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Phenobarbital 10 mg Rectal Suppository

FDA-approved generic
Dose form
Suppository
Active ingredients
Phenobarbital

The Phenobarbitone 10 mg Rectal Suppository is a solid dosage form designed for insertion into the rectum. Upon administration, it dissolves or melts, facilitating the release of Phenobarbitone for both local and systemic absorption. This formulation is primarily used in the management of seizures, providing anticonvulsant effects to treat various forms of epilepsy. Additionally, it serves as a sedative to alleviate anxiety and tension, and is occasionally employed in the emergency control of certain acute convulsive episodes, such as those associated with status epilepticus. Its rectal administration is particularly useful in patients who are unable to take medications orally.

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For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription detailsOrder form
Controlled substance: e-prescribe (EPCS) from your EHR. Faxed and phoned prescriptions cannot be accepted for this preparation.
Send it from your EHR, or fax to (401) 284-4506. How to e-prescribe this formula
Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
To prescribe, you must be a verified prescriber.
To prescribe, you must be in a state where we hold an active out-of-state pharmacy license.
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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.

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Compounded preparations are prepared by Bayview pursuant to a prescription for an individual patient. They are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Phenobarbital
Suppository
65ce3b679d509ffd7a2dccd7

Formula Information

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Phenobarbital 10 mg Rectal Suppository is a solid dosage form designed for insertion into the rectum, where it dissolves or melts to release the active medication, phenobarbital, for local or systemic absorption. This route of administration is particularly useful when oral administration is not feasible due to vomiting, difficulty swallowing, or the need for a rapid onset of action. Phenobarbital is a long-acting barbiturate that exerts its effect by enhancing the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the brain, leading to sedation, hypnosis, and a decrease in neuronal excitability.

Phenobarbital is primarily used in the management of seizure disorders, including generalized tonic-clonic seizures and focal seizures. It is also utilized in emergency settings for the acute treatment of status epilepticus, a life-threatening condition where seizures persist for an extended period. Additionally, phenobarbital has applications in the preoperative setting to relieve anxiety and tension, and in certain cases, it may be used to treat hyperbilirubinemia in neonates. The rectal suppository form is particularly beneficial in pediatric populations or in patients who are unconscious or otherwise unable to take medications orally.

When using Phenobarbital 10 mg Rectal Suppositories, it is important for prescribers to consider the potential for sedation and respiratory depression, especially in elderly patients or those with compromised pulmonary function. Regular monitoring of blood levels may be necessary to avoid toxicity, as phenobarbital has a narrow therapeutic index. Additionally, they should be made aware of the potential side effects, including drowsiness, dizziness, and dependence with long-term use.

As compounding pharmacists at Bayview Pharmacy, we are committed to providing high-quality, patient-specific formulations. Our team is available to answer any questions and provide guidance on the use of Phenobarbital 10 mg Rectal Suppositories. We can also assist in adjusting the dosage form and strength to meet the unique needs of each patient. If you have any questions or require further information about this formulation, please do not hesitate to reach out to us.

Drug Interactions

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Phenobarbital is a barbiturate that acts as a central nervous system depressant. It is commonly used for the treatment of seizures and may also be used for sedation or to relieve anxiety. When formulated as a 10 mg rectal suppository, phenobarbital is intended for rectal administration, where it can be absorbed into the bloodstream and exert its therapeutic effects. This route of administration can be particularly useful in patients who are unable to take medications orally.

Phenobarbital has a wide range of drug interactions that must be considered to avoid potential adverse effects or reduced efficacy. It is a potent inducer of cytochrome P450 enzymes, particularly CYP2C9 and CYP3A4, which can lead to increased metabolism and decreased effectiveness of other medications. Drugs that are substrates of these enzymes, such as warfarin, certain antiepileptics (like phenytoin and valproate), and oral contraceptives, may have reduced efficacy when used concurrently with phenobarbital. Patients and prescribers should monitor for changes in the effectiveness of these medications and adjust dosages as necessary.

Conversely, phenobarbital's metabolism may be affected by inhibitors of CYP2C9 and CYP3A4, potentially leading to increased phenobarbital levels and an enhanced risk of toxicity. Caution is advised when combining phenobarbital with inhibitors such as fluconazole, ketoconazole, and macrolide antibiotics. Additionally, phenobarbital may enhance the metabolism of drugs like corticosteroids, leading to a potential decrease in their therapeutic effects.

Phenobarbital may also interact with other central nervous system depressants, including alcohol, opioids, benzodiazepines, and other sedative-hypnotics, which can lead to additive sedative effects and increased risk of respiratory depression. Patients should be advised to avoid or limit the use of alcohol and consult with their healthcare provider before using other CNS depressants.

Furthermore, phenobarbital can decrease the effectiveness of anticoagulants like warfarin, requiring close monitoring of coagulation parameters and possible dose adjustments of the anticoagulant. It can also interfere with the effectiveness of certain antihypertensive drugs and heart medications, potentially necessitating dose adjustments or alternative therapies.

Patients with a history of porphyria should avoid phenobarbital, as it can exacerbate the condition. Additionally, phenobarbital may decrease serum levels of folic acid and vitamin D, so supplementation may be necessary during long-term use.

It is crucial for patients and prescribers to be aware of these interactions and to manage them appropriately. Monitoring therapeutic drug levels, adjusting dosages, and considering alternative treatments may be necessary to ensure safe and appropriate use of phenobarbital. If you have any questions or require further information regarding drug interactions with phenobarbital rectal suppositories, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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Phenobarbital is a barbiturate that is commonly used as a sedative and an anticonvulsant. The Phenobarbital 10 mg Rectal Suppository is a solid dosage form designed to be inserted into the rectum, where it dissolves or melts. Upon administration, the suppository base, typically made from substances like cocoa butter or a synthetic substitute, begins to melt at body temperature, releasing the active ingredient, Phenobarbital, into the rectal mucosa. The rectal route is particularly useful when the oral route is not feasible due to vomiting, unconsciousness, or difficulty swallowing.

Once Phenobarbital is released from the suppository, it is absorbed into the bloodstream through the rich vascular network found in the rectal area. This allows the medication to bypass the first-pass metabolism in the liver, which can be significant with oral administration. As a result, the drug can reach therapeutic levels more quickly and efficiently. Phenobarbital works by enhancing the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the brain. This action results in the stabilization of neuronal membranes and a decrease in nerve impulses that can cause seizures and anxiety.

In terms of treating disease states, Phenobarbital is primarily used to control seizures in various types of epilepsy. It is also utilized for its sedative effects to relieve anxiety and tension. By increasing the inhibitory effects of GABA, Phenobarbital helps to calm the nervous system, which can prevent the onset of seizure activity and promote relaxation. The rectal suppository form is particularly useful in emergency situations where rapid seizure control is necessary, and other routes of administration are not possible.

Regular monitoring of drug levels and patient response is necessary to ensure safety and efficacy. If you have any questions or require further information about the Phenobarbital 10 mg Rectal Suppository, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support for your specific healthcare needs.

Other Uses

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Phenobarbital 10 mg rectal suppository is primarily used for its anticonvulsant properties to manage seizures. However, it also has sedative and hypnotic effects that can be useful in certain clinical scenarios. For example, this formulation can be employed in the management of acute anxiety or panic episodes, where other routes of administration are not feasible. Due to its capability to reduce central nervous system activity, it may also be used off-label for the purpose of alleviating withdrawal symptoms in individuals being treated for acute alcohol withdrawal when oral administration is not possible. Additionally, in the palliative care setting, phenobarbital suppositories can provide comfort care in situations where patients are unable to take medications by mouth and require seizure control or sedation.

Although the primary absorption is expected to be rectal, providing local and systemic effects, there may be occasions where the phenobarbital suppository could be used vaginally for its systemic action, though this is less common and not the primary design of the dosage form. It is crucial for prescribers to weigh the benefits against the potential risks, such as respiratory depression, especially in elderly or debilitated patients when considering alternate uses of this formulation. Furthermore, given its potential for dependence and tolerance, healthcare providers should carefully monitor patients receiving this medication for long-term therapy.

It is important for both patients and prescribers to understand that the off-label uses of phenobarbital suppositories should be considered only when other more conventional treatment options are contraindicated or unavailable. As with any medication, adherence to the prescribed dosage and administration techniques is essential for ensuring effectiveness and minimizing adverse effects. If there are any questions or concerns regarding the use of phenobarbital 10 mg rectal suppositories for conditions other than seizures, please reach out to us at Bayview Pharmacy for expert advice on compounding and alternative treatment options.

Frequently Asked Questions

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What is Phenobarbital 10 mg Rectal Suppository?

A Phenobarbital 10 mg Rectal Suppository is a solid dosage form containing the sedative and anticonvulsant drug Phenobarbital, at a dose of 10 milligrams. This medication is designed to be inserted into the rectum, where it will dissolve or melt to release the drug for absorption into the bloodstream.

How do you use a Phenobarbital rectal suppository?

To use a Phenobarbital rectal suppository, first, wash your hands thoroughly. Remove the suppository from its packaging. Lie on your side with your lower leg straightened out and your upper leg bent forward toward your stomach. Gently insert the suppository into the rectum, pointed end first, making sure it is well inside. Remain lying down for a few minutes to allow the suppository to dissolve.

What is Phenobarbital used for?

Phenobarbital is commonly used to control seizures in various types of epilepsy and is sometimes used for its sedative effects to alleviate anxiety or induce sleep. It may also be part of the treatment protocol in certain emergency situations when administered via rectal suppository.

Who should not use Phenobarbital rectal suppositories?

Individuals with a known hypersensitivity to Phenobarbital or barbiturates should not use this medication. It is also contraindicated in patients with a history of severe liver disease, respiratory depression, or certain metabolic disorders. Always consult a healthcare provider to ensure the medication is safe for you.

Are there any side effects associated with Phenobarbital suppositories?

Yes, possible side effects may include drowsiness, dizziness, nausea, vomiting, constipation, and headaches. In some cases, individuals may experience allergic reactions, respiratory depression, or dependency with prolonged use. Contact your doctor if you notice severe or concerning symptoms.

Is Phenobarbital safe for children?

Phenobarbital can be used in children under the guidance of a healthcare provider. Dosing for children is typically determined by weight, and careful monitoring is necessary due to possible side effects and the risk of over-sedation. Always follow the pediatric dosage recommendations provided by your healthcare professional.

Can you use Phenobarbital suppositories while pregnant?

Phenobarbital may have risks when used during pregnancy, as it can cross the placental barrier. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and it should be prescribed by a healthcare provider familiar with your medical history and condition.

How should Phenobarbital suppositories be stored?

Phenobarbital suppositories should be stored at room temperature away from light and moisture. Keep this medication out of reach and sight of children and pets, and avoid storing it in the bathroom where the warm, moist environment could affect its stability.

Can Phenobarbital rectal suppositories be used for long-term treatment?

While Phenobarbital can be used for chronic conditions such as epilepsy, the long-term use of barbiturates like Phenobarbital can lead to tolerance, dependence, and potentially significant side effects. The decision for long-term treatment should be made by a healthcare provider who can regularly monitor patient response and adjust treatment as necessary.

Can you drink alcohol while using Phenobarbital suppositories?

Alcohol should be avoided while using Phenobarbital suppositories, as it can enhance the sedative effects and depress the central nervous system further. Combining alcohol with Phenobarbital can increase the risk of respiratory depression, deep sedation, or other dangerous side effects.

About this compounded preparation

This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.

The conditions listed on this page are indications prescribers have ordered this preparation for. They are not FDA-approved indications, and listing them is not a statement that this preparation is effective for them.

A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice — discuss your situation with a licensed healthcare provider.

This preparation is a controlled substance. Additional prescribing, refill, and shipping restrictions apply, and the states Bayview can dispense it to are narrower than for non-controlled preparations.

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.
For prescribers

How to e-prescribe this formula

Controlled substance: e-prescribe only (EPCS). Faxed, phoned, and handwritten prescriptions cannot be filled. Rhode Island law (R.I. Gen. Laws § 21-28-3.18) requires Schedule II to V prescriptions to be transmitted electronically.
1

Find Bayview in your EHR's pharmacy directory

Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.

NCPDP4106882NPI1750455143Address3844 Post Rd, Warwick, RI 02886Phone(401) 284-4505Fax(401) 284-4506
2

Enter the formula as a compound

Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.

Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.

3

Copy the prescription details

RxFormula name
Dose formDose form
Quantity________
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription details

Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.

4

Send it

Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.

Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.

Do not use Notes to Pharmacy for the formula. Some EHRs keep that field internal and never transmit it. A prescription that arrives without the formula is delayed while we call your office.

Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.

Phenobarbital 10 mg Rectal Suppository
Suppository
30 suppositories
controlled

Insert 1 unwrapped suppository