COMPOSITIONS :
Clindamycin HCl Capsule 300 mg, each capsule contains : Clindamycin HCl equivalent to Clindamycin 300 mg.
DESCRIPTIONS :
Clindamycin HCl with Clindamycin HCl (equivalent to Clindamycin) as active ingredient is available in capsule 300 mg.
INDICATIONS :
For the treatment of serious infections caused by sensitive anaerobes Gram-positive bacteria, such as Streptococcus, Pneumococcus and Staphylococcus :
- Respiratory tract : Empyema, anaerobic pneumonitis and lung abscess.
- Skin and soft tissues infections.
- Septicemia.
- Intra-abdominal infections e.g., peritonitis and intra-abdominal abscess.
- Gynecological infections including endometritis, pelvic cellulitis and post surgical vaginal cuff infection.
- Joints and bones infections.
DOSAGE AND ADMINISTRATIONS :
Adults :
- Serious infections : 150 – 300 mg every 6 hours.
- More severe infections : 300 – 450 mg every 6 hours.
Children :
- Serious infections : 8 – 16 mg/kgBW/day divided into 3 – 4 equal doses.
- More severe infections : 16 – 20 mg/kgBW/day divided into 3 – 4 equal doses.
If significant diarrhea occurs during therapy, this antibiotic should be discontinued. To avoid the possibility of esophageal irritation, Clindamycin should be taken with a full glass of water.
In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
CONTRAINDICATIONS :
- Patients with known hypersensitivity to antibiotic Clindamycin or Lincomycin.
- Patients with diarrhea.
WARNINGS AND PRECAUTIONS :
- Clindamycin only used for treatment serious infection.
- Clindamycin should not be used in patient with upper respiratory tract infections.
- Caution when administered to patient with a history of gastrointestinal disease, especially colitis.
- In patients with renal or liver disfunction, dosage may be decreased because on those patients, the half time of Clindamycin has prolonged.
- Caution used in elderly patients. An alteration of defecation frequency must be monitored, because elderly with severe disease are sensitive with diarrhea.
- Caution used in atopic patients.
- Clindamycin may cause an overgrowth of non-susceptible organism particularly yeasts. If super-infections occur, appropriate measures should be taken as indicated by patient clinical condition.
- Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
- During prolonged therapy, liver and kidney function tests should be done periodically and blood counts should be performed.
- In patients with severe renal disease which have severe abnormal metabolism, the dosage must be administered carefully and the concentration of Clindamycin in serum must be monitored during the high dosage treatment.
- Since Clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
- Clindamycin is excreted through breast milk, therefore in neonates must be considered to making decision for lactation or stop lactation taking into consideration interests of the treatment.
- Administered in newborn babies, the monitoring of organ function must be done adequately. For injection which contain of Benzyl alcohol as an excipient may cause “gasping syndrome” in premature baby.
DRUG INTERACTIONS :
- Antagonism has been demonstrated between Clindamycin and Erythromycin in vitro, because clinically the possibility, then both of these two drugs should not be administrated concurrently.
- Clindamycin has a neuromuscular-blocking properties that may increase the action of other neuromuscular-blocking agents. Therefore, it should be used with caution in patients receiving this drug.
ADVERSE REACTIONS :
- Gastrointestinal : Colitis which related to antibiotics, abdominal pain, nausea, vomiting and diarrhea, metallic taste in the mouth after an IV administration of Clindamycin phosphate in high dosage.
- Hypersensitivity : Maculopapular rash and urticaria, mild-moderate morbiliform-like skin rashes, Steven-Johnson syndrome, anaphylactic.
- Liver : Jaundice and abnormalities in liver function tests.
- Renal : Renal disfunction including azotemia, oliguria and/or proteinuria.
- Hematopoetic : Neutropenia (leucopenia) and eosinofilia, rare : Agranulocytosis, thrombocytopenia.
- Local reaction: Pain, induration, an abscess after an IV infusion administration.
- Musculoskeletal : Polyarthritis (rare).
- Cardiovascular : Cardiopulmonary arrest, hypotension (rare).
- Skin and mucous membranes : Pruritus, vaginitis and rare cases ; exfoliative and vesicolobullous dermatitis.
PRESENTATION :
Clindamycin HCl Capsule 300 mg Box, 10 strips @ 10 capsules
Reg. No. GKL1002343101B1
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
