Calcium carbonate/Magnesium hydroxide

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Healthcare professionals should refer to the prescribing information for detailed indications and usage recommendations.

Limitations of use and any potential teratogenic or nonteratogenic effects have not been specified in the provided information. It is essential for healthcare providers to evaluate the risk-benefit profile of this drug in the context of individual patient circumstances.

Dosage and Administration

The medication is administered orally. Each dose contains 675 mg of Calcium Carbonate and 135 mg of Magnesium Hydroxide.

Healthcare professionals should ensure that patients adhere to the prescribed dosing regimen. It is important to monitor the patient's response to the medication and adjust the dosage as necessary based on clinical judgment and individual patient needs.

Patients should be advised to take the medication with a full glass of water to facilitate proper absorption.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment and consider individual patient circumstances when prescribing.

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular laboratory tests may be necessary to assess the patient's response to therapy and to ensure safety. Specific monitoring parameters should be established based on the individual patient's health status and the medication's profile.

In the event of severe side effects or unexpected reactions, immediate medical attention should be sought. Healthcare providers should instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.

Overall, a thorough understanding of the potential risks and the implementation of appropriate monitoring strategies are vital for the safe administration of this medication.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. The following sections outline these reactions, categorized by seriousness and frequency.

Gastrointestinal disorders are among the most commonly reported adverse reactions. Patients may experience diarrhea, constipation, abdominal pain, nausea, and vomiting. In clinical trials, these gastrointestinal symptoms were frequently observed, indicating a need for monitoring in affected individuals.

Metabolic disorders, including hypercalcemia and hypermagnesemia, have also been reported. These conditions may arise from the medication's effects on mineral balance and should be considered, particularly in patients with pre-existing metabolic issues.

Renal disorders, specifically kidney stones, have been noted as a potential adverse reaction. Patients with a history of renal impairment should use this medication with caution, as it may exacerbate their condition.

Cardiovascular disorders, such as bradycardia, have been documented. This reaction necessitates careful monitoring of heart rate in patients receiving treatment.

Neurological disorders, including dizziness and headache, have been reported by some patients. These symptoms may impact the patient's ability to perform daily activities and should be addressed as necessary.

Allergic reactions, such as rash, itching, and swelling, have been observed. In postmarketing experience, severe allergic reactions, including anaphylaxis, have been reported, highlighting the importance of immediate medical attention in such cases. Additionally, gastrointestinal obstruction has been noted in postmarketing reports, warranting vigilance in patients presenting with gastrointestinal symptoms.

It is important to note that overuse of this medication may lead to metabolic alkalosis. Therefore, healthcare providers should ensure appropriate dosing and monitor patients for signs of this condition.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Calcium Carbonate, Magnesium Hydroxide. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric use is not specifically addressed in the available prescribing information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of specific data.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal impacts associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that pregnant patients discuss their treatment options with their healthcare provider to ensure informed decision-making regarding their health and the health of the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 prescribing information.

Overdosage

Overdosage of calcium carbonate and magnesium hydroxide can lead to significant health complications, including hypercalcemia and metabolic alkalosis, among other adverse effects.

Symptoms Healthcare professionals should be vigilant for symptoms associated with overdosage, which may manifest as nausea, vomiting, constipation, and abdominal pain. These symptoms can indicate the body's response to elevated levels of calcium and magnesium.

Recommended Actions In the event of an overdosage, it is imperative to seek medical attention immediately. Prompt intervention is crucial to manage the potential complications effectively and to mitigate any serious health risks associated with the overdosage of these compounds.

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 provided data.

Patient Counseling

Patients should be advised to chew the tablets thoroughly before swallowing to ensure proper absorption and effectiveness of the medication.

It is important to inform patients that this product may cause gastrointestinal discomfort. If such symptoms persist, they should be encouraged to consult a healthcare professional for further evaluation and management.

Healthcare providers should discuss the significance of informing them if they are pregnant, plan to become pregnant, or are breastfeeding, as this information is crucial for assessing the safety and appropriateness of the medication.

Additionally, patients should be instructed to keep the product out of reach of children. In the event of an overdose, they must seek medical help or contact a Poison Control Center immediately to ensure their safety.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature, within the range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Calcium Carbonate, Magnesium Hydroxide, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)