Defensol-Ito

Description

Defensol-ito is a pharmaceutical formulation designed for specific therapeutic applications. The product is characterized by its unique chemical composition and formulation attributes. It is presented in a dosage form suitable for administration, ensuring optimal bioavailability and efficacy.

The molecular weight of Defensol-ito is indicative of its active components, contributing to its pharmacological properties. The chemical formula reflects the precise arrangement of atoms within the compound, which is essential for its intended mechanism of action.

The appearance of Defensol-ito is consistent with industry standards for pharmaceutical products, ensuring that it meets the necessary quality and safety requirements for clinical use. Inactive ingredients included in the formulation serve to enhance stability, absorption, and overall performance of the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including nasal congestion and cough due to minor throat and bronchial irritation. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions to facilitate drainage of the bronchial tubes.

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

Dosage and Administration

The dosing regimen is determined by the patient's weight; if the weight is unknown, the patient's age should be used as a guide. Doses should not exceed the maximum allowed in any 24-hour period and should be administered every 4 hours as needed.

For patients aged 2 to under 6 years, weighing between 24 to 47 pounds, the recommended dose is 1 mL. For patients under 2 years of age and weighing less than 24 pounds, the appropriate dose must be determined by a healthcare professional.

It is essential to measure the dose using the dosing device provided with the medication. The use of any other measuring device is not recommended to ensure accurate dosing.

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 accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

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 a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Before administering this product, it is essential to consult a healthcare provider if the child has any of the following conditions: heart disease, thyroid disease, a cough associated with excessive phlegm, a chronic cough such as that seen in asthma, high blood pressure, or diabetes. It is also critical to adhere strictly to the recommended dosage and not exceed the directed amount.

Caregivers should be instructed to discontinue use and seek medical advice if the child experiences nervousness, dizziness, or insomnia. Additionally, if symptoms do not improve within seven days, recur, or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, medical evaluation is warranted as these may indicate a serious underlying condition.

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

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in children who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is crucial to avoid the use of this medication in such cases due to the risk of significant interactions.

Before administering this medication, it is advisable to consult a healthcare professional if the child has any of the following conditions: heart disease, thyroid disease, a cough that produces excessive phlegm, a chronic cough such as that associated with asthma, high blood pressure, or diabetes. These pre-existing conditions may increase the risk of adverse reactions or complicate the treatment.

Patients should discontinue use and seek medical advice if the child experiences symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, recur, or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires further evaluation.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Specifically, it should not be administered to children who are currently taking a prescription MAOI, which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this medication should not be used for a period of 2 weeks following the discontinuation of an MAOI.

Healthcare professionals are advised to monitor for potential adverse effects and to ensure that patients are not concurrently using MAOIs during the specified timeframe to avoid serious interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Defensol-Ito (dextromethorphan, guiafenesin, phenylephrine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

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

For dosing, the recommended administration is as follows: for children aged 2 to under 6 years weighing between 24-47 lbs, the dose is 1 mL. For infants under 2 years weighing less than 24 lbs, a healthcare provider should be consulted for appropriate dosing guidance.

This medication should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought or contact a Poison Control Center 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. The use of this product is not recommended during pregnancy due to potential risks to the fetus. There may be risks associated with the active ingredients, including dextromethorphan, guaifenesin, and phenylephrine, when used during pregnancy.

Pregnant women are advised to seek medical advice before using this product. If necessary, dosage adjustments should be discussed with a healthcare provider to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of Defensol-ito in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Defensol-ito in breast milk or any associated risks to breastfed infants.

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

Overdosage of this product can lead to serious health consequences. It is imperative that healthcare professionals advise patients to adhere strictly to the recommended dosage guidelines. Exceeding the directed dosage may result in adverse effects, the severity of which can vary based on individual patient factors and the extent of the overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient for any potential symptoms that may arise. Symptoms of overdosage can include, but are not limited to, increased severity of side effects associated with the product.

Management of overdosage should involve immediate medical evaluation. Healthcare professionals are encouraged to implement supportive care measures and consider symptomatic treatment as necessary. If the overdosage is significant, further interventions may be required, including the possibility of activated charcoal administration if appropriate and within the recommended time frame post-ingestion.

In all cases of overdosage, it is advisable to contact a poison control center or seek specialized medical assistance to ensure the best possible outcome for the patient.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no observed increase in fetal malformations, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

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 reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, any unused product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients should be informed that the medication is administered orally and should not exceed the recommended doses within a 24-hour period. Dosing may be repeated every 4 hours as needed.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose.

Drug Information (PDF)

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

View product document (PDF)