What is Dalacin T used for?

Dalacin T is indicated for the treatment of *acne vulgaris*.

What pharmaceutical form is Dalacin T available in?

Dalacin T: Żel 10 mg/g (1%) (na skórę)

Is Dalacin T OTC or prescription only?

Dalacin T requires a doctor's prescription.

What are the side effects of Dalacin T?

The following table lists adverse reactions identified during clinical trials and post-marketing surveillance, by system organ class and frequency of occurrence. Adverse reactions identified post-marketing are shown in *italics* in the table. Frequencies are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Withi

Who should NOT take Dalacin T?

Dalacin T is contraindicated in patients with a history of hypersensitivity to clindamycin, lincomycin, or to any of the excipients listed in section 6.1. Dalacin T is contraindicated in patients with a history of antibiotic-associated colitis. 4.4

Can Dalacin T be used during pregnancy?

( AHT ) For the active ingredient clindamycin This medicine is generally considered safe during pregnancy if taken as directed. During pregnancy, you should discuss your medicine use with your doctor or pharmacist.

What precautions should be taken with Dalacin T?

Clindamycin administered orally and parenterally, as with many other antibiotics, has been associated with severe diarrhoea and pseudomembranous colitis (see section 4.8). Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhoea and colitis have rarely been reported in connection with the use of Dalacin T. For this reason, the clinician should be alert to the possible development of antibiotic-associated diarrhoea or colitis. If seve

What ATC class does Dalacin T belong to?

Dalacin T: ATC D10AF01. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Dalacin T

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: anti-acne preparations, antiinfectives for treatment of acne, ATC code: D10AF01 Mechanism of action Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis. It binds to the 50S ribosomal subunit and affects the process of ribosomal assembly as well as the translational process. Although clindamycin phosphate is not active *in vitro*, rapid *in vivo* hydrolysis converts this compound to clindamycin, which has antibacterial activity. Clindamycin has demonstrated *in vitro* activity against isolates of the following microorganisms: Anaerobic Gram-positive non-spore-forming bacteria, including: *Propionibacterium acnes*. Pharmacodynamic effects Activity correlates with the period of time during which drug levels exceed the minimum inhibitory concentration (MIC) of the pathogen (%T/MIC). Resistance Resistance to clindamycin in *Propionibacterium acnes* may be caused by mutations in the rRNA antibiotic binding site or by methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit. These alterations may confer cross-resistance to macrolides and streptogramins B (MLSB phenotype). Macrolide-resistant isolates should be tested for inducible clindamycin resistance using the D-test. Cross-resistance between clindamycin and lincomycin has been demonstrated. The prevalence of acquired resistance may vary geographically and over time for selected species, and local information on resistance is desirable, particularly when treating severe infections. Where necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable. Particularly in severe infections or treatment failure, microbiological diagnosis is recommended with verification of the pathogen and its susceptibility to clindamycin. Resistance is usually defined on the basis of susceptibility interpretive criteria (breakpoints) established by regulatory agencies; CLSI (Clinical and Laboratory Standards Institute) or EUCAST (European Committee on Antimicrobial Susceptibility Testing) for systemically administered antibiotics. These breakpoints may be less relevant for topically administered clindamycin. Although clindamycin is not specifically referenced, EUCAST suggests that resistance for topically administered antimicrobial agents be defined using epidemiological cut-off values (ECOFFs) rather than the clinical breakpoints established for systemic administration. However, MIC distributions and ECOFFs for *P. acnes* have not been published by EUCAST. Based on correlations between clinical outcomes in patients with acne and the clindamycin MIC of their *P. acnes* isolates, values ≤ 256 mg/L are considered susceptible for topical administration of clindamycin. CLSI has published MIC ranges for a limited number (58) of unique clinical isolates of *P. acnes* collected between 2010 and 2012 in US hospitals. 91% of these isolates were susceptible to clindamycin (MIC ≤ 8 mg/L). A recent Belgian surveillance study (2011–2012) of anaerobic bacteria included 22 isolates of *P. acnes*. 95.5% were susceptible to clindamycin. An earlier European surveillance study, which included 304 isolates of *P. acnes*, reported a 15% rate of clindamycin resistance. In that study, however, a breakpoint of 0.12 mg/L was applied. Had the current breakpoint of 4 mg/L been used, no isolates would have been classified as resistant. Breakpoints The CLSI and EUCAST breakpoints for Gram-positive anaerobic bacteria are listed below. Although the two organisations report different values, the resistance breakpoint is identical, as CLSI recognises an intermediate susceptibility category (4 mg/mL). As noted above, the breakpoints are based on use in systemic infections. EUCAST breakpoints for systemically administered clindamycin Pathogen Susceptible Resistant Gram-positive anaerobic bacteria (except *Clostridium difficile*) ≤ 4 mg/L > 4 mg/L CLSI breakpoints for systemically administered clindamycin Pathogen Susceptible Resistant Anaerobes ≤ 2 mg/L > 8 mg/L

Dalacin T

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