CLEOCIN ® Clindamycin

CLEOCIN ® is a drug based on Clindamycin sulfate

THERAPEUTIC GROUP: Antibiotics - Antimicrobials and gynecological antiseptics

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications CLEOCIN ® Clindamycin

CLEOCIN ® is indicated in the treatment of vaginal infections sustained by microorganisms sensitive to lincosamides such as Clindamycin.

Mechanism of action CLEOCIN ® Clindamycin

Clindamycin, the active ingredient of CLEOCIN ®, is a semi-synthetic antibiotic obtained through halogenation of Lincomycin particularly effective in the treatment of infections caused by anaerobic flora, replacing in some cases Metronidazole for the treatment of vaginitis and vaginosis.

The topical use in cream rather than the use of vaginal ovules, allows the active principle to reach therapeutic concentrations locally useful to carry out the bacteriostatic activity through the bond with the 50S ribosomal subunit and the consequent inhibition of the elongation of the nascent peptide chain mediated by the enzyme peptidyl transferase.

The mechanism of action of Clindamycin and more generally of lincosamides, superimposable to that of macrolides, is often responsible for cross-reactions to macrolides, as in the case of hypersensitivity to the active principle rather than to the onset of resistance mechanisms characterized by:

Expression of efflux pumps on the surface of the bacterial cell;
Expression of inactivating enzymes of the active ingredient;
Genetic and structural variations of the biological target.

This drug has proved its effectiveness especially in relation to some microorganisms normally responsible for bacterial vaginosis such as Gardnerella vaginalis, Mobiluncus, Bacteroides, Mycoplasma Hominis and Peptostreptococcus.

Studies carried out and clinical efficacy

1 CLINICAL TRIAL ON THE EFFECTIVENESS OF THE CLINDAMYCIN

Gynecol Obstet Invest. 2012; 73 (1): 8-15.

Clinical trial that demonstrates the same effectiveness of the application of Clindamycin in cream compared to the vaginal tablets of other drugs, in the treatment of bacterial vaginitis, but with fewer side effects.

2. THE EFFECTIVENESS OF THE CLINDAMYCIN IN CREAM IN PREGNANT WOMEN

Int J STD AIDS. 2012 Aug; 23 (8): 565-9.

Rescreening for abnormal vaginal flora in pregnancy and re-treating with clindamycin vaginal cream significantly increases care and improvement rates.

Lamont RF, Taylor-Robinson D, Bassett P.

Study that demonstrates the effectiveness of the use of Clindamycin in cream for the treatment of bacterial vaginosis in pregnant women, significantly reducing in just 7 days of therapy both in associated symptoms and in positive microbiological tests.

3. SEXUAL PRACTICE AND RECURRENT INFECTIONS

Clin Infect Dis. 2012 Dec 12.

An interesting study that demonstrates intense sexual activity and the use of hormonal contraceptives can facilitate the onset of recurrent bacterial infections responsible for vaginosis, while reducing the effectiveness of antibiotic therapy.

Method of use and dosage

CLEOCIN ®

100 mg vaginal ovules of Clindamycin;

2% Clindamycin vaginal cream.

Generally the therapeutic scheme envisaged for CLEOCIN ® vaginal ovules is one ovum a day for intravaginal administration before going to bed, while for CLEOCIN ® in cream a 5 g application for 3-7 days.

Warnings CLEOCIN ® Clindamycin

Although topical use and vaginal administration are generally safer than oral, it is always necessary to consider the potential side effects of Clindamycin therapy, mainly represented by a profound intestinal dysbiosis, due to the impairment of the microflora, responsible for severe diarrhea, often accompanied by Clostridium Difficile superinfections, then by pseudomembranous colitis.

For this reason the use of CLEOCIN ® should be carried out with particular caution in patients with a history of gastro-enteric pathologies, liver and kidney pathologies.

Prolonged use of Clindamycin could also cause colonization by germs resistant to antibiotic therapy, in particular fungi, responsible for a serious deterioration of the clinical conditions.

The presence of paraffin in CLEOCIN ® cream could reduce the effectiveness of some contraceptive methods such as the diagram and the condom.

PREGNANCY AND BREASTFEEDING

The use of Clindamycin in pregnancy is still debated, given the presence of conflicting studies concerning the safety of antibiotic therapy.

In fact, considering the general contraindication to the use of the drug in the first trimester, there are still no statistically significant works able to characterize the safety profile of Clindamycin for the fetus exposed in the following quarters.

Therefore, considering also that this active ingredient, absorbed systemically, is excreted in breast milk, we do not recommend the use of CLEOCIN ® during pregnancy and in the subsequent period of breastfeeding.

Interactions

Despite the low systemic absorption of Clindamycin used topically, it is always useful to remember to avoid the simultaneous administration of:

Other therapeutic products intravaginally;
Macrolides for the enhancement of side effects;
Erythromycin for the natural antagonism observed;
Drugs with neuromuscular blocking activity to enhance inhibitory activity.

Contraindications CLEOCIN ® Clindamycin

The use of CLEOCIN ® is contraindicated in patients with established hypersensitivity to the active ingredient or to one of its excipients, as well as to a history of colitis linked to antibiotic therapy.

Undesirable effects - Side effects

The use of CLEOCIN ® is generally well tolerated and has no clinically relevant side effects.

In some cases, however, superinfections with resistant pathogens such as Candida albicans and Trichomonas vaginalis have been observed, with consequent vulvar irritation, abdominal cramps and diarrhea, itching and only rarely dermatological reactions due to hypersensitivity to the drug.