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Formulas

Diazepam 1 mg/mL Rectal Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Diazepam

Diazepam 1 mg/mL Rectal Gel is a semisolid formulation designed for rectal administration, utilizing a pump mechanism to ensure easy and precise application. This gel-like consistency allows for targeted treatment and effective absorption of the active ingredient, diazepam.

This formulation is primarily used in the management of acute repetitive seizures and status epilepticus, providing rapid relief and stabilization for patients experiencing these conditions.

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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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This medication requires a prescription from your doctor

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.

For prescribersSign in for prescription details and order forms.
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.
Diazepam
Topical Gel

Formula Information

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Diazepam 1 mg/mL Rectal Gel is a compounded pharmaceutical formulation designed to deliver diazepam efficiently and effectively via rectal administration. Diazepam is a benzodiazepine medication known for its anxiolytic, anticonvulsant, muscle relaxant, and sedative properties. The rectal gel form allows for rapid absorption of the medication into the bloodstream, making it particularly useful in situations where oral administration is not feasible or when a quick onset of action is required.

This semisolid gel is dispensed through a pump mechanism, ensuring precise dosing and ease of administration. The gel-like consistency facilitates comfortable rectal application, enhancing patient compliance. The rectal route bypasses the gastrointestinal tract, which is beneficial in patients who are vomiting, have difficulty swallowing, or are unconscious. This method of delivery provides a reliable and consistent absorption of diazepam.

Diazepam rectal gel is commonly used in the management of seizure disorders, including acute repetitive seizures and status epilepticus. It serves as an emergency treatment to control seizures and prevent prolonged episodes, which can be life-threatening. By enhancing the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain, diazepam helps to stabilize neuronal activity and halt seizure progression.

For prescribers, this formulation offers a valuable option for patients who require immediate anticonvulsant effects but cannot receive intravenous therapy. It can be used in both pediatric and adult populations, with dosing adjusted according to the patient's weight and clinical condition. This personalized approach ensures optimal efficacy and safety for each individual patient.

Patients and caregivers will find the pump mechanism user-friendly, reducing administration errors and improving confidence in managing acute episodes.

As with all medications, monitoring for potential side effects is important. Common adverse effects may include drowsiness, dizziness, and fatigue. Prescribers should assess the patient's overall medication regimen to avoid excessive sedation or respiratory depression, particularly when used in conjunction with other central nervous system depressants.

If you have any questions about Diazepam 1 mg/mL Rectal Gel or its use, please reach out to us. Our knowledgeable team at Bayview Pharmacy is here to provide support and information to both patients and healthcare providers.

Drug Interactions

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Diazepam 1 mg/mL Rectal Gel is a semisolid formulation designed for rectal administration, allowing for targeted treatment and absorption of the active ingredient, diazepam, through the rectal mucosa. This formulation is particularly useful for patients who require rapid relief from conditions such as acute anxiety episodes, muscle spasms, or seizures, where oral administration may not be feasible or effective. The gel is dispensed through a pump mechanism, ensuring precise dosing and ease of application.

When considering the use of Diazepam 1 mg/mL Rectal Gel, it is crucial to be aware of potential drug interactions that may affect the efficacy and safety of the treatment. Diazepam is a benzodiazepine that acts on the central nervous system (CNS) to produce a calming effect. As such, it can interact with other CNS depressants, including alcohol, opioids, and other benzodiazepines, leading to enhanced sedative effects, respiratory depression, and increased risk of overdose. Patients should be advised to avoid consuming alcohol and to use caution when taking other medications that may depress the CNS.

Diazepam is metabolized primarily by the cytochrome P450 3A4 (CYP3A4) enzyme. Therefore, drugs that inhibit or induce CYP3A4 can alter the plasma concentration of diazepam, potentially leading to reduced efficacy or increased toxicity. Strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and certain macrolide antibiotics, can increase diazepam levels, necessitating dose adjustments and careful monitoring for signs of excessive sedation or respiratory depression. Conversely, CYP3A4 inducers like rifampin, carbamazepine, and phenytoin may decrease diazepam levels, potentially reducing its therapeutic effects.

Additionally, diazepam may interact with medications that affect its binding to plasma proteins. Drugs such as valproic acid and phenytoin can displace diazepam from its protein-binding sites, leading to increased free concentrations of diazepam and a heightened risk of adverse effects. Patients on such medications should be closely monitored, and dose adjustments may be necessary to maintain therapeutic efficacy while minimizing side effects.

Patients with hepatic or renal impairment should use diazepam with caution, as these conditions can alter the drug's metabolism and excretion, increasing the risk of accumulation and toxicity. In such cases, dose adjustments and more frequent monitoring may be required to ensure appropriate treatment.

For prescribers and patients considering the use of Diazepam 1 mg/mL Rectal Gel, it is essential to review the patient's current medication regimen for potential interactions and to adjust the treatment plan accordingly. If you have any questions or require further information, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist you in optimizing patient care and ensuring the safe use of this formulation.

How Does it Work

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Diazepam 1 mg/mL Rectal Gel is a specialized formulation designed to deliver diazepam, a benzodiazepine, through a semisolid gel that is applied rectally. This method of administration is particularly beneficial for patients who require rapid absorption of the medication, such as those experiencing acute episodes of anxiety, muscle spasms, or seizures. The rectal route allows for the medication to bypass the gastrointestinal tract, leading to faster onset of action compared to oral administration. This is especially crucial in emergency situations where quick relief is necessary.

The gel formulation is dispensed through a pump mechanism, which ensures precise dosing and minimizes the risk of over- or under-dosing. This is particularly important for diazepam, as it is a potent medication with a narrow therapeutic index. The pump mechanism also enhances ease of use, making it accessible for both patients and caregivers, and reducing the potential for administration errors. The gel-like consistency of the formulation allows for smooth application and optimal contact with the rectal mucosa, facilitating efficient absorption of the active ingredient.

Once applied, diazepam is absorbed through the rectal mucosa into the bloodstream, where it exerts its effects by enhancing the activity of gamma-aminobutyric acid (GABA), a neurotransmitter that inhibits nerve transmission in the brain. This action results in the calming of neuronal activity, providing relief from anxiety, muscle spasms, and seizures. The rectal gel formulation is particularly useful for patients who are unable to take oral medications due to nausea, vomiting, or difficulty swallowing, and for those who require a non-invasive, yet effective, method of administration.

For prescribers, it is important to consider the patient's overall health status, current medications, and specific needs when prescribing Diazepam 1 mg/mL Rectal Gel. The formulation offers a unique advantage in terms of rapid onset and ease of administration, making it a valuable option in acute care settings. Patients and caregivers should be educated on the correct use of the pump mechanism to ensure accurate dosing and optimal therapeutic outcomes.

If you have any questions or require further information about Diazepam 1 mg/mL Rectal Gel, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have regarding this formulation.

Other Uses

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Diazepam 1 mg/mL Rectal Gel, while primarily used for the management of acute repetitive seizures and certain anxiety disorders, may have other potential applications that could be beneficial for both patients and prescribers to consider. This semisolid formulation, dispensed through a pump mechanism, allows for easy and precise application, which can be advantageous in various clinical scenarios. One such potential use is in the management of muscle spasms or spasticity associated with neurological conditions such as multiple sclerosis or cerebral palsy. The localized application of diazepam gel can provide targeted relief, minimizing systemic exposure and potentially reducing the risk of systemic side effects commonly associated with oral or intravenous administration.

Additionally, the rectal gel formulation may be considered for patients who have difficulty swallowing or those who are unable to take oral medications due to nausea, vomiting, or gastrointestinal disturbances. This can be particularly useful in palliative care settings, where maintaining patient comfort is a priority. The gel's ability to be absorbed through the skin also opens up possibilities for its use in managing localized pain or discomfort, potentially serving as an adjunct to other pain management strategies.

Furthermore, the ease of application and precise dosing offered by the pump mechanism can enhance adherence to treatment regimens, especially in pediatric or geriatric populations where dosing accuracy is crucial. It is important for prescribers to evaluate the individual needs of their patients and consider the potential benefits of this formulation in contexts beyond its primary indications. As always, any off-label use should be approached with caution, and prescribers should weigh the potential benefits against any risks. If you have any questions or need further information about the use of Diazepam 1 mg/mL Rectal Gel, please reach out to us at Bayview Pharmacy.

Frequently Asked Questions

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What is Diazepam 1 mg/mL Rectal Gel used for?

Diazepam 1 mg/mL Rectal Gel is primarily used for the management of anxiety disorders, muscle spasms, and seizures. It is also used in certain medical procedures to provide sedation and muscle relaxation.

How is the Diazepam Rectal Gel applied?

The gel is dispensed through a pump mechanism, allowing for easy and precise application. It is applied rectally, where it is absorbed through the mucous membranes for targeted treatment.

What are the benefits of using a rectal gel formulation?

The rectal gel formulation allows for rapid absorption of the active ingredient, providing quick relief from symptoms. It is also beneficial for patients who have difficulty swallowing pills or require a non-oral route of administration.

How should I store Diazepam 1 mg/mL Rectal Gel?

Store the gel at room temperature, away from direct sunlight and moisture. Keep it out of reach of children and pets to prevent accidental ingestion or misuse.

Can I use Diazepam Rectal Gel if I am pregnant or breastfeeding?

Consult your healthcare provider before using Diazepam Rectal Gel if you are pregnant or breastfeeding. They will assess the potential risks and benefits to determine if it is appropriate for your situation.

Are there any side effects associated with Diazepam Rectal Gel?

Common side effects may include drowsiness, dizziness, and fatigue. If you experience severe side effects such as difficulty breathing or allergic reactions, seek medical attention immediately.

How often can I use Diazepam 1 mg/mL Rectal Gel?

The frequency of use will depend on your specific medical condition and the advice of your healthcare provider. Follow their instructions carefully to ensure safe and appropriate use.

Is Diazepam Rectal Gel suitable for children?

Diazepam Rectal Gel may be prescribed for children in certain cases, such as for the management of seizures. However, it should only be used under the guidance of a healthcare professional.

Can I use Diazepam Rectal Gel with other medications?

Inform your healthcare provider about all medications you are currently taking, as Diazepam can interact with other drugs. They will advise you on any potential interactions and necessary precautions.

What should I do if I miss a dose of Diazepam Rectal Gel?

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up.

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.

Diazepam 1 mg/mL Rectal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)