Rompe Pecho

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough and nasal congestion associated with the common cold. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways.

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

Dosage and Administration

The medication should be shaken well before use. For adults and children aged 12 years and older, the recommended dosage is 10 mL (2 teaspoons) every 4 hours, not to exceed 6 doses within a 24-hour period unless directed by a physician. For children aged 6 to under 12 years, the dosage is 5 mL (1 teaspoon) every 4 hours, adhering to the same maximum of 6 doses in a 24-hour period. For children under 6 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients with the following conditions:

Patients should consult a healthcare professional prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, individuals with a persistent or chronic cough, a cough accompanied by excessive phlegm, or those with breathing problems related to smoking, asthma, chronic bronchitis, or emphysema should avoid use.

Discontinue use and seek medical advice if symptoms do not improve within 7 days, or if symptoms are accompanied by fever, rash, or persistent headache, as these may indicate a serious condition. Use is also contraindicated if nervousness, dizziness, or sleeplessness occurs.

Warnings and Precautions

It is imperative to adhere strictly to the recommended dosage to avoid potential adverse effects. The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult their doctor or pharmacist if there is any uncertainty regarding the presence of an MAOI in their prescription medications.

Before initiating treatment, it is essential for healthcare providers to assess patients for the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough, a cough accompanied by excessive phlegm (mucus), or any breathing problems associated with smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate special consideration or alternative therapeutic approaches.

Patients should be instructed to discontinue use and seek medical advice if symptoms do not improve within seven days, or if they experience additional symptoms such as fever, rash, or persistent headache. A persistent cough may indicate a serious underlying condition that requires further evaluation. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should stop taking the product and consult their healthcare provider.

In the event of an accidental overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action is crucial to ensure patient safety and effective management of any potential overdose situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is crucial to adhere to the recommended dosage, as exceeding this limit may lead to serious complications.

The use of this product is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. Patients who are uncertain whether their prescription medication contains an MAOI are advised to consult their healthcare provider or pharmacist prior to using this product.

These precautions are essential to ensure patient safety and to minimize the risk of adverse reactions.

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 Rompe Pecho (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 5 mL (1 teaspoon) every 4 hours. For children under 6 years of age, it is advised to consult a doctor prior to use. Careful consideration should be given to dosing in this younger age group to ensure safety and efficacy.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution 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 lack of targeted data for this population.

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 currently no available data regarding the excretion of this medication 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available 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 typically involves supportive care, which may include the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's needs.

3. Decontamination: If the overdose is recent, consider gastrointestinal decontamination methods, such as activated charcoal, if appropriate and within the recommended time frame.

4. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or advanced management strategies, if applicable.

It is crucial for healthcare professionals to document the incident thoroughly and report any adverse events to the appropriate regulatory authorities. Continuous education on the signs of overdose and the management protocols is recommended to ensure patient safety.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of ongoing safety monitoring.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Providers should encourage patients to consult with their doctor prior to using the medication if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough, a cough accompanied by excessive phlegm (mucus), or any breathing problems associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients should be informed to discontinue use and consult their doctor if symptoms do not improve within 7 days, or if they experience a fever, rash, or persistent headache. Additionally, a persistent cough may indicate a serious condition that requires medical evaluation. If patients experience nervousness, dizziness, or sleeplessness, they should also stop using the medication and seek medical advice.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F) to maintain its efficacy.

To ensure the integrity of the product, it must be protected from light exposure. Prior to administration, it is important to shake the product well to ensure proper mixing. Additionally, once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to keep the medication out of reach of children, and in the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)