Dalacin C Ampoule - Clindamycin
Dalacin C AmpouleClindamycin. (clindamycin. phosph.) 300 mg
Company Name
Memphis/pfizerTherapeutic Group
MACROLIDES & SIMILAR TYPEPharmaceutical form
AmpoulePackage
Packaging containing 1 ampoule of 2 ml.Clindamycin Indications
"Clindamycin is indicated in the treatment of serious infections due to clindamycin sensitive micro-organisms (including Staphylococcus aureus) in patients who are allergic for penicillins. In cases of aerobic infections clindamycin is an alternative if other antimicrobial drugs are inactive or contraindicated. In cases of anaerobic infections clindamycin can be considered as a first choice drug.Upper airway infections: chronic sinusitis due to anaerobic germs. Clindamycin can be used in certain cases of chronic suppurative otitis media or as a supportive therapy in combination with an antibiotic active against Gram negative aerobic organisms. Infections due to H. influenzae are not an indication (see under Properties).
Clindamycin can also be used in cases of recurrent pharyngotonsillitis when other antimicrobial drugs are inactive or are contraindicated (penicillins, erythromycin and chemical related macrolides, cephalosporins).
Lower airway infections such as:
aspiration pneumonia, lung abscess, necrotising pneumonia and empyema
bacterial lung infection. DALACIN C® can also be used as an adjuvant in the treatment of Gram negative lung infection in order to suppress Gram positive cocci and anaerobic organisms.
1. Serious infections of the skin and of the soft tissues.
2. Bone and joint infections such as osteomyelitis and septic arthritis.
3. Serious gynaecological infections of the pelvis (PID) including endometritis, subcutaneous infections, perivaginal infections, tubo ovarial abscesses and salpingitis with simultaneous administration of an antibiotic with adequate activity against Gram negative aerobic organisms. Single therapy with clindamycin in cases of cervicitis due to Chlamydia trachomatis.
4. In intra abdominal infections, including peritonitis and abdominal abscess, the choice treatment is clindamycin associated with an antibiotic with adequate activity against Gram negative aerobic organisms.
In simultaneous administration associated with a suitable Gram negative antibiotic such as an aminoside, clindamycin appears to be effective in preventing peritonitis or intra abdominal abscesses after intestinal perforation and bacterial contamination following trauma.
5. Septicaemia and endocarditis. The effectiveness of clindamycin in the treatment of selected cases of endocarditis is documented (after the bactericidal effect of clindamycin against the causal germ was demonstrated in in vitro tests with adequate, obtainable serum levels).
6. Dental infections such as peridental abscess and parodontitis.
7. Limited clinical research suggests that clindamycin can be used for the treatment of encephalitis due to Toxoplasma in patients with AIDS. In patients who do not tolerate the usual treatment, clindamycin associated to pyrimethamine was found to be effective.
8. Limited clinical research suggests that clindamycin can be used for the treatment of Pneumocystis carinii pneumonia in patients with AIDS. In patients who do not tolerate the usual treatment (with sulfadiazine) or who do not adequately respond to this treatment, clindamycin can be used in association with primaquine.
9. Clinical studies show that clindamycin can be an alternative therapy alone or associated to quinine or amodiaquine for the treatment of malaria due to drug resistant P. falciparum.
As for all antibiotics, in vitro sensitivity tests should be carried out in cases of serious infections.
Clindamycin Warning & Precautions
"The injectable form of this product contains benzyl alcohol (9 mg/ml). It was reported that benzyl alcohol can be associated to the fatal ""gasping syndrome"" (respiratory disorder characterized by chronic gasping for breath) in premature babies.
The treatment with clindamycin was associated to serious colitis with a possible fatal issue. Toxins, produced by Clostridium difficile are the main cause of antibiotic induced colitis.
This form of colitis is characterized by mild, watery diarrhoea that may develop to serious, chronic diarrhoea, leukocytosis, fever, serious abdominal cramps that may be accompanied by loss of blood and slime. Without further treatment peritonitis, shock and toxic megacolon may develop.
Antibiotic induced colitis can occur with clindamycin up to 2 to 3 weeks after discontinuation of the treatment. The diagnosis of an antibiotic induced colitis is usually made based on clinical symptoms. The diagnosis can be confirmed by endoscopic demonstration of pseudomembranous colitis or by demonstrating the presence of Clostridium difficile and toxins in the faeces.
The treatment of antibiotic induced colitis can involve one or more of the following steps:
1) mild antibiotic induced colitis:
discontinuation of the treatment with clindamycin administration of colestipol (3 x 5 mg per day recommended) or cholestyramine resins (3 x 4 mg per day recommended)
2) serious antibiotic induced colitis:
administration of electrolyte solution and protein supplements
administration of metronidazole (500 mg, oral, every 8 hours for 10 days)
administration of vancomycin (125 to 500 mg, oral, every 6 hours for 7 to 10 days)
administration of vancomycin in the event of recurrences
simultaneous administration of vancomycin and cholestyramine is associated to the risk of binding. It is, therefore, recommended to leave a time interval between the administrations
administration of 25 000 units of oral bacitracin, four times daily for 7 to 10 days as an alternative treatment
3) Drugs that inhibit the intestinal motility should be avoided. Clindamycin should be prescribed with caution to individuals whit a history of gastrointestinal conditions, particularly colitis. Antibiotic induced colitis and diarrhoea occur more frequently and in more serious forms in debilitated and/or older patients. Since clindamycin does not penetrate adequately in the cerebrospinal fluid, this drug should not be used to treat meningitis.
Antagonism between clindamycin and erythromycin was demonstrated in vitro. Because of the possible clinical significance of this finding, both drugs should not be used simultaneously. With prolonged treatment, the function of the liver and of the kidneys should be monitored. The use of clindamycin phosphate can result in an overgrowth of insensitive organisms, mainly yeasts.
Clindamycin phosphate should never be administered in I.V. bolus in undiluted form, but must be infused over a time period of at least 10 60 minutes (See Posology and method of administration). Clindamycin appears to have neuromuscular blocking properties that can enhance the effects of other neuromuscular blocking drugs. In patients that are treated with these drugs, clindamycin should, therefore, be used with caution.
In patients with hypersensitivity, clindamycin phosphate should be administered with caution. In patients with serious renal disorders and/or serious liver conditions associated to serious metabolic conditions, clindamycin should be administered cautiously. The serum levels of clindamycin should be monitored if high doses are required. See above, under Posology and method of administration.
Product Type
Human
Clindamycin Dosage
"The dose and the mode of administration should be determined by the seriousness of the infection, the patient's condition and the sensitivity of the disease causing germ. It is recommended to swallow the capsules with a glass of water in order to avoid irritation of the esophagus.
ADULTS (I.M. OR I.V. ADMINISTRATION) (CLINDAMYCIN PHOSPHATE)
The usual daily dose of clindamycin phosphate is 2400 2700 mg in 2, 3 or 4 equal doses for intra abdominal infections, pelvic infections in women and other serious infections, usually combined with a suitable Gram negative aerobic antibiotic.
Less complicated infections due to more sensitive germs may respond to lower doses of 1200 1800 mg/day, divided in 3 or 4 equal doses.
Adults were successfully treated with doses up to 4800 mg.
Intramuscular administration of more than 600 mg in one administration is not recommended.
Treatment of PID: clindamycin phosphate I.V. 900 mg every 8 hours, associated to a suitable Gram negative antibiotic (e.g. gentamicin 2 mg/kg, followed by 1.5 mg/kg every 8 hours) in patients with a normal renal function. This treatment should be administered for at least 4 days. From the moment clinical improvement occurs, the treatment should be continued for another 2 days. Then 1800 mg of clindamycin hydrochloride per day should be administered, divided over several administrations, up to a total treatment duration of 10 to 14 days.
ADULTS (ORAL ADMINISTRATION) (CLINDAMYCIN HYDROCHLORIDE CAPSULES)
The current posology is 600-1800 mg divided in 3 or 4 administrations.
In the exceptional case of a treatment for recurrent infection with haemolytic streptococcal infection: 300 mg, twice daily for at least 10 days (see limitations in the section Indications).
Cervicitis due to Chlamydia trachomatis: 1800 mg per day, divided over several administrations for 10-14 days.
CHILDREN (OLDER THAN 1 MONTH) (I.V. OR I.M. ADMINISTRATION) (CLINDAMYCIN PHOSPHATE)
20 40 mg/kg/day in 3 or 4 equal administrations.
CHILDREN (OLDER THAN 1 MONTH) (ORAL ADMINISTRATION) CLINDAMYCIN HYDROCHLORIDE CAPSULES)
8 25 mg/kg/day in 3 or 4 equal administrations.
NEONATES (YOUNGER THAN 1 MONTH) (I.V. OR I.M. ADMINISTRATION) (CLINDAMYCIN PHOSPHATE)
15 20 mg/kg/day in 3 or 4 equal doses.
The lowest dose can be indicated for small premature babies.
DOSE IN CASES OF IMPAIRED RENAL AND/OR LIVER FUNCTION
Dose adjustment is not necessary in patients with an impaired renal function. Haemodialysis and peritoneal dialysis are not effective to remove clindamycin from the blood.
In patients with moderately to seriously reduced liver function, a prolonged half life of clindamycin was seen. Accumulation is rare if clindamycin is administered every 8 hours. A dose reduction is, therefore, not considered necessary.
ENCEPHALITIS DUE TO TOXOPLASMA IN PATIENTS WITH AIDS
DALACIN C ® solution for injection or DALACIN C ® capsules in a dose of 600-1200 mg every 6 hours for 2 weeks, followed by oral administration of 300-600 mg every 6 hours. The total treatment usually lasts 8 to 10 weeks. Oral administration of 25 mg to 75 mg of pyrimethamine per day for 8 to 10 weeks is necessary. With higher doses of pyrimethamine one should administer 10 to 20 mg of folic acid per day.
PNEUMOCYSTIS CARINII PNEUMONIA IN PATIENTS WITH AIDS
DALACIN C ® solution for injection in intravenous infusion in a dose of 600 to 900 mg every 6 hours or DALACIN C ® solution for injection in intravenous infusion in a dose of 900 mg every 8 hours or DALACIN C ® Capsules in a dose of 300 to 450 mg every 6 hours for 21 days, combined with 15 to 30 mg of oral primaquine per day for 21 days MALARIA
20 mg/kg/day oral or parenteral treatment for at least 5 days.
DILUTION AND INFUSION RATES
The concentration of clindamycin in the dilution medium should not be more than 18 mg per ml and the infusion rate should not be more than 30 mg per minute (See Side-effects). The normal infusion rates are as follows:
Dose Dilution agent Time
300 mg 50 ml 10 min.
600 mg 50 ml 20 min.
900 mg 100 ml 30 min.
1200 mg 100 ml 40 min.
Intravenous infusions of more than 1200 mg per hour are not recommended.
Clindamycin Adverse Reactions
"1. Gastrointestinal: abdominal pain, nausea, vomiting and diarrhoea (see Special precautions); oesophagitis for the oral preparations. Nearly all antibiotics can (sometimes after a latency time) cause serious diarrhoea, colitis and pseudomembranous colitis due to the toxins of Clostridium difficile. In cases of serious or prolonged cases of diarrhoea during treatment, the therapy should be discontinued. Colitis should be specifically treated, e.g. with oral vancomycin, associated to adequate administration of fluids, electrolytes and proteins. Drugs that inhibit the gastrointestinal peristalsis must be avoided.
2. Hypersensitivity reactions: maculopapular rash and urticaria were observed during drug treatment. The treatment with clindamycin has been associated to measles-like skin rash. Rare cases of erythema multiforme, sometimes similar to the Stevens Johnson syndrome, were reported. Cases of anaphylactoid reactions were reported. Anaphylactic shock was reported following intravenous administration. In cases of serious anaphylactoid reactions, immediate measures should be taken with the administration of epinephrine, oxygen and intravenous steroids. Mechanical ventilation, possibly with intubation, should also be applied if necessary.
3. Liver: jaundice and abnormal liver function tests were observed during treatment with clindamycin.
4. Skin and mucosae: pruritus, vaginitis and rare cases of exfoliative and vesiculobullous dermatitis.
5. Haematopoiesis: transient neutropenia (leukopenia) and eosinophilia, agranulocytosis and thrombocytopenia. In none of these cases a direct etiological link with the treatment with clindamycin could be observed.
6. Cardiovascular: rare cases of cardiopulmonary arrest and hypotension following rapid intravenous administration (see Posology and method of administration).
7. Local reactions: following I.M. injection: local irritation, pain and abscess; following I.V. injection: thrombophlebitis. These reactions can be reduced to a minimum by deep administration of I.M. injections and by avoiding prolonged catheterisation in the same vein.
8. The use of clindamycin phosphate can cause overgrowth of insensitive germs, particularly yeasts.
Clindamycin Contraindications
Clindamycin is contraindicated in patients who previously were hypersensitive to clindamycin or lincomycin or one of the other constituents of the product and in cases of infectious meningitis.
Clindamycin Drug Interactions
"An antagonism was demonstrated between clindamycin, erythromycin and chemically related macrolides.
Clindamycin appears to have neuromuscular blocking properties that can enhance the effect of other neuromuscular blockers. In patients treated with such drugs, clindamycin should, therefore, be used with caution.
Product Type
Human
Clindamycin Dosage
"The dose and the mode of administration should be determined by the seriousness of the infection, the patient's condition and the sensitivity of the disease causing germ. It is recommended to swallow the capsules with a glass of water in order to avoid irritation of the esophagus.
ADULTS (I.M. OR I.V. ADMINISTRATION) (CLINDAMYCIN PHOSPHATE)
The usual daily dose of clindamycin phosphate is 2400 2700 mg in 2, 3 or 4 equal doses for intra abdominal infections, pelvic infections in women and other serious infections, usually combined with a suitable Gram negative aerobic antibiotic.
Less complicated infections due to more sensitive germs may respond to lower doses of 1200 1800 mg/day, divided in 3 or 4 equal doses.
Adults were successfully treated with doses up to 4800 mg.
Intramuscular administration of more than 600 mg in one administration is not recommended.
Treatment of PID: clindamycin phosphate I.V. 900 mg every 8 hours, associated to a suitable Gram negative antibiotic (e.g. gentamicin 2 mg/kg, followed by 1.5 mg/kg every 8 hours) in patients with a normal renal function. This treatment should be administered for at least 4 days. From the moment clinical improvement occurs, the treatment should be continued for another 2 days. Then 1800 mg of clindamycin hydrochloride per day should be administered, divided over several administrations, up to a total treatment duration of 10 to 14 days.
ADULTS (ORAL ADMINISTRATION) (CLINDAMYCIN HYDROCHLORIDE CAPSULES)
The current posology is 600-1800 mg divided in 3 or 4 administrations.
In the exceptional case of a treatment for recurrent infection with haemolytic streptococcal infection: 300 mg, twice daily for at least 10 days (see limitations in the section Indications).
Cervicitis due to Chlamydia trachomatis: 1800 mg per day, divided over several administrations for 10-14 days.
CHILDREN (OLDER THAN 1 MONTH) (I.V. OR I.M. ADMINISTRATION) (CLINDAMYCIN PHOSPHATE)
20 40 mg/kg/day in 3 or 4 equal administrations.
CHILDREN (OLDER THAN 1 MONTH) (ORAL ADMINISTRATION) CLINDAMYCIN HYDROCHLORIDE CAPSULES)
8 25 mg/kg/day in 3 or 4 equal administrations.
NEONATES (YOUNGER THAN 1 MONTH) (I.V. OR I.M. ADMINISTRATION) (CLINDAMYCIN PHOSPHATE)
15 20 mg/kg/day in 3 or 4 equal doses.
The lowest dose can be indicated for small premature babies.
DOSE IN CASES OF IMPAIRED RENAL AND/OR LIVER FUNCTION
Dose adjustment is not necessary in patients with an impaired renal function. Haemodialysis and peritoneal dialysis are not effective to remove clindamycin from the blood.
In patients with moderately to seriously reduced liver function, a prolonged half life of clindamycin was seen. Accumulation is rare if clindamycin is administered every 8 hours. A dose reduction is, therefore, not considered necessary.
ENCEPHALITIS DUE TO TOXOPLASMA IN PATIENTS WITH AIDS
DALACIN C ® solution for injection or DALACIN C ® capsules in a dose of 600-1200 mg every 6 hours for 2 weeks, followed by oral administration of 300-600 mg every 6 hours. The total treatment usually lasts 8 to 10 weeks. Oral administration of 25 mg to 75 mg of pyrimethamine per day for 8 to 10 weeks is necessary. With higher doses of pyrimethamine one should administer 10 to 20 mg of folic acid per day.
PNEUMOCYSTIS CARINII PNEUMONIA IN PATIENTS WITH AIDS
DALACIN C ® solution for injection in intravenous infusion in a dose of 600 to 900 mg every 6 hours or DALACIN C ® solution for injection in intravenous infusion in a dose of 900 mg every 8 hours or DALACIN C ® Capsules in a dose of 300 to 450 mg every 6 hours for 21 days, combined with 15 to 30 mg of oral primaquine per day for 21 days MALARIA
20 mg/kg/day oral or parenteral treatment for at least 5 days.
DILUTION AND INFUSION RATES
The concentration of clindamycin in the dilution medium should not be more than 18 mg per ml and the infusion rate should not be more than 30 mg per minute (See Side-effects). The normal infusion rates are as follows:
Dose Dilution agent Time
300 mg 50 ml 10 min.
600 mg 50 ml 20 min.
900 mg 100 ml 30 min.
1200 mg 100 ml 40 min.
Intravenous infusions of more than 1200 mg per hour are not recommended.
Clindamycin Adverse Reactions
"1. Gastrointestinal: abdominal pain, nausea, vomiting and diarrhoea (see Special precautions); oesophagitis for the oral preparations. Nearly all antibiotics can (sometimes after a latency time) cause serious diarrhoea, colitis and pseudomembranous colitis due to the toxins of Clostridium difficile. In cases of serious or prolonged cases of diarrhoea during treatment, the therapy should be discontinued. Colitis should be specifically treated, e.g. with oral vancomycin, associated to adequate administration of fluids, electrolytes and proteins. Drugs that inhibit the gastrointestinal peristalsis must be avoided.
2. Hypersensitivity reactions: maculopapular rash and urticaria were observed during drug treatment. The treatment with clindamycin has been associated to measles-like skin rash. Rare cases of erythema multiforme, sometimes similar to the Stevens Johnson syndrome, were reported. Cases of anaphylactoid reactions were reported. Anaphylactic shock was reported following intravenous administration. In cases of serious anaphylactoid reactions, immediate measures should be taken with the administration of epinephrine, oxygen and intravenous steroids. Mechanical ventilation, possibly with intubation, should also be applied if necessary.
3. Liver: jaundice and abnormal liver function tests were observed during treatment with clindamycin.
4. Skin and mucosae: pruritus, vaginitis and rare cases of exfoliative and vesiculobullous dermatitis.
5. Haematopoiesis: transient neutropenia (leukopenia) and eosinophilia, agranulocytosis and thrombocytopenia. In none of these cases a direct etiological link with the treatment with clindamycin could be observed.
6. Cardiovascular: rare cases of cardiopulmonary arrest and hypotension following rapid intravenous administration (see Posology and method of administration).
7. Local reactions: following I.M. injection: local irritation, pain and abscess; following I.V. injection: thrombophlebitis. These reactions can be reduced to a minimum by deep administration of I.M. injections and by avoiding prolonged catheterisation in the same vein.
8. The use of clindamycin phosphate can cause overgrowth of insensitive germs, particularly yeasts.
Clindamycin Contraindications
Clindamycin is contraindicated in patients who previously were hypersensitive to clindamycin or lincomycin or one of the other constituents of the product and in cases of infectious meningitis.
Clindamycin Drug Interactions
"An antagonism was demonstrated between clindamycin, erythromycin and chemically related macrolides.
Clindamycin appears to have neuromuscular blocking properties that can enhance the effect of other neuromuscular blockers. In patients treated with such drugs, clindamycin should, therefore, be used with caution.
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