Clindamycin 300mg/d5w 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
Antibiotic
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Pharmacologic Class
Lincosamide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Jul 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin is an antibiotic medication given by injection into a vein. It works by stopping the growth of certain bacteria that cause infections. It's used to treat serious bacterial infections, especially those caused by anaerobic bacteria (bacteria that live without oxygen) and some other types of bacteria.
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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. Adhere to the dosage and administration guidelines provided. This medication is administered via injection into a muscle or as an intravenous infusion over a specified period.

If you are required to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Report any diarrhea, especially if severe, persistent, or bloody, to your doctor immediately, even if it occurs weeks after stopping the medication.
  • 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.
  • Stay hydrated, especially if experiencing diarrhea.

Dosing & Administration

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Adult Dosing

Standard Dose: 300 mg IV every 6-8 hours for less severe infections, infused over 10-60 minutes. For serious infections, typical doses are 600-900 mg IV every 8 hours.
Dose Range: 300 - 4800 mg

Condition-Specific Dosing:

severe_infections: 600-900 mg IV every 8 hours, up to 4800 mg/day in life-threatening situations.
prophylaxis_surgical: 900 mg IV prior to surgery.
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Pediatric Dosing

Neonatal: 15-20 mg/kg/day IV in 3-4 divided doses (for full-term infants >7 days old). Lower doses for premature or younger neonates.
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, typically 20-40 mg/kg/day IV in 3-4 divided doses, not to exceed adult maximums.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment generally required.
Moderate: No dose adjustment generally required.
Severe: No dose adjustment generally required for single doses. For prolonged therapy, consider monitoring serum levels in severe renal impairment (CrCl <30 mL/min) and adjusting dose if accumulation occurs.
Dialysis: Clindamycin is not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose is needed after dialysis, but monitoring for accumulation during prolonged therapy is prudent.

Hepatic Impairment:

Mild: No dose adjustment generally required.
Moderate: No dose adjustment generally required. Monitor liver function tests and consider dose reduction if severe hepatic dysfunction or accumulation occurs.
Severe: Consider dose reduction and monitor serum levels and liver function tests due to prolonged half-life.

Pharmacology

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Mechanism of Action

Clindamycin is a lincosamide antibiotic that 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. It is active against a wide range of Gram-positive aerobic bacteria and anaerobic bacteria.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Not applicable (IV administration, peak concentration achieved at end of infusion)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 0.6-1.2 L/kg
ProteinBinding: 90-94%
CnssPenetration: Limited (does not achieve therapeutic levels in CSF even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (adults); slightly longer in neonates and patients with severe hepatic impairment.
Clearance: Approximately 30-40 mL/min/kg
ExcretionRoute: Approximately 10% via urine, 3.6% via feces as active drug; remainder as inactive metabolites.
Unchanged: Approximately 10% (urine), 3.6% (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)
Confidence: High

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 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.
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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 when 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 also affect other organs. Seek medical help immediately 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 symptoms that bother you or do not go away, contact your doctor:

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, or bloody diarrhea
  • Abdominal pain or cramping
  • Fever
  • Rash, hives, or itching
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • 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 if it is safe to take this medication in conjunction with your other medications and health issues.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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 products containing 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.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Exaggerated side effects such as severe gastrointestinal upset (diarrhea, abdominal pain)
  • Hypotension (low blood pressure)
  • Respiratory depression (if given with neuromuscular blockers)

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) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin may enhance the neuromuscular blocking action, leading to increased or prolonged respiratory depression/paralysis.
  • Erythromycin: Antagonistic effect; should not be administered concurrently.
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Moderate Interactions

  • Kaolin-pectin (if oral clindamycin): May decrease absorption of clindamycin.
  • Warfarin and other Vitamin K antagonists: May enhance the anticoagulant effect, leading to increased INR/bleeding risk (monitor INR).
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Confidence Interactions

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline hematologic status, especially for prolonged therapy, due to rare reports of transient neutropenia and agranulocytosis.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

Rationale: To establish baseline hepatic function, as clindamycin is metabolized by the liver and can rarely cause transient elevations in LFTs.

Timing: Prior to initiation of therapy.

Renal Function Tests (BUN, Creatinine)

Rationale: To establish baseline renal function, although dose adjustment is generally not needed, it's important for overall patient assessment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Bowel movements/Diarrhea

Frequency: Daily, throughout therapy and for several weeks post-therapy.

Target: Absence of significant diarrhea.

Action Threshold: Onset of significant diarrhea, especially if severe, persistent, or bloody, should prompt immediate discontinuation and investigation for *Clostridioides difficile*-associated diarrhea (CDAD).

Liver Function Tests (LFTs)

Frequency: Periodically (e.g., weekly or bi-weekly) for patients on prolonged therapy or with pre-existing hepatic impairment.

Target: Within normal limits or stable baseline.

Action Threshold: Significant or progressive elevation may warrant dose adjustment or discontinuation.

Renal Function Tests (BUN, Creatinine)

Frequency: Periodically for patients on prolonged therapy or with pre-existing renal impairment.

Target: Within normal limits or stable baseline.

Action Threshold: Significant or progressive elevation may warrant monitoring of clindamycin levels if available, though dose adjustment is often not required.

Complete Blood Count (CBC)

Frequency: Periodically (e.g., weekly or bi-weekly) for patients on prolonged therapy.

Target: Within normal limits.

Action Threshold: Significant decrease in white blood cell count (especially neutrophils) or other cell lines may warrant discontinuation.

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Symptom Monitoring

  • Diarrhea (especially severe, persistent, or bloody)
  • Abdominal pain or cramping
  • Fever
  • Skin rash or itching (signs of allergic reaction)
  • Yellowing of skin or eyes (jaundice)
  • Unusual fatigue or weakness

Special Patient Groups

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Pregnancy

Clindamycin is generally considered safe for use during pregnancy when clearly needed. It is classified as Pregnancy Category B, meaning animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women, or animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed in human studies.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe; no adverse effects on the fetus or newborn reported.
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Lactation

Clindamycin is excreted into breast milk. While generally considered compatible with breastfeeding (Lactation Risk L2), 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 risk of adverse effects; monitor for gastrointestinal disturbances or candidiasis.
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Pediatric Use

Clindamycin can be used in pediatric patients, including neonates, with appropriate dose adjustments based on weight and age. Close monitoring for adverse effects, particularly diarrhea, is important. Dosage should be carefully calculated to avoid exceeding recommended limits.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, elderly patients may be more susceptible to the development of severe colitis associated with clindamycin. Monitor closely for diarrhea and other adverse effects. Consider age-related decline in renal or hepatic function when assessing overall patient status.

Clinical Information

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Clinical Pearls

  • Always infuse IV clindamycin slowly over at least 10-60 minutes (depending on dose) to avoid hypotension and cardiac arrest.
  • Clindamycin is highly effective against anaerobic bacteria, making it a valuable agent 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 considered, even weeks after therapy cessation.
  • It is a common alternative for penicillin-allergic patients, particularly for dental infections or skin and soft tissue infections.
  • Clindamycin does not penetrate the central nervous system well, so it is not suitable for treating meningitis.
  • For severe infections, higher doses (e.g., 600-900 mg IV every 8 hours) are typically used, while 300 mg every 6-8 hours might be for less severe or specific indications.
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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: Varies widely, typically $5-$50 per 300mg/50mL vial per vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 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 the 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 by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, it is critical to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. Be prepared to provide detailed information about the overdose, including the type of medication taken, the amount, and the time it occurred, to ensure you receive appropriate treatment.