-D3) is sometimes used in people with pernicious anemia, diabetes, and other conditions.

Methylcobalamin (Celol-D3) may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

The optimal daily dose of Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) must be carefully determined for each patient. Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) can be administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/mL). Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)), serum calcium levels should be checked at least twice weekly. When the optimal dosage of Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.

Oral Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.

Hypoparathyroidism

The recommended initial dosage of Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) may be needed.

Predialysis Patients

The recommended initial dosage of Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 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 (Celol-D3) (Calcitriol (Celol-D3)) is 10 to 15 ng/kg/day.

How supplied

Capsules: 0.25 mcg Calcitriol (Celol-D3) in soft gelatin, light orange, oval capsules, imprinted with Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 0.25 ROCHE; bottles of 30 (NDC 0004-0143-23), and bottles of 100 (NDC 0004-0143-01).

Capsules: 0.5 mcg Calcitriol (Celol-D3) in soft gelatin, dark orange, oblong capsules, imprinted with Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 0.5 ROCHE; bottles of 100 (NDC 0004-0144-01).

Oral Solution

Calcitriol (Celol-D3) (Calcitriol (Celol-D3)) 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

Oral

Nutritional supplementation

Adult: Usual dose range: 125-250 mg 1-2 times daily. Dosing instruction may vary according to the product used.

Usual Adult Dose for Megaloblastic Anemia

1 mg orally, intramuscularly, subcutaneously or IV once a day. May continue until clinical symptoms of folate deficiency and the hematological profile have normalized.

Usual Adult Dose for Folic acid (Celol-D3) Deficiency

400 to 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Women of childbearing age, pregnant, and lactating women: 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Folic acid (Celol-D3) Deficiency

Infant:

0.1 mg orally, intramuscularly, subcutaneously or IV once a day.

Child:

Less than 4 years: up to 0.3 mg orally, intramuscularly, subcutaneously or IV once a day.

4 years or older: 0.4 mg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Vitamin/Mineral Supplementation

Recommended daily allowance (RDA):

Premature neonates: 50 mcg/day (15 mcg/kg/day).

Full-term neonates and infants 1 to 6 months: 25 to 35 mcg/day.

Children:

1 to 3 years: 150 mcg/day.

4 to 8 years: 200 mcg/day.

9 to 13 years: 300 mcg/day.

14 years and older: 400 mcg/day.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Rarely, a dosage of 2 mg/day may be required, particularly in patients with malabsorption, alcoholism, chronic hemolysis, chronic exfoliative skin disease or who are on concomitant anticonvulsant therapy.

Dialysis

Folic acid (Celol-D3) is removed by both hemodialysis and peritoneal dialysis. The amount removed varies with type equipment used.

Because folate may accumulate in patients with end-stage renal disease, side effects may be more likely in this patient who is undergoing dialysis. Once this patient's body stores of folate are replete, three times a week dosing may be just as beneficial as once daily dosing but should portend a lower risk of side effects.

Other Comments

The recommended daily allowance of Folic acid (Celol-D3) for adult males and females ranges from 150 to 200 and 150 to 180 mcg/day, respectively.

There is a potential danger in administering Folic acid (Celol-D3) to patients with undiagnosed anemia, since Folic acid (Celol-D3) may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress.

Severe megaloblastic anemia may require therapy for 4 to 5 weeks. Once stabilized, if dietary intake is inadequate, maintenance therapy can be started.

Tablet: Adults: Usual Daily Dose: 3 tabs, equivalent to a total of 1500 mcg of mecobalamin, administered orally in 3 divided doses. The dose should be adjusted according to age of patient and severity of symptoms.

Injection: Peripheral Neuropathies: The usual adult dosage is 1 amp, equivalent to 500 mcg of mecobalamin administered IM or IV 3 times a week. The dosage should be adjusted according to age of patient and severity of symptoms.

Megaloblastic Anemia: The usual adult dosage is 1 amp, equivalent to 500 mcg of mecobalamin administered IM or IV 3 times a week. After approximately 2 months of medication, the dose should be reduced to a single administration of 1 amp at 1- to 3-month intervals for maintenance therapy.

See also:
What is the most important information I should know about Calcitriol (Celol-D3)?

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

Before using Calcitriol (Celol-D3) 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 (Celol-D3) topical is for use only on areas of psoriasis. Avoid getting it on healthy skin areas. Calcitriol (Celol-D3) 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 (Celol-D3) 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 Folic acid (Celol-D3)?

Because it may mask the hematologic abnormalities while neurological damage progresses, Folic acid (Celol-D3) should not be used in the therapy of patients with vitamin B12 deficiency of any cause, unless there is associated folate deficiency. The Folic acid (Celol-D3) content of one tablet a day however, is unlikely to mask pernicious anemia should this condition be present. Also, pregnancy during pernicious anemia is very rare.

Use Calcitriol (Celol-D3) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Calcitriol (Celol-D3) solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Calcitriol (Celol-D3) solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Calcitriol (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) solution.

Use Folic acid (Celol-D3) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Folic acid (Celol-D3) may be administered as an injection by your health care professional.
• If you are using Folic acid (Celol-D3) at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
• If you miss a dose of Folic acid (Celol-D3), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Folic acid (Celol-D3).

Calcitriol (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) 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 (Celol-D3)

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 (Celol-D3) (at least 2 hours apart, longer if possible). It may be easiest to take Calcitriol (Celol-D3) 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.

Docosahexaenoic acid (Celol-D3) (DHA) is used to prevent age related macular degeneration (loss of vision due to aging), coronary artery disease (blockage in arteries supplying blood to the heart), high cholesterol, type II diabetes, attention deficit hyperactive disorder (a type of brain disorder in which there are problems paying attention, excessive activity or difficulty controlling behavior), stroke, menstrual pain (dysmenorrhea) and memory disorders. DHA in combination with Eicosapentaenoic acid (EPA) is prescribed for the treatment of heart diseases, bipolar disorders (a mental condition marked by alternating periods of elation and depression), rheumatoid arthritis (a chronic progressive disease causing inflammation in the joints), renal diseases, Systemic lupus erythematosus (a type of autoimmune disorder), asthma and ulcerative colitis (disease causing inflammation and ulcer in the colon).

To delay the progression and reduce symptoms of diabetic neuropathy and other associated symptoms of diabetes mellitus particularly in subjects with good blood sugar control and limited microangiopathy.

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

Folic acid (Celol-D3) is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells.

Folic acid (Celol-D3) supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of Folic acid (Celol-D3) either through their diet or supplements to prevent infant spinal cord birth defects.

How to use Folic acid (Celol-D3)

Take this product by mouth with or without food as directed by your doctor, usually once daily. If you are taking the over-the-counter product, follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.

Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this product more often than directed.

Take this product regularly to get the most benefit from it. To help you remember, take it at the same time each day. Follow the diet plan recommended by your doctor or dietician. See also Notes section.

If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away.

Methylcobalamin (Celol-D3) is an active form of vitamin B12, which is used to treat anemia as well as nerve damage with numbness, tingling, pain in various neurological disorders.

See also:
What other drugs will affect Calcitriol (Celol-D3)?

Cholestyramine:

Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of Calcitriol (Celol-D3).

Phenytoin/Phenobarbital:

The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of Calcitriol (Celol-D3), but may reduce endogenous plasma levels of 25(OH)D3 by accelerating metabolism. Since blood level of Calcitriol (Celol-D3) will be reduced, higher doses of Calcitriol (Celol-D3) 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 (Celol-D3) causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.

Digitalis:

Calcitriol (Celol-D3) 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 (Celol-D3). Reductions in serum endogenous Calcitriol (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with Calcitriol (Celol-D3) 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 (Celol-D3) by patients on chronic renal dialysis.

Monitor prothrombin time when used with anticoagulant medications (including warfarin), aspirin or aspirin-containing products, NSAIDs, antiplatelet agents (e.g. ticlopidine, clopidogrel, dipyridamole). May increase hypotension when used with antihypertensive medications.

See also:
What other drugs will affect Folic acid (Celol-D3)?

Medications that interfere with your bodys ability to use folate may also increase the need for this vitamin. Medications can interfere with folate utilization, including: anticonvulsant medications (such as phenytoin, and primidone) metformin (sometimes prescribed to control blood sugar in type 2 diabetes) sulfasalazine (used to control inflammation associated with Crohns disease and ulcerative colitis) triamterene (a diuretic) Methotrexate There has been concern about the interaction between vitamin B12 and Folic acid (Celol-D3). Folic acid (Celol-D3) supplements can correct the anemia associated with vitamin B12 deficiency. Unfortunately, Folic acid (Celol-D3) will not correct changes in the nervous system that result from vitamin B12 deficiency. Permanent nerve damage could theoretically occur if vitamin B12 deficiency is not treated. Therefore, intake of supplemental Folic acid (Celol-D3) should not exceed 1000 micrograms (g, sometimes mcg) per day to prevent Folic acid (Celol-D3) from masking symptoms of vitamin B12 deficiency. It is important for older adults to be aware of the relationship between Folic acid (Celol-D3) and vitamin B12 because they are at greater risk of having a vitamin B12 deficiency. If you are 50 years of age or older, ask your physician to check your B12 status before you take a supplement that contains Folic acid (Celol-D3).

See also:
What are the possible side effects of Calcitriol (Celol-D3)?

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 (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) 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 (Celol-D3) 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.

GI disturbances (especially at high doses) e.g. nausea, eructation, vomiting, abdominal distension, diarrhoea and constipation.

Nausea, Gastrointestinal discomfort, Belching, Vomiting, Constipation, Diarrhoea

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 Folic acid (Celol-D3)?

Allergic sensitization has been reported following both oral and parenteral administration of Folic acid (Celol-D3).

Folic acid (Celol-D3) is relatively nontoxic in man. Rare instances of allergic responses to Folic acid (Celol-D3) preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg Folic acid (Celol-D3) daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B12 serum levels may occur in patients receiving prolonged Folic acid (Celol-D3) therapy.

In an uncontrolled study, orally administered Folic acid (Celol-D3) was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of Folic acid (Celol-D3) daily.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 844-740-7500.

See also:
What are the possible side effects of Methylcobalamin (Celol-D3)?

Tablet: Gastrointestinal: Symptoms eg, anorexia, nausea or diarrhea may occur infrequently.

Dermatological: Skin rash may occur rarely.

Others: Prolonged use of larger doses of Methylcobalamin (Celol-D3) is not recommended for patients whose occupation requires handling of mercury or its compounds.

Injection: Hypersensitivity: Use of Methylcobalamin (Celol-D3) should be discontinued if symptoms of hypersensitivity eg, eruptions, occur.

Others: Pain and induration may infrequently occur at the site of IM injection and headache, sweating or hot sensation may rarely occur.