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.

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 appropriate 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 as deemed necessary.

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

Patients should be advised of the following warnings and precautions associated with the use of this product.

Warnings This product is contraindicated in certain conditions.

General Precautions Healthcare professionals should counsel patients to consult a physician 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 seek medical advice if they have experienced 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 are also advised to inform their healthcare provider or pharmacist if they are taking any other medications. It is recommended that this product be taken at least two hours before or after the administration of other drugs, as laxatives may influence the efficacy of concurrent medications.

Emergency Medical Help Instructions In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a physician if they experience rectal bleeding or fail to have a bowel movement after using the product, as these symptoms may indicate a serious underlying condition.

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 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 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 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 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

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 appropriate management. Specifically, patients with reduced creatinine clearance may require a reduced dose to avoid potential toxicity. Additionally, special considerations should be taken 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

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, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or treatments should be administered as per established guidelines. Continuous monitoring of the patient’s condition is crucial, and further interventions may be required based on the severity of symptoms and the clinical judgment of the healthcare provider.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant toxicology resources for guidance on management and treatment 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 compound in these areas.

Postmarketing Experience

There are no specific adverse reactions or safety updates related to postmarketing experience for CITROMA (magnesium citrate liquid) reported in the available data.

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 inform patients that they should take this product at least two hours before or after taking other drugs, as laxatives may influence the efficacy 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 storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

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)