Magnesium Citrate

Description

Magnesium citrate is a saline laxative available as an oral solution. The product contains a lemon flavor and has an alcohol content of 0.025%, which is derived from flavoring. It is packaged in a volume of 10 fl oz (296 mL).

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity). It generally produces a bowel movement within ½ to 6 hours of administration.

Limitations of Use: There are no 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 maximum dosage is between 3 to 7 fluid ounces, with a maximum of 7 fluid ounces allowed in a 24-hour period.

For children aged 2 to under 6 years, the dosage should not exceed 2 to 3 fluid ounces, with a maximum of 3 fluid ounces permitted 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 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

Healthcare professionals are advised to exercise caution when recommending this product, particularly in patients with specific medical conditions. Prior to use, it is essential to consult a physician if the patient has any of the following:

• Kidney disease

• A magnesium-restricted diet

• Symptoms such as abdominal pain, nausea, or vomiting

• A sudden change in bowel habits that persists for more than two weeks

• A history of laxative use exceeding one week

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

Patients should be instructed to discontinue use and consult their healthcare provider if they experience rectal bleeding or fail to have a bowel movement after using the product. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may include rectal bleeding and failure to have a bowel movement after use, which could indicate a serious underlying condition. In such cases, patients are advised to stop use and consult a healthcare professional immediately.

Additionally, patients should seek medical advice before using this medication if they have any of the following conditions: kidney disease, a magnesium-restricted diet, abdominal pain, nausea, or vomiting. It is also important for patients to report any sudden changes in bowel habits that persist for more than two weeks or if they have been using a laxative for longer than one week, as these may warrant further evaluation by a healthcare provider.

Drug Interactions

Laxatives, particularly magnesium citrate, may influence the efficacy of concomitantly administered medications. To minimize the risk of interactions, it is recommended that magnesium citrate be taken at least 2 hours before or after the administration of other drugs. This timing helps ensure that the absorption and effectiveness of other medications are not compromised.

No additional drug interactions or laboratory test interactions have been identified for this product.

Packaging & NDC

Below are the non-prescription pack sizes of Magnesium Citrate (magnesium citrate oral solution). 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, with a limit of 7 fluid ounces within a 24-hour period. For children aged 2 to under 6 years, the maximum dosage is 2 to 3 fluid ounces, not exceeding 3 fluid ounces in a 24-hour timeframe. 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

It is imperative to monitor the patient closely for any evolving symptoms and to provide symptomatic treatment as required. Documentation of the incident and any interventions performed should be meticulously recorded for future reference and quality assurance.

In summary, while specific overdosage information is not available, healthcare professionals should be prepared to act swiftly and effectively in managing potential overdose situations, ensuring patient safety and optimal outcomes.

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 keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience rectal bleeding or fail to have a bowel movement after using the product, as these symptoms may indicate a serious underlying condition.

Additionally, healthcare providers should recommend that patients consult with a doctor or pharmacist prior to use if they are currently taking any other medications. It is important to instruct patients to 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)