Clindamycin 150mg Capsules

Manufacturer AUROBINDO Active Ingredient Clindamycin Capsules(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
Aug 1969
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin is an antibiotic used to treat various bacterial infections, including skin infections, bone and joint infections, and certain types of pneumonia. It works by stopping the growth of bacteria. It is important to take the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

You can take this medication with or without food. If it causes stomach upset, taking it with food may help. To minimize the risk of throat irritation and ulcers, take your medication with a full glass of water (6 to 8 ounces or 200 to 250 mL). After taking your medication, remain upright for at least 30 minutes to reduce the risk of esophageal irritation.

Storing and Disposing of Your Medication

Store your medication at room temperature, avoiding refrigeration and freezing. Keep it in a dry place, away from bathrooms and moisture. Ensure that all medications are kept out of the reach of children and pets, and store them in a safe and secure location.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's 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 each dose with a full glass of water to prevent irritation of the esophagus.
  • May be taken with or without food, but taking with food may help reduce stomach upset.
  • Do not lie down for at least 30 minutes after taking the capsule.
  • Finish the entire course of medication, even if symptoms improve.
  • Do not share this medication with others.
  • Avoid alcohol if it causes stomach upset, though no direct interaction.

Dosing & Administration

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Adult Dosing

Standard Dose: 150 mg to 450 mg orally every 6 to 8 hours
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
streptococcal_pharyngitis: 300 mg orally twice daily for 10 days
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Pediatric Dosing

Neonatal: Not established (use caution, consider IV/IM)
Infant: 8-16 mg/kg/day orally divided into 3 or 4 equal doses
Child: 8-25 mg/kg/day orally divided into 3 or 4 equal doses
Adolescent: Same as adult dosing (150-450 mg orally every 6-8 hours)
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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, but monitor for accumulation in severe impairment (CrCl < 30 mL/min)
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 reduction may be necessary in patients with severe hepatic disease; monitor liver function tests and serum clindamycin levels if available.

Pharmacology

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Mechanism of Action

Clindamycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby preventing peptide bond formation and inhibiting the early stages of protein synthesis. It is primarily bacteriostatic but may be bactericidal against highly susceptible organisms at high concentrations.
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Pharmacokinetics

Absorption:

Bioavailability: 90%
Tmax: 45-60 minutes (oral capsule)
FoodEffect: Food does not significantly alter the extent of absorption, but may delay the rate of absorption (Tmax).

Distribution:

Vd: 0.6-1.2 L/kg
ProteinBinding: 92-94%
CnssPenetration: Limited (does not achieve therapeutic levels in CSF even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (adults); 3-4 hours (neonates)
Clearance: Not readily available as a single value, but primarily hepatic metabolism and renal/biliary excretion.
ExcretionRoute: Approximately 10% excreted in urine as active drug or 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 (within 1 hour for oral absorption)
PeakEffect: Within 1 hour (oral)
DurationOfAction: 6-8 hours (based on dosing frequency)
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. Therefore, 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. Clostridium 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. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
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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 weight gain
Joint pain or swelling
Yellowing of the skin or eyes (jaundice)
Vaginal itching or discharge
Throat irritation
Coughing up blood
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Severe Skin Reactions

In rare cases, severe skin reactions can occur anywhere from 1 hour to several weeks after receiving this medication. These reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), 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 the 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. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:

Diarrhea
Stomach pain
Upset stomach
Vomiting
* Bad taste in the 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 (even weeks after stopping the medication)
  • Severe stomach pain or cramping
  • Rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
  • Sore throat, fever, or chills (signs of new infection or blood problems)
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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 (prescription, over-the-counter, natural products, and vitamins) and health conditions 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 issues. Do not initiate, discontinue, or modify 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 work and other laboratory tests 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.

If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient.

Adults 60 years of age and older should exercise caution when using this drug, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor 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:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Treatment is generally supportive as there is no specific antidote.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin may enhance the neuromuscular blocking effect, leading to prolonged respiratory depression.
  • Erythromycin: Antagonistic effect; should not be administered concurrently.
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Moderate Interactions

  • Kaolin-pectin antidiarrheals: May decrease oral absorption of clindamycin; administer clindamycin at least 2 hours before kaolin-pectin.
  • Oral typhoid vaccine: Antibiotics may reduce the therapeutic effect of live bacterial vaccines.
  • Warfarin and other vitamin K antagonists: May enhance the anticoagulant effect (increased INR/bleeding risk); monitor INR closely.
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Minor Interactions

  • Cyclosporine: May decrease cyclosporine levels; monitor cyclosporine levels.

Monitoring

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Baseline Monitoring

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, particularly for prolonged courses.

Complete Blood Count (CBC)

Rationale: To establish baseline hematologic status, as rare cases of transient neutropenia and agranulocytosis have been reported.

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

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Routine Monitoring

Stool for C. difficile toxin

Frequency: As needed, if diarrhea develops

Target: Negative

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

Renal and hepatic function tests

Frequency: Periodically during prolonged therapy (e.g., every 1-2 weeks)

Target: Within normal limits

Action Threshold: Significant elevations may warrant dose adjustment or discontinuation.

CBC with differential

Frequency: Periodically during prolonged therapy (e.g., every 1-2 weeks)

Target: Within normal limits

Action Threshold: Significant decreases in WBC or neutrophil count may warrant discontinuation.

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Symptom Monitoring

  • Severe or persistent diarrhea (especially watery or bloody stools)
  • Abdominal pain or cramping
  • Fever
  • Rash, itching, hives (signs of allergic reaction)
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Sore throat, fever, or other signs of infection (may indicate blood dyscrasias)

Special Patient Groups

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Pregnancy

Clindamycin is generally considered safe for use during pregnancy (Category B). Animal reproduction studies have not demonstrated a risk to the fetus, and there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed in human studies.
Second Trimester: No increased risk of major birth defects observed.
Third Trimester: No increased risk of major birth defects observed.
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Lactation

Clindamycin is excreted into breast milk. While generally considered compatible with breastfeeding, monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions. The amount transferred is small.

Infant Risk: L3 (Moderate risk - use with caution, monitor infant)
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Pediatric Use

Clindamycin capsules are generally safe and effective for pediatric patients. Dosage is based on body weight. Neonates and infants should be monitored closely due to immature renal and hepatic function, which may prolong half-life. Oral solution is preferred for younger children who cannot swallow capsules.

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Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients may be more susceptible to severe adverse reactions, particularly C. difficile-associated diarrhea. Monitor renal and hepatic function, and observe for adverse effects.

Clinical Information

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Clinical Pearls

  • Always warn patients about the risk of C. difficile-associated diarrhea (CDAD), which can occur during or even weeks after therapy. Instruct them to seek immediate medical attention if they develop severe, watery, or bloody diarrhea.
  • Advise patients to take clindamycin capsules with a full glass of water to prevent esophageal irritation and ulceration.
  • Clindamycin is effective against many Gram-positive bacteria (including MRSA in some cases) and most anaerobic bacteria, making it useful for skin and soft tissue infections, intra-abdominal infections, and gynecological infections.
  • It is not effective against Gram-negative aerobic bacteria.
  • Consider clindamycin as an alternative for penicillin-allergic patients, but be aware of potential cross-reactivity with lincomycin.
  • For severe infections, IV clindamycin is often used initially, with a step-down to oral capsules once the patient is stable and able to tolerate oral intake.
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Vancomycin (for C. difficile infection, MRSA)
  • Linezolid (for MRSA, VRE)
  • Doxycycline (for skin/soft tissue infections, some MRSA)
  • Trimethoprim-sulfamethoxazole (for skin/soft tissue infections, some MRSA)
  • Beta-lactam antibiotics (e.g., penicillin, amoxicillin, cephalexin - depending on susceptibility and infection type)
  • Macrolides (e.g., azithromycin, clarithromycin - for some respiratory or skin infections, but resistance is common)
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (150mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. 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, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.