Mag-Tab SR

Although a balanced diet usually supplies all the magnesium a person needs, magnesium supplements may be needed by patients who have lost magnesium because of illness or treatment with certain medicines.

Lack of magnesium may lead to irritability, muscle weakness, and irregular heartbeat.

Injectable magnesium is given only by or under the supervision of a health care professional . Some oral magnesium preparations are available only with a prescription. Others are available without a prescription.

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

The best dietary sources of magnesium include green leafy vegetables, nuts, peas, beans, and cereal grains in which the germ or outer layers have not been removed. Hard water has been found to contain more magnesium than soft water . A diet high in fat may cause less magnesium to be absorbed . Cooking may decrease the magnesium content of food.

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

For U.S.a€”

• 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 Canadaa€”

• 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 magnesium are generally defined as follows:

This product is available in the following dosage forms:

• Powder


• Capsule


• Powder for Suspension


• Liquid


• Capsule, Liquid Filled


• Syrup


• Tablet


• Tablet, Enteric Coated


• Tablet, Extended Release


• Packet

Before Using

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Studies have shown that older adults may have lower blood levels of magnesium than younger adults. Your health care professional may recommend that you take a magnesium supplement.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals 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 dietary supplements during pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breastfeeding

It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals 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.

Drug Interactions

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin


• Eltrombopag


• Levomethadyl


• Licorice


• Mycophenolate Mofetil


• Mycophenolic Acid

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart diseasea€”Magnesium supplements may make this condition worse.

• Kidney problemsa€”Magnesium supplements may increase the risk of hypermagnesemia (too much magnesium in the blood), which could cause serious side effects; your health care professional may need to change your dose .

Proper Use

Magnesium supplements should be taken with meals . Taking magnesium supplements on an empty stomach may cause diarrhea.

For individuals taking the extended-release form of this dietary supplement:

• Swallow the tablets whole. Do not chew or suck on the tablet .


• Some tablets may be broken or crushed and sprinkled on applesauce or other soft food. However, check with your health care professional first, since this should not be done for most tablets.

For individuals taking the powder form of this dietary supplement:

• Pour powder into a glass.


• Add water and stir.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules, chewable tablets, crystals for oral solution, extended-release tablets, enteric-coated tablets, powder for oral solution, tablets, oral 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 magnesium. The salt form [e.g., magnesium chloride, magnesium gluconate, etc.] has a different strength.):
    
    
    For the U.S.
    
    • Adult and teenage malesa€”270 to 400 milligrams (mg) per day.
    
    
    • Adult and teenage femalesa€”280 to 300 mg per day.
    
    
    • Pregnant femalesa€”320 mg per day.
    
    
    • Breast-feeding femalesa€”340 to 355 mg per day.
    
    
    • Children 7 to 10 years of agea€”170 mg per day.
    
    
    • Children 4 to 6 years of agea€”120 mg per day.
    
    
    • Children birth to 3 years of agea€”40 to 80 mg per day.
    
    
    
    
    
    For Canada
    
    • Adult and teenage malesa€”130 to 250 mg per day.
    
    
    • Adult and teenage femalesa€”135 to 210 mg per day.
    
    
    • Pregnant femalesa€”195 to 245 mg per day.
    
    
    • Breast-feeding femalesa€”245 to 265 mg per day.
    
    
    • Children 7 to 10 years of agea€”100 to 135 mg per day.
    
    
    • Children 4 to 6 years of agea€”65 mg per day.
    
    
    • Children birth to 3 years of agea€”20 to 50 mg per day.
    
    
    
    
  
  
  • To treat deficiency:
    
    
    
    • Adults, teenagers, and childrena€”Treatment dose is determined by prescriber for each individual based on severity of deficiency .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss taking your magnesium supplement for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in magnesium. However, if your health care professional has recommended that you take magnesium, try to remember to take it as directed every day.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Side Effects

Along with its needed effects, a medicine 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:

Rare

• Dizziness or fainting


• Flushing


• Irritation and pain at injection sitea€”for intramuscular administration only


• Muscle paralysis


• Troubled breathing

Symptoms of overdose (rare in individuals with normal kidney function)

• Blurred or double vision


• Coma


• Dizziness or fainting


• Drowsiness (severe)


• Increased or decreased urination


• Slow heartbeat


• Troubled breathing

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common (with oral magnesium)

• Diarrhea

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.