Gyne-Lotrimin cream (Clotrimazole)

Clotrimazole Vaginal Cream is an antifungal medication primarily used to treat vaginal yeast infections caused by Candida species. It works by inhibiting the growth of fungi, thereby alleviating symptoms such as itching, burning, and discharge associated with these infections.

In Canada, clotrimazole vaginal creams are available under several brand names, including:

• Gyne-Lotrimin (where available), a clotrimazole-based vaginal antifungal.
• Clotrimaderm, available in both 1% and 2% strengths.
• Rexall, offers a 2% clotrimazole vaginal cream.
• Equate, provides a 2% clotrimazole vaginal cream as a 3-day treatment.

What Is Clotrimazole Vaginal Cream?

Clotrimazole is an azole antifungal effective against various fungal infections, particularly vulvovaginal candidiasis. It is available in cream form for intravaginal use, typically administered at bedtime for a specified duration, depending on the concentration.

A yeast infection is a common type of vaginal infection. Your doctor may call it candidiasis. This condition is caused by an organism called Candida, a yeast type. Healthy women usually have this yeast on the skin, in the mouth, in the digestive tract, and in the vagina. At times, the yeast can increase. The infection is sometimes called yeast (Candida) "overgrowth." Some women may have a yeast infection on the skin outside the vagina (vulva) associated with the vaginal infection.

A yeast infection can occur at any age. It is most common during the childbearing years. Women who are pregnant or diabetic, taking antibiotics, birth control pills, or steroids, or who have a weakened immune system are more likely to get repeated yeast infections.

Various medical conditions can damage the body's normal defences against infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV, the virus that causes AIDS). The HIV causes the body to be more likely to get infections, including vaginal yeast infections. Therefore, women with HIV infection may have frequent vaginal yeast infections that do not clear up quickly with proper treatment. If you may have been exposed to HIV and are experiencing repeated vaginal yeast infections, you should see your doctor right away.

In Canada, clotrimazole vaginal creams are regulated and approved by Health Canada, the federal department responsible for national health policy.

Clotrimazole vaginal creams are widely recognized in Canada for their effectiveness in treating yeast infections. Their over-the-counter availability underscores their safety profile. Health Canada provides guidelines on the proper use and labelling of these products to ensure consumer safety. However, healthcare professionals across Canada commonly recommend and prescribe this treatment for vaginal yeast infections.

Symptoms of a Vaginal Yeast Infection

There are many symptoms of a vaginal yeast infection; they include:

• vaginal itching (ranging from mild to severe);
• a clumpy vaginal discharge that may look like cottage cheese;
• vaginal soreness, irritation, or burning;
• rash or redness on the skin outside the vagina (vulvar irritation).

Forms and Dosage of Clotrimazole

In Canada, clotrimazole vaginal creams are available in various strengths and formulations:

• 1% Cream: Typically used once daily for 7 days.
• 2% Cream: Often used once daily for 3 days.

These formulations are designed for intravaginal application, and some products may come with applicators for ease of use.

How to Use Clotrimazole for Vaginal Application:

• Wash your hands before use.
• Use the provided applicator to insert the cream as high as possible into the vagina, preferably at bedtime.
• Ensure to clean the area before application and wash hands afterward.
• Avoid using tampons, douches, or spermicides during treatment, and abstain from sexual intercourse to prevent irritation and ensure effectiveness.

It's essential to follow the specific instructions provided by a healthcare professional or those on the medication label to ensure effective treatment and avoid complications. Use the cream only for vaginal application. Keep out of your nose, mouth, and eyes (may burn). Using it at bedtime will help achieve the best results. If symptoms persist or worsen after treatment, consult a healthcare provider.

What Do I Do if I Miss a Dose?

If you forgot about your dose, use a missed dose as soon as you think about it. If it is close to your next dose, skip the missed dose and return to your schedule. Never use two doses at the same time or extra doses to avoid overdose.

Prescription

Clotrimazole Vaginal Cream is available over-the-counter (OTC) in many regions, meaning a prescription is not typically required for purchase.

Clotrimazole vaginal creams are also available over-the-counter (OTC) in Canada. However, it is advisable to consult a healthcare provider if this is the first occurrence of symptoms or if symptoms persist.

Clinical Pharmacology

Clotrimazole is a broad-spectrum antifungal agent belonging to the imidazole class, primarily used to treat various fungal infections, including those caused by Candida species and dermatophytes. Its pharmacological profile encompasses several key aspects, including its mechanism of action, pharmacodynamics, pharmacokinetics, and therapeutic applications.

Mechanism of Action

Clotrimazole exerts its antifungal effects primarily by inhibiting the biosynthesis of ergosterol, a crucial component of the fungal cell membrane. It blocks the enzyme lanosterol 14-alpha demethylase, which converts lanosterol to ergosterol. This inhibition disrupts the integrity and functionality of the fungal cell membrane, leading to cell death or growth inhibition. The action can be fungistatic (inhibiting growth) at lower concentrations and fungicidal (killing fungi) at higher concentrations.

Pharmacodynamics

Clotrimazole has a broad spectrum of activity against dermatophytes, yeasts, and molds. It is effective against Trichophyton rubrum, Candida albicans, and Epidermophyton floccosum. The minimum inhibitory concentration (MIC) values for these fungi typically range from less than 0.062 to 8.0 µg/ml, depending on the organism and conditions tested.

Pharmacokinetics

Clotrimazole is administered via topical, oral (transmucosal), and intravaginal routes. Clotrimazole Vaginal Cream should be applied intravaginally. About 5% to 10% of clotrimazole is absorbed when administered vaginally. Therapeutic concentrations can persist in the vagina for up to three days post-application.

Clotrimazole's clinical pharmacology highlights its effectiveness as a topical antifungal agent with a well-defined mechanism of action targeting ergosterol synthesis. Its minimal systemic absorption further supports its safety profile for both local and intravaginal applications.

Important Safety Information

Patients should be aware of potential side effects such as vaginal burning, irritation, and abdominal cramps. If severe allergic reactions occur or symptoms do not improve after treatment, medical attention should be sought immediately.

Tell all of your healthcare providers that you take clotrimazole vaginal cream. This includes your doctors, nurses, pharmacists, and dentists.

This medicine may cause harm if swallowed. If clotrimazole vaginal cream is swallowed, call a doctor or poison control centre right away.

Use with care in children. Talk with the doctor.

If vaginal yeast infections happen often, talk with the doctor.

Protect clothing and fabrics from staining; try to wear cotton underwear.

Do not use clotrimazole vaginal cream if you have belly pain, fever, or bad-smelling vaginal discharge. Talk with your doctor.

Do not use clotrimazole vaginal cream for itching caused by a health problem other than a vaginal yeast infection. Talk with the doctor.

Condoms or diaphragms may not work to prevent pregnancy or stop the spread of diseases passed through sex while using clotrimazole vaginal cream and for some time after you stop clotrimazole vaginal cream. You will need to use some other kind of birth control for some time after the last dose. Be sure you know how long to do this.

Do not douche or use other vaginal products like tampons while you are using clotrimazole vaginal cream. You may need to avoid these things for some time after the last dose. If you have questions, talk with your doctor.

Tell your doctor if you are pregnant, plan on getting pregnant, or are breastfeeding. You must talk about the benefits and risks to you and the baby.

Call your doctor if your symptoms or health problems do not improve or if they worsen. Do not share your drugs with others, and do not take anyone else's drugs.

Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about clotrimazole vaginal cream, please talk with your doctor, nurse, pharmacist, or other health care provider.

What do I need to tell my doctor before I take Clotrimazole Vaginal Cream?

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. Inform your doctor about the following:

• if you are allergic to clotrimazole vaginal cream; any part of clotrimazole vaginal cream; or any other drugs, foods, or substances;
• if you have nail or scalp infections.

This is not a list of all drugs or health problems that interact with clotrimazole vaginal cream.

Stop using and ask a doctor in the following cases:

• symptoms do not get better in 3 days;
• symptoms last more than 7 days;
• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.

Contraindications to Clotrimazole

Clotrimazole is generally well-tolerated; however, there are specific contraindications and precautions to consider before using this medication. Here are the key contraindications:

1. Allergy to Clotrimazole. Individuals with a known hypersensitivity or allergy to clotrimazole or any of its components should not use this medication.
2. Unverified Vaginal Infections. Clotrimazole should not be used by patients who have never had a vaginal infection diagnosed by a healthcare provider. Self-treatment without a confirmed diagnosis may lead to inappropriate use.
3. Concurrent Use with Certain Products. The use of clotrimazole is contraindicated with tampons, douches, spermicides, or other vaginal products during treatment, as these can interfere with the effectiveness of the medication.
4. Severe Burns Risk. Clotrimazole cream may pose a fire hazard if it comes into contact with flammable materials. Patients are advised not to smoke or be near open flames while using the product.
5. Pediatric Considerations. Caution is advised in very young patients, particularly regarding the formulation and dosage used.
6. Pregnancy and Breastfeeding. Use during pregnancy only when needed, and discuss risks versus benefits with a healthcare provider.
7. Eye Contact. Clotrimazole should not come into contact with the eyes due to the risk of severe irritation.

Before using clotrimazole, patients must discuss their medical history and allergies with their healthcare provider. Proper diagnosis and adherence to usage guidelines can help prevent adverse effects and ensure effective treatment.

DailyMed, an online resource operated by the U.S. National Library of Medicine (NLM) that provides up-to-date and accurate drug labeling information, has provided more details about directions and contraindications, click here.

Side Effects

Even though it may be rare, some people may have severe side effects when taking a drug. Tell your doctor or get medical help immediately if you have any signs or symptoms related to severe side effects.

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Blisters or sores that ooze, drain, or crust over.
• Irritation where clotrimazole vaginal cream is used.
• Swelling where clotrimazole vaginal cream is used.
• Upset stomach or throwing up.
• Burning.
• Belly pain.
• Bad-smelling vaginal discharge.

Users in Canada have reported side effects such as vaginal burning, itching, or irritation. Some may experience abdominal cramps or a rash. These side effects are generally mild and temporary. If symptoms persist or worsen, it's advisable to consult a healthcare professional.

For a comprehensive list of side effects and severe reactions, please check here. The information is provided by Drugs.com.

Interactions of Clotrimazole Cream with Other Medicines

Clotrimazole cream has potential interactions with various medications. However, it is generally considered to have a low risk of significant interactions due to its minimal systemic absorption. Here are the key points regarding drug interactions with clotrimazole:

• Tacrolimus: Clotrimazole can significantly increase blood levels of tacrolimus, which may lead to toxicities associated with this immunosuppressant drug. Caution is advised when using these medications together, especially in patients who have undergone organ transplantation.
• Corticosteroids (e.g., Betamethasone): When clotrimazole is combined with topical corticosteroids like Betamethasone, there may be an increased risk of aggravating fungal infections due to the immunosuppressive effects of corticosteroids.
• Anticoagulants (e.g., Acenocoumarol, Dicoumarol): The therapeutic efficacy of anticoagulants may be increased when combined with clotrimazole, necessitating careful monitoring of coagulation parameters.
• Clindamycin: The metabolism of clindamycin may be altered when combined with clotrimazole, potentially affecting its effectiveness.
• Other Medications: Clotrimazole may interact with various other drugs, including certain antihistamines (like cetirizine), antidiabetic agents (such as metformin), and medications for hypertension (like amlodipine and atorvastatin).

While clotrimazole cream is generally safe and effective for treating fungal infections, awareness of its potential interactions with other medications is essential for patient safety and therapeutic efficacy. Regular communication with healthcare providers can help manage any risks associated with these interactions.

More information can be found here. The information is provided by MedlinePlus, an online health information resource designed for patients, and operated by the National Library of Medicine (NLM), and is recognized as the world's largest medical library.

Overdose of Clotrimazole Cream

If you think there has been an overdose, call your poison control centre or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

To read the label information, check the Clotrimazole Vaginal Cream information provided by the FDA.

Storage

Clotrimazole cream should be stored properly to ensure its effectiveness and safety. It is best kept at room temperature, ideally between 20°C to 25°C (68°F to 77°F), although a range of 15°C to 30°C (59°F to 86°F) is also acceptable. The cream should be placed in a cool, dry location, away from excess heat, moisture, and direct sunlight. Avoid storing it in areas like bathrooms or kitchens where humidity and temperature fluctuations can occur.

Always keep the medication in its original container and close it tightly to protect it from environmental factors. It is important to store clotrimazole cream out of reach of children to prevent accidental ingestion or misuse. Additionally, check the expiry date on the packaging regularly; do not use the cream after this date.

When it comes to disposal, unused or expired clotrimazole should not be thrown away via wastewater or household waste. Instead, consult a pharmacist for proper disposal methods. Following these guidelines will help maintain the cream's effectiveness and safety.

Similar Medications Available

Other antifungal treatments for vaginal yeast infections in Canada include:

• Miconazole: Available under brand names like Monistat.
• Tioconazole: Offered in specific formulations.

These medications function similarly to clotrimazole in treating fungal infections.

Benefits of Using Clotrimazole Cream

Here is the more detailed information provided by the Health Service Canada.