Cleocin Phos 9gm Inj, 60ml

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
Dec 1967
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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 to treat serious bacterial infections. It works by stopping the growth of bacteria. It is particularly effective against certain types of bacteria, including those that cause skin infections, bone infections, and infections inside the body.
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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 instructions provided to ensure safe and effective use. 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 are required 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, especially if it contains blood or mucus, to your doctor immediately. This could be a sign of a serious bowel infection.
  • Stay well-hydrated during treatment.
  • 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 1.2 g/day IV in 2 to 4 equally divided doses for severe infections; up to 2.7 g/day IV for more severe infections
Dose Range: 600 - 2700 mg

Condition-Specific Dosing:

Severe Infections: 600 mg to 1.2 g/day IV in 2 to 4 equally divided doses
More Severe Infections: 1.2 g to 2.7 g/day IV in 2 to 4 equally divided doses
Life-threatening Infections: Up to 4.8 g/day IV (rarely, in life-threatening situations)
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Pediatric Dosing

Neonatal: 15-20 mg/kg/day IV in 3-4 equally divided doses (for full-term infants >7 days old); 10-15 mg/kg/day IV in 2-3 equally divided doses (for full-term infants <7 days old or premature infants)
Infant: 20-40 mg/kg/day IV in 3-4 equally divided doses
Child: 20-40 mg/kg/day IV in 3-4 equally divided doses
Adolescent: 20-40 mg/kg/day IV in 3-4 equally divided doses (max 2.7 g/day, or 4.8 g/day in life-threatening situations)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment generally required.
Moderate: No dosage adjustment generally required.
Severe: No dosage adjustment generally required for single doses or short courses. For prolonged therapy, consider monitoring serum levels and adjusting dose if accumulation occurs, though significant accumulation is rare.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No dosage adjustment generally required.
Moderate: No dosage adjustment generally required.
Severe: Dosage adjustment may be necessary in patients with severe hepatic disease due to prolonged half-life. Monitor liver function tests and consider serum levels if available.

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. This binding prevents peptide bond formation and inhibits the initiation of polypeptide chains, 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: Immediate (IV)
FoodEffect: Not applicable (IV)

Distribution:

Vd: 0.6-1.2 L/kg
ProteinBinding: 93-94%
CnssPenetration: Limited (poor penetration into CSF, even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (adults); prolonged in neonates and patients with severe hepatic impairment
Clearance: Not available (variable)
ExcretionRoute: Primarily via bile and feces (approx. 60-70%), with a smaller portion excreted in urine (approx. 10-20%)
Unchanged: Less than 10% (urine); approximately 4% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (IV)
PeakEffect: Within minutes of IV infusion completion
DurationOfAction: 6-8 hours (due to post-antibiotic effect and 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 patient 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. The colitis is usually characterized by severe persistent diarrhea and severe 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 stool 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 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
Nausea or 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 (may occur up to several weeks after stopping the medication)
  • Severe abdominal pain or cramping
  • Rash, itching, or hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual tiredness or weakness
  • Signs of a new infection (e.g., fever, sore throat, vaginal discharge)
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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 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 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 second infection.

Administering this drug intravenously too quickly can cause severe hypotension and serious heart problems. If you have any questions or concerns, 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, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of using this medication during pregnancy or breastfeeding.
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Overdose Information

Overdose Symptoms:

  • No specific symptoms of acute overdose are well-documented for clindamycin injection. Overdose may lead to increased severity of known side effects such as gastrointestinal disturbances (diarrhea, abdominal pain) or liver enzyme elevations.

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) 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: Antagonistic effect due to competition for the same ribosomal binding site. Avoid concomitant use.
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Moderate Interactions

  • Kaolin-pectin antidiarrheals: May reduce oral absorption of clindamycin (not relevant for IV formulation, but important if switching to oral).
  • Warfarin and other Vitamin K antagonists: May enhance the anticoagulant effect, leading to increased INR/bleeding risk. Monitor INR closely.
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Minor Interactions

  • Live bacterial vaccines (e.g., typhoid vaccine): Antibiotics may reduce the therapeutic effect of live bacterial vaccines. Administer vaccine at least 24 hours after clindamycin discontinuation.

Monitoring

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Baseline Monitoring

Allergy history

Rationale: To identify potential hypersensitivity reactions.

Timing: Prior to administration

Baseline renal and hepatic function tests (BUN, creatinine, AST, ALT, bilirubin)

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Bowel movements/Diarrhea

Frequency: Daily

Target: Normal bowel habits

Action Threshold: Onset of significant diarrhea, especially if severe, persistent, or bloody, requires immediate investigation for C. difficile-associated diarrhea (CDAD).

Liver function tests (AST, ALT, bilirubin)

Frequency: Periodically (e.g., weekly or bi-weekly)

Target: Within normal limits

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

Renal function tests (BUN, creatinine)

Frequency: Periodically (e.g., weekly or bi-weekly)

Target: Within normal limits

Action Threshold: Significant elevation may warrant re-evaluation of therapy, though clindamycin is not primarily renally cleared.

Complete Blood Count (CBC) with differential

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

Target: Within normal limits

Action Threshold: Significant changes (e.g., leukopenia, neutropenia, thrombocytopenia) may indicate bone marrow suppression.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Rash or hives
  • Signs of allergic reaction (e.g., swelling of face/throat, difficulty breathing)
  • Signs of superinfection (e.g., new or worsening fever, oral thrush, vaginal yeast infection)

Special Patient Groups

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Pregnancy

Clindamycin is generally considered safe for use during pregnancy (Pregnancy Category B). Studies in animals have not shown harm to the fetus, and adequate and well-controlled studies in pregnant women have not demonstrated a risk to the fetus in the first trimester, and there is no evidence of risk in later trimesters.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of birth defects.
Second Trimester: No evidence of increased risk.
Third Trimester: No evidence of increased risk.
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Lactation

Clindamycin is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk L2).

Infant Risk: Low risk. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions. The amount transferred is generally not considered clinically significant.
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Pediatric Use

Clindamycin injection can be used in pediatric patients, including neonates, infants, children, and adolescents. Dosage is weight-based. Close monitoring for adverse effects, particularly diarrhea, is important.

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Geriatric Use

No specific dosage 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.

Clinical Information

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Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria and many Gram-positive aerobic bacteria, including MRSA in some cases, making it useful for skin and soft tissue infections, intra-abdominal infections, and gynecological infections.
  • The most significant adverse effect is Clostridium difficile-associated diarrhea (CDAD), which can range from mild diarrhea to fatal pseudomembranous colitis. This risk persists for several weeks after discontinuation.
  • It has excellent penetration into bone and abscesses, making it a good choice for osteomyelitis and deep-seated infections.
  • Clindamycin does not penetrate the central nervous system well, so it is not typically used for meningitis.
  • Rapid IV infusion can lead to hypotension and cardiac arrest; administer over at least 10-60 minutes depending on the dose.
  • Consider alternative antibiotics if a patient develops significant diarrhea during clindamycin therapy.
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Vancomycin (for Gram-positive infections, including MRSA)
  • Linezolid (for Gram-positive infections, including MRSA and VRE)
  • Doxycycline (for some skin and soft tissue infections)
  • Beta-lactam/beta-lactamase inhibitor combinations (e.g., amoxicillin/clavulanate, piperacillin/tazobactam for mixed aerobic/anaerobic infections)
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Cost & Coverage

Average Cost: Varies widely by supplier and contract; typically $10-$50 per 600mg/4mL 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 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. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.