Clindamy/d5w 600mg/50ml Inj, 50ml

Manufacturer NOVAPLUS/BAXTER HEALTHCARE 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 that fights bacteria in your body. It works by stopping the growth of bacteria that cause infections. It's used to treat serious bacterial infections, including those of the skin, bones, joints, lungs, and internal organs.
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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 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.

What to Do If You Miss a Dose

If you miss a dose, contact your doctor to find out the best course of action.
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Lifestyle & Tips

  • 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.
  • Report any severe or persistent diarrhea, abdominal pain, or blood/mucus in your stool to your doctor immediately, as this could be a sign of a serious bowel infection (C. difficile-associated diarrhea).
  • Stay hydrated by drinking plenty of fluids.
  • Avoid taking anti-diarrhea medications without consulting your doctor if you develop diarrhea while on clindamycin, as this can worsen C. difficile infection.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

Severe infections: 900 mg to 1200 mg IV every 8 hours (up to 4.8 g/day)
Prophylaxis for endocarditis (dental procedures): 600 mg IV 30-60 minutes prior to procedure (if unable to take oral)
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Pediatric Dosing

Neonatal: 15-20 mg/kg/day in 3-4 divided doses (for full-term infants >1 month of age). For premature infants, dosage may need adjustment based on gestational age and weight.
Infant: 20-40 mg/kg/day in 3-4 divided doses
Child: 20-40 mg/kg/day in 3-4 divided doses
Adolescent: 20-40 mg/kg/day in 3-4 divided doses, or adult dose if weight appropriate
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed
Moderate: No adjustment typically needed
Severe: No adjustment typically needed, but monitor for accumulation in severe renal disease with concomitant severe hepatic disease.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No adjustment typically needed
Moderate: No adjustment typically needed
Severe: Monitor for accumulation; dosage reduction may be necessary in patients with severe hepatic disease and concomitant severe renal disease.

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 the early stages of protein synthesis. It is primarily bacteriostatic but can be bactericidal at higher 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: 0.6-1.2 L/kg
ProteinBinding: Approximately 90-94%
CnssPenetration: Limited (does not achieve therapeutic levels in CSF, even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (adults with normal renal/hepatic function)
Clearance: Approximately 30-40 mL/min
ExcretionRoute: Approximately 10% excreted in urine as active drug and metabolites, 3.6% in feces as active drug, and the 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 dosing interval (typically 8 hours)

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, as described in the INDICATIONS AND USAGE section. 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 or 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 symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Stomach pain
Upset stomach
Nausea or vomiting
Bad taste in your mouth

Reporting Side Effects

This is not a comprehensive list of all possible 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
  • Severe stomach pain or cramping
  • Fever
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual bleeding or bruising
  • Signs of a severe allergic reaction (e.g., rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing, dizziness)
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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 if it is safe to take this medication in conjunction with your other medications and health conditions.

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 too quickly through a vein 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.

Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your doctor will help you weigh the benefits and risks of using this medication during these situations 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)
  • Respiratory depression (rare, but possible with very high doses or rapid infusion)

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. In case of suspected overdose, contact a poison control center immediately (e.g., call 1-800-222-1222 in the US) or seek emergency medical attention.

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.
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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.
  • Live bacterial vaccines (e.g., typhoid vaccine): Antibiotics may reduce the therapeutic effect of live bacterial vaccines.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., leukopenia, neutropenia, thrombocytopenia) with prolonged therapy.

Timing: Prior to initiation of therapy, especially for prolonged courses.

Liver Function Tests (LFTs)

Rationale: To establish baseline and monitor for potential hepatotoxicity, especially in patients with pre-existing hepatic impairment or during prolonged therapy.

Timing: Prior to initiation of therapy, especially for prolonged courses.

Renal Function Tests (BUN, Creatinine)

Rationale: To establish baseline and monitor for potential nephrotoxicity, especially in patients with pre-existing renal impairment or during prolonged therapy.

Timing: Prior to initiation of therapy, especially for prolonged courses.

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Routine Monitoring

Bowel movements/Stool consistency

Frequency: Daily during therapy and for several weeks post-therapy

Target: Normal bowel habits

Action Threshold: Onset of severe, persistent diarrhea, abdominal pain, or fever; consider C. difficile testing.

Liver Function Tests (LFTs)

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

Target: Within normal limits or stable baseline

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

Renal Function Tests (BUN, Creatinine)

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

Target: Within normal limits or stable baseline

Action Threshold: Significant elevation of BUN/creatinine; consider dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically (e.g., weekly or bi-weekly) for prolonged therapy (>10 days).

Target: Within normal limits

Action Threshold: Significant decrease in WBC, neutrophil, or platelet counts; consider discontinuation.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Nausea
  • Vomiting
  • Skin rash or itching
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual bleeding or bruising
  • Signs of allergic reaction (e.g., swelling of face/throat, difficulty breathing)

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. Limited data from human pregnancies suggest no increased risk of major birth defects or miscarriage. 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; no specific risks identified.
Third Trimester: Generally considered safe; no specific risks identified.
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Lactation

Clindamycin is excreted into breast milk in small amounts. The American Academy of Pediatrics considers clindamycin to be 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) - Low risk of adverse effects in breastfed infants. Monitor for GI upset or candidiasis.
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Pediatric Use

Clindamycin is generally safe and effective for use in pediatric patients, including neonates (with appropriate dose adjustments for age and weight). Close monitoring for adverse effects, particularly diarrhea and pseudomembranous colitis, is crucial. Dosage should be carefully calculated based on body weight.

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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 renal and hepatic function, and observe closely for diarrhea and other adverse effects.

Clinical Information

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Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria, making it a valuable agent for intra-abdominal, gynecological, and skin/soft tissue infections.
  • The most significant adverse effect is *Clostridioides difficile*-associated diarrhea (CDAD), which can range from mild diarrhea to severe, life-threatening pseudomembranous colitis. This can occur during therapy or up to several weeks after discontinuation.
  • Rapid IV infusion can lead to hypotension and cardiac arrest; infuse over at least 10-60 minutes (typically 30 minutes for 600 mg).
  • Clindamycin does not penetrate the CNS well, so it is not a primary choice for CNS infections unless used in combination with other agents or for specific pathogens (e.g., toxoplasmosis).
  • Consider clindamycin as an alternative for penicillin-allergic patients, especially for dental or skin infections, but be aware of potential cross-reactivity with lincomycin.
  • Resistance to clindamycin can develop, particularly in staphylococci (inducible clindamycin resistance, D-test positive). Susceptibility testing is important.
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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/cilastatin, meropenem)
  • Moxifloxacin (for some anaerobic and aerobic infections)
  • Vancomycin (for MRSA or severe Gram-positive infections where clindamycin is not appropriate)
  • Linezolid (for MRSA or VRE)
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Cost & Coverage

Average Cost: Not available (varies widely by supplier and contract) per 600mg/50ml 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 or take someone else's medication. 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 best disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may have additional patient information leaflets, so it is a good idea to check with your pharmacist. 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 was taken to ensure prompt and effective treatment.