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 0.5 to 6 hours following 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. 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 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.

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 ensure patient safety and mitigate potential adverse effects.

Patients should discontinue use and consult a healthcare professional 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 providers are advised to monitor patients closely for these signs and symptoms to ensure timely management and to prevent complications associated with the use of this product.

Side Effects

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

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Citroma (magesium 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 under 2 years of age, it is advised to consult a doctor before administration.

It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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

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. Prior to initiating therapy, renal function tests should be performed, and these tests should be conducted periodically thereafter to ensure ongoing safety and efficacy. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with treatment.

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 unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center or a medical toxicologist for further guidance on management strategies tailored to the specific situation. Continuous assessment of the patient's clinical status is essential to ensure appropriate interventions are implemented promptly.

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.

Postmarketing Experience

Postmarketing experience has revealed reports of adverse reactions associated with the use of magnesium citrate, including gastrointestinal disturbances such as diarrhea, abdominal cramping, and nausea. Additionally, there have been rare reports of allergic reactions, including rash and itching, following the use of magnesium citrate. Some patients have experienced electrolyte imbalances, particularly in individuals with pre-existing kidney conditions or those taking other medications that may affect electrolyte levels. Monitoring for signs of dehydration is recommended, especially in patients using magnesium citrate for extended periods or in high doses.

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.

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 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 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 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 must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should 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)