Citroma

Description

GoodSense Magnesium Citrate is an oral solution formulated as a saline laxative. It is presented in a 10 fluid ounce (296 mL) container and features a pleasing lemony flavor. The product is pasteurized to ensure safety and efficacy. Known as "The Sparkling Laxative," it provides a gentle and effective means of relief for occasional constipation.

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 effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients should consume 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 recommended 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 timeframe.

For children aged 2 to under 6 years, the appropriate dosage is 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.

Unused product should be discarded within 24 hours of opening the bottle to ensure safety and efficacy.

Contraindications

Use is contraindicated in patients experiencing rectal bleeding or failure to have a bowel movement after use, as these may indicate a serious underlying condition. In such cases, it is essential to seek medical advice promptly.

Warnings and Precautions

Patients should not use this product if they are on a low salt diet due to potential health risks associated with sodium intake.

In the event of rectal bleeding or failure to have a bowel movement after use, patients are advised to discontinue use immediately and consult a healthcare professional. These symptoms may indicate a serious underlying condition that requires medical evaluation.

In cases of overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay.

Before initiating treatment, patients should exercise caution and consult a healthcare provider if they have any of the following conditions: kidney disease, a magnesium or sodium-restricted diet, abdominal pain, nausea, or vomiting. Additionally, individuals who have experienced a sudden change in bowel habits persisting for two weeks or who have been using a laxative for more than one week should also seek medical advice prior to use.

Patients are encouraged to consult with a doctor or pharmacist before using this product if they are currently taking any other medications. It is recommended to administer this laxative at least two hours before or after taking other drugs, as laxatives may influence the efficacy of concurrent medications.

Side Effects

Patients should be aware of several important warnings and recommendations regarding the use of this product. It is contraindicated for individuals on a low salt diet. Patients are advised to discontinue use and consult a healthcare professional if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms may indicate a serious underlying condition.

Prior to using this product, patients should seek medical advice if they have a history of kidney disease, are on a magnesium or sodium-restricted diet, or are experiencing abdominal pain, nausea, or vomiting. Additionally, those who notice a sudden change in bowel habits that persists for more than two weeks or who have been using a laxative for longer than one week should also consult a healthcare provider.

Furthermore, patients taking other medications should ask a doctor or pharmacist before use, as this product may interact with other drugs. It is recommended to take this laxative at least two hours before or after other medications to minimize potential interactions.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product if they are currently taking any other medications.

To minimize potential interactions, it is recommended that this product be administered at least 2 hours before or after the administration of other drugs.

Additionally, the use of laxatives may influence the efficacy of other medications. Therefore, careful consideration and monitoring are advised when combining laxatives with other therapeutic agents.

Packaging & NDC

Below are the non-prescription pack sizes of Citroma (magnesium citrate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may receive a dosage of 6.5 to 10 fl oz, with a maximum limit of 10 fl oz in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage ranges from 3 to 7 fl oz, not exceeding 7 fl oz in 24 hours. In children aged 2 to under 6 years, the dosage is 2 to 3 fl oz, with a maximum of 3 fl oz in 24 hours. For infants and children under 2 years of age, it is advised to consult a doctor before administration.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is essential for geriatric patients to consult a healthcare provider prior to use if they have a history of kidney disease, as this may necessitate dosage adjustments or increased monitoring.

Additionally, patients on a magnesium or sodium-restricted diet should seek medical advice before initiating treatment, as the formulation may contain these elements. Geriatric patients experiencing abdominal pain, nausea, or vomiting should also consult a physician before use, as these symptoms may indicate underlying health issues that require attention.

Patients who notice a sudden change in bowel habits persisting for more than two weeks should seek medical advice prior to using this medication. Furthermore, those who have been using a laxative for longer than one week should consult a healthcare provider, as prolonged use may lead to complications.

Elderly patients are advised to discontinue use and consult a doctor if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms could signify a serious medical condition that warrants immediate evaluation.

Pregnancy

Pregnant patients and those who are breastfeeding 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 seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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

Overdosage may lead to severe dehydration, electrolyte imbalance, and other serious complications. Healthcare professionals should be vigilant for symptoms that may arise in such cases, which can include nausea, vomiting, abdominal pain, and diarrhea.

In the event of an overdosage, it is imperative to seek immediate medical attention. Prompt intervention is crucial to manage the potential complications associated with overdosage effectively.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 if they fail to have a bowel movement after use, as these symptoms may indicate a serious condition.

Prior to using this product, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have kidney disease, are on a magnesium or sodium-restricted diet, or are experiencing abdominal pain, nausea, or vomiting. Additionally, patients should be informed that a sudden change in bowel habits persisting for more than two weeks or the use of a laxative for longer than one week should also prompt a consultation with a healthcare professional.

Patients should be reminded to inform their doctor or pharmacist about any other medications they are currently taking. It is crucial to take this product at least two hours before or after 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 46º to 86º F (8º to 30º C) to maintain its efficacy and stability. 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 exposure to conditions outside the recommended temperature range.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Citroma, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)