DALABAC Capsule

Indications:

Treatment of the following infections caused by susceptible anaerobic bacteria or susceptible strains of gram-positive aerobic bacteria, eg streptococci, straphylococci and pneumonococci; and susceptible strains of Chlamydia trachomatis.

• Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever.

• Lower respiratory infections including bronchitis, pneumonia, empyema and lung abscess.

• Skin and soft tissue infections including acne, furuncles, cellulitis, impetigo, abscesses and wound infections, specific skin and soft tissue infections caused by susceptible organisms, eg erysipelas and paronychia.

• Bone and joint infections including osteomyelitis and septic arthritis.

• Gynecological infections including endometritis, cellulitis, vaginal cuff infection, tubo-ovarian abscess, salpingitis and pelvic inflammatory disease when given in conjunction with an

antibiotic of appropriate gram-negative spectrum. In cases of cervicitis due to Chlamydia

trachomatis, single-drug therapy with clindamycin has been shown to be effective in

eradicating the organism.

• Intra-abdominal infections including peritonitis and abdominal abscess when given in

conjunction with an antibiotic of appropriate gram-negative aerobic spectrum.

• Septicemia and endocarditis.

• Dental infections, eg periodental abscess and periodontitis.

Dosage:

This drug is used upon doctor's prescription only.

Dosage should be determined by the severity of the infection, the condition of the patient and the susceptibility of the causative microorganisms.

Adults: 2 capsules/day.

serious line: 4-6 capsules/day.

Children: 8-16 mg(potency)/kg/day in 3 or 4 equal doses.

serious line: 16-20 mg(potency)/kg/day in 3 or 4 equal doses.

In case of (-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

DALABAC is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea and esophagitis.

Hypersensitivity reactions: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most

frequently reported.

Rare instances of erythema multiforme, some resembling Stevens -Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported reactions.

Liver: Jaundice and abnormalities in liver function tests have been observed during

clindamycin therapy.

Skin and mucous membranes: Pruritus, vaginitis and rare instances of exfoliative and

vesiculobullous dermatitis have been reported reactions.

Hematopoietic: Transient neutropenia and eosinophilia have been reported. Reports of

agranulocytosis and thrombocytopenia have been made.

inform your doctor of any adverse effect related to drug use.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Antagonism has been demonstrated between clindamycin and erythromycin in vitro.

Therefore, these two drugs should not be administered concurrently.

Used in pregnancy:

Reproduction studies performed in rats and mice using oral doses of clindamycin up to

600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of the human response, this drug

should be used during pregnancy only if clearly needed.

Used in lactation:

Clindamycin has been reported to appear in breast milk in the range of 0. 7 to 3.8 g/ml.

Caution should be exercised when clindamycin is administered to a nursing woman.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit

overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic associated colitis"

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug

discontinuation alone. In moderate to severe cases, consideration should be given to

management with fluids and electrolytes, protein supplementation, and treatment with an

antibacterial drug clinically effective against C.difficile colitis.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin.

Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should

not be used in the treatment of meningitis.

The drug should be prescribed with caution in patients with a history of gastrointestinal

disease, particularly colitis.

The use of clindamycin occasionally results in overgrowth of nonsusceptible organisms.

Should superinfections occur, appropriate measures should be taken as indicated by the

clinical situation.

If therapy is prolonged, periodic liver and kidney function tests and blood counts should be

performed.

Clindamycin dosage modification is not necessary in patients with renal disease.

In patients with moderate to severe liver disease, prolongation of the half-life of clindamycin has been found, but a pharmacokinetic study has shown that, when given every 8 hours,

accumulation of clindamycin should rarely occur. Therefore, dosage reduction in liver disease is not considered necessary.