Magnesium Citrate

Description

Leader Magnesium Citrate Grape is a dietary supplement formulated to provide magnesium in the form of magnesium citrate. The product is presented as a grape-flavored liquid solution, designed for oral administration. Magnesium citrate is known for its high bioavailability, facilitating effective absorption in the gastrointestinal tract. The formulation is intended to support various physiological functions, including muscle and nerve function, as well as maintaining normal bone structure.

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 experiencing rectal bleeding or failure to have a bowel movement after use, as these symptoms may indicate a serious underlying condition. In such cases, it is essential to discontinue use and consult a healthcare professional.

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.

Healthcare professionals should advise patients to seek immediate medical attention if they experience abdominal pain, nausea, or vomiting, as these symptoms may indicate an adverse reaction or underlying issue. Furthermore, patients who notice a sudden change in bowel habits that persists for more than two weeks should be evaluated for potential gastrointestinal disorders. It is also critical to monitor patients who have been using a laxative for longer than one week, as prolonged use may lead to dependency or other complications.

In the event of an overdose, it is imperative to obtain emergency medical assistance or contact a Poison Control Center without delay to mitigate potential risks.

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

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 consult a healthcare professional. A sudden change in bowel habits that persists for more than two weeks is also a cause for concern, as is the use of a laxative for longer than one week.

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

Drug Interactions

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

Healthcare professionals should monitor patients for any changes in the efficacy of other medications when used in conjunction with 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 - grape). 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 doctor 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 potential 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 potential risks and benefits must be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

Lactating mothers are advised to consult a healthcare professional before 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 may need to adhere to a magnesium-restricted diet to prevent potential complications associated with elevated magnesium levels. Regular monitoring of renal function is recommended to guide treatment decisions and adjust dosages as necessary.

Hepatic Impairment

There is no information available regarding hepatic impairment, including dosage adjustments, special monitoring requirements, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment. It is advised that healthcare professionals exercise clinical judgment when considering treatment options for this patient population.

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 adhere to general principles of management in cases of 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 measures. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of overdosage cases. It is critical to provide comprehensive care tailored to the patient's needs, including potential interventions based on the severity of symptoms presented.

In summary, due to the lack of specific overdosage information, a cautious and supportive approach is recommended for the management of any suspected cases.

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 these contexts.

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 crucial for patients to be aware of the signs that warrant discontinuation of the product; they should stop use and consult a doctor if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms may indicate a serious condition.

Patients should also be encouraged to consult with their healthcare provider or pharmacist prior to using this product if they are currently taking any other medications. It is important to inform patients that they should take this product at least 2 hours before or after taking other drugs, as laxatives may influence the effectiveness of concurrent medications.

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 efficacy and safety. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

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)