Clindamycin 150mg/ml Inj, 60ml

Manufacturer FRESENIUS KABI Active Ingredient Clindamycin Injection(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.
đŸˇī¸
Drug Class
Antibiotic
đŸ§Ŧ
Pharmacologic Class
Lincosamide antibiotic
🤰
Pregnancy Category
Category B
✅
FDA Approved
Jul 1967
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Clindamycin is an antibiotic 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

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This medication is administered either as an intramuscular injection or as an intravenous infusion, which is given over a specified period of time.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
💡

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.
  • Report any severe or persistent diarrhea, especially if it contains blood or mucus, to your doctor immediately. This could be a sign of a serious bowel infection (C. difficile-associated diarrhea).

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Serious infections: 600-1200 mg/day IV or IM in 2, 3, or 4 equally divided doses. More severe infections: 1200-2700 mg/day IV or IM in 2, 3, or 4 equally divided doses. Life-threatening infections: up to 4800 mg/day IV.
Dose Range: 600 - 4800 mg

Condition-Specific Dosing:

intra-abdominal infections: 600-900 mg IV every 8 hours
pelvic inflammatory disease: 900 mg IV every 8 hours (often with gentamicin)
toxic shock syndrome: 900 mg IV every 8 hours (often with penicillin G or ceftriaxone)
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for premature infants (e.g., <1200g: 5 mg/kg/dose every 12 hours; >1200g: 5 mg/kg/dose every 8 hours) may be used in specific circumstances, consult guidelines.
Infant: 15-25 mg/kg/day IV or IM in 3 or 4 equally divided doses for serious infections. For more severe infections, 25-40 mg/kg/day IV or IM in 3 or 4 equally divided doses.
Child: 15-25 mg/kg/day IV or IM in 3 or 4 equally divided doses for serious infections. For more severe infections, 25-40 mg/kg/day IV or IM in 3 or 4 equally divided doses. Max 4800 mg/day.
Adolescent: Same as adult dosing (600-2700 mg/day IV or IM in 2, 3, or 4 equally divided doses, up to 4800 mg/day for life-threatening infections).
âš•ī¸

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 or short-term therapy. For severe renal impairment or anuria, consider reducing dose or extending dosing interval (e.g., 600 mg every 12 hours) based on clinical status and severity of infection.
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. Monitor liver function tests.
Severe: Dosage adjustment may be necessary in patients with severe hepatic disease due to prolonged half-life. Monitor liver function tests and consider extending dosing interval.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Clindamycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, primarily at the A-site, thereby preventing peptide bond formation and inhibiting the early stages of protein synthesis. It is primarily bacteriostatic but may be bactericidal at high concentrations against highly susceptible organisms.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV/IM injection (100% for IV)
Tmax: IV: End of infusion; IM: 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 prolonged in neonates and patients with severe hepatic impairment.
Clearance: Not readily available as a single value, varies with patient factors.
ExcretionRoute: Urine (10-20% as active drug and metabolites), Feces (4-10% as active drug and metabolites), Bile (major route for metabolites)
Unchanged: Less than 10% in urine, less than 4% in feces
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (IV)
PeakEffect: IV: End of infusion; IM: 1-3 hours
DurationOfAction: 6-8 hours (related to dosing interval)

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Clindamycin therapy has been associated with severe colitis which may result in patient death. 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. 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. 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.
âš ī¸

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 signs or 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
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 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:

Diarrhea
Stomach pain
Upset stomach
Nausea or 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, watery, or bloody diarrhea
  • Abdominal pain or cramping
  • Fever
  • Skin rash, itching, or hives
  • Difficulty breathing or swallowing
  • Swelling of the face, lips, tongue, or throat
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
📋

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 conditions 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 issues. Do not initiate, discontinue, or adjust the dosage of any medication without first consulting your doctor.
âš ī¸

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.

When administered intravenously, this drug can cause low blood pressure and severe heart problems if given too quickly. If you have any concerns or questions, discuss them with your doctor.

Some formulations of this medication may contain benzyl alcohol. It is crucial to avoid products with benzyl alcohol in newborns and infants whenever possible, as high doses of benzyl alcohol can cause serious 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, use this medication with caution, as you may be more susceptible to side effects.

Before taking this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of using this medication during pregnancy or breastfeeding to ensure the best possible outcome for you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Hypotension (low blood pressure)
  • Respiratory depression (rare)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive; hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the blood.

Drug Interactions

🔴

Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin may enhance the neuromuscular blocking action, leading to increased or prolonged respiratory depression and paralysis.
  • Erythromycin: Antagonistic effect; concurrent use is not recommended as they compete for the same ribosomal binding site.
🟡

Moderate Interactions

  • Kaolin-pectin (if oral clindamycin): May decrease absorption of clindamycin. Administer clindamycin at least 2 hours before kaolin-pectin.
  • Warfarin and other Vitamin K antagonists: May enhance the anticoagulant effect, leading to increased INR/bleeding risk. Monitor INR closely.
  • Live bacterial vaccines (e.g., typhoid vaccine): Antibiotics may reduce the therapeutic effect of live bacterial vaccines. Avoid concurrent use or administer vaccine after antibiotic course.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Patient history for gastrointestinal disease (especially colitis)

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

Timing: Prior to initiation

Liver function tests (ALT, AST, bilirubin)

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

Renal function tests (BUN, creatinine)

Rationale: Although not primarily renally cleared, baseline assessment is prudent, especially in patients with pre-existing renal impairment or for prolonged therapy.

Timing: Prior to initiation, especially for prolonged therapy

📊

Routine Monitoring

Bowel movements/Stool consistency

Frequency: Daily during therapy and for several weeks post-therapy

Target: Normal bowel habits

Action Threshold: Onset of significant diarrhea, abdominal pain, fever, or bloody stools (suggestive of CDAD); discontinue drug and initiate appropriate treatment.

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically (e.g., weekly or bi-weekly) for prolonged therapy (>10 days) or in patients with hepatic impairment.

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x ULN); consider dose adjustment or discontinuation.

Renal function tests (BUN, creatinine)

Frequency: Periodically for prolonged therapy or in patients with renal impairment.

Target: Within normal limits

Action Threshold: Significant elevation; consider dose adjustment or discontinuation.

Complete Blood Count (CBC) with differential

Frequency: Periodically for prolonged therapy.

Target: Within normal limits

Action Threshold: Significant neutropenia, leukopenia, or thrombocytopenia; consider discontinuation.

đŸ‘ī¸

Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Bloody or mucous stools
  • Skin rash or hives
  • Difficulty breathing or swallowing
  • Swelling of face, lips, tongue, or throat
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness

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, but human experience suggests no increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: No increased risk of birth defects observed.
Second Trimester: No increased risk of birth defects observed.
Third Trimester: No increased risk of birth defects observed.
🤱

Lactation

Clindamycin is excreted into breast milk. While generally considered compatible with breastfeeding (L3), monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions. The amount transferred is generally low.

Infant Risk: Low to moderate risk; potential for gastrointestinal disturbance (diarrhea) or sensitization in the infant. Use with caution.
đŸ‘ļ

Pediatric Use

Clindamycin injection contains benzyl alcohol as a preservative, which has been associated with a fatal 'gasping syndrome' in premature infants. Therefore, clindamycin injection should be used with caution in neonates and infants, and the benefits should outweigh the potential risks. Dosing is weight-based. Close monitoring for adverse effects is crucial.

👴

Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients may be more susceptible to adverse effects, particularly severe diarrhea and CDAD. Monitor renal and hepatic function, and bowel habits closely.

Clinical Information

💎

Clinical Pearls

  • Always dilute clindamycin injection before IV administration. Do not administer as an IV bolus.
  • Infuse IV clindamycin slowly over 10-60 minutes (typically 30 mg/min or less) to avoid hypotension and cardiopulmonary arrest.
  • Clindamycin is effective against many anaerobic bacteria, including Bacteroides fragilis, and is a common choice for intra-abdominal and gynecological infections.
  • It is also used for certain Gram-positive infections, including methicillin-susceptible and some methicillin-resistant Staphylococcus aureus (MRSA) infections, and Streptococcus pyogenes.
  • The most significant adverse effect is Clostridioides difficile-associated diarrhea (CDAD), which can occur even weeks after discontinuing the drug. Educate patients on this risk.
  • Consider D-test for inducible clindamycin resistance in staphylococci if erythromycin resistance is present but clindamycin appears susceptible.
🔄

Alternative Therapies

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

Cost & Coverage

Average Cost: Not available per 60ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
📚

General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them 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. 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.