Magnesium Citrate

Description

Freskaro Magnesium Citrate Cherry 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 cherry flavor enhances palatability, making it suitable for a wide 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 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. 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, it is advised to consult a doctor or pharmacist prior to use if the patient is currently taking any other medications. This product should be administered at least 2 hours before or after other drugs, as laxatives may alter the efficacy of concurrent 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, they should be advised to discontinue use and consult their healthcare provider to prevent potential complications.

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

Patients must be instructed to stop taking the medication and contact their doctor immediately if they experience rectal bleeding or fail to have a bowel movement after use. These symptoms could signify a serious medical condition that requires prompt attention.

Side Effects

Patients using this medication should be aware of several important warnings and potential adverse reactions. Serious adverse reactions may include symptoms related to kidney disease, which necessitate careful monitoring. Patients on a magnesium-restricted diet should also exercise caution, as this medication may not be suitable for them.

Common adverse reactions reported include abdominal pain, nausea, and vomiting. Additionally, patients should be vigilant for any sudden changes in bowel habits that persist for more than two weeks, as this may indicate a need for medical evaluation. It is also advised that patients refrain from using laxatives for longer than one week without consulting a healthcare professional.

Patients are instructed 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 signify a serious underlying condition.

Furthermore, it is important to note that the use of this laxative may interact with other medications, potentially affecting their efficacy. Therefore, patients should inform their healthcare provider of all medications they are currently taking.

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 concomitantly administered medications.

Healthcare professionals should monitor patients for any changes in the effectiveness of their other medications when using 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 (freskaro 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 doctor before administration.

Geriatric Use

There is no specific information available 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. 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 before using this medication. There is no specific data available regarding the excretion of this medication in 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 specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely and provide supportive care as needed.

Given the absence of detailed guidance, it is recommended that clinicians utilize standard protocols for managing drug overdosage, which may include symptomatic treatment and supportive measures. Continuous assessment of the patient's clinical status is essential to address any emerging symptoms promptly.

In cases of suspected overdosage, it is prudent to consult local poison control centers or relevant medical authorities for further assistance and guidance on management strategies.

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 understand the importance of stopping the use of this product and consulting a doctor if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms may indicate a serious underlying 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 essential to inform patients that this product should be taken at least 2 hours before or after the administration of 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 integrity. 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)