Cleocin 75mg 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
Dec 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin is an antibiotic used to treat serious bacterial infections, including those of the skin, bones, joints, lungs, and internal organs. It works by stopping the growth of bacteria. It is important to take this medication exactly as prescribed and to finish the entire course, even if you feel better, to prevent the infection from returning.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

You can take your medication with or without food. If it causes stomach upset, taking it with food may help. To minimize the risk of throat irritation and ulcers, take your medication with a full glass of water (6 to 8 ounces or 200 to 250 mL). After taking your medication, remain upright for at least 30 minutes to reduce the risk of irritation.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from moisture. Do not refrigerate or freeze your medication. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets to ensure their safety.

What to Do If You Miss 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 a missed one.
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Lifestyle & Tips

  • Take with a full glass of water to prevent esophageal irritation.
  • May be taken with or without food, but taking with food may help reduce stomach upset.
  • Avoid lying down for at least 30 minutes after taking the capsule to prevent esophageal irritation.
  • Do not share this medication with others, even if they have similar symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 150 mg to 450 mg every 6 to 8 hours, depending on the severity of the infection.
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 divided into 3 or 4 equal doses (for infants >1 month of age)
Child: 8-25 mg/kg/day divided into 3 or 4 equal doses (maximum 450 mg/dose)
Adolescent: Dosing typically follows adult guidelines based on weight and severity of infection, often 150-450 mg every 6-8 hours.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment generally necessary.
Moderate: No dosage adjustment generally necessary.
Severe: No dosage adjustment generally necessary for mild to moderate renal impairment. For severe renal impairment (CrCl <30 mL/min), consider extending dosing interval to every 8-12 hours or reducing dose, though accumulation is not significant. Monitor drug levels if available or clinical response.
Dialysis: Clindamycin is not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose is needed after dialysis.

Hepatic Impairment:

Mild: No dosage adjustment generally necessary.
Moderate: No dosage adjustment generally necessary.
Severe: Use with caution in patients with severe hepatic disease. Half-life may be prolonged. Consider extending dosing interval or reducing dose. Monitor liver function tests and clinical response.

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. This binding prevents peptide bond formation and inhibits the early stages of protein synthesis, leading to a bacteriostatic effect. It is active against a wide range of Gram-positive aerobic bacteria and anaerobic bacteria.
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Pharmacokinetics

Absorption:

Bioavailability: 90% (oral)
Tmax: 0.75-1 hour (oral capsule)
FoodEffect: Food does not significantly alter the absorption of clindamycin capsules, but peak serum concentrations may be delayed.

Distribution:

Vd: 0.6-1.2 L/kg
ProteinBinding: 92-94%
CnssPenetration: Limited (does not achieve therapeutic levels in CSF even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (adults), 2.5-5.4 hours (neonates)
Clearance: Not available (variable)
ExcretionRoute: Urine (10-20%), Feces (4-10%)
Unchanged: Less than 10% (urine), Less than 4% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes for IV, within 1 hour for oral)
PeakEffect: 1 hour (oral)
DurationOfAction: 6-8 hours (due to 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. It should not be used in patients with nonbacterial infections such as 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. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
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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 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 anywhere from 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, contact your doctor or seek medical help if they bother you or persist:

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 or watery diarrhea (especially if bloody or mucus-like)
  • Severe stomach pain or cramps
  • Fever
  • Rash, hives, or severe itching
  • Difficulty breathing or swallowing
  • Swelling of the face, lips, tongue, or throat
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Signs of a new infection (e.g., persistent sore throat, fever, chills)
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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 stomach or bowel problems, such as 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 (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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, your doctor will likely recommend regular blood tests and other laboratory evaluations to monitor your condition.

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 developing 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.

Adults 60 years of age and older should exercise caution when using this drug, as they may be more susceptible to experiencing side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain

What to Do:

There is no specific antidote for clindamycin overdose. Treatment is supportive and symptomatic. Induce emesis or perform gastric lavage if ingestion is recent. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the blood. Call 1-800-222-1222 (Poison Control Center) immediately for advice.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin has neuromuscular blocking properties that may enhance the action of these agents, leading to increased or prolonged respiratory depression/paralysis.
  • Erythromycin: Antagonism may occur due to competition for the same ribosomal binding site.
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Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease clindamycin levels, potentially reducing efficacy.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir): May increase clindamycin levels, potentially increasing adverse effects.
  • Oral typhoid vaccine (Ty21a): Antibiotics may inactivate the live bacterial vaccine.
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Minor Interactions

  • Kaolin-pectin antidiarrheals: May reduce absorption of clindamycin if administered concurrently (separate by at least 2 hours).

Monitoring

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Baseline Monitoring

History of gastrointestinal disease (especially colitis)

Rationale: Increased risk of C. difficile-associated diarrhea (CDAD).

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: Clindamycin is metabolized by the liver; baseline assessment is prudent, especially in patients with pre-existing hepatic impairment.

Timing: Prior to initiation of therapy, if clinically indicated

Renal function (BUN, creatinine)

Rationale: Although not primarily renally cleared, baseline assessment is good practice, especially in patients with pre-existing renal impairment.

Timing: Prior to initiation of therapy, if clinically indicated

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Routine Monitoring

Stool for C. difficile toxin

Frequency: As needed, if diarrhea develops

Target: Negative

Action Threshold: Positive test with symptoms warrants discontinuation and appropriate treatment for CDAD.

Complete Blood Count (CBC)

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

Target: Within normal limits

Action Threshold: Significant leukopenia, neutropenia, or thrombocytopenia may warrant discontinuation.

Liver function tests (ALT, AST, bilirubin)

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

Target: Within normal limits or stable

Action Threshold: Significant elevation may warrant discontinuation.

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Symptom Monitoring

  • Diarrhea (especially severe, persistent, or bloody)
  • Abdominal pain or cramping
  • Nausea
  • Vomiting
  • Skin rash or itching
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Sore throat or fever (signs of infection/blood dyscrasias)

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, particularly for specific infections where its benefits outweigh potential risks.

Trimester-Specific Risks:

First Trimester: Generally considered low risk, but use only if clearly indicated.
Second Trimester: Generally considered safe and commonly used for appropriate infections.
Third Trimester: Generally considered safe and commonly used for appropriate infections.
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Lactation

Clindamycin is excreted into breast milk in small amounts. The American Academy of Pediatrics considers clindamycin compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: L2 (Safer) - Limited data suggest no adverse effect on infant.
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Pediatric Use

Clindamycin capsules are approved for use in pediatric patients. Dosage is based on body weight and severity of infection. Neonates and infants should be monitored closely due to immature renal and hepatic function. The 75mg capsule may be suitable for some pediatric dosing, but liquid formulations are often preferred for precise dosing in younger children.

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Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients may be more susceptible to the development of severe colitis associated with clindamycin. Monitor renal and hepatic function, and observe closely for diarrhea and other adverse effects.

Clinical Information

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Clinical Pearls

  • Always warn patients about the risk of C. difficile-associated diarrhea (CDAD) and instruct them to seek immediate medical attention if severe, persistent, or bloody diarrhea occurs.
  • Clindamycin is a good option for anaerobic infections, including those in the abdomen, pelvis, and skin/soft tissue.
  • It is also effective against many Gram-positive organisms, including MRSA in some cases (check susceptibility).
  • Ensure patients take capsules with a full glass of water and remain upright for at least 30 minutes to prevent esophageal irritation and ulceration.
  • Consider alternative antibiotics if a patient has a history of severe GI issues or CDAD with other antibiotics.
  • Resistance to clindamycin can develop, especially in staphylococci and streptococci, often through inducible macrolide-lincosamide-streptogramin B (iMLSB) resistance (D-test positive). Susceptibility testing is crucial.
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Beta-lactam/beta-lactamase inhibitor combinations (e.g., amoxicillin/clavulanate, piperacillin/tazobactam)
  • Carbapenems (e.g., imipenem, meropenem)
  • Vancomycin (for MRSA or severe Gram-positive infections)
  • Linezolid (for MRSA or VRE)
  • Doxycycline (for some skin/soft tissue infections, including MRSA)
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (75mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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.