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Spironolactone 10% Topical Cream

FDA-approved generic
Dose form
Topical Cream
Active ingredients
Spironolactone

Spironolactone 10% Topical Cream is a semisolid preparation formulated for ease of use and precise dosing through a pump mechanism. This cream is intended for topical application on the skin where it serves to deliver the active ingredient, spironolactone, directly to the affected area. Spironolactone, a potassium-sparing diuretic with anti-androgen properties, is utilized in this formulation to treat a variety of dermatological conditions. These include acne vulgaris, particularly in adult women, androgenetic alopecia (pattern hair loss), and hirsutism (excessive hair growth). The cream's localized effect minimizes systemic absorption, thereby reducing potential systemic side effects associated with oral spironolactone. The pump dispenser ensures that each application delivers a consistent dose, promoting optimal therapeutic outcomes.

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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.

For prescribersSign in for prescription details and order forms.
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.
Spironolactone
Topical Cream
65d61ed3b6d5eee6ae740087
Service area

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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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Spironolactone 10% Topical Cream is a specially formulated medication that combines the diuretic and anti-androgen properties of spironolactone with the convenience of a topical delivery system. This semisolid preparation is dispensed in a pump mechanism, which ensures a controlled and consistent dose with each application. The cream is designed for direct application to the skin, where it can provide localized treatment or facilitate the absorption of the active ingredient, spironolactone, into the systemic circulation.

Spironolactone, the active ingredient in this formulation, is traditionally known for its use as an oral diuretic and antihypertensive agent. Its anti-androgenic effects can reduce the production of sebum and the occurrence of acne, making it a valuable option for patients with acne-prone skin. Additionally, spironolactone can help in the management of hair loss conditions such as androgenetic alopecia by inhibiting the action of androgens at the level of the hair follicle.

The 10% concentration of spironolactone in this cream is specifically chosen to maximize therapeutic effects while minimizing systemic absorption and potential side effects. The topical route of administration allows for targeted action at the site of application, which can be beneficial for patients who may not tolerate or wish to avoid systemic effects associated with oral spironolactone. The pump mechanism of the container not only facilitates ease of use but also helps to protect the integrity of the formulation by minimizing exposure to air and contaminants.

Patients using Spironolactone 10% Topical Cream should be advised to apply the cream as directed by their healthcare provider, typically to clean, dry skin. It is important to follow the prescribed regimen to achieve the best results. Prescribers considering this formulation for their patients should be aware of the potential for local skin reactions and should monitor for any signs of systemic side effects, although these are less likely with topical versus oral administration.

For any questions regarding the formulation, its uses, or potential side effects, both patients and prescribers are encouraged to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing expert guidance and support to ensure the safe and appropriate use of Spironolactone 10% Topical Cream.

Drug Interactions

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Spironolactone is a potassium-sparing diuretic commonly used orally to treat conditions such as heart failure, hypertension, and conditions associated with hyperaldosteronism. When formulated as a 10% topical cream, it is primarily used for dermatological conditions such as acne and hirsutism due to its anti-androgenic effects. While the systemic absorption of spironolactone from a topical formulation is expected to be lower than that from oral administration, there is still potential for systemic effects and drug interactions.

Patients using spironolactone in any form should be cautious about concomitant use with other potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or direct renin inhibitors, as these can lead to hyperkalemia, a condition characterized by high levels of potassium in the blood. This is particularly important for patients with kidney problems or those who are elderly, as they may be more susceptible to hyperkalemia. Regular monitoring of serum potassium levels is recommended when these drugs are used together.

Concomitant use of spironolactone with nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the diuretic, natriuretic, and antihypertensive effects of spironolactone. Patients should be monitored for the efficacy of spironolactone when starting or stopping NSAIDs. Additionally, the use of spironolactone with other medications that may increase serum potassium levels, such as potassium supplements or salt substitutes containing potassium, should be undertaken with caution and under medical supervision.

Spironolactone may also interact with digoxin and can affect the digoxin levels in the blood. Patients taking digoxin may require dose adjustments and monitoring of their digoxin levels when starting or stopping topical spironolactone therapy. Similarly, caution is advised when spironolactone is used with antihypertensive drugs and other medications that lower blood pressure, as there may be an additive effect leading to hypotension.

Topical spironolactone may also have interactions with drugs metabolized by the cytochrome P450 enzyme system, particularly CYP3A4. Inhibitors of this enzyme, such as ketoconazole, may increase the levels of spironolactone, while inducers, such as rifampin, may decrease its levels. It is important to monitor for signs of increased or decreased efficacy of spironolactone when these drugs are used concomitantly.

It is essential for patients to inform their healthcare provider of all medications, supplements, and herbal products they are currently using before starting treatment with spironolactone 10% topical cream. Healthcare providers should review the patient's medication history for potential drug interactions and adjust therapy as needed. If you have any questions or concerns regarding the use of spironolactone 10% topical cream and potential drug interactions, please reach out to us at Bayview Pharmacy for further assistance.

How Does it Work

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Spironolactone 10% Topical Cream is a semisolid preparation that is specifically formulated to deliver spironolactone, a potent diuretic and anti-androgen, directly to the targeted area of the skin. This cream is dispensed in a pump mechanism, which allows for convenient, hygienic, and controlled application. The pump ensures that each dose is consistent, reducing the risk of over or under-application and enhancing the efficacy of the treatment.

The active ingredient, spironolactone, works by inhibiting the action of androgens, which are hormones that can contribute to the development of acne and the overproduction of sebum. By blocking androgen receptors in the skin, spironolactone reduces the activity of sebaceous glands, leading to decreased oil production and the potential for clearer skin. Additionally, spironolactone has anti-inflammatory properties that can further alleviate acne symptoms.

Spironolactone 10% Topical Cream is particularly useful in the treatment of acne vulgaris, especially in cases where the condition is thought to be exacerbated by hormonal imbalances. It may also be beneficial for other skin conditions that are responsive to anti-androgen therapy. The topical formulation allows for the active ingredient to exert its effects directly on the skin with potentially fewer systemic side effects compared to oral administration.

For optimal results, patients should apply the cream as directed by their healthcare provider, usually once or twice daily to the affected area. It is important to use the cream consistently and for the duration prescribed to achieve the best outcomes. Patients should also be advised that improvements may take several weeks to become noticeable, and they should continue the treatment even if they do not see immediate results.

As with any medication, there may be potential side effects, and patients should be informed about what to watch for and when to seek medical advice. It is also important for prescribers to consider any contraindications or potential drug interactions when prescribing Spironolactone 10% Topical Cream.

If you have any questions or require further information about Spironolactone 10% Topical Cream, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the support and guidance needed to ensure the safe and appropriate use of this formulation for both patients and prescribers.

Other Uses

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Spironolactone 10% Topical Cream, formulated as a semisolid preparation in a pump mechanism, is primarily indicated for the management of dermatological conditions such as acne vulgaris, particularly in adult women experiencing hormonal acne. However, there are other potential applications for this medication based on its mechanism of action. Spironolactone acts as an antagonist of the androgen receptor and as an inhibitor of steroidogenesis. This androgen-blocking property makes it relevant for use in the treatment of other skin conditions exacerbated by androgens, such as hirsutism (excessive facial or body hair growth in women) and androgenetic alopecia (pattern hair loss) in both men and women, although in these cases, careful consideration and monitoring are essential, particularly in the male population.

Furthermore, due to its anti-androgenic effects, spironolactone can be used off-label to manage symptoms of cutaneous manifestations of hyperandrogenism which may include seborrhea (excessive oiliness) and folliculitis when linked to increased androgen levels. It's worth noting that while the systemic effects of topical spironolactone are expected to be minimal, its application should still be guided by a healthcare professional to ensure appropriate use and to monitor side effects, mainly because individual responses to treatment can vary widely.

Patients with a history of sensitivity or allergic reactions to spironolactone should not use this cream. As with any medication, use during pregnancy or lactation is advised only if the potential benefit justifies the potential risk to the fetus or nursing infant. Finally, while this topical formulation of spironolactone has been studied less extensively than oral preparations, it holds promise for patients seeking alternatives to systemic treatments with potentially fewer systemic side effects.

If you are a patient or prescriber with further questions regarding the unique applications and considerations of Spironolactone 10% Topical Cream in this specific dose form, please feel free to reach out to us at Bayview Pharmacy.

Frequently Asked Questions

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What is Spironolactone 10% Topical Cream used for?

Spironolactone 10% Topical Cream is used to treat a variety of skin conditions where androgen hormones such as testosterone may play a role, including acne, hair loss, and hirsutism (excessive hair growth). It works by blocking the effects of androgen hormones on the skin.

How do I apply Spironolactone 10% Topical Cream?

Clean and dry the affected area of skin before application. Use the pump mechanism to dispense a small amount of cream onto your fingertips and then apply a thin layer of the cream to the affected area as directed by your healthcare provider. Gently rub into the skin until it is evenly distributed. Wash your hands after applying the cream unless your hands are the treated area.

Can Spironolactone Topical Cream be used on any part of the body?

Spironolactone Topical Cream should only be used on the specific areas of the skin that your healthcare provider has directed you to treat. Avoid sensitive areas such as mucous membranes or the eyes.

How often should I use Spironolactone 10% Topical Cream?

The frequency of application will depend on your specific condition and the instructions provided by your healthcare provider. Typically, it might be applied once or twice daily, but follow your provider's guidelines closely.

Are there any side effects associated with Spironolactone 10% Topical Cream?

While most people do not experience serious side effects, some individuals may experience mild irritation, redness, or dryness at the site of application. If you experience severe or persistent side effects, contact your healthcare provider.

Can I use makeup or sunscreen over the Spironolactone Topical Cream?

Yes, but it is best to wait until the cream has been fully absorbed into the skin before applying any makeup or sunscreen. This usually takes about 5-10 minutes after application.

Does Spironolactone 10% Topical Cream affect the whole body?

Spironolactone 10% Topical Cream is designed for localized treatment and works primarily where it is applied. However, as with all medications, there is a possibility that some of the active ingredient could be absorbed systemically. Discuss any concerns with your healthcare provider.

What should I do if I miss a dose of the Spironolactone Topical Cream?

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

How should I store Spironolactone 10% Topical Cream?

Store the cream at room temperature away from light and moisture. Do not store in the bathroom and keep all medications away from children and pets. The pump dispenser should be closed when not in use.

Can I use Spironolactone Topical Cream if I am pregnant or breastfeeding?

Spironolactone Topical Cream may not be suitable for use during pregnancy or breastfeeding. There is a risk that spironolactone could cause harm to an unborn baby or pass into breast milk. Always consult with your healthcare provider before beginning any new medication if you are pregnant or breastfeeding.

Is a prescription required for Spironolactone 10% Topical Cream?

Yes, Spironolactone 10% Topical Cream is a prescription medication and requires authorization from a healthcare provider for use.

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.

Spironolactone 10% Topical Cream
Topical Cream
30 g
controlled

Apply topically to affected area(s)

Twice daily