Citroma

Description

Magnesium Citrate Saline Laxative Oral Solution is manufactured by WESTERN FAMILY. This formulation is presented as an oral solution, with a total volume of 10 fluid ounces (296 mL). The product features a tamper-evident design, and it is advised not to use the solution if the breakaway band on the cap is broken or missing.

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 of administration.

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

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.

Any 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 symptoms may indicate a serious underlying condition. In such cases, it is essential to discontinue use and consult a healthcare professional.

Warnings and Precautions

The use of this product is contraindicated in individuals adhering to a low salt diet.

Healthcare professionals should advise patients to discontinue use and seek medical attention if they experience rectal bleeding or fail to have a bowel movement after administration, as these symptoms may indicate a serious underlying condition.

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

Prior to recommending this product, it is essential to consult a healthcare provider if the patient has any of the following conditions: kidney disease, a magnesium or sodium-restricted diet, abdominal pain, nausea, or vomiting. Additionally, patients should be evaluated if they have observed a sudden change in bowel habits persisting for two weeks or longer, or if they have been using a laxative for more than one week.

No specific laboratory tests are required for the safe use of this product.

Side Effects

Patients should be advised to stop use and consult a doctor if they experience rectal bleeding or failure to have a bowel movement after use, as these symptoms may indicate a serious underlying condition.

It is important to note that this product should not be used by individuals on a low salt diet. Additionally, patients are encouraged to seek medical advice before using this product if they have kidney disease, are on a magnesium or sodium-restricted diet, or are experiencing abdominal pain, nausea, or vomiting. A sudden change in bowel habits that persists for more than two weeks or the use of a laxative for longer than one week also warrants consultation with a healthcare professional.

Patients taking other medications should consult a doctor or pharmacist prior to use, as this product may interact with other drugs. It is recommended that this laxative be taken 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 intake 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 consult a healthcare provider prior to use, particularly if they have a history of kidney disease. Additionally, those on a magnesium or sodium-restricted diet are advised to seek medical advice before using this product.

For dosing, adults and children aged 12 years and older may take between 6.5 to 10 fluid ounces, with a maximum limit of 10 fluid ounces within a 24-hour period. In children aged 6 to under 12 years, the recommended dosage ranges from 3 to 7 fluid ounces, with a maximum of 7 fluid ounces in 24 hours. For children aged 2 to under 6 years, the dosage is 2 to 3 fluid ounces, not exceeding 3 fluid ounces in a 24-hour period. It is important to note that for children under 2 years of age, a healthcare provider should be consulted before administration.

Careful monitoring and adherence to these guidelines are essential to ensure the safety and efficacy of the treatment in geriatric patients.

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 known. 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

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 information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response. In the event of suspected overdosage, it is recommended that healthcare professionals initiate supportive care and symptomatic treatment as necessary.

Management procedures may include the following steps:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care tailored to the patient's needs, which may involve intravenous fluids, oxygen supplementation, or other interventions as indicated.

3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies and potential antidotes, if applicable.

It is essential for healthcare professionals to remain vigilant and prepared to address any complications that may arise from an overdosage scenario, even in the absence of specific guidance in the SPL.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Adverse reactions have been reported in the postmarketing experience, including but not limited to diarrhea, abdominal cramping, nausea, vomiting, electrolyte imbalances, dehydration, and allergic reactions such as rash and itching. The frequency of these adverse reactions is not known.

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 to instruct patients 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.

Patients should be encouraged to consult with their healthcare provider prior to use if they have any of the following conditions: kidney disease, a magnesium or sodium-restricted diet, 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 warrants a discussion with their doctor.

Furthermore, healthcare providers should remind patients to consult with a doctor or pharmacist before using this product if they are currently taking any other medications. It is essential to instruct patients to take this laxative at least two hours before or after taking other drugs, as laxatives may influence the efficacy of concurrent medications.

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 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 Citroma, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)