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Phenytoin sodium 400 mg Rectal Suppository

The Phenytoin sodium 400 mg Rectal Suppository is a solid dosage form designed for rectal administration. Upon insertion into the rectum, the suppository dissolves or melts, facilitating the release of the active ingredient, phenytoin sodium, for both local and systemic absorption. This formulation is primarily used in the management of seizures, providing an alternative route of administration for patients unable to take oral medications. It is effective in treating various disease states, including epilepsy and status epilepticus, where maintaining therapeutic drug levels is crucial for seizure control.

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Formula Information

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Phenytoin sodium is an anticonvulsant medication commonly used to manage and prevent seizures in various forms of epilepsy. The 400 mg Phenytoin sodium rectal suppository is a solid dosage form designed for insertion into the rectum, where it dissolves or melts to release the active medication. This route of administration can be particularly useful when oral administration is not feasible, such as in patients with impaired consciousness or difficulty swallowing.

The rectal suppository allows for the medication to be absorbed directly into the bloodstream through the rectal mucosa, bypassing the gastrointestinal tract and potentially reducing gastrointestinal side effects. This can also be advantageous in situations where maintaining a steady plasma concentration of phenytoin is critical, as it avoids the variability of absorption associated with the oral route. Phenytoin works by stabilizing the neuronal membrane and decreasing electrical conductance among brain cells, thereby reducing the likelihood of seizure activity.

Phenytoin sodium rectal suppositories are indicated for the treatment of tonic-clonic (grand mal) seizures, complex partial seizures, and to prevent and treat seizures occurring during or following neurosurgery. The use of this formulation requires careful monitoring of phenytoin serum levels to ensure therapeutic effectiveness and to avoid toxicity, as the therapeutic window of phenytoin is narrow. Side effects may include CNS disturbances such as nystagmus, ataxia, slurred speech, and mental confusion. Long-term use of phenytoin can lead to gingival hyperplasia, hirsutism, and folate deficiency, among other effects.

It is important for prescribers to consider the patient's overall medication profile, as phenytoin has numerous drug interactions that can affect its efficacy and safety. Adjustments in dosage may be necessary based on the patient's clinical response and serum drug levels. Patients and caregivers should be educated on the proper insertion technique for rectal suppositories to ensure effective administration and to minimize discomfort.

For more detailed information on the use of Phenytoin sodium 400 mg rectal suppositories, or if you have any questions regarding this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing comprehensive support to both patients and healthcare providers to ensure optimal treatment outcomes.

Drug Interactions

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Phenytoin sodium is an anticonvulsant medication used to treat and prevent seizures. When formulated as a 400 mg rectal suppository, it is intended for use when oral administration is not possible, such as in patients with impaired consciousness or difficulty swallowing. The rectal route provides an alternative for systemic absorption of the drug. It is important to consider potential drug interactions when prescribing or administering phenytoin sodium in any form, including rectal suppositories.

Phenytoin is a substrate of the hepatic cytochrome P450 enzyme system, particularly CYP2C9 and CYP2C19. It can be affected by inducers or inhibitors of these enzymes. Drugs that induce these enzymes, such as rifampin, carbamazepine, and St. John's Wort, may decrease phenytoin levels, potentially reducing its efficacy. Conversely, inhibitors of these enzymes, such as fluconazole, isoniazid, and certain SSRIs, may increase phenytoin levels, leading to toxicity.

Phenytoin itself is an enzyme inducer and can decrease the levels of other drugs metabolized by the same enzyme system, including warfarin, oral contraceptives, and some antiretrovirals. This can lead to therapeutic failure of the affected drugs. Patients on such medications may require dose adjustments and close monitoring when starting or stopping phenytoin therapy.

Additionally, phenytoin has a narrow therapeutic index, and its serum levels can be affected by drugs that alter its protein binding. For example, valproic acid can displace phenytoin from protein binding sites, leading to an increase in the free (active) fraction of phenytoin and potential toxicity. Similarly, phenytoin can displace other highly protein-bound drugs, such as warfarin, leading to increased effects of these drugs.

Phenytoin's absorption from the rectal mucosa can be influenced by drugs that affect gastrointestinal motility. For instance, anticholinergic drugs may slow GI motility, potentially affecting the absorption rate of the rectal suppository.

It is also important to monitor for potential additive CNS depressant effects when phenytoin is used concomitantly with other CNS depressants, such as benzodiazepines, opioids, and alcohol. This can increase the risk of sedation and respiratory depression.

Patients with conditions that phenytoin treats, such as epilepsy, often require long-term medication regimens, and any changes in their medication profile should be approached with caution. Regular monitoring of phenytoin serum levels, as well as observation for clinical signs of toxicity or seizure control, is recommended.

Given the complexity of drug interactions with phenytoin, prescribers should conduct a thorough medication review for each patient before initiating therapy with phenytoin rectal suppositories. Pharmacists can provide valuable assistance in identifying potential interactions and recommending appropriate management strategies. If you have any questions or require further information regarding drug interactions with phenytoin sodium rectal suppositories, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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The Phenytoin sodium 400 mg Rectal Suppository is a solid dosage form designed for rectal administration. When inserted into the rectum, the suppository base, typically composed of substances like cocoa butter or a synthetic substitute, begins to melt or dissolve due to the warmth of the body. As the base melts, the active ingredient, phenytoin sodium, is released into the rectal mucosa. From there, the drug is absorbed into the bloodstream, where it can exert its therapeutic effects.

Phenytoin sodium is an anticonvulsant medication that works by stabilizing the electrical activity in the brain. It does so by inhibiting the spread of seizure activity and reducing the seizure's intensity. The exact mechanism of action is not fully understood, but phenytoin is thought to limit the repetitive firing of neurons by affecting sodium channels in the neuronal cell membrane. By doing so, it helps to prevent the abnormal electrical activity that can lead to seizures.

This rectal suppository formulation is particularly useful in patients who are unable to take medications orally, such as those with impaired consciousness or difficulty swallowing. It provides an alternative route for administration, ensuring that patients who require phenytoin can still receive their medication. The rectal route can also be advantageous in avoiding the first-pass metabolism that occurs when drugs are taken orally, potentially leading to more consistent blood levels of the drug.

Phenytoin sodium rectal suppositories are used in the treatment of various seizure types, including tonic-clonic (grand mal) seizures, complex partial seizures, and seizures occurring during or after neurosurgery. They may also be used in status epilepticus, a medical emergency involving prolonged or repeated seizures. It is important to note that while phenytoin can help control seizures, it does not cure epilepsy and must be taken regularly to be effective.

For patients and prescribers considering the use of Phenytoin sodium 400 mg Rectal Suppositories, it is essential to understand the proper insertion technique, potential side effects, and the importance of consistent dosing. Monitoring of phenytoin blood levels may be necessary to ensure therapeutic effectiveness and to avoid toxicity. 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 needed to ensure safe and effective treatment with phenytoin sodium rectal suppositories.

Other Uses

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Phenytoin sodium, traditionally known for its use in managing seizures, also has potential for other applications embodied within a rectal suppository form. While its primary indication remains within the realm of anti-epileptic treatment, particularly when oral administration is not feasible, its usage as a rectal suppository might encompass the provision of a sustained plasma concentration for seizure management in patients who are non-compliant or unable to ingest medications orally due to various reasons such as surgery, gastrointestinal disturbances, or altered levels of consciousness.

In certain cases, phenytoin sodium rectal suppositories may serve as an alternative route for drug delivery in patients with enteral feeding tubes or those with malabsorption issues, where drug absorption from the gastrointestinal tract is compromised. Furthermore, the rectal administration bypasses the first-pass metabolism, potentially offering pharmacokinetic advantages for patients who require careful management of drug levels.

It's important to consider that while rectal suppositories offer an alternative route of administration, factors like rectal diseases or recent rectal surgery might influence the absorption and efficacy of the medication. Additionally, patient comfort and preference play significant roles in the selection of this route of administration. Caregivers and patients should be made aware of proper administration techniques to maximize the suppository's efficacy when used in an outpatient setting.

Moreover, while our present literature focuses on the benefits and uses within a neurological purview, ongoing research might reveal further applications for rectal phenytoin sodium suppositories, potentially expanding its utilization in other therapeutic domains. It is always important to assess the suitability of this delivery system on a case-by-case basis, considering individual patient characteristics and clinical circumstances.

If you have any questions or require additional information regarding the use of phenytoin sodium rectal suppositories, or if you are contemplating this formulation for an off-label use, we invite you to reach out to us at Bayview Pharmacy. We are committed to providing expert advice and support for both patients and prescribers to ensure the safe and effective use of compounded medications.

Frequently Asked Questions

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What is a Phenytoin sodium 400 mg Rectal Suppository?

A Phenytoin sodium 400 mg Rectal Suppository is a solid medication formulation designed to be inserted into the rectum. It contains 400 mg of phenytoin sodium, which is used to control seizures. Once inserted, the suppository melts or dissolves, releasing the medication for absorption into the bloodstream to exert its therapeutic effects.

How is the Phenytoin sodium suppository administered?

The Phenytoin sodium suppository is administered rectally. It should be inserted into the rectum, beyond the sphincter muscles, to ensure it stays in place and is properly absorbed. Always follow the specific instructions provided by your healthcare provider or the leaflet included with the medication.

Who should use the Phenytoin sodium rectal suppository?

This form of phenytoin is generally used for patients who cannot take oral medication and require consistent blood levels of the drug to manage their seizure conditions. Consult with your healthcare provider to determine if this form of medication is appropriate for you or the person in your care.

How often should I use the Phenytoin sodium rectal suppository?

The frequency of use for Phenytoin sodium rectal suppositories will depend on your individual treatment plan prescribed by your healthcare provider. It's essential to follow their directions carefully and not alter the dosing schedule without consulting them.

What should I do if I miss a dose of Phenytoin sodium suppository?

If you miss a dose, insert the missed suppository as soon as you remember, unless it is close to the time of your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the doses to catch up. For detailed advice, contact your healthcare provider.

Are there any side effects associated with Phenytoin sodium suppositories?

As with any medication, Phenytoin sodium suppositories can cause side effects. Common side effects may include local irritation or discomfort. Systemic side effects can vary and may affect the nervous system, such as dizziness, confusion, or ataxia. Severe side effects should be reported to your healthcare provider immediately.

Can Phenytoin sodium suppositories be used during pregnancy?

Phenytoin may have risks associated with its use during pregnancy. It is crucial to discuss the benefits and risks with your healthcare provider to determine the best course of action for your particular situation.

How should the suppositories be stored?

Phenytoin sodium suppositories should be stored in a cool, dry place, away from light and moisture. Keep them in their original packaging until ready to use and out of reach of children and pets. Consult the packaging or your pharmacist for specific storage instructions.

Can I use laxatives while on Phenytoin sodium rectal suppositories?

Laxatives may alter the absorption of the medication. Before using any laxatives, it is important to consult your healthcare provider regarding potential interactions and the best approach to managing constipation while on this medication.

What should I avoid while using Phenytoin sodium suppositories?

While using Phenytoin sodium suppositories, avoid activities that require alertness, such as driving or operating heavy machinery, until you know how the medication affects you. Also, avoid alcohol consumption, as it can increase the side effects of phenytoin. Consult with your healthcare provider for a complete list of activities and substances to avoid.

Can the Phenytoin sodium suppository be used with other medications?

Phenytoin can interact with a variety of other medications, potentially altering their effects or increasing the risk of side effects. Always inform your healthcare provider of all medications, supplements, and herbal products you are taking to ensure that the Phenytoin sodium suppository is safe in combination with them.

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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.