Cleocin T 1% Topical Solution 60ml

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
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
Jun 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin topical solution is an antibiotic medicine 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. 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, 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.
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.
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Lifestyle & Tips

  • Cleanse the affected skin area gently before applying the solution.
  • Apply a thin film of the solution to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on broken or irritated skin.
  • Be consistent with application; it may take several weeks to see improvement.
  • Sun sensitivity is not a primary concern, but always use sun protection as part of a good skincare routine.
  • Avoid using other topical acne treatments that may cause excessive dryness or irritation unless directed by your doctor.

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, morning and evening.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for children under 12 years. For children 12 years and older, same as adult dosing.
Adolescent: Apply a thin film to the affected area twice daily, morning and evening.
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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

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting the initiation of peptide chain formation. It has bacteriostatic activity against Propionibacterium acnes (now Cutibacterium acnes), which is implicated in the pathogenesis of acne vulgaris.
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Pharmacokinetics

Absorption:

Bioavailability: Less than 5% (systemic after topical application)
Tmax: Not well-defined for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical solution.

Distribution:

Vd: Not clinically relevant for topical application due systemically absorbed amounts are negligible.
ProteinBinding: Not clinically relevant for topical application.
CnssPenetration: Limited (not clinically significant for topical use)

Elimination:

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

OnsetOfAction: Several weeks (for acne improvement)
PeakEffect: Typically 8-12 weeks (for acne improvement)
DurationOfAction: Maintained with continued use

Safety & Warnings

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BLACK BOX WARNING

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Because topical clindamycin can result in systemic absorption, this possibility should be considered in patients who present with diarrhea subsequent to the administration of topical clindamycin.
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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 or seek medical attention immediately:

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. Seek medical help right away if you experience:
+ 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea (especially if bloody or watery)
  • Severe abdominal pain or cramping
  • Severe skin irritation (e.g., excessive redness, burning, itching, peeling, swelling)
  • Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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 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 specifically 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, make sure to wash the area thoroughly before nursing your child.
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Overdose Information

Overdose Symptoms:

  • Overdose from topical application is unlikely due to minimal systemic absorption. However, excessive application may lead to increased local irritation.

What to Do:

If swallowed, or if severe symptoms occur, seek immediate medical attention or call a poison control center (1-800-222-1222).

Drug Interactions

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Moderate Interactions

  • Erythromycin (antagonistic effect when used concomitantly with clindamycin)

Monitoring

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Baseline Monitoring

Skin assessment (type, severity of acne, presence of lesions)

Rationale: To establish baseline for efficacy evaluation and identify any pre-existing skin conditions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Skin assessment (reduction in inflammatory and non-inflammatory lesions)

Frequency: Every 4-8 weeks initially, then as needed

Target: Reduction in lesion count, improvement in overall skin appearance

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

Local skin irritation (dryness, peeling, erythema, burning)

Frequency: At each follow-up visit and patient self-monitoring

Target: Minimal to no irritation

Action Threshold: Severe or persistent irritation may require reduction in frequency or temporary discontinuation.

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Symptom Monitoring

  • Severe diarrhea
  • Abdominal pain
  • Bloody stools
  • Persistent nausea or vomiting
  • Severe skin irritation (redness, itching, burning, peeling)

Special Patient Groups

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Pregnancy

Clindamycin topical is Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. While systemic absorption is minimal, use during pregnancy should be only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Low risk based on animal data and minimal systemic absorption.
Second Trimester: Low risk based on animal data and minimal systemic absorption.
Third Trimester: Low risk based on animal data and minimal systemic absorption.
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Lactation

Clindamycin is excreted in breast milk after oral or IV administration. While systemic absorption from topical application is minimal, caution should be exercised when administering to a nursing mother. The potential for adverse effects in the infant is low, but monitor for diarrhea or rash.

Infant Risk: L3 (Moderately safe; potential for low-level exposure, but adverse effects in infant are unlikely due to minimal maternal systemic absorption).
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Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established. Commonly used in adolescents (12 years and older) for acne vulgaris, with dosing similar to adults.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is expected to be similar to that in younger adults, given the minimal systemic absorption.

Clinical Information

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Clinical Pearls

  • Topical clindamycin is often used in combination with other acne treatments (e.g., benzoyl peroxide, retinoids) to enhance efficacy and reduce the development of bacterial resistance.
  • Applying benzoyl peroxide in the morning and clindamycin in the evening (or vice versa) can be an effective strategy to minimize irritation and maximize benefits.
  • Patients should be advised that improvement in acne may not be seen for several weeks, and consistent use is crucial.
  • The solution contains alcohol, which can be drying. Advise patients about potential dryness and to use a non-comedogenic moisturizer if needed.
  • The 'swab' refers to the applicator often included with the solution for easy and targeted application.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Topical antibiotics (e.g., erythromycin topical)
  • Topical salicylic acid
  • Topical azelaic acid
  • Oral antibiotics (e.g., doxycycline, minocycline, erythromycin - for more severe acne)
  • Oral isotretinoin (for severe, recalcitrant acne)
  • Hormonal therapies (e.g., oral contraceptives, spironolactone - for hormonal acne)
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Cost & Coverage

Average Cost: $50 - $150 per 60ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.