Cleocin T 1% Topical Solution 30ml

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, topical 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?

Cleocin T is a topical antibiotic solution used 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. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning.

Application Instructions

1. Wash your hands before and after applying the medication.
2. Clean the affected area before use and make sure it is completely dry.
3. Apply a thin layer of the medication to the affected skin. Do not apply it to open sores or broken skin.
4. If using pledgets (swabs), remove one from the foil packaging immediately before use. Use it once and then discard it. You may use more than one pledget as needed.

Continuing Treatment

Continue using the medication as directed, even if your symptoms improve.

Storage and Disposal

To maintain the medication's effectiveness and safety:

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

Missed Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled 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 one.
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Lifestyle & Tips

  • Cleanse skin gently before application.
  • Apply a thin film to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Wash hands thoroughly after application.
  • Use consistently as directed, even if acne appears to improve.
  • Sun protection (sunscreen, protective clothing) is recommended as some acne treatments can increase sun sensitivity.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film of Cleocin T Topical Solution to the affected area twice daily.

Condition-Specific Dosing:

acne_vulgaris: Apply a thin film to the entire affected area (e.g., face, chest, back) twice daily, morning and evening.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 12 years and older, dosing is generally the same as adults. Safety and efficacy in children under 12 years have not been established.
Adolescent: Apply a thin film of Cleocin T Topical Solution to the 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 specific considerations for topical use 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), which is implicated in the pathogenesis of acne vulgaris.
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Pharmacokinetics

Absorption:

Bioavailability: Less than 5% (systemic absorption after topical application)
Tmax: Not well-defined for systemic levels after topical application; local concentrations peak rapidly.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not applicable for topical formulation due to minimal systemic absorption.
ProteinBinding: Not applicable for topical formulation due to minimal systemic absorption.
CnssPenetration: Limited (not relevant for topical use).

Elimination:

HalfLife: Not applicable for topical formulation due to minimal systemic absorption (systemic half-life is 2-3 hours if absorbed).
Clearance: Not applicable for topical formulation due to minimal systemic absorption.
ExcretionRoute: Not applicable for topical formulation due to minimal systemic absorption (systemic excretion is primarily via urine and feces).
Unchanged: Not applicable for topical formulation due to minimal systemic absorption.
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Pharmacodynamics

OnsetOfAction: Reduction in acne lesions typically observed within 2-6 weeks.
PeakEffect: Optimal results may take 8-12 weeks of consistent use.
DurationOfAction: Requires continuous application for sustained effect.

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 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
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. 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. 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 persist or bother you:

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 not mentioned here. If you have questions or concerns about side effects, consult 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 (especially if bloody or watery)
  • Abdominal pain or cramping
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Severe skin irritation (excessive redness, burning, peeling, blistering)
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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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction 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 covering the treated area with 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 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.

For breastfeeding mothers using this drug on the breast or nipple, make sure to wash the area thoroughly before feeding your child to prevent any potential exposure.
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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 gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

If ingested, seek medical attention. For topical overdose, wash off excess medication. Call 1-800-222-1222 (Poison Control) for advice if concerns arise.

Drug Interactions

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Moderate Interactions

  • Neuromuscular blocking agents (potential for enhanced neuromuscular blockade due to clindamycin's properties)

Monitoring

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Symptom Monitoring

  • Improvement in acne lesions (reduction in inflammatory and non-inflammatory lesions)
  • Skin irritation (redness, dryness, peeling, itching, burning)
  • Development of severe diarrhea or pseudomembranous colitis symptoms (rare but serious)

Special Patient Groups

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Pregnancy

Clindamycin topical is generally considered safe for use during pregnancy (Category B). Studies in pregnant women have not shown an increased risk of fetal abnormalities.

Trimester-Specific Risks:

First Trimester: Low risk based on available data.
Second Trimester: Low risk based on available data.
Third Trimester: Low risk based on available data.
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Lactation

Clindamycin is excreted in breast milk after systemic administration. However, systemic absorption from topical application is minimal. It is considered L2 (likely compatible) by Hale's classification. Use with caution, apply to areas not accessible to the infant, and avoid applying to the breast area.

Infant Risk: Low risk of adverse effects in breastfed infants due to minimal maternal systemic absorption.
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Pediatric Use

Safety and efficacy in children under 12 years of age have not been established. For adolescents 12 years and older, dosing is generally the same as adults.

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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 drug exposure.

Clinical Information

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Clinical Pearls

  • Topical clindamycin is effective for inflammatory acne lesions (papules and pustules) but less so for comedones (blackheads and whiteheads).
  • Often used in combination with other topical agents like benzoyl peroxide to enhance efficacy and reduce the risk of bacterial resistance.
  • Applying benzoyl peroxide in the morning and clindamycin in the evening can be a common regimen to minimize irritation and optimize efficacy.
  • Patients should be advised that improvement is gradual and consistent use is key.
  • The solution formulation may be preferred for oily skin, while gels or lotions might be better for drier or sensitive skin.
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Alternative Therapies

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

Average Cost: Varies widely, typically $50 - $200+ per 30ml solution
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 condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. 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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.