Cleocin Phos 600mg/4ml Inj, 4ml

Manufacturer PFIZER U.S. 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
Aug 1970
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DEA Schedule
Not Controlled

Overview

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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, either into a vein (IV) or a muscle (IM).
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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 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 way to store it.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next.
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Lifestyle & Tips

  • Report any severe or persistent diarrhea, especially if it's watery or bloody, as this could be a sign of a serious bowel infection (C. difficile).
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products.
  • 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.
  • Avoid self-treating diarrhea without consulting your doctor, especially if it's severe, as some anti-diarrhea medications can worsen C. difficile infection.

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg to 2.7 g/day in 2, 3, or 4 equally divided doses
Dose Range: 600 - 4800 mg

Condition-Specific Dosing:

severeInfections: 1.2 to 2.7 g/day in 3 or 4 equally divided doses
lifeThreateningInfections: Up to 4.8 g/day (IV infusion only)
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Pediatric Dosing

Neonatal: Not established for neonates less than 1 month of age. For infants >1 month: 20-40 mg/kg/day in 3 or 4 equally divided doses.
Infant: 20-40 mg/kg/day in 3 or 4 equally divided doses (IV or IM)
Child: 20-40 mg/kg/day in 3 or 4 equally divided doses (IV or IM)
Adolescent: 20-40 mg/kg/day in 3 or 4 equally divided doses (IV or IM) or adult dosing if weight appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed.
Moderate: No adjustment typically needed.
Severe: No dose adjustment is generally required for patients with renal disease. However, in patients with severe renal impairment and/or severe hepatic impairment, the half-life is prolonged, and accumulation may occur. Monitor drug levels if prolonged therapy or high doses are used.
Dialysis: Clindamycin is not effectively removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis, but monitor for accumulation with prolonged therapy.

Hepatic Impairment:

Mild: No adjustment typically needed.
Moderate: No adjustment typically needed.
Severe: No dose adjustment is generally required for patients with hepatic disease. However, in patients with severe hepatic impairment and/or severe renal impairment, the half-life is prolonged, and accumulation may occur. Monitor drug levels if prolonged therapy or high doses are used.

Pharmacology

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Mechanism of Action

Clindamycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby preventing peptide bond formation and inhibiting ribosomal translocation. It is primarily bacteriostatic but can be bactericidal at higher concentrations or against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV/IM administration)
Tmax: Peak plasma concentrations are achieved rapidly after IV infusion (end of infusion) or IM injection (within 1-3 hours).
FoodEffect: Not applicable (IV/IM administration)

Distribution:

Vd: 0.8-1.3 L/kg
ProteinBinding: Approximately 90-94%
CnssPenetration: Limited (poor penetration into cerebrospinal fluid, even with inflamed meninges)

Elimination:

HalfLife: Approximately 2-3 hours (in adults with normal renal and hepatic function)
Clearance: Approximately 30-40 mL/min/kg
ExcretionRoute: Primarily via urine and feces (as active drug and metabolites)
Unchanged: Approximately 10% in urine and 4% in feces
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: Achieved at the end of IV infusion or within 1-3 hours after IM injection.
DurationOfAction: Dependent on dosing interval, typically maintained for 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 should not be used in patients with nonbacterial infections such as most 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 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
+ 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 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. 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 or seek medical help:

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, or bloody diarrhea
  • Abdominal pain or cramping
  • Fever
  • Rash, itching, hives, or other signs of an allergic reaction (e.g., difficulty breathing, swelling of face/throat)
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Sore throat, fever, or other signs of new infection
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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 symptoms you experienced.
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 in conjunction with 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 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 severe heart problems and low blood pressure if given too quickly. If you have any concerns or questions, be sure to 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 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, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Hypotension (with rapid IV infusion)
  • Neuromuscular blockade (rare, especially with concomitant use of neuromuscular blockers)

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) immediately for advice.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin has neuromuscular blocking properties and may enhance the action of these agents, leading to increased or prolonged respiratory depression/paralysis.
  • Erythromycin: Antagonism has been demonstrated in vitro between clindamycin and erythromycin; these drugs should not be administered concurrently.
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Moderate Interactions

  • 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.

Monitoring

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Baseline Monitoring

Culture and Susceptibility Testing

Rationale: To confirm susceptibility of the causative organism to clindamycin.

Timing: Prior to initiation of therapy.

Renal and Hepatic Function Tests (e.g., BUN, creatinine, AST, ALT)

Rationale: To establish baseline function, especially in patients with pre-existing impairment, as clindamycin is metabolized by the liver and excreted by the kidneys.

Timing: Prior to initiation of therapy, particularly for prolonged courses or in patients with known organ dysfunction.

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Routine Monitoring

Bowel Movements/Stool Characteristics

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

Target: Normal bowel habits.

Action Threshold: Development of significant diarrhea, abdominal pain, or fever; consider *Clostridioides difficile* infection (CDI).

Complete Blood Count (CBC) with differential

Frequency: Periodically, especially during prolonged therapy (e.g., >10 days).

Target: Within normal limits.

Action Threshold: Significant changes (e.g., leukopenia, neutropenia, thrombocytopenia) may warrant discontinuation.

Renal and Hepatic Function Tests

Frequency: Periodically, especially during prolonged therapy or in patients with pre-existing impairment.

Target: Within acceptable limits.

Action Threshold: Significant elevation of liver enzymes or renal parameters may require dose adjustment or discontinuation.

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Symptom Monitoring

  • Severe or persistent diarrhea (potentially bloody or watery)
  • Abdominal pain or cramping
  • Fever
  • Rash, itching, hives, or other signs of allergic reaction (e.g., anaphylaxis)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual fatigue or weakness
  • Sore throat, fever, or other signs of infection (due to potential blood dyscrasias)

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. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies show no evidence of teratogenicity. Use if clearly indicated.
Second Trimester: Generally considered safe for use if indicated.
Third Trimester: Generally considered safe for use if indicated.
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Lactation

Clindamycin is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., diarrhea, candidiasis, pseudomembranous colitis), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Monitor breastfed infants for gastrointestinal disturbances.

Infant Risk: L3 (Moderate concern - potential for GI upset, candidiasis in infant)
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Pediatric Use

Clindamycin injection is approved for use in pediatric patients 1 month of age and older. Dosing is weight-based (20-40 mg/kg/day). Safety and effectiveness in neonates less than 1 month of age have not been established. Monitor for adverse effects, especially gastrointestinal issues.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients may have reduced renal or hepatic function, which could prolong the half-life of clindamycin. Monitor renal and hepatic function, and observe for adverse effects, particularly severe diarrhea, more closely in this population.

Clinical Information

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Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria, making it a common choice for intra-abdominal infections, pelvic infections, and aspiration pneumonia.
  • It is also used for certain skin and soft tissue infections, including those caused by susceptible MRSA strains.
  • Rapid intravenous infusion can lead to hypotension and cardiac arrest; infuse over at least 10-60 minutes depending on the dose (typically 30 mg/min or less).
  • Clindamycin does not penetrate the central nervous system well, even with inflamed meninges, and is therefore not suitable for treating meningitis.
  • The most significant adverse effect is *Clostridioides difficile*-associated diarrhea (CDAD), which can range from mild to life-threatening. Patients should be educated to report any diarrhea immediately.
  • Consider clindamycin as an alternative for penicillin-allergic patients, especially for dental infections or certain skin infections.
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Vancomycin (for MRSA, C. difficile)
  • Linezolid (for MRSA, VRE)
  • Daptomycin (for MRSA, VRE)
  • Beta-lactam/beta-lactamase inhibitor combinations (e.g., piperacillin/tazobactam, amoxicillin/clavulanate for mixed aerobic/anaerobic infections)
  • Carbapenems (e.g., imipenem/cilastatin, meropenem for broad-spectrum coverage including anaerobes)
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Cost & Coverage

Average Cost: Not available (highly variable) per 4ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic), Tier 3 (for brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. 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, 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.