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Phentermine HCl 30 mg/Topiramate 25 mg Slow Release (ME4M) Oral Capsules

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The Phentermine HCl 30 mg/Topiramate 25 mg Slow Release (ME4M) Oral Capsules are a specialized formulation designed to aid in weight management for individuals with obesity or overweight with related health conditions such as hypertension, type 2 diabetes, or dyslipidemia. This combination medication encapsulates two active ingredients within a Methocel E4M matrix, a hydrophilic controlled-release polymer that ensures a gradual and sustained release of phentermine and topiramate over an extended period.

Phentermine is a sympathomimetic amine anorectic that suppresses appetite, while topiramate, an anticonvulsant, is believed to induce satiety and decrease appetite. The use of Methocel E4M in the capsule formulation allows for a slower absorption rate, which not only maintains consistent drug levels in the bloodstream but also minimizes the potential for side effects and reduces the need for multiple daily doses, thereby enhancing patient adherence to the weight management regimen.


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Slow Release Capsules
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Formula Information

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Our custom-formulated Phentermine HCl 30 mg/Topiramate 25 mg Slow Release (ME4M) Oral Capsules are meticulously crafted to provide patients with a controlled and sustained release of the active ingredients. This formulation is encapsulated using Methocel E4M, a high-viscosity grade hydroxypropyl methylcellulose (HPMC) polymer that is widely recognized for its ability to create a gel barrier as it comes into contact with gastrointestinal fluids. This gel barrier controls the drug release rate, ensuring a gradual and consistent delivery of the medication over an extended period. The slow-release mechanism is particularly beneficial for maintaining steady therapeutic levels of the medication in the bloodstream, which can lead to enhanced efficacy and reduced side effects compared to immediate-release formulations.

Phentermine HCl is a sympathomimetic amine anorectic agent that suppresses appetite and stimulates the central nervous system (CNS) to increase heart rate and blood pressure, thereby aiding in weight loss. Topiramate, on the other hand, is an anticonvulsant that has weight loss effects, possibly due to its ability to induce satiety and decrease appetite. The combination of phentermine and topiramate in a single capsule provides a synergistic effect that enhances weight loss in patients with obesity or overweight with related comorbidities such as hypertension, type 2 diabetes, or dyslipidemia. The slow-release formulation is designed to minimize the potential for side effects that can be associated with peak concentrations of these medications, and to improve adherence by reducing the dosing frequency to once daily.

It is important for prescribers to consider the patient's overall health status, potential drug interactions, and contraindications before initiating therapy with this combination product. Patients should be counseled on the importance of adhering to the prescribed dosing schedule and be made aware of the potential side effects, which may include dry mouth, insomnia, constipation, and paresthesia. Regular monitoring of weight loss and other health parameters is recommended to ensure the safety and effectiveness of the treatment. As with any medication, adjustments to the dose or regimen may be necessary based on the patient's response and tolerance.

For patients and prescribers interested in this custom slow-release formulation, our team at Bayview Pharmacy is available to provide additional information and support. We are committed to ensuring the highest quality compounding services and patient care. If you have any questions or require further assistance, please do not hesitate to reach out to us.

Drug Interactions

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The combination of Phentermine HCl and Topiramate in a slow-release formulation is used primarily for the management of obesity. Phentermine is a sympathomimetic amine anorectic, which acts as an appetite suppressant, while Topiramate is an anticonvulsant that has weight loss effects. When considering the use of this combination therapy, it is important to be aware of potential drug interactions that may affect the efficacy and safety of the treatment.

Phentermine may interact with other central nervous system stimulants, which can increase the risk of adverse cardiovascular effects such as increased heart rate and blood pressure. Caution is advised when co-administering with other sympathomimetic drugs, decongestants, and monoamine oxidase inhibitors (MAOIs). MAOIs should be discontinued at least 14 days prior to initiating therapy with Phentermine to avoid hypertensive crisis.

Topiramate may increase the plasma levels of Phentermine by decreasing its metabolism. This could potentially enhance the therapeutic and adverse effects of Phentermine. Additionally, Topiramate itself can interact with other medications. For instance, it can reduce the effectiveness of oral contraceptives, necessitating the use of alternative or additional contraceptive methods. Topiramate may also increase the risk of kidney stones when taken with other carbonic anhydrase inhibitors. Concurrent use with central nervous system depressants may enhance sedative effects.

Both Phentermine and Topiramate can interact with alcohol, leading to enhanced sedation, dizziness, and an increased risk for seizures. Patients should be advised to limit or avoid alcohol consumption while taking this medication. Additionally, the use of other weight loss medications should be avoided due to the potential for additive effects and increased risk of cardiovascular side effects.

Patients with diabetes should be monitored closely as weight loss can affect glycemic control, potentially requiring adjustments in antidiabetic medication dosages. Furthermore, the use of antiepileptic drugs (AEDs) with Topiramate may require dose adjustments due to potential interactions affecting drug levels.

It is also important to monitor for the development of mood changes or depression, as both Phentermine and Topiramate have been associated with mood disturbances. If a patient is taking antidepressants, particularly SSRIs or SNRIs, careful monitoring for serotonin syndrome is warranted.

Given the complexity of these interactions, prescribers should review the patient's complete medication profile for potential interactions before initiating therapy with Phentermine HCl/Topiramate slow-release capsules. Patients should be advised to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and herbal supplements. For any questions or concerns regarding drug interactions with this formulation, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The formulation of Phentermine HCl 30 mg/Topiramate 25 mg Slow Release (ME4M) Oral Capsules is a sophisticated approach to weight management therapy, designed to provide a steady release of the active ingredients over an extended period. This is achieved through the incorporation of Methocel E4M, a hydrophilic methylcellulose polymer that swells and forms a gel when it comes into contact with gastric fluids. This gel matrix creates a barrier through which the active ingredients, phentermine and topiramate, must diffuse to be absorbed into the bloodstream.

Phentermine is a sympathomimetic amine anorectic, which means it stimulates the nervous system to suppress appetite. It is thought to increase the release of certain neurotransmitters in the brain that help reduce hunger sensations. Topiramate, on the other hand, is a medication originally used to treat epilepsy but has been found to have weight loss properties. The exact mechanism by which topiramate induces weight loss is not fully understood, but it is believed to work in part by enhancing the feeling of fullness and making foods taste less appealing, thus reducing calorie intake.

When combined in a single capsule, these two medications work synergistically to help patients with weight management. The slow-release formulation is particularly beneficial for maintaining consistent drug levels in the body, which can help manage appetite and satiety over a longer period compared to immediate-release formulations. This can lead to improved adherence to the weight management regimen, as patients are required to take the medication less frequently, reducing the inconvenience of multiple daily dosages.

The controlled-release aspect of this formulation is critical for both phentermine and topiramate, as it helps to minimize potential side effects that can be associated with peak concentrations of these drugs in the bloodstream. By smoothing out the release curve, patients may experience fewer side effects and a more tolerable treatment experience. This is particularly important for medications like topiramate, which can have central nervous system-related side effects.

This formulation is intended for use as part of a comprehensive weight management program that includes dietary changes, exercise, and behavior modification, under the supervision of a healthcare provider. It is important for prescribers to evaluate the suitability of this medication for each individual patient, considering factors such as the patient's medical history, the presence of comorbid conditions, and potential drug interactions.

If you have any questions about this formulation or how it can be integrated into a treatment plan for weight management, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is ready to provide the necessary support and guidance to ensure safe and effective use of Phentermine HCl 30 mg/Topiramate 25 mg Slow Release (ME4M) Oral Capsules.

Other Uses

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The Phentermine HCl 30 mg/Topiramate 25 mg Slow Release (ME4M) Oral Capsules, compounded at Bayview Pharmacy using Methocel E4M, are primarily prescribed for their weight management benefits in patients who are obese or overweight with related health conditions such as hypertension, type 2 diabetes, or dyslipidemia. Phentermine, as an appetite suppressant, works to decrease appetite and increase energy expenditure, whereas Topiramate, originally used as an anticonvulsant and migraine preventative, may also aid in satiety and additional weight loss.

Aside from the primary use in weight management, though it is off-label, Topiramate has shown positive effects in the management of binge-eating disorder and alcohol dependence. Phentermine's psychostimulant properties may also be beneficial in treating attention-deficit/hyperactivity disorder (ADHD), though its use for this purpose is less common and not approved by the FDA. These other uses should only be considered when the benefits outweigh the risks, and under the close supervision of a healthcare provider due to the potential for abuse and side effects associated with phentermine. Patients and prescribers should be cautioned on the potential for abuse and dependence with phentermine, as it is a schedule IV controlled substance. Additionally, Topiramate carries risks such as cognitive side effects, potential for birth defects if used during pregnancy, and a risk for development of glaucoma.

Patients and prescribers electing to use the Phentermine HCl/Topiramate Slow Release capsules for indications other than weight loss should have a clear understanding of the risks versus benefits of such treatment. It's essential that monitoring is put in place for potential adverse effects and medication effectiveness, with regular follow-ups and adjustments as necessary. The specific design of these capsules using Methocel E4M ensures a slow and consistent release of the active medications, potentially minimizing side effects that can be associated with peak doses of the medicines, as well as improving adherence by decreasing the pill burden on the patient. However, use for these other indications should strictly adhere to a thorough patient evaluation and be grounded in clinical judgement.

As with any medication, it is crucial to align with the guidance provided by healthcare professionals and thoroughly understand both the potential risks and benefits. If there are any questions regarding the use of Phentermine HCl/Topiramate Slow Release capsules or possible alternative therapeutic uses apart from those commonly indicated, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is dedicated to providing accurate and comprehensive information to both patients and prescribing physicians for ensuring the safe and effective use of this formulation.

Frequently Asked Questions

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What is ME4M Oral Capsule formulated with Phentermine HCl and Topiramate?

ME4M Oral Capsule is a compounded formulation that combines 30 mg of Phentermine HCl and 25 mg of Topiramate. These capsules are designed to release their active ingredients slowly over time due to the Methocel E4M polymer, which provides a sustained therapeutic effect.

How does the slow release mechanism of ME4M Capsules work?

The slow release mechanism of ME4M Capsules works through the use of Methocel E4M, a controlled-release polymer that creates a gel matrix when ingested. This matrix gradually releases the medication into the bloodstream, ensuring prolonged effectiveness and reduced dosing frequency.

What are the benefits of taking ME4M Capsules over immediate-release formulations?

ME4M Capsules offer several benefits over immediate-release formulations, including a prolonged therapeutic effect, reduced dosing frequency which can lead to improved patient compliance, and a potential reduction in the side effects associated with peak concentrations of the drugs.

How often should ME4M Capsules be taken?

The dosing frequency for ME4M Capsules will be determined by your healthcare provider. Due to the slow-release properties of Methocel E4M, the capsules might be taken less frequently than immediate-release formulations. Always follow the dosing instructions provided by your healthcare provider.

Can the ME4M Capsule be split or opened?

ME4M Capsules are designed to be taken whole to maintain the integrity of the slow-release system. Opening, breaking, or crushing the capsules can result in the immediate release of the active ingredients, which can alter the effectiveness of the medication and increase the risk of side effects.

What conditions are ME4M Capsules used to treat?

ME4M Capsules can be used for conditions that benefit from combined weight management therapy, such as obesity or overweight with related health complications. Always use this medication under the guidance of a healthcare provider.

Are there any dietary restrictions while taking ME4M Capsules?

There may be dietary restrictions while taking ME4M Capsules, especially since Phentermine HCl is an appetite suppressant. Your healthcare provider may recommend a reduced-calorie diet plan. Additionally, Topiramate may influence the taste of certain foods. Discuss any dietary considerations with your healthcare provider.

What should I do if I miss a dose of ME4M Capsules?

If you miss a dose of ME4M Capsules, take it as soon as you remember if it's not too close to the time for your next dose. If it's almost time for the next dose, skip the missed dose. Do not double the dose to catch up. For specific guidance, consult your healthcare provider.

Are there any possible side effects of taking ME4M Capsules?

As with any medication, ME4M Capsules can cause side effects. Commonly reported side effects may include dry mouth, constipation, tingling hands/feet, and dizziness. More serious side effects should be reported to your healthcare provider immediately.

Can I take other medications while using ME4M Capsules?

Before using ME4M Capsules, inform your healthcare provider of all the medications you are currently taking, including over-the-counter drugs and dietary supplements, as there can be interactions. Your healthcare provider will advise you on the safety of combining MEM4 with other medications.

How should I store ME4M Capsules?

Store ME4M Capsules at room temperature away from light and moisture. Keep the medication out of reach of children and pets. Do not store in the bathroom, and make sure the cap is tightly closed when not in use to maintain the integrity of the medication.

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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.