Clindamycin


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Anaerobic infections
Adult: Serious infections caused by susceptible staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis), pneumococci, and anaerobic pathogen: Moderately severe: 150-300 mg every 6 hours. Severe: 300-450 mg every 6 hours. In cases of β-haemolytic streptococcal infection: Continue for at least 10 days to prevent subsequent rheumatic fever or glomerulonephritis.
Child: <12 years 3-6 mg/kg every 6 hours.
Reconstitution: Oral solution: Reconstitute by adding 75 mL of water to a 100 mL bottle. Initially, add a large portion of 75 mL water and shake vigorously. Then, add the remainder and shake until the solution is uniform.

Oral
Disease due to Gram-positive bacteria
Adult: Serious infections caused by susceptible staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis), pneumococci, and anaerobic pathogen: Moderately severe: 150-300 mg every 6 hours. Severe: 300-450 mg every 6 hours. In cases of β-haemolytic streptococcal infection: Continue for at least 10 days to prevent subsequent rheumatic fever or glomerulonephritis.
Child: <12 years 3-6 mg/kg every 6 hours.
Reconstitution: Oral solution: Reconstitute by adding 75 mL of water to a 100 mL bottle. Initially, add a large portion of 75 mL water and shake vigorously. Then, add the remainder and shake until the solution is uniform.

Parenteral
Disease due to Gram-positive bacteria
Adult: Serious infection caused by susceptible staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis), pneumococci, and anaerobic pathogen: 600-1,200 mg daily. Severe infections: 1,200-2,700 mg daily, may be increased up to 4,800 mg (IV) daily in life-threatening situations. All doses are given in 2-4 equally divided doses. Max: 600 mg (single IM inj); 1,200 mg (single 1-hour IV infusion). IV doses must be infused over at least 10-60 minutes. Max infusion rate: 30 mg/minute. In cases of β-haemolytic streptococcal infection: Continue for at least 10 days to prevent subsequent rheumatic fever or glomerulonephritis.
Child: >1 month Serious infection: 15-25 mg/kg daily. Severe infection: 25-40 mg/kg daily with a minimum dose of 300 mg daily (regardless of body weight). All doses are given in 3 or 4 equally divided doses.
Reconstitution: IV infusion: Dilute with 50-100 mL of compatible diluent (e.g. 5% dextrose in water, normal saline) to a final concentration not exceeding 18 mg/mL.
Incompatibility: Incompatible with alkaline preparations, drugs unstable at low pH, ampicillin, aminophylline, barbiturates, Ca gluconate, ceftriaxone, ciprofloxacin, idarubicin, Mg sulfate, phenytoin and ranitidine.

Parenteral
Anaerobic infections
Adult: Serious infection caused by susceptible staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis), pneumococci, and anaerobic pathogen: 600-1,200 mg daily. Severe infections: 1,200-2,700 mg daily, may be increased up to 4,800 mg (IV) daily in life-threatening situations. All doses are given in 2-4 equally divided doses. Max: 600 mg (single IM inj); 1,200 mg (single 1-hour IV infusion). IV doses must be infused over at least 10-60 minutes. Max infusion rate: 30 mg/minute. In cases of β-haemolytic streptococcal infection: Continue for at least 10 days to prevent subsequent rheumatic fever or glomerulonephritis.
Child: >1 month Serious infection: 15-25 mg/kg daily. Severe infection: 25-40 mg/kg daily with a minimum dose of 300 mg daily (regardless of body weight). All doses are given in 3 or 4 equally divided doses.
Reconstitution: IV infusion: Dilute with 50-100 mL of compatible diluent (e.g. 5% dextrose in water, normal saline) to a final concentration not exceeding 18 mg/mL.
Incompatibility: Incompatible with alkaline preparations, drugs unstable at low pH, ampicillin, aminophylline, barbiturates, Ca gluconate, ceftriaxone, ciprofloxacin, idarubicin, Mg sulfate, phenytoin and ranitidine.

Topical/Cutaneous
Acne vulgaris
Adult: As lotion/solution: Apply a thin film bid to the affected area. As gel/foam: Apply once daily to the affected area. Review patient response after 6-8 weeks of treatment.

Vaginal
Bacterial vaginosis
Adult: As 2% cream: Apply 100 mg (1 applicator-full) intravaginally at bedtime for 3-7 consecutive days. As pessary: 100 mg once daily preferably at bedtime for 3 consecutive days.
Administration
Cap: May be taken with or without food. Swallow whole w/ a full glass of water & in an upright position.
Granules: Should be taken with food.
Contraindications
Hypersensitivity. Topical and vaginal: History of inflammatory bowel disease, regional enteritis, ulcerative colitis or antibiotic-associated colitis. Neonates (parenteral).
Special Precautions
Patients with history of gastrointestinal disease (e.g. colitis); atopic individuals. Not intended for the treatment of meningitis. Not recommended for severe nodulocystic acne (topical lotion). Severe hepatic impairment. Debilitated patients. Children. Pregnancy and lactation. Patient Counselling Vaginal preparations may decrease the effectiveness of latex or rubber contraceptive agents (e.g. condoms, diaphragms). Monitoring Parameters Monitor CBC, LFT, and renal function periodically during prolonged treatment.
Adverse Reactions
Significant: Superinfection. Blood and lymphatic system disorders: Leucopenia, agranulocytosis, eosinophilia, neutropenia, thrombocytopenia. Gastrointestinal disorders: Diarrhoea, abdominal pain, nausea, vomiting, oesophagitis, oesephageal ulcer. General disorders and administration site conditions: Application site reactions (e.g. inflammation, irritation, burning sensation, pain, dryness, oiliness), inj site reactions (e.g. pain, irritation, abscess, induration). Hepatobiliary disorders: Jaundice. Immune system disorders: Urticaria. Infections and infestations: Cervicitis, vaginal candidiasis, vaginitis. Investigations: Abnormal LFT. Nervous system disorders: Dysgeusia, headache, dizziness. Renal and urinary disorders: Azotaemia, oliguria, proteinuria. Reproductive system and breast disorders: Vulvovaginal irritation, vaginal moniliasis. Skin and subcutaneous tissue disorders: Maculopapular rash, pruritus, erythema, seborrhoea, contact dermatitis. Vascular disorders: Hypotension (IV), thrombophlebitis (IV).
Potentially Fatal: Pseudomembranous colitis, Clostridium difficile-associated diarrhoea (CDAD), severe hypersensitivity reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS); gasping syndrome (in neonates).
Overdosage
Symptoms: Dermatitis, nephrotoxicity, hepatotoxicity, haematological abnormalities, severe diarrhoea and pseudomembranous colitis that may result to death. Rapid IV administration of large doses may cause ventricular dysrhythmia, hypotension and cardiac arrest. Management: Symptomatic and supportive treatment. Administer adrenaline for serious anaphylactoid reactions. Administer oxygen and IV corticosteroids as indicated.
Drug Interactions
May enhance the action of neuromuscular blocking agents. May antagonise the effects of parasympathomimetics. May competitively inhibit the effects of macrolides, ketolides, streptogramins, linezolid and chloramphenicol. May increase coagulation tests (e.g. prothrombin time, INR) and risk of bleeding with vitamin K antagonists (e.g. warfarin, acenocoumarol, fluindione). May decrease therapeutic effect with rifampicin. May reduce clearance with CYP3A4 and CYP3A5 inhibitors. Erythromycin may diminish therapeutic effect of clindamycin (topical).
Food Interaction
Oral: May reduce rate of absorption with food.
Action
Clindamycin, a lincosamide antibiotic, inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunit, thereby preventing the peptide bond formation, ribosome assembly and translation process.
Absorption: As clindamycin hydrochloride: Rapidly absorbed from the gastrointestinal tract (approx 90%). As clindamycin phosphate: Minimally absorbed from the skin (approx 4-5%) and vagina (vaginal cream: approx 5%; vaginal pessary: approx 30%). Oral: Reduced rate of absorption with food. Time to peak plasma concentration: Within 1 hour (oral); 1-3 hours (IM); Approx 10-14 hours (vaginal cream); Approx 5 hours (vaginal pessary).
Distribution: Widely distributed in body fluids (except CSF) and tissues, including bone. Crosses placenta and enters breast milk. Plasma protein binding: >90%.
Metabolism: Metabolised in the liver mainly via oxidation by CYP3A4 and to a lesser extent by CYP3A5 to form clindamycin sulfoxide (major metabolite) and N-desmethylclindamycin (minor metabolite). Rapidly converted from biologically inactive clindamycin phosphate to active clindamycin (IV) or clindamycin hydrochloride (topical).
Excretion: Via urine (Oral: Approx 10%; Topical lotion, foam, solution: <0.2%) as active drug and metabolites, faeces (approx 4%) and the remainder as inactive metabolites. Elimination half-life: Approx 3 hours; 1.5-2.6 hours (vaginal cream); 11 hours (vaginal pessary).
Storage
Oral: Cap/Oral solution: Store between 20-25°C. Parenteral: Solution for inj: May be stored either below 25°C or between 2-8°C. Storage recommendations may vary among countries or individual products. Refer to specific product guidelines. Topical/Cutaneous: Cream/Lotion/Foam/Gel: Store between 20-25°C. Vaginal: Cream: Store between 20-25°C.
CIMS Class
Acne Treatment Preparations / Other Antibiotics / Preparations for Vaginal Conditions / Topical Antibiotics
ATC Classification
J01FF01 - clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections.
G01AA10 - clindamycin ; Belongs to the class of antibiotics. Used in the treatment of gynecological infections.
D10AF01 - clindamycin ; Belongs to the class of topical antiinfective preparations used in the treatment of acne.
Disclaimer: This information is independently developed by CIMS based on clindamycin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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