Magnesium Citrate

Description

Leader Magnesium Citrate Cherry is a dietary supplement formulated to provide magnesium in the form of magnesium citrate. This compound is known for its high bioavailability and is often utilized to support various physiological functions, including muscle and nerve function, as well as maintaining normal bone structure. The product is presented in a cherry-flavored dosage form, enhancing palatability for users.

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity). It generally produces a bowel movement within 1/2 to 6 hours of administration.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be shaken well before use. It is recommended that patients drink a full glass (8 ounces) of liquid with each dose to ensure proper administration.

For adults and children aged 12 years and older, the dosage ranges from 6.5 to 10 fluid ounces, with a maximum limit of 10 fluid ounces within a 24-hour period.

For children aged 6 to under 12 years, the dosage is between 3 to 7 fluid ounces, not exceeding 7 fluid ounces in a 24-hour period.

For children aged 2 to under 6 years, the recommended dosage is 2 to 3 fluid ounces within a 24-hour timeframe, with a maximum of 3 fluid ounces in that period.

For children under 2 years of age, it is advised to consult a physician for appropriate dosing recommendations.

The medication may be administered as a single daily dose or divided into multiple doses as deemed appropriate by the healthcare provider.

Contraindications

Use is contraindicated in patients with rectal bleeding or failure to have a bowel movement after use, as these may indicate a serious underlying condition.

Warnings and Precautions

Patients with a history of kidney disease should exercise caution when using this medication, as it may exacerbate their condition. Additionally, individuals on a magnesium-restricted diet must be aware of the potential for increased magnesium levels, which could lead to serious complications.

Abdominal pain, nausea, or vomiting may occur during treatment. If these symptoms manifest, it is advisable to consult a healthcare professional. Furthermore, any sudden change in bowel habits that persists for more than two weeks warrants immediate medical evaluation, as it may indicate an underlying issue. Patients who have been using a laxative for longer than one week should also seek medical advice, as prolonged use can lead to dependency or other gastrointestinal complications.

In the event of an overdose, it is critical to seek emergency medical assistance or contact a Poison Control Center without delay.

Patients should discontinue use and contact their healthcare provider if they experience rectal bleeding or fail to have a bowel movement after administration. These symptoms may signify a serious medical condition that requires prompt attention.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. Individuals with kidney disease or those on a magnesium-restricted diet should exercise caution. Additionally, patients experiencing abdominal pain, nausea, or vomiting should consider discontinuing use and consulting a healthcare professional. A sudden change in bowel habits that persists for more than two weeks, or the use of a laxative for longer than one week, may also warrant medical attention.

Patients are advised to stop use and seek medical advice if they experience rectal bleeding or failure to have a bowel movement after use, as these symptoms could indicate a serious underlying condition.

Drug Interactions

The concomitant use of this product with other medications should be approached with caution due to potential interactions. It is recommended that this product be administered at least 2 hours before or after other drugs. This precaution is advised because laxatives may influence the absorption and efficacy of co-administered medications.

Healthcare professionals should monitor patients for any changes in the effectiveness of their medications when used alongside this product, particularly if the timing of administration is not adhered to. Adjustments to the dosing schedule of other medications may be necessary based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Magnesium Citrate (leader magnesium citrate oral solution - cherry). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a maximum dosage of 3 to 7 fluid ounces within a 24-hour period, with a strict limit of 7 fluid ounces. For children aged 2 to under 6 years, the recommended dosage is 2 to 3 fluid ounces in a 24-hour period, not exceeding 3 fluid ounces. For infants and children under 2 years of age, it is advised to consult a healthcare professional before administration.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with kidney disease, it is essential to assess renal clearance to ensure appropriate therapeutic levels are maintained. Additionally, patients on a magnesium-restricted diet should be monitored closely, as renal impairment can affect magnesium levels and overall electrolyte balance. Regular evaluation of renal function is recommended to guide treatment decisions and minimize the risk of adverse effects.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the individual patient's liver status when prescribing this medication.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, as these could indicate an adverse response to the medication.

Management Procedures Healthcare professionals should follow established protocols for managing drug overdosage, which may include activated charcoal administration if the patient presents within a suitable timeframe. Additionally, consultation with a poison control center or toxicology expert is recommended to guide further management and treatment options.

In summary, due to the lack of specific overdosage information, healthcare professionals must rely on their clinical judgment and standard overdosage management practices to ensure patient safety and effective care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to be aware of the signs of potential serious conditions; therefore, they should be instructed to stop using the product and consult a doctor if they experience rectal bleeding or fail to have a bowel movement after use.

Patients should also be encouraged to discuss their current medications with their healthcare provider or pharmacist prior to using this product. This is crucial as the use of laxatives may influence the effectiveness of other drugs. Providers should emphasize the importance of taking this product at least 2 hours before or after administering any other medications to minimize potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures ranging from 46° to 86°F (8° to 30°C) to maintain its integrity and efficacy. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Magnesium Citrate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)