Clindamy/d5w 900mg/50ml Inj, 50ml

Manufacturer BAXTER HEALTHCARE CORP 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
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, especially those caused by anaerobic bacteria (bacteria that live without oxygen). It works by stopping the growth of bacteria. It is given as an injection into a vein.
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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's essential to follow the dosage instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.

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 to receive guidance on what to do next.
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Lifestyle & Tips

  • Report any new or worsening diarrhea immediately to your healthcare provider, 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 to feel 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 mg to 900 mg IV every 8 hours
Dose Range: 600 - 2700 mg

Condition-Specific Dosing:

seriousInfections: 600 mg to 1.2 g/day IV in 2 to 4 equally divided doses
moreSevereInfections: 1.2 g to 2.7 g/day IV in 2 to 4 equally divided doses
lifeThreateningInfections: Up to 4.8 g/day IV
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Pediatric Dosing

Neonatal: Not established (use with caution, monitor for adverse effects)
Infant: 20 to 40 mg/kg/day IV in 3 or 4 equally divided doses
Child: 20 to 40 mg/kg/day IV in 3 or 4 equally divided doses
Adolescent: 20 to 40 mg/kg/day IV in 3 or 4 equally divided doses (or adult dose if weight/severity warrants)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed for single doses. For severe renal impairment (CrCl <30 mL/min) and/or severe hepatic impairment, dose reduction or increased dosing interval may be considered, but generally not required due to minimal renal excretion of parent drug.
Dialysis: Clindamycin is not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose is needed after dialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Dose reduction or increased dosing interval may be considered for severe hepatic impairment, especially if accompanied by severe renal impairment, due to prolonged half-life. Monitor liver function tests.

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% (IV administration)
Tmax: Immediately after IV infusion
FoodEffect: Not applicable for IV formulation

Distribution:

Vd: 0.8-1.2 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 or renal impairment
Clearance: Not available
ExcretionRoute: Approximately 10% excreted in urine and 3.6% in feces as active drug; remainder excreted as inactive metabolites.
Unchanged: Approximately 10% (urine), 3.6% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (after IV infusion)
PeakEffect: Immediately after IV infusion
DurationOfAction: Dependent on half-life and post-antibiotic effect; typically dosed every 6-8 hours

Safety & Warnings

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BLACK BOX WARNING

Clindamycin therapy has been associated with severe colitis which may result in death. It should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It is important to consider the diagnosis of pseudomembranous colitis in patients who develop diarrhea subsequent to the administration of antimicrobial agents. Because clindamycin has been shown to have in vitro antagonism with erythromycin, these two drugs should not be administered concurrently.
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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 signs or symptoms, contact your doctor or seek immediate medical attention:

Allergic reaction symptoms, 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
Kidney problem signs, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden significant 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:

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, watery diarrhea or bloody diarrhea
  • Abdominal pain or cramping
  • Fever
  • Rash, itching, or hives
  • 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
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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 and its symptoms.
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 alongside your other treatments and health conditions. Never start, stop, 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 long-term, 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 an extended period beyond the prescribed duration. Prolonged use may increase the risk of a secondary infection.

Administering this drug intravenously at too rapid a rate has been associated with severe hypotension and cardiac complications. If you have any concerns or questions, consult your doctor.

Some formulations of this product may contain benzyl alcohol. Whenever possible, it is recommended to avoid using products containing benzyl alcohol in newborns and infants, as certain doses of benzyl alcohol can cause severe adverse 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 of age or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects.

Prior to initiating treatment with this drug, inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your doctor will discuss the potential benefits and risks of using this medication during pregnancy or breastfeeding to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Exaggerated adverse effects such as severe gastrointestinal upset, liver dysfunction, or neuromuscular blockade (if given with NMBAs).

What to Do:

There is no specific antidote for clindamycin overdose. Treatment is symptomatic and supportive. 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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Contraindicated Interactions

  • Erythromycin (antagonistic effect)
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Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium) - potentiates neuromuscular blockade
  • Kaolin (oral clindamycin only - reduces absorption)
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Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease clindamycin levels
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) - may increase clindamycin levels
  • Warfarin (may enhance anticoagulant effect, monitor INR)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline and identify pre-existing hepatic impairment, as clindamycin is metabolized by the liver.

Timing: Prior to initiation of therapy, especially in patients with pre-existing liver disease.

Renal function tests (BUN, creatinine)

Rationale: To establish baseline and identify pre-existing renal impairment, though dose adjustment is usually not needed, it helps assess overall patient status.

Timing: Prior to initiation of therapy, especially in patients with pre-existing renal disease.

Complete Blood Count (CBC) with differential

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

Timing: Prior to initiation of therapy, especially for prolonged courses.

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Routine Monitoring

Stool frequency and consistency

Frequency: Daily

Target: Normal bowel habits

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

Signs and symptoms of infection resolution

Frequency: Daily

Target: Resolution of fever, reduction in inflammatory markers, improvement in clinical signs.

Action Threshold: Lack of improvement or worsening of infection; consider re-evaluation of diagnosis or antibiotic regimen.

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically (e.g., weekly) for prolonged therapy (>10-14 days)

Target: Within normal limits or stable

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

Renal function tests (BUN, creatinine)

Frequency: Periodically (e.g., weekly) for prolonged therapy or in patients with underlying renal disease

Target: Within normal limits or stable

Action Threshold: Significant elevation; re-evaluate patient status.

Complete Blood Count (CBC) with differential

Frequency: Periodically (e.g., weekly) for prolonged therapy (>10-14 days)

Target: Within normal limits or stable

Action Threshold: Significant decrease in WBC, neutrophil, or platelet counts; consider discontinuation.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent)
  • Abdominal pain or cramping
  • Fever
  • Rash or hives
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness

Special Patient Groups

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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 limited human data.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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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 significant risk to the infant. Monitor for GI upset.
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Pediatric Use

Clindamycin is used in pediatric patients, including neonates, infants, children, and adolescents. Dosing is typically weight-based (mg/kg). Caution is advised in neonates due to immature renal and hepatic function, which may prolong half-life. Monitor for adverse effects, especially C. difficile-associated diarrhea.

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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 C. difficile-associated diarrhea, and may have age-related decline in renal or hepatic function. Monitor closely for adverse reactions and adjust dose if significant organ impairment is present.

Clinical Information

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Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria and many Gram-positive aerobes (e.g., Staphylococcus, Streptococcus), but not Gram-negative aerobes.
  • It has excellent tissue penetration, including bone, abscesses, and soft tissues, making it useful for osteomyelitis, intra-abdominal infections, and skin/soft tissue infections.
  • The most significant adverse effect is C. difficile-associated diarrhea (CDAD), which can range from mild diarrhea to fatal pseudomembranous colitis. This risk persists even weeks after discontinuation.
  • Due to its mechanism of action, it can exhibit a post-antibiotic effect, meaning bacterial growth is suppressed even after drug levels fall below the MIC.
  • IV clindamycin should be infused slowly over 10-60 minutes (not exceeding 30 mg/min) to avoid hypotension and cardiac arrest.
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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/cilastatin, meropenem)
  • Vancomycin (for MRSA or severe Gram-positive infections, but different spectrum)
  • Linezolid (for MRSA and VRE, different class)
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Cost & Coverage

Average Cost: Varies widely by manufacturer and quantity per 50ml vial (900mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the best method for disposing of your medication, consult your pharmacist for guidance. Many communities have 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, do not hesitate to 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 it was taken, as this will aid in providing appropriate treatment.