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Doxylamine Succinate 10 mg/Pyridoxine HCl 10 mg Slow Release (MEM4) Oral Capsules

The Doxylamine Succinate 10 mg/Pyridoxine HCl 10 mg Slow Release (MEM4) Oral Capsules are a specialized pharmaceutical formulation designed to alleviate symptoms associated with specific disease states. Each capsule contains a combination of doxylamine succinate and pyridoxine hydrochloride (vitamin B6), both dosed at 10 mg, and is compounded using Methocel E4M. This controlled-release polymer ensures that the active ingredients are released gradually over an extended period, providing sustained therapeutic effects.

This formulation is primarily used to treat nausea and vomiting of pregnancy (NVP), commonly known as morning sickness, which can significantly impact a pregnant woman's quality of life. The slow release mechanism of the capsules allows for reduced dosing frequency, which may enhance patient compliance and provide consistent symptom relief throughout the day. Additionally, the use of Methocel E4M in the capsule matrix helps to maintain steady blood levels of the active ingredients, potentially minimizing the risk of peaks and troughs that could lead to side effects or decreased efficacy.

By combining doxylamine succinate, an antihistamine that possesses antiemetic properties, with pyridoxine hydrochloride, which has been shown to have a beneficial effect on NVP, this formulation offers a dual approach to managing symptoms. The slow release capsules are an innovative solution for patients seeking a more convenient and effective treatment for the discomfort associated with morning sickness.

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Slow Release Capsules
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Formula Information

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The Doxylamine Succinate 10 mg/Pyridoxine HCl 10 mg Slow Release (MEM4) Oral Capsules are a specialized pharmaceutical formulation designed to provide a controlled release of the active ingredients doxylamine succinate and pyridoxine hydrochloride. Doxylamine succinate is an antihistamine with sedative properties, commonly used to treat symptoms of allergies, the common cold, and as a short-term sleep aid. Pyridoxine hydrochloride, also known as vitamin B6, is essential for many bodily functions, including neurotransmitter synthesis, and is often used to prevent or treat low levels of vitamin B6, as well as to alleviate nausea and vomiting during pregnancy.

This unique formulation incorporates Methocel E4M, a hydrophilic methylcellulose derivative, which acts as a controlled-release polymer. When encapsulated with the active ingredients, Methocel E4M swells and forms a gel barrier upon contact with gastrointestinal fluids. This gel barrier controls the rate at which the active ingredients are released into the body, ensuring a gradual and sustained release over an extended period. This slow-release mechanism allows for a reduction in dosing frequency, which can lead to improved patient compliance, especially beneficial for those who require consistent therapeutic levels of medication throughout the day or night.

The combination of doxylamine succinate and pyridoxine hydrochloride in a slow-release capsule is particularly effective in treating nausea and vomiting of pregnancy (NVP), commonly known as morning sickness. The dual action of doxylamine's antiemetic effects and pyridoxine's role in nausea reduction provides a synergistic approach to managing NVP symptoms. The controlled-release aspect of the formulation ensures that the therapeutic effects are maintained, potentially providing relief for a more extended period than immediate-release formulations.

For patients and prescribers considering this formulation, it is important to note that the slow-release capsules should be swallowed whole and not crushed or chewed, to maintain the integrity of the controlled-release system. As with any medication, potential side effects, contraindications, and interactions with other drugs should be reviewed with a healthcare provider. The compounding pharmacists at Bayview Pharmacy are available to answer any questions regarding this formulation and can provide additional information tailored to individual patient needs or prescriber requirements. 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 Doxylamine Succinate and Pyridoxine HCl in a slow-release formulation is commonly used to manage symptoms of nausea and vomiting during pregnancy, a condition known as morning sickness. Doxylamine is an antihistamine that can help reduce nausea and vomiting, while Pyridoxine, a form of vitamin B6, has been shown to improve symptoms of morning sickness. When considering the use of this combination therapy, it is important to be aware of potential drug interactions that may occur.

Doxylamine Succinate may interact with other central nervous system depressants, such as alcohol, benzodiazepines, opioids, and other antihistamines, potentially enhancing sedative effects. Caution is advised when patients are taking these medications concurrently. Additionally, monoamine oxidase inhibitors (MAOIs) can increase the anticholinergic effects of antihistamines, leading to an increased risk of side effects such as dry mouth, urinary retention, and constipation. It is generally recommended to avoid the use of MAOIs within two weeks of taking medications containing Doxylamine.

Pyridoxine HCl can interact with medications that affect vitamin B6 levels. For example, isoniazid, used to treat tuberculosis, can deplete vitamin B6 and may necessitate supplementation. Conversely, high doses of Pyridoxine can decrease the efficacy of levodopa, a medication used to treat Parkinson's disease, unless a dopa decarboxylase inhibitor is also being used. Additionally, Pyridoxine may reduce the effectiveness of phenobarbital and phenytoin, two antiepileptic drugs.

Since this formulation is designed to release the active ingredients slowly over time, it is important to consider that interactions may be prolonged or delayed. Patients should be advised not to crush or chew the capsules, as this could disrupt the controlled-release mechanism and potentially lead to a rapid release of the active ingredients, increasing the risk of side effects and interactions.

Patients should be encouraged to inform their healthcare providers of all medications, supplements, and herbal products they are currently taking to avoid potential interactions. Healthcare providers should review the patient's medication regimen for possible interactions before prescribing this slow-release formulation of Doxylamine Succinate and Pyridoxine HCl.

If you have any questions or require further information regarding drug interactions with this formulation, please reach out to us at Bayview Pharmacy. Our team is committed to ensuring the safe and effective use of medications and is available to provide the necessary support and guidance.

How Does it Work

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The Doxylamine Succinate 10 mg/Pyridoxine HCl 10 mg Slow Release (MEM4) Oral Capsules are a specialized pharmaceutical formulation designed to manage symptoms associated with certain conditions, such as nausea and vomiting during pregnancy. This formulation utilizes Methocel E4M, a hydrophilic matrix of hypromellose, which is a type of controlled-release polymer. When the capsule is ingested, the Methocel E4M swells upon contact with gastric fluids, forming a gel-like matrix that encapsulates the active ingredients, doxylamine succinate and pyridoxine HCl.

Doxylamine succinate is an antihistamine that works by blocking histamine receptors in the brain, which helps to reduce symptoms of nausea and vomiting. Pyridoxine HCl, also known as vitamin B6, is often used in combination with doxylamine to enhance its antiemetic effects and has been shown to be effective in reducing nausea and vomiting during pregnancy. The combination of these two ingredients in a slow-release formulation ensures a steady absorption and prolonged effect, which can be particularly beneficial for managing symptoms that require consistent relief over time.

The slow-release mechanism of Methocel E4M is based on the principle of diffusion and erosion. As the gel matrix forms, it creates a barrier through which the active ingredients must diffuse to reach the bloodstream. This process is controlled by the rate at which the polymer matrix erodes and the drug dissolves. The result is a gradual and sustained release of doxylamine succinate and pyridoxine HCl, maintaining therapeutic levels in the body for an extended period. This reduces the need for frequent dosing, which can improve patient compliance and convenience, especially for patients experiencing discomfort due to frequent nausea and vomiting.

By using this controlled-release technology, the Doxylamine Succinate/Pyridoxine HCl Slow Release Capsules can provide a more consistent therapeutic effect, potentially leading to better management of symptoms and an overall improvement in the quality of life for patients. It is important for both patients and prescribers to understand the benefits and mechanisms of this formulation to ensure optimal use and adherence to the treatment regimen. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the support and guidance you need.

Other Uses

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While the combination of Doxylamine Succinate and Pyridoxine HCl is primarily indicated for the management of nausea and vomiting associated with pregnancy, the constituents of this formulation possess pharmacological properties that enable their use in other contexts as well. Doxylamine Succinate, as a first-generation antihistamine, exhibits sedative properties which can be beneficial in the treatment of insomnia or for patients requiring a sedative-hypnotic agent. In environments where a patient is in need of sustained sleep support, the slow-release nature of this formulation could provide a measured sedative effect throughout the night, potentially improving sleep quality and duration.

Pyridoxine HCl (Vitamin B6), aside from its established role in the treatment of nausea, plays a substantial role in amino acid metabolism, neurotransmitter synthesis, and the modulation of steroid hormone activity. Having the ability to slowly release Pyridoxine could afford a steady state of this crucial vitamin, possibly aiding in the management of conditions associated with Pyridoxine deficiency such as sideroblastic anemia, certain types of seizures in infants, and, in some cases, peripheral neuropathy induced by isoniazid.

Patients interested in this formulation for alternative uses should consult with a healthcare provider to ascertain the suitability and appropriate dosing regimen for their specific condition. While this slow-release capsule format can provide benefits in terms of convenience and compliance, not all off-label uses for the active ingredients are necessarily appropriate for controlled-release delivery. Additionally, when considering the use of this combination formulation for indications other than nausea and vomiting during pregnancy, it's crucial to note that the efficacy and safety profiles for these alternative uses are not as well-established.

Furthermore, pharmacists should evaluate the totality of a patient’s medication regimen and health conditions before recommending or prescribing this formulation for other uses. The slow-release aspect may interact differently with concomitant medications or underlying diseases. Also, although Methocel E4M ensures that the drugs are released slowly, the pharmacokinetics associated with sustained release may alter the drugs' usual side effect profile.

We understand that healthcare professionals and patients alike may require additional information when considering the use of our compounded formulations. Our team at Bayview Pharmacy is equipped with the skills and knowledge to help guide and assist you through this process. If you have any questions or need further clarification regarding this specific formulation or its potential applications, please do not hesitate to reach out to us.

Frequently Asked Questions

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What is Doxylamine Succinate/Pyridoxine HCl Slow Release Oral Capsule?

This medication is a compounded formulation consisting of Doxylamine Succinate and Pyridoxine Hydrochloride (Vitamin B6), each at a strength of 10 mg, encapsulated in a slow-release formula. It is designed to gradually release the active ingredients over an extended period of time, enhancing therapeutic effects and improving patient compliance.

How does the slow release mechanism of this medication work?

The capsule is formulated with Methocel E4M, a hydrophilic controlled-release polymer, which swells in the presence of gastric fluid and gradually releases the incorporated drugs, Doxylamine Succinate and Pyridoxine HCl, over an extended period. This mechanism ensures a sustained release of the active ingredients into the body, resulting in a reduced need for frequent dosing.

What are the benefits of taking a slow release capsule?

Sustained release capsules offer several benefits, including maintaining steadier blood levels of the medication, reducing the frequency of doses needed throughout the day, and minimizing potential side effects associated with peak concentrations of drugs. This leads to improved patient adherence to the medication regimen.

What are the indications for Doxylamine Succinate/Pyridoxine HCl Slow Release Oral Capsules?

This combination medication is commonly used for the management of nausea and vomiting associated with pregnancy, commonly known as morning sickness, where a sustained release can help manage symptoms over a longer period of time.

Are there any potential side effects associated with Doxylamine Succinate/Pyridoxine HCl Slow Release Oral Capsules?

Like all medications, these capsules can cause side effects. Common side effects include drowsiness, dry mouth, and dizziness. Less common side effects could include gastrointestinal disturbances, headache, or allergic reactions. If you experience any severe side effects, contact your healthcare provider immediately.

How should I take Doxylamine Succinate/Pyridoxine HCl Slow Release Oral Capsules?

Take the medication exactly as prescribed by your healthcare provider. The slow release capsules should be swallowed whole with water, and not chewed or crushed, as this may affect the controlled-release mechanism.

Can I take this medication with food?

Yes, you can take Doxylamine Succinate/Pyridoxine HCl Slow Release Oral Capsules with or without food. However, taking it with a meal may help if you experience stomach upset.

What should I do if I miss a dose?

If you miss a dose of the medication, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

Can I stop taking Doxylamine Succinate/Pyridoxine HCl Slow Release Oral Capsules if I feel better?

You should continue to take the medication for the duration prescribed by your healthcare provider, even if you feel better, to ensure that you are adequately managing your symptoms. If you have questions about the duration of treatment, consult with your healthcare provider.

How should I store the medication?

Store Doxylamine Succinate/Pyridoxine HCl Slow Release Oral Capsules at room temperature away from light and moisture. Keep them out of reach of children and pets, and do not store in the bathroom as the humidity could affect the capsules.

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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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