Topcare Mucus Dm

Description

Guaifenesin 600 mg and dextromethorphan hydrobromide 30 mg are combined in an extended-release tablet formulation designed for the management of cough and mucus congestion. This product functions as both an expectorant and a cough suppressant, providing relief for up to 12 hours. The formulation aids in thinning and loosening mucus, facilitating easier expectoration while effectively controlling cough. Each package contains 40 extended-release tablets, ensuring a sustained therapeutic effect.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and reduces the impulse to cough, which may assist patients in achieving restful sleep.

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

Dosage and Administration

The tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended that the tablet be ingested with a full glass of water. This medication can be administered without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. The use of this product is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Children under 12 years of age.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past 2 weeks. Due to the potential for serious interactions, it is essential to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in any prescription medication.

Additionally, it is advised not to exceed the recommended dosage while using this product.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Healthcare professionals should advise patients to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current prescription regimen.

General precautions should be observed prior to use. Patients should be advised to seek medical consultation if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider before using this product.

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.

Patients should discontinue use and consult a healthcare professional if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, and it is crucial to adhere to the following warnings and recommendations.

This product is contraindicated for use in children under 12 years of age and should not be taken concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

While using this product, it is imperative that patients do not exceed the recommended dosage. If a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, patients should discontinue use and consult a healthcare provider, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Mucus Dm (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a health professional prior to use. It is important to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may not require specific dosage adjustments or safety considerations when using Topcare Mucus DM (dextromethorphan hydrobromide, guaifenesin), as the provided drug insert does not indicate any unique geriatric use considerations. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general increased sensitivity of elderly patients to medications. It is advisable to assess the overall health status and concurrent medications of geriatric patients to ensure safe and effective use of this product.

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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additionally, cases of hallucinations, confusion, agitation, increased heart rate, and respiratory depression have been documented.

Reports of misuse, abuse, and dependence have also been received. Instances of serotonin syndrome have been noted, particularly among patients concurrently using other serotonergic medications. Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.

Some patients have experienced a worsening of cough or respiratory symptoms, alongside gastrointestinal disturbances, including diarrhea and constipation. Postmarketing surveillance has indicated that certain patients may experience paradoxical reactions, such as increased cough or agitation. Ongoing postmarketing surveillance continues to collect and evaluate additional safety information.

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 essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

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 temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed foil under the cap is broken or missing, as this may indicate compromised safety or quality. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)