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Drugs Clindastad have composition Clindamycin150mg , Clindamycin is a primarily bacteriostatic antibacterial used chiefly in the treatment of serious anaerobic infections, notably due to Bacteroides fragilis, and in some staphylococcal and streptococcal infections

OpeCipro 500mg is indicated for severe infections

Klamentin 1g indications Bone and joint infection , Upper, Lower respiratory tract infections

Cefdinir 300mg indication Community acquired pneumonia, acute course of chronic bronchitis , Nephritis

COMPOSITION

Each capsule contains:

Clindamycin (hydrochloride)   150mg

Excipients q.s   1 capsule

(Macrocrystalline cellulose, magnesium stearate)

Clindastad 150mg - Clindamycin 150mg

DESCRIPTION

Hard gelatin capsule size No.1 with opaque red cap-transparent violet body, imprinted ‘STADA’ on both parts, contains white to off-white powder.

PHARMACODYNAMICS

Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Most Gram-negative aerobic bacteria, including the Enterobacteriaceae, are resistant to clindamycin. Uncosamides such as clindamycin bind to the SOS subunit of the bacterial ribosome similarly to macrolides such as erythromycin and inhibit the early stages of protein synthesis. The action of clindamycin 150mg is predominantly bacteriostatic although high concentrations may be slowly bactericidal against sensitive strains.

PHARMACOKINETICS

About 90% of a dose of Clindastad is absorbed from the gastrointestinal tract; concentrations of 2 to 3 ug/ml occur within 1 hour after a 150 mg ora! dose of clindamycin, with average concentrations of about 700 nanograms/ml after 6 hours. After doses of 300 and 600 mg peak plasma concentrations of 4 and 8 ug/ml, respectively, have been reported. Absorption is not significantly diminished by food in the stomach but the rate of absorption may be reduced. Clindamycin is widely distributed in body fluids and tissues including bone, but it does not reach the CSF in significant concentrations. It diffuses across the placenta into the fetal circulation and has been reported to appear 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 preterm neonates and in patients with severe renal impairment. Clindamycin  undergoes metabolism, presumably in the liver, to the active N-demethyl and sulfoxide metabolites, and also to some inactive metabolites. About 10% of a dose 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.

INDICATIONS

Clindamycin is a primarily bacteriostatic antibacterial used chiefly in the treatment of serious anaerobic infections, notably due to Bacteroides fragilis, and in some staphylococcal and streptococcal infections. However, because of its potential for causing pseudomembranous colitis, it is usually used only when alternative drugs are unsuitable. Amongst the conditions that it may be used to treat are liver abscess, actinomycosis, biliary-tract infections, staphylococcal bone and joint infections, the carrier state of diphtheria, gas gangrene, various gynaecological infections including bacterial vaginosis, endometritis, and pelvic inflammatory disease (the latter two in combination with an aminoglycoside), necrotising fasciitis, secondary peritonitis, streptococcal pharyngitis (usually to treat the carrier state), pneumonia (especially lung abscess), septicaemia, and skin infections involving heavy colonisation with streptococci or anaerobes.

It is used in the prophylaxis of endocarditis in penicillin-allergic patients, in the prevention at perinatal streptococcal infections, and with other drugs for the prophylaxis of surgical infection.

DOSAGE AND ADMINISTRATION

Clindastad is administered orally. The capsule should be taken with a glass of water.

Adults. The usual dose is 150-300 mg of clindamycin every 6 hours, in severe dose may be increased to 450 mg every 6 hours.

10 kg or less should receive at developing endocarditis and who cannot be 600 mg. given 1 hour before 18 extractions under local or no anaesthesia, has been suggested

CONTRAINDICATIONS

Patients previously found to be sensitive to clindamycin, lincomycin or to any component of the formulation

PRECAUTIONS

–        Clindastad should be used with caution in patients with gastrointestinal disease, particularly those with a history of colitis. Clindamycin should be withdrawn immediately if significant diarrhoea or colitis occurs. Elderly and female patients may be more likely to experience severe diarrhoea or pseudomembranous colitis

–        Caution has also been advised in atopic patients.

–        Patients with hepatic or renal impairment may require dosage adjustment.

–        Periodic tests of liver and kidney function and blood counts have been recommended in patients receiving prolonged therapy, and in infants.

DRUG INTERACTIONS

–        Neuromuscular blocking agents: Clindamycin has been shown to have neuromuscular blocking properties that may enhance the neuromuscular blocking action of other agents (e.g., ether, tubocurarine. pancuronium). Clindamycin should be used with caution in patients receiving such agents and such patients should be observed for prolongation of neuromuscular blockade.

–        Aminoglycosides: Clindamycin has been reported to antagonize the bactericidal activity of aminoglycosides in vitro, and these drugs not be used concomitantly

However, in vivo antagonism has not been demonstrated, and clindamycin has been administered successfully in conjunction with an aminoglycoside with no apparent decrease in activity.

–        Erythromycin: There is in vitro evidence of antagonism between erythromycin and clindamycin.

PREGNANCY AND LACTATION

– Pregnancy: There are no adequate and controlled studies to date using clindamycin in pregnant women, clindamycin should be used during pregnancy only when clearly needed.

– Lactation: Clindamycin is distributed into milk. Because of the potential for serious adverse reactions from clindamycin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of , the drug to the woman.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable.

ADVERSE REACTIONS

– Gastrointestinal tract: Nausea, vomiting, abdominal pain, diarrhoea and oesophagus Haematopoietic: Transient neutropenia (leucopenia), eosinophilia. agranulocytosis and thrombocytopenia have been reported.

– Skin and mucous membranes: Pruritus, vaginitis and rare instances of exfoliative and vesiculobullous dermatitis have been reported.

– Hypersensitivity reactions: Maculopapular rash and urticaria have been observed during drug therapy. Generalised mild to moderate moftMlirform-hke skin rashes are the most frequently reported reactions. Rare instances of erythema multiform and Stevens-Johnson syndrome have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported.

– Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

OVERDOSAGE

In cases of overdosage no specific treatment is indicated The serum biological half-life of clindamycin 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,

STORAGE: Store in a well-dosed container, in a dry place. Do not store above 30 C.

SHELF-UFE : 48 months from the date of manufacturing

PACKAGING: Blister of 10capsules .Box of 5 btisters.

Blister of 10 capsules. Boxof 10 blisters.

SPECIFICATION: Manufacturer’s specification.

3 Comments

  1. tony says:

    Thanks a lot for sharing this with all of us you really know what you are talking about! Bookmarked.

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