Actinel Dm Pediatric

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with respiratory conditions. It helps to loosen phlegm (mucus) and thin bronchial secretions, thereby making coughs more productive.

This drug temporarily relieves nasal congestion due to the common cold and alleviates cough resulting from minor throat and bronchial irritation associated with a cold or inhaled irritants.

Limitations of use have not been specified; however, healthcare professionals should consider the patient's overall condition and any potential contraindications when prescribing this medication.

Dosage and Administration

Administration should be performed according to the following guidelines to ensure safe and effective use.

For children aged 6 to under 12 years, the recommended dosage is 10 mL (equivalent to 2 teaspoons) administered every 4 hours. It is important to note that the total number of doses should not exceed 6 in any 24-hour period.

For children aged 2 to under 6 years, the dosage is 5 mL (equivalent to 1 teaspoon) every 4 hours, adhering to the same maximum limit of 6 doses within a 24-hour timeframe.

For children under 2 years of age, it is imperative to consult a healthcare professional prior to administration to determine the appropriate dosage and ensure safety.

Healthcare professionals should ensure that the correct measuring device is used for accurate dosing and that parents or caregivers are instructed on the proper administration technique.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an accidental overdose, it is imperative to seek professional assistance or contact a poison control center immediately.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

Healthcare professionals should advise caregivers to seek medical guidance before using this product if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, cough accompanied by excessive phlegm (mucus), or a persistent or chronic cough, particularly in cases of asthma.

During the use of this product, it is critical to adhere strictly to the recommended dosage. Exceeding the recommended dosage may lead to adverse effects.

Caregivers should be instructed to discontinue use and consult a healthcare provider if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than one week, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires medical evaluation.

In the event of an accidental overdose, immediate professional assistance should be sought, or the local poison control center should be contacted without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. It is contraindicated for use in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of such medication, which is commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease.

Before administering this product to a child, it is advisable to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, cough accompanied by excessive phlegm (mucus), or a persistent or chronic cough, such as that which occurs with asthma.

During the use of this product, caregivers should monitor for specific adverse reactions. If a child experiences nervousness, dizziness, or sleeplessness, it is recommended to discontinue use and seek medical advice. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious condition, and medical consultation should be sought promptly.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Administration in pediatric patients who are currently taking an MAOI or have discontinued an MAOI within the past two weeks may result in serious interactions. It is imperative to avoid this combination to ensure patient safety. Monitoring for adverse effects is advised if there is any uncertainty regarding the patient's medication history related to MAOIs.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to use, it is advisable to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, or a persistent or chronic cough, such as that associated with asthma.

Dosage recommendations for this product are as follows: for children aged 6 to under 12 years, the dosage is 10 mL (2 teaspoons) every 4 hours; for children aged 2 to under 6 years, the dosage is 5 mL (1 teaspoon) every 4 hours. For children under 2 years of age, a doctor should be consulted before administration.

It is important not to exceed the recommended dosage. Parents or caregivers should discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if the cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache.

This product should be kept out of reach of children. In the event of an accidental overdose, professional assistance should be sought or a poison control center contacted immediately.

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. There may be potential risks to the fetus, and further studies are needed to determine the safety profile of this product in pregnant individuals.

No specific dosage modifications are provided for pregnant individuals. It is recommended that this product be used during pregnancy only if clearly needed, and when the potential benefits justify the potential risks to the fetus.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 event of an accidental overdose, it is imperative to seek professional assistance without delay. Healthcare professionals should be contacted, or a poison control center should be reached immediately to ensure appropriate management of the situation.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is essential. Prompt recognition of symptoms can facilitate timely intervention and improve patient outcomes.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and provide necessary interventions based on the clinical presentation. It is crucial to follow established protocols for overdose management, which may include decontamination, administration of antidotes if applicable, and supportive measures to stabilize the patient.

In summary, immediate action and professional guidance are critical in the event of an overdose to mitigate potential risks and ensure the safety of the patient.

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 compound in these areas.

Postmarketing Experience

Serious side effects have been reported voluntarily through various channels, including surveillance programs. Individuals are encouraged to report any serious adverse events to the designated phone number, which is available on weekdays from 8 AM to 4 PM AST.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek professional assistance or contact a poison control center immediately. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in packaging that ensures integrity and safety. It is essential to inspect the inner seal before use; the product should not be utilized if the inner seal is torn, cut, or opened.

For optimal storage, the product must be kept at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). It is crucial to avoid exposure to excessive heat or humidity to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)