Cleocin 300mg Capsules
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.
Drug Class
Antibiotic
Pharmacologic Class
Lincosamide antibiotic
Pregnancy Category
Category B
FDA Approved
Dec 1967
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clindamycin is an antibiotic used to treat serious bacterial infections. It works by stopping the growth of bacteria. It's important to take it exactly as prescribed and to finish the entire course of treatment, even if you feel better, to prevent the infection from coming back.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you 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 this 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, avoiding refrigeration or freezing. Keep it in a dry place, away from bathrooms. Ensure all medications are stored in a safe location, out of reach of children and pets.
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.
To ensure you 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 this 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, avoiding refrigeration or freezing. Keep it in a dry place, away from bathrooms. Ensure all medications are stored in a safe location, out of reach of children and pets.
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.
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.
- Do not lie down for at least 30 minutes after taking the capsule.
- Avoid antidiarrheal medications without consulting your doctor if you develop diarrhea, as this could worsen C. difficile infection.
- Inform your doctor if you are pregnant, breastfeeding, or have a history of liver or kidney disease, or gastrointestinal problems (especially colitis).
Available Forms & Alternatives
Available Strengths:
- Cleocin 150mg Capsules
- Cleocin 75mg Capsules
- Cleocin 75mg/5ml Granules100ml
- Cleocin T 1% Topical Solution 30ml
- Cleocin T 1% Topical Solution 60ml
- Cleocin T 1% Lotion 60ml
- Cleocin 300mg Capsules
- Cleocin 2% Vaginal Cream 40gm
- Cleocin T 1% Pledgete 60s
- Cleocin 100mg Vaginal Ovule 3s
- Cleocin Phos 9gm Inj, 60ml
- Cleocin Phos 600mg/4ml Inj, 4ml
- Cleocin Phos 900mg/6ml Inj, 6ml
- Cleocin 300mg/2ml Inj, 2ml
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
150 mg to 450 mg orally every 6 to 8 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
Pediatric Dosing
Neonatal:
Not established (use with caution, monitor for adverse effects)
Infant:
8-16 mg/kg/day orally divided into 3 or 4 equal doses
Child:
8-25 mg/kg/day orally divided into 3 or 4 equal doses
Adolescent:
8-25 mg/kg/day orally divided into 3 or 4 equal doses (max 1.8 g/day)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed
Moderate:
No adjustment typically needed
Severe:
No adjustment typically needed for single dose or short course; for severe impairment and/or hepatic impairment, consider dose reduction or increased dosing interval (e.g., every 8-12 hours) based on severity and patient response.
Dialysis:
Clindamycin is not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose is needed after dialysis.
Hepatic Impairment:
Mild:
No adjustment typically needed
Moderate:
No adjustment typically needed
Severe:
Consider dose reduction or increased dosing interval (e.g., every 8-12 hours) in patients with severe hepatic disease due to prolonged half-life. Monitor liver function tests.
Pharmacology
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 early stages of protein synthesis, leading to a bacteriostatic effect.
Pharmacokinetics
Absorption:
Bioavailability:
90%
Tmax:
0.75-1 hour (oral capsule)
FoodEffect:
Food does not significantly alter the total amount absorbed, but may delay the rate of absorption.
Distribution:
Vd:
0.8-1.3 L/kg
ProteinBinding:
92-94%
CnssPenetration:
Limited (does not readily cross the blood-brain barrier, even with inflamed meninges)
Elimination:
HalfLife:
2-3 hours (normal renal/hepatic function)
Clearance:
Not available
ExcretionRoute:
Urine (10-20% as active drug and metabolites), Feces (4-10% as active drug and metabolites)
Unchanged:
Less than 10% (urine), Less than 4% (feces)
Pharmacodynamics
OnsetOfAction:
Rapid (within 30-60 minutes for oral absorption)
PeakEffect:
1 hour (oral)
DurationOfAction:
6-8 hours (related to dosing interval)
Safety & Warnings
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) must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history should be taken since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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
+ Difficulty 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 attention 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 for advice:
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.
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
+ Difficulty 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 attention 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 for advice:
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.
Seek Immediate Medical Attention If You Experience:
- Severe, persistent, or bloody diarrhea (even weeks after stopping the medication)
- Severe abdominal pain or cramping
- Rash, hives, or severe itching
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Unusual tiredness or weakness
- Sore throat, fever, or chills (signs of infection or blood problems)
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.
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.
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 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 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.
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.
Adults 60 years of age 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 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.
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. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the blood. Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention.
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (e.g., succinylcholine, vecuronium): Clindamycin may enhance the neuromuscular blocking action, leading to respiratory depression or paralysis.
- Erythromycin: Antagonistic effect; avoid concomitant use as they compete for the same ribosomal binding site.
Moderate Interactions
- Kaolin-pectin antidiarrheals: May decrease oral absorption of clindamycin. Administer clindamycin at least 2 hours before kaolin-pectin.
- Oral typhoid vaccine: Antibiotics may reduce the therapeutic effect of live bacterial vaccines. Avoid concurrent use.
- Warfarin and other vitamin K antagonists: May enhance the anticoagulant effect, leading to increased INR/bleeding risk. Monitor INR closely.
Monitoring
Baseline Monitoring
Patient history (especially GI disorders, allergies)
Rationale: To identify risk factors for adverse effects (e.g., C. difficile-associated diarrhea) and contraindications.
Timing: Prior to initiation of therapy
Liver function tests (LFTs)
Rationale: Clindamycin is metabolized by the liver; baseline assessment is important, especially in patients with pre-existing hepatic impairment.
Timing: Prior to initiation, especially for prolonged therapy or in patients with hepatic dysfunction
Renal function tests (e.g., SCr, BUN)
Rationale: Although not primarily renally eliminated, baseline assessment is prudent, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation, especially for prolonged therapy or in patients with renal dysfunction
Routine Monitoring
Stool frequency and consistency
Frequency: Daily
Target: Normal bowel habits
Action Threshold: Onset of significant diarrhea, especially if persistent, severe, or bloody; immediately investigate for C. difficile.
Signs and symptoms of hypersensitivity reactions (e.g., rash, itching, swelling)
Frequency: Daily
Target: Absence of allergic reactions
Action Threshold: Any signs of allergic reaction; discontinue drug immediately.
Liver function tests (LFTs)
Frequency: Periodically (e.g., weekly to bi-weekly)
Target: Within normal limits
Action Threshold: Significant elevation of transaminases or bilirubin; consider dose adjustment or discontinuation.
Renal function tests (e.g., SCr, BUN)
Frequency: Periodically (e.g., weekly to bi-weekly) for prolonged therapy
Target: Within normal limits
Action Threshold: Significant elevation; consider dose adjustment or discontinuation.
Complete Blood Count (CBC)
Frequency: Periodically (e.g., weekly to bi-weekly) for prolonged therapy
Target: Within normal limits
Action Threshold: Significant changes in white blood cell count (leukopenia, neutropenia), platelet count (thrombocytopenia); consider discontinuation.
Symptom Monitoring
- Diarrhea (especially severe, persistent, or bloody)
- Abdominal pain or cramping
- Nausea
- Vomiting
- Skin rash or hives
- Itching
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing or swallowing
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual tiredness or weakness
- Sore throat or fever (signs of blood dyscrasias)
Special Patient Groups
Pregnancy
Clindamycin is generally considered safe for use during 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. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in human studies.
Second Trimester:
Generally considered safe.
Third Trimester:
Generally considered safe.
Lactation
Clindamycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding, but caution is advised. Monitor the infant for potential adverse effects.
Infant Risk:
L3 (Moderate risk). Potential for adverse effects in the breastfed infant include changes in bowel flora (leading to diarrhea, candidiasis), and allergic sensitization. Observe infant for diarrhea, candidiasis (thrush, diaper rash), or rash.
Pediatric Use
Clindamycin capsules contain tartrazine (FD&C Yellow No. 5), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals, especially those with aspirin sensitivity. Safety and effectiveness in neonates (infants less than 1 month of age) have not been established. For older pediatric patients, dosing is weight-based. Monitor for C. difficile-associated diarrhea.
Geriatric Use
Clinical studies of clindamycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience has not identified differences in responses between the elderly and younger patients. Dose adjustment is not generally necessary based on age alone, but consider age-related decline in renal or hepatic function and increased susceptibility to adverse effects (e.g., C. difficile-associated diarrhea) in elderly patients.
Clinical Information
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, even after stopping the antibiotic.
- Clindamycin is a common cause of CDAD, so it should be reserved for serious infections where less toxic agents are inappropriate.
- Ensure patients take capsules with a full glass of water and remain upright for at least 30 minutes to prevent esophageal irritation and ulceration.
- It is highly effective against many anaerobic bacteria, making it useful for aspiration pneumonia, intra-abdominal infections, and gynecological infections.
- Resistance to clindamycin can develop, particularly in staphylococci and streptococci, often through inducible macrolide-lincosamide-streptogramin B (iMLSB) resistance (D-test positive). Susceptibility testing is crucial.
- Not effective for viral infections.
Alternative Therapies
- Metronidazole (for anaerobic infections)
- Beta-lactam antibiotics (e.g., penicillin, amoxicillin, cephalexin for susceptible Gram-positive infections)
- Macrolides (e.g., azithromycin, clarithromycin, though cross-resistance can occur)
- Tetracyclines (e.g., doxycycline, minocycline for certain skin/soft tissue infections or acne)
- Vancomycin (for severe Gram-positive infections, including MRSA)
Cost & Coverage
Average Cost:
Varies widely ($20-$100+) per 30 capsules (300mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.