Clindamycin (Dalacin C)

1. Health Canada Product Monograph — Clindamycin

• Clindamycin treats serious infections caused by susceptible anaerobic bacteria, such as Bacteroides, Peptostreptococcus, and Clostridium species.
• Clindamycin treats serious infections caused by susceptible gram-positive bacteria, including staphylococci, streptococci, and pneumococci, when a patient cannot tolerate or does not respond to other appropriate antibiotics.
• Clindamycin, combined with primaquine, is used to treat Pneumocystis jirovecii pneumonia in patients with AIDS who cannot tolerate or do not respond to conventional therapy.
• Clindamycin is used to prevent infection of the heart valves (bacterial endocarditis) before dental, oral, or upper respiratory surgery in penicillin-allergic patients who are at risk.
• Clindamycin should only be used to treat infections proven or strongly suspected to be caused by susceptible bacteria, to help limit the development of antibiotic resistance.

• Clindamycin has not been well studied in pregnant women, and safety in pregnancy has not been established.
• Clindamycin should not be used in pregnancy unless clearly needed and the expected benefit to the mother outweighs any potential risk to the baby.
• Clindamycin crosses the placenta and reaches the developing baby's tissues, with the highest concentrations found in the liver.
• Animal studies have not shown harm to the fetus except at doses that were also toxic to the mother.

• Clindamycin passes into breast milk.
• Clindamycin may affect a nursing infant's digestive system, potentially causing diarrhea, blood in the stool, or rash.
• If clindamycin is needed by a nursing mother, it is not automatically a reason to stop breastfeeding, but an alternative antibiotic may be preferred; if used, the infant should be monitored for these effects.

• There is insufficient data on clindamycin use in patients aged 65 and older to determine whether they respond differently than younger adults.
• Antibiotic-associated colitis may occur more frequently and with greater severity in older or debilitated patients, who should be carefully monitored for diarrhea.
• No routine dosage adjustment is required for older adults with normal liver and kidney function.

• Clindamycin is authorized for use in children over one month of age.
• Clindamycin dosing in children is based on total body weight.
• Clindamycin capsules are not suitable for children unable to swallow them whole; the oral solution may be used instead.
• Clindamycin has not been established as safe for use in newborns under 30 days of age.

• For mild infections in adults, the usual dose is 150 mg every 6 hours.
• For moderately severe infections in adults, the usual dose is 300 mg every 6 hours.
• For severe infections in adults, the usual dose is 450 mg every 6 hours.
• For children over one month of age able to swallow capsules, the dose is calculated by body weight, divided into 3 or 4 equal doses per day depending on infection severity.
• For prevention of endocarditis, adults take a single dose before the procedure followed by a second, smaller dose 6 hours later; children are dosed by weight.
• For streptococcal infections, treatment should continue for at least 10 days to reduce the risk of rheumatic fever or kidney inflammation.
• No dose modification is generally needed for kidney disease or in older adults with normal liver and kidney function.
• No dose modification is generally needed for liver insufficiency, though periodic liver enzyme monitoring is recommended in severe liver disease.
• If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose; doses should not be doubled.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• No cases of clindamycin overdose have been reported in humans.
• If overdose were to occur, gastrointestinal symptoms such as abdominal pain, nausea, vomiting, and diarrhea would be expected.
• Activated charcoal may help reduce absorption of unabsorbed drug if given promptly.
• Hemodialysis and peritoneal dialysis are not effective at removing clindamycin from the blood, and no specific antidote exists.
• General supportive care is recommended for overdose management.

• Diarrhea may occur.
• Nausea may occur.
• Abdominal pain may occur.
• Vomiting may occur.
• Abnormal liver function test results may occur.
• Skin rash may occur.
• Altered taste (dysgeusia) may occur.
• Pain, irritation, or abscess formation may occur at an injection site with injectable forms.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Clostridioides difficile-associated diarrhea and colitis, which can range from mild diarrhea to severe or life-threatening colitis, may occur during or up to two months after treatment.
• Severe allergic reactions, including anaphylaxis and angioedema, may occur.
• Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported.
• Kidney injury, including acute kidney failure, has been reported.
• Blood disorders such as agranulocytosis, low white blood cell counts, and low platelet counts have been reported.
• Esophagitis and esophageal ulcers have been reported with the oral capsules, particularly when taken with too little water or right before lying down.
• Liver problems, including jaundice, have been reported.
• Joint pain and swelling (polyarthritis) has been reported.
• Seek urgent medical attention for severe or bloody diarrhea, signs of a severe allergic reaction, unusual bleeding or bruising, or a severe skin rash.

• Use with caution in patients with a history of gastrointestinal disease, particularly colitis or inflammatory bowel disease.
• Use with caution in patients with a history of antibiotic-associated colitis.
• Use with caution in patients with atopic conditions such as eczema, asthma, or hay fever.
• Use with caution in patients with severe liver disease, and monitor liver function periodically during prolonged therapy.
• Use with caution in patients with pre-existing kidney disease or those taking other drugs that can harm the kidneys, and monitor kidney function.
• Use with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency who are also taking primaquine, due to the risk of hemolytic reactions.
• Clindamycin does not adequately penetrate the fluid around the brain and spinal cord, so it should not be used to treat meningitis.

• Contraindicated in patients with known hypersensitivity to clindamycin, lincomycin, or any ingredient in the formulation.
• Not indicated for use in newborns under 30 days of age until further clinical experience is available.

• Clindamycin has neuromuscular blocking properties and may enhance the effect of neuromuscular blocking agents used during anesthesia, such as atracurium, pancuronium, or vecuronium.
• Clindamycin and erythromycin should not be given together, as they may compete for the same binding site on bacteria and antagonize each other's effectiveness.
• Clindamycin may reduce the effectiveness of aminoglycoside antibiotics against bacteria in laboratory studies, though this has not been shown to matter in the body.
• Drugs that strongly inhibit the CYP3A4 and CYP3A5 enzymes may reduce clearance of clindamycin, increasing its blood levels.
• Strong inducers of CYP3A4, such as rifampin, can dramatically decrease clindamycin blood levels and reduce its effectiveness, requiring close monitoring.

• Clindamycin can be taken with or without food, as absorption is not significantly changed by eating.

• Clindamycin may be taken at any time of day, with or without meals, according to the prescribed schedule.
• Each dose should be taken with a full glass of water, and the patient should remain upright for at least 30 minutes afterward to reduce the risk of throat or esophagus irritation.

• Store clindamycin capsules at controlled room temperature (15°C to 30°C).

• Take clindamycin with a full glass of water and stay upright for at least 30 minutes afterward to protect your esophagus.
• Contact your healthcare provider promptly if you develop watery or bloody diarrhea, even after finishing treatment.
• Finish the full course of clindamycin as prescribed, even if you feel better, unless told otherwise by your healthcare provider.
• Clindamycin does not treat viral infections such as colds or flu.