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 within a 24-hour period. This can be administered as a single daily dose or divided into multiple doses throughout the day.

For children aged 6 to under 12 years, the recommended dosage is between 3 to 7 fluid ounces, with a maximum limit of 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 within 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 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 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 a healthcare professional if they experience rectal bleeding or if there is a failure to have a bowel movement after administration. These symptoms may indicate a serious underlying condition that requires medical evaluation and intervention.

Healthcare professionals are advised to monitor patients for these critical 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, including rectal bleeding or failure to have a bowel movement after use, as these may indicate a serious underlying condition.

Common adverse reactions may include gastrointestinal symptoms such as abdominal pain, nausea, or vomiting. Patients are advised to consult a healthcare professional before using this product if they have a history of kidney disease, are on a magnesium-restricted diet, or have noticed a sudden change in bowel habits that persists for more than two weeks. Additionally, individuals who have been using a laxative for longer than one week should seek medical advice prior to use.

It is also recommended that patients inform their doctor or pharmacist if they are taking any other medications, as the use of this product may affect the efficacy of other drugs. To minimize potential 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 magnesium citrate be taken at least 2 hours before or after other drugs to minimize potential interactions.

Currently, there is no available information regarding other drug interactions or interactions with laboratory tests. Therefore, healthcare professionals should remain vigilant and monitor patients for any unexpected effects when these agents are used together.

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 fluid ounces within a 24-hour period. For children aged 6 to under 12 years, the maximum dosage is 7 fluid ounces in 24 hours, with a recommended range of 3 to 7 fluid ounces. In children aged 2 to under 6 years, the dosage is limited to 2 to 3 fluid ounces 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 may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 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

Renal impairment may necessitate dosage adjustments for patients receiving treatment. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Renal function tests should be performed prior to the initiation of therapy and periodically during treatment to assess any changes in renal status. A reduced dose is recommended for patients with moderate to severe renal impairment to mitigate the risk of adverse effects. Additionally, special consideration should be given to patients with end-stage renal disease, as their renal function significantly impacts drug metabolism and 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. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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

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 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 inform their healthcare provider if they have noticed a sudden change in bowel habits that persists for more than two weeks or if they have been using a laxative for longer than one week.

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 take this product at least two hours before or after 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 container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's integrity.

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)