Defensol Adult Syrup

Description

Defensol Adult Syrup is a pharmaceutical formulation designed for adult use. The effective date of the insert is February 18, 2022. The package label features a multimedia reference that includes an image of the product, providing visual identification for healthcare professionals.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough associated with respiratory infections.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 teaspoonfuls (10 mL) administered orally every 4 hours. It is important not to exceed 6 doses within a 24-hour period. For children under 12 years of age, the use of this medication is not advised.

Contraindications

This product is contraindicated in patients with persistent or chronic cough, including those associated with smoking, asthma, chronic bronchitis, or emphysema, as well as in cases where the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

Additionally, the use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare provider is advised prior to using this product.

Warnings and Precautions

Exceeding the recommended dosage of this medication is contraindicated and may lead to serious adverse effects. Healthcare professionals should ensure that patients adhere strictly to the prescribed dosage to mitigate the risk of overdose.

A persistent cough may indicate an underlying serious condition. If a patient experiences a cough that lasts longer than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, it is imperative to advise them to consult a healthcare provider promptly for further evaluation and management.

Side Effects

Patients should be aware that a persistent cough may indicate a serious underlying condition. If a cough persists for more than one week, tends to recur, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, it is advised that they consult a healthcare professional for further evaluation.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric or emotional conditions, and Parkinson’s disease. Patients should not use this product while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 teaspoonfuls (10 mL) every 4 hours. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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

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 no specific data available regarding the excretion of this medication in 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In cases of overdosage, it is imperative that healthcare professionals adhere to the recommended dosage guidelines to prevent adverse effects. Exceeding the recommended dosage may lead to serious health complications.

Recommended Actions

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers are advised to monitor the patient closely for any signs of toxicity and to initiate appropriate management protocols.

Potential Symptoms

Symptoms of overdosage may vary depending on the specific substance involved but can include a range of physiological and psychological effects. It is crucial for healthcare professionals to be vigilant in identifying these symptoms to ensure timely intervention.

Management Procedures

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare professionals should be prepared to implement standard overdose management protocols, which may include activated charcoal administration, intravenous fluids, and other interventions as clinically indicated. Continuous monitoring of vital signs and laboratory parameters is essential to assess the patient's condition and guide further treatment decisions.

In summary, adherence to recommended dosages is critical in preventing overdosage, and prompt action is necessary should an overdosage occur.

Nonclinical Toxicology

If you are pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions associated with the use of the product. These include allergic reactions such as rash, pruritus, and urticaria. Neurological effects reported include dizziness, somnolence, confusion, hallucinations, and seizures. Gastrointestinal disturbances, including nausea, vomiting, diarrhea, and constipation, have also been noted.

Serious adverse events include respiratory depression, particularly in cases of overdose, which has led to severe outcomes, including death. There have been reports of serotonin syndrome, especially when the product is used in conjunction with other serotonergic drugs. Additionally, there are concerns regarding the abuse potential of dextromethorphan, with reports of misuse and dependence.

Psychiatric events have been documented, including mood changes, agitation, anxiety, and suicidal ideation. Cardiovascular events such as tachycardia and hypertension have also been reported. Other significant adverse reactions include hepatotoxicity, renal impairment, and skin reactions, including Stevens-Johnson syndrome. Finally, withdrawal symptoms have been reported upon discontinuation after prolonged use.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product within the temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper storage conditions should be observed to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)