Cleocin T 1% Pledgete 60s

Manufacturer PFIZER Active Ingredient Clindamycin Solution and Swab(klin da MYE sin) Pronunciation KLIN-da-MYE-sin
It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Topical anti-acne agent
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Pharmacologic Class
Lincosamide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Sep 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin topical solution is an antibiotic medication applied to the skin to treat acne. It works by stopping the growth of bacteria that cause acne and by reducing inflammation.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.

Application Instructions

Apply this medication only to your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Clean the affected area before application and dry it thoroughly.
Apply a thin layer of the medication to the affected skin. Do not apply it to open sores or broken skin.
If using pledgets (swabs), remove one from the foil immediately before use, and discard it after a single use. You may use more than one pledget as needed.

Storage and Disposal

Store this medication at room temperature, away from heat sources.
Keep it in a dry place, avoiding storage in a bathroom.
Do not freeze the medication.

Missed Dose

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 two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash and dry affected skin before application.
  • Apply a thin film to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, nostrils, and other mucous membranes.
  • Do not use on broken or irritated skin.
  • May cause skin dryness or irritation; use a non-comedogenic moisturizer if needed.
  • Sun protection is advisable as skin may become more sensitive to sunlight.
  • Do not share medication with others.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area twice daily

Condition-Specific Dosing:

acne vulgaris: Apply a thin film to the affected area twice daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Apply a thin film to the affected area twice daily (typically for children 12 years and older)
Adolescent: Apply a thin film to the affected area twice daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting peptide bond formation. For acne, it inhibits the growth of Cutibacterium acnes (formerly Propionibacterium acnes) and reduces inflammation.
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Pharmacokinetics

Absorption:

Bioavailability: <5% (systemic absorption from topical application)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not applicable (primarily localized)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Not applicable (minimal systemic absorption)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Weeks (for clinical improvement of acne)
PeakEffect: Weeks to months
DurationOfAction: Continuous with regular application

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
A severe form of diarrhea called C. diff-associated diarrhea (CDAD), which can be life-threatening. This may occur during or after treatment with the antibiotic. Warning signs include:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools

Do not attempt to treat diarrhea without consulting your doctor first.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Irritation at the site of application
Burning
Itching
Dry skin
Redness
Oily skin

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea (even weeks after stopping treatment)
  • Severe abdominal pain or cramps
  • Bloody or watery stools
  • Severe skin irritation, redness, or peeling that does not improve
  • Signs of allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
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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.
A history of certain health conditions, including:
+ Crohn's disease
+ Other stomach or bowel problems, such as colitis or enteritis
+ Severe bowel problems that have occurred while taking an antibiotic, including severe diarrhea, bowel swelling, or stomach pain
Current use of any products containing erythromycin

This list is not exhaustive, and it is crucial to discuss all of your medications, health problems, and supplements with your doctor and pharmacist. This includes:

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

Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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.

When using this drug, avoid covering the treated area with bandages, dressings, or makeup unless your doctor has instructed you to do so.

You may need to wait several weeks to experience the full effects of this medication.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.

This drug can be harmful if ingested. If you accidentally swallow it, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.

If you are breastfeeding and apply this drug to your breast or nipple, be sure to wash the area thoroughly before nursing your child.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts could potentially lead to systemic effects like gastrointestinal upset.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222 in the US). For topical overdose, wash off excess medication.

Drug Interactions

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Moderate Interactions

  • Erythromycin (potential antagonism if applied concomitantly)
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Minor Interactions

  • Topical peeling, desquamating, or abrasive agents (may increase irritation)

Monitoring

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Routine Monitoring

Local skin irritation (dryness, redness, peeling)

Frequency: Regularly during treatment

Target: Minimal to none

Action Threshold: If severe or persistent, consider reducing frequency or discontinuing

Clinical improvement of acne

Frequency: Monthly or as clinically indicated

Target: Reduction in lesion count and inflammation

Action Threshold: If no improvement after 6-8 weeks, re-evaluate treatment

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Symptom Monitoring

  • Dryness
  • Peeling
  • Erythema (redness)
  • Burning/stinging
  • Itching
  • Oily skin
  • Folliculitis
  • Gastrointestinal symptoms (e.g., diarrhea, abdominal pain - rare but possible with systemic absorption)

Special Patient Groups

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Pregnancy

Clindamycin topical is generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and human data suggest low risk due to minimal systemic absorption.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Clindamycin topical is considered compatible with breastfeeding (L3). While clindamycin is excreted in breast milk after systemic administration, systemic absorption from topical application is minimal, making infant exposure very low. Monitor the infant for signs of diarrhea.

Infant Risk: Low risk. Monitor for diarrhea or rash in the infant.
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Pediatric Use

Safe for use in adolescents and children, typically 12 years of age and older, for the treatment of acne vulgaris. Dosing is generally the same as for adults. Safety and efficacy in younger children have not been established.

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Geriatric Use

No specific dose adjustments are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to significantly impact drug exposure.

Clinical Information

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Clinical Pearls

  • Topical clindamycin is often used in combination with benzoyl peroxide to enhance efficacy and minimize the development of bacterial resistance.
  • Patients should be advised that it may take several weeks (typically 6-8 weeks) of consistent use to see significant improvement in acne.
  • Apply to the entire affected area where acne lesions occur, not just individual spots, to prevent new breakouts.
  • Pledgets are convenient for targeted application and can be useful for hard-to-reach areas or for patients who prefer a pre-measured dose.
  • Counsel patients on the importance of adherence and proper application technique for optimal results.
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Alternative Therapies

  • Other topical antibiotics (e.g., erythromycin topical)
  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Benzoyl peroxide topical
  • Azelaic acid topical
  • Salicylic acid topical
  • Oral antibiotics (e.g., doxycycline, minocycline, for more severe acne)
  • Oral isotretinoin (for severe, recalcitrant acne)
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Cost & Coverage

Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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 safe and effective treatment, 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 for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate timely and appropriate care.