Dalacin C (Clindamycin HCl)

DALACINĀ® C

Pharmacia & Upjohn

Clindamycin HCl

Antibiotic

Action And Clinical Pharmacology: Clindamycin exerts its antibacterial effect by causing cessation of protein synthesis and also causing a reduction in the rate of synthesis of nucleic acids.

In vitro studies indicate that clindamycin has antibacterial activity against sensitive gram-positive organisms. The spectrum of activity includes staphylococci (including penicillinase-producing and methicillin resistant strains), hemolytic streptococci, S. viridans and S. pneumoniae. In addition, some strains of C. tetani, C. perfringens, C. diphtheriae, P. acnes, A. israelii, H. influenzae, N. gonorrheae and C. trachomatis are sensitive in vitro. Clindamycin is not active against strains of S. faecalis, E. coli, Shigella spp., Salmonella spp., Proteus spp., Pseudomonas spp., and K. pneumoniae.

Clindamycin is rapidly and almost completely absorbed from the gastrointestinal tract in man and peak serum levels are seen in about 45 minutes. The average peak serum level following a single 150 mg dose in adults is 2.74 g/mL. Therapeutically effective average levels at 6 hours after a 150 mg dose of 0.73 g/mL are found.

The absorption of clindamycin is not appreciably affected by food intake.

Indications And Clinical Uses: The treatment of serious infections due to sensitive anaerobic bacteria, such as Bacteroides species, peptostreptococcus, anaerobic streptococci, Clostridium species and microaerophilic streptococci.

Also indicated in serious infections due to sensitive gram- positive organisms (staphylococci, including penicillinase-producing staphylococci, streptococci and pneumococci) when the patient is intolerant of, or the organism resistant to other appropriate antibiotics.

Clindamycin is indicated for prophylaxis against alpha-hemolytic (viridans group) Streptococci before dental, oral and upper respiratory tract surgery.

a) The prophylaxis of bacterial endocarditis in patients allergic to penicillin with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular dysfunction, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemic-pulmonary shunts, mitral valve prolapse with valvular regurgitation or mitral valve prolapse without regurgitation but associated with thickening and/or redundancy of the valve leaflets.

b) Patients taking oral penicillin for prevention or recurrence of rheumatic fever should be given another agent such as clindamycin, for prevention of bacterial endocarditis.

Contra-Indications: As with all drugs, the use of clindamycin is contraindicated in patients previously found to be hypersensitive to this compound. Although cross-sensitization with lincomycin has not been demonstrated, it is recommended that clindamycin not be used in patients who have demonstrated lincomycin sensitivity.

Until further clinical experience is obtained clindamycin is not indicated in the newborn (infants below 30 days of age), or in pregnant women.

Manufacturers’ Warnings In Clinical States: Some cases of severe and persistent diarrhea have been reported during or after therapy with clindamycin. This diarrhea has been occasionally associated with blood and mucus in the stools and has at times resulted in acute colitis. When endoscopy has been performed, some of these cases have shown pseudomembrane formation.

If significant diarrhea occurs during therapy, this drug should be discontinued or, if necessary, continued only with close observation. Significant diarrhea occurring up to several weeks post therapy should be managed as if antibiotic-associated.

If colitis is suspected, endoscopy is recommended. Mild cases showing minimal mucosal changes may respond to simple drug discontinuance. Moderate to severe cases, including those showing ulceration or pseudomembrane formation should be managed with fluid, electrolyte and protein supplementation as indicated. Corticoid retention enemas and systemic corticoids may be of help in persistent cases, anticholinergic and antiperistaltic agents may worsen the condition. Other causes of colitis should be considered.

Studies indicate a toxin(s) produced by Clostridia (especially C. difficile) may be a principal cause of clindamycin and other antibiotic-associated colitis. These studies also indicate that this toxigenic Clostridium is usually sensitive in vitro to vancomycin. When 125 mg to 500 mg of vancomycin were administered orally 4 times a day for 5 to 10 or more days, there was a rapid observed disappearance of the toxin from fecal samples and a coincidental recovery from the diarrhea.

It should be noted that serious relapses have occurred up to 1 month after apparently successful treatment. A relatively prolonged period of continuing observation is therefore recommended.

Precautions: Clindamycin like any drug, should be prescribed with caution in atopic individuals.

The use of antibiotics occasionally results in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfections occur, appropriate measures should be taken as dictated by the clinical situation.

As with all antibiotics, perform culture and sensitivity studies in conjunction with drug therapy.

Since abnormalities of liver function tests have been noted occasionally in animals and man, periodic liver function tests should be performed during prolonged therapy. Blood counts should also be monitored during extended therapy.

Clindamycin may be used in anuretic patients. Since the serum half-life of clindamycin in patients with impaired hepatic function is greater than that found in normal patients, the dose of clindamycin should be appropriately decreased. Hemodialysis and peritoneal dialysis are not effective means of removing the compound from the blood. Periodic serum levels should be determined in patients with severe hepatic and renal insufficiency.

Adverse Reactions: Only 65 of the 851 patients treated for infections developed side effects representing 7.6% of the total study group or 8% of the 813 patients with follow-up. Only 22 of these patients’ symptoms were considered due to clindamycin for an incidence of 2.7% among the 813 cases with follow-up.

Gastrointestinal: Abdominal pain occurred in 12 patients for an overall incidence of 1.4% in 851 patients and was considered drug related in 7 (0.8%).

Diarrhea occurred in 22 cases for an overall incidence of 2.6% and was drug related in 13 (1.5%). Vomiting occurred in 14 cases with an overall incidence of 1.6%. Seven patients (0.8%) had nausea which was drug related in 2 cases (0.2%). Side effects were severe in 10 instances. (see Warnings). Esophagitis, at times severe, has been reported.

Hemopoietic: Transient neutropenia (leukopenia) has been reported. Its relationship to therapy is unknown. No irreversible hematologic toxicity has been reported.

Skin and Mucous Membranes: Skin rashes have been reported in 6 patients (0.7%), none of which could be determined as drug related. One case of urticaria was reported but its relationship to drug therapy could not be determined.

Liver: Although no direct relationship of clindamycin to liver dysfunction has been noted, transient abnormalities in liver function tests (elevations of alkaline phosphatase and serum transaminase) have been observed in a few instances.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No cases of overdosage have been reported. It would be expected however, that should overdosage occur, gastrointestinal side effects including abdominal pain, nausea, vomiting and diarrhea might be seen. During clinical trials, one 3 year old child was given 100 mg/kg of clindamycin for 5 days and showed mild abdominal pain and diarrhea. One 13 year old patient was given 75 mg/kg for 5 days with no side effects. In both cases laboratory values remained normal.

Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Dosage And Administration: Adults: 150 mg every 6 hours; moderately severe infections: 300 mg every 6 hours; severe infections: 450 mg every 6 hours. Children (over 1 month of age): One of the following two dosage ranges should be selected depending on the severity of the infection: 1) 8 to 16 mg/kg/day divided into 3 or 4 equal doses. 2) 16 to 20 mg/kg/day divided into 3 or 4 equal doses.

Absorption of clindamycin is not appreciably modified by ingestion of food and may be taken with meals.

To avoid the possibility of esophageal irritation, clindamycin capsules should be taken with a full glass of water.

For prevention of endocarditis: Adults: 300 mg orally 1 hour before procedure; then 150 mg 6 hours after initial dose.

Children: 10 mg/kg (not to exceed adult dose) orally 1 hour before procedure; then 5 mg/kg 6 hours after initial dose.

Note: With B-hemolytic streptococcal infections, treatment should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis.

Availability And Storage: 150 mg: Each hard gelatin capsule with maroon cap and lavender body, branded “Upjohn 225”, contains: clindamycin HCl hydrate equivalent to 150 mg of clindamycin base. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate and talc.

300 mg: Each hard gelatin capsule with light blue cap and body branded, “Upjohn 395” contains: clindamycin HCl hydrate equivalent to 300 mg of clindamycin base. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate and talc. Sodium:

DALACINĀ® C Pharmacia & Upjohn Clindamycin HCl Antibiotic

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