Drug Name

Dalacin-C (Clindamycin)

 Drug 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 C is effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of 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 C.
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. 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.

For patients taking the capsule form of clindamycin:

• The capsule form of clindamycin should be taken with a full glass (8 ounces) of water or with meals to prevent irritation of the esophagus (tube between the throat and stomach).

For patients taking the oral liquid form of clindamycin:

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
• Do not use after the expiration date on the label. The medicine may not work properly after this date. Check with your pharmacist if you have any questions about this.

To help clear up your infection completely, keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days. If you have a ``strep'' infection, you should keep taking this medicine for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at evenly spaced times day and night . For example, if you are to take 4 doses a day, doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing- The dose of clindamycin will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of clindamycin. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or teaspoonfuls of solution that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking clindamycin .

• For bacterial infection:
  • For oral dosage forms (capsules and solution):
    • Adults and teenagers-150 to 300 milligrams (mg) every six hours.
    • Children-
      • Infants up to 1 month of age: Use and dose must be determined by your doctor.
      • Infants and children 1 month of age and older: Dose is based on body weight. The usual dose is 2 to 5 mg per kilogram (kg) (0.9 to 2.3 mg per pound) of body weight every six hours; or 2.7 to 6.7 mg per kg (1.2 to 3.0 mg per pound) of body weight every eight hours.
  • For injection dosage form:
    • Adults and teenagers-300 to 600 mg every six to eight hours injected into a muscle or vein; or 900 mg every eight hours injected into a muscle or vein.
    • Children-
      • Infants up to 1 month of age: Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight every six hours injected into a muscle or vein; or 5 to 6.7 mg per kg (2.3 to 3.0 mg per pound) of body weight every eight hours injected into a muscle or vein.
      • Infants and children 1 month of age and older: Dose is based on body weight. The usual dose is 3.75 to 10 mg per kg (1.7 to 4.5 mg per pound) of body weight every six hours injected into a muscle or vein; or 5 to 13.3 mg per kg (2.3 to 6.0 mg per pound) of body weight every eight hours injected into a muscle or vein.

 Drug Class and Mechanism

Antibacterial antibiotics and anti-infections.
Microbiology: Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. The 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 C demonstrates cross-resistance with lincomycin. When tested by in vitro methods, some staphylococcal strains originally resistant to erythromycin rapidly developed resistance to Dalacin C.
Dalacin C susceptibility discs may be used for determination of the in vitro susceptibility of aerobic bacteria to Dalacin C.
Dalacin C susceptibility powder may be used for determination of the in vitro susceptibility of anaerobic and aerobic bacteria to Dalacin C*.
*Dalacin C susceptibility discs 2 mcg. 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 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 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.
Pharmacokinetics: Capsule: Serum level studies with a 150-mg oral dose of Dalacin C in 24 normal adult volunteers showed that Dalacin C 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 C is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing Dalacin C from the serum.
Concentrations of Dalacin C 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 C 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 bioinactive metabolites. Doses of up to 2 g of Dalacin C/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.
Ampoule: 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 2? 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.

If you miss a dose of this medicine, take it as soon as possible. This will help to keep a constant amount of medicine in the blood. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not refrigerate the oral liquid form of clindamycin. If chilled, the liquid may thicken and be difficult to pour. Follow the directions on the label.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

 Warnings/Precautions

Newborns and Infants: When Dalacin C is administered to newborns and infants, appropriate monitoring of organ system functions is desirable.
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 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.
Ampoule: Newborns and Infants: Safety and appropriate dosages in infants <1 month old have not been established.
Serious anaphylactoid reactions require immediate emergency treatment with epinephrine; oxygen and IV corticosteroids should also be administered as indicated.

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 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.
Ampoule: 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.

 Possible Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal or stomach cramps and pain (severe); abdominal tenderness; diarrhea (watery and severe), which may also be bloody; fever

(the above side effects may also occur up to several weeks after you stop taking this medicine)

Less common

Sore throat and fever; skin rash, redness, and itching; unusual bleeding or bruising

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Diarrhea (mild); nausea and vomiting; stomach pain

Less common

Itching of rectal, or genital (sex organ) areas

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

 More Information

Dalacin-C should not be used by anyone allergic to clindamycin or to lincomycin or to any of the ingredients of the medication.

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