Magnesium Citrate

Description

Freskaro Magnesium Citrate Grape Version 1 is a dietary supplement formulated to provide magnesium in the form of magnesium citrate. This product is designed to support various physiological functions, including muscle and nerve function, energy production, and bone health. The grape flavor enhances palatability, making it suitable for a wider range of consumers. The formulation is intended for oral administration, ensuring optimal absorption of magnesium.

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity). It generally produces a bowel movement within 0.5 to 6 hours following administration.

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

Dosage and Administration

Patients should shake the product well before use. It is recommended that each dose be taken with a full glass (8 ounces) of liquid. The medication may be administered as a single daily dose or divided into multiple doses throughout the day.

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 recommended 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 dosage should be between 2 to 3 fluid ounces, with a maximum of 3 fluid ounces in a 24-hour period. For children under 2 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients experiencing rectal bleeding or failure to have a bowel movement after use, as these may indicate a serious underlying condition requiring medical evaluation. Additionally, this product should not be taken concurrently with other medications; it is advised to administer this product at least 2 hours before or after other drugs to prevent potential interactions that may affect the efficacy of those medications.

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 symptoms such as abdominal pain, nausea, or vomiting. These symptoms may indicate an adverse reaction or other underlying issues that require further evaluation.

Patients should be closely monitored for any sudden changes in bowel habits that persist for more than two weeks. Such changes may warrant further investigation to rule out serious gastrointestinal conditions. Furthermore, if a patient has been using a laxative for longer than one week, it is crucial to reassess their treatment plan to avoid potential complications.

In the event of an overdose, patients must receive emergency medical assistance or contact a Poison Control Center without delay to mitigate risks associated with excessive intake.

Patients are advised to discontinue use and consult their healthcare provider if they experience rectal bleeding or fail to have a bowel movement after using the medication. These symptoms could signify a serious underlying condition that necessitates 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, or the use of a laxative for longer than one week, may also warrant medical attention.

Patients are advised to stop using the medication 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 in conjunction with this product. Adjustments to the timing of administration may be necessary to mitigate any potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Magnesium Citrate (freskaro 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any 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 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 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 based on individual patient circumstances.

Overdosage

In the context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive measures be employed. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the use of activated charcoal if the ingestion occurred within a timeframe that warrants its use.

Healthcare providers should remain vigilant and report any observed adverse effects to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

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 safety profile 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 upon request. It is essential to store the product at temperatures ranging from 46° to 86°F (8° to 30°C) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment to prevent degradation. Special handling needs should be observed to ensure the integrity of the product throughout its storage period.

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.

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