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|Calcium-Sandoz Forte

CALCIUM SUPPLEMENTS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Alka-Mints ²
• Amitone ²
• Calcarb 600 ²
• Calci-Chew ²
• Calciday 667 ²
• Calcilac ²
• Calci-Mix ²
• Calcionate ⁵
• Calcium 600 ²
• Calglycine ²
• Calphosan ⁹
• Cal-Plus ²
• Caltrate 600 ²
• Caltrate Jr ²
• Chooz ²
• Citracal ⁴
• Citracal Liquitabs ⁴
• Dicarbosil ²
• Gencalc 600 ²
• Liquid-Cal ²
• Liquid Cal-600 ²
• Maalox Antacid Caplets ²
• Mallamint ²
• Neo-Calglucon ⁵
• Nephro-Calci ²
• Os-Cal 500 ²
• Os-Cal 500 Chewable ²
• Oysco ²
• Oysco 500 Chewable ²
• Oyst-Cal 500 ²
• Oystercal 500 ²
• Posture ¹³
• Rolaids Calcium Rich ²
• Titralac ²
• Tums ²
• Tums 500 ²
• Tums E-X ²

In Canada—

• Apo-Cal ²
• Calciject ³
• Calcite 500 ²
• Calcium-Sandoz ⁵
• Calcium-Sandoz Forte ¹¹
• Calcium Stanley ⁷
• Calsan ²
• Caltrate 600 ²
• Gramcal ¹¹
• Nu-Cal ²
• Os-Cal ²
• Os-Cal Chewable ²
• Tums Extra Strength ²
• Tums Regular Strength ²

Category

• Antacid—Calcium Carbonate
• Antihyperkalemic—Calcium Chloride; Calcium Gluconate Injection
• Antihypermagnesemic—Calcium Chloride; Calcium Gluceptate; Calcium Gluconate Injection
• Antihyperphosphatemic—Calcium Carbonate; Calcium Citrate
• Antihypocalcemic—Calcium Acetate; Calcium Carbonate; Calcium Chloride; Calcium Citrate; Calcium Glubionate; Calcium Gluceptate; Calcium Gluconate; Calcium Glycerophosphate and Calcium Lactate; Calcium Lactate; Calcium Lactate-Gluconate and Calcium Carbonate; Calcium Phosphate, Dibasic; Calcium Phosphate, Tribasic
• Cardiotonic—Calcium Chloride; Calcium Gluconate Injection
• Electrolyte replenisher—Calcium Acetate; Calcium Chloride; Calcium Gluceptate; Calcium Gluconate Injection
• Nutritional supplement, mineral—Calcium Carbonate; Calcium Citrate; Calcium Glubionate, Oral; Calcium Gluceptate and Calcium Gluconate; Calcium Gluconate, Oral; Calcium Lactate; Calcium Lactate-Gluconate and Calcium Carbonate; Calcium Phosphate, Dibasic; Calcium Phosphate, Tribasic

Description

Calcium supplements are taken by individuals who are unable to get enough calcium in their regular diet or who have a need for more calcium. They are used to prevent or treat several conditions that may cause hypocalcemia (not enough calcium in the blood). The body needs calcium to make strong bones. Calcium is also needed for the heart, muscles, and nervous system to work properly.

The bones serve as a storage site for the body"s calcium. They are continuously giving up calcium to the bloodstream and then replacing it as the body"s need for calcium changes from day to day. When there is not enough calcium in the blood to be used by the heart and other organs, your body will take the needed calcium from the bones. When you eat foods rich in calcium, the calcium will be restored to the bones and the balance between your blood and bones will be maintained.

Pregnant women, nursing mothers, children, and adolescents may need more calcium than they normally get from eating calcium-rich foods. Adult women may take calcium supplements to help prevent a bone disease called osteoporosis. Osteoporosis, which causes thin, porous, easily broken bones, may occur in women after menopause, but may sometimes occur in elderly men also. Osteoporosis in women past menopause is thought to be caused by a reduced amount of ovarian estrogen (a female hormone). However, a diet low in calcium for many years, especially in the younger adult years, may add to the risk of developing it. Other bone diseases in children and adults are also treated with calcium supplements.

Calcium supplements may also be used for other conditions as determined by your health care professional.

Injectable calcium is administered only by or under the supervision of your health care professional. Other forms of calcium are available without a prescription.

Calcium supplements are available in the following dosage forms:

• Oral
• Calcium Carbonate
  • Capsules (U.S. and Canada)
  • Oral suspension (U.S.)
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S. and Canada)
• Calcium Citrate
  • Tablets (U.S.)
  • Tablets for solution (U.S.)
• Calcium Glubionate
  • Syrup (U.S. and Canada)
• Calcium Gluceptate and Calcium Gluconate
  • Oral solution (Canada)
• Calcium Gluconate
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S.)
• Calcium Lactate
  • Tablets (U.S. and Canada)
• Calcium Lactate-Gluconate and Calcium Carbonate
  • Tablets for solution (Canada)
• Dibasic Calcium Phosphate
  • Tablets (U.S.)
• Tribasic Calcium Phosphate
  • Tablets (U.S.)

• Parenteral
• Calcium Acetate
  • Injection (U.S.)
• Calcium Chloride
  • Injection (U.S. and Canada)
• Calcium Glubionate
  • Injection (Canada)
• Calcium Gluceptate
  • Injection (U.S.)
• Calcium Gluconate
  • Injection (U.S. and Canada)
• Calcium Glycerophosphate and Calcium Lactate
  • Injection (U.S.)

A calcium ``salt"" contains calcium along with another substance, such as carbonate or gluconate. Some calcium salts have more calcium (elemental calcium) than others. For example, the amount of calcium in calcium carbonate is greater than that in calcium gluconate. To give you an idea of how different calcium supplements vary in calcium content, the following chart explains how many tablets of each type of supplement will provide 1000 milligrams of elemental calcium. When you look for a calcium supplement, be sure the number of milligrams on the label refers to the amount of elemental calcium, and not to the strength of each tablet.

Importance of Diet

The daily amount of calcium needed is defined in several different ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person"s age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for calcium are generally defined as follows:

Getting the proper amount of calcium in the diet every day and participating in weight-bearing exercise (walking, dancing, bicycling, aerobics, jogging), especially during the early years of life (up to about 35 years of age) is most important in helping to build and maintain bones as dense as possible to prevent the development of osteoporosis in later life.

The following table includes some calcium-rich foods. The calcium content of these foods can supply the daily RDA or RNI for calcium if the foods are eaten regularly in sufficient amounts.

Vitamin D helps prevent calcium loss from your bones. It is sometimes called ``the sunshine vitamin"" because it is made in your skin when you are exposed to sunlight. If you get outside in the sunlight every day for 15 to 30 minutes, you should get all the vitamin D you need. However, in northern locations in winter, the sunlight may be too weak to make vitamin D in the skin. Vitamin D may also be obtained from your diet or from multivitamin preparations. Most milk is fortified with vitamin D.

Do not use bonemeal or dolomite as a source of calcium . The Food and Drug Administration has issued warnings that bonemeal and dolomite could be dangerous because these products may contain lead.

Before Using This Dietary Supplement

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For calcium supplements, the following should be considered:

Pregnancy—It is especially important that you are receiving enough calcium when you become pregnant and that you continue to receive the right amount of calcium throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement during pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast-feeding—It is especially important that you receive the right amount of calcium so that your baby will also get the calcium needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Children—Problems in children have not been reported with intake of normal daily recommended amounts. Injectable forms of calcium should not be given to children because of the risk of irritating the injection site.

Older adults—Problems in older adults have not been reported with intake of normal daily recommended amounts. It is important that older people continue to receive enough calcium in their daily diets. However, some older people may need to take extra calcium or larger doses because they do not absorb calcium as well as younger people. Check with your health care professional if you have any questions about the amount of calcium you should be taking in each day.

Medicines or other dietary supplements—Although certain medicines or dietary supplements should not be used together at all, in other cases they may be used together even if an interaction might occur. In these cases, your health care professional may want to change the dose, or other precautions may be necessary. When you are taking calcium supplements, it is especially important that your health care professional know if you are taking any of the following:

• Calcium-containing medicines, other—Taking excess calcium may cause too much calcium in the blood or urine and lead to medical problems

• Cellulose sodium phosphate (e.g., Calcibind)—Use with calcium supplements may decrease the effects of cellulose sodium phosphate

• Digitalis glycosides (heart medicine)—Use with calcium supplements by injection may increase the chance of irregular heartbeat

• Etidronate (e.g., Didronel)—Use with calcium supplements may decrease the effects of etidronate; etidronate should not be taken within 2 hours of calcium supplements

• Gallium nitrate (e.g., Ganite)—Use with calcium supplements may cause gallium nitrate to not work properly

• Magnesium sulfate (for injection)—Use with calcium supplements may cause either medicine to be less effective

• Phenytoin (e.g., Dilantin)—Use with calcium supplements may decrease the effects of both medicines; calcium supplements should not be taken within 1 to 3 hours of phenytoin

• Tetracyclines (medicine for infection) taken by mouth—Use with calcium supplements may decrease the effects of tetracycline; calcium supplements should not be taken within 1 to 3 hours of tetracyclines

Other medical problems—The presence of other medical problems may affect the use of calcium supplements. Make sure you tell your health care professional if you have any other medical problems, especially:

• Diarrhea or
• Stomach or intestinal problems—Extra calcium or specific calcium preparations may be necessary in these conditions

• Heart disease—Calcium by injection may increase the chance of irregular heartbeat

• Hypercalcemia (too much calcium in the blood) or
• Hypercalciuria (too much calcium in the urine)—Calcium supplements may make these conditions worse

• Hyperparathyroidism or
• Sarcoidosis—Calcium supplements may increase the chance of hypercalcemia (too much calcium in the blood)

• Hypoparathyroidism—Use of calcium phosphate may cause high blood levels of phosphorus which could increase the chance of side effects

• Kidney disease or stones—Too much calcium may increase the chance of kidney stones

Proper Use of This Dietary Supplement

Dosing—The amount of calcium needed to meet normal daily recommended intakes will be different for different individuals. The following information includes only the average amounts of calcium.

• For oral dosage form (capsules, chewable tablets, lozenges, oral solution, oral suspension, syrup, tablets, extended-release tablets, tablets for solution):
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes (Note that the normal daily recommended intakes are expressed as an actual amount of calcium. The salt form [e.g., calcium carbonate, calcium gluconate, etc.] has a different strength):
    • For the U.S.
    • Adults and teenagers—800 to 1200 milligrams (mg) per day.
    • Pregnant and breast-feeding females—1200 mg per day.
    • Children 4 to 10 years of age—800 mg per day.
    • Children birth to 3 years of age—400 to 800 mg per day.
    • For Canada
    • Adult and teenage males—800 to 1100 mg per day.
    • Adult and teenage females—700 to 1100 mg per day.
    • Pregnant and breast-feeding females—1200 to 1500 mg per day.
    • Children 7 to 10 years of age—700 to 1100 mg per day.
    • Children 4 to 6 years of age—600 mg per day.
    • Children birth to 3 years of age—250 to 550 mg per day.
  • To treat deficiency:
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.

Drink a full glass (8 ounces) of water or juice when taking a calcium supplement. However, if you are taking calcium carbonate as a phosphate binder in kidney dialysis, it is not necessary to drink a glass of water.

This dietary supplement is best taken 1 to 11/2 hours after meals , unless otherwise directed by your health care professional. However, patients with a condition known as achlorhydria may not absorb calcium supplements on an empty stomach and should take them with meals.

For individuals taking the chewable tablet form of this dietary supplement:

• Chew the tablets completely before swallowing.

For individuals taking the syrup form of this dietary supplement:

• Take the syrup before meals. This will allow the dietary supplement to work faster.
• Mix in water or fruit juice for infants or children.

Take this dietary supplement only as directed. Do not take more of it and do not take it more often than recommended on the label. To do so may increase the chance of side effects.

Missed dose—If you are taking this dietary supplement on a regular schedule and you miss a dose, take it as soon as possible, then go back to your regular dosing schedule.

Storage—To store this dietary supplement:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the dietary supplement to break down.
• Keep the liquid form of this dietary supplement from freezing.
• Do not keep outdated dietary supplements or those no longer needed. Be sure that any discarded dietary supplement is out of the reach of children.

Precautions While Using This Dietary Supplement

If this dietary supplement has been ordered for you by your health care professional and you will be taking it in large doses or for a long time, your health care professional should check your progress at regular visits. This is to make sure the calcium is working properly and does not cause unwanted effects.

Do not take calcium supplements within 1 to 2 hours of taking other medicine by mouth . To do so may keep the other medicine from working properly.

Unless you are otherwise directed by your health care professional, to make sure that calcium is used properly by your body:

• Do not take other medicines or dietary supplements containing large amounts of calcium, phosphates, magnesium, or vitamin D unless your health care professional has told you to do so or approved .
• Do not take calcium supplements within 1 to 2 hours of eating large amounts of fiber-containing foods, such as bran and whole-grain cereals or breads, especially if you are being treated for hypocalcemia (not enough calcium in your blood) .
• Do not drink large amounts of alcohol or caffeine-containing beverages (usually more than 8 cups of coffee a day), or use tobacco .

Some calcium carbonate tablets have been shown to break up too slowly in the stomach to be properly absorbed into the body. If the calcium carbonate tablets you purchase are not specifically labeled as being ``USP,"" check with your pharmacist. He or she may be able to help you determine which tablets are best.

Side Effects of This Dietary Supplement

Along with its needed effects, a dietary supplement may cause some unwanted effects. Although the following side effects occur very rarely when the calcium supplement is taken as recommended, they may be more likely to occur if:

• It is taken in large doses.
• It is taken for a long time.
• It is taken by patients with kidney disease.

Check with your health care professional as soon as possible if any of the following side effects occur:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.

Additional Information

Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, calcium supplements are used in certain patients with the following medical condition:

• Hyperphosphatemia (too much phosphate in the blood)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 07/18/1995

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