Clindamycin 1% Lotion 60ml

Manufacturer TARO 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
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
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin lotion is a topical antibiotic used to treat acne. It works by stopping the growth of bacteria that can 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, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Clean the affected area before application and make sure it is dry.
Apply a thin layer of the medication to the affected skin. Avoid applying 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 application schedule.
Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Cleanse skin gently before applying the lotion.
  • Apply a thin film to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, nose, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not apply to irritated or broken skin.
  • 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 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: Safety and efficacy not fully established for children under 12 years; for children 12 years and older, dosing is similar to adults.
Adolescent: Apply a thin film 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 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 binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting bacterial protein synthesis. It is primarily bacteriostatic.
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Pharmacokinetics

Absorption:

Bioavailability: <5% (systemic absorption from topical application)
Tmax: Not well-defined for systemic absorption from topical application
FoodEffect: Not applicable for topical formulation

Distribution:

Vd: Not significant systemically from topical application
ProteinBinding: Not significant systemically from topical application
CnssPenetration: No

Elimination:

HalfLife: Not significant systemically from topical application
Clearance: Not significant systemically from topical application
ExcretionRoute: Not significant systemically from topical application
Unchanged: Not significant systemically from topical application
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Pharmacodynamics

OnsetOfAction: Improvement typically seen within 4-6 weeks
PeakEffect: Full therapeutic effect may take up to 12 weeks
DurationOfAction: Maintained with continued use

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 when 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. Warning signs include:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools

If you experience any of these symptoms, do not attempt to treat the diarrhea without first consulting your doctor.

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 is 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 where the medication was applied
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
  • Bloody or tarry stools
  • Severe abdominal pain or cramping
  • Excessive skin irritation, redness, burning, or peeling that does not subside
  • Signs of allergic reaction (e.g., 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 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. They will help determine if it is safe to take this medication 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 your doctor has specifically instructed you to do so.

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

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Local irritation may worsen.

What to Do:

If accidentally ingested, seek medical attention. For excessive topical application, wash off with water. For any severe or unusual symptoms, call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

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 50S ribosomal subunit.
  • Neuromuscular blocking agents: Clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. (Theoretical, highly unlikely with topical use due to minimal systemic absorption).
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Minor Interactions

  • Other topical acne preparations (e.g., salicylic acid, retinoids, benzoyl peroxide): May increase skin irritation, dryness, or peeling if used concomitantly. Use with caution or at different times of day.

Monitoring

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Baseline Monitoring

Skin assessment (type and severity of acne lesions)

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in acne lesions)

Frequency: Every 4-6 weeks initially, then as needed

Target: Reduction in inflammatory and non-inflammatory lesions

Action Threshold: Consider alternative or adjunctive therapy if no significant improvement after 8-12 weeks

Local adverse reactions (e.g., dryness, peeling, erythema, burning, itching)

Frequency: At each follow-up visit or as reported by patient

Target: Minimal to no irritation

Action Threshold: Reduce frequency of application, discontinue, or use emollients if severe irritation occurs

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Bloody stools
  • Abdominal cramps
  • Pseudomembranous colitis symptoms (rare, but a serious systemic side effect of clindamycin)
  • Excessive skin dryness, peeling, redness, or irritation at application site

Special Patient Groups

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Pregnancy

Clindamycin is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Due to minimal systemic absorption from topical application, the risk to the fetus is considered low. Use only 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

Clindamycin is excreted in breast milk following oral or parenteral administration. While systemic absorption from topical application is minimal, caution should be exercised when administering to a nursing mother. Monitor infant for potential gastrointestinal effects (e.g., diarrhea, candidiasis). Apply to areas where infant will not ingest.

Infant Risk: L3 (Moderately safe; potential for GI effects in infant, but systemic exposure is low).
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Pediatric Use

Safety and efficacy have not been fully established in children under 12 years of age. For adolescents 12 years and older, dosing is similar to adults. Use in younger children should be under strict medical supervision.

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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 often used in combination with benzoyl peroxide (applied at different times of day) to enhance efficacy and reduce the development of bacterial resistance.
  • Patients should be advised that significant improvement in acne may take several weeks to months of consistent use.
  • Wash hands thoroughly after applying the lotion.
  • Avoid using abrasive cleansers or other topical products that may cause excessive dryness or irritation while using clindamycin lotion.
  • Although rare, systemic absorption can occur, and patients should be advised to report any severe or persistent diarrhea, as this could indicate Clostridioides difficile-associated diarrhea (CDAD).
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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, 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: Varies widely, typically $30 - $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 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, including the name of the medication taken, the amount, and the time it occurred.