Cleocin 150mg Capsules

Manufacturer PFIZER Active Ingredient Clindamycin Capsules(klin da MYE sin) Pronunciation KLIN-da-MYE-sin
WARNING: Diarrhea is common with antibiotics. Rarely, a severe form called C diff?associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem. CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea. @ COMMON USES: It is used to treat or prevent bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Lincosamide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Jul 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin is an antibiotic used to treat various bacterial infections, including skin infections, bone infections, and certain types of pneumonia. It works by stopping the growth of bacteria. It is important to take this medication exactly as prescribed and to finish the entire course of treatment, even if you feel better.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you're feeling well. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.

To reduce the risk of throat irritation and ulcers, take the medication with a full glass of water (6 to 8 ounces or 200 to 250 mL). After taking the medication, remain upright for at least 30 minutes to help prevent these potential side effects.

Storing and Disposing of Your Medication

Store the medication at room temperature, avoiding refrigeration or freezing. Keep it in a dry location, such as a closet or drawer, and avoid storing it in a bathroom. Ensure that all medications are kept in a safe and secure place, out of the reach of children and pets.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take each dose with a full glass of water to prevent irritation of the esophagus.
  • Do not lie down for at least 30 minutes after taking the capsule.
  • Do not skip doses or stop taking the medication early, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Avoid alcohol if experiencing gastrointestinal upset, as it may worsen symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 150 mg every 6 hours
Dose Range: 150 - 450 mg

Condition-Specific Dosing:

Serious infections: 150-300 mg every 6 hours
More severe infections: 300-450 mg every 6 hours
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Pediatric Dosing

Neonatal: Not established (use with caution, monitor for adverse effects)
Infant: 8-16 mg/kg/day in 3 or 4 equal doses (oral)
Child: 8-25 mg/kg/day in 3 or 4 equal doses (oral)
Adolescent: Same as adult dosing, typically 150-450 mg every 6 hours
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed for single dose or short-term therapy; for prolonged therapy, consider increasing dosing interval in severe impairment (CrCl <30 mL/min) based on clinical response and serum levels if available.
Dialysis: Clindamycin is not effectively removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Half-life may be prolonged; however, dose adjustment is generally not considered necessary due to compensatory increase in renal excretion. Monitor liver function tests and clinical response.

Pharmacology

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Mechanism of Action

Clindamycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria. This binding prevents peptide bond formation and inhibits the initiation of polypeptide chains, leading to bacteriostatic effects. It is active against a wide range of Gram-positive aerobic bacteria and anaerobic bacteria.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: Approximately 45-60 minutes (oral capsule)
FoodEffect: Food does not significantly affect the extent of absorption (AUC), but may delay the time to peak concentration (Tmax).

Distribution:

Vd: 0.6-1.2 L/kg
ProteinBinding: Approximately 90-95%
CnssPenetration: Limited (poor penetration into CSF even with inflamed meninges)

Elimination:

HalfLife: Approximately 2-3 hours (normal renal/hepatic function)
Clearance: Not readily available as a single rate, but primarily hepatic and renal
ExcretionRoute: Approximately 10% via urine, 3.6% via feces as active drug; remainder as inactive metabolites.
Unchanged: Approximately 10% (urine), 3.6% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes for IV, within an hour for oral)
PeakEffect: Approximately 1 hour (oral)
DurationOfAction: 6-8 hours (based on dosing interval)

Safety & Warnings

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BLACK BOX WARNING

Clindamycin therapy has been associated with severe colitis which may result in patient death. Therefore, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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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 immediate 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
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Joint pain or swelling
Yellowing of the skin or eyes (jaundice)
Vaginal itching or discharge
Throat irritation
Coughing up blood
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Severe Skin Reactions

In rare cases, severe skin reactions can occur within 1 hour to several weeks after receiving this medication. These reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can be life-threatening and may also affect internal organs. Seek immediate medical help if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

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. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Stomach pain
Upset stomach
Vomiting
* Bad taste in your mouth

Reporting Side Effects

If you have questions or concerns about side effects, contact 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, watery, or bloody diarrhea (even weeks after stopping the medication)
  • Abdominal cramps or pain
  • Fever
  • Skin rash, itching, or hives
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Sore throat or fever (may indicate a serious blood problem)
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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 stomach or bowel problems, including colitis.
* If you have been diagnosed with meningitis. Note that this medication is not intended to treat meningitis.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, 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. If you are using this drug for an extended period, be sure to undergo regular blood tests and other laboratory evaluations as directed by your doctor.

This medication is not intended to treat the common cold, and you should not use it for longer than prescribed. Prolonged use may increase the risk of a secondary infection.

If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient.

Individuals aged 60 and older should exercise caution when using this drug, as they may be more susceptible to side effects.

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 to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Abdominal pain
  • Hypotension (rare)

What to Do:

Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is generally supportive, as there is no specific antidote. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the blood.

Drug Interactions

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Major Interactions

  • Erythromycin (antagonistic effect, avoid concomitant use)
  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium - clindamycin may enhance neuromuscular blockade, leading to respiratory depression)
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Moderate Interactions

  • Warfarin (may enhance anticoagulant effect, monitor INR)
  • Kaolin-pectin (may decrease clindamycin absorption, separate administration by at least 2 hours)
  • Live bacterial vaccines (e.g., typhoid vaccine - clindamycin may reduce therapeutic effect of vaccine)
  • Cyclosporine (clindamycin may decrease cyclosporine levels)

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: To establish baseline and identify pre-existing hepatic impairment, as clindamycin is metabolized by the liver.

Timing: Prior to initiating prolonged therapy or in patients with known hepatic dysfunction.

Renal function tests (e.g., BUN, creatinine)

Rationale: To establish baseline and identify pre-existing renal impairment, though dose adjustment is generally not needed, it's important for overall patient assessment.

Timing: Prior to initiating prolonged therapy or in patients with known renal dysfunction.

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Routine Monitoring

Stool frequency and consistency

Frequency: Daily, throughout therapy and for several weeks post-therapy

Target: Normal bowel habits

Action Threshold: Onset of significant diarrhea, especially if severe, persistent, or bloody, or associated with abdominal cramps or fever (suspect C. difficile-associated diarrhea).

Liver function tests (LFTs)

Frequency: Periodically, for prolonged therapy (e.g., >10 days)

Target: Within normal limits or stable

Action Threshold: Significant elevation (e.g., >3x ULN) or signs of hepatic injury.

Renal function tests

Frequency: Periodically, for prolonged therapy (e.g., >10 days)

Target: Within normal limits or stable

Action Threshold: Significant decline in renal function.

Complete Blood Count (CBC)

Frequency: Periodically, for prolonged therapy

Target: Within normal limits

Action Threshold: Significant changes (e.g., leukopenia, neutropenia, thrombocytopenia, eosinophilia).

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Symptom Monitoring

  • Severe, persistent, or bloody diarrhea
  • Abdominal pain or cramping
  • Fever
  • Skin rash or itching
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Sore throat or fever (signs of agranulocytosis)

Special Patient Groups

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Pregnancy

Clindamycin is classified as 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. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed in human studies.
Second Trimester: Generally considered safe; often used for bacterial vaginosis.
Third Trimester: Generally considered safe.
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Lactation

Clindamycin is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised. Monitor breastfed infants for potential adverse effects.

Infant Risk: L3 (Moderately Safe). Potential for adverse effects in the infant include changes in bowel flora (leading to diarrhea, candidiasis), and theoretical risk of sensitization. Monitor infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
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Pediatric Use

Clindamycin capsules are approved for use in pediatric patients. Dosing is weight-based. Due to the risk of C. difficile-associated diarrhea, use should be carefully considered and monitored, especially in very young infants.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, elderly patients may have age-related decreases in renal or hepatic function, which could prolong the half-life. Monitor renal and hepatic function, and observe for adverse effects, particularly C. difficile-associated diarrhea, which may be more severe in the elderly.

Clinical Information

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Clinical Pearls

  • Always warn patients about the risk of C. difficile-associated diarrhea (CDAD), which can occur during or even weeks after therapy. Instruct them to seek immediate medical attention if severe, persistent, or bloody diarrhea occurs.
  • Advise patients to take clindamycin capsules with a full glass of water to prevent esophageal irritation and ulceration, and to remain upright for at least 30 minutes after administration.
  • Clindamycin is highly effective against many anaerobic bacteria and some Gram-positive aerobes (e.g., Staphylococcus, Streptococcus), making it useful for skin and soft tissue infections, intra-abdominal infections, and certain respiratory tract infections.
  • It is NOT effective against viral infections and should not be used for them.
  • Consider alternative antibiotics if the patient develops significant diarrhea, even if not confirmed C. diff, to prevent worsening symptoms.
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Linezolid (for Gram-positive infections, including MRSA)
  • Vancomycin (for severe Gram-positive infections, including MRSA and C. difficile)
  • Doxycycline (for skin and soft tissue infections, some respiratory infections)
  • Other beta-lactam antibiotics (e.g., penicillin, cephalosporins, carbapenems, depending on the specific infection and susceptibility)
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (generic 150mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Brand)
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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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.