Orally administered Aknemycin stearate is readily and reliably absorbed. Optimal serum levels of Aknemycin are reached when the drug is taken in the fasting state or immediately before meals.
Aknemycin diffuses readily into most body fluids. Only low concentrations are normally achieved in the spinal fluid, but passage of the drug across the blood-brain barrier increases in meningitis. In the presence of normal hepatic function, Aknemycin is concentrated in the liver and excreted in the bile; the effect of hepatic dysfunction on excretion of Aknemycin by the liver into the bile is not known. Less than 5% of the orally administered dose of Aknemycin is excreted in active form in the urine.
Microbiology: Biochemical tests demonstrate Aknemycin inhibits protein synthesis of the pathogen without directly affecting nucleic acid synthesis. Antagonism has been demonstrated between clindamycin and Aknemycin.
Aknemycin binds to the 50S ribosomal subunits of susceptible bacteria and suppresses protein synthesis.
Aknemycin is usually active against most strains of the following organisms both in vitro and in clinical infections: Gram-Positive Organisms: Corynebacterium diphtheriae, Corynebacterium minutissimum, Listeria monocytogenes, Staphylococcus aureus (resistant organisms may emerge during treatment), Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-Negative Organisms: Bordetella pertussis, Legionella pneumophilia, Neisseria gonorrhoeae.
Other Microorganisms: Chlamydia trachomatis, Entamoeba histolytica, Mycoplasma pneumoniae, Ureaplasma urealyticum.
Aknemycin has been shown to be active in vitro against most strains of the following organisms; however, the safety and efficacy of Aknemycin in treating infections due to these organisms have not been established in adequate and well-controlled trials: Gram-Positive Organisms: Alpha hemolytic streptococci (viridans group).
Gram-Negative Organisms: Moraxella (Branhamella) catarrhalis.
Other Microorganisms: Entamoeba histolytica, Treponema pallidum.
Disc Susceptibility Tests: Quantitative methods require measurement of zone diameters give the most precise estimates of antibiotic susceptibility. One recommended procedure uses Aknemycin class discs for testing susceptibility; interpretations correlate zone diameters of this disc test with MIC values for Aknemycin. With this procedure, a report from the laboratory of "susceptible" indicates the infecting organism is likely to respond to therapy. A report of "resistant" indicates the infective organism is not likely to respond to therapy. A report of "intermediate susceptibility" indicates the result be considered equivocal, and if, the pathogen is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. This category provides a buffer zone, which prevents small, uncontrolled technical factors from causing major discrepancies in interpretation.
Note: Many strains of Haemophilus influenzae are resistant to Aknemycin alone, but are susceptible to Aknemycin and sulfonamides together. Staphylococci resistant to Aknemycin may emerge during a course of Aknemycin therapy. Culture and susceptibility testing should be performed.
Before applying Aknemycin, thoroughly wash the affected area with warm water and soap, rinse well, and pat dry. After washing or shaving, it is best to wait 30 minutes before applying the pledget (swab), topical gel, or topical liquid form. The alcohol in them may irritate freshly washed or shaved skin.
For patients using the pledget (swab), topical gel, or topical liquid form of Aknemycin:
Aknemycin will not cure your acne. However, to help keep your acne under control, keep using Aknemycin for the full time of treatment, even if your symptoms begin to clear up after a few days. You may have to continue using Aknemycin every day for months or even longer in some cases. If you stop using Aknemycin too soon, your symptoms may return. It is important that you do not miss any doses.
The dose of Aknemycin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Aknemycin. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of Aknemycin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
You may take Aknemycin with or without food.
Do not crush, chew, break, or open an Aknemycin tablet or capsule. Swallow it whole.
Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Aknemycin.
Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Aknemycin will not treat a viral infection such as the common cold or flu.
Store at room temperature away from moisture and heat, unless otherwise directed on the medicine label.
Orally administered Aknemycin ethylsuccinate suspensions and Filmtab tablets are readily and reliably absorbed. Comparable serum levels (Aknemycin ethylsuccinate) of Aknemycin are achieved in the fasting and nonfasting states.
Aknemycin diffuses readily into most body fluids. Only low concentrations are normally achieved in the spinal fluid, but passage of the drug across the blood-brain barrier increases in meningitis. In the presence of normal hepatic function, Aknemycin is concentrated in the liver and excreted in the bile; the effect of hepatic dysfunction on excretion of Aknemycin by the liver into the bile is not known. Less than 5 percent of the orally administered dose of Aknemycin is excreted in active form in the urine.
Aknemycin crosses the placental barrier, but fetal plasma levels (Aknemycin ethylsuccinate) are low. The drug is excreted in human milk.
Aknemycin acts by inhibition of protein synthesis by binding 50 S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has been demonstrated in vitro between Aknemycin and clindamycin, lincomycin, and chloramphenicol.
Many strains of Haemophilus influenzae are resistant to Aknemycin alone but are susceptible to Aknemycin and sulfonamides used concomitantly.
Staphylocci resistant to Aknemycin may emerge during a course of therapy.
Aknemycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Staphylococcus aureus(resistant organisms may emerge during treatment)
The following in vitro data are available, but their clinical significance is unknown.
Aknemycin exhibits in vitro minimal inhibitory concentrations (MIC's) of 0.5 μg/mL or less against most ( ≥ 90%) strains of the following microorganisms; however, the safety and effectiveness (Aknemycin ethylsuccinate) of Aknemycin in treating clinical infections due to these microorganisms have not been established in adequate and well controlled clinical trials.
Viridans group streptococci
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution methodrequires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 15-μg Aknemycin to test the susceptibility of microorganisms to Aknemycin.
Reports from the laboratory providing results of the standard single-disk susceptibility test with a 15
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Information checked by Dr. Sachin Kumar, MD Pharmacology