Topcare Dual Action Complete

Description

FAMOTIDINE 10 mg, CALCIUM CARBONATE 800 mg, and MAGNESIUM HYDROXIDE 165 mg are formulated as chewable tablets. This combination serves as an acid reducer and antacid, providing relief from heartburn associated with acid indigestion. The tablets are presented in a berry flavor, enhancing palatability for the user.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach. It is intended for use in adults and pediatric patients as directed.

Dosage and Administration

Adults and children aged 12 years and older are advised to chew 1 tablet completely before swallowing to relieve symptoms. It is important to note that the tablet should not be swallowed whole. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in patients who experience difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated.

Warnings and Precautions

Patients should be aware of the following warnings and precautions associated with the use of this medication.

Allergy Alert This medication should not be used by individuals who are allergic to famotidine or other acid reducers.

Contraindications The medication is contraindicated in patients experiencing difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition. In such cases, it is imperative to seek medical attention promptly. Additionally, this medication should not be used concurrently with other acid reducers.

Pre-Use Consultation Healthcare professionals should be consulted prior to use if the patient has experienced heartburn for more than three months, as this may suggest a more serious condition. Patients should also seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or if they have a history of kidney disease.

Drug Interactions Patients taking prescription medications should consult with their doctor or pharmacist before using this product, as antacids and acid reducers may interact with certain prescription drugs.

Monitoring and Discontinuation Patients are advised to discontinue use and consult a healthcare professional if heartburn persists or worsens, or if the medication is required for more than 14 days.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to discontinue use and consult a healthcare professional if they experience any of the following symptoms: difficulty or pain when swallowing, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.

Patients should also seek medical advice prior to using this medication if they have experienced heartburn for more than three months, as this may signal a more serious condition. Additional warning signs that warrant consultation include heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain accompanied by shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or a history of kidney disease.

Common adverse reactions may include persistent heartburn or worsening symptoms. Patients are advised to stop using the medication and consult a healthcare provider if their heartburn continues or worsens, or if they find it necessary to use the product for more than 14 days. Additionally, patients should not use this medication in conjunction with other acid reducers, as this may increase the risk of adverse effects.

Patients with known allergies to famotidine or other acid reducers should avoid using this medication.

Drug Interactions

Antacids and acid reducers may interact with certain prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of administration when these agents are used concurrently. Patients should be counseled to separate the dosing of antacids or acid reducers from the prescribed medications to minimize the risk of interaction. Adjustments to the dosage of the affected prescription drugs may be necessary based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Dual Action Complete (famotidine, calcium carbonate and magnesium hydroxide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and adults aged 12 years and older, it is important to note that the tablet should not be swallowed whole; it must be chewed completely to effectively relieve symptoms. The maximum recommended dosage for this age group is 2 chewable tablets within a 24-hour period.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations associated with pharmacotherapy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve the administration of activated charcoal, intravenous fluids, or other interventions based on the clinical presentation.

It is vital for healthcare professionals to remain vigilant and prepared to address any complications that may arise from an overdose, ensuring the best possible outcomes for affected individuals.

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 text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients not to use the product if they experience difficulty or pain while swallowing food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical evaluation.

Patients should be cautioned against using this product in conjunction with other acid reducers. They must be instructed to discontinue use and consult a healthcare professional if their heartburn persists or worsens. Additionally, patients should be advised to stop using the product and seek medical advice if they find it necessary to take it for more than 14 days.

Healthcare providers should encourage patients to consult a doctor before using the product if they have experienced heartburn for over three months, as this may signal a more serious condition. Patients should also be informed to seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness, or if they have chest pain or shoulder pain along with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders.

Furthermore, patients should be advised to consult a healthcare professional if they frequently experience chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain. Those with a history of kidney disease should also be encouraged to seek medical advice prior to use.

Lastly, patients should be reminded to consult their doctor or pharmacist before using this product if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, it is essential to protect the product from moisture to prevent degradation. Proper adherence to these storage conditions will help ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. For adults and children aged 12 years and older, the tablet should not be swallowed whole; it must be chewed completely before swallowing, with a maximum of two chewable tablets allowed within a 24-hour period. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important for patients to read the directions and warnings provided on the bottle, as it contains essential information regarding the medication's use.

Drug Information (PDF)

This file contains official product information for Topcare Dual Action Complete, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)