Cleocin Phos 900mg/6ml Inj, 6ml

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
Jul 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. It works by stopping the growth of bacteria. It's given as an injection into a vein or muscle, usually in a hospital or clinic setting.
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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 proper storage procedure.

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 symptoms to your healthcare provider immediately.
  • Do not take anti-diarrhea medications without consulting your doctor if you develop diarrhea, as this could worsen a serious condition called C. difficile-associated diarrhea.
  • 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 mg to 900 mg IV every 8 hours
Dose Range: 600 - 2700 mg

Condition-Specific Dosing:

Serious infections: 600 mg to 1.2 g/day IV or IM in 2 to 4 equally divided doses
More severe infections: 1.2 g to 2.7 g/day IV or IM in 2 to 4 equally divided doses
Life-threatening infections: 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 or IM in 3 or 4 equally divided doses
Child: 20 to 40 mg/kg/day IV or IM in 3 or 4 equally divided doses
Adolescent: 20 to 40 mg/kg/day IV or IM in 3 or 4 equally divided doses (or adult dosing if weight/severity warrants)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment generally necessary
Moderate: No dosage adjustment generally necessary
Severe: No dosage adjustment generally necessary for single or short-term use. For severe renal impairment and/or severe hepatic impairment, consider monitoring clindamycin serum levels and adjusting dose if necessary.
Dialysis: Clindamycin is not effectively 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
Severe: No dosage adjustment generally necessary for single or short-term use. For severe hepatic impairment and/or severe renal impairment, consider monitoring clindamycin serum levels and adjusting dose if necessary.
Confidence: Medium

Pharmacology

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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 early chain elongation. It is primarily bacteriostatic but may be bactericidal at high concentrations or against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV/IM administration)
Tmax: Not applicable (IV/IM administration)
FoodEffect: Not applicable (IV/IM administration)

Distribution:

Vd: 0.6 to 1.2 L/kg
ProteinBinding: 40% to 90% (concentration-dependent)
CnssPenetration: Limited (poor penetration into CSF, even with inflamed meninges)

Elimination:

HalfLife: 2 to 3 hours (adults); may be prolonged in neonates and patients with severe renal/hepatic impairment
Clearance: Approximately 10 to 15 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 (IV)
PeakEffect: End of infusion (IV)
DurationOfAction: Dependent on half-life and dosing interval (typically 6-8 hours for therapeutic levels)
Confidence: Medium

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. The colitis is usually characterized by severe persistent diarrhea and significant abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued or, if necessary, continued only with close observation of the patient. Large bowel endoscopy is recommended in cases of severe diarrhea. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition.
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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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 your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other 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 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 (possibly bloody or with mucus)
  • Abdominal pain or cramping
  • Fever
  • Skin rash, itching, or hives
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • 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 symptoms you experienced as a result of the allergy.
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 (including 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 may increase the risk of a secondary infection.

Administering this drug intravenously too quickly can cause severe hypotension and serious heart problems. If you have any concerns or questions, consult 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. Discuss with your doctor whether 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. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • No specific symptoms of overdose are well-documented, but adverse effects (e.g., gastrointestinal distress, hypersensitivity reactions) may be exaggerated.

What to Do:

There is no specific antidote. 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 or paralysis.
  • Erythromycin: Antagonism may occur due to competitive binding at the 50S ribosomal subunit.
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Moderate Interactions

  • Warfarin and other Vitamin K antagonists: May enhance the anticoagulant effect, leading to increased INR and bleeding risk. Monitor INR closely.
  • Kaolin-pectin antidiarrheals: May decrease absorption of oral clindamycin (not relevant for IV/IM, but good to note for overall drug knowledge).
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Confidence Interactions

Monitoring

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Baseline Monitoring

Culture and Susceptibility Testing

Rationale: To identify the causative organism and confirm its susceptibility to clindamycin, guiding appropriate therapy.

Timing: Prior to initiation of therapy

Baseline Renal and Hepatic Function (BUN, Creatinine, LFTs)

Rationale: To assess baseline organ function, especially in patients with pre-existing impairment or those receiving prolonged therapy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Bowel Movements

Frequency: Daily

Target: Normal bowel habits

Action Threshold: Development of severe, persistent diarrhea, abdominal pain, or fever; consider C. difficile testing and discontinuation of clindamycin.

Liver Function Tests (ALT, AST, Bilirubin)

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

Target: Within normal limits or stable

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

Renal Function Tests (BUN, Creatinine)

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

Target: Within normal limits or stable

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

Complete Blood Count (CBC)

Frequency: Periodically (e.g., weekly) for prolonged therapy

Target: Within normal limits

Action Threshold: Significant changes (e.g., leukopenia, neutropenia, thrombocytopenia); consider discontinuation.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Bloody or mucoid stools
  • Skin rash or itching
  • Signs of hypersensitivity (e.g., swelling of face/throat, difficulty breathing)
  • Jaundice or dark urine (signs of liver dysfunction)

Special Patient Groups

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Pregnancy

Clindamycin is generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and adequate, well-controlled studies in pregnant women have not demonstrated a risk to the fetus in any trimester. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk based on available data.
Second Trimester: Low risk based on available data.
Third Trimester: Low risk based on available data.
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Lactation

Clindamycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (L3 - Moderately Safe). Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low to moderate risk. Potential for disruption of infant gut flora, leading to diarrhea or candidiasis. Allergic sensitization is also a theoretical risk.
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Pediatric Use

Clindamycin is used in pediatric patients, including infants. Dosage is typically weight-based. Caution is advised in neonates and infants due to immature renal and hepatic function, which may prolong half-life. Monitor for adverse effects, especially gastrointestinal issues.

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Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients may have age-related decreases in renal or hepatic function, or multiple comorbidities, which may warrant closer monitoring of adverse effects, particularly C. difficile-associated diarrhea.

Clinical Information

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Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria, making it a go-to for many intra-abdominal, gynecological, and skin/soft tissue infections.
  • Always consider the risk of *Clostridioides difficile*-associated diarrhea (CDAD) with clindamycin, even after discontinuation. Educate patients on symptoms and to seek immediate medical attention if severe diarrhea occurs.
  • Rapid IV infusion can lead to hypotension and cardiac arrest; infuse over at least 10-60 minutes depending on dose (typically 30 mg/min or less).
  • Antagonism with erythromycin is a known interaction; avoid concomitant use.
  • While generally not requiring dose adjustment for renal/hepatic impairment, monitor patients with severe dysfunction or those on prolonged therapy for accumulation and adverse effects.
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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)
  • Other antibiotics depending on the specific pathogen and site of infection (e.g., vancomycin for MRSA, daptomycin, linezolid)
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Cost & Coverage

Average Cost: Varies widely by supplier and contract per 6ml vial (900mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 for further guidance. 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; 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 it was taken to ensure prompt and effective treatment.