Magnesium Citrate

Description

Freskaro Magnesium Citrate is a dietary supplement formulated to provide magnesium in a citrate form. The product is presented in a lemon-flavored version, enhancing palatability. Magnesium citrate is known for its bioavailability and is commonly used to support various physiological functions, including muscle and nerve function, as well as maintaining normal bone structure. The specific formulation is designed to deliver an effective dose of magnesium while ensuring ease of consumption.

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.

There are no teratogenic or nonteratogenic effects mentioned 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 allowed 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, patients who experience a sudden change in bowel habits that persists for more than two weeks should seek medical evaluation, as this may indicate an underlying issue that requires attention.

Prolonged use of laxatives, specifically beyond one week, is discouraged. Patients should discontinue use and contact their healthcare provider if they experience rectal bleeding or fail to have a bowel movement after administration, as these symptoms may signify a serious medical condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay to ensure appropriate management.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include rectal bleeding and failure to have a bowel movement after use, which may indicate a serious underlying condition. Patients are advised to discontinue use and consult a healthcare professional if they experience these symptoms.

Common adverse reactions may include abdominal pain, nausea, or vomiting. Additionally, patients with kidney disease or those on a magnesium-restricted diet should exercise caution when using this product. A sudden change in bowel habits that persists for more than two weeks or the prolonged use of a laxative for more than one week should also prompt consultation with a healthcare provider.

It is important for patients to inform their healthcare provider or pharmacist if they are taking any other medications, as laxatives may influence the efficacy of other drugs.

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 necessary as the laxative properties of this product may influence the absorption and efficacy of co-administered medications.

Healthcare professionals should monitor patients for any potential alterations in the therapeutic effects of other drugs when used in conjunction with this product. Adjustments to the dosing regimen of other medications may be warranted based on clinical response and individual patient factors.

Packaging & NDC

Below are the non-prescription pack sizes of Magnesium Citrate (freskaro magnesium citrate oral solution - lemon). 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 potential adverse effects or changes in efficacy, 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. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances and any potential risks with their healthcare provider prior to use.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data 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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring in this population.

Overdosage

Overdosage may result in severe diarrhea, which can subsequently lead to dehydration and electrolyte imbalances. Healthcare professionals should be vigilant for symptoms associated with overdosage, which may include abdominal pain, nausea, and vomiting.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Prompt intervention is crucial to manage the potential complications arising from the symptoms and to restore electrolyte balance as necessary.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 discuss their current medication regimen with their healthcare provider or pharmacist before using this product. It is essential to inform them that this product should be taken at least 2 hours before or after the administration of other medications, as laxatives may influence the effectiveness of other drugs.

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 container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's integrity.

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)