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Diphenhydramine HCL 12.5 mg/Haloperidol 0.5 mg/Lorazepam 0.5 mg/Metoclopramide 5 mg/ml Transdermal Gel

The Diphenhydramine HCL 12.5 mg/Haloperidol 0.5 mg/Lorazepam 0.5 mg/Metoclopramide 5 mg/ml Transdermal Gel is a specialized medication compounded to manage symptoms associated with various disease states. This semisolid formulation is designed for transdermal delivery, allowing the active ingredients to be absorbed through the skin. The gel is dispensed through a pump mechanism, which ensures easy and precise dosing.

Diphenhydramine HCL is an antihistamine that can help alleviate allergic reactions and provide sedation. Haloperidol is an antipsychotic used for its antiemetic and sedative properties. Lorazepam, a benzodiazepine, is included for its anxiolytic and sedative effects. Metoclopramide is a prokinetic agent that aids in gastrointestinal motility and also serves as an antiemetic. Together, these medications work synergistically to treat conditions such as severe nausea and vomiting, anxiety, agitation, and insomnia, particularly in a palliative care setting.

This transdermal gel formulation is particularly useful for patients who have difficulty swallowing oral medications or require a rapid onset of action. It is important to apply the gel as directed by a healthcare professional to ensure optimal therapeutic outcomes.

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Formula Information

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This transdermal gel formulation combines four active pharmaceutical ingredients (APIs): Diphenhydramine HCl, Haloperidol, Lorazepam, and Metoclopramide, each with distinct therapeutic effects. Diphenhydramine HCl, an antihistamine, is known for its anticholinergic and sedative properties, which can help alleviate symptoms of allergies and provide sedation. Haloperidol, an antipsychotic, is effective in reducing agitation and delirium. Lorazepam, a benzodiazepine, is included for its anxiolytic, sedative, and muscle relaxant effects. Lastly, Metoclopramide, a dopamine antagonist, is primarily used for its prokinetic properties that enhance gastrointestinal motility, which can be beneficial in treating gastroparesis and similar conditions.

The combination of these APIs in a transdermal gel allows for a multi-modal approach to treatment, targeting various symptoms that may coexist in complex clinical scenarios. For instance, this formulation could be used in palliative care settings to manage symptoms such as nausea, anxiety, restlessness, and allergic reactions. The transdermal route offers the advantage of a non-invasive application with the potential for steady absorption and reduced systemic side effects compared to oral administration.

The semisolid formulation is designed to be dispensed through a pump mechanism, which ensures that each dose is consistent, providing precise dosing and ease of use for both patients and caregivers. The gel-like consistency facilitates application to the skin, allowing for targeted treatment and potentially improving patient compliance. It is important to note that the skin's absorption rate can be influenced by various factors, including the site of application and the skin's condition. Therefore, patients should be instructed on proper application techniques to maximize the therapeutic benefits of the medication.

Prescribers considering this formulation should be aware of the potential interactions and contraindications associated with each component, as well as the cumulative effects when these medications are combined. Monitoring for side effects, such as sedation, extrapyramidal symptoms, or changes in blood pressure, is essential. This formulation should be customized to individual patient needs and used under the guidance of a healthcare professional with experience in compounding and transdermal medication administration.

For more detailed information on this formulation, including its pharmacokinetics, potential side effects, contraindications, and specific usage instructions, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is ready to provide the necessary support and guidance to ensure safe and effective treatment for your patients.

Drug Interactions

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The combination of diphenhydramine HCL, haloperidol, lorazepam, and metoclopramide in a transdermal gel formulation presents a unique profile of potential drug interactions that must be carefully considered by both patients and prescribers. Diphenhydramine, an antihistamine with sedative properties, can enhance the sedative effects of lorazepam, a benzodiazepine, and haloperidol, an antipsychotic. Concurrent use of these medications with other central nervous system depressants, such as opioids, barbiturates, or alcohol, can lead to increased sedation, respiratory depression, and potentially dangerous impairment of cognitive and motor functions.

Haloperidol can interact with drugs that prolong the QT interval, such as certain antiarrhythmics, antibiotics, and antidepressants, increasing the risk of cardiac arrhythmias. Patients with cardiovascular disease or electrolyte imbalances may be at higher risk and should be monitored closely. Additionally, haloperidol may antagonize the effects of dopamine agonists and levodopa, which could be relevant for patients with Parkinson's disease or other dopaminergic disorders.

Lorazepam, when used with other benzodiazepines or drugs that act on the GABA system, such as zolpidem or eszopiclone, can potentiate sedative effects and depress central nervous system function. Caution is advised when combining lorazepam with medications that inhibit hepatic enzymes, particularly CYP3A4, as this can lead to increased lorazepam plasma levels and enhanced effects.

Metoclopramide, a prokinetic agent, can interact with anticholinergic drugs, reducing its efficacy due to opposing effects on gastrointestinal motility. It also has the potential to interact with neuroleptic medications, increasing the risk of extrapyramidal symptoms and neuroleptic malignant syndrome. Serotonergic drugs, such as SSRIs, can increase the risk of serotonin syndrome when used with metoclopramide.

It is important to note that the transdermal route of administration may alter the interaction profile compared to oral administration, but systemic interactions are still possible. Patients should be advised to inform their healthcare providers of all medications they are taking, including over-the-counter drugs and herbal supplements. Prescribers should carefully evaluate the patient's medication regimen for potential interactions before initiating treatment with this transdermal gel. Monitoring for adverse effects and therapeutic efficacy is recommended, and dose adjustments may be necessary based on the patient's clinical response and any concurrent medications. If you have any questions or require further information, please reach out to us at Bayview Pharmacy.

How Does it Work

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The transdermal gel formulation containing Diphenhydramine HCL, Haloperidol, Lorazepam, and Metoclopramide is designed to deliver medication directly through the skin, offering an alternative route of administration for patients who may have difficulties with oral medications. This semisolid formulation is dispensed through a pump mechanism, which allows for easy and precise dosing. The gel is applied topically, where it penetrates the skin to exert its therapeutic effects.

Diphenhydramine HCL is an antihistamine that works by blocking histamine H1 receptors, which can help alleviate allergic reactions and provide sedative effects. In this transdermal formulation, Diphenhydramine HCL can help reduce nausea and vomiting by its antiemetic properties, and it may also aid in improving sleep or reducing anxiety due to its sedative effects.

Haloperidol is an antipsychotic medication that works by blocking dopamine receptors in the brain. It is commonly used to treat psychiatric conditions such as schizophrenia, but in this combination, it is used for its antiemetic properties. Haloperidol can help control nausea and vomiting, particularly when these symptoms are resistant to other treatments.

Lorazepam is a benzodiazepine that enhances the effect of the neurotransmitter gamma-aminobutyric acid (GABA) at the GABA-A receptor, which results in sedative, anxiolytic (anti-anxiety), and anticonvulsant effects. In this formulation, Lorazepam is used primarily for its ability to reduce anxiety and help with insomnia, which can be beneficial for patients experiencing distress due to their medical conditions.

Metoclopramide is a prokinetic and antiemetic agent that works by blocking dopamine receptors in the chemoreceptor trigger zone and increasing the upper gastrointestinal tract motility. It accelerates gastric emptying and improves gastroesophageal sphincter tone. Metoclopramide's inclusion in this gel is particularly useful for treating gastroparesis and refractory nausea and vomiting.

This combination transdermal gel is particularly useful in palliative care, where patients may have multiple symptoms such as nausea, vomiting, anxiety, and insomnia. The transdermal route provides a non-invasive option that can be easier for patients who are unable to swallow or have gastrointestinal issues that interfere with oral medication absorption. The gel formulation allows for the medication to be absorbed steadily over time, providing a consistent therapeutic effect.

It is important for both patients and prescribers to understand that the effectiveness and safety of this transdermal gel formulation depend on proper dosing and application. The skin site should be clean and free from any cuts or irritations to ensure optimal absorption. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. We are here to support your healthcare needs with our expertise in compounding pharmacy.

Other Uses

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The formulation of Diphenhydramine HCL 12.5 mg/Haloperidol 0.5 mg/Lorazepam 0.5 mg/Metoclopramide 5 mg/ml as a transdermal gel is primarily designed for its antiemetic, anxiolytic, antipsychotic, and antihistaminic effects. However, other possible uses could take advantage of the sedative properties of diphenhydramine and lorazepam and the anti-nausea effects conferred by metoclopramide and haloperidol. Besides the apparent applications in managing nausea, vomiting, anxiety, and allergic reactions, this preparation may be of benefit in patients experiencing pruritis, such as that due to allergic reactions or chronic diseases like eczema or psoriasis, where the antihistaminic action of diphenhydramine can provide relief.

Furthermore, this gel could be considered for off-label use in the palliative care setting for the management of terminal restlessness or agitation, under the guidance of medical professionals experienced in palliative care. Haloperidol and lorazepam's combination could provide sedation and relief of distress, whereas metoclopramide could aid in controlling nausea and vomiting often seen in terminally ill patients. It is essential to recognize that uses outside the primary indications should be thoroughly evaluated on a case-by-case basis, taking into account the patient's entire clinical picture and potential drug-drug interactions.

Due to the inclusive nature of this formulation and its potential systemic effects, it is also conceivable that it could be used to manage acute dystonic reactions, a possible side effect of dopamine antagonists such as haloperidol. The anticholinergic effects of diphenhydramine may counteract dystonic reactions, while the anxiolytic properties of lorazepam could help reduce the distress associated with such reactions. In treating migraines, where nausea and vomiting are prominent, the combination of these agents may offer symptomatic relief.

It is important to remember that the use of this formulation requires careful consideration and should be done under the supervision of a healthcare provider. The potential risks and benefits should be weighed, especially in patients with underlying health conditions or those who are taking other medications. Patient education on the correct method of application and adherence to the dosage guidelines is crucial for ensuring both the safety and efficacy of treatment with this transdermal gel.

If you have any questions regarding this formulation or its potential other uses, please reach out to us at Bayview Pharmacy. As compounding pharmacists, we are committed to providing our knowledge and guidance to ensure safe and effective medication use tailored to individual patient needs.

Frequently Asked Questions

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What is the purpose of this compounded transdermal gel?

This compounded transdermal gel is used for the targeted treatment of various symptoms such as allergies, nausea, vomiting, agitation, and anxiety by combining the effects of Diphenhydramine HCL, Haloperidol, Lorazepam, and Metoclopramide in a single formulation. It is designed for patients who may require a multimodal approach to symptom management without the need to take oral medications.

How do I use the transdermal gel?

To use the transdermal gel, press the pump mechanism to dispense the prescribed amount of medication onto your fingertip or directly onto the skin. Apply the gel to an area of the skin as advised by your healthcare provider, usually to an area with thin skin, such as the inside of the wrist, to facilitate absorption. Rub the gel gently into the skin until it is fully absorbed.

How often should I apply the compounded transdermal gel?

The frequency of application will depend on the individual treatment plan prescribed by your healthcare provider. Generally, the gel is applied one to three times daily or as directed. Always follow the specific instructions provided by your doctor or pharmacist.

What are the possible side effects of using this transdermal gel?

Side effects could include drowsiness, dry mouth, changes in appetite, restlessness, skin irritation at the application site, and, in rare instances, more severe symptoms such as irregular heartbeat or severe dizziness. If you experience any concerning symptoms, contact your healthcare provider immediately.

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

No, the gel should only be applied to areas of the skin that are recommended by your healthcare provider, typically areas with thinner skin for better absorption, such as the inner wrists or behind the ears. Avoid areas that are cut, bruised, or irritated.

Can this transdermal gel be used with other medications?

This medication may interact with other drugs. It is important to inform your healthcare provider of all medications you are currently taking, including prescription, over-the-counter medications, and any supplements, before starting this treatment.

Should I use a bandage over the application site?

Do not cover the application site with a bandage unless advised to do so by your healthcare provider, as this could change the absorption rate of the medication.

What should I do if I miss a dose?

If you miss a dose, apply it as soon as you remember, unless it is close to the time of your next dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

How should I store the compounded transdermal gel?

Store the gel at room temperature away from light and moisture. Do not refrigerate or freeze, and keep the gel out of reach of children and pets.

What should I do in case of an overdose?

If you suspect an overdose or experience severe symptoms, such as difficulty breathing or unconsciousness, seek emergency medical attention immediately. Have the medication container or label ready to show medical personnel.

Can I stop using the compounded transdermal gel whenever I feel better?

Do not discontinue the use of the gel without consulting with your healthcare provider. Your doctor will advise you on how to safely taper off the medication if needed.

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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.