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DALACIN ® Capsules
Clindamycin
COMPOSITION
Each capsule contains:
Clindamycin (I.N.N.) base (clindamycin hydrochloride) … 150 mg. .……. 300 mg.
Excipients:
Lactose, maize starch, talc, magnesium stearate………….. q.s. ………….... q.s.
ACTION
Clindamycin hydrochloride is rapidly hydrolyzed in vivo converting this compound to active clindamycin base.
DALACIN is a very effective antibiotic against the majority of gram-positive cocci such as staphylococci (coagulase-positive and -negative), streptococci (except Streptococcus faecalis) and pneumococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, the use of penicillin is inappropriate. It is also effective against some gram-positive bacilli, such as Eubacterium species and Actinomyces species and anaerobic gram-negative bacilli, such as Bacteroides species and Fusobacterium species.
Dalacin has been shown to be effective in eradicating susceptible strains of Chlamydia trachomatis.
INDICATIONS
Upper or lower respiratory tract infections, provided that they are of bacterial nature, when caused by susceptible strains of the abovementioned bacteria and that don't respond to viral process. Skin and soft tissue infections: abscesses, cellulitis and infected wounds. Severe dental infections: periapical abscesses and gingivitis. Serious infections: acute and chronic osteomyelitis and bacteraemia.
As an alternative therapy for the treatment of infections of the female pelvis and genital tract such as endometritis, postsurgical vaginal cuff infection, nongonococcal tubo-ovarian abscess, salpingitis and acute pelvic inflammatory disease only when Clindamycin is given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum. In cases of cervicitis due to Chlamydia trachomatis, mono therapy with Clindamycin has been shown to be effective in eradicating the organism.
Toxoplasmic encephalitis in patients with AIDS. In patients who are intolerant to conventional treatment, clindamycin in combination with pyrimethamine has been shown to be efficacious.
Pneumocystis carinii pneumonia in patients with AIDS. In patients who are intolerant to or do not respond appropriately to conventional treatment, clindamycin in combination with primaquine can be administered.
CONTRAINDICATIONS
DALACIN is contraindicated in individuals with a previously found hypersensitivity to preparations containing clindamycin or lincomycin. Clindamycin should not be used in the treatment of meningitis. It is not indicated for use in newborns.
SIDE EFFECTS
DALACIN is generally well tolerated. The most frequently reported side effect is diarrhoea (10 - 20% of patients that take clindamycin). The onset of pseudomembranous colitis is the most serious side effect caused by the administration of this antibiotic. Other side effects include: abdominal pain, nausea, vomiting, hypersensitivity reactions (maculopapular rash, pruritus, urticaria, generalized morbilli form-like skin rashes), abnormalities in liver function tests, jaundice and vaginitis.
PRECAUTIONS
Severe and persistent diarrhoea has been reported during or after treatment with clindamycin. This diarrhoea may be associated with blood and mucous in the stools and has sometimes resulted in acute colitis (usually caused by toxins produced by Clostridium difficile). Endoscopic examination may reveal pseudomembrane formation. Colitis has started during the administration or even two or three weeks following administration of clindamycin. The disease is likely to take a more severe course in older patients or in patients who are debilitated.
If persistent and significant diarrhoea occurs during therapy, the medication should be discontinued, and if necessary, continued only with close observation of the patient. If colitis is suspected endoscopy is recommended. Mild cases of diarrhoea, showing minimal mucosal changes may decrease upon drug discontinuance. Treatment with Cholestyramine or Colestipol resins have shown to be useful in these cases. Moderate or severe cases, including those showing ulceration or pseudomembrane formation, should be managed with fluid electrolyte, protein supplementation and an appropriate antibiotic (Vancomycin 125 to 500 mg. orally, every 6 hours administered for seven to ten days). Relapse may occur after treatment with vancomycin. If the resins are administered concurrently with the antibiotic, it may be advisable to administer the medicines several hours apart.
Anticholinergics and antiperistaltic agents may worsen the condition of the patient. Other causes of colitis should be considered.
The use of antibiotics occasionally results in overgrowth of nonsusceptible organisms-particularly yeasts.
During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed. Safety for use in pregnancy has not yet been established.
This preparation contains lactose. Even though, intolerance to this ingredient has been reported in children and adolescents, the quantity present in this medication is probably not sufficient to cause symptoms of intolerance. If diarrhea occurs consult your doctor.
INCOMPATIBILITIES AND INTERACTIONS
Some cases of cross resistance (antagonism) in vitro have been demonstrated between clindamycin and erythromycin.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.
ADMINISTRATION AND DOSAGE
Adults:
150 to 450 mg. every 6 hours, depending on the severity of the infection.
Infants over one month of age:
8 to 25 mg./kg./day divided into three or four equal doses. The absorption of DALACIN is not appreciably modified by the presence of food and can be taken with meals.
NOTE: In cases of beta haemolytic streptococcal infection, treatment with Dalacin should continue for at least 10 days.
For treatment of acute pelvic inflammatory disease - Inpatient treatment:
Treatment should commence with 900 mg. (IV) every 8 hours plus an antibiotic with an appropriate gram negative aerobic spectrum administered IV. Continue (IV) drugs for at least 4 days and at least 48 hours after the patient improves. Then continue with oral clindamycin hydrochloride 450 mg. every 6 hours to complete 10 - 14 days total therapy.
For treatment of cervicitis due to Chlamydia trachomatis:
450 mg. Clindamycin hydrochloride by mouth every 6 hours, for 10 - 14 days.
For the treatment of toxoplasmic encephalitis in patients with AIDS:
Treatment should commence with 600 - 1200 mg. every 6 hours for two weeks followed by 300 - 600 mg. every 6 hours. The usual total duration of therapy is 8 to 10 weeks. The dose of pyrimethamine is 25 - 75 mg. by mouth daily for 8 - 10 weeks. 10 - 20 mg./day folinic acid should be given with higher doses of pyrimethamine.
For the treatment of Pneumocystis carinii pneumonia in patients with AIDS:
Administer 300 - 450 mg. clindamycin hydrochloride by mouth every 6 hours for 21 days. The dose of primaquine is 15 - 30 mg. by mouth once daily for 21 days.
OVERDOSE AND ITS TREATMENT
A few cases of anaphylactoid reactions have been reported. If hypersensitivity reactions occur it is recommended that the administration of the medication be discontinued. In the case of severe reactions, therapy should be with the usual emergency treatments, including epinephrine, corticosteroids and antihistamines.
In the case of an overdose or accidental ingestion, contact your local poison control centre (Servicio de Información Toxicologica. Telephone: (91) 562 04 20) immediately.
CONDITIONS FOR STORAGE
Store in a cool, dry place.
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