Clindamycin 1% Topical Soln 60ml

Manufacturer TARO 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 1980
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin topical solution is an antibiotic medication 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, avoiding the mouth, nose, and 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, avoiding open sores or broken skin.
If using pledgets (swabs), remove one from the foil immediately 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 to make up for a missed one.
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Lifestyle & Tips

  • Cleanse skin gently before application.
  • Apply a thin layer to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Wash hands thoroughly after application.
  • Use sunscreen and protective clothing, as some acne treatments can increase sun sensitivity.
  • Be patient; it may take several weeks to see improvement.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to affected areas twice daily (morning and evening).

Condition-Specific Dosing:

acne_vulgaris: Apply a thin film to affected areas twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 12 years and older: Apply a thin film to affected areas twice daily.
Adolescent: Apply a thin film to affected areas 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, thereby inhibiting the initiation of peptide chain formation. It has bacteriostatic activity against Propionibacterium acnes (now Cutibacterium acnes), reducing inflammation and the number of acne lesions.
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Pharmacokinetics

Absorption:

Bioavailability: Less than 5% (systemic absorption from topical application)
Tmax: Not clinically significant for topical use; systemic levels are very low.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not clinically significant for topical use.
ProteinBinding: Not clinically significant for topical use.
CnssPenetration: Limited (not relevant for topical use).

Elimination:

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

OnsetOfAction: Weeks to months for full therapeutic effect in acne.
PeakEffect: Typically 8-12 weeks for optimal acne improvement.
DurationOfAction: Requires continuous application for sustained effect.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 help 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 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. Contact your doctor or seek medical help if you experience:

Irritation at the site where the medication was applied
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 or persistent diarrhea (even if it occurs weeks after stopping the medication)
  • Abdominal pain or cramping
  • Bloody or mucus-containing stools
  • Severe skin irritation, redness, itching, or peeling that does not improve
  • Hives or allergic reaction (rare)
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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
+ Other 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 you determine if it is safe to take this medication with your existing health conditions and other medications.

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.

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 an event, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as they will help you weigh the advantages and disadvantages for both you and your baby.

For breastfeeding mothers who apply this drug to their breast or nipple, it is recommended to wash the area thoroughly before breastfeeding your child to ensure safety.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption.

What to Do:

If accidental ingestion occurs, seek medical attention. For excessive topical application, wash off with water. Call 1-800-222-1222 (Poison Control).

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 ribosomal 50S subunit. Avoid concomitant use.

Monitoring

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Routine Monitoring

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

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

Target: Minimal to no irritation.

Action Threshold: If severe irritation occurs, reduce frequency or discontinue use and consult a healthcare provider.

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 plan.

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Symptom Monitoring

  • Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea, though rare with topical use)
  • Abdominal pain or cramping
  • Bloody or mucus-containing stools
  • Severe skin irritation, blistering, or rash

Special Patient Groups

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Pregnancy

Clindamycin topical is considered Category B. Studies in animals have shown no evidence of harm to the fetus, and human data suggest low risk due to minimal systemic absorption. Use if clearly needed.

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

Considered compatible with breastfeeding (L2). Minimal systemic absorption means very little clindamycin is expected to be excreted into breast milk. Monitor infant for diarrhea or rash.

Infant Risk: Low risk. Advise applying to areas where the infant will not come into direct contact with the medication.
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Pediatric Use

Safe and effective for acne in children 12 years and older. Safety and efficacy in children younger than 12 years have not been established.

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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 often used in combination with benzoyl peroxide to enhance efficacy and reduce the development of bacterial resistance.
  • Patients should be advised that improvement in acne may not be seen for several weeks to months.
  • Although rare, C. difficile-associated diarrhea (CDAD) has been reported with topical clindamycin. Patients should be instructed to discontinue use and contact their physician if significant diarrhea develops.
  • The solution formulation may be drying; patients with sensitive skin may prefer a gel or lotion formulation if available.
  • Avoid concurrent use with topical erythromycin due to potential antagonism.
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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: $30 - $100 per 60ml bottle (generic)
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 your 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.