Calcium Gluconate is the calcium salt of gluconic acid, an oxidation product of glucose, and contains 9.3% calcium, which is about one-third of the calcium in strength of calcium chloride USP. Since it is soluble to the extent of only one part in 30 parts of cold water, the 10% solution is supersaturated and is stabilized by the addition of calcium saccharate tetrahydrate 0.46% w/v (which supplies calcium 6.2%). Each mL contains 98 mg of calcium gluconatemonohydrate, 4.6 mg of calcium saccharate tetrahydrate, and Water for Injection USP, q.s. Each mL provides 9.3 mg (0.465 milliequivalents) of calcium.

The 100 mL Pharmacy Bulk Package contains many single doses for use in a pharmacy admixture program in the preparation of parenteral fluids. See directions for dispensing from the 100 mL Pharmacy Bulk Package. pH is adjusted with sodium hydroxide and/or hydrochloric acid.

The structural formula is:

C₁₂H₂₂CaO₁₄..........................430.38

Last updated on RxList: 4/2/2009

Calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyrodism and hypocalcemia due to rapid growth or pregnancy. It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage. Calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, nonthrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. In hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity provided the patient is not receiving digitalis therapy.

Calcium Gluconate should be administered intravenously either directly or by infusion. The dose is dependent upon the individual requirements of the patient. Calcium Gluconate may also be administered by intermittent infusion at a rate not exceeding 200 mg/min, or by continuous infusion.

DIRECTIONS FOR DISPENSING FROM 100 mL PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION.

The 100 mL Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. The 100 mL Pharmacy Bulk Package should be suspended (inverted) by its IV hang label in a laminar flow hood or biological safety cabinet. Prior to entering a Pharmacy Bulk Package remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. Entry into the Pharmacy Bulk Package must be made with a sterile transfer set or other sterile dispensing device and the contents dispensed in aliquots using aseptic technique. Use of a syringe needle is not recommended as it may cause leakage. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS AFTER INITIAL ENTRY. The date and the time initially opened should be recorded in the space provided on the Pharmacy Bulk Package label.

Usual Dosage

Adults: 500 mg - 2 grams (5-20 mL)

Children: 200-500 mg (2-5 mL)

Infants: not more than 200 mg (not more than 2 mL)

Calcium Gluconate Injection, USP 10%

NDC 0517-3910-25	10%	10 mL Single Dose Vials packed in boxes of 25
NDC 0517-3950-25	10%	50 mL Single Dose Vials packed in boxes of 25
NDC 0517-3900-25	10%	100 mL Pharmacy Bulk Package packed in boxes of 25

Supersaturated solutions are prone to precipitation.

NOTE: If crystallization has occurred, warming in a 60°C water bath for 15-30 minutes with occasional shaking, may dissolve the precipitate. Cool to body temperature before use. The injection must be clear at the time of use. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

No preservative added. Unused portion of vial should be discarded. Use only if solution is clear and seal intact.

Store at controlled room temperature 15º- 30ºC (59º- 86ºF) (See USP).

American Regent Laboratories, Inc. Shirley, NY 11967. Rev: 2/00

Last updated on RxList: 4/2/2009

Patients may complain of tingling sensations, a sense of oppression or heat waves and a calcium or chalky taste following the intravenous administration of calcium gluconate.

Rapid intravenous injection of calcium salts may cause vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmias, syncope and cardiac arrest. Use in digitalized patients may precipitate arrhythmias.

Local necrosis and abscess formation may occur with intramuscular injection.

The ionotropic and toxic effects of cardiac glycosides and calcium are synergistic and arrhythmias may occur if these drugs are given together (particularly when calcium is given intravenously). Intravenous administration of calcium should be avoided in patients receiving cardiac glycosides; if necessary, calcium should be given slowly in small amounts.

Calcium complexes tetracycline antibiotics rendering them inactive. The two drugs should not be given at the same time orally nor should they be mixed for parenteral administration.

Calcium Gluconate Injection has been reported to be incompatible with intravenous solutions containing various drugs. Published data are too varied and/or limited to permit generalizations, and specialized references should be consulted for specific information.

Drug/Laboratory Test Interactions

Transient elevations of plasma 11-hydroxy-corticosteroid levels (Glenn-Nelson technique) may occur when intravenous calcium is administered, but levels return to control values after one hour. In addition, intravenous calcium gluconate can produce false-negative values for serum and urinary magnesium.

Last updated on RxList: 12/8/2004

For intravenous use only. Subcutaneous or intramuscular injection may cause severe necrosis and sloughing. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

General

To avoid undesirable reactions that may follow rapid intravenous administration of calcium gluconate, the drug should be given slowly, e.g., approximately 1.5 mL over a period of one minute. When injected intravenously, calcium gluconate should be injected through a small needle into a large vein in order to avoid too rapid increase in serum calcium and extravasation of calcium solution into the surrounding tissue with resultant necrosis.

Rapid injection of calcium gluconate may cause vasodilation decreased blood pressure, bradycardia, cardiac arrhythmias, syncope and cardiac arrest.

Because of the danger involved in simultaneous use of calcium salts and drugs of the digitalis group, a digitalized patient should not receive an intravenous injection of a calcium compound unless indications are clearly defined.

Pregnancy Category C

Animal reproduction studies have not been conducted with calcium gluconate. It is also not known whether calcium gluconate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium gluconate should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when calcium gluconate is administered to a nursing woman.

Last updated on RxList: 4/2/2009

No information provided.

Calcium salts are contraindicated in patients with ventricular fibrillation or hypercalcemia. Intravenous administration of calcium is contraindicated when serum calcium levels are above normal.

Last updated on RxList: 4/2/2009

Calcium is the fifth most abundant element in the body and is essential for maintenance of the functional integrity of nervous, muscular and skeletal systems and cell membrane and capillary permeability. It is also an important activator in many enzymatic reactions and is essential to a number of physiologic processes including transmission of nerve impulses; contraction of cardiac, smooth and skeletal muscles; renal function; respiration and blood coagulation. Calcium also plays regulatory roles in the release and storage of neurotransmitters and hormones, in the uptake and binding of amino acids, and in cyanocobalamin (vitamin B₁₂) absorption and gastrin secretion.

Last updated on RxList: 4/2/2009

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 4/2/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CALCIUM SUPPLEMENTS - ORAL

USES: This medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. It may be used to treat conditions caused by low calcium levels such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany). It may also be used in certain patients to make sure they are getting enough calcium (e.g., women who are pregnant, nursing, or postmenopausal, people taking certain medications such as phenytoin, phenobarbital, or prednisone).

Calcium plays a very important role in the body. It is necessary for normal functioning of nerves, cells, muscle, and bone. If there is not enough calcium in the blood, then the body will take calcium from bones, thereby weakening bones. Having the right amount of calcium is important for building and keeping strong bones.

HOW TO USE: Take this medication by mouth with food. Follow all directions on the product package, or take as directed by your doctor. For best absorption, if your daily dose is more than 600 milligrams, then divide your dose and space it throughout the day. If you are uncertain about any of the information, consult your doctor or pharmacist.

If you are using the chewable product, chew it well before swallowing.

If you are using the effervescent tablet, allow the tablet to fully dissolve in a glass of water before drinking it. Do not chew or swallow the tablet whole.

If you are using the liquid product, measure the medication with a dose-measuring spoon or device to make sure you get the correct dose. Do not use a household spoon. If the liquid product is a suspension, shake the bottle well before each dose.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

If your doctor has recommended that you follow a special diet, 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, seek immediate medical attention.

SIDE EFFECTS: Constipation and upset stomach may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: nausea/vomiting, loss of appetite, unusual weight loss, mental/mood changes, bone/muscle pain, headache, increased thirst/urination, weakness, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking calcium, tell your doctor or pharmacist if you have any allergies.

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high calcium levels (hypercalcemia).

If you have any of the following health problems, consult your doctor or pharmacist before using this product: kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, a certain lung disease (sarcoidosis), difficulty absorbing nutrition from food (malabsorption syndrome).

Some sugar-free formulations of calcium may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this product, tell your doctor or pharmacist if you use any of the following products: digoxin, cellulose sodium phosphate, certain phosphate binders (e.g., calcium acetate).

Calcium can decrease the absorption of other drugs such as bisphosphonates (e.g., alendronate), tetracycline antibiotics (e.g., doxycycline, minocycline), estramustine, levothyroxine, and quinolone antibiotics (e.g., ciprofloxacin, levofloxacin). Therefore, separate your doses of these medications as far as possible from your doses of calcium. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.

Check the labels on all your prescription and nonprescription/herbal products (e.g., antacids, vitamins) because they may contain calcium. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea/vomiting, loss of appetite, mental/mood changes, headache, weakness, tiredness.

NOTES: Foods rich in calcium include: dairy products (e.g., milk, yogurt, cheese, ice cream), dark-green leafy vegetables (e.g., broccoli, spinach, bok choy), and calcium-fortified foods (e.g., orange juice).

Vitamin D helps with the absorption of calcium. Foods rich in vitamin D include: fortified dairy products, eggs, sardines, cod liver oil, chicken livers, and fatty fish. Vitamin D is also made by the body as a result of exposure to the sun.

Keep all regular medical and laboratory appointments. If your doctor has directed you to take this medication, laboratory and/or medical tests (e.g., calcium levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. See packaging for the exact temperature range. If you have any questions about storage, ask your pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.