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 consume 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 may 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 timeframe.

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 may indicate a serious underlying condition. In such cases, it is advised 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 mitigate potential adverse effects associated with overdose.

Patients should discontinue use and consult their healthcare provider if they experience rectal bleeding or an inability to have a bowel movement following 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 using this product should be aware of potential adverse reactions and the importance of monitoring their health during treatment. Serious adverse reactions may include rectal bleeding or failure to have a bowel movement after use, which could indicate a serious underlying condition. In such cases, patients are advised to stop use and consult a healthcare professional immediately.

Before initiating treatment, patients should seek medical advice if they have a history of kidney disease, are on a magnesium-restricted diet, or are experiencing abdominal pain, nausea, or vomiting. Additionally, those who have noticed a sudden change in bowel habits persisting for more than two weeks or have been using a laxative for longer than one week should also consult a healthcare provider.

It is crucial 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, it is recommended that this product be taken at least two hours before or after the administration of 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, no specific dosage adjustments or monitoring recommendations can be provided for other medications in relation to this product.

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 within 24 hours. For infants 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 using this medication, particularly if they have a history of kidney disease. It is essential for geriatric patients to inform their doctor or pharmacist about any other medications they are currently taking to avoid potential drug interactions.

In the event of rectal bleeding or failure to have a bowel movement after use, elderly patients are advised to discontinue use and seek medical attention, as these symptoms may indicate a serious underlying condition. Additionally, pregnant or breastfeeding geriatric patients should consult a healthcare professional before using this medication to ensure safety for both themselves and their child.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on 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 that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

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 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. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the patient's condition.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for further guidance on management strategies tailored to the specific situation.

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 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 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 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 advised to speak with their doctor or pharmacist before using this product if they are currently taking any other medications. It is essential to instruct patients to 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)