Clindamycin 1% Foam 100gm

Manufacturer PERRIGO Active Ingredient Clindamycin Foam(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
Dec 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin foam is a topical antibiotic medication used to treat acne. It works by stopping the growth of bacteria that contribute to 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. Avoid getting it 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.
To apply the foam, place it on a cool surface or in a cap. Avoid putting the foam in your hands.
If the can feels warm or the foam seems runny, run cold water over the can to cool it down.

Storage and Disposal

Store this medication at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom.
Protect the medication from heat and sunlight.
Do not puncture or burn the can, even if it seems empty.

Missed Dose

If you miss a dose, use 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 use two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Wash and dry affected areas before application.
  • Apply a thin layer of foam to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not use on broken or irritated skin.
  • Use consistently as directed, even if acne appears to improve.
  • Sun protection is recommended as some acne treatments can increase sun sensitivity.
  • Avoid excessive washing or scrubbing of the skin, which can worsen acne.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to affected areas once daily.

Condition-Specific Dosing:

acne_vulgaris: Apply a thin layer to affected areas once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Safety and efficacy not established in pediatric patients under 12 years of age.
Adolescent: Apply a thin layer to affected areas once daily (12 years and older).
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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 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: Minimal systemic absorption (less than 1%)
Tmax: Not applicable (topical, minimal systemic absorption)
FoodEffect: Not applicable (topical)

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 (for acne improvement)
PeakEffect: Typically 8-12 weeks for maximal acne improvement
DurationOfAction: Maintained with continued use

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While 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 immediately or seek emergency 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 during or after treatment with the antibiotic. 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. Although many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Irritation at the site of application
Burning
Itching
Dry skin
Redness
Oily skin
* Headache

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 (may indicate Clostridioides difficile-associated diarrhea, even with topical use)
  • Severe abdominal pain
  • Bloody stools
  • Severe 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.
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, 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 modify the dosage 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.

If this drug is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.

This medication is flammable, so it is crucial to keep it away from open flames and not to use it while smoking.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to you and your baby.

For breastfeeding mothers who apply this drug to their breast or nipple, it is necessary 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 could lead to systemic clindamycin effects.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222). For topical overuse, wash off excess and monitor for severe local irritation.

Drug Interactions

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Moderate Interactions

  • Neuromuscular blocking agents (potential for enhanced neuromuscular blockade)

Monitoring

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Routine Monitoring

Skin irritation (redness, dryness, peeling, burning)

Frequency: Regularly during treatment

Target: Minimal to none

Action Threshold: If severe or persistent, discontinue use and consult physician.

Acne lesion count/severity

Frequency: Monthly or as clinically indicated

Target: Reduction in inflammatory and non-inflammatory lesions

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

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Symptom Monitoring

  • Diarrhea (especially severe or persistent)
  • Abdominal pain
  • Fever
  • Skin rash
  • Itching
  • Dryness
  • Peeling
  • Burning
  • Stinging

Special Patient Groups

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Pregnancy

Clindamycin is generally considered Category B for pregnancy. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Topical absorption is minimal, further reducing risk.

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 topical absorption is minimal, caution is advised. L2 (safer) to L3 (moderately safe) depending on extent of application and infant age. Monitor infant for diarrhea or rash.

Infant Risk: Low risk of adverse effects due to minimal maternal systemic absorption. Monitor for diarrhea or rash in breastfed infant.
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Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents (12 years and older) is common and generally well-tolerated.

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Geriatric Use

No specific dosage adjustments are necessary. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Minimal systemic absorption suggests no age-related concerns.

Clinical Information

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Clinical Pearls

  • Clindamycin foam is an effective topical treatment for inflammatory acne.
  • Patients should be instructed on proper application technique: apply a thin layer to the entire affected area, not just individual lesions.
  • Remind patients that improvement in acne takes time, typically 8-12 weeks, and consistent use is key.
  • Although rare with topical use, patients should be educated about the risk of severe diarrhea (Clostridioides difficile-associated diarrhea) and to seek medical attention if it occurs.
  • The foam formulation may be preferred by some patients due to its ease of application and less greasy feel compared to creams or gels.
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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: Varies widely, typically $100-$500+ per 100gm foam
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization for brand)
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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. 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 information about the medication taken, the amount, and the time it happened.