Clotrimazole 2% 3 Day Vag Crm 21gm

Manufacturer TARO Active Ingredient Clotrimazole Vaginal Cream(kloe TRIM a zole) Pronunciation kloe TRIM a zole
It is used to treat vaginal infections. If this drug has been given for some other reason, talk with the doctor for more information.
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Drug Class
Antifungal
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Pharmacologic Class
Imidazole Antifungal
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Pregnancy Category
Category B
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FDA Approved
Jan 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clotrimazole vaginal cream is an antifungal medicine used to treat vaginal yeast infections. It works by stopping the growth of the yeast that causes the infection.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the instructions closely. Continue using the medication as directed, even if your symptoms improve. For best results, apply the medication at bedtime.

Before and after applying the medication, wash your hands thoroughly. This medication is for vaginal use only and should not be taken orally. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation.

To prevent irritation and ensure proper absorption, dry the outside vaginal area completely after showering, bathing, or swimming. Change out of wet bathing suits or damp workout clothes promptly.

While using this medication, refrain from engaging in vaginal sex. If you need to apply the cream to the skin outside the vagina, squeeze a small amount onto your fingertip and gently apply it to the affected area.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, avoiding storage in a bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Insert the cream high into the vagina, preferably at bedtime.
  • Complete the full 3-day course of treatment, even if symptoms improve sooner.
  • Avoid sexual intercourse during treatment to prevent reinfection or transmission to partner.
  • Wear cotton underwear and avoid tight-fitting clothing.
  • Avoid douching, perfumed feminine hygiene products, and bubble baths during treatment.
  • If using tampons, diaphragms, or condoms, be aware that the cream may weaken latex products; consider alternative birth control methods during treatment and for 3 days after.

Dosing & Administration

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Adult Dosing

Standard Dose: One applicatorful (approx. 5 grams of 2% cream) intravaginally once daily at bedtime for 3 consecutive days.

Condition-Specific Dosing:

vulvovaginalCandidiasis: One applicatorful (approx. 5 grams of 2% cream) intravaginally once daily at bedtime for 3 consecutive days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (self-treatment not recommended for children under 12 years; consult physician)
Adolescent: For adolescents 12 years and older, same as adult dosing for vulvovaginal candidiasis.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Clotrimazole inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional impairment of the cytoplasmic membrane, resulting in leakage of cellular contents and ultimately cell death.
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Pharmacokinetics

Absorption:

Bioavailability: < 10% (systemic absorption from vaginal application)
Tmax: Not clinically relevant for vaginal application (systemic Tmax not well-defined due to minimal absorption)
FoodEffect: Not applicable for vaginal cream.

Distribution:

Vd: Not clinically relevant for vaginal application (minimal systemic distribution)
ProteinBinding: 90-95% (if absorbed systemically)
CnssPenetration: Limited (not relevant for vaginal application)

Elimination:

HalfLife: 3-5 hours (systemic, but minimal absorption from vaginal route)
Clearance: Not clinically relevant for vaginal application
ExcretionRoute: Biliary/fecal and renal (if absorbed systemically)
Unchanged: < 1% (from vaginal application)
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Pharmacodynamics

OnsetOfAction: Symptom relief may begin within 2-3 days.
PeakEffect: Full therapeutic effect typically seen after completion of the 3-day course.
DurationOfAction: Effects persist for the duration of treatment and resolution of infection.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
Blisters or sores that ooze, drain, or crust over
Burning sensation
Swelling at the site where the medication was applied
Upset stomach or vomiting
Bad-smelling vaginal discharge
Stomach pain

Other Possible Side Effects

As with any medication, side effects can occur. However, many people may not experience any side effects or may only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.

To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms worsen or do not improve after 3 days of treatment.
  • Symptoms return within 2 months.
  • You experience abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge (these may indicate a more serious infection).
  • You are pregnant or think you might be.
  • You have frequent vaginal yeast infections (more than 3 in 6 months).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.

Additionally, to ensure safe treatment, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems

This will enable your doctor to assess potential interactions between this medication and your other medications or health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you accidentally swallow this drug, it can be harmful. Immediately contact a doctor or a poison control center for assistance.

If you experience recurring vaginal yeast infections, consult your doctor to discuss the best course of action.

To prevent staining, take precautions to protect your clothing and fabrics.

Do not use this medication if you have abdominal pain, fever, or a foul-smelling vaginal discharge. Instead, consult your doctor for proper evaluation and guidance.

This drug is specifically designed to treat vaginal yeast infections. Do not use it to treat itching caused by other health issues. If you are unsure about the cause of your symptoms, consult your doctor for an accurate diagnosis and appropriate treatment.

While using this medication and for a period after stopping it, condoms and diaphragms may not be effective in preventing pregnancy or protecting against sexually transmitted diseases. You will need to use an alternative form of birth control for a certain period after the last dose. Be sure to discuss with your doctor the duration for which you need to use additional birth control measures.

Avoid douching or using other vaginal products, such as tampons, during treatment with this medication. You may also need to refrain from using these products for some time after the last dose. If you have any questions or concerns, consult your doctor for guidance.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with vaginal application due to minimal systemic absorption. Ingestion of large amounts may cause nausea, vomiting, or abdominal cramps.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222). Treatment is generally supportive.

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical symptoms (itching, burning, discharge)

Rationale: To assess the severity of the infection before treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Resolution of symptoms (itching, burning, discharge)

Frequency: Daily during treatment, and 3-7 days post-treatment.

Target: Complete resolution or significant improvement.

Action Threshold: If symptoms persist or worsen after 3 days, or recur within 2 months, medical consultation is needed.

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Symptom Monitoring

  • Reduction in vaginal itching
  • Decrease in vaginal burning
  • Reduction in abnormal vaginal discharge
  • Absence of vaginal irritation or soreness

Special Patient Groups

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Pregnancy

Clotrimazole vaginal cream is generally considered safe for use during pregnancy (Pregnancy Category B), particularly after the first trimester. However, it should only be used under the guidance of a healthcare provider.

Trimester-Specific Risks:

First Trimester: Generally considered low risk due to minimal systemic absorption, but use with caution and only if clearly needed.
Second Trimester: Considered safe for use.
Third Trimester: Considered safe for use.
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Lactation

Clotrimazole is minimally absorbed systemically from vaginal application, and therefore, very little is expected to be excreted into breast milk. It is generally considered compatible with breastfeeding (Lactation Risk L3).

Infant Risk: Low risk to the infant due to minimal systemic absorption by the mother.
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Pediatric Use

Not for self-treatment in children under 12 years of age. Diagnosis of vaginal candidiasis in prepubertal girls should be confirmed by a physician. Use in adolescents 12 years and older is similar to adult dosing.

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Geriatric Use

No specific dose adjustments are necessary for geriatric patients. Efficacy and safety are similar to those in younger adults.

Clinical Information

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Clinical Pearls

  • Advise patients to complete the entire 3-day course of therapy, even if symptoms improve, to ensure complete eradication of the infection and prevent recurrence.
  • Remind patients that clotrimazole vaginal cream can weaken latex condoms and diaphragms, so alternative birth control methods should be used during treatment and for at least 3 days after.
  • Counsel patients on proper hygiene practices to prevent future infections, such as wearing cotton underwear and avoiding irritating products.
  • If symptoms persist or recur frequently, advise the patient to consult a healthcare provider to rule out other conditions or identify underlying causes.
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Alternative Therapies

  • Miconazole vaginal cream (e.g., 2% for 7 days, 4% for 3 days)
  • Tioconazole vaginal ointment (e.g., 6.5% for 1 day)
  • Butoconazole vaginal cream (e.g., 2% for 3 days)
  • Oral Fluconazole (single 150 mg dose, prescription only)
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Cost & Coverage

Average Cost: $10 - $30 per 21gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.