And dosage form
Each capsule contains:
a. equivalent ..................... 300 mg
Excipient c.b.p. 1 capsule.
Clindamycin is indicated for the treatment of infections of dental and periodontal origin, such as dental abscesses, periodontal abscesses, infectious pericoronitis, facial cellulitis, osteomyelitis and facial abscesses of the jaw. Clindamycin is an antibiotic of choice for prophylactic regimens in patients allergic to penicillin, with a history of rheumatic fever or bacterial endocarditis.
CLENDIX ® is indicated for the treatment of upper respiratory tract infections such as tonsillitis, pharyngitis, sinusitis, including dental origin and otitis media, as well as lower respiratory tract: bronchitis, pneumonia, empyema and lung abscess, skin infections and soft tissue, bone and joint infections, septicemia, endocarditis and intra-abdominal infections. Is also indicated for pelvic infections and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal infections caused by medical and susceptible anaerobic bacteria.
Clindamycin is an antibiotic effective against gram-positive aerobes such as Staphylococcus and Streptococcus (S. pneumoniae). The drug is also active against gram-negative microaerophilic and anaerobic organisms and gram-positive, including Actinomyces, Bacteroides, Eubacterium, Propionibacterium, Peptococcus, Peptostreptococcus and Veillonella.
Absorption: When administering an oral dose of clindamycin, approximately 90% of it is rapidly absorbed from the gastrointestinal tract. The drug is not inactivated by gastric juice. Clindamycin serum concentrations increase linearly with increasing dose. If ingested with food clindamycin, the extent of absorption and peak serum concentrations are not affected.
After orally administering a dose of 150 mg of clindamycin hydrochloride in healthy fasting adults, peak serum concentrations averaged 1.9 and 3.9 mcg / ml was reached within 45 to 60 minutes. After 3 hours the serum concentrations averaged 1.5 mcg / ml and 6 hours 0.7 mcg / ml. Its half-life is approximately 2.7 hours.
Distribution: Clindamycin is widely distributed in tissues and body fluids, including saliva, ascites, pleural, synovial, bile and bone tissue. Clindamycin crosses the placenta rapidly and have reported concentrations in umbilical cord blood equivalent to 46% of the concentrations found in maternal blood.
It is distributed in the cerebrospinal fluid. Clindamycin passes into breast milk in concentrations of 1 mg / ml. 93% of the drug is bound to serum proteins.
Elimination: In adults and children with normal kidney function, half-life of clindamycin is 2 to 3 hours. The half-life is slightly increased in patients with marked reduction in hepatic or renal function. In infants, the elimination half-life depends on gestational age and chronological, and body weight. Serum drug concentrations are not significantly affected by hemodialysis, peritoneal dialysis or prolonged administration in patients with normal renal function.
Clindamycin is partially metabolized to bioactive metabolites and inactive. The main bioactive are clindamycin sulfoxide and N-dimethyl clindamycin, which are excreted in urine, bile and feces. At an oral dose of clindamycin in the first 24 hours of the dose is excreted unchanged in the urine, 3.6% is excreted in the feces as active drug and metabolites, and the rest of the dose is excreted as inactive metabolites .
It is contraindicated in patients with a history of hypersensitivity to clindamycin or lincomycin. Should not be administered with erythromycin.
For 2 to 3 weeks after administration of clindamycin may present a picture of severe and persistent diarrhea should be suspected that the presence of pseudomembranous colitis, which requires the immediate suspension of clindamycin treatment and management of the specific duty. Because it has been demonstrated in vitro antagonism between clindamycin and erythromycin, both drugs should not be used together.
Because clindamycin has been shown to have neuromuscular blocking properties, should be used with caution in patients taking drugs with this action. If treatment is prolonged, tests for liver function and kidney function. It is not necessary to change the dose of clindamycin in patients with kidney disease. In patients with moderate or severe liver disease, just space the drug every 8 hours to avoid the accumulation of it not being necessary to reduce doses.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING
Has not been established the drug's safety when administered during pregnancy.Because clindamycin is excreted in breast milk should be evaluated whether to discontinue nursing or therapy, taking into account the importance of the drug to the mother.
In administering the drug orally were presented gastrointestinal reactions such as diarrhea, nausea, vomiting and abdominal pain, esophagitis and pseudomembranous colitis.
There have also been hypersensitivity reactions such as hives, itching, fever, hypotension, maculopapular rash and some cases of erythema multiforme syndrome resembling Stevens-Johnson. Have also been reported severe hepatic, hematopoietic and cardiovascular diseases.
DRUG INTERACTIONS AND OTHER GENDER
Clindamycin has shown neuromuscular blocking properties that may increase the action of other agents with the same action has also been reported to antagonize clindamycin in vitro bactericidal activity of aminoglycosides, it is recommended not to use them concurrently. In vitro antagonism has been observed with the antibacterial activity of erythromycin.
CHANGES IN RESULTS OF LABORATORY TESTS
It has been observed transient increase in serum bilirubin, alkaline phosphatase and AST (SGOT). No other alterations have been reported.
PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility
The long-term studies in animals showed no evidence of impaired carcinogenic, mutagenic or teratogenic or fertility.
DOSAGE AND ADMINISTRATION
Oral. The usual dose of clindamycin in adults is 150 to 450 mg every 6 hours. In children, the recommended dose is 8 to 30 mg / kg daily administered in 3 or 4 equal doses. In children weighing less than or equal to 10 kg minimum recommended oral dose is 37.5 mg 3 times daily.
The dose and duration of treatment should be determined according to the severity of the infection, the patient's condition and the susceptibility of the causative agent. To avoid the possibility of oesophageal irritation, the capsules should be swallowed with a full glass of water.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION
Overdose may favor the occurrence of side effects. If swallowed, give fluids to dilute.
Retail Box with blister pack with 16 and 21 capsules.
Store at room temperature to no more than 30 º C and dry.
LEGENDS OF PROTECTION
Its sale requires a prescription.
Keep out of reach of children.
Do not administer during the
pregnancy and lactation.