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Formulas

Dextromethorphan Hydrobromide 120 mg Slow Release (MEM4) Oral Capsules

Description: Dextromethorphan Hydrobromide 120 mg Slow Release (MEM4) Oral Capsules are meticulously crafted to provide a controlled and extended release of dextromethorphan hydrobromide, utilizing Methocel E4M, a sophisticated controlled-release polymer. This formulation is specifically designed to maintain a consistent therapeutic level of the medication in the bloodstream, thereby ensuring sustained cough suppression. The slow release mechanism allows for reduced dosing frequency, which can significantly enhance patient compliance. These capsules are primarily indicated for the treatment of cough associated with respiratory conditions such as the common cold, bronchitis, and other upper respiratory tract infections.

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Slow Release Capsules
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Formula Information

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Dextromethorphan Hydrobromide 120 mg Slow Release (MEM4) Oral Capsules are a sophisticated pharmaceutical formulation designed to provide patients with a consistent and prolonged therapeutic effect. The active ingredient, Dextromethorphan Hydrobromide, is a widely recognized antitussive agent used to suppress coughs. It operates by affecting the signals in the brain that trigger the cough reflex, thereby providing relief from nonproductive coughs often associated with common colds and other upper respiratory infections.

The innovative aspect of this formulation lies in the use of Methocel E4M, a high-viscosity grade of hydroxypropyl methylcellulose. This controlled-release polymer is instrumental in creating a matrix that encapsulates the active ingredient, allowing for a slow and steady release of Dextromethorphan Hydrobromide into the digestive system. By employing this technology, the capsules ensure a sustained release of the medication over an extended period, which can be particularly beneficial for patients requiring round-the-clock cough suppression. This can lead to a significant reduction in the dosing frequency, potentially enhancing patient compliance and convenience, especially for those who may have difficulty adhering to more frequent dosing schedules.

For prescribers, it is important to note that the slow-release mechanism of these capsules may alter the onset of action when compared to immediate-release formulations. As such, they are not intended for the relief of acute coughing spells but rather for the management of persistent coughs where steady plasma levels of the medication are desired. Additionally, the Methocel E4M polymer ensures that the release rate of Dextromethorphan is not significantly affected by pH changes throughout the gastrointestinal tract, providing a predictable pharmacokinetic profile.

Patients should be advised that the slow-release capsules must be swallowed whole and not crushed or chewed, as this could disrupt the controlled-release system and lead to the rapid release of the entire dose at once, increasing the risk of adverse effects. It is also important for patients to understand that while Dextromethorphan Hydrobromide can provide relief from cough, it does not treat the cause of the cough or speed recovery from the underlying condition.

As with any medication, potential side effects may include drowsiness, dizziness, nausea, and others, and patients should be counseled on what to expect and when to seek medical attention. Prescribers should consider the patient's overall medication regimen to avoid interactions, particularly with other central nervous system depressants and monoamine oxidase inhibitors (MAOIs).

For more detailed information or specific inquiries regarding the Dextromethorphan Hydrobromide 120 mg Slow Release (MEM4) Oral Capsules, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing the highest level of support and expertise to both patients and healthcare providers.

Drug Interactions

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Dextromethorphan hydrobromide is a cough suppressant that acts on the cough center in the brain to provide relief from persistent coughing. When formulated as a slow-release capsule with Methocel E4M, it is intended to provide a steady release of the medication over an extended period, which can be particularly beneficial for managing symptoms during both daytime and nighttime, potentially improving sleep and daily functioning. However, it is important to be aware of potential drug interactions when taking this medication.

One significant interaction is with monoamine oxidase inhibitors (MAOIs), which are used to treat depression and other psychiatric conditions. Patients taking MAOIs or who have taken them within the past 14 days should not use dextromethorphan, as this combination can lead to serious side effects, including serotonin syndrome, which is characterized by symptoms such as confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea.

Additionally, caution is advised when dextromethorphan is taken with other serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and triptans used for migraines, as the risk of serotonin syndrome is also increased with these combinations. Patients should be monitored closely for signs of serotonin syndrome, especially when starting or increasing the dose of these medications.

Concomitant use of dextromethorphan with other central nervous system (CNS) depressants, including alcohol, antihistamines, sedatives, tranquilizers, sleeping medications, and other narcotics, can enhance the sedative effects, leading to increased drowsiness, dizziness, and difficulty concentrating. Patients should avoid or limit the use of alcohol and be cautious when performing tasks that require alertness.

Furthermore, certain medications that inhibit the CYP2D6 enzyme, such as quinidine, fluoxetine, paroxetine, and amiodarone, can affect the metabolism of dextromethorphan and lead to increased levels of the drug in the body, potentially resulting in enhanced effects or toxicity. Patients on these medications may require dose adjustments or more careful monitoring.

It is also important to note that the slow-release nature of this formulation may alter the interaction profile compared to immediate-release forms of dextromethorphan. The extended release of the active ingredient could potentially lead to prolonged interactions with other medications. Therefore, it is crucial for prescribers to consider the timing of administration when co-prescribing other drugs.

Patients should always inform their healthcare provider of all the medications they are currently taking, including over-the-counter drugs, herbal supplements, and vitamins, to ensure safe use of dextromethorphan slow-release capsules. If you have any questions or concerns about potential drug interactions with dextromethorphan slow-release capsules, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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Dextromethorphan Hydrobromide is an antitussive medication, which means it is used to suppress coughing. It works by affecting the signals in the brain that trigger the cough reflex. When formulated into a 120 mg slow-release oral capsule using Methocel E4M, the medication is designed to be released gradually into the bloodstream over an extended period. Methocel E4M is a type of hydrophilic polymer, also known as hypromellose, which swells and forms a gel when it comes into contact with water. This gel matrix creates a barrier that controls the rate at which the dextromethorphan is released from the capsule.

The slow-release mechanism is beneficial for maintaining consistent therapeutic levels of the medication in the body, which is particularly useful for managing symptoms that require round-the-clock control. By providing a steady release of dextromethorphan, these capsules help to alleviate coughing with less frequent dosing, which can improve patient compliance. This is especially important for patients who may have difficulty adhering to a more frequent dosing schedule or for those who experience disrupted sleep due to nocturnal coughing.

These slow-release capsules are indicated for the treatment of coughs resulting from various causes, including the common cold, influenza, and other respiratory conditions where cough is a primary concern. The extended release of dextromethorphan provided by the Methocel E4M polymer ensures that the therapeutic effect is sustained over a longer period compared to immediate-release formulations, which can lead to more effective symptom management and improved patient outcomes.

It is important for both patients and prescribers to understand that while the slow-release formulation offers convenience and potentially better compliance, it is essential to adhere to the prescribed dosing regimen and not to crush or chew the capsules, as this could disrupt the controlled-release mechanism and lead to the rapid release of the entire dose at once. If you have any questions about this formulation or its suitability for treating specific disease states, please reach out to us at Bayview Pharmacy for further information and guidance.

Other Uses

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Dextromethorphan hydrobromide (DXM) is primarily recognized for its use as an antitussive, providing relief from cough. However, when formulated into slow-release capsules utilizing Methocel E4M as a polymer, the scope of its potential applications may extend to other therapeutic areas, although these are less well-established and may require further investigation. For example, some research suggests that dextromethorphan may have a role in managing certain types of neuropathic pain due to its NMDA receptor antagonist properties. This mechanism may prove useful in conditions such as diabetic neuropathy or fibromyalgia, where modulation of the NMDA receptor can be a key to symptom management.

In mental health, there have been investigations into the use of dextromethorphan for the treatment of mood disorders, with particular focus on its sigma-1 agonist activity. Though not conventionally used for this purpose and not well established in clinical practice, there is ongoing research in this area that may in future support the application of slow-release DXM formulations in managing symptoms associated with depression or anxiety. Clinical trials and further research are necessary to clarify the effectiveness and safety profile for these potential uses.

Furthermore, the slow-release mechanism provided by Methocel E4M can be particularly beneficial for patients requiring a steady plasma concentration of dextromethorphan over an extended period, which is not only convenient but may also ameliorate some side-effects associated with peak dosing. This could offer an advantage for patients with swallowing difficulties or those who find adherence to frequent dosing schedules challenging. It should be noted that while the slow-release formulation could provide certain benefits for alternative indications, the primary use of dextromethorphan remains symptomatic relief from cough, and off-label uses should always be approached with caution and under proper medical supervision.

Beyond the therapeutic effects, the slow-release formulation may also be of benefit for research purposes, especially in pharmacokinetic studies where a controlled release of the active substance is required to monitor its effects over a prolonged period. Such studies could utilize slow-release dextromethorphan capsules to gain insights into the pharmacodynamic and pharmacokinetic profiles of the drug for various potential indications.

It is critical, however, to remain cognizant that off-label uses of medications can carry risks, and therefore, prescribers should strictly follow prevailing guidelines and evidence when considering dextromethorphan for any applications beyond cough suppression. Patients should also only use the medication for its intended purposes unless advised by their healthcare provider. Should prescribers or patients have inquiries concerning the off-label use of slow-release dextromethorphan capsules or need more detailed information about this specific formulation, they are encouraged to reach out to us at Bayview Pharmacy for guidance and consultation.

Frequently Asked Questions

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What is Dextromethorphan Hydrobromide 120 mg Slow Release (MEM4) Oral Capsules?

Dextromethorphan Hydrobromide 120 mg Slow Release (MEM4) Oral Capsules are a medication designed to relieve cough by acting on the brain to suppress the cough reflex. The 'slow release' formulation is designed to release the active ingredient gradually over time, thanks to the Methocel E4M polymer, which provides a controlled and prolonged release of dextromethorphan.

What is Methocel E4M and how does it work in these capsules?

Methocel E4M is a type of controlled-release polymer that is used to encapsulate the active ingredient in these capsules. It is a hydrophilic methylcellulose derivative that gels and forms a viscous solution in the digestive tract. This creates a barrier that allows the dextromethorphan to be released slowly over an extended period of time, thus providing sustained therapeutic effects.

How often do I need to take Dextromethorphan Hydrobromide Slow Release Capsules?

The dosage frequency of Dextromethorphan Hydrobromide Slow Release Capsules is generally less than that of immediate-release formulations, due to the extended release mechanism. However, you should always follow the specific dosing instructions provided by your healthcare provider or the directions on the prescription label.

Can I take these capsules if I have a persistent or chronic cough?

Dextromethorphan is often used for temporary relief of coughs due to common cold or other conditions. If you have a persistent or chronic cough, you should consult your healthcare provider to determine the appropriate treatment for your condition.

Can I open the capsule and sprinkle its contents on food?

You should not open the capsules because doing so can affect the controlled-release mechanism of the medication. The capsule should be swallowed whole to ensure the medication is released steadily over time as intended.

How long does it take for Dextromethorphan Hydrobromide Slow Release Capsules to start working?

The onset of action for Dextromethorphan Hydrobromide Slow Release Capsules may vary between individuals. Generally, it might take longer for you to feel the effects compared to immediate-release forms due to the gradual release of the active ingredient.

Are there any possible side effects from taking these capsules?

As with any medication, Dextromethorphan Hydrobromide Slow Release Capsules can cause side effects. Common side effects include dizziness, drowsiness, nausea, and vomiting. If you experience any severe side effects or signs of an allergic reaction, seek medical attention immediately.

Can I use these capsules during pregnancy or while breastfeeding?

The safety of Dextromethorphan Hydrobromide Slow Release Capsules during pregnancy or breastfeeding has not been fully established. If you are pregnant or breastfeeding, it is important to consult your healthcare provider before taking this medication.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take extra capsules to make up for a missed dose.

How should I store Dextromethorphan Hydrobromide Slow Release Capsules?

Store Dextromethorphan Hydrobromide Slow Release Capsules at room temperature, away from moisture and heat. Keep the capsules in their original container, and make sure the container is tightly closed when not in use. Keep out of reach of children.

Can I take these capsules with other medications?

Before taking Dextromethorphan Hydrobromide Slow Release Capsules, inform your healthcare provider about all other medications and supplements you are currently taking. Dextromethorphan can interact with some medications, which may affect how it works or increase the risk of side effects.

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Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.
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