CLINDO 300
-
Chemical Name:
Clindamycin (HCl) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Lincosamide -
Pharmaceutical Form:
Capsules -
Composition:
Clindamycin (HCl) 300mg
CLINDO
Capsules
Clindamycin (HCl)
1.PHARMACOLOGY:
- Clindamycin HCl has been shown to have in vitro activity against the following gram-positive aerobic organisms:
Staphylococcus aureus and Staphylococcus epidermidis (both penicillinase and non-penicillinase producing strains), Streptococci (expect Enterococcus faecalis), Pneumococci
- Anaerobic gram negative bacilli, including :
Bacteroides species (including Bacteroides melaninogenicus group and Bacteroides fragilis group), and Fusobacterium species.
-Anaerobic gram positive nonsporeforming bacilli, including:
Propionibacterium, Eubacterium and Actinomyces species
-Anaerobic and microaerophilic gram positive cocci, including:
Peptococcus species, Peptostrepococcus species, Micro aerophilic streptococci and Clostridia.
-Cross resistance has been demonstrated between clindamycin and lincomycin.
Antagonism has been demonstrated between clindamycin and erythromycin.
2.PHARMACOKINETICS:
Serum level studies with a 150 mg oral dose of Clindamycin HCl in 24 normal adult volunteers showed that Clindamycin HCl was rapidly absorbed after oral administration. An average peak serum level of 2.50 mcg/ml was reached in 45 minutes; serum level averaged 1.51 mcg/ml at 3 hours and 0.70 mcg/ml at 6 hours .
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 predictably from person to person and dose to dose. Serum level studies following multiple doses of Clindamycin HCl for up to 14 days show no evidence of accumulation or altered metabolism of drug.
Serum half-life of Clindamycin HCl is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing Clindamycin HCl from the serum.
Concentrations of Clindamycin HCl in the serum increased linearly with increased dose. Serum levels exceed the MIC for most indicated organisms for at least six hours following administration of the usually recommended doses. Clindamycin HCl is widely distributed in body fluids and tissues ( including bones ). The average biological half-life is 2.4 hours. Approximately 10% of the bio-activity is excreted in the urine and 3.6% in feces; the remainder is excreted as bio-inactive metabolites. Doses of up to 2 gm of Clindamycin HCl per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastro-intestinal side effects is greater with higher doses.
3.INDICATIONS:
CLINDO-PLUS is indicated in the 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 treatment and prevention of streptococcal pharyngitis and in long-term prophylaxis of rheumatic fever. CLINDO-PLUS (Clindamycin HCl ) is effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of orally administered CLINDO-PLUS 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 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 Clindamycin.
In Vitro Susceptibility Testing: A standardized methods are recommended for determining susceptibility to aerobic and anaerobic bacteria to Clindamycin.
4.CONTRA-INDICATIONS:
This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
5.WARNINGS:
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
6.PRECAUTIONS:
-Clindamycin HCl products should be prescribed with caution in the following:
-Individuals with a history of gastrointestinal diseases, particularly colitis.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy.
-The use may result in overgrowth of nonsusceptible organisms particularly yeasts. If superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
-Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. --Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease.
Laboratory Tests: During prolonged therapy periodic liver and kidney function tests and blood counts should be performed.
Pregnancy: This drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Because of the potential for adverse reactions due to clindamycin in neonates the decision to discontinue the drug should be made, taking into account the importance of the drug to the mother.
7.SIDE EFFECTS:
-The following reactions have been reported with the use of clindamycin:
Gastrointestinal: Antibiotic-associated colitis, pseudomembranous colitis, abdominal pain, nausea and vomiting.
Hypersensitivity reactions: Rash and urticaria have been observed during drug therapy.
8.DRUG INTERACTIONS:
-Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
-Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, the two drugs should not be administered concurrently.
9.DOSAGE & ADMINISTRATION:
Adults:
Mild to moderately severe infections: 150 to 300 mg every 6 hours.
Severe Infections : 300 to 450 mg every 6 hours.
Children:
Mild to moderately severe infections: 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses.
Severe Infections : 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal dose.
- In the treatment of streptococcal pharyngitis: 300mg for adults and 150 mg for children may be administered twice daily for ten days.
- In case of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
To avoid the possibility of esophageal irritation the drug should be taken with plenty of water.
10.PACKAGING & COMPOSITION:
CLINDO 75 Capsules: A pack of 12 capsules. Each capsule contains Clindamycin HCl equivalent to Clindamycin 75 mg.
CLINDO 150 Capsules: A pack of 12 capsules. Each capsule contains Clindamycin HCl equivalent to Clindamycin 150 mg.
CLINDO 300 Capsules: A pack of 12 capsules. Each capsule contains Clindamycin HCl equivalent to Clindamycin 300 mg.
11.STORAGE CONDITIONS:
Store CLINDO Capsules at temperature between (15-30)°C.
Related Products
