Clindamycin 900mg Inj, 50ml

Manufacturer SANDOZ 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.
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Drug Class
Lincosamide antibiotic
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Pharmacologic Class
Protein synthesis inhibitor (50S ribosomal subunit)
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Pregnancy Category
Category B
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FDA Approved
Jan 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 serious bacterial infections, especially those caused by anaerobic bacteria (bacteria that live without oxygen) and some other types of bacteria. It works by stopping the growth of these bacteria. This medication is given as an injection into a vein.
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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 provided guidelines. 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.
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Lifestyle & Tips

  • Report any severe or persistent diarrhea immediately to your doctor, even if it occurs weeks after stopping the medication.
  • Stay well-hydrated unless otherwise instructed by your doctor.
  • 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.

Dosing & Administration

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Adult Dosing

Standard Dose: 600-900 mg IV every 8 hours
Dose Range: 600 - 4800 mg

Condition-Specific Dosing:

Serious infections: 600-900 mg IV every 8 hours
Life-threatening infections: 1200 mg IV every 6 hours (up to 4800 mg/day)
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Pediatric Dosing

Neonatal: 15-20 mg/kg/day IV in 3-4 divided doses (for full-term infants >1 month: 20-40 mg/kg/day)
Infant: 20-40 mg/kg/day IV in 3-4 divided doses
Child: 20-40 mg/kg/day IV in 3-4 divided doses
Adolescent: Same as adult dosing for serious infections (600-900 mg IV every 8 hours)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No routine adjustment needed; however, monitor for accumulation in severe impairment (CrCl <30 mL/min) and consider extending dosing interval if necessary.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Monitor liver function tests and consider dose reduction or extended dosing interval based on severity and patient response.

Pharmacology

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Mechanism of Action

Clindamycin binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. It is primarily bacteriostatic but may be bactericidal at high concentrations or against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: Immediate (IV infusion)
FoodEffect: Not applicable for IV administration

Distribution:

Vd: 0.6-1.2 L/kg
ProteinBinding: 60-94%
CnssPenetration: Limited (poor penetration into CSF, even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (adults); slightly prolonged in neonates and patients with severe hepatic impairment
Clearance: Not available (variable)
ExcretionRoute: Biliary/fecal (major), Renal (minor)
Unchanged: Approximately 10-20% (urine), 4% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: At end of infusion
DurationOfAction: 6-8 hours (based on dosing interval)

Safety & Warnings

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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. If CDAD is suspected or confirmed, ongoing antibacterial 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 while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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 conditions. These reactions can be life-threatening and may affect other organs in the body. Seek medical help immediately 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe watery diarrhea or bloody stools
  • Abdominal cramps or pain
  • Fever
  • Skin rash, itching, or hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
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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 conditions 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 issues. Do not initiate, discontinue, 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, 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 intravenously too quickly 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 high 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 breastfeeding. 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.
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Overdose Information

Overdose Symptoms:

  • Diarrhea (potentially severe)
  • Abdominal pain
  • Nausea
  • Vomiting

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) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin may potentiate the action of these agents, leading to prolonged neuromuscular blockade and respiratory depression.
  • Erythromycin: Antagonistic effect; concurrent use is not recommended.
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Moderate Interactions

  • Kaolin-pectin (oral): May decrease absorption of oral clindamycin (not relevant for IV formulation, but important if switching to oral).
  • Warfarin: May enhance the anticoagulant effect of warfarin, leading to increased INR and bleeding risk. Monitor INR closely.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., neutropenia, thrombocytopenia) with prolonged therapy.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: To establish baseline and monitor for potential hepatotoxicity, especially in patients with pre-existing hepatic impairment or during prolonged therapy.

Timing: Prior to initiation of therapy

Renal Function Tests (BUN, Creatinine)

Rationale: To establish baseline and monitor for potential nephrotoxicity, although rare. Important for dose consideration in severe renal impairment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Bowel movements/Stool consistency

Frequency: Daily

Target: Normal bowel habits

Action Threshold: Onset of significant diarrhea, abdominal pain, or fever; consider C. difficile testing immediately.

Liver Function Tests (LFTs)

Frequency: Weekly or bi-weekly for prolonged therapy (>10-14 days)

Target: Within normal limits or stable baseline

Action Threshold: Significant elevation (e.g., >3x ULN) of AST/ALT, bilirubin; consider drug discontinuation or dose adjustment.

Complete Blood Count (CBC)

Frequency: Weekly for prolonged therapy (>10-14 days)

Target: Within normal limits or stable baseline

Action Threshold: Significant decrease in WBC, neutrophils, or platelets; consider drug discontinuation.

Signs of infection resolution

Frequency: Daily

Target: Improvement in fever, WBC, inflammatory markers, clinical symptoms

Action Threshold: Lack of improvement or worsening symptoms; consider re-evaluation of diagnosis or treatment.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Rash or hives
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Yellowing of skin or eyes (jaundice)
  • Unusual bleeding or bruising
  • Sore throat or fever (signs of blood dyscrasias)

Special Patient Groups

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Pregnancy

Clindamycin is generally considered safe for use during pregnancy when clearly indicated. It is classified as Pregnancy Category B.

Trimester-Specific Risks:

First Trimester: No evidence of harm in animal studies or human data.
Second Trimester: No evidence of harm in animal studies or human data.
Third Trimester: No evidence of harm in animal studies or human data.
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Lactation

Clindamycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L2). Monitor breastfed infants for potential adverse effects.

Infant Risk: Low risk. Monitor infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reactions. The amount transferred is generally not considered clinically significant.
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Pediatric Use

Clindamycin can be used in pediatric patients, including neonates, with appropriate weight-based dosing. Close monitoring for adverse effects, particularly diarrhea, is important.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Clindamycin is a key agent for anaerobic infections, including those above and below the diaphragm.
  • It is also effective against many Gram-positive bacteria, including some MRSA strains (if susceptible).
  • The most significant adverse effect is *Clostridioides difficile*-associated diarrhea (CDAD), which can be severe and even fatal. Patients must be educated to report diarrhea immediately.
  • Due to its excellent penetration into bone and abscesses, it's often used for osteomyelitis and soft tissue infections.
  • Administer IV infusions slowly over 10-60 minutes to avoid hypotension and cardiopulmonary arrest.
  • Antagonism with erythromycin is a known interaction; avoid concurrent use.
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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)
  • Linezolid (for Gram-positive infections, including MRSA)
  • Vancomycin (for Gram-positive infections, including MRSA)
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Cost & Coverage

Average Cost: Highly variable, typically $50-$200 per 900mg/50ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 or take someone else's medication. 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.