Magnesium L-aspartate Hydrochloride

Dietary Reference Intake for Magnesium: Dosage is in terms of elemental magnesium (IOM, 1997): Oral:

RDA:

19-30 years:

Females: 310 mg daily

Pregnant females: 350 mg daily

Lactation: 310 mg daily

Males: 400 mg daily

≥31 years:

Females: 320 mg daily

Pregnant females: 360 mg daily

Lactation: 320 mg daily

Males: 420 mg daily

OTC labeling:

Dietary supplement (dosage in terms of magnesium-L-aspartate hydrochloride salt): Adults: Oral: One packet or 2 tablets (1230 mg) up to 3 times daily

No dosage adjustment provided in manufacturer’s labeling; however, magnesium is renally excreted. Use caution; accumulation of magnesium in renal impairment may lead to magnesium toxicity.

Oral granules: Mix each packet in 4 ounces of water or juice prior to administration.

Granules: Mix each packet prior to administration

Tablet, enteric coated: Do not crush or chew

Alfacalcidol: May increase the serum concentration of Magnesium Salts. Consider therapy modification

Alpha-Lipoic Acid: Magnesium Salts may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Magnesium Salts. Consider therapy modification

Bisphosphonate Derivatives: Magnesium Salts may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral magnesium salts within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Consider therapy modification

Calcitriol (Systemic): May increase the serum concentration of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving calcitriol. If magnesium-containing products must be used with calcitriol, serum magnesium concentrations should be monitored closely. Consider therapy modification

Calcium Channel Blockers: May enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Monitor therapy

Deferiprone: Magnesium Salts may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Consider therapy modification

Dolutegravir: Magnesium Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral magnesium salts. Consider therapy modification

Doxercalciferol: May enhance the hypermagnesemic effect of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving doxercalciferol. If magnesium-containing products must be used with doxercalciferol, serum magnesium concentrations should be monitored closely. Consider therapy modification

Eltrombopag: Magnesium Salts may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any magnesium-containing product. Consider therapy modification

Gabapentin: Magnesium Salts may enhance the CNS depressant effect of Gabapentin. Specifically, high dose intravenous/epidural magnesium sulfate may enhance the CNS depressant effects of gabapentin. Magnesium Salts may decrease the serum concentration of Gabapentin. Management: Administer gabapentin at least 2 hours after oral magnesium salts administration. Monitor patients closely for evidence of reduced response to gabapentin therapy. Monitor for CNS depression if high dose IV/epidural magnesium sulfate is used. Consider therapy modification

Levothyroxine: Magnesium Salts may decrease the serum concentration of Levothyroxine. Management: Separate administration of oral levothyroxine and oral magnesium salts by at least 4 hours. Consider therapy modification

Multivitamins/Fluoride (with ADE): Magnesium Salts may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, magnesium salts may decrease fluoride absorption. Management: To avoid this potential interaction separate the administration of magnesium salts from administration of a fluoride-containing product by at least 1 hour. Consider therapy modification

Mycophenolate: Magnesium Salts may decrease the serum concentration of Mycophenolate. Management: Separate doses of mycophenolate and oral magnesium salts. Monitor for reduced effects of mycophenolate if taken concomitant with oral magnesium salts. Consider therapy modification

Neuromuscular-Blocking Agents: Magnesium Salts may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Phosphate Supplements: Magnesium Salts may decrease the serum concentration of Phosphate Supplements. Management: This applies only to oral phosphate and magnesium administration. Administer oral phosphate supplements at least 1 hour before, or 2 hours after, oral magnesium salt administration. Exceptions: Sodium Glycerophosphate Pentahydrate. Consider therapy modification

Quinolone Antibiotics: Magnesium Salts may decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Exceptions: LevoFLOXacin (Oral Inhalation). Consider therapy modification

Raltegravir: Magnesium Salts may decrease the serum concentration of Raltegravir. Management: Avoid the use of oral / enteral magnesium salts with raltegravir. No dose separation schedule has been established that adequately reduces the magnitude of interaction. Avoid combination

Tetracycline Derivatives: Magnesium Salts may decrease the absorption of Tetracycline Derivatives. Only applicable to oral preparations of each agent. Consider therapy modification

Trientine: May decrease the serum concentration of Magnesium Salts. Magnesium Salts may decrease the serum concentration of Trientine. Consider therapy modification

Disease-related concerns:

• Constipation (self-medication, OTC use): Appropriate use: For occasional use only; serious side effects may occur with prolonged use. For use only under the supervision of a physician in patients with kidney dysfunction, sodium or magnesium restricted diets, abdominal pain/nausea/vomiting, or with a sudden change in bowel habits which has persisted for >2 weeks. If rectal bleeding develops or a bowel movement does not occur after use, discontinue use and consult a healthcare provider.

• Neuromuscular disease: Use with extreme caution in patients with myasthenia gravis or other neuromuscular disease.

• Renal impairment: Use with caution in patients with renal impairment; accumulation of magnesium may lead to magnesium intoxication.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of magnesium aspartate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.