clindamicine

clindamicine

  • clindamicine
Therapeutic Categories: Respiratory Tract Drugs
Pharmaceutical Form: Capsules
Caliber: 150 , 300
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Clindamycin Biomed

(Capsules)

Composition:

Each Clindamycin Biomed Capsule contains:

 Clindamycin Hcl equivalent to 75, 150, 300 mg Clindamycin.

 

CLINICAL PHARMACOLOGY

Pharmacokinetics

Serum level studies with a 150 mg oral dose of Clindamycin Hcl showed that Clindamycin was rapidly absorbed after oral administration. An average peak serum level of 2.50 mcg/mL was reached in 45 minutes; serum levels decreased to 1.51 mcg/mL after 3 hours and reached to 0.70 mcg/mL after 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 level studies following multiple doses of Clindamycin for up to 14 days show no evidence of accumulation or altered metabolism of drug. Serum half-life of Clindamycin is increased slightly in patients with markedly reduced renal function. Concentrations of Clindamycin in the serum increased linearly with increased dose. Clindamycin is widely distributed in body fluids and tissues (including bones). The average biological half-life is 2.4 hours. 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 Clindamycin per day for 14 days have been well tolerated by healthy volunteers.

Microbiology

Clindamycin inhibits bacterial protein synthesis by binding to the 50S subunit of the ribosome. It has activity against Gram-positive aerobes and anaerobes as well as the Gram-negative anaerobes. Cross-resistance between Clindamycin and Lincomycin is complete. Clindamycin has been shown to be active against most of the isolates of the following microorganisms, both in vitro and in clinical infections

§  Gram-positive aerobes

Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pneumoniae (penicillin-susceptible strains), Streptococcus pyogenes.

§  Anaerobes

Prevotella melaninogenica, Fusobacterium necrophorum, Fusobacterium nucleatum, Peptostreptococcus anaerobius, Clostridium perfringens.

 

INDICATIONS AND USAGE

Clindamycin Biomed is indicated in the treatment of susceptible anaerobic infections, notably due to bacteroides fragilis and in susceptible strains of streptococci, pneumococci, staphylococci. It use should be reserved for penicillin-allergic patients. Clindamycin Biomed may be used in the following conditions:

§  Serious respiratory tract infections such as, pneumonia (especially lung abscess), streptococcal pharyngitis (usually to treat the carrier state), the carrier state of diphtheria.

§  Various gynecological infections including bacterial vaginosis, tubo-ovarian abscess, endometritis, pelvic inflammatory disease.

§  Intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract), liver abscess, actinomycosis biliary-tract infections, septicemia, gas gangrene.

§  Serious skin and soft tissue infections involving colonization with streptococci or anaerobes, necrotizing fasciitis.

§  Staphylococcal bone and joint infections.

§  Anaerobe dental and oral infections, dento-alveolar abscess, and chronic dental infection.   

§  Prophylaxis of endocarditis in penicillin-allergic patients.

§  Prevention of prenatal streptococcal infections, and with other drugs for prophylaxis of surgical infection.

 

CONTRAINDICATIONS

Clindamycin Biomed is contraindicated in individuals with a history of hypersensitivity to preparations containing Clindamycin or Lincomycin.

 

WARNINGS

§  Clostridium difficil associated diarrhea(CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Biomed, and may range in severity from mild diarrhea to fatal  colitis, the ongoing antibiotic use not directed against C.difficile may need to be discontinued . Clindamycin Biomed should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis,The drug should be taken with caution in atopic individuals .

§  A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.

§  Clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

 

PRECAUTIONS

§  In general, surgical procedures should be performed in conjunction with antibiotic therapy.

§  The use of Clindamycin Biomed occasionally results in overgrowth of nonsusceptible organisms. Should 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.

§  Clindamycin Biomed should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance.

 

Laboratory Tests

During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

 

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, these two drugs should not be administered concurrently.

 

Pregnancy and Nursing Mothers:

 (Pregnancy category B):

There are no adequate and well-controlled studies in pregnant women. Caution must be considered when the drug is used during pregnancy. Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL.

Geriatric Use

Clinical experience indicates that antibiotic-associated colitis and diarrhea(due to clostridium difficile ) seen in association with most antibiotics which occurs more frequently in the elderly (>60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.

 

ADVERSE REACTIONS

Common: diarrhea, abdominal pain, nausea, vomiting, esophagitis, and antibiotic-associated pseudo membraneous colitis .

Other: urticaria, rashes, transient neutropenia, eosinophilia, agranulocytosis, thrombocytopenia, erythema multiforme. Vesiculobullous and exfoliative dermatitis. Jaundice, abnormalities in liver function tests, hepatic damage, polyarthritis, few cases of anaphylactoid reactions.

 

OVERDOSAGE

In case of overdosage, hemodialysis and peritoneal dialysis are not effective in removing Clindamycin from the serum.

 

 

 

DOSAGE AND ADMINISTRATION

Adults:

§  Serious infections: 150 to 300 mg every 6 hours.

§  More severe Infections: 300 to 450 mg every 6 hours.

 

Pediatric:

§  Serious infections: (8 to 16 mg/kg/day) divided into three or four equal doses.

§  More severe Infections: (16 to 20 mg/kg/day) divided into three or four equal dose.

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

In case of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

 

Storage  Conditions :

Store in dry place at room temperature (20-25)٥ C , protected from light and out of the reach of children .

 

PRESENTATION

Clindamycin Biomed 75 mg: Box contains 20 Capsules.

Clindamycin Biomed 150 mg: Box contains 20 Capsules.

Clindamycin Biomed 300 mg: Box contains 20 Capsules.