Clinmed

Each mL contains: Clindamycin Phosphate USP eq. to Clindamycin USP 150 mg, Benzyl alcohol BP 9.45 mg, Water for Injection USP q.s.

Pharmacology: Clindamycin exhibits its action by binding to the 50S subunit of the bacterial ribosome and thereby suppressing protein synthesis. On parenteral administration, the phosphate ester is rapidly hydrolyzed to the active parent compound. Following intramuscular injection, peak plasma concentrations are only attained after 3 hours in adults and 1 hour in children. The peak plasma concentrations obtained following intramuscular administration are 6 μg/mL with a 300 mg dose and 9 μg/mL with a 600 mg dose in adults. Immediately after a 20-45 minute intravenous infusion of 600 mg, the plasma concentrations is approximately 10 μg/mL. The half-life of clindamycin is about 2.7 hours and modest accumulation is thus expected to occur if it is given every 6 hours. The half-life may be lengthened in patients with impaired renal function, and dosage in these patients should he adjusted according to plasma concentrations. Accumulation may also occur in patients with hepatic failure. Clindamycin is 90% plasma protein bound. It is widely distributed in many fluids and tissues including bone, but not in sufficient concentrations in the cerebrospinal fluid. It does however cross the placental barrier. It accumulates in polymorphonuclear leukocytes and alveolar macrophages and is also concentrated in abscesses in experimental animals. About 10% of clindamycin is excreted unaltered in the urine and small quantities are to be found in the faeces. Clindamycin has been shown to have in vitro activity against isolates of the following organisms (in vitro sensitivity does not necessarily imply in vivo efficacy): Gram positive cocci: Staphylococcus aureus; Streptococcus (anaerobic species); Streptococcus pneurnoniae.  Gram negative cocci: Clostridium perfringens. Gram negative bacilli: Campylobacter jejuni, Bacteroides species; Fusobacterium nucleatum. Susceptibility test should be performed.
Pharmacokinetics: General characteristics of active substance: Following parenteral administration, the biologically inactive clindamycin phosphate hydrolysed to clindamycin. When the equivalent of 300 mg of clindamycin is injected intramuscularly, a mean peak plasma concentration of 6 microgram/mL is achieved within three hours; 600 mg gives peak concentration of 9 microgram/mL. In children, peak concentration may be reached within one hour. When the same doses are infused intravenously, peak concentrations of 7 and 10 micrograms per mL respectively are achieved by the end of infusion. Clindamycin is widely distributed in body fluids and tissues, including bone, but it does not reach the cerebrospinal fluid in significant concentrations. It diffuses across the placenta into the foetal circulation and appears in breast milk. High concentrations occur in bile. It accumulates in leucocytes and macrophages. Over 90% of clindamycin in the circulation is bound to plasma proteins. The half-life is 2 to 3 hours, although this may be prolonged in pre-term neonates and patients with severe renal impairment, Clindamycin undergoes metabolism, to the active-demethyl and sulphoxide metabolites and also some inactive metabolites. About 10% of the drug is excreted in the urine as active drug or metabolites and about 4% in the faeces; the remainder is excreted as inactive metabolites. Excretion is slow and takes place over several days. It is not effectively removed from the blood by dialysis.

Indicated for serious infections caused by susceptible Gram-positive organisms, staphylococci (both penicillinase and non-penicillinase-producing), streptococci (except Streptococcus faecalis) and pneumococci. It is also indicated in serious infections caused by susceptible anaerobic pathogens such as Bacteroides spp., Fusobacterium spp., Propionibacterium spp., Peptostreptococcus spp., and Microaerophilic streptococci.

Parenteral (IM or IV administration). Clindamycin Phosphate must be diluted prior to IV administration and should be infused over at least 10-60 minutes.
Adults: Serious infections: 600 mg-1.2 g/day in two, three or four equal doses.
More severe infections: 1.2-2.7 g/day in two, three or four equal doses. Single IM injections of greater than 600 mg are not recommended nor are administration of more than 1.2 g in a single one-hour infusion For more serious infections, these doses may have to be increased. In life-threatening situations, doses as high as 4.8 g daily have been given intravenously to adults. Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion.
Children (over 1 month of age:) Serious infections: 15-25 mg/kg/day in three or four equal doses. More severe infections: 25-40 mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.
Elderly patients: The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone.
Dosage in Renal/Hepatic Impairment: clindamycin dosage modification is not necessary in patients with renal or hepatic insufficiency, Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.
The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL and INFUSION RATES SHOULD NOT EXCEED 30 mg PER MINUTE The usual infusion rates are as follows: See table.

Click on icon to see table/diagram/image

In cases of overdosage no specific treatment is indicated.
The serum biological half-life of lincomycin is 2.4 hours. Clindamycin cannot readily be removed from the blood by dialysis or peritoneal dialysis. If an allergic adverse reaction occurs, therapy should be with the usual emergency treatments, including corticosteroids, adrenaline and antihistamines.

Clindamycin Phosphate is contraindicated in patients previously found to be sensitive to clindamycin, lincomycin or to any component of the formulation.

This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping syndrome" in premature infants. Clindamycin Phosphate should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

Caution should be used when prescribing Clindamycin Phosphate to individuals with a history of gastrointestinal disease, especially colitis. Periodic liver and kidney function tests should be carried out during prolonged therapy. Such monitoring is also recommended in neonates and infants. Safety and appropriate dosage in infants less than one month old have not been established.
Prolonged administration of Clindamycin Phosphate, as with any anti-infective, may result in super-infection due to organisms resistant to clindamycin. Care should be observed in the use of Clindamycin Phosphate in atopic individuals.

Safety for use in pregnancy has not been established. Clindamycin is excreted in human milk. Caution should be exercised when Clindamycin Phosphate is administered to a nursing mother. It is unlikely that a nursing infant can absorb a significant amount of clindamycin from its gastro-intestinal tract.

Gastro-intestinal Disorders: Oesophageal ulcers and oesophagitis with oral preparations, nausea, vomiting, abdominal pain and diarrhoea.
Blood and Lymphatic System Disorders: Transient neutropenia (leucopenia), eosinophilia, agranulocytosis and thrombocytopenia.
Immune System Disorders: anaphylactoid reactions.
Skin and Subcutaneous Tissue Disorders: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported reactions. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. Pruritus, vaginitis and rare instances of exfoliative and vesicubullous dermatitis have been reported. Serious cutaneous adverse reaction (SCAR) and rare cases of toxic epidermal necrolysis.
Hepatobiliary disorders: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
Cardiac Disorders: Rare instances of cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration.
Nervous System Disorders: Frequent cases of Dysgeusia have been observed upon systemic administration of clindamycin using injectables (IM or IV), capsules, or oral granulate solutions, which include a few (non-frequent) serious adverse events.
General Disorders and Administration Site Conditions: Local irritation, pain, abscess formation have been observed in conjunction with IM injection. These reactions can be minimized by deep IM injection. Thrombophlebitis has been reported with IV injection.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. It should be used with caution, therefore, 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.
Vitamin K antagonists increased coagulation tests (PT/INR) and/or bleeding have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.

Store at temperatures not exceeding 30°C. Protect from light.

Other Antibiotics

J01FF01 - clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections.

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