Dextromethorphan hydrobromide

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. Inactive ingredients include microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The product is supplied in bottles containing 100 tablets.

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.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 2 capsules every 6 to 8 hours as needed. It is imperative that no more than 8 capsules are taken within a 24-hour period to avoid potential overdose. This product is not intended for use in children under 12 years of age; therefore, administration in this population is contraindicated.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it is advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and seek medical attention if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to obtain immediate medical assistance or contact a Poison Control Center without delay. Prompt action is essential to ensure patient safety and appropriate management of the situation.

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 patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant health risks.

Common adverse reactions include persistent cough, which warrants immediate medical attention if it lasts for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Additionally, patients should be cautious of a cough that produces excessive phlegm (mucus) or a chronic cough associated with conditions such as smoking, asthma, or emphysema. Such presentations may necessitate a reassessment of the patient's treatment plan.

It is essential for patients to communicate any concerning symptoms to their healthcare provider to ensure appropriate management and care.

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 conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing 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 Dextromethorphan Hbr 15 mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children within this age group. Therefore, it is contraindicated for use in individuals under 12 years old.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 currently no available data on the excretion of this drug in human 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should be aware that prompt intervention is crucial in managing potential complications associated with overdosage.

To prevent accidental ingestion, it is essential to keep this medication out of reach of children. This precaution helps mitigate the risk of overdose and ensures the safety of vulnerable populations.

In cases of suspected overdose, the symptoms may vary depending on the specific medication involved. Therefore, a thorough assessment and appropriate management strategies should be employed based on the clinical presentation and the substance involved.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise 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 overdose.

Patients should be instructed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

It is important for patients to consult with a doctor or pharmacist if they experience a cough that is associated with excessive phlegm (mucus). Additionally, patients should be encouraged to seek professional advice if they have a cough that is chronic or lasts for an extended period, particularly in cases related to smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dextromethorphan Hbr 15 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)