Tusnel-Dm Pediatric

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. It also provides temporary relief of nasal congestion due to the common cold and assists in thinning bronchial secretions, thereby making coughs more productive. Additionally, this medication helps to loosen phlegm (mucus) and further facilitates the productivity of coughs.

Dosage and Administration

The recommended dosage for children aged 2 to under 6 years (weighing 24-47 lbs) is 2 mL administered every 4 to 6 hours as needed. It is important to note that no more than 4 doses should be given within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 2 years of age (weighing less than 24 lbs), it is advised to consult a doctor before administration.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Healthcare professionals should advise caregivers to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Prior to administration, it is essential to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm, or a persistent or chronic cough associated with asthma. Coughs accompanied by excessive mucus should only be treated under medical guidance.

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

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice 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 beyond seven days, recurs, or is associated with fever, rash, or a persistent headache, medical evaluation is warranted. A persistent cough may indicate a more serious underlying condition.

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

Side Effects

Patients using this product may experience a range of adverse reactions. Serious adverse reactions include nervousness, dizziness, and sleeplessness. If any of these symptoms occur, patients are advised to stop use and consult a healthcare professional.

In clinical trials, it was noted that symptoms such as nervousness and dizziness were reported, prompting recommendations for patients to seek medical advice if these reactions arise. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, patients should discontinue use and consult a doctor, as these may indicate a more serious underlying condition.

It is important to note that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Furthermore, patients should seek medical advice before using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or if they are experiencing a cough that produces excessive phlegm or is chronic in nature, particularly in the context of asthma.

Patients are also cautioned against exceeding the recommended dosage to minimize the risk of adverse reactions.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This precaution is due to the potential for serious interactions that may arise from the combination of these agents.

No additional drug interactions or laboratory test interactions have been identified or documented for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Tusnel-Dm Pediatric (dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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, a cough with excessive phlegm, or a persistent cough associated with asthma.

When administering this product, caregivers must adhere to the recommended dosage and should not exceed it. If the child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever, use should be discontinued and a doctor consulted. Additionally, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, medical advice should be sought, as these may indicate a serious condition.

For dosing, children aged 2 to under 6 years (weighing 24-47 lbs) should take 2 mL every 4-6 hours. For children under 2 years of age (weighing under 24 lbs), consultation with a doctor is required before use.

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 adverse effects or changes in therapeutic response, 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. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of this product in this population. There are no specific dosage modifications for pregnant individuals; therefore, it is essential to seek guidance from a healthcare professional regarding appropriate use.

Lactation

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

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 arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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 the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a bottle that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)