Clindamycin Ped 75mg/5ml Sol 100ml

Manufacturer AUROBINDO PHARMA 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.
đŸˇī¸
Drug Class
Antibiotic
đŸ§Ŧ
Pharmacologic Class
Lincosamide antibiotic
🤰
Pregnancy Category
Category B
✅
FDA Approved
Jul 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Clindamycin is an antibiotic medicine used to treat various bacterial infections. It works by stopping the growth of bacteria. It's important to take it exactly as prescribed, even if you start feeling better, to ensure the infection is fully cleared.
📋

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 this side effect.

Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully 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 and freezing. Keep it in a dry place, away from the bathroom. 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 dose.
💡

Lifestyle & Tips

  • Take with a full glass of water to prevent esophageal irritation.
  • May be taken with or without food. If stomach upset occurs, take with food.
  • Do not lie down for at least 30 minutes after taking the dose.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Do not share this medication with others.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

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

Condition-Specific Dosing:

mildToModerateInfections: 150-300 mg orally every 6 hours
severeInfections: 300-450 mg orally every 6 hours
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for routine use; use with caution and dose adjustment based on gestational age and weight if absolutely necessary (e.g., 10-15 mg/kg/day divided every 6-8 hours, adjusted for prematurity).
Infant: 8-25 mg/kg/day orally divided into 3 or 4 equal doses (e.g., 2-6.25 mg/kg every 6 hours or 2.67-8.33 mg/kg every 8 hours).
Child: 8-25 mg/kg/day orally divided into 3 or 4 equal doses (e.g., 2-6.25 mg/kg every 6 hours or 2.67-8.33 mg/kg every 8 hours). Max 450 mg/dose.
Adolescent: Same as adult dosing, 150-450 mg orally every 6-8 hours.
âš•ī¸

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.
Dialysis: Clindamycin is not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose is needed after dialysis.

Hepatic Impairment:

Mild: No dosage adjustment generally required.
Moderate: No dosage adjustment generally required.
Severe: For severe hepatic impairment, consider dosage reduction or extending dosing interval (e.g., every 8-12 hours) and monitor liver function tests. Plasma half-life may be prolonged.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible bacteria. This binding inhibits the initiation of peptide chains and interferes with peptidyl transferase activity, leading to a bacteriostatic effect.
📊

Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.8-1.1 L/kg
ProteinBinding: Approximately 92-94%
CnssPenetration: Limited (does not achieve therapeutic levels in CSF, even with inflamed meninges)

Elimination:

HalfLife: 2-3 hours (adults); slightly longer in neonates and patients with severe hepatic impairment.
Clearance: Not available (varies)
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)
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within 30 minutes for IV, within 1 hour for oral)
PeakEffect: 1 hour (oral)
DurationOfAction: 6-8 hours (related to dosing interval)

Safety & Warnings

âš ī¸

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 is important to consider the diagnosis of pseudomembranous colitis (Clostridium difficile-associated diarrhea [CDAD]) in patients who develop diarrhea subsequent to the administration of antimicrobial agents. Because clindamycin has been shown to be associated with a higher incidence of colitis than many other antibiotics, the physician should consider whether the infection is of such a nature that the less toxic alternatives (e.g., erythromycin) are not appropriate.
âš ī¸

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 medical attention immediately:

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

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 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. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe, watery diarrhea or bloody stools (even weeks after stopping the medication)
  • Severe stomach pain or cramps
  • Fever
  • Rash, itching, or hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bruising or bleeding
📋

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 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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
âš ī¸

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 are 60 years or older, it is crucial to use this medication with caution, as you may be more susceptible to side effects.

Before taking this drug, inform your doctor if you are pregnant, planning 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.
🆘

Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is generally supportive, as clindamycin is not readily removed by dialysis.

Drug Interactions

🔴

Major Interactions

  • Neuromuscular blocking agents (e.g., atracurium, rocuronium, vecuronium): Clindamycin may potentiate the neuromuscular blocking action, leading to increased or prolonged respiratory depression/paralysis.
  • Erythromycin: Antagonistic effect; avoid concomitant use.
🟡

Moderate Interactions

  • Kaolin-pectin antidiarrheals: May decrease oral absorption of clindamycin; administer clindamycin at least 2 hours before kaolin-pectin.
  • Oral typhoid vaccine (Ty21a): Antibiotics may inactivate the live bacterial vaccine; avoid concurrent use.
  • Warfarin and other vitamin K antagonists: May enhance anticoagulant effects (increased INR/bleeding risk); monitor INR closely.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Patient history (allergies, GI disorders, renal/hepatic function)

Rationale: To identify contraindications, precautions, and potential risk factors for adverse effects (e.g., C. difficile-associated diarrhea).

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Stool frequency and consistency

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

Target: Normal bowel habits

Action Threshold: Onset of significant diarrhea, especially if severe, persistent, or bloody; consider C. difficile testing.

Renal and hepatic function tests (BUN, creatinine, AST, ALT)

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

Target: Within normal limits or stable baseline

Action Threshold: Significant elevation indicating organ dysfunction; consider dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically, especially during prolonged therapy.

Target: Within normal limits

Action Threshold: Significant changes (e.g., leukopenia, neutropenia, thrombocytopenia); consider discontinuation.

đŸ‘ī¸

Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Bloody stools
  • Rash or hives
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness

Special Patient Groups

🤰

Pregnancy

Clindamycin is generally considered safe for use during pregnancy when clearly needed. Animal studies have not shown harm to the fetus, and human data suggest no increased risk of major birth defects or miscarriage. However, use only if clearly indicated.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of birth defects.
Second Trimester: No evidence of increased risk of adverse outcomes.
Third Trimester: No evidence of increased risk of adverse outcomes.
🤱

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 such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: Low risk, but monitor for GI upset (diarrhea, vomiting), candidiasis, or rash.
đŸ‘ļ

Pediatric Use

Clindamycin oral solution is commonly used in pediatric patients. Dosing is weight-based. Neonates and infants may have prolonged half-lives due to immature hepatic and renal function, requiring careful monitoring and potential dose adjustment. The oral solution contains alcohol and/or artificial sweeteners; consider specific product formulation for very young infants.

👴

Geriatric Use

No specific dosage adjustment is required based solely on age. However, elderly patients may be more susceptible to severe C. difficile-associated diarrhea and should be monitored closely. Consider age-related decline in renal/hepatic function if present.

Clinical Information

💎

Clinical Pearls

  • Clindamycin is highly effective against anaerobic bacteria, making it a valuable agent for aspiration pneumonia, intra-abdominal infections, and skin/soft tissue infections caused by anaerobes.
  • It is also used for certain Gram-positive aerobic infections, including methicillin-susceptible Staphylococcus aureus (MSSA) and some methicillin-resistant Staphylococcus aureus (MRSA) strains (after D-test to confirm susceptibility).
  • The most significant adverse effect is C. difficile-associated diarrhea (CDAD), which can range from mild diarrhea to fatal pseudomembranous colitis. Patients should be counseled to report any diarrhea immediately.
  • Oral clindamycin should be taken with a full glass of water to prevent esophageal irritation and ulceration.
  • Due to its limited CNS penetration, clindamycin is generally not recommended for CNS infections unless used in combination with other agents that do penetrate the CNS (e.g., for toxoplasmosis in HIV patients).
🔄

Alternative Therapies

  • Metronidazole (for anaerobic infections)
  • Amoxicillin/clavulanate (for mixed aerobic/anaerobic infections)
  • Linezolid (for resistant Gram-positive infections, including MRSA)
  • Vancomycin (for severe Gram-positive infections, including MRSA)
  • Doxycycline (for certain skin/soft tissue infections, including some MRSA)
💰

Cost & Coverage

Average Cost: Varies widely (e.g., $20-$100+) per 100ml bottle of 75mg/5ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
📚

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 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 information about the medication taken, the amount, and the time it happened.