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Metformin HCl 5%/Progesterone 1%/Spirolactone 5% Topical Gel

FDA-approved generic
Dose form
Topical Gel
Active ingredients
Metformin Hydrochloride
Progesterone
Spironolactone

This Metformin HCl 5%/Progesterone 1%/Spironolactone 5% Topical Gel is a semisolid formulation designed for easy and precise application on the skin through a pump mechanism. Its gel-like consistency ensures targeted treatment and effective absorption of active ingredients.

This formulation is used to treat conditions such as polycystic ovary syndrome (PCOS), hirsutism, and acne, providing a multifaceted approach to managing these disease states.

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For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription detailsOrder form
Controlled substance: e-prescribe (EPCS) from your EHR. Faxed and phoned prescriptions cannot be accepted for this preparation.
Send it from your EHR, or fax to (401) 284-4506. How to e-prescribe this formula
Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
To prescribe, you must be a verified prescriber.
To prescribe, you must be in a state where we hold an active out-of-state pharmacy license.
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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.

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Compounded preparations are prepared by Bayview pursuant to a prescription for an individual patient. They are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Metformin Hydrochloride
Progesterone
Spironolactone
Topical Gel
Service area

Can we ship this formula to your state?

Bayview fills prescriptions for patients in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, Pennsylvania and Rhode Island. New York patients are served on a limited basis while nonresident pharmacy registration is pending.

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Formula Information

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This topical gel formulation combines Metformin HCl 5%, Progesterone 1%, and Spironolactone 5% in a semisolid form dispensed through a pump mechanism, allowing for precise application to the skin. This combination is designed to deliver synergistic effects for the targeted treatment of certain dermatological and hormonal conditions.

Metformin HCl is traditionally used orally to manage blood glucose levels in patients with type 2 diabetes. However, when applied topically, Metformin has shown potential in improving skin conditions by reducing insulin resistance locally, which can help regulate sebum production and improve acne lesions associated with hormonal imbalances.

Progesterone is a natural hormone that plays a crucial role in regulating the menstrual cycle and maintaining pregnancy. In topical applications, Progesterone can help balance hormonal levels in the skin, potentially reducing symptoms of hormonal acne or other skin conditions exacerbated by hormonal fluctuations.

Spironolactone is a potassium-sparing diuretic with anti-androgenic properties. When used topically, Spironolactone can inhibit the effects of androgens on sebaceous glands, decreasing oil production and reducing the severity of acne. It may also help manage conditions like hirsutism by reducing unwanted hair growth.

The combination of Metformin, Progesterone, and Spironolactone in a topical gel addresses various pathways involved in hormonal skin conditions. By targeting insulin resistance, hormonal imbalances, and androgen effects on the skin, this formulation aims to provide comprehensive management of conditions such as acne, hirsutism, and

Drug Interactions

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When considering the use of Metformin HCl 5%/Progesterone 1%/Spironolactone 5% Topical Gel, it is crucial to be aware of potential drug interactions that may affect the efficacy and safety of the treatment. This formulation is designed for topical application, which generally reduces the risk of systemic drug interactions compared to oral administration. However, interactions can still occur, particularly if the patient is using other medications that have systemic effects or if the patient has underlying health conditions that may alter drug metabolism or absorption.

Metformin, primarily used for managing blood glucose levels in diabetes, is generally well-tolerated with minimal interaction when used topically. However, patients should be cautious if they are concurrently using other medications that affect blood glucose levels, such as insulin or sulfonylureas, as there may be an additive effect leading to hypoglycemia. Although the systemic absorption of metformin from topical application is expected to be low, monitoring blood glucose levels is advisable, especially in patients with diabetes.

Progesterone, a hormone involved in the menstrual cycle and pregnancy, can interact with other hormone therapies. Patients using additional hormone replacement therapies or contraceptives should consult with their healthcare provider to avoid potential hormonal imbalances or reduced efficacy of contraceptives. Additionally, progesterone may interact with medications that affect liver enzymes, such as certain anticonvulsants or antibiotics, which could alter the metabolism of progesterone and affect its efficacy.

Spironolactone, a potassium-sparing diuretic, can interact with medications that affect potassium levels, such as ACE inhibitors, ARBs, or potassium supplements, potentially leading to hyperkalemia. Although the topical application of spironolactone is less likely to cause systemic effects, patients with renal impairment or those on medications affecting renal function should be monitored for changes in potassium levels. Furthermore, spironolactone may interact with other diuretics or antihypertensive medications, potentially enhancing their effects.

Patients and prescribers should also consider the potential for local skin reactions or interactions with other topical agents. The use of multiple topical products simultaneously can lead to irritation or reduced absorption of active ingredients. It is advisable to apply different topical medications at different times or on different areas of the skin to minimize these interactions.

Overall, while the risk of systemic drug interactions with this topical gel formulation is lower than with oral medications, it is essential to consider the patient's complete medication profile and health status. Patients should inform their healthcare providers of all medications they are taking, including over-the-counter drugs and supplements, to ensure safe and appropriate use of this formulation. If you have any questions or concerns about potential drug interactions, please reach out to us for further guidance.

How Does it Work

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The Metformin HCl 5%/Progesterone 1%/Spironolactone 5% Topical Gel is a specialized formulation designed to deliver a combination of active pharmaceutical ingredients directly to the skin, where they can be absorbed and exert their therapeutic effects. This semisolid formulation is dispensed through a pump mechanism, which ensures easy and precise application, allowing for targeted treatment of specific skin conditions or systemic absorption of the active ingredients.

Metformin HCl, commonly known for its use in managing type 2 diabetes, has been incorporated into this topical gel for its potential benefits in treating skin conditions such as acne and other dermatological disorders. Metformin may help reduce inflammation and improve insulin sensitivity in the skin, which can be beneficial in conditions where insulin resistance plays a role. By applying it topically, the formulation aims to localize its effects, minimizing systemic exposure and potential side effects.

Progesterone, a naturally occurring hormone, is included in this formulation to address hormonal imbalances that can contribute to skin issues. Topical application of progesterone can help regulate sebum production and improve skin texture, making it particularly useful in treating conditions like acne or other hormone-related skin disorders. The 1% concentration is carefully chosen to provide therapeutic benefits while minimizing the risk of systemic absorption and hormonal side effects.

Spironolactone, a well-known anti-androgen and diuretic, is used in this gel primarily for its ability to block androgen receptors in the skin. By delivering spironolactone topically at a 5% concentration, the formulation targets the skin directly, potentially reducing the risk of systemic side effects associated with oral administration.

The gel-like consistency of this formulation ensures that it spreads easily over the skin, allowing for uniform application and absorption of the active ingredients. The pump mechanism not only facilitates precise dosing but also maintains the stability and integrity of the formulation by minimizing exposure to air and contaminants. This is particularly important for maintaining the efficacy of the active ingredients over the course of treatment.

For both patients and prescribers, this compounded formulation offers a unique approach to managing skin conditions that may be influenced by metabolic, hormonal, or androgenic factors. By combining these three active ingredients, the formulation provides a multifaceted treatment option that can be tailored to the specific needs of the patient. If you have any questions or need further information about this formulation, please reach out to us at Bayview Pharmacy. We are here to assist you with any inquiries or concerns you may have.

Other Uses

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The Metformin HCl 5%/Progesterone 1%/Spironolactone 5% Topical Gel is a unique formulation that combines the therapeutic benefits of three active ingredients, each with distinct pharmacological properties. While this formulation is primarily used for specific dermatological conditions, its components suggest potential off-label uses that may be of interest to both patients and prescribers. Metformin, commonly known for its role in managing type 2 diabetes, has shown promise in dermatology for its anti-inflammatory and anti-aging properties. It may help in reducing skin inflammation and improving skin texture, making it a potential adjunctive treatment for conditions like rosacea or even as a part of anti-aging skincare regimens.

Progesterone, a hormone involved in the menstrual cycle and pregnancy, has been used topically to address hormonal imbalances that affect the skin. It may be beneficial in managing symptoms of hormonal acne or other skin conditions exacerbated by hormonal fluctuations, such as those experienced during menopause. The topical application allows for targeted delivery, potentially minimizing systemic side effects associated with oral hormone therapies.

Spironolactone, a diuretic with anti-androgen properties, is often used off-label for treating acne, particularly in women with hormonal acne. Its inclusion in a topical gel formulation may offer a localized treatment option, reducing the risk of systemic side effects like electrolyte imbalances. Additionally, spironolactone's potential to reduce sebum production and its anti-inflammatory effects could make this formulation useful for managing seborrheic dermatitis or other oily skin conditions.

While these potential uses are promising, it is important for prescribers to consider the individual patient's medical history and current medications to avoid interactions and ensure safety. Patients should be advised to apply the gel as directed, typically in a thin layer to the affected area, and to report any adverse reactions or lack of improvement to their healthcare provider. As with any compounded medication, the efficacy and safety of this formulation for off-label uses have not been established through large-scale clinical trials, and its use should be guided by clinical judgment and patient-specific factors.

If you have any questions or need further information about this formulation, 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.

Frequently Asked Questions

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What is the purpose of Metformin HCl 5%/Progesterone 1%/Spirolactone 5% Topical Gel?

This topical gel is formulated to deliver a combination of active ingredients directly to the skin, targeting specific conditions such as hormonal imbalances, acne, or other dermatological issues that may benefit from these compounds.

How should I apply the Metformin HCl 5%/Progesterone 1%/Spirolactone 5% Topical Gel?

The gel should be applied to clean, dry skin. Dispense the recommended amount using the pump mechanism and gently massage it into the affected area until fully absorbed.

How often should I use this topical gel?

The frequency of application will depend on your specific condition and the advice of your healthcare provider. Typically, it may be used once or twice daily, but follow your provider's instructions.

Can I use this gel on my face?

Yes, this gel can be used on the face if prescribed by your healthcare provider. Be sure to avoid contact with the eyes, mouth, and other sensitive areas.

Are there any side effects associated with this topical gel?

Some users may experience mild skin irritation, redness, or dryness. If you experience severe reactions or persistent irritation, discontinue use and consult your healthcare provider.

Can I use other skincare products with this gel?

Yes, you can use other skincare products, but it is advisable to apply the gel first and allow it to fully absorb before applying other products. Consult your healthcare provider for specific recommendations.

Is this topical gel suitable for all skin types?

This gel is generally suitable for most skin types, but individuals with sensitive skin should use it with caution and consult their healthcare provider if they have concerns.

How should I store the Metformin HCl 5%/Progesterone 1%/Spirolactone 5% Topical Gel?

Store the gel in a cool, dry place away from direct sunlight and out of reach of children. Ensure the cap is tightly closed after each use.

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.

What should I do if I miss a dose of the topical gel?

If you miss a dose, apply it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply extra gel to make up for a missed dose.

About this compounded preparation

This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.

The conditions listed on this page are indications prescribers have ordered this preparation for. They are not FDA-approved indications, and listing them is not a statement that this preparation is effective for them.

A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice — discuss your situation with a licensed healthcare provider.

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.
For prescribers

How to e-prescribe this formula

Controlled substance: e-prescribe only (EPCS). Faxed, phoned, and handwritten prescriptions cannot be filled. Rhode Island law (R.I. Gen. Laws § 21-28-3.18) requires Schedule II to V prescriptions to be transmitted electronically.
1

Find Bayview in your EHR's pharmacy directory

Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.

NCPDP4106882NPI1750455143Address3844 Post Rd, Warwick, RI 02886Phone(401) 284-4505Fax(401) 284-4506
2

Enter the formula as a compound

Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.

Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.

3

Copy the prescription details

RxFormula name
Dose formDose form
Quantity________
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription details

Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.

4

Send it

Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.

Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.

Do not use Notes to Pharmacy for the formula. Some EHRs keep that field internal and never transmit it. A prescription that arrives without the formula is delayed while we call your office.

Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.

Metformin HCl 5%/Progesterone 1%/Spirolactone 5% Topical Gel
Topical Gel
60 g
controlled

Apply topically to affected area(s)

Once daily