Clindets 1% Pledgets 69s

Manufacturer STIEFEL 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
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Pharmacologic Class
Lincosamide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Aug 1976
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin is an antibiotic applied to the skin to treat acne. It works by stopping the growth of bacteria that cause acne and 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, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication 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 to open sores or broken skin.
If using pledgets (swabs), remove one from the foil just before use, use it once, and then discard it. 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 application 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

  • Apply the pledget to the entire affected area, not just individual pimples.
  • Wash and dry the skin thoroughly before application.
  • Avoid contact with eyes, mouth, nose, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on irritated or broken skin.
  • Sun protection (sunscreen, protective clothing) is recommended as some acne treatments can increase sun sensitivity.
  • Consistency is key; use regularly as prescribed for best results, even if acne seems to improve.
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Available Forms & Alternatives

Available Strengths:

Generic Alternatives:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected area once or twice daily

Condition-Specific Dosing:

Acne Vulgaris: Apply a thin film of Clindets 1% Pledgets to the affected area once or twice daily, as directed by a physician.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Safety and efficacy established for children 12 years and older. Dosing is similar to adults.
Adolescent: Apply to affected area once or twice daily, similar to adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (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 and inhibiting the early stages of protein synthesis. It has bacteriostatic activity against Propionibacterium acnes (now Cutibacterium acnes), reducing the number of bacteria and the associated inflammation in acne lesions.
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Pharmacokinetics

Absorption:

Bioavailability: Very low (<4% systemically absorbed after topical application)
Tmax: Not well-defined for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not clinically significant for topical application.
ProteinBinding: Not clinically significant for topical application.
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not clinically significant for topical application.
Clearance: Not clinically significant for topical application.
ExcretionRoute: Not clinically significant for topical application.
Unchanged: Not clinically significant for topical application.
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Pharmacodynamics

OnsetOfAction: Weeks to months for noticeable improvement in acne.
PeakEffect: Typically 8-12 weeks of continuous use.
DurationOfAction: Maintained with continued use; effects diminish upon discontinuation.

Safety & Warnings

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BLACK BOX WARNING

Clindamycin can cause severe colitis, which may result in death. It has been reported to occur following oral and parenteral administration of clindamycin, but rarely with topical formulations. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea develops, the drug should be discontinued.
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Side Effects

Urgent Side Effects: Seek Medical Help 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 attention 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. If you experience:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools
contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

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

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Bloody or tarry stools
  • Severe skin irritation (e.g., excessive redness, burning, itching, peeling)
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, 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 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
* If you are currently using any products that contain erythromycin

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

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

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

This medication 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 both 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 feeding your child to minimize any potential exposure.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption.
  • Excessive application may lead to increased local irritation.

What to Do:

If accidentally ingested, seek medical attention. For excessive topical application, wash the area with water. For any concerning symptoms, call 1-800-222-1222 (Poison Control) or seek emergency medical care.

Drug Interactions

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Major Interactions

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

  • Neuromuscular blocking agents: Clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Use with caution in patients receiving such agents.

Monitoring

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Baseline Monitoring

Skin assessment (acne severity)

Rationale: To establish baseline for treatment efficacy evaluation.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Skin irritation (redness, dryness, peeling, burning)

Frequency: Regularly during treatment, especially in the first few weeks.

Target: Minimal to none.

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

Acne lesion count/severity

Frequency: Monthly or as clinically indicated.

Target: Reduction in inflammatory and non-inflammatory lesions.

Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of therapy.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain
  • Bloody stools
  • Skin irritation (redness, dryness, peeling, burning, itching)
  • Allergic reactions (rash, hives, swelling)

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 are limited but do not suggest an increased risk of birth defects. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, Category B.
Second Trimester: Low risk, Category B.
Third Trimester: Low risk, Category B.
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Lactation

Clindamycin is excreted in breast milk after systemic administration. While systemic absorption from topical application is minimal, caution is advised. Considered L2 (Likely Compatible) by some sources. Monitor breastfed infant for diarrhea or rash.

Infant Risk: Low risk of adverse effects due to minimal systemic absorption by the mother. Monitor for gastrointestinal upset (e.g., diarrhea) in the infant.
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Pediatric Use

Safety and efficacy have been established in pediatric patients 12 years of age and older. Use in younger children is not well-established, but topical clindamycin is often used off-label in younger children for acne under medical supervision. Dosing is similar to adults for those 12 and older.

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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 unlikely to significantly impact safety or efficacy.

Clinical Information

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Clinical Pearls

  • Topical clindamycin is primarily used for inflammatory acne (papules and pustules) due to its antibacterial and anti-inflammatory properties.
  • Often used in combination with other topical agents like benzoyl peroxide or retinoids to enhance efficacy and reduce the risk of bacterial resistance.
  • Applying benzoyl peroxide in the morning and clindamycin at night (or vice versa) can be a common strategy to maximize benefits and minimize irritation.
  • Patients should be advised that improvement may take several weeks to months, and consistent use is crucial.
  • Warn patients about the potential for dryness, redness, and peeling, especially when starting treatment or combining with other active topicals.
  • Although rare with topical use, educate patients on the symptoms of pseudomembranous colitis (severe diarrhea, abdominal pain) and to seek medical attention if they occur.
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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 more severe acne
  • Oral isotretinoin (for severe, recalcitrant acne)
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Cost & Coverage

Average Cost: $50 - $200 per 60 pledgets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.