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Formulas

Ergotamine Tartrate 2 mg/Caffeine 10 mg/Promethazine HCl 12.5 mg Suppositories

This formulation consists of Ergotamine Tartrate 2 mg, Caffeine 10 mg, and Promethazine HCl 12.5 mg in suppository form. It is a solid dosage form designed for insertion into a body cavity, typically the rectum, where it dissolves or melts to release medication for local or systemic absorption.

This combination is primarily used to treat migraine headaches. Ergotamine Tartrate works by constricting blood vessels in the brain, Caffeine enhances the absorption and effectiveness of Ergotamine, and Promethazine HCl helps alleviate nausea and vomiting associated with migraines.

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Ergotamine Tartrate
Caffeine
Promethazine Hydrochloride
Suppository
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Formula Information

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The Ergotamine Tartrate 2 mg/Caffeine 10 mg/Promethazine HCl 12.5 mg suppository is a compounded medication designed for rectal administration. This solid dosage form is inserted into the rectum, where it dissolves or melts, allowing the active ingredients to be absorbed into the bloodstream for systemic effect. The combination of ergotamine tartrate, caffeine, and promethazine hydrochloride offers a multifaceted approach to managing certain medical conditions, particularly those involving vascular headaches.

Ergotamine tartrate is an ergot alkaloid that constricts blood vessels by stimulating alpha-adrenergic and serotonin receptors. It is primarily used in the acute treatment of migraine attacks. By narrowing dilated blood vessels in the brain, ergotamine helps alleviate the throbbing pain associated with migraines. Its effectiveness is enhanced when administered at the onset of symptoms.

Caffeine acts as a central nervous system stimulant and vasoconstrictor. In this formulation, caffeine enhances the absorption and efficacy of ergotamine. It amplifies ergotamine's vasoconstrictive effects, helping to further reduce the dilation of cerebral blood vessels that contribute to migraine pain. Additionally, caffeine can improve mental alertness, which might be diminished during a migraine attack.

Promethazine hydrochloride is an antihistamine with antiemetic and sedative properties. It is effective in preventing nausea and vomiting, common symptoms accompanying migraines and side effects of ergotamine therapy. By mitigating these gastrointestinal symptoms, promethazine improves patient comfort and tolerance of the medication. Its sedative effects can also promote rest, which is beneficial during acute migraine episodes.

This compounded suppository is beneficial for patients who may have difficulty taking oral medications due to nausea, vomiting, or gastrointestinal absorption issues. The rectal route bypasses the digestive system, providing a direct method for the medication to enter systemic circulation. This can lead to a faster onset of action, which is crucial in aborting migraine attacks promptly.

For patients, it is important to use this medication exactly as prescribed. The suppository should be inserted rectally at the first sign of a migraine for optimal effectiveness. Patients should be aware of potential side effects, including dizziness, drowsiness, dry mouth, or changes in blood pressure. It is advisable to avoid operating heavy machinery or driving until you know how the medication affects you. Inform your healthcare provider of all medications you are taking to prevent possible drug interactions.

Prescribers should consider this formulation for patients who experience migraines accompanied by severe nausea and vomiting or for those who cannot tolerate or absorb oral medications effectively. The combination of ergotamine and caffeine enhances anti-migraine efficacy, while promethazine addresses associated symptoms and improves patient compliance. Careful patient evaluation is necessary to rule out contraindications such as cardiovascular disease, hypertension, peripheral vascular disease, or hypersensitivity to any components.

Monitoring for signs of ergotism, such as numbness or tingling in fingers and toes, muscle pain, or weakness, is important due to the vasoconstrictive properties of ergotamine. Adjustments to dosage or frequency may be necessary based on patient response and occurrence of adverse effects. Patient education on proper administration techniques and adherence to dosing schedules will enhance treatment outcomes.

If you have any questions or need additional information about this compounded formulation, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist both patients and healthcare providers with their specific needs.

Drug Interactions

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Ergotamine Tartrate 2 mg/Caffeine 10 mg/Promethazine HCl 12.5 mg suppositories are a compounded formulation designed to provide relief from migraine headaches and associated symptoms. This combination works synergistically to alleviate migraine symptoms through different mechanisms of action. Ergotamine tartrate is a vasoconstrictor that helps reduce the dilation of blood vessels in the brain, which is often associated with migraine attacks. Caffeine enhances the vasoconstrictive effects of ergotamine and can improve its absorption. Promethazine HCl is an antihistamine with antiemetic properties, which helps manage nausea and vomiting that often accompany migraines.

When considering the use of this formulation, it is crucial to be aware of potential drug interactions that may affect its safety and efficacy. Ergotamine tartrate can interact with other vasoconstrictors, such as triptans, leading to an increased risk of severe vasoconstriction and potential cardiovascular complications. Therefore, concurrent use with triptans should be avoided or closely monitored. Additionally, ergotamine is metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme, and its use with strong CYP3A4 inhibitors, such as certain antifungals (e.g., ketoconazole) and macrolide antibiotics (e.g., clarithromycin), can lead to elevated ergotamine levels and increased risk of ergot toxicity.

Caffeine, a central nervous system stimulant, can interact with other stimulants, potentially leading to increased heart rate and blood pressure. Patients should be advised to limit the intake of other caffeine-containing products to avoid excessive stimulation. Promethazine HCl, being an antihistamine, can cause sedation and may enhance the sedative effects of other central nervous system depressants, such as benzodiazepines, opioids, and alcohol. Patients should be cautioned about engaging in activities requiring mental alertness, such as driving or operating heavy machinery, when using this formulation.

It is also important to consider the potential for interactions with medications that affect serotonin levels, as promethazine can contribute to serotonin syndrome when used with other serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Patients and prescribers should be vigilant for symptoms of serotonin syndrome, including confusion, agitation, rapid heart rate, and muscle rigidity.

Patients with pre-existing conditions such as cardiovascular disease, hypertension, or peripheral vascular disease should use this formulation with caution due to the vasoconstrictive properties of ergotamine. Additionally, those with a history of drug allergies or sensitivities should discuss their medical history with their healthcare provider before using this medication.

If you have any questions or concerns about the use of Ergotamine Tartrate 2 mg/Caffeine 10 mg/Promethazine HCl 12.5 mg suppositories, or if you need further information on potential drug interactions, please reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to assist you.

How Does it Work

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Ergotamine Tartrate 2 mg/Caffeine 10 mg/Promethazine HCl 12.5 mg suppositories are a compounded formulation designed to provide relief from migraine headaches and associated symptoms. This combination of active ingredients is delivered in a solid dosage form that is inserted into a body cavity, typically the rectum, where it dissolves or melts to release medication for local or systemic absorption. The rectal route of administration is particularly beneficial for patients who experience nausea and vomiting during migraine attacks, as it bypasses the gastrointestinal tract and allows for more direct absorption into the bloodstream.

Ergotamine Tartrate is a well-known ergot alkaloid that works by constricting blood vessels in the brain. During a migraine attack, blood vessels in the brain can become dilated, leading to the characteristic throbbing pain. By promoting vasoconstriction, Ergotamine Tartrate helps to alleviate this pain and reduce the duration of the migraine. It is most effective when taken at the first sign of a migraine attack.

Caffeine is included in this formulation to enhance the vasoconstrictive effects of Ergotamine Tartrate. Caffeine is a central nervous system stimulant that can increase the absorption and effectiveness of ergotamine. By narrowing the blood vessels, caffeine helps to potentiate the action of ergotamine, leading to more effective relief from migraine symptoms.

Promethazine HCl is an antihistamine with antiemetic properties, which means it helps to prevent nausea and vomiting. These symptoms are common during migraine attacks and can be particularly distressing for patients. By including Promethazine HCl in the suppository formulation, patients can experience relief from these symptoms, making the overall treatment more tolerable and effective.

This compounded formulation is particularly useful for patients who have difficulty swallowing pills or who experience severe nausea and vomiting during migraines, as the rectal administration allows for effective absorption without the need for oral intake. The combination of ergotamine, caffeine, and promethazine provides a multi-faceted approach to managing migraines, addressing both the pain and associated symptoms.

For prescribers, it is important to consider the individual patient's medical history and any potential contraindications or interactions with other medications the patient may be taking. As with any medication, the benefits and risks should be carefully weighed. Patients should be advised on the proper use of suppositories and the importance of using them at the onset of migraine symptoms for maximum effectiveness.

If you have any questions about this formulation or its use, 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.

Other Uses

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Ergotamine Tartrate 2 mg/Caffeine 10 mg/Promethazine HCl 12.5 mg suppositories are primarily used for the treatment of migraine headaches, particularly when oral administration is not feasible due to nausea or vomiting. However, this formulation may have other potential uses that could be considered by healthcare providers based on their clinical judgment and patient-specific factors. One such use could be in the management of cluster headaches, which are severe, unilateral headaches that occur in cyclical patterns or clusters. The combination of ergotamine and caffeine can help constrict blood vessels and reduce headache symptoms, while promethazine can alleviate associated nausea and enhance the absorption of ergotamine.

Additionally, this formulation might be considered for use in patients who experience severe nausea and vomiting in conjunction with their headaches, as the rectal route of administration bypasses the gastrointestinal tract, allowing for more effective delivery of medication. The inclusion of promethazine, an antihistamine with antiemetic properties, can further aid in controlling nausea and vomiting, making this formulation particularly beneficial for patients who cannot retain oral medications.

In some cases, this combination may be explored for off-label use in treating other conditions characterized by vascular headaches or severe nausea, such as certain types of tension headaches or post-dural puncture headaches, although such uses should be approached with caution and under the guidance of a healthcare professional. It is important for prescribers to carefully evaluate the risk-benefit profile for each patient, considering potential side effects and contraindications associated with ergotamine, caffeine, and promethazine.

Patients should be informed about the proper use of suppositories, including how to insert them correctly and the importance of adhering to prescribed dosages to avoid potential adverse effects. They should also be made aware of possible side effects, such as dizziness, drowsiness, or gastrointestinal disturbances, and advised to contact their healthcare provider if they experience any concerning symptoms. As always, if you have any questions or need further information, please reach out to us at Bayview Pharmacy.

Frequently Asked Questions

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What is the purpose of Ergotamine Tartrate/Caffeine/Promethazine HCl suppositories?

This compounded formulation is used to treat migraine headaches. Ergotamine Tartrate helps to narrow blood vessels around the brain, Caffeine enhances the effects of Ergotamine, and Promethazine HCl helps to prevent nausea and vomiting associated with migraines.

How do I use these suppositories?

Insert the suppository into the rectum or vagina as directed by your healthcare provider. It is important to follow the specific instructions provided with your prescription for proper use.

How often can I use these suppositories?

The frequency of use should be determined by your healthcare provider. It is important not to exceed the recommended dosage to avoid potential side effects or complications.

What should I do if I miss a dose?

If you miss a dose, use it as soon as you remember. 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.

Are there any side effects associated with this medication?

Common side effects may include dizziness, drowsiness, or mild irritation at the site of insertion. If you experience severe side effects such as difficulty breathing, severe headache, or allergic reactions, seek medical attention immediately.

Can I use these suppositories if I am pregnant or breastfeeding?

You should consult your healthcare provider before using this medication if you are pregnant or breastfeeding, as it may not be safe for you or your baby.

How should I store these suppositories?

Store the suppositories in a cool, dry place away from direct sunlight and moisture. Keep them out of reach of children and pets.

Can I use these suppositories with other medications?

Before using this medication, inform your healthcare provider about all other medications you are taking, including over-the-counter drugs and supplements, to avoid potential interactions.

What should I do if I experience severe side effects?

If you experience severe side effects, such as difficulty breathing, severe headache, or signs of an allergic reaction, seek immediate medical attention.

Is it normal to experience irritation after using the suppository?

Mild irritation at the site of insertion can occur, but if the irritation persists or becomes severe, contact your healthcare provider for advice.

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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.