Clindamycin 900mg/6ml Inj, 6ml

Manufacturer SAGENT 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 1970
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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 is given as an injection, usually 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 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 storage method.

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

  • Complete the entire course of treatment, even if you start to feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Report any severe or persistent diarrhea to your doctor immediately, as this could be a sign of a serious bowel infection (C. difficile-associated diarrhea).

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg to 900 mg IV every 8 hours
Dose Range: 600 - 4800 mg

Condition-Specific Dosing:

Serious infections: 600-1200 mg/day in 2-4 divided doses
More severe infections: 1200-2700 mg/day in 2-4 divided doses
Life-threatening infections: Up to 4800 mg/day in 2-4 divided doses
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Pediatric Dosing

Neonatal: Not established (use with caution, monitor)
Infant: 20-40 mg/kg/day IV in 3 or 4 divided doses
Child: 20-40 mg/kg/day IV in 3 or 4 divided doses
Adolescent: 20-40 mg/kg/day IV in 3 or 4 divided doses (or adult dosing if weight appropriate)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed for single doses. For prolonged therapy, consider extending dosing interval or reducing dose based on clinical response and serum levels if available, as half-life may be prolonged.
Dialysis: Clindamycin is not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose is needed after dialysis, but monitor for accumulation with prolonged therapy.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed for single doses. For prolonged therapy, consider extending dosing interval or reducing dose based on clinical response and serum levels if available, as half-life may be prolonged.

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)
Tmax: End of infusion (IV)
FoodEffect: Not applicable for IV formulation

Distribution:

Vd: 0.6-1.1 L/kg
ProteinBinding: 90-94%
CnssPenetration: Limited (poor penetration into CSF, even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (normal renal/hepatic function)
Clearance: Not available (variable)
ExcretionRoute: Renal (10-20% as active drug and metabolites), Fecal (4-10% as active drug and metabolites)
Unchanged: Approximately 10% (urine), 4% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (IV)
PeakEffect: End of infusion (IV)
DurationOfAction: Dependent on dosing interval (typically 6-8 hours)

Safety & Warnings

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BLACK BOX WARNING

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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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Side Effects

Important Side Effects to Report to Your Doctor 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, seek medical attention 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 reactions. These conditions can be life-threatening and may also affect other organs in the body. Seek immediate medical attention 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 report any concerns to 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, call 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 stools
  • Abdominal cramps or pain
  • Fever
  • Rash, itching, or hives
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Yellowing of the skin or eyes (jaundice)
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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 issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, 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 low blood pressure and severe heart problems 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, use this medication with caution, 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 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 (low blood pressure)
  • Neuromuscular blockade (rare, but possible with very high doses or rapid infusion)

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive, as there is no specific antidote. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the blood.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Clindamycin has neuromuscular blocking properties and may enhance the action of these agents, leading to prolonged respiratory depression.
  • Erythromycin: In vitro antagonism has been demonstrated between clindamycin and erythromycin; concurrent use is not recommended.
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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.
  • Kaolin-pectin (oral clindamycin only): May reduce absorption of oral clindamycin. Separate administration by several hours.
  • 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

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

Timing: Prior to initiation of therapy

Renal and Hepatic Function Tests (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/Stool Characteristics

Frequency: Daily

Target: Normal bowel habits

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

Renal and Hepatic Function Tests

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

Target: Within normal limits or stable baseline

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

Complete Blood Count (CBC)

Frequency: Periodically for prolonged therapy (>10 days)

Target: Within normal limits

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

Injection Site

Frequency: Daily

Target: No signs of inflammation, pain, or phlebitis

Action Threshold: Redness, swelling, pain, or induration; consider site rotation or alternative access.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Rash or hives
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual bleeding or bruising

Special Patient Groups

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Pregnancy

Clindamycin is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. 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 human studies.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Clindamycin is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: L3 (Moderately safe - compatible with breastfeeding, but monitor infant for GI upset or candidiasis).
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Pediatric Use

Dosing is weight-based. Neonates and infants may have immature renal and hepatic function, requiring careful monitoring. The preservative benzyl alcohol in some formulations can be toxic to neonates (gasping syndrome); preservative-free formulations should be used in this population.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients are more likely to have decreased renal or hepatic function, which may necessitate dose adjustment or closer monitoring. They may also be more susceptible to C. difficile-associated diarrhea.

Clinical Information

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Clinical Pearls

  • Clindamycin IV should be infused slowly over 10-60 minutes (typically 30 mg/min or less) to avoid hypotension and cardiac arrest. Do not administer as an IV bolus.
  • The risk of *Clostridioides difficile*-associated diarrhea (CDAD) is a significant concern with clindamycin, and it can occur even weeks after discontinuation of therapy. Educate patients on symptoms and the importance of reporting them.
  • Clindamycin is effective against many Gram-positive aerobes (including MRSA in some cases, depending on D-test results) and a wide range of anaerobes, making it useful for skin and soft tissue infections, intra-abdominal infections, and gynecological infections.
  • For severe infections, a loading dose may be considered, especially in critically ill patients, to rapidly achieve therapeutic concentrations.
  • Oral clindamycin should be taken with a full glass of water to prevent esophageal irritation.
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Vancomycin (for MRSA and C. difficile)
  • Linezolid (for MRSA and VRE)
  • Daptomycin (for MRSA and VRE)
  • Beta-lactam antibiotics (e.g., penicillin, cephalosporins, carbapenems, depending on specific pathogen and site of infection)
  • Macrolides (e.g., azithromycin, erythromycin - note antagonism with clindamycin)
  • Tetracyclines (e.g., doxycycline)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 900mg/6ml vial per 900mg/6ml vial
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. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult 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.