Cleocin 75mg/5ml Granules100ml

Manufacturer PFIZER Active Ingredient Clindamycin Oral Solution(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 medicine used to treat many different types of bacterial infections, such as skin infections, bone infections, and infections in the lungs or abdomen. It works by stopping the growth of bacteria.
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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. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.

Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, carefully measure the liquid using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.

Storing and Disposing of Your Medication

Store this medication at room temperature, avoiding refrigeration or freezing. Keep it in a dry place, away from bathrooms. If you have not used the entire contents of the medication within 2 weeks, discard any remaining amount.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take this medicine exactly as prescribed by your doctor, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to the infection coming back or becoming harder to treat.
  • You can take clindamycin with or without food, but taking it with a full glass of water may help prevent irritation of the esophagus.
  • Shake the oral solution well before each use.
  • Use the provided measuring device to ensure you get the correct dose.
  • Do not use antidiarrhea medicines without talking to your doctor if you develop diarrhea, as this could worsen a serious side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: 150 mg to 450 mg orally every 6 to 8 hours, depending on the severity of the infection.
Dose Range: 150 - 450 mg

Condition-Specific Dosing:

serious_infections: 300 mg orally every 6 hours
more_severe_infections: 450 mg orally every 6 hours
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Pediatric Dosing

Neonatal: Not established for routine use; use with caution and monitor closely due to immature renal/hepatic function.
Infant: 8 to 25 mg/kg/day orally in 3 or 4 equally divided doses.
Child: 8 to 25 mg/kg/day orally in 3 or 4 equally divided doses.
Adolescent: 8 to 25 mg/kg/day orally in 3 or 4 equally divided doses (or adult dosing if weight allows).
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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, but monitor for accumulation in severe renal impairment (CrCl < 30 mL/min).
Dialysis: Clindamycin is not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No dosage adjustment generally necessary.
Moderate: No dosage adjustment generally necessary, but monitor for accumulation in patients with severe hepatic disease.
Severe: Consider dosage reduction or increased dosing interval in patients with severe hepatic disease and significant accumulation. Monitor liver function tests.

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 assembly of ribosomal subunits, thereby inhibiting bacterial growth.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 45-60 minutes (oral solution)
FoodEffect: Minimal effect on absorption, but may delay Tmax slightly.

Distribution:

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

Elimination:

HalfLife: 2-3 hours (may be prolonged in severe renal or hepatic impairment)
Clearance: Not available (variable)
ExcretionRoute: Urine (10-20% as active drug and metabolites), Feces (4-10% as active drug and metabolites)
Unchanged: Approximately 10% (urine), 4% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes to hours for clinical effect)
PeakEffect: Within 1 hour after oral administration
DurationOfAction: 6-8 hours (based on dosing interval)

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 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 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 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 significant 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

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 internal organs. Seek immediate medical help 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 discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:

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 (which may be bloody or contain mucus)
  • Severe stomach pain or cramps
  • Fever
  • Rash, hives, or itching
  • Swelling of your face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of your 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 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.

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, be sure to follow your doctor's instructions for regular blood work and other laboratory tests.

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.

If you are 60 years or older, exercise caution when using this drug, 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 discuss the potential 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:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive, as clindamycin is not readily removed by hemodialysis or peritoneal dialysis.

Drug Interactions

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Contraindicated Interactions

  • Not applicable (no absolute contraindications other than hypersensitivity)
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Major Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Clindamycin may enhance the neuromuscular blocking effect, leading to prolonged respiratory depression.
  • Erythromycin: Antagonistic effect; avoid concomitant use as they compete for the same ribosomal binding site.
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Moderate Interactions

  • Kaolin-pectin: May decrease the absorption of oral clindamycin; administer clindamycin at least 2 hours before kaolin-pectin.
  • Warfarin and other Vitamin K antagonists: May increase INR and risk of bleeding; monitor INR closely.
  • Live bacterial vaccines (e.g., typhoid vaccine): Antibiotics may reduce the therapeutic effect of live bacterial vaccines.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Patient history for gastrointestinal disease (especially colitis)

Rationale: To assess risk for C. difficile-associated diarrhea (CDAD).

Timing: Prior to initiation of therapy.

Liver function tests (LFTs) and Renal function tests (RFTs)

Rationale: For patients with pre-existing hepatic or renal impairment, or for prolonged therapy, to assess baseline organ function.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Stool for C. difficile toxin

Frequency: As needed, if diarrhea develops during or after therapy.

Target: Negative

Action Threshold: Positive result with symptoms warrants discontinuation of clindamycin and initiation of appropriate treatment for CDAD.

Complete Blood Count (CBC)

Frequency: Periodically, for patients on prolonged therapy (e.g., >10 days).

Target: Within normal limits

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

Liver function tests (LFTs)

Frequency: Periodically, for patients on prolonged therapy or with pre-existing hepatic impairment.

Target: Within normal limits

Action Threshold: Significant elevations may warrant discontinuation.

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Bloody or mucoid stools
  • Skin rash or hives
  • Itching
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, or tongue
  • Yellowing of skin or eyes (jaundice)

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 there are no adequate and well-controlled studies in pregnant women, but human experience suggests no increased risk of birth defects.

Trimester-Specific Risks:

First Trimester: Generally considered safe; no increased risk of major birth defects observed.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Clindamycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L2 - Safer). Monitor breastfed infants for potential adverse effects.

Infant Risk: Low risk. Potential for disruption of infant gut flora (leading to diarrhea or candidiasis), or allergic reaction. Observe infant for diarrhea, candidiasis (thrush, diaper rash), or rash.
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Pediatric Use

Clindamycin oral solution is commonly used in pediatric patients. Dosing is weight-based. Caution should be exercised in neonates and infants due to immature renal and hepatic function, and careful monitoring is advised.

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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 adverse gastrointestinal effects.

Clinical Information

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Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria and many Gram-positive aerobes, making it useful for skin and soft tissue infections, dental infections, and intra-abdominal infections.
  • The most significant adverse effect is C. difficile-associated diarrhea (CDAD), which can range from mild diarrhea to fatal pseudomembranous colitis. This can occur during or even weeks after therapy.
  • Oral clindamycin can cause esophageal irritation; advise patients to take it with a full glass of water.
  • It is a common alternative for penicillin-allergic patients, especially for dental infections or certain skin infections.
  • Resistance to clindamycin can develop, particularly in Staphylococcus aureus (inducible clindamycin resistance, D-test should be performed).
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Linezolid (for resistant Gram-positive infections)
  • Doxycycline (for skin/soft tissue infections, some respiratory infections)
  • Macrolides (e.g., Azithromycin, Clarithromycin - for respiratory or skin infections, but resistance patterns differ)
  • Beta-lactam antibiotics (e.g., Amoxicillin, Cephalexin - depending on the specific infection and susceptibility)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100 per 100ml bottle of 75mg/5ml oral solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.