Clindamycin 300mg Capsules

Manufacturer AUROBINDO Active Ingredient Clindamycin Capsules(klin da MYE sin) Pronunciation KLIN-duh-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 (50S ribosomal subunit)
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Pregnancy Category
Category B
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FDA Approved
Jul 1969
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clindamycin is an antibiotic that stops the growth of bacteria. It's used to treat various bacterial infections, including those of the skin, bones, joints, lungs, and female reproductive organs. It works by preventing bacteria from making the proteins they need to multiply.
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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 the full course of medication as prescribed, even if you feel better. Stopping early can lead to resistant bacteria.
  • Take each dose with a full glass of water to prevent irritation of the esophagus.
  • Clindamycin can be taken with or without food, but taking it with food may help reduce stomach upset.
  • Do not lie down for at least 30 minutes after taking a dose to prevent esophageal irritation.
  • Avoid antidiarrheal medications (like Imodium) if you develop severe diarrhea, as this can worsen a serious side effect called C. difficile colitis. Contact your doctor immediately if you experience severe diarrhea.

Dosing & Administration

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Adult Dosing

Standard Dose: 150-450 mg orally every 6-8 hours
Dose Range: 150 - 450 mg

Condition-Specific Dosing:

mildToModerateInfections: 150-300 mg orally every 6 hours
severeInfections: 300-450 mg orally every 6 hours
bacterialVaginosis: 300 mg orally twice daily for 7 days (extended-release vaginal ovule also available)
acneVulgaris: 150-300 mg orally twice daily (often topical preferred)
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Pediatric Dosing

Neonatal: Not established for oral capsules; IV/IM dosing typically 15-20 mg/kg/day in 3-4 divided doses.
Infant: 8-25 mg/kg/day orally in 3 or 4 divided doses (max 450 mg/dose)
Child: 8-25 mg/kg/day orally in 3 or 4 divided doses (max 450 mg/dose)
Adolescent: 8-25 mg/kg/day orally in 3 or 4 divided doses (max 450 mg/dose or adult dose if higher)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment generally needed.
Moderate: No adjustment generally needed.
Severe: No adjustment generally needed for mild to moderate infections. For severe infections, consider extending dosing interval to every 8-12 hours.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No adjustment generally needed.
Moderate: No adjustment generally needed.
Severe: Consider dose reduction or increased dosing interval (e.g., every 8-12 hours) in patients with severe hepatic impairment and concomitant severe renal impairment. Monitor liver function tests.

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: Approximately 90%
Tmax: 0.75-1 hour (oral capsule)
FoodEffect: Food does not significantly affect the extent of absorption, but may slightly delay the rate of absorption (Tmax).

Distribution:

Vd: 0.8-1.3 L/kg
ProteinBinding: Approximately 93%
CnssPenetration: Limited (does not achieve therapeutic levels in CSF, even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (normal renal/hepatic function); may be prolonged in severe renal or hepatic impairment.
Clearance: Approximately 30 L/hr (total body clearance)
ExcretionRoute: Primarily via bile and feces (active metabolites and small amount of unchanged drug); approximately 10% excreted in urine as active drug or metabolites.
Unchanged: Approximately 10% (urine), 3.6% (feces)
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Pharmacodynamics

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

Safety & Warnings

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BLACK BOX WARNING

Clindamycin therapy has been associated with severe colitis which may result in death. It should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It is important to consider the diagnosis of colitis in patients who develop diarrhea subsequent to the administration of clindamycin. Because clindamycin has been shown to be associated with severe colitis, its use 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 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 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 has been recommended in cases of severe diarrhea. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition and should not be used. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 125 mg to 500 mg orally 3 or 4 times a day for 7 to 10 days. Cholestyramine resin or colestipol resin have been shown to bind the toxin in vitro. When these resins are administered concomitantly with vancomycin, it may be advisable to separate the time of administration of each drug. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin.
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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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ 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 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 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 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, 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 cramps
  • Rash, itching, or hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual bruising or bleeding
  • Signs of a new infection (e.g., fever, sore throat that doesn't go away)
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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 treatments and health issues. Never start, stop, 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 may increase the risk of developing 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 experiencing 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:

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 significantly removed by hemodialysis or peritoneal dialysis.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin may enhance the neuromuscular blocking action, leading to increased or prolonged respiratory depression/paralysis.
  • Erythromycin: Antagonistic effect due to competition for the same ribosomal binding site. Avoid concomitant use.
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Moderate Interactions

  • Kaolin-pectin antidiarrheals: May reduce absorption of oral clindamycin. Administer clindamycin at least 2 hours before kaolin-pectin.
  • Oral typhoid vaccine (Ty21a): Antibiotics may inactivate the live bacterial vaccine. Avoid clindamycin for at least 24 hours before and after vaccine administration.
  • Warfarin and other vitamin K antagonists: May enhance anticoagulant effect (increased INR/bleeding risk). Monitor INR closely.

Monitoring

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Baseline Monitoring

Baseline liver and kidney function tests (LFTs, SCr, BUN)

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

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 during or after therapy.

Target: Negative

Action Threshold: Positive test with symptoms requires discontinuation and appropriate treatment for CDAD.

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, for prolonged therapy (e.g., >10-14 days) or in patients with pre-existing hepatic impairment.

Target: Within normal limits

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

Renal function tests (SCr, BUN)

Frequency: Periodically, for prolonged therapy or in patients with pre-existing renal impairment.

Target: Within normal limits

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

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Symptom Monitoring

  • Severe or persistent diarrhea (especially if bloody or watery)
  • Abdominal pain or cramping
  • Fever
  • Rash or hives
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual fatigue or weakness

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 clinical experience suggests no increased risk.

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, but monitor the infant for potential adverse effects.

Infant Risk: Low risk. Potential for altered bowel flora (diarrhea, candidiasis), but serious adverse effects are rare. Observe infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reaction.
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Pediatric Use

Dosing is weight-based. Oral capsules may not be suitable for very young children due to difficulty swallowing. Monitor for C. difficile-associated diarrhea, as children are also susceptible.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, elderly patients may have reduced renal or hepatic function, which could necessitate dose adjustments. They may also be more susceptible to C. difficile-associated diarrhea. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria, making it a common choice for intra-abdominal infections, pelvic infections, and aspiration pneumonia.
  • It has good penetration into bone and soft tissue, making it useful for osteomyelitis and skin/soft tissue infections.
  • The most significant adverse effect is Clostridium difficile-associated diarrhea (CDAD), which can range from mild diarrhea to severe, life-threatening pseudomembranous colitis. This can occur during or even weeks after therapy.
  • Due to the risk of esophageal irritation, advise patients to take capsules with a full glass of water and remain upright for at least 30 minutes after administration.
  • Clindamycin is often used in combination with other antibiotics for polymicrobial infections (e.g., with an aminoglycoside for severe abdominal infections).
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Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Amoxicillin/clavulanate (for mixed aerobic/anaerobic infections)
  • Moxifloxacin (for anaerobic and aerobic coverage)
  • Linezolid (for resistant Gram-positive infections, including MRSA)
  • Doxycycline (for skin/soft tissue infections, some respiratory infections)
  • Vancomycin (for severe Gram-positive infections, including MRSA)
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (300mg)
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 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 details about the medication taken, the amount, and the time it occurred.