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Promethazine Hydrochloride 2.5 mg/mL Rectal Gel

Promethazine Hydrochloride 2.5 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.

This formulation is primarily used to treat nausea, vomiting, and motion sickness. It is also effective in managing allergy symptoms, such as itching, runny nose, and sneezing, and can be used as a sedative or sleep aid in certain cases.

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Promethazine Hydrochloride
Topical Gel
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Formula Information

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Drug Interactions

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Promethazine Hydrochloride 2.5 mg/mL Rectal Gel is a compounded formulation designed for rectal administration, providing a semisolid consistency that allows for precise dosing and targeted treatment. This formulation is particularly useful for patients who may have difficulty with oral administration or require localized treatment. Promethazine is an antihistamine with antiemetic, sedative, and anticholinergic properties, commonly used to treat nausea, vomiting, allergies, and motion sickness, as well as to provide sedation.

When considering the use of Promethazine Hydrochloride 2.5 mg/mL Rectal Gel, it is crucial to be aware of potential drug interactions that may affect the safety and efficacy of the treatment. Promethazine can interact with a variety of medications, which may enhance or diminish its effects or increase the risk of adverse reactions. Patients and prescribers should be particularly cautious when using this formulation in conjunction with other central nervous system (CNS) depressants, such as benzodiazepines, opioids, barbiturates, and alcohol, as these combinations can lead to enhanced sedative effects, respiratory depression, and profound CNS depression.

Additionally, promethazine may interact with monoamine oxidase inhibitors (MAOIs), leading to an increased risk of severe side effects such as hypotension, respiratory depression, and extrapyramidal symptoms. It is generally advised to avoid concurrent use of promethazine with MAOIs or to proceed with extreme caution under close medical supervision. Anticholinergic medications, including certain antidepressants, antipsychotics, and medications for Parkinson's disease, may also interact with promethazine, potentially exacerbating anticholinergic side effects such as dry mouth, urinary retention, constipation, and confusion.

Promethazine may also affect the metabolism of other drugs by inhibiting cytochrome P450 enzymes, particularly CYP2D6. This can lead to increased plasma concentrations of drugs metabolized by this pathway, such as certain beta-blockers, antidepressants, and antipsychotics, potentially resulting in toxicity. Conversely, medications that induce CYP450 enzymes may reduce the effectiveness of promethazine by increasing its metabolism and clearance from the body.

Patients with pre-existing conditions such as glaucoma, cardiovascular disease, respiratory disorders, or prostate enlargement should use promethazine with caution, as the drug's anticholinergic and sedative properties may exacerbate these conditions. It is essential for prescribers to thoroughly review a patient's medication history and current drug regimen to identify potential interactions and adjust treatment plans accordingly.

For any questions or concerns regarding the use of Promethazine Hydrochloride 2.5 mg/mL Rectal Gel, or to discuss specific patient cases, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is available to provide expert guidance and support to ensure safe and effective use of this formulation.

How Does it Work

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Promethazine Hydrochloride 2.5 mg/mL Rectal Gel is a specialized formulation designed to deliver the active ingredient, promethazine hydrochloride, through the rectal mucosa. This semisolid gel is dispensed via a pump mechanism, allowing for precise dosing and easy application. The gel-like consistency ensures that the medication remains in contact with the mucosal surface for optimal absorption. Promethazine is an antihistamine that works by blocking the action of histamine, a substance in the body that causes allergic symptoms. It also has antiemetic, sedative, and anticholinergic properties, making it effective in treating a variety of conditions.

When applied rectally, the gel formulation allows for the active ingredient to be absorbed directly into the bloodstream through the rich vascular network of the rectal mucosa. This route of administration can be particularly beneficial for patients who are unable to take medications orally due to nausea, vomiting, or other gastrointestinal issues. The rectal gel formulation bypasses the gastrointestinal tract, reducing the risk of degradation by stomach acids and enzymes, and providing a more rapid onset of action compared to oral administration.

Promethazine Hydrochloride Rectal Gel is commonly used to treat conditions such as nausea and vomiting, motion sickness, and allergic reactions. Its sedative properties also make it useful for preoperative sedation and as an adjunct to analgesics for pain management. The precise dosing mechanism of the pump ensures that patients receive the correct amount of medication, minimizing the risk of side effects associated with overdosage, such as drowsiness, dizziness, and dry mouth.

For prescribers, this formulation offers a versatile option for patients who require an alternative to oral or injectable routes. The ease of application and controlled dosing make it a practical choice for both acute and chronic management of symptoms. It is important to instruct patients on the correct method of application to ensure maximum efficacy and safety. Patients should be advised to apply the gel as directed, typically to the rectal area, and to wash their hands thoroughly after application to prevent accidental contact with the eyes or other mucous membranes.

If you have any questions about Promethazine Hydrochloride 2.5 mg/mL Rectal Gel, its uses, or its application, please 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 ensure the best possible outcomes for your patients.

Other Uses

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Promethazine Hydrochloride 2.5 mg/mL Rectal Gel, while primarily used for its antiemetic and antihistamine properties, has potential applications beyond the treatment of nausea, vomiting, and allergic reactions. This semisolid formulation, dispensed through a pump mechanism, allows for easy and precise application, making it suitable for various off-label uses that may benefit from its pharmacological effects. One such potential use is in the management of motion sickness, where its ability to prevent nausea and vomiting can be particularly beneficial for patients who have difficulty swallowing oral medications or who require a more rapid onset of action. Additionally, the sedative properties of promethazine may be utilized in certain cases to help manage anxiety or agitation, especially in patients who are unable to take oral medications due to gastrointestinal issues or other contraindications.

Furthermore, the anti-inflammatory properties of promethazine may offer relief in conditions characterized by localized inflammation or irritation, such as certain dermatological conditions. The gel formulation allows for targeted application, potentially reducing systemic side effects and focusing the therapeutic effects on the affected area. In some cases, promethazine gel may also be considered for use in managing symptoms of vertigo, where its vestibular suppressant effects can help alleviate dizziness and balance disturbances. It is important for prescribers to consider the individual needs of their patients and the specific clinical context when exploring these alternative uses, ensuring that the benefits outweigh any potential risks.

Patients should be informed about the potential off-label uses of promethazine gel and should consult with their healthcare provider to determine if this formulation is appropriate for their specific condition. As with any medication, it is crucial to follow the prescribed dosage and application instructions to minimize the risk of adverse effects. If you have any questions or need further information about the use of Promethazine Hydrochloride 2.5 mg/mL Rectal Gel, please 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.

Frequently Asked Questions

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What is Promethazine Hydrochloride 2.5 mg/mL Rectal Gel used for?

Promethazine Hydrochloride 2.5 mg/mL Rectal Gel is used for the treatment of nausea, vomiting, and allergy symptoms. It may also be used to help with motion sickness and as a sedative or sleep aid.

How is the gel applied?

The gel is dispensed through a pump mechanism, allowing for easy and precise application on the skin. It is designed for targeted treatment or absorption of active ingredients.

Where should I apply the gel?

The gel should be applied to the rectal area as directed by your healthcare provider. Ensure the area is clean and dry before application.

How often should I use the gel?

The frequency of use will depend on your specific condition and the advice of your healthcare provider. Follow the prescribed dosage instructions carefully.

Can I use this gel for children?

Promethazine Hydrochloride Rectal Gel should only be used in children if prescribed by a healthcare provider. It is important to follow the dosage and application instructions provided by the healthcare professional.

Are there any side effects associated with this gel?

Possible side effects may include drowsiness, dizziness, dry mouth, or irritation at the application site. If you experience severe side effects or an allergic reaction, seek medical attention immediately.

Can I use this gel if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult your healthcare provider before using this gel to ensure it is safe for you and your baby.

How should I store the gel?

Store the gel at room temperature, away from direct sunlight and moisture. Keep it out of reach of children and pets.

What should I do if I miss a dose?

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.

Can I use other medications while using this gel?

Before using other medications, including over-the-counter drugs and supplements, consult your healthcare provider to avoid potential interactions.

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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.