Clindamycin

Clindamycin is an antibiotic agent belonging to the pharmacological class of Lincosamide Antibiotics

Clindamycin has been approved to relieve symptoms and also for the treatment and maintenance of Anthrax, Babesiosis, Bacterial vaginosis, Bite wound infection, prophylaxis of high-risk bite or treatment, Diabetic foot infection, mild to moderate, Gingivitis, acute simple, plaque-associated, Hidradenitis suppurativa, Malaria, treatment, Mastitis, lactational, Neutropenic fever, empiric therapy for low-risk patients with cancer, Osteomyelitis, Pelvic inflammatory disease, severe, Pneumocystis jirovecii pneumonia, treatment, Pneumonia, Postpartum endometritis, Prosthetic joint infection, Rhinosinusitis, acute bacterial, Septic arthritis due to S. aureus, Skin and soft tissue infection, Streptococcus, group A, Streptococcus, group B, maternal prophylaxis for prevention of neonatal disease, Surgical prophylaxis, Toxic shock syndrome, toxin production suppression, Toxoplasma gondii encephalitis and pneumonitis, Acne vulgaris, Bacterial vaginosis, Hidradenitis suppurativa and Rosacea.

Clindamycin is well-absorbed after oral administration, with peak plasma concentrations achieved within 1 to 3 hours. The bioavailability of oral Clindamycin is approximately 90%. It has a large volume of distribution, indicating extensive tissue penetration.Clindamycin is extensively bound to plasma proteins, with approximately 90% bound. It has been detected in various tissues, including the skin, bone, and respiratory tract, indicating good distribution throughout the body.Metabolism of Clindamycin primarily occurs in the liver, where it undergoes biotransformation to form active metabolites, including Clindamycin sulfoxide and N-demethylClindamycin. These metabolites also possess antimicrobial activity. The parent drug and its metabolites are excreted primarily in the bile and feces, with only a small portion excreted unchanged in the urine.The elimination half-life of Clindamycin is approximately 2 to 3 hours in healthy individuals. However, in patients with severe renal impairment, the half-life may be prolonged. In individuals with normal renal function, approximately 10% of the administered dose is excreted unchanged in the urine within 24 hours.

The common side effects involved in using Clindamycin are Nausea, Vomiting, Diarrhea, Abdominal pain, Gastrointestinal discomfort, Skin rash, Itching, Hives (urticaria), Injection site pain, Injection site redness, Injection site swelling, Allergic reactions.

Clindamycin is available in the form of oral capsules , oral solution , injectable solution, and topical gel.

Clindamycin is approved in Germany, Japan, Malaysia, India, the U.K., the U.S., and China.

Clindamycin belongs to the pharmacological class of Lincosamide Antibiotics

Clindamycin works by binding to the 23S RNA of the 50S subunit of the bacterial ribosome, inhibiting bacterial protein synthesis. It hinders the assembly of the ribosome and the translation process. This mechanism is believed to be attributed to the structural similarity of Clindamycin to certain tRNA molecules involved in the peptide elongation cycle, specifically the 3'-ends of L-Pro-Met-tRNA and deacylated-tRNA. By acting as a structural analog, Clindamycin interferes with peptide chain initiation and may promote the dissociation of peptidyl-tRNA from bacterial ribosomes.

The precise mechanism of topical Clindamycin in treating acne vulgaris is not fully understood, but it is thought to be associated with its activity against Propionibacterium acnes, a bacterium commonly linked to acne.

Clindamycin has been approved to relieve symptoms and also for the treatment and maintenance of Anthrax, Babesiosis, Bacterial vaginosis, Bite wound infection, prophylaxis of high-risk bite or treatment, Diabetic foot infection, mild to moderate, Gingivitis, acute simple, plaque-associated, Hidradenitis suppurativa, Malaria, treatment, Mastitis, lactational, Neutropenic fever, empiric therapy for low-risk patients with cancer, Osteomyelitis, Pelvic inflammatory disease, severe, Pneumocystis jirovecii pneumonia, treatment, Pneumonia, Postpartum endometritis, Prosthetic joint infection, Rhinosinusitis, acute bacterial, Septic arthritis due to S. aureus, Skin and soft tissue infection, Streptococcus, group A, Streptococcus, group B, maternal prophylaxis for prevention of neonatal disease, Surgical prophylaxis, Toxic shock syndrome, toxin production suppression, Toxoplasma gondii encephalitis and pneumonitis, Acne vulgaris, Bacterial vaginosis, Hidradenitis suppurativa and Rosacea.

The oral form of Clindamycin usually starts to take effect within 1 to 3 hours after administration.The duration of action of oral Clindamycin can range from 6 to 8 hours, depending on the individual and the condition being treated.

Topical Clindamycin products, such as gels or lotions, typically have a rapid onset of action. They can start working within a few hours of application.The duration of action for topical Clindamycin can last for several hours. It is usually recommended to apply the medication once or twice daily, depending on the specific product and the severity of the condition.

Intravenous administration of Clindamycin results in a rapid onset of action. It begins to work within 1 hour after infusion.The duration of action for intravenous Clindamycin can last for approximately 6 to 8 hours. The dosage and frequency of administration may vary depending on the indication and the patient's condition.

Clindamycin is found to be available in the form of oral capsules , oral solution , injectable solution, and topical gel.

Clindamycin can be used in the following treatment:

• Anthrax
• Babesiosis
• Bacterial vaginosis
• Bite wound infection, prophylaxis of high-risk bite or treatment
• Diabetic foot infection, mild to moderate
• Gingivitis, acute simple, plaque-associated
• Hidradenitis suppurativa
• Malaria, treatment
• Mastitis, lactational
• Neutropenic fever, empiric therapy for low-risk patients with cancer
• Osteomyelitis
• Pelvic inflammatory disease, severe
• Pneumocystis jirovecii pneumonia, treatment
• Pneumonia
• Postpartum endometritis
• Prosthetic joint infection
• Rhinosinusitis, acute bacterial
• Septic arthritis due to S. aureus
• Skin and soft tissue infection
• Streptococcus, group A
• Streptococcus, group B, maternal prophylaxis for prevention of neonatal disease
• Surgical prophylaxis
• Toxic shock syndrome, toxin production suppression
• Toxoplasma gondii encephalitis and pneumonitis
• Acne vulgaris
• Bacterial vaginosis
• Hidradenitis suppurativa
• Rosacea

Clindamycin can help to relieve symptoms and also for the treatment and maintenance of Anthrax, Babesiosis, Bacterial vaginosis, Bite wound infection, prophylaxis of high-risk bite or treatment, Diabetic foot infection, mild to moderate, Gingivitis, acute simple, plaque-associated, Hidradenitis suppurativa, Malaria, treatment, Mastitis, lactational, Neutropenic fever, empiric therapy for low-risk patients with cancer, Osteomyelitis, Pelvic inflammatory disease, severe, Pneumocystis jirovecii pneumonia, treatment, Pneumonia, Postpartum endometritis, Prosthetic joint infection, Rhinosinusitis, acute bacterial, Septic arthritis due to S. aureus, Skin and soft tissue infection, Streptococcus, group A, Streptococcus, group B, maternal prophylaxis for prevention of neonatal disease, Surgical prophylaxis, Toxic shock syndrome, toxin production suppression, Toxoplasma gondii encephalitis and pneumonitis, Acne vulgaris, Bacterial vaginosis, Hidradenitis suppurativa and Rosacea.

Clindamycin is approved for use in the following clinical indications:

• Anthrax
• Babesiosis
• Bacterial vaginosis
• Bite wound infection, prophylaxis of high-risk bite or treatment
• Diabetic foot infection, mild to moderate
• Gingivitis, acute simple, plaque-associated
• Hidradenitis suppurativa
• Malaria, treatment
• Mastitis, lactational
• Neutropenic fever, empiric therapy for low-risk patients with cancer
• Osteomyelitis
• Pelvic inflammatory disease, severe
• Pneumocystis jirovecii pneumonia, treatment
• Pneumonia
• Postpartum endometritis
• Prosthetic joint infection
• Rhinosinusitis, acute bacterial
• Septic arthritis due to S. aureus
• Skin and soft tissue infection
• Streptococcus, group A
• Streptococcus, group B, maternal prophylaxis for prevention of neonatal disease
• Surgical prophylaxis
• Toxic shock syndrome, toxin production suppression
• Toxoplasma gondii encephalitis and pneumonitis
• Acne vulgaris
• Bacterial vaginosis
• Hidradenitis suppurativa
• Rosacea

• Anthrax:
• Adult dosage: IV: 600 to 900 mg every 8 hours.

Babesiosis:

• Adult dosage: Oral: 600 mg every 8 hours for 7 to 10 days.

Bacterial vaginosis:

• Adult dosage: Vaginal cream: Insert 1 applicatorful (5 g) intravaginally once daily at bedtime for 7 days.

Bite wound infection, prophylaxis of high-risk bite or treatment:

• Adult dosage: Oral: 300 to 450 mg every 6 hours.

Diabetic foot infection, mild to moderate:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Gingivitis, acute simple, plaque-associated:

• Adult dosage: Oral rinse: Rinse with 15 mL for 30 seconds twice daily for 9 days.

Hidradenitis suppurativa:

• Adult dosage: Oral: 300 mg every 6 hours or 450 mg every 8 hours.

Malaria treatment:

• Adult dosage: Oral:
• Chloroquine-resistant malaria: 600 mg every 8 hours for 7 days.
• Chloroquine-sensitive malaria: 900 mg every 8 hours for 7 days.

Mastitis, lactational:

• Adult dosage: Oral: 300 to 450 mg every 6 hours.

Neutropenic fever, empiric therapy for low-risk patients with cancer:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Osteomyelitis:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Pelvic inflammatory disease, severe:

• Adult dosage: IV: 900 mg every 8 hours plus an additional antibiotic.

Pneumocystis jirovecii pneumonia, treatment:

• Adult dosage: IV: 600 to 900 mg every 6 to 8 hours.

Pneumonia:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Postpartum endometritis:

• Adult dosage: IV: 900 mg every 8 hours plus an additional antibiotic.

Prosthetic joint infection:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Rhinosinusitis, acute bacterial:

• Adult dosage: Oral: 300 to 450 mg every 6 hours.

Septic arthritis due to S. aureus:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Skin and soft tissue infection:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Streptococcus, group A:

• Adult dosage: Oral: 300 to 450 mg every 6 hours.

Streptococcus, group B, maternal prophylaxis for prevention of neonatal disease:

• Adult dosage: IV: 900 mg as a single dose.

Surgical prophylaxis:

• Adult dosage: IV: 600 to 900 mg as a single dose within 60 minutes prior to the procedure.

Toxic shock syndrome, toxin production suppression:

• Adult dosage: IV: 600 to 900 mg every 8 hours.

Toxoplasma gondii encephalitis and pneumonitis:

• Adult dosage: IV: 600 to 900 mg every 6 to 8 hours.
• ote: To minimize the risk of antibiotic resistance, it is recommended to use Clindamycin in combination with benzoyl peroxide (Ref).
• Topical:
• Gel (Cleocin T, ClindaMax), pledget, lotion, solution: Apply a thin layer twice daily.
• Gel (Clindagel), foam (Evoclin): Apply once daily.

Bacterial vaginosis:

• Bacterial vaginosis:
• 2% cream (Cleocin): Intravaginal use: Apply one applicatorful (5 g containing approximately 100 mg Clindamycin) once daily at bedtime for 7 days
• 2% cream (Clindesse) (alternative agent): Intravaginal use: Apply one applicatorful (5 g containing approximately 100 mg Clindamycin) as a single dose
• 100 mg suppository (alternative agent): Intravaginal use: Insert one suppository once daily at bedtime for 3 days

Hidradenitis suppurativa:

• Hidradenitis suppurativa (off-label use): Topical solution: Apply to the affected area twice daily

Rosacea:

• Rosacea (off-label use): Topical lotion: Apply twice daily to the face.

• Oral Capsules:
• 75 mg
• 150 mg
• 300 mg
• Oral Suspension:
• 75 mg/5 mL
• 150 mg/5 mL
• Injectable Solution:
• 150 mg/mL
• 300 mg/mL
• Topical Gel:
• 1%
• 1.2%

Oral Capsules: Clindamycin is commonly available in capsule form for oral administration. The capsules contain the active ingredient Clindamycin and are available in various strengths, such as 75 mg, 150 mg, and 300 mg.

Oral Suspension: Clindamycin is also available as an oral suspension, which is a liquid form of the medication. The suspension is usually reconstituted by adding water to the powder form of Clindamycin, creating a suspension that can be easily swallowed. It is commonly available in strengths of 75 mg/5 mL and 150 mg/5 mL.

Injectable Solution: Clindamycin is available as an injectable solution for intravenous (IV) administration. This form is typically used in hospital settings or under medical supervision. The injectable solution is available in different concentrations, such as 150 mg/mL and 300 mg/2 mL.

Topical Gel/Lotion: Clindamycin is formulated into topical gels or lotions for the treatment of acne or certain skin infections. These formulations are applied directly to the affected area of the skin.

• Dosage Adjustments in Kidney Patients:

Mild to moderate impairment: The manufacturer's labeling does not recommend any dosage adjustments.

Severe impairment: Caution should be exercised, and the dose should be reduced by 70% to 75%.

End-stage renal disease (ESRD) on hemodialysis: The manufacturer's labeling does not provide specific dosage adjustments. However, caution should be exercised when using the medication, as it is not effectively removed by hemodialysis.

Peritoneal dialysis: The manufacturer's labeling does not specify dosage adjustments. Use the medication with caution, as it is not effectively removed by peritoneal dialysis.

• Dosage Adjustments in Hepatic Impairment Patients:

No dosage adjustments are provided in the manufacturer's labeling.

• Dosage Adjustments in Pediatric Patients:

Anthrax:

• Infants, Children, and Adolescents:
• Postexposure prophylaxis (inhalational exposure): Oral: 30 mg/kg/day divided every 8 hours for 60 days; maximum dose: 900 mg/dose.
• Cutaneous infection without systemic involvement: Oral: 30 mg/kg/day divided every 8 hours for 7 to 10 days (naturally acquired infection) or 60 days (biological weapon-related event); maximum dose: 600 mg/dose.
• Systemic involvement (including severe disease): IV: 40 mg/kg/day divided every 8 hours for ≥14 days (if meningitis is excluded) or ≥14 to 21 days (if meningitis cannot be excluded) until patient clinically stable; maximum dose: 900 mg/dose.
• Step-down therapy for severe infection: Oral: 30 mg/kg/day divided every 8 hours for ≥14 days following initial treatment; maximum dose: 600 mg/dose.

Babesiosis:

• Infants, Children, and Adolescents:
• Mild to moderate disease or oral step-down therapy: Oral: 7 to 10 mg/kg/dose every 6 to 8 hours in combination with quinine for 7 to 10 days; maximum dose: 600 mg/dose. The duration may be longer in highly immunocompromised patients.
• Severe disease, initial therapy: IV: 7 to 10 mg/kg/dose every 6 to 8 hours in combination with quinine; maximum dose: 600 mg/dose. Change to oral Clindamycin once symptoms improve.

Endocarditis, prophylaxis before invasive dental or respiratory tract procedures:

• Infants, Children, and Adolescents: Oral, IV, IM: 20 mg/kg administered 30 to 60 minutes prior to the procedure; maximum dose: 600 mg/dose.

Exit-site or tunnel infection, peritoneal dialysis catheter:

• Infants, Children, and Adolescents: Oral: 10 mg/kg/dose three times daily; maximum dose: 600 mg/dose.

Intra-abdominal infection, complicated:

• Infants, Children, and Adolescents: IV: 30 to 40 mg/kg/day divided every 6 to 8 hours in combination with other antibiotics; maximum daily dose: 2,700 mg/day.

Malaria, uncomplicated treatment (alternative agent):

• Infants, Children, and Adolescents: Oral: 20 mg/kg/day divided every 8 hours for 7 days in combination with quinine.

Osteoarticular infection, acute:

• Infants, Children, and Adolescents: IV, Oral: 30 to 40 mg/kg/day divided every 6 to 8 hours; maximum dose: IV: 900 mg/dose; Oral: 600 mg/dose. Duration should be individualized based on factors such as causative pathogen, response to therapy, and normalization of inflammatory markers.

Acute Otitis Media (alternative agent):

• Note: This is typically used for patients who cannot tolerate beta-lactam antibiotics or as an alternative when initial therapy fails for acute otitis media (AOM). In some cases, it may be used as part of a combination regimen for activity against specific bacteria like Haemophilus influenzae or Moraxella catarrhalis.
• Infants ≥6 months, Children, and Adolescents: Oral: 30 to 40 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 1,800 mg/day. Treatment duration varies depending on the severity and other factors.

Peritonitis (peritoneal dialysis):

• Infants, Children, and Adolescents:
• Prophylaxis for invasive dental procedures: Oral: 20 mg/kg administered 30 to 60 minutes before the procedure; maximum dose: 600 mg.
• Prophylaxis for GI or genitourinary procedures: IV: 10 mg/kg administered 30 to 60 minutes before the procedure; maximum dose: 600 mg.
• Treatment (intraperitoneal, continuous): Loading dose: 300 mg per liter of dialysate; maintenance dose: 125 to 150 mg per liter of dialysate.

Pneumocystis jirovecii pneumonia (PCP), treatment (alternative agent):

• HIV-exposed/-infected:
• Infants and Children: IV, Oral: 10 mg/kg/dose every 6 hours in combination with primaquine for 21 days; maximum IV dose: 600 mg/dose; maximum oral dose: 300 to 450 mg/dose.
• Adolescents: Oral: Mild to severe disease: 450 mg every 6 hours or 600 mg every 8 hours in combination with primaquine for 21 days. IV: Moderate to severe disease: 600 mg every 6 hours or 900 mg every 8 hours in combination with primaquine for 21 days.

Community-acquired Pneumonia:

• Infants ≥3 months, Children, and Adolescents:
• Moderate to severe infection: IV: 40 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 2,700 mg/day.
• Mild infection or oral step-down therapy: Oral: 30 to 40 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 1,800 mg/day. Treatment duration varies based on the pathogen and clinical course.

Acute Bacterial Rhinosinusitis (alternative agent):

• Children and Adolescents: Oral: 30 to 40 mg/kg/day divided every 8 hours for 10 to 14 days. Use as part of appropriate combination therapy if activity against H. influenzae or M. catarrhalis is desired.

Skin and Soft Tissue Infection (SSTI):

• Impetigo, Ecthyma (if MRSA is suspected or confirmed): Oral: 20 mg/kg/day in divided doses every 8 hours for 7 days; maximum dose: 400 mg/dose.
• Cellulitis, Erysipelas, Purulent/Fluctuant SSTI: IV: 25 to 40 mg/kg/day in divided doses every 8 hours; maximum dose: 600 mg/dose. Oral: Dosing varies depending on the type of infection and susceptibility.

Streptococcus, group A:

• Pharyngitis/tonsillitis (alternative agent for severe penicillin allergy): Children and Adolescents: Oral: 21 mg/kg/day in divided doses every 8 hours for 10 days; maximum dose: 300 mg/dose.

Surgical prophylaxis:

• Children and Adolescents: IV: 10 mg/kg within 30 to 60 minutes prior to the procedure; a repeat dose may be given in 6 hours if the procedure is prolonged or involves excessive blood loss.

There are no specific dietary restrictions associated with the use of Clindamycin.

Clindamycin may be contraindicated under the following conditions:

• Clindamycin should not be used in individuals with a known hypersensitivity or allergic reaction to the drug Clindamycin.

General:

• Caution should be exercised when combining Clindamycin with primaquine in patients with G-6-PD deficiency, as it may lead to hemolytic reactions. Other hematologic risk groups should also be considered (refer to the primaquine product monograph). If serious hematologic adverse effects occur, adjusting the dosage regimen of both drugs should be considered.
• Clindamycin should be used with caution in atopic individuals.
• Clindamycin injection must be diluted before intravenous administration and should not be injected undiluted as an intravenous bolus.
• Antibiotic use can sometimes result in the overgrowth of nonsusceptible organisms, particularly yeasts. If superinfections occur, appropriate measures should be taken based on the clinical situation.
• Care should be taken when treating patients who are taking multiple medications due to potential drug interactions.

Gastrointestinal:

• Clindamycin injection should be used with caution in patients with a history of gastrointestinal disease, including colitis, inflammatory bowel disease, or antibiotic-associated colitis. If diarrhea occurs during treatment, the antibiotic should be discontinued.

Clostridium difficile-associated disease (CDAD):

• CDAD, ranging from mild diarrhea to fatal colitis, has been reported with the use of Clindamycin and other antibacterial agents. CDAD can occur even after 2 months of antibiotic administration. It is important to consider CDAD in patients presenting with diarrhea or colitis symptoms. Treatment measures should be initiated if CDAD is suspected or confirmed, including discontinuation of non-Clostridium difficile-directed antibacterial agents, fluid and electrolyte management, protein supplementation, and appropriate antibiotic therapy.

Hepatic/Biliary/Pancreatic:

• In patients with moderate to severe liver disease, Clindamycin may have a prolonged half-life. However, dosage reduction is generally not necessary. Periodic liver enzyme monitoring is recommended in patients with severe liver disease.

Immune:

• Serious hypersensitivity reactions, including anaphylactoid reactions, severe skin reactions such as DRESS, SJS, TEN, and AGEP, have been reported with Clindamycin therapy. If a hypersensitivity reaction occurs, Clindamycin should be discontinued, and appropriate treatment should be initiated.

Renal:

• Dose modification of Clindamycin may not be necessary in patients with renal disease. However, the serum half-life of Clindamycin is slightly increased in patients with significantly reduced renal function.

Susceptibility/Resistance:

• Clindamycin should only be prescribed when there is a proven or strongly suspected bacterial infection. Its use in the absence of such infections is unlikely to provide benefits and increases the risk of developing drug-resistant bacteria.

While there is no specific food interaction between Clindamycin and alcohol, it's generally recommended to avoid alcohol when taking any antibiotic medication. Alcohol can interfere with the effectiveness of the medication and may also exacerbate certain side effects.

Clindamycin has been detected in human breast milk at levels ranging from <0.5 to 3.8 mcg/mL. There is a possibility that Clindamycin may have adverse effects on the gastrointestinal flora of breastfed infants, such as diarrhea, blood in the stool, or rash. It is important to note that the presence of Clindamycin in breast milk should not automatically lead to discontinuation of breastfeeding, but alternative medications may be preferred. If a nursing mother requires the use of Clindamycin, close monitoring of the infant for potential adverse effects on the gastrointestinal flora, including diarrhea, candidiasis (thrush, diaper rash), or blood in the stool indicating antibiotic-associated colitis, is advised.

When considering the use of Clindamycin, it is crucial to weigh the developmental and health benefits of breastfeeding against the mother's clinical need for the medication and any potential adverse effects it may have on the breastfed child, taking into account both Clindamycin itself and the underlying maternal condition.

Pregnancy Category C

There have been no sufficient and well-controlled studies conducted in pregnant women to determine the safety of Clindamycin use during pregnancy.

Unless there is a clear necessity and the potential benefits to the mother outweigh the potential risks to the fetus, Clindamycin should be avoided in pregnancy.

Clindamycin is capable of crossing the placenta in humans. Following multiple doses, concentrations of Clindamycin in amniotic fluid were approximately 30% of maternal blood concentrations. Clindamycin was found to be widely distributed in fetal tissues, with the highest concentration observed in the liver.

Reproduction studies conducted in rats and mice using subcutaneous and oral doses of Clindamycin ranging from 20 to 600 mg/kg/day did not demonstrate any evidence of impaired fertility or harm to the fetus, except at doses that caused maternal toxicity. In one strain of mice, cleft palates were observed in treated fetuses; however, this effect was not observed in other mouse strains or in other species, suggesting it may be specific to that particular strain. Reproductive toxicity studies in rats and rabbits involving oral and subcutaneous administration of Clindamycin did not reveal any evidence of impaired fertility or harm to the fetus, except at doses that caused maternal toxicity. It should be noted that animal reproduction studies do not always accurately predict the response in humans.

The adverse reactions related to Clindamycin can be categorized as follows:

Common:

• Nausea and vomiting
• Diarrhea
• Stomach pain or cramps

Less Common:

• Allergy
• Inflammation
• Hives
• Skin rashes

Rare:

• Acute kidney failure
• Decreased kidney function
• Skin inflammation with blisters
• Erythema multiforme (a type of allergic skin reaction)
• Toxic epidermal necrolysis (a skin disorder with blistering and peeling skin)
• Stevens-Johnson syndrome (a skin disorder with blistering and peeling skin)
• Rash with sloughing
• Abnormal liver function tests
• Anaphylaxis (a significant type of allergic reaction)
• Angioedema (a type of allergic reaction with swelling)
• Hypersensitivity reaction to the drug
• Jaundice (yellowing of the eyes or skin from bilirubin buildup)
• Acute generalized exanthematous pustulosis (a type of skin disorder)

Neuromuscular blocking agents:

Proper name: Examples include atracurium, doxacurium, pancuronium, vecuronium

Effect: Clindamycin has been shown to possess neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.

Clinical comment: Caution should be exercised when using Clindamycin concurrently with these agents.

Aminoglycosides:

Proper name: Not specified

Effect: Clindamycin is reported to antagonize the bactericidal activity of aminoglycosides in vitro. However, in vivo, antagonism has not been demonstrated.

Clinical comment: No specific clinical implications have been established regarding the concurrent use of Clindamycin and aminoglycosides.

Erythromycin:

Proper name: Not specified

Effect: Antagonism between Clindamycin and erythromycin has been demonstrated in vitro. They may compete for the same protein binding site in bacteria.

Clinical comment: Concurrent administration of Clindamycin and erythromycin should be avoided due to potential clinical significance.

Inhibitors of CYP3A4, CYP3A5:

Proper name: Not specified

Effect: Clearance of Clindamycin may be reduced.

Clinical comment: Close monitoring is advised to assess potential loss of effectiveness when Clindamycin is used with strong inhibitors of CYP3A4 and CYP3A5.

Inducers of CYP3A4, CYP3A5:

Proper name: Not specified

Effect: Clearance of Clindamycin may be increased.

Clinical comment: Careful monitoring of serum Clindamycin levels and effectiveness is recommended when Clindamycin is used concurrently with strong inducers of CYP3A4, such as rifampin.

Rifampin:

Proper name: Rifampin

Effect: Rifampin significantly decreases serum Clindamycin concentration.

Clinical comment: Close monitoring of serum Clindamycin levels and effectiveness is essential when used in combination with rifampin. No clinically relevant effect of Clindamycin on rifampin concentrations is expected.

The following are the side effects involving Clindamycin:

• Gastrointestinal effects: Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Pseudomembranous colitis (a severe intestinal condition)
• Skin reactions: Rash
• Itching
• Hives
• Severe allergic reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis
• Allergic reactions: Swelling of the face, lips, tongue, or throat
• Difficulty breathing
• Wheezing
• Yeast infections: Vaginal yeast infections
• Oral thrush (yeast infection in the mouth)
• Liver toxicity: Rare cases of liver damage or abnormal liver function tests
• Blood disorders: Rare cases of leukopenia (low white blood cell count)
• Neutropenia (low neutrophil count)
• Thrombocytopenia (low platelet count)
• Central nervous system effects: Headache
• Dizziness
• Rare cases of seizures or altered mental status

Pregnancy:

Pregnancy Category C

There have been no sufficient and well-controlled studies conducted in pregnant women to determine the safety of Clindamycin use during pregnancy.

Unless there is a clear necessity and the potential benefits to the mother outweigh the potential risks to the fetus, Clindamycin should be avoided in pregnancy.

Clindamycin is capable of crossing the placenta in humans. Following multiple doses, concentrations of Clindamycin in amniotic fluid were approximately 30% of maternal blood concentrations. Clindamycin was found to be widely distributed in fetal tissues, with the highest concentration observed in the liver.

Reproduction studies conducted in rats and mice using subcutaneous and oral doses of Clindamycin ranging from 20 to 600 mg/kg/day did not demonstrate any evidence of impaired fertility or harm to the fetus, except at doses that caused maternal toxicity. In one strain of mice, cleft palates were observed in treated fetuses; however, this effect was not observed in other mouse strains or in other species, suggesting it may be specific to that particular strain. Reproductive toxicity studies in rats and rabbits involving oral and subcutaneous administration of Clindamycin did not reveal any evidence of impaired fertility or harm to the fetus, except at doses that caused maternal toxicity. It should be noted that animal reproduction studies do not always accurately predict the response in humans.

Lactation:

Clindamycin has been detected in human breast milk at levels ranging from <0.5 to 3.8 mcg/mL. There is a possibility that Clindamycin may have adverse effects on the gastrointestinal flora of breastfed infants, such as diarrhea, blood in the stool, or rash. It is important to note that the presence of Clindamycin in breast milk should not automatically lead to discontinuation of breastfeeding, but alternative medications may be preferred. If a nursing mother requires the use of Clindamycin, close monitoring of the infant for potential adverse effects on the gastrointestinal flora, including diarrhea, candidiasis (thrush, diaper rash), or blood in the stool indicating antibiotic-associated colitis, is advised.

When considering the use of Clindamycin, it is crucial to weigh the developmental and health benefits of breastfeeding against the mother's clinical need for the medication and any potential adverse effects it may have on the breastfed child, taking into account both Clindamycin itself and the underlying maternal condition.

Pediatric:

Evaluation of pediatric patients' capability to swallow Clindamycin capsules is recommended. If a child is unable to consistently swallow capsules, the use of Clindamycin capsules should be avoided, and an appropriate alternative dosage form should be employed.

Geriatric Use:

The elderly population (age > 60 years): Based on experience, it has been observed that elderly and debilitated patients may have a higher likelihood of developing antibiotic-associated colitis, which can also be more severe in these individuals. Therefore, it is crucial to closely monitor these patients for the emergence of diarrhea.

Physicians should be knowledgeable as well as vigilant about the treatment and identification of overdosage of Clindamycin.

• Administration of activated charcoal may be considered to assist in eliminating unabsorbed medication. It is advisable to provide general supportive care.
• Although no cases of overdosage have been reported, it is anticipated that gastrointestinal side effects such as abdominal pain, nausea, vomiting, and diarrhea may occur in the event of an overdose. During clinical trials, mild abdominal pain and diarrhea were observed in a 3-year-old child who received 100 mg/kg of Clindamycin Hydrochloride Capsules for five days. A 13-year-old patient who received 75 mg/kg for five days experienced no side effects. Laboratory values remained within normal ranges in both cases.
• Hemodialysis and peritoneal dialysis are not effective methods for removing Clindamycin from the bloodstream. There is currently no known specific antidote.
• The average biological half-life of Clindamycin is approximately 2.4 hours.

Pharmacodynamics

• Clindamycin inhibits microbial protein synthesis, exerting a bacteriostatic effect.
• Due to its relatively short time to reach maximum concentration (Tmax) and half-life, Clindamycin needs to be administered every six hours to maintain sufficient antibiotic concentrations.
• The use of Clindamycin has been associated with Clostridium difficile-associated diarrhea (CDAD), ranging in severity from mild diarrhea to potentially fatal colitis. CDAD can occur even after two months of stopping Clindamycin therapy. Overgrowth of C. difficile, along with the production of toxins A and B, contributes to the adverse effects. Consequently, Clindamycin should be reserved for serious infections when less toxic antimicrobial agents are not suitable.
• Clindamycin is effective against various aerobic gram-positive bacteria, as well as both gram-positive and gram-negative anaerobes. Resistance to Clindamycin can develop due to modifications in the 23S ribosomal RNA. Complete cross-resistance exists between Clindamycin and lincomycin, and there may also be cross-resistance with macrolide antibiotics (e.g., erythromycin) due to similarities in their binding sites.
• It is important to consult local antibiograms, as antimicrobial susceptibility patterns can vary geographically, to ensure adequate coverage against relevant pathogens prior to Clindamycin use.

Pharmacokinetics

Absorption: Attainment of Equilibrium State and Peak Serum Levels

● Absorption of Clindamycin reaches an equilibrium state by the third dose. Following intramuscular injection, adults achieve peak serum levels within 3 hours, while pediatric patients achieve peak levels within 1 hour. With short-term intravenous infusion lasting 10 to 45 minutes, peak serum levels are immediately achieved.

Distribution: Binding and Tissue Penetration

● Clindamycin primarily binds to alpha-1-acid glycoprotein. The extent of protein binding depends on concentration, ranging from 60% to 94% at therapeutic serum levels.

● Clindamycin distributes into various body fluids and tissues, including bone, synovial fluid, bile, and pleural fluid. However, it does not significantly accumulate in cerebrospinal fluid, even in the presence of inflamed meninges, due to the inability to cross the blood-brain barrier.

● Clindamycin easily crosses the placenta and is also distributed into breast milk.

Metabolism: Oxidation by Enzymes

● In vitro studies using human liver and intestinal microsomes indicate that Clindamycin is primarily metabolized by the enzyme CYP3A4, with a minor contribution from CYP3A5. This metabolism results in the formation of Clindamycin sulfoxide and a minor metabolite called N-desmethylClindamycin.

Excretion: Routes and Elimination Half-Life

● Approximately 10% of the active form of Clindamycin is excreted in the urine, while about 4% is excreted in the feces. The remaining portion is excreted as biologically inactive metabolites.

● Clindamycin phosphate is rapidly eliminated from the serum, with an average elimination half-life of 6 minutes following intramuscular or intravenous administration in adults.

● In adults, the serum elimination half-life of Clindamycin is approximately 3 hours, while in pediatric patients, it is around 2.5 hours.

• https://medlineplus.gov/druginfo/meds/a682399.html
• https://www.drugs.com/Clindamycin.html
• https://www.webmd.com/drugs/2/drug-12235/Clindamycin-hcl-oral/details
• https://reference.medscape.com/drug/cleocin-Clindamycin-342558
• https://go.drugbank.com/drugs/DB01190
• https://labeling.pfizer.com/showlabeling.aspx?id=625
• https://www.rxlist.com/Clindamycin-drug.htm
• https://pdf.hres.ca/dpd_pm/00030738.PDF
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050162s085lbl.pdf
• https://www.sandoz.ca/sites/www.sandoz.ca/files/Clindamycin Injection USP Product Monograph_0.pdf