Titralac Plus

Description

Titralac™ PLUS ANTACID is a calcium-rich, sugar-free formulation designed to provide fast relief from symptoms associated with excess stomach acid. Each tablet contains simethicone, an anti-gas agent, to alleviate discomfort caused by gas. The product is characterized by its spearmint flavor, enhancing palatability. It is formulated with low aluminum and very low sodium content, making it suitable for a variety of dietary needs. The product is available in a bottle containing 100 tablets, with the National Drug Code (NDC) 055298-013-10.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas, including heartburn, sour stomach, and acid indigestion.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should chew, swallow, or allow two tablets to dissolve in the mouth every two to three hours as symptoms occur or as directed by a physician. It is important not to exceed a maximum of 19 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than two weeks.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a doctor or pharmacist prior to using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially affecting their efficacy or safety.

Patients are instructed to discontinue use and seek medical advice if symptoms persist for more than two weeks. This precaution is essential to ensure that any underlying conditions are properly evaluated and managed.

While no specific emergency medical instructions are provided, healthcare professionals should remain vigilant and encourage patients to seek immediate medical attention if they experience severe or unusual symptoms.

General precautions have not been specified; however, it is advisable to monitor patients for any adverse reactions or interactions, particularly in those with complex medication regimens.

Currently, there are no recommended laboratory tests associated with the use of this product. Nonetheless, healthcare providers should consider individual patient circumstances and may choose to conduct relevant assessments as deemed necessary.

Side Effects

Patients should be advised to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and seek medical advice.

Additionally, it is crucial to keep this product out of the reach of children to prevent accidental ingestion or misuse.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected medications is recommended when antacids are used concurrently.

Packaging & NDC

Below are the non-prescription pack sizes of Titralac Plus (calcium carbonate, dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety and prevent accidental ingestion by children.

Geriatric Use

Elderly patients may not have specific information regarding the use of Titralac Plus, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of detailed data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects and to consider individual patient factors when determining the appropriateness of treatment with Titralac Plus.

Pregnancy

There are no specific warnings, precautions, or dosage modifications regarding the use of Titralac Plus (calcium carbonate, dimethicone tablet) during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes.

Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the benefits against any potential risks. As with any medication, it is advisable to monitor pregnant patients closely and to discuss any concerns regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. However, it is advisable to monitor breastfed infants for any potential effects, as no data on excretion in breast milk or effects on nursing infants are provided.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care remain the cornerstone of managing overdose situations until the patient stabilizes or further interventions are deemed necessary.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation or alternative treatment options.

Additionally, it is important for healthcare providers to recommend that patients consult with a doctor or pharmacist before using the medication if they are currently taking any prescription drugs. This is crucial, as antacids may interact with certain prescription medications, potentially affecting their efficacy or safety.

Storage and Handling

The product is supplied in a bottle that features a printed foil seal under the cap for added protection. It should be stored at room temperature and must be protected from light to maintain its integrity.

Additional Clinical Information

The medication is administered orally, with patients instructed to chew, swallow, or allow two tablets to melt in the mouth every two to three hours as symptoms occur or as directed by a physician. It is important for patients not to exceed 19 tablets within a 24-hour period or to use the maximum dosage for more than two weeks. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Titralac Plus, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)