Clindamycin 1% Foam 50gm

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
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
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 used 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. 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.
When using 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 Instructions

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 affected skin gently before applying the foam.
  • Shake the can well before use.
  • Dispense a small amount of foam into the cap or onto a cool surface (not directly onto hands, as it will melt).
  • Apply a thin layer of foam to the affected area once daily, gently rubbing it in until it disappears.
  • Avoid contact with eyes, mouth, nose, and other mucous membranes.
  • Do not use on broken or irritated skin.
  • Avoid excessive sun exposure and use sunscreen, 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 layer of foam to the affected area once daily.

Condition-Specific Dosing:

acne vulgaris: Apply a thin layer of foam to the affected area once daily after washing the skin.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Safety and efficacy not established for children under 12 years of age.
Adolescent: For adolescents 12 years and older: Apply a thin layer of foam to the affected area once 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 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 (typically < 5%) after topical application.
Tmax: Not clinically significant due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not clinically significant due to minimal systemic absorption.
ProteinBinding: Not clinically significant due to minimal systemic absorption.
CnssPenetration: Limited

Elimination:

HalfLife: Not clinically significant for topical application (systemic half-life is 2-3 hours).
Clearance: Not clinically significant for topical application.
ExcretionRoute: Primarily via urine and feces if absorbed systemically.
Unchanged: Not clinically significant for topical application.
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Pharmacodynamics

OnsetOfAction: Weeks for noticeable improvement in acne (typically 2-6 weeks).
PeakEffect: Typically 8-12 weeks for maximal effect.
DurationOfAction: Maintained with continued use.
Confidence: High

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 following oral and parenteral administration of clindamycin, but rarely with topical formulations. Diarrhea, bloody diarrhea, and colitis (including 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 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. While many people experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor 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
* Headache

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 diarrhea (watery or bloody)
  • Severe stomach cramps or pain
  • Fever
  • Yellowing of skin or eyes (jaundice)
  • Severe skin irritation (e.g., excessive redness, burning, itching, peeling, swelling)
  • Signs of an allergic reaction (rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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, 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 the safety of taking this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or adjust 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 use this drug on their breast or nipple, it is important to wash the area thoroughly before breastfeeding your child.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. In case of accidental ingestion, symptoms might include gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

If accidental ingestion occurs, seek medical attention immediately. Call 1-800-222-1222 (Poison Control Center).

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.
  • Neuromuscular blocking agents (e.g., succinylcholine, vecuronium): Clindamycin has neuromuscular blocking properties and may enhance the action of these agents, leading to increased or prolonged 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: Discontinue if severe irritation occurs; consult physician.

Acne lesion count/severity

Frequency: Monthly or as clinically indicated

Target: Reduction in inflammatory and non-inflammatory lesions

Action Threshold: Re-evaluate treatment if no improvement after 8-12 weeks.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain
  • Fever
  • Bloody stools (signs of pseudomembranous colitis)
  • Severe skin irritation (e.g., excessive dryness, peeling, redness, burning, itching)

Special Patient Groups

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Pregnancy

Clindamycin is Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Due to minimal systemic absorption, topical clindamycin is generally considered low risk during pregnancy, but use only if clearly needed and potential benefits outweigh risks.

Trimester-Specific Risks:

First Trimester: Low risk, but use with caution.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Clindamycin is excreted in breast milk after systemic administration. While systemic absorption from topical application is minimal, caution should be exercised. Consider applying to areas not accessible to the infant or avoiding application to the breast area. Monitor the infant for diarrhea or rash.

Infant Risk: L2 (likely compatible) or L3 (moderately safe) - generally considered low risk due to minimal maternal systemic absorption.
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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 similar to adults.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related differences in pharmacokinetics are not expected to be clinically significant.

Clinical Information

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Clinical Pearls

  • Instruct patients to apply the foam to dry skin after washing. The foam melts quickly on contact with warm skin, so dispensing into the cap or a cool surface is important.
  • Emphasize the importance of consistent, once-daily application for optimal results.
  • Advise patients that improvement may not be seen for several weeks (typically 2-6 weeks), and full effect may take 8-12 weeks.
  • Counsel patients on the rare but serious risk of pseudomembranous colitis and to report any severe or persistent diarrhea immediately.
  • 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.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Topical benzoyl peroxide
  • Other topical antibiotics (e.g., erythromycin, dapsone)
  • Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) 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: $100 - $500+ per 50gm foam
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (may vary by plan)
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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 happened.