Fosteum Plus

For the treatment of vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. Also used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis. (Vitamin D deficiency; osteoporosis;)

Zinc glycinate (Fosteum Plus) 1 mg/mL (Zinc glycinate (Fosteum Plus) Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Zinc glycinate (Fosteum Plus) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

Cholecalciferol (Fosteum Plus) is a Cholecalciferol (Fosteum Plus). Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Cholecalciferol (Fosteum Plus) is used to treat or prevent many conditions caused by a lack of vitamin D, especially conditions of the skin or bones.

Cholecalciferol (Fosteum Plus) may also be used for purposes not listed in this medication guide.

Zinc glycinate (Fosteum Plus) is a naturally occurring mineral. Zinc glycinate (Fosteum Plus) is important for growth and for the development and health of body tissues.

Zinc glycinate (Fosteum Plus) sulfate is used to treat and to prevent Zinc glycinate (Fosteum Plus) deficiency.

Zinc glycinate (Fosteum Plus) sulfate may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Vitamin D Insufficiency

600 to 2,000 international units, orally, once a day

Maximum dose: 4,000 international units per day

Usual Adult Dose for Vitamin D Deficiency

Initial dose:

50,000 international units, once a week, for 8 weeks

or

6,000 international units, once a day, for 8 weeks

Maintenance dose: 1,500 to 2,000 international units, once a day

Maximum dose: 10,000 international units per day

Comments:

-Target blood levels above 30 ng/mL of 25(OH)D.

Usual Adult Dose for Prevention of Falls

800 international units, orally, once a day

-1,500 to 2,000 international units, once a day, may be needed to achieve blood levels of 25(OH)D above 30 ng/mL.

Usual Geriatric Dose for Prevention of Fractures

Over 70 years: 800 to 2,000 international units, orally, once a day

Usual Pediatric Dose for Vitamin D Insufficiency

0 to 12 months: 400 international units once a day

1 to 18 years: 600 international units once a day

Maximum dose:

-Up to 6 months: 1,000 international units per day

-7 months to 1 year: 1,500 international units per day

-1 to 3 years: 2,500 international units per day

-4 to 8 years: 3,000 international units per day

-9 years and older: 4,000 international units per day

Usual Pediatric Dose for Vitamin D Deficiency

-Up to 1 year old: 2,000 international units, orally, once a day, for 6 weeks

or

50,000 international units, once a week, for 6 weeks

Maintenance dose: 400 to 1,000 international units per day

-1 to 18 years: 2,000 international units, orally, once a day for at least 6 weeks

or

50,000 international units, once a week, for at least 6 weeks

Maintenance dose: 600 to 1,000 international units per day

Maximum dose:

-Up to 1 year: 2,000 international units per day

-1 to 18 years: 4,000 international units per day

Comments:

-Target blood levels above 30 ng/mL of 25(OH)D.

Renal Dose Adjustments

Do not use in severe renal impairment

Liver Dose Adjustments

Data not available

Dose Adjustments

Pregnancy or Lactation: 600 to 2,000 international units once a day; maximum 4,000 international units per day

-1,500 to 2,000 international units, once a day, may be needed to achieve blood levels of 25(OH)D above 30 ng/mL.

Obesity, Malabsorption Syndromes, or Medications Affecting Vitamin D Absorption:

-Treatment of Deficiency: 6,000 to 10,000 international units, once a day, until blood levels of 25(OH)D are above 30 ng/mL.

-Maintenance dose: 1,500 to 2,000 international units, once a day

Patients on anticonvulsants, glucocorticoids, antifungals such as ketoconazole, or medications for acquired immune deficiency syndrome may require 2 to 3 times more vitamin D.

Provide medical supervision if upper limits are exceeded.

Dialysis

Vitamin D and its metabolites are not dialyzable.

Zinc glycinate (Fosteum Plus) 1 mg/mL (Zinc glycinate (Fosteum Plus) Chloride Injection, USP) contains 1 mg Zinc glycinate (Fosteum Plus)/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg Zinc glycinate (Fosteum Plus)/day (2.5 to 4 mL/day). An additional 2 mg Zinc glycinate (Fosteum Plus)/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg Zinc glycinate (Fosteum Plus)/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg Zinc glycinate (Fosteum Plus)/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Zinc glycinate (Fosteum Plus) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Zinc glycinate (Fosteum Plus).

For full term infants and children up to 5 years of age, 100 mcg Zinc glycinate (Fosteum Plus)/kg/day

(0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg Zinc glycinate (Fosteum Plus)/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

How supplied

Zinc glycinate (Fosteum Plus) 1 mg/mL (Zinc glycinate (Fosteum Plus) Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

HOSPIRA, INC., LAKE FOREST, IL 60045 USA. Revised: October, 2004

See also:
What is the most important information I should know about Cholecalciferol (Fosteum Plus)?

Contraindications for vitamin D analogues (Vitamin D2, Cholecalciferol (Fosteum Plus), Calcitriol, and Calcidiol)

Vitamin D should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of vitamin D in patients with known hypersensitivity to vitamin D (or drugs of the same class) or any of the inactive ingredients is contraindicated.

See also:
What is the most important information I should know about Zinc glycinate (Fosteum Plus)?

Hypersensitivity to any of the ingredients of Zinc glycinate (Fosteum Plus).

Vitamin D (ergocalciferol-D2, Cholecalciferol (Fosteum Plus)-D3, alfacalcidol) is a fat-soluble vitamin that helps your body absorb calcium and phosphorus. Having the right amount of vitamin D, calcium, and phosphorus is important for building and keeping strong bones. Vitamin D is used to treat and prevent bone disorders (such as rickets, osteomalacia). Vitamin D is made by the body when skin is exposed to sunlight. Sunscreen, protective clothing, limited exposure to sunlight, dark skin, and age may prevent getting enough vitamin D from the sun.

Vitamin D with calcium is used to treat or prevent bone loss (osteoporosis). Vitamin D is also used with other medications to treat low levels of calcium or phosphate caused by certain disorders (such as hypoparathyroidism, pseudohypoparathyroidism, familial hypophosphatemia). It may be used in kidney disease to keep calcium levels normal and allow normal bone growth. Vitamin D drops (or other supplements) are given to breast-fed infants because breast milk usually has low levels of vitamin D.

How to use Cholecalciferol (Fosteum Plus)

Take vitamin D by mouth as directed. Vitamin D is best absorbed when taken after a meal but may be taken with or without food. Alfacalcidol is usually taken with food. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

If your doctor has prescribed this medication, take as directed by your doctor. Your dosage is based on your medical condition, amount of sun exposure, diet, age, and response to treatment.

Measure the liquid medication with the dropper provided, or use a medication-measuring spoon/device to make sure you have the correct dose. If you are taking the chewable tablet or wafers, chew the medication thoroughly before swallowing. Do not swallow whole wafers.

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

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day if you are taking it once a day. If you are taking this medication only once a week, remember to take it on the same day each week. It may help to mark your calendar with a reminder.

If your doctor has recommended that you follow a special diet (such as a diet high in calcium), it is very important to follow the diet to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins unless ordered by your doctor.

If you think you may have a serious medical problem, get medical help right away.

See also:
What other drugs will affect Cholecalciferol (Fosteum Plus)?

Interactions for vitamin D analogues (Vitamin D2, Cholecalciferol (Fosteum Plus), Calcitriol, and Calcidiol)

Cholestyramine

Cholestyramine has been reported to reduce intestinal absorption of fat soluble vitamins; as such it may impair intestinal absorption of any of vitamin D

Phenytoin/Phenobarbital

The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of vitamin D, but may reduce endogenous plasma levels of calcitriol/ergocalcitriol by accelerating metabolism. Since blood level of calcitriol/ergocalcitriol will be reduced, higher doses of Rocaltrol 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 vitamin D causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary

Digitalis

Vitamin D 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 vitamin D. Reductions in serum endogenous vitamin D 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 vitamin D 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 vitamin D 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

The coadministration of any of the vitamin D analogues should be avoided as this could create possible additive effects and hypercalcemia

Calcium Supplements

Uncontrolled intake of additional calcium-containing preparations should be avoided

Magnesium

Magnesium-containing preparations (eg, antacids) may cause hypermagnesemia and should therefore not be taken during therapy with vitamin D by patients on chronic renal dialysis.

See also:
What other drugs will affect Zinc glycinate (Fosteum Plus)?

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 glycinate (Fosteum Plus) may be reduced by iron supplements, penicillamine, phosphorus-containing preparations and tetracyclines. Zinc glycinate (Fosteum Plus) supplements reduce the absorption of copper, ciprofloxacin, iron, norfloxacin, penicillamine and tetracyclines.

See also:
What are the possible side effects of Cholecalciferol (Fosteum Plus)?

Applies to Cholecalciferol (Fosteum Plus): oral capsule, oral capsule liquid filled, oral solution, oral suspension, oral tablet, oral tablet chewable, oral wafer

Along with its needed effects, Cholecalciferol (Fosteum Plus) (the active ingredient contained in Cholecalciferol (Fosteum Plus)) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking Cholecalciferol (Fosteum Plus):

Incidence Not Known

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives or itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• unusual tiredness or weakness

See also:
What are the possible side effects of Zinc glycinate (Fosteum Plus)?

Applies to Zinc glycinate (Fosteum Plus) 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 glycinate (Fosteum Plus) sulfate (the active ingredient contained in Zinc glycinate (Fosteum Plus))

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.

Derivative of 7-dehydroxycholesterol formed by ultraviolet rays breaking of the C9-C10 bond. It differs from ergocalciferol in having a single bond between C22 and C23 and lacking a methyl group at C24. [PubChem]

Zinc glycinate (Fosteum Plus) Capsule: Each capsule contains Zinc glycinate (Fosteum Plus) sulphate monohydrate 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 glycinate (Fosteum Plus) Syrup: Each 5 mL contains Zinc glycinate (Fosteum Plus) 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.