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 of administration.

There are no teratogenic or nonteratogenic effects mentioned 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, 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.

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 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 and consult their healthcare provider 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.

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 laxative 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, specifically 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 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 should exercise caution when using this medication, particularly those with pre-existing kidney disease. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have any renal impairment, as this may necessitate dosage adjustments or increased monitoring.

Additionally, elderly patients are encouraged to seek guidance from a doctor or pharmacist before initiating this medication if they are concurrently taking other medications. This is crucial to avoid potential drug interactions that could adversely affect their health.

Furthermore, if geriatric patients experience rectal bleeding or fail to have a bowel movement after using this product, they should discontinue use immediately and consult a healthcare professional. These symptoms may indicate a serious underlying condition that requires prompt medical attention.

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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 significantly 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, and specific interventions may be required based on the symptoms presented.

Management of an overdose may involve the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk for aspiration. In cases of severe toxicity, advanced interventions such as airway management, intravenous fluids, or antidotes may be indicated, depending on the specific agent involved.

It is crucial for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide tailored recommendations based on the latest evidence and clinical protocols.

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. Further studies may be necessary to elucidate these aspects of nonclinical 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 failure 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 prior to use 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 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 in quality during storage.

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)