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 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 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 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

For this product, healthcare professionals should be aware of the following warnings and precautions to ensure safe usage.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial in managing potential overdose situations effectively.

General precautions should be observed, particularly regarding the signs of serious conditions. Patients should be advised to discontinue use and consult a physician 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.

Currently, there are no specific laboratory tests recommended for monitoring the use of this product. However, healthcare providers should remain vigilant and assess patients for any adverse effects or complications that may arise during treatment.

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.

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

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 potential interactions, it is recommended that this product be taken at least two hours before or after other medications.

Drug Interactions

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

No additional information regarding drug interactions or interactions with laboratory tests has been provided.

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 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 adverse effects or changes in therapeutic response, 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 drug 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 important to monitor renal function tests regularly in these patients to ensure appropriate dosing and minimize the risk of adverse effects. For patients with decreased creatinine clearance, a reduced dose should be considered to account for altered drug clearance. Additionally, special monitoring is required for patients with severe renal impairment to ensure their safety and the efficacy of 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 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

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 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 report any sudden changes in bowel habits that persist for more than two weeks or if they have been using a laxative for longer than one week.

Furthermore, patients should be instructed to speak with their doctor or pharmacist prior to use if they are currently taking any other medications. It is essential to inform patients that this product should be taken 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 a configuration that includes a tamper-evident twist-off cap. It is essential to ensure that the cap is intact; do not use the product if the cap is missing, broken, or separated from the neckring.

For optimal storage, the product should be maintained at temperatures ranging from 46° to 86°F (8° to 30°C). Proper adherence to these temperature guidelines is crucial to ensure the integrity and efficacy 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)