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Clindamycin

J01F - Macrolides, lincosamides and streptogramins ATC G01AA10 Small molecule approved 1970 Oral Natural product Black-box warning

JFDA label: Dalacin Vaginal Cream

⚠ Black-Box Warning
  • gastrointestinal toxicity — ChEMBL drug_warning (Black Box Warning) | United States
  • infectious disease — ChEMBL drug_warning (Black Box Warning) | United States
  • misuse — ChEMBL drug_warning (Black Box Warning) | United States
  • Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE and may range in severity from mild diarrhea to fatal co

Mechanism of Action

Mechanism of Action Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

Indications

Approved

  • Acne Vulgaris — acne
  • Bacterial Infections — bacterial disease
  • Endometritis — Endometritis
  • Infections — infection
  • Intraabdominal Infections — infection
  • Osteomyelitis — osteomyelitis

Off-label

  • Breast Neoplasms
  • Candidiasis, Vulvovaginal
  • Carcinoma, Non-Small-Cell Lung
  • Chorioretinitis
  • Hernia
  • Hernia, Ventral
  • Kidney Calculi
  • Malaria
  • Nasal Obstruction
  • Pain
  • Periapical Periodontitis
  • Pneumonia, Pneumocystis
  • Prediabetic State
  • Severe Acute Respiratory Syndrome
  • Skin Diseases
  • Staphylococcal Infections
  • Vaginosis, Bacterial

Antimicrobial Spectrum

Expected / intrinsic spectrum (EUCAST breakpoints & labels) — not local resistance. Source: EUCAST v16 · curated · openfda-label.

Bacteria

OrganismActivityMIC
Anaerobes Susceptible 45.0 mg/L
Bacillus spp. Susceptible 1.0 mg/L
Bacteroides fragilis group Susceptible 4.0 mg/L
Clostridium clostridioforme Active
Clostridium perfringens Active
Corynebacterium spp. Susceptible 0.5 mg/L
Enterococcus faecalis Active
Fusobacterium necrophorum Active
Fusobacterium nucleatum Active
Peptostreptococcus anaerobius Active
Prevotella bivia Active
Prevotella intermedia Active
Prevotella melaninogenica Active
Staphylococcus aureus Susceptible 0.25 mg/L
Staphylococcus epidermidis Active
Staphylococcus spp. Susceptible 0.25 mg/L
Streptococcus A/B/C/G Susceptible 0.5 mg/L
Streptococcus agalactiae Active
Streptococcus anginosus Active
Streptococcus mitis Active
Streptococcus oralis Active
Streptococcus pneumoniae Susceptible 0.5 mg/L
Streptococcus pneumoniae Susceptible 0.5 mg/L
Streptococcus pyogenes Susceptible 0.5 mg/L
Viridans group streptococci Susceptible 0.5 mg/L
Staphylococcus aureus Resistant 0.5 mg/L

Class profile

gramStatusGram+
spectrumBreadthModerate
atypicalCoverageNo
isBactericidal0
moaCategoryProtein synthesis inhibitor (50S ribosomal, 23S rRNA)
pdIndexTime-dependent
postAntibioticEffectShort
mrsaCoverage0
resistanceMechanismsTarget site methylation (erm genes),Efflux pumps

Contraindications

Source: openFDA

  • This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. Absolute

Dosing

Source: openFDA

If diarrhea occurs during therapy, this antibacterial drug should be discontinued (see WARNING box ). Clindamycin phosphate IM administration should be used undiluted. Clindamycin phosphate IV administration should be diluted (see Dilution for IV use and IV infusion rates below). Adults: Parenteral (IM or IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis , Peptococcus species and Clostridium species other than Clostridium perfringens ): 600–1200 mg/day in 2, 3 or 4 equal doses. More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens : 1200–2700 mg/day in 2, 3 or 4 equal doses. For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution for IV use and IV Infusion Rates section below. Single intramuscular injections of greater than 600 mg are not recommended. Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows: Table 2: Serum Clindamycin Levels Maintained, Rapid Infusion Rate and Maintenance Infusion Rate To maintain serum clindamycin levels Rapid infusion rate Maintenance infusion rate Above 4 mcg/mL 10 mg/min for 30 min 0.75 mg/min Above 5 mcg/mL 15 mg/min for 30 min 1.00 mg/min Above 6 mcg/mL 20 mg/min for 30 min 1.25 mg/min Pediatric Patients 1 month of age to 16 years: Parenteral (IM or IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. Clindamycin should be dosed based on total body weight regardless of obesity. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m 2 /day for serious infections and 450 mg/m 2 /day for more severe infections. Parenteral therapy may be changed to oral CLEOCIN PEDIATRIC ® Flavored Granules (clindamycin palmitate hydrochloride) or CLEOCIN HCl ® Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician. In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days. Pediatric Patients less than 1 month: The recommended dosage is 15 to 20 mg/kg/day in 3 to 4 equal doses. See Table 3 regarding the dosing regimen for pediatric patients with post-menstrual age (PMA) less than or equal to 32 weeks, or greater than 32 weeks to less than or equal to 40 weeks. Table 3: Dosing Regimens for Pediatric Patients with PMA less than or equal to 32 weeks, or greater than 32 weeks to less than or equal to 40 weeks PMA (weeks) Dose (mg/kg) Dosing Interval (hours) PMA: Post-Menstrual age Less than or equal to 32 5 8 Greater than or equal to 32 to less than or equal to 40 7 8 Dilution for IV use and IV Infusion Rates: The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows: Dose Diluent Time 300 mg 50 mL 10 min 600 mg 50 mL 20 min 900 mg 50–100 mL 30 min 1200 mg 100 mL 40 min Administration of more than 1200 mg in a single 1-hour infusion is not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of CLEOCIN PHOSPHATE Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing

Warnings & Precautions

Source: openFDA

Boxed Warning

Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . Because CLEOCIN PHOSPHATE therapy has been associated with severe colitis which may end fatally, it 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 most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

Warnings & Precautions

See BOXED WARNING . Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Anaphylactic and Severe Hypersensitivity Reactions Anaphylactic shock and anaphylactic reactions have been reported ( see ADVERSE REACTIONS ) . Severe hypersensitivity reactions, including acute myocardial ischemia with or without myocardial infarction, and severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported ( see ADVERSE REACTIONS ) . In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy. A careful inquiry should be made concerning previous sensitivities to drugs and other allergens. Benzyl Alcohol Toxicity in Neonates ("Gasping Syndrome") This product contains benzyl alcohol as a preservative. The administration of intravenous solutions containing the preservative benzyl alcohol has been associated with the "gasping syndrome", and death in neonates. Symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse. Although the normal therapeutic dose of this product delivers amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the min

Pregnancy & Lactation

Pregnancy

Lactation

Compatible Hale L1

If a nursing mother requires oral or intravenous clindamycin, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred.

LactMed: monitor the infant.

Monitoring

EfficacyCulture and susceptibility testing; clinical resolution (temperature, WBC, CRP, procalcitonin)
ToxicityRenal function (dose adjustment in renal impairment); hepatic function for hepatically cleared agents; signs of C. difficile infection (diarrhoea)
Clinical pearlCulture results guide de-escalation to narrower-spectrum therapy. Review antibiotic appropriateness at 48–72 h (antimicrobial stewardship).
CounselingComplete the full course. Report persistent diarrhoea, rash, or lack of improvement after 48–72 h.

Chemistry & Properties

2D structure
FormulaC18H33ClN2O5S
Molecular weight424.99 g/mol
IUPAC name(2S,4R)-N-[(1S,2S)-2-chloro-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide
CAS18323-44-9
PubChem CID446598
InChIKeyKDLRVYVGXIQJDK-AWPVFWJPSA-N
logP0.39 (XLogP 2.2)
Polar surface area102.26 Ų
H-bond acceptors / donors7 / 4
Drug-likeness (QED)0.44
Lipinski violations0
SMILESCCC[C@@H]1C[C@@H](C(=O)N[C@@H]([C@H]2O[C@H](SC)[C@H](O)[C@@H](O)[C@H]2O)[C@H](C)Cl)N(C)C1

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP2C19Substrate
CYP3A4Substrate

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OCT1 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)

Drug–drug interactions (72, DDInter)

Interacting drugSeverityManagement
Typhoid vaccine (live) major
Vibrio cholerae CVD 103-HgR strain live antigen (live) major
Abametapir (topical) moderate
Amprenavir moderate
Apalutamide moderate
Atazanavir moderate
Atracurium moderate
Attapulgite moderate
Balsalazide moderate
Bifidobacterium longum infantis moderate
Boceprevir moderate
Carbamazepine moderate
Ceritinib moderate
Cisatracurium moderate
Clarithromycin moderate
Cobicistat moderate
Conivaptan moderate
Cyclosporine moderate
Delavirdine moderate
Doxacurium moderate
Enzalutamide moderate
Erythromycin moderate
Estradiol moderate
Ethinylestradiol moderate
Fosamprenavir moderate
Fosphenytoin moderate
Gentamicin moderate
Givosiran moderate
Idelalisib moderate
Indinavir moderate
Indium In-111 oxyquinoline moderate
Itraconazole moderate
Kaolin moderate
Ketoconazole moderate
Lactobacillus acidophilus moderate
Lonafarnib moderate
Lumacaftor moderate
Mestranol moderate
Metocurine moderate
Mitotane moderate

Showing 40 of 72.

Registered Products (29)

BrandForm / strengthPackAgentCitizen (JOD)
Clidacin BA Free Ampoule 600 mg/4 ml 1 amp Manar Drug Store 1.740
Clinaram-150mg capsule Capsule 150 mg 16 cap pack varies AL-RAM PHARMA.INDUS.CO.LTD/JORDAN 2.430
Clindacin Capsules Capsule 150 mg 16 cap pack varies UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN 2.430
Clinimycin Caps Capsule 150 mg 16 cap pack varies Hayat Pharmaceutical Industries CO.PLC/JORDAN 2.430
Clinimycin Caps Capsule 150 mg 400 cap pack varies Hayat Pharmaceutical Industries CO.PLC/JORDAN 2.430
Lanacin cap Capsule 150 mg 16 cap pack varies Pharma International Company/ Jordan 2.430
DALACIN C CAPSULES Capsule 150 mg 16 cap Khoury Drug Store 2.560
DALACIN C INJ 300MG Injection 300 mg/2 ml 2 ml Khoury Drug Store 2.920
Clinceen 300mg/2ml Concetrate for solu for inj Injection 150 mg/ml 1 vial MS PHARMA/JORDAN 3.080
Clinaderm Solution Solution 1 % 30 ml PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN 3.240
Fouch Vaginal Cream Cream 2 % 40gm + 7 applicators AL-BARON DRUG STORE 3.270
Clindacin Gel Gel 10 mg/g 30 g tube UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN 3.480
Clindacin Capsule 300 mg 16 cap UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN 3.940
Clinimycin Tablet as Hcl 300 mg 16 tab Hayat Pharmaceutical Industries CO.PLC/JORDAN 3.940
DALACIN C CAPSULES Capsule 300 mg 16 cap Khoury Drug Store 4.150
Clinimycin T solution Solution 10 mg/ml 50 ml Hayat Pharmaceutical Industries CO.PLC/JORDAN 4.380
Dalacin-T Topical solution Solution 1 % 30 ml Khoury Drug Store 4.610
Clinimycin T gel Gel 1 % 45 g tube Hayat Pharmaceutical Industries CO.PLC/JORDAN 4.790
Clinceen Vial 150 mg/ml 1 vial MS PHARMA/JORDAN 4.950
DALACIN C INJ 600MG 4ML/A Injection 600 mg/4 ml 4 ml Khoury Drug Store 4.950
Lindacin Topical Solution Solution (as Phosphate) 10 mg/ml 50 ml Amman Pharmaceutical Industries Co 5.000
Dalacin T lotion Lotion 1 % 30 ml Khoury Drug Store 5.540
Acticare 1.2%,0.025% Cream 0.025 %, 1.2 % 30 gm pack varies Hayat Pharmaceutical Industries CO.PLC/JORDAN 6.170
Dalacin Vaginal Cream Cream 2 % 40gm+7appl Khoury Drug Store 7.640
Acticare 1.2%,0.025% Cream 0.025 %, 1.2 % 45 gm pack varies Hayat Pharmaceutical Industries CO.PLC/JORDAN 9.260
Clinaram-150mg capsule Capsule 150 mg 400 cap pack varies AL-RAM PHARMA.INDUS.CO.LTD/JORDAN 51.640
Lanacin cap Capsule 150 mg 400 cap pack varies Pharma International Company/ Jordan 51.640
Clindacin Capsules Capsule 150 mg 800 cap pack varies UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN 103.280
Clinaram-150mg capsule Capsule 150 mg 1000 cap pack varies AL-RAM PHARMA.INDUS.CO.LTD/JORDAN 129.090