Cleocin 300mg/2ml Inj, 2ml
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
Jun 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clindamycin is an antibiotic medication used to treat serious bacterial infections. It works by stopping the growth of bacteria. It is given as an injection into a vein (IV) or muscle (IM).
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. This medication can be administered in two ways: as an injection into a muscle or as an infusion into a vein, which is given over a period of time.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.
Missing a Dose
If you miss a dose, contact your doctor immediately to find out what steps to take next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. This medication can be administered in two ways: as an injection into a muscle or as an infusion into a vein, which is given over a period of time.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the best storage method.
Missing a Dose
If you miss a dose, contact your doctor immediately to find out what steps to take next.
Lifestyle & Tips
- Complete the full course of treatment as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
- Do not share this medication with others.
- Maintain good hydration, especially if experiencing diarrhea.
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
Dosing & Administration
Adult Dosing
Standard Dose:
600 mg to 2.7 g/day in 2, 3, or 4 equally divided doses. For more severe infections, 600-900 mg every 8 hours or 600 mg every 6 hours.
Dose Range:
600 - 2700 mg
Condition-Specific Dosing:
serious_infections:
600-1200 mg/day IV/IM in 2-4 divided doses
severe_infections:
1200-2700 mg/day IV/IM in 2-4 divided doses
life_threatening_infections:
Up to 4800 mg/day IV/IM in 2-4 divided doses (rarely used, consult guidelines)
Pediatric Dosing
Neonatal:
15-20 mg/kg/day IV/IM in 3-4 divided doses (for full-term infants >30 days old). For premature infants, dosing may vary, consult specific guidelines.
Infant:
20-40 mg/kg/day IV/IM in 3-4 divided doses (based on body weight, not to exceed adult dose).
Child:
20-40 mg/kg/day IV/IM in 3-4 divided doses (based on body weight, not to exceed adult dose).
Adolescent:
20-40 mg/kg/day IV/IM in 3-4 divided doses (based on body weight, not to exceed adult dose). For severe infections, adult dosing may apply.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment generally necessary.
Moderate:
No dosage adjustment generally necessary.
Severe:
No dosage adjustment generally necessary for single doses. For patients with severe renal impairment and/or severe hepatic impairment, monitoring of clindamycin serum levels should be considered.
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:
Half-life may be prolonged in patients with severe hepatic disease. Dosage adjustment is not usually necessary, but monitoring of clindamycin serum levels should be considered in patients with severe hepatic impairment and/or severe renal impairment.
Pharmacology
Mechanism of Action
Clindamycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting peptide bond formation and subsequent bacterial growth. It is primarily bacteriostatic but may be bactericidal at high concentrations or against highly susceptible organisms.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable for IV/IM injection (100% for IV)
Tmax:
Peak serum levels are attained immediately after IV infusion. For IM, peak levels are reached within 1-3 hours.
FoodEffect:
Not applicable for IV/IM injection
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); may be slightly longer in neonates and patients with severe renal/hepatic impairment.
Clearance:
Approximately 30-40 mL/min
ExcretionRoute:
Approximately 10% of the active drug is excreted in the urine and 3.6% in the feces; the remainder is excreted as biologically inactive metabolites.
Unchanged:
Approximately 10% (urine), 3.6% (feces)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes for IV)
PeakEffect:
Immediately after IV infusion; 1-3 hours after IM injection
DurationOfAction:
6-8 hours (related to half-life and dosing interval)
Safety & Warnings
BLACK BOX WARNING
Clostridioides 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. Because clindamycin therapy has been associated with severe colitis which may end fatally, 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 most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. 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. 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 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ 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
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Pain, redness, or swelling at the injection site
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions 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 the 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 the 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 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ 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
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Pain, redness, or swelling at the injection site
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions 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 the 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 the 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 stomach pain or cramps
- Fever
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Unusual tiredness or weakness
- New or worsening skin rash, hives, or itching
- Difficulty breathing or swallowing (signs of a severe allergic reaction)
- Swelling of the face, lips, tongue, or throat
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 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 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 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 can increase the risk of a second infection.
Administering this drug too quickly through a vein can cause severe hypotension and serious heart problems. If you have any concerns or questions, discuss them with your doctor.
Some formulations of this medication may contain benzyl alcohol. Whenever possible, it is recommended to avoid using products with benzyl alcohol in newborns and infants, as certain doses of benzyl alcohol can cause severe side effects in these children, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
If you are 60 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of using this medication during these situations 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 can increase the risk of a second infection.
Administering this drug too quickly through a vein can cause severe hypotension and serious heart problems. If you have any concerns or questions, discuss them with your doctor.
Some formulations of this medication may contain benzyl alcohol. Whenever possible, it is recommended to avoid using products with benzyl alcohol in newborns and infants, as certain doses of benzyl alcohol can cause severe side effects in these children, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
If you are 60 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of using this medication during these situations to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of acute overdose are well-documented for clindamycin injection. High doses may exacerbate side effects such as gastrointestinal upset or potentially lead to neuromuscular blockade if given with other agents.
What to Do:
There is no specific antidote for clindamycin overdose. Treatment should be symptomatic and supportive. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the blood. In case of suspected overdose, immediately contact a poison control center or emergency medical services. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin has neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents, leading to increased or prolonged respiratory depression/paralysis.
- Erythromycin: In vitro antagonism has been demonstrated between clindamycin and erythromycin; these drugs should not be administered concurrently.
Moderate Interactions
- Warfarin (and other vitamin K antagonists): May enhance the anticoagulant effect of warfarin, leading to increased INR and bleeding risk. Monitor INR closely.
- Kaolin-pectin antidiarrheals: May decrease the absorption of oral clindamycin (not directly relevant for injection, but good to note for overall drug profile).
Monitoring
Baseline Monitoring
Patient history for GI disorders (especially colitis)
Rationale: Clindamycin carries a Black Box Warning for Clostridioides difficile-associated diarrhea (CDAD), which can range from mild diarrhea to fatal colitis. Patients with a history of GI disease, particularly colitis, may be at increased risk.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (BUN, creatinine, AST, ALT, bilirubin)
Rationale: While dosage adjustments are not typically required for mild-moderate impairment, severe impairment may prolong half-life, and baseline assessment helps identify patients who may require closer monitoring or serum level checks.
Timing: Prior to initiation of therapy, especially for prolonged courses or in patients with pre-existing dysfunction.
Routine Monitoring
Bowel movements/Stool consistency
Frequency: Daily during therapy and for several weeks post-therapy
Target: Normal bowel habits
Action Threshold: Onset of diarrhea (especially severe, persistent, or bloody diarrhea); consider C. difficile testing and discontinuation of clindamycin.
Complete Blood Count (CBC)
Frequency: Periodically, especially during prolonged therapy (>10 days)
Target: Within normal limits
Action Threshold: Significant leukopenia, neutropenia, or thrombocytopenia (rare, but reported).
Liver function tests (AST, ALT, bilirubin)
Frequency: Periodically, especially during prolonged therapy or in patients with pre-existing hepatic impairment
Target: Within normal limits
Action Threshold: Significant elevation indicating hepatotoxicity (rare).
Symptom Monitoring
- Diarrhea (especially severe, persistent, or bloody)
- Abdominal pain or cramping
- Fever
- Nausea/vomiting
- Skin rash or itching (signs of allergic reaction)
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual fatigue or weakness
Special Patient Groups
Pregnancy
Clindamycin is classified as Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Limited data from human pregnancies suggest no increased risk of major birth defects or miscarriage. 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; no specific risks identified.
Third Trimester:
Generally considered safe; no specific risks identified.
Lactation
Clindamycin is excreted into breast milk in small amounts. The American Academy of Pediatrics considers clindamycin compatible with breastfeeding. Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.
Infant Risk:
Low risk (L2 - likely compatible). Potential for mild gastrointestinal upset (diarrhea) or alteration of gut flora in the infant.
Pediatric Use
Clindamycin injection is approved for use in pediatric patients from neonates (full-term, >30 days old) through adolescents. Dosing is weight-based. Close monitoring for adverse effects, particularly diarrhea, is important. In neonates and infants, monitoring of organ system functions is recommended.
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. Dosage adjustment is not generally necessary based solely on age, but consideration should be given to age-related decreases in renal and hepatic function and concomitant diseases/medications.
Clinical Information
Clinical Pearls
- Clindamycin is highly effective against anaerobic bacteria, making it a common choice for intra-abdominal infections, pelvic infections, and aspiration pneumonia.
- Despite its efficacy, the risk of Clostridioides difficile-associated diarrhea (CDAD) is a significant concern and should always be discussed with patients.
- Rapid IV infusion can lead to hypotension and cardiac arrest; administer IV clindamycin over at least 10-60 minutes, not exceeding 30 mg/minute.
- Clindamycin does not penetrate the blood-brain barrier well, so it is not a primary choice for CNS infections.
- It is often used in combination with other antibiotics for polymicrobial infections, especially those involving both aerobes and anaerobes.
Alternative Therapies
- Metronidazole (for anaerobic infections)
- Carbapenems (e.g., imipenem, meropenem, ertapenem) for broad-spectrum coverage including anaerobes
- Moxifloxacin (some activity against anaerobes)
- Tigecycline (broad-spectrum, including anaerobes)
- Linezolid (for Gram-positive infections, including MRSA, but not typically for anaerobes)
Cost & Coverage
Average Cost:
Varies widely, typically $5-$50 per 300mg/2ml vial per 300mg/2ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic formulations are usually preferred and covered well by most insurance plans)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. 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, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate care.