Clindamycin 1% Pledgets 60s

Manufacturer PERRIGO 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
Anti-acne agent; Antibiotic
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Pharmacologic Class
Lincosamide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Aug 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin pledgets are medicated pads used on the skin to treat acne. They contain an antibiotic that helps kill the bacteria that cause acne and reduce 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 use 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 just 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 and moisture.
Do not freeze the medication.
Keep it in a dry place, avoiding storage in a bathroom.

Missed Dose Instructions

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 to make up for a missed one.
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Lifestyle & Tips

  • Wash affected skin gently before applying the pledget.
  • Use the pledget to wipe the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not use on broken or irritated skin.
  • Allow the area to dry completely before applying other topical products or makeup.
  • Consistency is key; use as directed even if acne seems to improve.
  • Protect skin from sun exposure as some acne treatments can increase sun sensitivity.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected area twice daily

Condition-Specific Dosing:

acne vulgaris: Apply a thin film to the affected area twice daily (morning and evening).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Safety and efficacy not established for children under 12 years of age. Use in adolescents (12 years and older) is typically the same as adult dosing.
Adolescent: Apply to affected area twice daily
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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 adjustment needed 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

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. It exhibits bacteriostatic activity against Propionibacterium acnes (now Cutibacterium acnes), reducing the number of free fatty acids on the skin surface, which are thought to contribute to acne.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <4%) after topical application.
Tmax: Not applicable for systemic peak; local concentration achieved rapidly.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not applicable for systemic volume of distribution due to minimal absorption.
ProteinBinding: Not applicable for systemic protein binding due to minimal absorption.
CnssPenetration: Limited (not clinically significant for topical use).

Elimination:

HalfLife: Not applicable for systemic half-life due to minimal absorption.
Clearance: Not applicable for systemic clearance due to minimal absorption.
ExcretionRoute: Not applicable for systemic excretion route due to minimal absorption.
Unchanged: Not applicable for systemic unchanged excretion due to minimal absorption.
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Pharmacodynamics

OnsetOfAction: Weeks for noticeable improvement in acne (typically 4-6 weeks).
PeakEffect: Up to 12 weeks for maximal effect.
DurationOfAction: Maintained with continued use.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek 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
A severe form of diarrhea called C diff-associated diarrhea (CDAD), which can be life-threatening. This may occur while taking the antibiotic or within a few months after stopping it. Watch for:
+ 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. While many people may not experience any side effects or only minor 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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe diarrhea (watery or bloody stools)
  • Abdominal pain or cramping
  • Severe skin irritation (excessive redness, itching, burning, peeling)
  • Allergic reaction (rash, hives, swelling, difficulty 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 symptoms you experienced.
A history of certain health conditions, including:
+ Crohn's disease
+ Stomach or bowel problems, such as colitis or enteritis
+ Severe bowel problems that occurred while taking an antibiotic, including severe diarrhea, bowel swelling, or stomach pain
* Current use of products containing erythromycin

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not 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 applying any coverings, such as bandages, dressings, or makeup, unless specifically instructed to do so by your doctor.

Please note that it may take several weeks for the full effects of this medication to become apparent.

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

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

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

For breastfeeding mothers who apply this drug to the breast or nipple area, it is crucial to wash the area thoroughly before breastfeeding your child to prevent any potential exposure to the medication.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. However, excessive application could theoretically increase systemic absorption, leading to symptoms like gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

If accidental ingestion occurs or severe symptoms develop, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Moderate Interactions

  • Erythromycin (topical or systemic): May antagonize the antibacterial effect of clindamycin due to competitive binding at the 50S ribosomal subunit. Avoid concomitant use.

Monitoring

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Baseline Monitoring

Skin condition (severity of acne)

Rationale: To establish baseline for efficacy assessment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Skin irritation (redness, dryness, peeling, burning)

Frequency: Daily, or as symptoms arise.

Target: Minimal to none.

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

Efficacy (reduction in acne lesions)

Frequency: Monthly, or as clinically indicated.

Target: Gradual improvement over 8-12 weeks.

Action Threshold: If no improvement after 12 weeks, re-evaluate diagnosis or treatment plan.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal cramping
  • Bloody stools
  • Signs of pseudomembranous colitis (rare but possible with systemic absorption)

Special Patient Groups

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Pregnancy

Clindamycin is generally considered safe for use during pregnancy (Category B). Animal studies have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Systemic absorption from topical application is minimal.

Trimester-Specific Risks:

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

Clindamycin is considered compatible with breastfeeding (L2). While clindamycin is excreted in breast milk after systemic administration, systemic absorption from topical application is minimal, making infant exposure unlikely to be significant. Apply to areas where the infant will not come into direct contact.

Infant Risk: Low risk of adverse effects to the breastfed infant.
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Pediatric Use

Safety and efficacy have not been established in children under 12 years of age. Use in adolescents (12 years and older) is generally well-tolerated and follows adult dosing guidelines.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact safety or efficacy.

Clinical Information

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Clinical Pearls

  • Topical clindamycin is most effective when used consistently and as part of a comprehensive acne regimen, often in combination with a topical retinoid or benzoyl peroxide.
  • To minimize the risk of bacterial resistance, clindamycin topical solutions are often co-prescribed with benzoyl peroxide, which has no known resistance mechanisms.
  • Patients should be advised that improvement in acne may take several weeks (typically 8-12 weeks) and to continue treatment even if initial results are not immediately apparent.
  • Pledgets offer a convenient and mess-free application, ensuring even distribution over the affected area.
  • Although rare, patients should be educated about the signs of pseudomembranous colitis (severe diarrhea, abdominal pain) and instructed to seek medical attention if these symptoms occur, even with topical use.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Topical benzoyl peroxide
  • Topical azelaic acid
  • Topical dapsone
  • Oral antibiotics (e.g., doxycycline, minocycline, sarecycline) for moderate to severe acne
  • Oral isotretinoin for severe, recalcitrant acne
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Cost & Coverage

Average Cost: $30 - $100+ per 60 pledgets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 taken, the amount, and the time it happened.