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.

There are no 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 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 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 ensure patient safety and mitigate potential adverse effects.

Healthcare professionals should advise patients to discontinue use and consult a physician 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.

Monitoring for these adverse effects is essential to ensure the safe use of this product and to facilitate timely medical response when necessary.

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

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 6 to under 12 years may receive a maximum dosage of 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 24 hours. For infants under 2 years of age, consultation with a healthcare provider is advised prior to administration.

It is essential 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

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 on a magnesium-restricted diet should seek medical advice before initiating treatment, as the formulation may contain magnesium that could exacerbate their condition.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms may indicate a serious underlying condition that requires immediate attention.

For geriatric patients who are pregnant or breastfeeding, it is essential to consult a healthcare provider prior to use to ensure safety for both the patient and the child.

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 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 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 to ensure safety and efficacy. Regular monitoring of renal function tests is essential in this population to assess the need for any modifications in therapy. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is recommended that liver function tests be monitored closely in this population to ensure safety and efficacy. Caution should be exercised when administering this medication to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

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, 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 toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further treatment if required.

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 compound in these areas.

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.

Before initiating use, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have kidney disease, are on a magnesium-restricted diet, or are experiencing 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.

Patients should also be instructed to consult with their doctor or pharmacist prior to using this product if they are currently taking any other medications. It is essential to take this product 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 various package configurations, with specific NDC numbers available upon request. It is essential to store the product at temperatures ranging from 46° to 86°F (8° to 30°C) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent exposure to conditions outside the recommended temperature range.

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)