Cleocin T 1% Lotion 60ml

Manufacturer PFIZER Active Ingredient Clindamycin Gel and Lotion(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; Topical Antibiotic
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Pharmacologic Class
Lincosamide Antibiotic
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Pregnancy Category
Category B
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FDA Approved
Sep 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cleocin T 1% Lotion is a topical antibiotic used to treat acne. It works by stopping the growth of bacteria that cause acne and by reducing inflammation. Apply a thin layer to the affected skin areas, usually twice a day.
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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 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 the lotion form, shake the bottle well before application.

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 skin gently before application.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not apply to irritated or broken skin.
  • Use consistently as directed for best results; improvement may take several weeks.
  • Sun protection is recommended as some acne treatments can increase sun sensitivity.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

acne_vulgaris: Apply a thin film to the affected area(s) twice daily, morning and evening.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Safety and efficacy established in pediatric patients 12 years and older. Apply a thin film to the affected area(s) twice daily.
Adolescent: Apply a thin film to the affected area(s) twice daily, morning and evening.
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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 adjustment needed (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. It inhibits the initiation of peptide chain formation and interferes with peptidyl transferase activity. For acne, clindamycin reduces the number of Propionibacterium acnes (now Cutibacterium acnes) on the skin and in follicles, and also exhibits anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (less than 5% of applied dose)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: Limited (minimal systemic absorption)

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: Several weeks (typically 4-6 weeks for noticeable improvement in acne)
PeakEffect: Typically 8-12 weeks
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 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
+ Difficulty 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. Contact your doctor immediately 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 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. 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
  • Abdominal cramps
  • Bloody or mucus-containing stools (seek immediate medical attention, as these could be signs of pseudomembranous colitis, a rare but serious side effect)
  • Severe skin irritation (e.g., redness, itching, burning, peeling) that does not subside
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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 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 needs to assess whether it is safe for you to take this medication in combination with your other medications and health conditions. Do not initiate, stop, or adjust 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, to the treated area 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.

If this drug is accidentally swallowed, it can be harmful. In such cases, 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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

For breastfeeding mothers using this drug on the breast or nipple, it is recommended to wash the area thoroughly before breastfeeding your child to minimize any potential exposure.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. Ingestion may lead to systemic effects similar to oral clindamycin (e.g., gastrointestinal upset).

What to Do:

For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention. For excessive topical application, wash off with water.

Drug Interactions

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Moderate Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, vecuronium): Clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Use with caution.

Monitoring

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Routine Monitoring

Skin irritation (erythema, peeling, dryness, burning, itching)

Frequency: During initial weeks of treatment and as needed

Target: Minimal to none

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

Acne lesion count/severity

Frequency: Monthly or as clinically indicated

Target: Reduction in inflammatory and non-inflammatory lesions

Action Threshold: If no improvement after 8-12 weeks, re-evaluate treatment.

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Symptom Monitoring

  • Severe diarrhea
  • Abdominal pain
  • Bloody stools
  • Pseudomembranous colitis symptoms (rare, but serious)

Special Patient Groups

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Pregnancy

Considered Category B. Studies in animals have shown no evidence of harm to the fetus. Human studies are limited, but systemic absorption is minimal with topical use, suggesting low risk.

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

L2 (Safer). Clindamycin is excreted in breast milk following oral or parenteral administration. However, systemic absorption from topical application is minimal, making infant exposure unlikely to be clinically significant. Use with caution, avoid applying to areas where infant may ingest.

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

Safety and effectiveness in pediatric patients under 12 years of age have not been established. For patients 12 years and older, dosing is similar to 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 affect safety or efficacy.

Clinical Information

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Clinical Pearls

  • Topical clindamycin is effective for inflammatory acne, but less so for comedonal acne. Often used in combination with retinoids or benzoyl peroxide.
  • To minimize bacterial resistance, topical clindamycin is often prescribed with benzoyl peroxide, which has no known resistance development.
  • Patients should be advised that improvement in acne may not be seen for several weeks and consistent use is crucial.
  • Although rare, patients should be educated on the symptoms of pseudomembranous colitis (severe diarrhea, abdominal pain) and to discontinue the medication and seek medical attention if these occur.
  • The lotion formulation may be preferred for larger areas or for patients with sensitive or dry skin compared to gel or solution.
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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 - $150 per 60ml bottle
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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this 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 reporting the incident, be prepared to provide detailed information about the medication taken, the amount consumed, and the time it occurred.