Dalamax

Clindamycin hydrochloride.

Each Capsule contains: Clindamycin (as hydrochloride) 300 mg.

Pharmacotherapeutic Group: Anti-bacterial.
Pharmacology: Pharmacokinetics: Following oral administration, the bioavailability of the drug is about 90% with 150 mg dose and 23-38% with higher doses.
An hour after a single dose of 150 mg oral clindamycin, plasma concentration reaches 2-3 mcg/mL. After 6 hours, it increases to an average of 0.7 mg/mL. Peak plasma concentrations are 4 mcg/mL for 300 mg dose and 8 mcg/mL for 600 mg dose.
Food reduces the rate of absorption of clindamycin but does not affect the extent of absorption of the drug.
Clindamycin is about 90% protein bound. Its half-life is 2-3 hours and is prolonged to 3.5 to 5 hours in patients with anuria, and to 7-14 hours in patients with liver disease. Half-life is also prolonged in preterm neonates.
Clindamycin is metabolized in the liver to its active metabolites, n-demethyl and sulfoxide metabolites and to some inactive ones.
The volume of distribution of clindamycin is 0.66 mL/g. It is distributed in most tissues, body fluids, and bone. Significant concentration of clindamycin enough to treat meningitis is not reached in the cerebrospinal fluid.
Clindamycin is eliminated in the liver and is slowly excreted as active drug and metabolites in the urine (10%) and in the feces (4%). Clindamycin cannot be removed by dialysis.
In patients with AIDS, clindamycin shows higher bioavailability. Plasma clearance and volume of distribution is lower.

Clindamycin is a lincosamide bacteriostatic antibacterial which is used to treat anaerobic infections and some staphylococcal and streptococcal infections. However, because clindamycin may pose a risk of serious adverse effect, this drug is recommended only when penicillin or any alternative drug is not readily available or is inappropriate.
Clindamycin is used to treat gastrointestinal infections caused by Bacteroides fragilis and is an alternative drug for the treatment of infections caused by oropharyngeal strains of B. fragilis.
Clindamycin is also used in the treatment of respiratory tract infections and pharyngitis or tonsillitis caused by Streptococcus pyogenes, as well as in the treatment of other infections caused by Fusobacterium, anaerobic streptococci, Clostridium perfringes and penicillin-resistant strains of Staphylococcus aureus.
Other conditions where clindamycin is of benefit include liver abscess, actinomycosis, biliary tract infections, staphylococcal bone and joint infections, the carrier state of diphtheria, gas gangrene, gynecological infections such as bacterial vaginosis, necrotizing fasciitis, secondary peritonitis, aspiration pneumonia, pneumonia including lung abscess, septicemia, skin disorders with heavy streptococci or anaerobe colonization.
Clindamycin is used in combination with an aminoglycoside or metronidazole to treat penetrating wounds of the abdomen and gut, infections originating in the female genital tract, endometriosis and pelvic inflammatory disease.
Clindamycin is used for endocarditis prophylaxis in patients allergic to penicillin. It is also used as a prophylaxis for surgical infection, in combination with other drugs, and prophylaxis to prevent perinatal streptococcal infections.
Clindamycin exerts some protozoal activity especially in babesiosis, malaria and toxoplasmosis. It is also used with primaquine in the management of pneumocystis pneumonia.

The usual dose of clindamycin in adults is 150 to 300 mg every 6 hours.
For very severe infections, dose is increased to 300-450 mg every 6 hours.
Children may be given 3-6 mg per kg body weight every 6 hours. Children below 12 months or weighing ≤10 kg are given 37.5 mg every 8 hours.
Or as prescribed by the physician.

Clindamycin hydrochloride is contraindicated in patients with hypersensitivity to clindamycin and lincomycin.
It should not be used in patients with gastrointestinal disease especially those with history of colitis. Clindamycin is also contraindicated in patients with diarrhea.

If diarrhea or colitis develops, treatment with clindamycin should be discontinued. Clindamycin should also be used with caution in atopic patients.
Use in patients with renal and hepatic impairment: Caution must be taken when giving clindamycin to patients with renal and hepatic impairment. Adjustment of the dosage is required.
Blood counts, renal and liver function should be monitored in patients receiving prolonged treatment of clindamycin.
Use in pregnancy: US FDA CATEGORY B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women or Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Clindamycin is found to diffuse across the placenta and into the fetal circulation. It should therefore be used with caution in pregnant patients.
Use in lactation: Clindamycin is excreted in the breast milk. Breastfeeding should be avoided when taking the drug.
Use in infants and children: Blood counts, renal and liver function should be monitored in infants and children taking clindamycin.
Use in elderly: Renal and liver function should be monitored in the elderly being treated with clindamycin. Elderly patients should be monitored for any changes in the frequency of bowel movement or development of diarrhea.

Use in pregnancy: US FDA CATEGORY B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women or Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Clindamycin is found to diffuse across the placenta and into the fetal circulation. It should therefore be used with caution in pregnant patients.
Use in lactation: Clindamycin is excreted in the breast milk. Breastfeeding should be avoided when taking the drug.

Adverse effects experienced with the use of clindamycin include abdominal pain or cramps, nausea, vomiting, diarrhea and loose stools sometimes with traces of blood and mucus. Use of clindamycin should be discontinued if diarrhea develops.
Antibiotic-associated pseudomembranous colitis, which may be fatal, develops during or weeks after therapy with clindamycin and is common in women and elderly. This is caused by necrotizing toxins secreted by Clostridium spp., particularly Clostridium. difficile.
Allergic rashes and urticarial, Steven-Johnson-like syndrome, anaphylaxis transient leucopenia, leucopenia (with agranulocytosis), eosinophilia, thrombocytopenia, erythema multiforme, exfoliative and vesiculobullous dermatitis, polyarthritis, abnormalities of liver function tests, overt jaundice and hepatic damage have been reported with the use of clindamycin.

Clindamycin, which exhibits neuromuscular blocking activity, should not be used with drugs that have similar property (i.e. tubocurarine, pancuronium and atracurium). Concomitant use of the said drugs increases the risk of respiratory depression.
There were reports that clindamycin may inhibit the activity of aminoglycosides, in vitro. However, in vivo, there was neither antagonism observed nor any apparent decrease in the activity of clindamycin when given with aminoglycoside.
Diphenoxylate, loperamide and other opiate antidiarrheal drugs may exacerbate the symptoms of antibiotic-associated colitis by delaying the excretion of the toxin.
When kaolin-pectin suspension was given to patients taking clindamycin, the suspension did not affect the extent of absorption of clindamycin but it reduced its absorption rate significantly.
Concomitant use of clindamycin with parasympathomimetics such as neostigmine and pyridostigmine antagonizes the activity of the parasympathomimetics.

Shelf-Life: 24 months.

Other Antibiotics

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

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