Up and up Dual Action Acid Reducer and Antacid

Description

No description information is available for the drug.

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 instructed to chew 1 tablet completely before swallowing to relieve symptoms. It is essential that the tablet is not swallowed whole. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is advised 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 agents is contraindicated due to the potential for increased risk of adverse effects.

Warnings and Precautions

Patients should be advised of the following warnings and precautions prior to the use of this medication.

Allergy Alert This medication should not be used by individuals with a known allergy to famotidine or other acid-reducing agents.

Contraindications The medication is contraindicated in patients experiencing difficulty or pain when swallowing, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition. Such patients should seek medical attention promptly. Additionally, this medication should not be used concurrently with other acid reducers.

Pre-Use Consultation Healthcare professionals should be consulted before use in the following scenarios:

• Patients who have experienced heartburn for more than three months, as this may suggest a more serious condition.

• Individuals presenting with heartburn accompanied by lightheadedness, sweating, or dizziness.

• Patients experiencing chest or shoulder pain alongside shortness of breath, sweating, pain radiating to the arms, neck, or shoulders, or lightheadedness.

• Those with frequent chest pain or wheezing, particularly in conjunction with heartburn.

• Patients with unexplained weight loss, nausea, vomiting, or stomach pain.

• Individuals with a history of kidney disease.

Drug Interactions It is essential to consult a doctor or pharmacist before use if the patient is currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Monitoring and Discontinuation Patients should discontinue use and consult a healthcare provider 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 food, 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 symptoms that warrant consultation include 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; and frequent wheezing, particularly in conjunction with heartburn. Unexplained weight loss, nausea or vomiting, stomach pain, and a history of kidney disease are also important considerations that should prompt a discussion with a healthcare provider.

Common adverse reactions may include persistent heartburn or a worsening of symptoms. Patients are advised to stop using the medication and consult a doctor if their heartburn continues or worsens, or if they find it necessary to use the product for more than 14 days.

Additionally, patients should be cautious and avoid using this medication in conjunction with other acid reducers, as this may increase the risk of adverse effects. An allergy alert is also noted; individuals with a known allergy to famotidine or other acid reducers should refrain from using this product.

Drug Interactions

Antacids and acid reducers have the potential to interact with certain prescription medications. The mechanism of these interactions typically involves alterations in gastric pH, which can affect the solubility and absorption of various drugs.

Healthcare professionals should be aware of these interactions and consider monitoring patients for any changes in therapeutic efficacy or adverse effects when prescribing medications that may be affected by antacids or acid-reducing agents. Adjustments in dosage or timing of administration may be necessary to mitigate these interactions, although specific recommendations are not provided in the available data.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Up and up Dual Action Acid Reducer and Antacid (famotidine, calcium carbonate, 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. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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

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 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 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 may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical scenario.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed a range of adverse reactions associated with the use of the medication. Commonly reported events include headache, dizziness, constipation, diarrhea, and nausea. Additionally, allergic reactions such as rash, pruritus, and angioedema have been documented.

There have been instances of hepatic enzyme elevations and renal impairment observed in some patients. Reports indicate that confusion and hallucinations may occur, particularly in elderly patients or those with renal impairment. Rare cases of thrombocytopenia and agranulocytosis have also been noted.

Further, interstitial nephritis has been associated with the use of famotidine. Cardiac arrhythmias, including bradycardia and atrioventricular block, have been reported. Some patients have experienced exacerbation of existing liver disease, and there have been instances of pancreatitis in individuals taking famotidine.

The safety profile of the medication may evolve as additional data becomes available.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to inform patients that they should not use this product if they experience difficulty or pain when swallowing food, vomiting blood, or have bloody or black stools, as these symptoms may indicate a serious medical condition that requires a doctor's evaluation.

Patients should be cautioned against using this product in conjunction with other acid reducers. They should be instructed to discontinue use and consult a healthcare provider 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 this product if they have experienced heartburn for over three months, as this may signal a more serious condition. Patients should also be advised to seek medical attention 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, pain radiating to the arms, neck, or shoulders, or lightheadedness.

Furthermore, patients should be instructed to consult a healthcare provider if they experience frequent 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 seek medical advice before using this product.

Lastly, patients should be reminded to consult a doctor or pharmacist prior to use 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 a configuration that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Additionally, it is essential to protect the product from moisture to ensure optimal storage conditions. Proper handling and storage practices are crucial for preserving the quality of the product.

Additional Clinical Information

Patients aged 12 years and older should chew the tablet completely before swallowing to relieve symptoms, with a maximum of 2 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 medical advice before use if they have experienced heartburn for over three months, or if they exhibit symptoms such as lightheadedness, sweating, dizziness, chest pain, or pain radiating to the arms, neck, or shoulders. Additional concerns include unexplained weight loss, nausea, vomiting, stomach pain, or kidney disease. Patients should also be advised to consult a doctor or pharmacist if they are taking prescription medications, as antacids and acid reducers may interact with these drugs. Pregnant or breastfeeding patients should seek professional guidance before use.

Drug Information (PDF)

This file contains official product information for Up and up Dual Action Acid Reducer and Antacid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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