Calcium Gluconate

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.

Calcium gluconate is used to prevent and to treat calcium deficiencies.

Calcium gluconate may also be used for purposes not listed in this medication guide.

Do not take calcium gluconate or antacids that contain calcium without first asking your doctor if you also take other medicines. Calcium can make it harder for your body to absorb certain medicines.

Calcium gluconate works best if you take it with food.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• a history of kidney stones; or
• a parathyroid gland disorder.

Talk to your doctor before taking calcium gluconate if you are pregnant. Your dose needs may be different during pregnancy.

Talk to your doctor before taking calcium gluconate if you are breast-feeding a baby. Your dose needs may be different while you are nursing.

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

Calcium Gluconate is part of the drug class:

• CALCIUM

This is not a complete list of Calcium Gluconatedrug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Calcium Gluconate falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. Calcium Gluconate should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Calcium Gluconate should be given to a pregnant woman only if clearly needed.

Moderates nerve and muscle performance via action potential threshold regulation.

In hydrogen fluoride exposures, calcium gluconate provides a source of calcium ions to complex free fluoride ions and prevent or reduce toxicity; administration also helps to correct fluoride-induced hypocalcemia.

Absorption

Oral: Minimal unless chronic, high doses are given; predominantly in the duodenum and dependent on calcitriol and vitamin D; mean absorption of calcium intake varies with age (infants 60%, prepubertal children 28%, pubertal children 34%, adults 25%); during pregnancy, calcium absorption doubles; calcium is absorbed in soluble, ionized form; solubility of calcium is increased in an acidic environment (IOM 2011); decreased absorption occurs in patients with achlorhydria, renal osteodystrophy, steatorrhea, or uremia

Distribution

Primarily in skeleton (99%)

Excretion

Primarily feces (75%; as unabsorbed calcium salts); urine (20%) (IOM 2011)

Protein Binding

~40%, primarily to albumin

No initial dosage adjustment necessary; subsequent doses should be guided by serum calcium concentrations. In patients in the anhepatic stage of liver transplantation, equal rapid increases in ionized concentrations occur suggesting that calcium gluconate does not require hepatic metabolism for release of ionized calcium (Martin 1990).

IV: Store intact vials at 20°C to 25°C (68°F to 77°F). Do not freeze. Discard unused portion within 4 hours after initial puncture.

Oral: Store at room temperature; consult product labeling for specific requirements.

IV administration may produce falsely decreased serum and urine magnesium concentrations

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, hard stools (constipation), or bone pain.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• little or no urinating;

• swelling, rapid weight gain; or

• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or feeling tired.

Common side effects may include:

• upset stomach, gas; or

• constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Calcium can make it harder for your body to absorb certain medicines. If you take other medications, take them at least 2 hours before or 4 or 6 hours after you take calcium gluconate.

Other drugs may interact with calcium gluconate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.