Citroma

Description

No description information is available for the specified drug.

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 to ensure proper administration.

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.

The medication may be administered as a single daily dose or divided into multiple doses as deemed appropriate by the healthcare provider.

Contraindications

Use is contraindicated in patients who experience 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 seek medical advice promptly.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center. Prompt action is crucial to mitigate potential adverse effects associated with overdose.

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

Healthcare professionals are advised to monitor patients closely for these signs and symptoms to ensure timely management and to prevent complications.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions warrant immediate medical attention. Patients should stop use and consult a doctor if they experience rectal bleeding or failure to have a bowel movement after use, as these symptoms could indicate a serious underlying condition.

Common adverse reactions may include gastrointestinal disturbances. Patients are advised to seek medical advice before using this product if they have kidney disease, are on a magnesium-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 have been using a laxative for longer than one week should also consult a healthcare professional prior to use.

It is important for patients to inform their doctor or pharmacist if they are taking any other medications, as this product may interact with other drugs. To minimize the risk of such interactions, patients should take this product at least two hours before or after administering other medications.

Drug Interactions

Laxatives, particularly magnesium citrate, may influence the efficacy of concomitantly administered medications. It is recommended that this product be taken at least 2 hours before or after the administration of other drugs to minimize potential interactions.

No additional drug interactions or laboratory test interactions have been identified for this product. Therefore, no specific dosage adjustments or monitoring requirements are necessary beyond the aforementioned guidance regarding magnesium citrate.

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 renal function may be compromised in this population, potentially affecting drug metabolism and excretion.

Additionally, patients on a magnesium-restricted diet should seek medical advice before initiating treatment, as the formulation may contain magnesium, which could exacerbate their condition. 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 further evaluation.

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

Patients should discontinue use and contact a healthcare professional if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms could signify a serious medical condition requiring immediate attention. Careful monitoring and appropriate dose modifications may be necessary to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess the need for dosage modifications. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with altered drug clearance.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

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 be encouraged to consult with their healthcare provider before using this product if they have any of the following conditions: kidney disease, a magnesium-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 also necessitates a discussion with their doctor.

Furthermore, patients should be instructed to ask a doctor or pharmacist before using this product if they are currently taking any other medications. It is essential to inform patients that they should take this product at least two hours before or after taking other drugs, as laxatives may influence the effectiveness of other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at temperatures ranging from 46° to 86°F (8° to 30°C) to maintain its integrity and efficacy.

Care should be taken to ensure that the tamper-evident twist-off cap is intact; the product must not be used if the cap is missing, broken, or separated from the neckring. Proper handling and storage conditions are crucial to ensure the safety and effectiveness of the product.

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)