Clindamycin 75mg Capsules

Manufacturer MICRO 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
Lincosamide antibiotic
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Pharmacologic Class
Protein synthesis inhibitor
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Pregnancy Category
Category B
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FDA Approved
Jul 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 various bacterial infections, such as skin infections, respiratory infections, and gynecological infections. It works by stopping the growth of bacteria.
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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, away from moisture. Do not refrigerate or freeze your medication. Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom. Keep all medications out of the reach of children and pets to ensure their safety.

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 dose.
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Lifestyle & Tips

  • Take each dose with a full glass of water to prevent irritation of the esophagus.
  • Complete the full course of medication as prescribed, even if you start feeling better. Stopping early can lead to resistant bacteria.
  • Do not take antidiarrheal medications without consulting your doctor if you develop diarrhea, as this could worsen C. difficile infection.
  • Inform your doctor if you are taking any other medications, especially muscle relaxants or other antibiotics.

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. 75 mg is a low dose, typically not standard for most adult infections but may be used for specific indications or dose titration.
Dose Range: 75 - 450 mg

Condition-Specific Dosing:

mild_to_moderate_infections: 150 mg to 300 mg orally every 6 hours
severe_infections: 300 mg to 450 mg orally every 6 to 8 hours
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for premature infants may be 10-15 mg/kg/day divided every 8-12 hours, consult specialist.
Infant: 8 to 16 mg/kg/day orally divided into 3 or 4 equal doses (minimum 37.5 mg three times daily for infants weighing 10 kg or less)
Child: 8 to 25 mg/kg/day orally divided into 3 or 4 equal doses (maximum 450 mg per dose)
Adolescent: Same as adult dosing, typically 150 mg to 450 mg orally every 6 to 8 hours depending on weight and severity.
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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 mild to moderate renal impairment. For severe renal impairment (CrCl < 30 mL/min), consider extending dosing interval to every 8-12 hours, though not strictly necessary for most patients.
Dialysis: Clindamycin is 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: Consider dosage reduction or increased dosing interval in patients with severe hepatic impairment due to prolonged half-life. 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 early stages of protein synthesis, leading to a bacteriostatic effect.
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Pharmacokinetics

Absorption:

Bioavailability: 90% (oral)
Tmax: 0.75 - 1 hour
FoodEffect: Food does not significantly affect the absorption of clindamycin capsules, but peak plasma concentrations may be delayed.

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: 2.0 - 3.0 hours (prolonged in severe renal or hepatic impairment)
Clearance: Not available
ExcretionRoute: Primarily fecal (60-70%), renal (10-20%)
Unchanged: Less than 10% (urine), 3.6% (feces)
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Pharmacodynamics

OnsetOfAction: Rapid (within 30 minutes to 1 hour for oral absorption)
PeakEffect: 1 hour (oral)
DurationOfAction: 6-8 hours (based on dosing interval)

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, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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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 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, 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, or bloody diarrhea (even weeks after stopping the medication)
  • Severe abdominal pain or cramping
  • Fever
  • Rash, itching, or hives
  • Difficulty breathing or swallowing
  • Swelling of the face, lips, tongue, or throat
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Unusual bleeding or bruising
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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 undergo regular blood tests and other laboratory examinations as directed by your doctor.

This medication is not intended to treat the common cold. Do not exceed the prescribed duration of use, as this 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.

Individuals aged 60 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 are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the well-being of both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain

What to Do:

There is no specific antidote for clindamycin overdose. Treatment is supportive. In case of suspected overdose, immediately contact a poison control center (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, succinylcholine, vecuronium): Clindamycin may enhance the neuromuscular blocking effects, leading to respiratory depression or paralysis.
  • Erythromycin: Antagonism in vitro; concurrent use is not recommended.
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Moderate Interactions

  • Live bacterial vaccines (e.g., Typhoid vaccine, live): Antibiotics may reduce the therapeutic effect of live bacterial vaccines.
  • Kaolin-pectin antidiarrheals: May decrease absorption of clindamycin if administered concurrently (separate by at least 2 hours).

Monitoring

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Baseline Monitoring

Baseline liver and kidney function tests (AST, ALT, bilirubin, BUN, creatinine)

Rationale: To assess baseline organ function, especially if prolonged therapy or pre-existing impairment is suspected.

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

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Routine Monitoring

Frequency and consistency of bowel movements

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

Target: Normal bowel habits

Action Threshold: Onset of significant diarrhea, abdominal pain, or fever (suggestive of C. difficile-associated diarrhea)

Liver function tests (AST, ALT)

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

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x upper limit of normal)

Renal function tests (BUN, creatinine)

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

Target: Within normal limits

Action Threshold: Significant elevation

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Symptom Monitoring

  • Severe or persistent diarrhea (especially if bloody or watery)
  • Abdominal pain or cramping
  • Fever
  • Rash or hives
  • Signs of allergic reaction (e.g., swelling of face/lips/tongue, difficulty breathing)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness

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 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: No increased risk of major birth defects observed.
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 in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk L2 - Likely Compatible). Monitor breastfed infants for changes in bowel habits (e.g., diarrhea), rash, or candidiasis (thrush, diaper rash).

Infant Risk: Low risk of adverse effects. Potential for disruption of infant gut flora, leading to diarrhea or candidiasis.
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Pediatric Use

Dosing is weight-based and should be carefully calculated. Neonates and infants may have immature renal and hepatic function, requiring careful monitoring. The 75mg capsule strength is often suitable for pediatric dosing.

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Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients may be more susceptible to adverse effects, particularly C. difficile-associated diarrhea, and may have age-related decline in renal or hepatic function, necessitating careful monitoring.

Clinical Information

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Clinical Pearls

  • Always advise patients to take clindamycin capsules with a full glass of water to prevent esophageal irritation and ulceration.
  • Emphasize the importance of completing the entire course of therapy, even if symptoms improve, to prevent bacterial resistance and recurrence of infection.
  • Educate 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 severe, watery, or bloody diarrhea develops.
  • Clindamycin is not effective against viral infections.
  • It is a good alternative for patients with penicillin allergies, especially for anaerobic infections or certain skin/soft tissue infections.
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Vancomycin (for severe C. difficile infection, not as a general alternative)
  • Linezolid (for resistant Gram-positive infections)
  • Doxycycline (for certain skin/soft tissue infections)
  • Amoxicillin/Clavulanate (for mixed aerobic/anaerobic infections)
  • Cephalexin (for skin and soft tissue infections)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 capsules (75mg)
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'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 details. If you have any questions or concerns about this 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 information about the medication taken, the amount, and the time it happened.