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Amitriptyline HCl 2%/Ketamine HCl 1.15% Vaginal Cream

This formulation is a semisolid cream containing Amitriptyline HCl at a concentration of 2% and Ketamine HCl at a concentration of 1.15%. It is dispensed in a tube for convenient and precise application in the vaginal area. The cream is designed to deliver medication and provide therapeutic effects for specific gynecological conditions.

Amitriptyline HCl is a tricyclic antidepressant that has been found to be effective in treating vulvodynia, a chronic pain condition in the vulvar area. Ketamine HCl, on the other hand, is a potent analgesic that can provide relief from severe and chronic pain conditions. Together, these two active ingredients work synergistically to alleviate pain and discomfort associated with various gynecological conditions.

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Amitriptyline Hydrochloride
Ketamine Hydrochloride
Vaginal Cream
653176a0b8e8453dd5cac5a8
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Formula Information

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This formulation is a compounded vaginal cream containing Amitriptyline HCl at a concentration of 2% and Ketamine HCl at a concentration of 1.15%. It is a semisolid preparation that is dispensed in a tube for easy and accurate application in the vaginal area. This formulation is specifically designed to provide therapeutic effects for certain gynecological conditions.

Amitriptyline HCl is a tricyclic antidepressant that has been found to be effective in managing chronic pain, including pelvic pain and vulvodynia. It works by increasing the levels of certain chemicals in the brain that help elevate mood and alleviate pain. Ketamine HCl, on the other hand, is a potent analgesic that works by blocking the NMDA receptors in the brain, which play a significant role in pain perception. The combination of these two active ingredients in a single formulation provides a synergistic effect, enhancing pain relief and improving the quality of life for patients suffering from these conditions.

It is important to note that this formulation should be used as directed by a healthcare provider. The cream should be applied topically to the vaginal area, usually once or twice daily or as directed by a healthcare provider. Patients should wash their hands before and after applying the cream. It is also recommended to wear a sanitary napkin to prevent the cream from staining underwear. Side effects may include drowsiness, dry mouth, constipation, and blurred vision. If any of these side effects persist or worsen, patients should promptly inform their healthcare provider.

Prescribers should be aware that this formulation may interact with other medications, including MAO inhibitors, SSRIs, and certain antihistamines. Therefore, a thorough medication history should be obtained before prescribing this formulation. Additionally, this formulation should be used with caution in patients with a history of cardiac disease, glaucoma, urinary retention, or those who are pregnant or breastfeeding.

If you have any questions or need further information about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always ready to assist you.

Drug Interactions

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Amitriptyline HCl and Ketamine HCl are both active ingredients in this vaginal cream formulation. Amitriptyline is a tricyclic antidepressant that has been found to be effective in treating vulvodynia and other chronic pain conditions, while Ketamine is an NMDA receptor antagonist that can provide pain relief in conditions such as interstitial cystitis. However, these medications can interact with other drugs, potentially altering their effects or increasing the risk of adverse reactions.

Patients using this formulation should be aware that Amitriptyline can interact with other antidepressants, including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (MAOIs). These interactions can increase the risk of serotonin syndrome, a potentially life-threatening condition characterized by symptoms such as agitation, hallucinations, rapid heartbeat, and fever. If you are taking any of these medications, inform your healthcare provider before starting this treatment.

Ketamine can interact with central nervous system depressants, including alcohol, benzodiazepines, and opioids. These interactions can increase the risk of respiratory depression, sedation, and potentially fatal overdose. Avoid consuming alcohol or using other CNS depressants while using this formulation.

Both Amitriptyline and Ketamine can interact with certain anticholinergic drugs, potentially increasing the risk of side effects such as dry mouth, constipation, urinary retention, and confusion. If you are taking any medications with anticholinergic effects, inform your healthcare provider.

Furthermore, both medications can cause QT prolongation, a serious heart rhythm condition. The risk of QT prolongation may be increased if you are taking other medications that cause this effect, or if you have certain medical conditions. Inform your healthcare provider if you have a history of heart disease or if you are taking any medications that can affect heart rhythm.

This formulation is intended for vaginal use only and should not be ingested or applied to other areas of the body. Avoid contact with the eyes. If this medication gets into your eyes, rinse thoroughly with water and contact your healthcare provider.

Always inform your healthcare provider of all the medications you are currently taking, including prescription drugs, over-the-counter medications, and dietary supplements. This will help your healthcare provider to monitor for drug interactions and manage them appropriately.

If you have any questions about this formulation or its potential interactions with other medications, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always here to assist you.

How Does it Work

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Amitriptyline HCl 2%/Ketamine HCl 1.15% Vaginal Cream is a specially compounded medication that combines two active ingredients, Amitriptyline HCl and Ketamine HCl, in a cream base. This formulation is designed to be applied directly to the vaginal area, providing targeted relief for specific gynecological conditions.

Amitriptyline HCl is a tricyclic antidepressant that has been found to be effective in managing chronic pain. It works by increasing the levels of certain chemicals in the brain that help elevate mood and reduce the sensation of pain. When applied topically in the form of a cream, Amitriptyline HCl can provide localized pain relief without the systemic side effects often associated with oral administration.

Ketamine HCl, on the other hand, is a powerful anesthetic that works by blocking the NMDA receptors in the brain, which are involved in pain signaling. This action can help to reduce the perception of pain in the treated area. Like Amitriptyline HCl, when Ketamine HCl is applied topically, it can provide localized pain relief with minimal systemic side effects.

Together, these two active ingredients work synergistically to provide effective pain relief for a variety of gynecological conditions. These may include vulvodynia, vestibulodynia, lichen sclerosus, and other conditions characterized by chronic pain or discomfort in the vaginal area. The cream formulation allows for direct application to the affected area, providing targeted relief and minimizing systemic side effects.

It's important to note that this medication should be used under the supervision of a healthcare provider, and the dosage and frequency of application should be determined based on the individual patient's condition and response to therapy. As with any medication, potential side effects may occur and should be discussed with a healthcare provider.

If you have any questions about Amitriptyline HCl 2%/Ketamine HCl 1.15% Vaginal Cream, or if you would like more information about how this medication may benefit you or your patients, please don't hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is always here to help.

Other Uses

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The formulation of Amitriptyline HCl 2%/Ketamine HCl 1.15% Vaginal Cream is primarily aimed to treat gynecological conditions such as vulvodynia and vestibulodynia, which involve chronic pain, irritation, or discomfort in the vaginal area. However, its analgesic and antidepressant properties can also be applied to treat other pain syndromes.

For instance, the cream could be used to manage painful bladder syndrome/interstitial cystitis, a condition characterized by recurring discomfort or pain in the bladder and the surrounding pelvic region. In such cases, the cream can be applied to the urethral opening or the perineum. Amitriptyline, a tricyclic antidepressant, could alleviate the pain and urgency, while the ketamine component could help suppress nerve-related pain at the application site.

Besides, this formulation might also bring therapeutic benefits for individuals suffering from localized neuropathic pain syndromes such as post-herpetic neuralgia, where standard systemic therapy may be inadequate or associated with unacceptable side effects. This use, however, is considered off-label and should only be considered after a comprehensive medical evaluation, and under the supervision of a qualified medical professional.

Amitriptyline/Ketamine formulation could also be potent in the management of complex regional pain syndrome, a form of chronic pain that typically affects an arm or leg. However, it's crucial to note that the application should be done under a physician's direction and dosage may vary based on individual needs.

As always, when considering off-label or novel uses for any drug formulation, it is paramount to balance potential therapeutic benefits against potential risks and side effects. Ensure to communicate openly with the healthcare provider about all medications, supplements, and health conditions before beginning a new therapeutic regimen. We encourage patients and prescribers to reach out to us with any inquiries regarding this formulation.

Frequently Asked Questions

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What is Amitriptyline HCl 2%/Ketamine HCl 1.15% Vaginal Cream?

This is a semisolid formulation of drugs, dispensed in a tube and designed for application in the vaginal area. It serves to deliver medication or provide therapeutic effects for specific gynecological conditions.

How is this cream supposed to be used?

This cream is designed for vaginal use and should be applied as prescribed by your healthcare provider. The tube is designed for convenient and precise application to the vaginal area.

What conditions does this cream treat?

This compounded formulation is utilized to manage specific gynecological conditions. The exact condition to be treated is determined by your healthcare provider, based on your symptoms and medical history.

What are the active ingredients in the cream?

This cream contains two active ingredients: Amitriptyline HCl at a concentration of 2% and Ketamine HCl at a concentration of 1.15%.

How does this cream work?

The cream works by delivering Amitriptyline HCl and Ketamine HCl directly to the affected area. These drugs work together to provide therapeutic effects for specific gynecological conditions.

Can this cream be used during pregnancy?

You should consult your healthcare provider before using this cream during pregnancy. The provider will assess the benefits and potential risks associated with its use during this period.

Are there any side effects associated with this cream?

Like all medications, the Amitriptyline HCl/Ketamine HCl Vaginal Cream may have side effects. It is important to consult your healthcare provider immediately if you experience any unwanted side effects while using this cream.

How should I store this cream?

Store this cream as recommended by your pharmacist or healthcare provider. Generally, it should be stored in a cool and dry place, away from light and heat, and out of reach from children and pets.

Who should not use this cream?

People who are allergic to Amitriptyline HCl, Ketamine HCl or any of the ingredients in the cream should not use it. Also, it should not be used without the recommendation or prescription of a healthcare provider.

Can I use this cream while breastfeeding?

Before using this cream while breastfeeding, it is essential to consult your healthcare provider. They will be able to advise you based on the benefits and risks associated with its use during this period.

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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.