Dextromethorphan Hbr 15 mg

Description

Dextromethorphan HBr Capsules contain 15 mg of dextromethorphan hydrobromide per capsule. This product is supplied in a bulk quantity of 12,000 capsules, identified by NDC No. 53345-028-01. It is essential to inspect the shipment immediately upon receipt. The capsules are intended solely for further manufacturing, processing, or repacking. Proper storage conditions must be maintained; the product should be protected from heat, humidity, and light, and refrigeration is not recommended.

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 medication.

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. This product is not intended for use in children under 12 years of age; therefore, administration in this population is contraindicated.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare provider or pharmacist prior to using this product.

Healthcare professionals should advise patients to discontinue use and seek medical advice if a 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 a serious underlying condition that requires further evaluation.

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

For patients who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the patient and the child.

Side Effects

Patients should be aware of the following 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.

Patients are advised to consult a healthcare professional before using this medication if they have a cough that is productive of excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, or emphysema.

It is important for patients to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additional considerations include the need for pregnant or breastfeeding individuals to consult a healthcare professional prior to use. Furthermore, this medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

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, psychiatric disorders, emotional 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 confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Dextromethorphan Hbr 15 mg (dextromethorphan hbr). 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

Elderly patients should be aware that this adult product is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 capsules every 6 to 8 hours, as needed.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering potential age-related physiological changes that may affect drug metabolism and clearance. Monitoring for efficacy and adverse effects is advised, as elderly patients may have an increased sensitivity to medications. Adjustments to the dosage regimen may be necessary based on individual patient response and tolerability.

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 regarding the excretion of this medication 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 have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology provided in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. The following events have been documented: dizziness, nausea, vomiting, somnolence, confusion, hallucinations, agitation, rash, pruritus, urticaria, and anaphylaxis. These adverse reactions were reported during the postmarketing experience and may not be included in the product labeling.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the last two weeks. If patients are uncertain whether their prescription contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should also instruct patients to discontinue use and seek medical advice if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, patients should be advised to consult a doctor before using the medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with 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, specifically temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

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 Dextromethorphan Hbr 15 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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