Clindamycin 1% Topical Soln 30ml

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
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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 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. 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 if needed.

Continuing Treatment

Continue using the medication as directed, even if your symptoms improve. This will help ensure that the condition is fully treated.

Storage and Disposal

To store this medication, keep it at room temperature and protect it from heat. Store it in a dry place, avoiding bathrooms and areas where it may be exposed to moisture. 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 continue with 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 applying the solution.
  • Apply a thin film to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not apply to irritated or broken skin.
  • Use sunscreen and protective clothing as skin may become more sensitive to sun.
  • Be patient; it may take several weeks to see improvement.
  • Do not share this medication with others.

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
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Apply a thin film to the affected area twice daily (safety and efficacy established in patients 12 years and older)
Adolescent: Apply a thin film to the affected area twice daily
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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 of susceptible bacteria, thereby inhibiting peptide bond formation. It is primarily bacteriostatic. In acne, it reduces the number of Propionibacterium acnes (now Cutibacterium acnes) on the skin and in follicles, and also has anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: <5% (systemic after topical application)
Tmax: Not well-defined for systemic absorption from topical application; local effect is gradual.
FoodEffect: Not applicable for topical formulation

Distribution:

Vd: Not well-defined for topical systemic absorption
ProteinBinding: Not well-defined for topical systemic absorption
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Not well-defined for topical systemic absorption (systemic half-life is 2-3 hours)
Clearance: Not well-defined for topical systemic absorption
ExcretionRoute: Not well-defined for topical systemic absorption
Unchanged: Not well-defined for topical systemic absorption
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Pharmacodynamics

OnsetOfAction: Several weeks for noticeable improvement in acne
PeakEffect: Typically 8-12 weeks for maximal effect
DurationOfAction: Maintained with continued use

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 over 2 months after the administration of clindamycin. Diarrhea, colitis, and pseudomembranous colitis have been reported with the use of topical clindamycin. If significant diarrhea occurs, the drug should be discontinued.
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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 attention 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. 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 pain or cramping
  • Bloody or mucus-containing stools
  • Severe skin irritation, redness, or peeling that does not improve
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble 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 symptoms you experienced as a result of the allergy.
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 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 your doctor has 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 and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.

For breastfeeding mothers who apply this drug to their breast or nipple, it is crucial to wash the area thoroughly before feeding your child to prevent any potential exposure to the medication.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts could theoretically lead to systemic effects like abdominal pain, nausea, vomiting, or diarrhea.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222). For topical overdose, wash the area with water. Treatment is generally supportive.

Drug Interactions

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Moderate Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Clindamycin may potentiate the action of neuromuscular blocking agents, leading to increased or prolonged neuromuscular blockade. Use with caution.
  • Erythromycin (topical or systemic): Concurrent use may result in antagonism due to competitive binding at the 50S ribosomal subunit. Avoid concomitant use.

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline for treatment efficacy and adverse effects.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in acne lesions)

Frequency: Monthly or as clinically indicated

Target: Improvement in lesion count and overall skin appearance

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

Local skin reactions (dryness, peeling, redness, irritation, burning)

Frequency: At each follow-up visit

Target: Minimal to no irritation

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

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal cramping
  • Bloody stools
  • Signs of pseudomembranous colitis (rare with topical use, but possible due to systemic absorption)

Special Patient Groups

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Pregnancy

Clindamycin topical solution is generally considered safe for use during pregnancy (Category B). Systemic absorption is minimal, reducing the risk of fetal exposure. However, use only if clearly needed and potential benefits outweigh risks.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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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. The risk to the infant is generally considered low (L3). Avoid applying to areas where the infant may ingest the medication.

Infant Risk: Low (L3 - Moderately Safe)
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Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established. For adolescents (12 years and older), dosing is similar to adults. Due to potential for systemic absorption, monitor for systemic adverse effects, especially diarrhea.

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Geriatric Use

No specific dose 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 often used in combination with a topical retinoid or benzoyl peroxide for enhanced efficacy and to reduce the development of bacterial resistance.
  • Patients should be advised that improvement in acne may not be seen for several weeks, and consistent application is key.
  • Although rare, patients should be educated about the risk of severe diarrhea (pseudomembranous colitis) and instructed to discontinue the medication and seek medical attention if it occurs.
  • The solution contains alcohol, which can cause stinging or burning, especially on sensitive or broken skin. It can also be drying.
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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: $20 - $100 per 30ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.