Citroma

Description

No description information is available for the 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.

There are no teratogenic or nonteratogenic effects associated with this drug as per the available data.

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 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 recommended 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 doctor for appropriate dosing recommendations.

The medication may be administered as a single daily dose or divided into multiple doses, depending on the clinical judgment of the healthcare provider.

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 discontinue use and consult a healthcare professional.

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 of this product 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 professionals 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 (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 may not require specific dosage adjustments when using this medication, as there are no recommendations provided for this population. However, it is important to note that the absence of explicit safety concerns or special precautions for geriatric patients does not negate the need for careful consideration of their overall health status.

Given that elderly patients often present with comorbidities, particularly renal impairment, it is advisable for healthcare providers to assess kidney function prior to prescribing this medication. Patients with kidney disease should consult their physician before use, as this condition may influence the safety and efficacy of the treatment.

The recommended dosage for adults and children aged 12 years and older is 6.5 to 10 fl oz, with a maximum of 10 fl oz within a 24-hour period. While no specific geriatric dosage is outlined, healthcare providers should monitor elderly patients closely for any adverse effects or complications that may arise during treatment.

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 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure safety and efficacy. A reduced dose should be considered for patients with a creatinine clearance below a specified threshold. Additionally, special monitoring is required for patients with severe renal impairment to manage potential risks effectively.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 stop using the product 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 warrants a discussion with their doctor.

Furthermore, patients should be instructed to consult 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°F to 86°F (8°C 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)