Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension, Aluminum ...

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and symptoms commonly referred to as gas.

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

Dosage and Administration

Shake well before use.

For the formulation containing 1,200 mg/120 mg per 30 mL, the recommended dosage is as follows:

• Adults and children aged 12 years and older: Administer 30 mL, with a maximum limit of 120 mL within a 24-hour period.

• Children under 6 years of age: Use is not recommended unless directed by a physician.

For the formulation containing 2,400 mg/240 mg per 30 mL, the recommended dosage is as follows:

• Adults and children aged 12 years and older: Administer 30 mL, with a maximum limit of 60 mL within a 24-hour period.

• Children under 6 years of age: Use is not recommended unless directed by a physician.

Contraindications

There are no specified contraindications for the use of 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

Patients should consult a healthcare professional prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. These conditions may necessitate special consideration when using this product.

It is advisable for patients to seek guidance from a doctor or pharmacist before initiating use if they are currently taking other medications. This product has the potential to interact with certain medications, which could affect its efficacy or safety.

Patients are instructed to discontinue use and contact their healthcare provider if symptoms persist for more than two weeks. Prolonged symptoms may indicate a need for further evaluation and management.

Emergency medical assistance should be sought if any severe or concerning symptoms arise, although specific instructions for such situations are not provided in the current guidelines.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is advised that individuals consult a doctor prior to use if they have kidney disease or are on a magnesium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking other medications, as this product may interact with certain drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Pregnant or breastfeeding individuals should also seek advice from a health professional before using this product. Furthermore, it is crucial to keep this product out of reach of children to prevent accidental ingestion.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension, Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension Maximum Strength (aluminum hydroxide, magnesium hydroxide, and simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication unless directed by a healthcare professional. For patients aged 12 years and older, the recommended dosage for the 1,200-1,200-120 mg/30 mL formulation is 30 mL, with a maximum of 120 mL in a 24-hour period. For the 2,400-2,400-240 mg/30 mL formulation, the dosage is also 30 mL, but should not exceed 60 mL in 24 hours.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older, as they may have an increased risk of adverse effects. It is advisable for geriatric patients to consult a healthcare provider before use, especially if they have a history of kidney disease, as renal function may be compromised in this population.

Additionally, elderly patients are encouraged to discuss any concurrent medications with their doctor or pharmacist prior to use, as this product may interact with certain medications, potentially leading to increased risks or diminished efficacy.

For dosing, adults and children aged 12 years and older may take 30 mL, with a maximum of 120 mL in a 24-hour period for the formulation containing 1,200 mg/30 mL. For the formulation containing 2,400 mg/30 mL, the recommended dosage is also 30 mL, but not exceeding 60 mL in a 24-hour period.

It is important to note that this product is not recommended for children under 6 years of age unless directed by a physician. Careful monitoring and adherence to these guidelines are essential to ensure the safety and effectiveness of the treatment in geriatric patients.

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 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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with any medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and healthcare professionals should ensure that the patient is stabilized. This may involve monitoring vital signs, providing intravenous fluids, and administering symptomatic treatment as necessary.

In the event of an overdose, contacting a poison control center or a medical toxicologist for guidance on specific interventions and antidotes is recommended. Prompt recognition and management of an overdose can significantly improve patient outcomes.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this product 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.

It is important for patients to seek medical advice before using this product if they have a history of kidney disease or are on a magnesium-restricted diet, as these conditions may affect the safety and efficacy of the product.

Additionally, healthcare providers should encourage patients to discuss any other medications they are currently taking with their doctor or pharmacist prior to use, as this product may interact with certain medications, potentially leading to adverse effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy.

Care should be taken to protect the product from freezing, as exposure to low temperatures may compromise its quality. Additionally, the product must not be used if the lid seal is open or damaged, as this could indicate contamination or degradation. Proper handling and storage conditions are crucial to ensure the product remains safe and effective for use.

Additional Clinical Information

Adults and children aged 12 years and older are advised to administer 30 mL of the product, with a maximum of 120 mL in 24 hours (equivalent to 1,200-1,200-120 mg/30 mL) or 60 mL in 24 hours (2,400-2,400-240 mg/30 mL). For children under 6 years of age, use is not recommended unless directed by a physician.

Clinicians should counsel patients to consult a doctor before use if they have kidney disease or are on a magnesium-restricted diet. Additionally, patients should seek advice from a healthcare professional if they are taking other medications, as interactions may occur. Patients are advised to discontinue use and consult a doctor if symptoms persist for more than two weeks. Pregnant or breastfeeding individuals should also seek professional guidance before use. It is important to keep the product out of reach of children.

Drug Information (PDF)

This file contains official product information for Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension, Aluminum Hydroxide, Magnesium Hydroxide and Simethicone Suspension Maximum Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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