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Mirtazapine 3.25 mg/0.5 mL Transdermal Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Mirtazapine

The Mirtazapine 3.25 mg/0.5 mL Transdermal Gel is a semisolid formulation designed for ease of use and precise dosing through a pump mechanism. This gel-like medication is applied topically to the skin, where it is absorbed to exert its therapeutic effects. Mirtazapine is commonly used in the management of depression and anxiety disorders, providing an alternative route of administration for patients who may have difficulties with oral dosing. Additionally, this transdermal system can be beneficial in the treatment of conditions such as insomnia and various forms of chronic pain, where mirtazapine's sedative and analgesic properties can be advantageous. The transdermal delivery system ensures a targeted approach, potentially reducing systemic side effects and improving patient compliance.

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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.
Mirtazapine
Topical Gel
65bbdfe58f8435d568e2f248
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Bayview fills prescriptions for patients in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, Pennsylvania and Rhode Island. New York patients are served on a limited basis while nonresident pharmacy registration is pending.

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Formula Information

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Mirtazapine 3.25 mg/0.5 mL Transdermal Gel is a specialized medication formulated for patients who require an alternative to oral administration of mirtazapine, an antidepressant commonly used to treat major depressive disorder and various other mental health conditions. This semisolid formulation is designed to be dispensed through a pump mechanism, which ensures a consistent and precise dose with each application. The gel-like consistency of the medication allows for easy application and targeted treatment, as it can be applied directly to the skin where absorption into the bloodstream can occur.

The transdermal delivery system offers several advantages, including the bypassing of gastrointestinal absorption, which can be beneficial for patients with gastrointestinal issues or those who experience nausea or vomiting with oral medications. Additionally, this route of administration may reduce the risk of first-pass metabolism by the liver, potentially leading to more stable plasma concentrations of the drug and improved efficacy. Mirtazapine is known for its sedative effects, which can be helpful for patients with depression who also suffer from insomnia. By using a transdermal gel, patients may experience a more gradual onset of these sedative effects, which could be more tolerable for some individuals.

The use of mirtazapine transdermal gel may be particularly useful for patients who have difficulty swallowing pills, those with noncompliance issues, or for certain populations such as the elderly or those with neurological disorders that make oral administration challenging. It is important to note that the transdermal route may also alter the pharmacokinetic profile of mirtazapine, and careful monitoring by healthcare providers is necessary to ensure therapeutic effectiveness and to minimize the risk of adverse effects.

For prescribers considering this formulation for their patients, it is essential to understand that the dosing and absorption of transdermal medications can differ from oral forms. Therefore, dose adjustments may be necessary when transitioning patients from oral to transdermal mirtazapine. Pharmacists at Bayview Pharmacy are available to provide guidance on the appropriate use of this formulation, including dosing recommendations, application instructions, and monitoring parameters. We encourage both patients and prescribers to reach out to us with any questions or concerns regarding the use of Mirtazapine 3.25 mg/0.5 mL Transdermal Gel, as we are committed to ensuring appropriate treatment.

Drug Interactions

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Mirtazapine is a tetracyclic antidepressant commonly used to treat major depressive disorder and, in some cases, anxiety, insomnia, and various other conditions. When formulated as a 3.25 mg/0.5 mL transdermal gel, it is absorbed through the skin, potentially altering its interaction profile compared to oral administration. However, it is important to consider that mirtazapine, regardless of the route of administration, can interact with a variety of substances.

One significant interaction is with central nervous system (CNS) depressants. Mirtazapine can enhance the sedative effects of other CNS depressants, including benzodiazepines, opioids, antihistamines, antipsychotics, and alcohol. Patients should be advised to avoid or limit the use of alcohol and be cautious when taking other CNS depressants concurrently with mirtazapine transdermal gel.

Another important interaction is with monoamine oxidase inhibitors (MAOIs). The use of mirtazapine in combination with MAOIs is contraindicated due to the risk of serotonin syndrome, a potentially life-threatening condition. A washout period of at least 14 days should be observed when switching between mirtazapine and MAOIs.

Additionally, mirtazapine may interact with serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and triptans, among others. The concomitant use of these medications can increase the risk of serotonin syndrome. Symptoms of serotonin syndrome may include mental status changes, autonomic instability, neuromuscular aberrations, and gastrointestinal symptoms. Patients should be monitored closely for signs of serotonin syndrome, especially when starting or increasing the dose of any serotonergic medication.

Patients taking warfarin or other anticoagulants should be monitored for changes in prothrombin time or INR, as mirtazapine can affect platelet function and potentially alter the anticoagulant effect.

Furthermore, mirtazapine may interact with drugs that affect hepatic enzymes, particularly those that are metabolized by cytochrome P450 enzymes such as CYP2D6 and CYP3A4. Inhibitors of these enzymes may increase mirtazapine levels, while inducers may decrease them, potentially leading to altered efficacy or side effects of mirtazapine.

It is also important to consider the potential for pharmacodynamic interactions. For example, mirtazapine may enhance the antihypertensive effects of antihypertensive agents, which could lead to an increased risk of hypotension.

Patients should be advised to inform their healthcare providers of all medications they are taking, including prescription drugs, over-the-counter medications, and herbal supplements. This will help to identify and manage any potential drug interactions. Additionally, patients should be instructed to report any unusual symptoms or changes in their condition to their healthcare provider.

For prescribers and patients considering the use of mirtazapine transdermal gel, it is crucial to review the patient's medication profile for potential interactions. If you have any questions or require further information regarding drug interactions with mirtazapine transdermal gel, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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The Mirtazapine 3.25 mg/0.5 mL Transdermal Gel is a specialized medication designed for transdermal delivery, meaning it is absorbed through the skin. This particular formulation is a semisolid gel, which is dispensed from a pump mechanism. The pump allows for precise dosing, ensuring that each application delivers a consistent amount of the active ingredient, mirtazapine, to the patient. The gel base is designed to facilitate the penetration of mirtazapine through the skin barrier, allowing it to enter the systemic circulation and exert its therapeutic effects.

Mirtazapine is a tetracyclic antidepressant that works by modulating the activity of certain chemical messengers in the brain, particularly serotonin and norepinephrine. It is thought to enhance mood by increasing the levels of these neurotransmitters in the brain. While mirtazapine is commonly taken orally, the transdermal route offers several advantages, including the potential for steady absorption, reduced gastrointestinal side effects, and convenience for patients who may have difficulty swallowing pills.

The transdermal gel is particularly useful for patients with depression or anxiety who may benefit from the effects of mirtazapine but are unable to tolerate oral medication due to side effects or other conditions that affect the gastrointestinal tract. Additionally, the transdermal delivery system can be advantageous for achieving a more stable blood concentration of the drug, potentially leading to better control of symptoms with fewer peaks and troughs than oral administration.

It is important for both patients and prescribers to understand that while the transdermal delivery of mirtazapine offers a novel approach to treatment, it should be used according to the specific instructions provided with the medication. The site of application should be clean, dry, and free of any cuts or irritations to ensure optimal absorption and minimize the risk of skin reactions. The use of this formulation should be regularly evaluated by a healthcare provider to ensure its effectiveness and safety for the individual patient.

If you have any questions about the Mirtazapine 3.25 mg/0.5 mL Transdermal Gel or its use in treating depression or anxiety, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide you with the information and support you need to effectively manage your health condition.

Other Uses

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The Mirtazapine 3.25 mg/0.5 mL Transdermal Gel is primarily prescribed as an off-label use for mental health conditions such as depression in patients who may have difficulty swallowing or have gastrointestinal issues that reduce the efficacy of oral medications. However, beyond its primary application, this formulation has shown potential in addressing other conditions that could benefit from its unique administration route.

Research indicates that the unique transdermal delivery system of this formulation may be advantageous in managing certain cases of chronic pain, specifically neuropathic pain, where traditional routes of administration are not ideal or well-tolerated. The gel's ability to bypass the gastrointestinal tract allows for steady absorption through the skin, potentially providing more consistent plasma levels of mirtazapine. This transdermal system may help mitigate some systemic side effects associated with the oral route and may offer a more favorable option for patients with digestive complications or those who cannot comply with oral medication regimens.

Moreover, the transdermal application has been explored as a mode of therapy for patients experiencing anxiety or sleep disturbances. The sedative properties of mirtazapine may be beneficial in these cases, with the gel format allowing for a less invasive treatment method that can be self-administered in a home setting. Although not extensively studied, there is anecdotal evidence suggesting transdermal mirtazapine may assist in managing certain behaviors in geriatric patients with dementia when other medications are not suitable.

It is also worth considering the potential use of this transdermal gel in synergistic therapies, where mirtazapine is used as an adjunct to other treatments prescribed for conditions such as major depressive disorder or generalized anxiety disorder, especially when managing side effects or augmenting therapeutic outcomes. The transdermal route may be particularly beneficial in cases where multiple drugs are administered, reducing the pill burden and potentially improving compliance.

As with all off-label uses, prescribers should evaluate the potential benefits against any risks, considering the individual circumstances of their patients. Ongoing monitoring and dosage adjustments may be necessary to optimize therapeutic outcomes. If you have any questions or require more information regarding the potential other uses of Mirtazapine 3.25 mg/0.5 mL Transdermal Gel, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to both patients and prescribers considering this formulation.

Frequently Asked Questions

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What is Mirtazapine 3.25 mg/0.5 mL Transdermal Gel?

Mirtazapine Transdermal Gel is a medication formulated for application to the skin. It contains 3.25 milligrams of Mirtazapine per 0.5 mL of gel, and it is used to treat various conditions as determined by a healthcare professional. The gel is dispensed through a pump for easy and precise dosing.

How should I use Mirtazapine Transdermal Gel?

Clean and dry the area of skin where the gel will be applied. Press the pump to dispense the recommended dose, and gently spread the gel over the skin as directed by your healthcare provider. The dosage and specific application site may vary based on your treatment plan.

How often should I apply Mirtazapine Transdermal Gel?

The frequency of application will depend on your individual prescription. Always follow the dosing instructions provided by your healthcare professional.

What are the benefits of using a transdermal gel formulation for Mirtazapine?

A transdermal gel allows for targeted treatment and can provide a steady absorption of the active ingredient through the skin, potentially resulting in reduced side effects and improved patient adherence.

Can I apply the gel to any area of the skin?

No, you should only apply the gel to the area of skin as instructed by your healthcare provider. Some areas of the skin may absorb the medication better or may minimize the risk of interaction with other substances.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember. However, if it is near the time for your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Are there any side effects of Mirtazapine Transdermal Gel?

As with any medication, side effects are possible. Common side effects may include irritation at the application site, dizziness, or drowsiness. Contact your healthcare provider if you experience any severe or concerning symptoms.

How should I store Mirtazapine Transdermal Gel?

Store the gel at room temperature, away from heat and direct light. Do not freeze the medication. Keep the container tightly closed when not in use.

Can I shower or swim after applying the gel?

Wait until the gel has completely dried on your skin before swimming or bathing to ensure proper absorption of the medication. Your healthcare provider can give you more specific guidelines regarding wait times.

Is Mirtazapine Transdermal Gel safe for children or pets?

This medication should be used only as prescribed and typically is not indicated for children or pets without specific advice from a healthcare provider. Keep this and all medications out of the reach of children and pets.

Can I cover the area with a bandage after applying the gel?

Do not cover the treated area with a bandage or occlusive dressing unless specifically directed by your healthcare provider as this can alter the absorption of the medication.

What should I do in case of an overdose?

If you or someone else has used too much of this medication, contact a healthcare provider or the local poison control center immediately. If the person has collapsed or is not breathing, call 911.

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.

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.

Mirtazapine 3.25 mg/0.5 mL Transdermal Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Twice daily