Rompe Pechito

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Prior to administration, the product must be shaken well to ensure proper mixing. Dosing should be measured exclusively with the provided dosing cup, which should be kept with the product for convenience.

For children aged 6 to under 12 years, the recommended dosage is 5 mL every 4 hours. For children aged 4 to under 6 years, the dosage is 2.5 mL every 4 hours. The product is not recommended for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to administration of this product.

Warnings and Precautions

The use of this product is contraindicated in children 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, it should not be administered for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm whether a child’s prescription includes an MAOI by consulting with a doctor or pharmacist prior to the administration of this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare providers should instruct patients or caregivers to discontinue use and seek medical advice if the child experiences a cough accompanied by excessive phlegm (mucus) or a persistent or chronic cough, which may be indicative of serious underlying conditions such as asthma or chronic bronchitis.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in patients who are concurrently taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric or emotional conditions, or Parkinson’s disease. The use of this product is contraindicated in such patients and should not be initiated until at least two weeks after discontinuation of the MAOI. It is essential for patients or caregivers to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the patient's prescription medication.

In addition, patients are advised to discontinue use and seek medical advice if they experience a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, such as that associated with asthma or chronic bronchitis. These symptoms may indicate a serious underlying condition that requires further evaluation by a healthcare provider.

Drug Interactions

Dextromethorphan should not be administered to children who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks following the discontinuation of an MAOI. The combination may result in serious interactions, necessitating careful consideration and avoidance of this combination in the specified population. No additional drug interactions or drug and laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Rompe Pechito (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not be administered this product if they are taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. It is essential for caregivers to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

For dosing, children aged 6 to under 12 years may receive 5 mL every 4 hours, while those aged 4 to under 6 years should receive 2.5 mL every 4 hours. This product is not recommended for children under 4 years of age.

Caregivers are advised to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals. Currently, no specific dosage modifications for pregnant individuals are provided; therefore, it is essential for healthcare professionals to offer guidance based on individual circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information provided about the potential for excretion in breast milk or any associated risk to breastfed infants.

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 this 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. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, itching, and swelling. Other reported events encompass dizziness and drowsiness, nausea and vomiting, and gastrointestinal disturbances.

Additionally, there have been reports of increased heart rate, hallucinations, and confusion. In cases of overdose, respiratory depression has been noted. There are also concerns regarding misuse and abuse, particularly among adolescents. The potential for serotonin syndrome has been highlighted when the product is used in conjunction with other serotonergic drugs.

Rare cases of severe skin reactions have been documented, along with reports of seizures in patients with a history of seizure disorders. Furthermore, there is an increased risk of adverse effects in patients with pre-existing respiratory conditions.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to emphasize that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be administered for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult with a doctor or pharmacist prior to using this product.

Providers should also instruct patients to discontinue use and consult a doctor if a cough occurs that is accompanied by excessive phlegm (mucus) or if there is a persistent or chronic cough, such as that associated with asthma or chronic bronchitis. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Storage and Handling

This product is supplied in a configuration that includes a tamper-evident feature. It is essential to ensure that the printed security seal is intact; do not use the product if the seal is torn, broken, or missing.

For optimal storage, this product should be maintained at a temperature range of 15 to 30 °C (59 to 86 °F). It is important to note that refrigeration is not recommended, as the product should not be stored at lower temperatures. Proper handling and adherence to these storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)