Dalacin/Dalacin C

Dalacin/Dalacin C

clindamycin

Manufacturer:

Pfizer

Distributor:

DKSH
Full Prescribing Info
Contents
Clindamycin salts.
Description
Dalacin capsules contain clindamycin HCl hydrate, while Dalacin C ampoules contain clindamycin phosphate.
Each mL of ampoule also contains benzyl alcohol, disodium edetate and water for injection. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.
Clindamycin HCl hydrate is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Clindamycin phosphate is a water-soluble ester of the antibiotic clindamycin [7(S)chloro-7-deoxylincomycin] and phosphoric acid. Clindamycin is produced by a 7-chloro-substitution at the 7(R)-hydroxyl group of the parent compound lincomycin. As a result of this chemical alteration, Dalacin/Dalacin C has more in vitro potency than lincomycin.
Action
Antibacterial antibiotics and anti-infections.
Pharmacokinetics: Dalacin: Serum level studies with a 150-mg oral dose of Dalacin in 24 normal adult volunteers showed that Dalacin was rapidly absorbed after oral administration. An average peak serum level of 2.5 mcg/mL was reached in 45 min; serum levels averaged 1.51 mcg/mL at 3 hrs and 0.7 mcg/mL at 6 hrs. Absorption of an oral dose is virtually complete (90%), and the concomitant administration of food does not appreciably modify the serum concentrations; serum levels have been uniform and predictable from person to person and dose to dose. Serum level studies following multiple doses of clindamycin HCl hydrate for up to 14 days show no evidence of accumulation or altered metabolism of drug.
Serum half-life of Dalacin is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing Dalacin from the serum.
Concentrations of Dalacin in the serum increased linearly with increased dose. Serum levels exceed the MIC for most indicated organisms for at least 6 hrs following administration of the usual recommended doses. Dalacin is widely distributed in body fluids and tissues (including bones). The average biological half-life is 2.4 hrs. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bio-inactive metabolites. Doses of up to 2 g of Dalacin/day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses.
No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.
Dalacin C: Biologically inactive clindamycin phosphate is rapidly converted to active clindamycin. By the end of short-term IV infusion, peak serum levels of active clindamycin are reached. Biologically inactive clindamycin phosphate disappears rapidly from the serum, the average disappearance half-life is 6 min; however, the serum disappearance half-life of active clindamycin is about 3 hrs in adults and 2½ hrs in children. After IM injection of clindamycin phosphate, peak levels of active clindamycin are reached within 3 hrs in adults and 1 hr in children. Serum level curves may be constructed from IV peak serum levels as given in Table 1 by application of disappearance half-lives listed previously. Serum levels of clindamycin can be maintained above the in vitro minimum inhibitory concentrations for most indicated organisms by administration of clindamycin phosphate every 8-12 hrs in adults and every 6-8 hrs in children or by continuous IV infusion. An equilibrium state is reached by the 3rd dose. No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. The disappearance half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function; dosage schedules need not be modified in the presence of mild or moderate renal or hepatic disease. Serum assays for active clindamycin require an inhibitor to prevent in vitro hydrolysis of clindamycin phosphate. (See Table 1.)

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Microbiology: Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. The Dalacin/Dalacin C spectrum of in vitro activity includes the following gram-positive aerobic organisms: Staphylococcus aureus and Staphylococcus epidermidis (both penicillinase- and nonpenicillinase-producing strains), Streptococci (except S. faecalis), Pneumococci and anaerobic organisms: Anaerobic gram-negative bacilli eg, Bacteroides and Fusobacterium spp; anaerobic gram-positive nonspore-forming bacilli eg, Propionibacterium, Eubacterium and Actinomyces spp; and anaerobic and microaerophilic gram-positive cocci eg, Peptococcus sp, Peptostreptococcus sp and microaerophilic Streptococci; and Clostridium sp. (Clostridium perfringens for Dalacin C Phosphate.)
Dalacin/Dalacin C demonstrates cross-resistance with lincomycin. When tested by in vitro methods, some staphylococcal strains originally resistant to erythromycin rapidly developed resistance to Dalacin/Dalacin C.
Dalacin/Dalacin C susceptibility discs may be used for determination of the in vitro susceptibility of aerobic bacteria to Dalacin/Dalacin C.
Dalacin/Dalacin C susceptibility powder may be used for determination of the in vitro susceptibility of anaerobic and aerobic bacteria to Dalacin/Dalacin C*.
*Dalacin/Dalacin C susceptibility discs 2 mcg. Dalacin/Dalacin C susceptibility powder 20 mg.
Susceptibility Testing: In vitro (Dalacin C Phosphate), a standardized disc testing procedure* is recommended for determining susceptibility of aerobic bacteria to clindamycin. A description is contained in the Dalacin/Dalacin C susceptibility disc insert. Using this method, the laboratory can designate isolates as resistant, intermediate or susceptible. Tube or agar dilution methods may be used for both anaerobic and aerobic bacteria following the directions in the Dalacin/Dalacin C susceptibility powder insert.
At present, only dilution methods can be recommended for testing antibiotic susceptibility of obligate/fastidious anaerobes.
Additional data and simplification of techniques will be necessary before the routine employment of disc susceptibility testing of anaerobes can be recommended as a reliable means of assaying in vitro susceptibility of these organisms.
Ampoule: *Bauer, A.W., Kirby, W.M.M., Sherris, J.C., Turck.M.: Antibiotic susceptibility testing by a standardized single disc method. Am.J.Clin.Path., 45: 493-496.
Indications/Uses
Treatment of infections caused by susceptible strains of the following microorganisms:
Streptococci: Upper respiratory tract infections (injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal pharyngitis and in long-term prophylaxis of rheumatic fever.) Dalacin/Dalacin C is effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Dalacin/Dalacin C in the subsequent prevention of rheumatic fever are not available at present. Lower respiratory tract infections. Skin and soft tissue infections.
Staphylococci: Upper and lower respiratory tract infections. Skin and soft tissue infections.
Pneumococci: Upper and lower respiratory tract infections.
Adjunctive Therapy: Dental infections due to susceptible organisms.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to Dalacin/Dalacin C.
(See Susceptibility Testing under Actions.)
Ampoule: Streptococci: Septicemia.
Staphylococci: Septicemia, acute hematogenous osteomyelitis.
Anaerobic Bacteria: Lower respiratory tract infections eg, empyema, anaerobic pneumonitis and lung abscess. Skin and soft tissue infections. Septicemia. Diabetic foot infection. Bone and joint infections. Intra-abdominal infections eg, peritonitis and intra-abdominal abscess. (Typically resulting from anaerobic organisms resident in the normal gastrointestinal tract.) Infections of the female pelvic and genital tract eg, endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection.
Dosage/Direction for Use
Dalacin: Adults: Mild to Moderately Severe Infections: 150-300 mg every 6 hrs. Severe Infections: 300-450 mg every 6 hrs.
Children: Mild to Moderately Severe Infections: 8-16 mg/kg/day (4-8 mg/lb/day) divided into 3 or 4 equal doses.
Severe Infections: 16-20 mg/kg/day (8-10 mg/lb/day) divided into 3 or 4 equal doses.
In the treatment of streptococcal pharyngitis, 300 mg for adults and 150 mg for children may be administered twice daily. In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
Diabetic Foot Infections: 300 mg orally 3-4 times daily for 7-14 days.
Ampoule: Adults: Parenteral (IM or IV Administration):
Mild Infections or Infections Due to Highly Susceptible Pathogens: 600 mg/day in 2 equal doses.
Moderate to Severe Infections: 600-1200 mg/day in 2, 3 or 4 equal doses.
Severe Infections: 1200-2700 mg/day in 2, 3 or 4 equal doses.
Note: For more serious infections, these doses may have to be increased. In life-threatening situations, doses of as much as 4.8 g daily have been given IV to adults. See Dilution and Infusion Rates section. Alternatively, may be administered in the form of a single rapid infusion of the 1st dose followed by continuous IV infusion as follows: See Table 2.

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Children (>1 month): Parenteral (IM or IV Administration):
Mild Infections or Infections Due to Highly Susceptible Pathogens: 10-15 mg/kg/day in 3 or 4 equal doses.
Moderately Severe Infections: 15-20 mg/kg/day in 3 or 4 equal doses.
Severe Infections: 25-40 mg/kg/day in 3 or 4 equal doses.
As an alternative to dosing on a body weight basis, children may be given doses on the basis of square meters body surface, 350 mg/m2/day for mild to moderately severe infections and 450 mg/m2/day for moderately severe or severe infections.
Note: In severe infections, it is recommended that children be given not <300 mg/day regardless of body weight.
Dilution and Infusion Rates: Single IM injections of >600 mg are not recommended. Clindamycin phosphate must be diluted prior to IV administration to a dilution of 300 mg in 50 mL of diluent (6 mg/mL) or more. Diluent: Dextrose 5% in water, 0.9% NaCl or Lactated Ringer's solution to yield final concentration of 6,9 or 12 mg/mL. Infusion rates are as follows: See Table 3.

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Administration of >1200 mg in a single 1-hr infusion is not recommended.
Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hrs at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin phosphate in IV solutions containing NaCl, glucose, calcium or potassium and solutions containing vitamin B-complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin. The following drugs are physically incompatible with clindamycin phosphate: Ampicillin, diphenylhydantoin, barbiturates, aminophylline, calcium gluconate and magnesium sulfate.
Contraindications
Individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
Warnings
The clindamycin phosphate injectable formulation contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “gasping syndrome” in premature infants.
Meningitis: Since clindamycin does not diffuse adequately into the cerebrospinal fluid, it should not be used in the treatment of meningitis.
Antagonism has been demonstrated in vitro between Dalacin/Dalacin C and erythromycin. Because of possible clinical significance, these 2 drugs should not be administered concurrently.
Cases of severe and persistent diarrhea have been reported and have been occasionally associated with acute colitis. Should marked diarrhea occur and colitis be suspected, cessation of treatment should be considered and appropriate symptomatic and diagnostic procedures instituted.
Studies indicate a toxin(s) produced by Clostridia (especially Clostridium difficile) is the principal direct cause of antibiotic-associated colitis. These studies also indicate that this toxigenic Clostridium is usually sensitive in vitro to vancomycin. When 125-500 mg of vancomycin is administered orally 4 times a day, there is a rapid observed disappearance of the toxin from fecal samples and a coincident clinical recovery from the diarrhea.
Dalacin C: Newborns and Infants: Safety and appropriate dosages in infants <1 month have not been established.
Serious anaphylactoid reactions require immediate emergency treatment with epinephrine; oxygen and IV corticosteroids should also be administered as indicated.
Special Precautions
Dalacin/Dalacin C should be prescribed with caution in atopic individuals.
During prolonged therapy, periodic liver and kidney (ampoule) function tests and blood counts should be performed.
The use of Dalacin/Dalacin C may result in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
Patients with very severe renal and/or hepatic disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high-dose therapy.
Clindamycin has been shown to have neuromuscular-blocking properties. Therefore, it should be used with caution in patients receiving such agents with similar properties.
Dalacin C: Should not be injected IV undiluted as a bolus, but should be infused over at least 20-60 min as directed in the Dosage & Administration.
Use in Pregnancy: Safety for use in pregnancy has not been established.
Use In Pregnancy & Lactation
Use in Pregnancy: Safety for use in pregnancy has not been established.
Adverse Reactions
The following reactions have been reported:
Gastrointestinal: Nausea, vomiting and diarrhea (see Warnings.)
Hypersensitivity Reactions: Maculopapular rash and urticaria have been observed during drug therapy. Cases of anaphylactoid reaction and Stevens-Johnson syndrome have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.
Liver: Abnormalities in liver function tests (elevations of serum transaminases) have been observed during Dalacin/Dalacin C.
Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Relationship to therapy is unknown.
Dalacin: Gastrointestinal: Abdominal pain.
Hypersensitivity Reactions: The usual agents (epinephrine, corticosteroids, antihistamines) should be available for emergency treatment of serious reactions (Dalacin).
Liver: Jaundice.
Dalacin C: Local Reactions: Pain, induration and sterile abscess have been reported after IM injection and thrombophlebitis after IV infusion. Reactions can be minimized or avoided by giving deep IM injections and avoiding prolonged use of in dwelling IV catheters.
MIMS Class
ATC Classification
J01FF01 - clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections.
Cap: D; Inj: S
Presentation/Packing
Dalacin: Cap 150 mg x 100's. 300 mg x 20's. Dalacin C: Inj 150 mg/mL (amp, sterile soln) x 2 mL, 4 mL, 6 mL.
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