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Formulas

Diphenhydramine HCl 25 mg/Promethazine HCl 25 mg Rectal Suppository

The Diphenhydramine HCl 25 mg/Promethazine HCl 25 mg Rectal Suppository is a solid dosage form designed for insertion into the rectum. Upon insertion, the suppository dissolves or melts, facilitating the release of two active pharmaceutical ingredients, Diphenhydramine HCl and Promethazine HCl, for both local and systemic absorption. This combination medication is commonly used for the treatment of various disease states including allergies, motion sickness, nausea, vomiting, and as a sedative or sleep aid. The dual-action of Diphenhydramine, an antihistamine, and Promethazine, a phenothiazine, provides effective symptom relief for these conditions.

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Formula Information

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The Diphenhydramine HCl 25 mg/Promethazine HCl 25 mg Rectal Suppository is a solid dosage form designed for insertion into the rectum, where it dissolves or melts to release the active ingredients for absorption. This combination medication is used primarily for the management of various conditions such as allergies, motion sickness, nausea, vomiting, and for sedation prior to or after surgery. Diphenhydramine is an antihistamine that works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Promethazine is a phenothiazine that acts as an antihistamine with additional antiemetic (anti-vomiting) and sedative properties.

When compounded into a rectal suppository, these medications can provide relief for patients who are unable to take oral medications due to vomiting, are unconscious, or for other reasons where oral administration is not feasible. The rectal route can offer a more comfortable alternative for patients, especially children or the elderly, and can provide systemic effects similar to oral administration. The combination of diphenhydramine and promethazine in a single suppository can be particularly beneficial for synergistic effects, as both drugs can enhance the efficacy of the other in treating the aforementioned conditions.

It is important for prescribers to consider the potential side effects of both medications, which may include drowsiness, dizziness, constipation, blurred vision, or dry mouth. Caution is advised when prescribing this medication to patients with certain medical conditions or when taking other medications that may interact with antihistamines. Additionally, the use of this suppository form should be carefully considered in patients with rectal disorders or those who have recently undergone rectal surgery.

As compounding pharmacists at Bayview Pharmacy, we ensure that each suppository is prepared to the highest standards of quality and safety, tailored to meet the specific needs of the patient. We are available to answer any questions and provide guidance on the appropriate use of this formulation. If you have any questions or require further information, please do not hesitate to reach out to us.

Drug Interactions

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The combination of Diphenhydramine HCl and Promethazine HCl in a rectal suppository form is intended for the relief of various symptoms such as allergies, motion sickness, nausea, vomiting, and for sedation. Both active ingredients are antihistamines with sedative properties, and when used together, they may enhance each other's effects. It is crucial to be aware of potential drug interactions when using this formulation.

Concomitant use of other central nervous system depressants, including alcohol, benzodiazepines, opioids, and other sedatives, can increase the risk of sedation, respiratory depression, and other CNS depressant effects. Patients should be advised to avoid or limit the use of alcohol and other CNS depressants while using this suppository formulation.

Anticholinergic drugs, such as atropine, scopolamine, and some antidepressants (tricyclics), antipsychotics, and antiparkinsonian drugs, can enhance the anticholinergic effects of both diphenhydramine and promethazine, leading to increased risk for dry mouth, urinary retention, constipation, and potential heat prostration in hot environments due to decreased sweating.

MAO inhibitors (MAOIs) can prolong and intensify the anticholinergic effects of antihistamines and may lead to hypotension and central nervous system excitation or depression. It is generally recommended to avoid the use of MAOIs within 14 days of taking medications containing diphenhydramine or promethazine.

Use of this suppository in conjunction with other antihistamines, either prescription or over-the-counter, can increase the risk of additive antihistamine effects, such as increased sedation, dizziness, and dry mouth. Patients should be advised to check with a healthcare provider before using additional antihistamines.

Patients with certain medical conditions, such as glaucoma, enlarged prostate, thyroid dysfunction, cardiovascular disease, or respiratory conditions like asthma, COPD, or sleep apnea, should use this formulation with caution due to the potential exacerbation of symptoms related to these conditions.

It is important to note that this is not an exhaustive list of all possible drug interactions. Patients should be encouraged to inform their healthcare provider of all medications, supplements, and herbal products they are currently taking to ensure safety and efficacy of the diphenhydramine and promethazine suppository. If you have any questions or concerns regarding this formulation or its interactions with other drugs, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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The Diphenhydramine HCl 25 mg/Promethazine HCl 25 mg Rectal Suppository is a solid dosage form designed for insertion into the rectum. Upon insertion, the suppository base, typically made from substances like cocoa butter or a synthetic substitute, begins to melt or dissolve due to the warmth of the body. As the base dissolves, it releases the active pharmaceutical ingredients, Diphenhydramine HCl and Promethazine HCl, which are then absorbed through the rectal mucosa.

Diphenhydramine HCl is an antihistamine that works by blocking the action of histamine, a substance in the body that causes allergic symptoms. It is commonly used for the relief of allergic symptoms, including itching and hives, as well as for its sedative effects to treat insomnia. In addition, it possesses anticholinergic properties that can help with the symptoms of Parkinson's disease and motion sickness.

Promethazine HCl is another antihistamine with a similar profile to Diphenhydramine. It also acts as an antiemetic, reducing the effects of nausea and vomiting, and has significant sedative properties. Promethazine is often used in the prevention and treatment of motion sickness, to alleviate allergy symptoms, and as a preoperative sedative.

When combined in a rectal suppository, these two medications can provide significant relief from various conditions. The rectal route is particularly useful when patients are unable to take medications orally due to vomiting, or when a rapid onset of action is desired. The absorption through the rectal mucosa bypasses the first-pass metabolism in the liver, which can lead to more of the drug reaching the systemic circulation and potentially a quicker onset of action compared to oral administration.

This formulation is used to treat conditions such as severe allergic reactions, nausea and vomiting associated with certain types of anesthesia and surgery, and to induce sedation for the management of anxiety or sleep disorders. The combination of Diphenhydramine and Promethazine in a suppository form can be particularly beneficial for patients who require both the antihistaminic and antiemetic effects of these medications.

It is important for patients and prescribers to understand that while this formulation provides the benefits of both medications, it also has the potential for additive side effects, such as increased drowsiness, dry mouth, blurred vision, or urinary retention. Therefore, caution should be exercised when using this suppository, especially in the elderly or in those with underlying health conditions. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with your medication needs.

Other Uses

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The diphenhydramine HCl 25 mg/promethazine HCl 25 mg rectal suppository is primarily indicated for the management of various conditions that include allergic reactions, motion sickness, nausea, vomiting, and for inducing sedation. However, the unique combination of antihistamine and phenothiazine in this formulation allows for potential off-label uses that should be approached with caution and under the guidance of a healthcare professional. For example, the sedative properties may be helpful in patients with insomnia, especially when conventional oral medications are not suitable or in cases of significant nausea where oral administration is compromised.

In addition to its use in treating allergic reactions, such as for symptoms of hay fever or reaction to insect bites, diphenhydramine, an antihistamine, can also be beneficial in managing cases of dystonic reactions due to its anticholinergic effects. On the other hand, promethazine has anti-emetic and anticholinergic properties, making this suppository potentially useful in managing severe morning sickness during pregnancy, although this should be considered with extreme caution due to potential risks to the fetus. The antiemetic properties of promethazine also could extend the use of this formulation for postoperative patients who are unable to take oral medications and are experiencing nausea and vomiting.

Other less common uses include the use of this rectal suppository formulation for managing anxiety and providing mild sedation in patients who cannot tolerate oral medications or have needle phobia, ensuring the medication can be delivered effectively without the distress associated with other routes of administration. The formulation's rectal mode of application also provides an alternative route of delivery for patients with gastrointestinal issues that affect oral drug absorption or with complications such as gastroparesis where delayed gastric emptying can hinder effective treatment.

While this suppository may be used to address various health issues, it is important to note that this combination medication may not be appropriate for all patients. Particular caution should be exercised in the pediatric and geriatric population due to possible increased sensitivity to the side effects such as dizziness, confusion, or sedation, which can lead to an increased risk of falls and injuries in these groups.

Any additional uses of this medication, beyond those described in this section, should be done with a thorough understanding of the patient's medical history and other medications they are taking, to avoid drug interactions and potential adverse effects. As with all medications, the benefits of off-label uses must be carefully weighed against the risks, and they should be explored under the direct supervision of a healthcare provider. If you have any questions about the formulation, potential uses, or if it is appropriate for you or your patient, please reach out to us at Bayview Pharmacy for more information and personalized guidance.

Frequently Asked Questions

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What is a Diphenhydramine HCl/Promethazine HCl Rectal Suppository used for?

Diphenhydramine HCl/Promethazine HCl Rectal Suppository is a medication used primarily to reduce symptoms associated with allergies, motion sickness, nausea, vomiting, and to induce sedation. By combining two antihistamines, it provides relief from these symptoms by blocking certain natural substances your body makes during an allergic reaction.

How does this rectal suppository work?

This rectal suppository is inserted into the rectum where it dissolves or melts, enabling the medication to be absorbed into the bloodstream. This allows for local or systemic delivery of the medications, Diphenhydramine HCl and Promethazine HCl, to exert their effects.

How do I use a Diphenhydramine HCl/Promethazine HCl Rectal Suppository?

To use the suppository, first wash your hands thoroughly. Remove any wrapping from the suppository before insertion. Lie on your side and gently push the suppository into the rectum with your finger, pointed end first. Remain lying down for a few minutes to ensure that the suppository stays in place and can start to dissolve.

How often can I use Diphenhydramine HCl/Promethazine HCl Rectal Suppositories?

The frequency of use for these rectal suppositories should be as directed by your healthcare provider. It's important not to exceed the recommended dose or frequency to avoid potential overdose or increased risk of side effects.

Can children use Diphenhydramine HCl/Promethazine HCl Rectal Suppositories?

The use of Diphenhydramine HCl/Promethazine HCl Rectal Suppositories in children should be under the guidance of a healthcare professional. Due to the risks of side effects, especially in younger children, proper dosing and monitoring are imperative.

What should I do if I miss a dose?

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

Can I drive or operate machinery after using this suppository?

It is recommended to avoid driving or operating machinery until you know how the combination of Diphenhydramine HCl and Promethazine HCl affects you, as it can cause drowsiness, dizziness, or blurred vision.

Are there any potential side effects?

Like all medications, the use of Diphenhydramine HCl/Promethazine HCl Rectal Suppositories can cause side effects, although not everyone will experience them. Possible side effects include drowsiness, dizziness, confusion, dry mouth, blurred vision, or constipation. If you experience any severe side effects or signs of an allergic reaction, seek medical attention immediately.

How should I store these suppositories?

Suppositories should be stored in their original packaging, away from direct light and heat. Keep them at room temperature and out of reach of children and pets. Do not store them in the bathroom, as the humidity can affect the medication.

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

If you are pregnant or breastfeeding, it's crucial to consult your healthcare provider before using Diphenhydramine HCl/Promethazine HCl Rectal Suppositories, as the safety of use during pregnancy and breastfeeding has not been fully established.

Can I consume alcohol while using these suppositories?

It is advisable to avoid alcohol while using Diphenhydramine HCl/Promethazine HCl Rectal Suppositories since alcohol can increase drowsiness and dizziness side effects associated with these medications.

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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.