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Professional information: Clindamycin - 1 A Pharma® 600 mg film-coated tablets
1 A Pharma GmbH
Clindamycin - 1 A Pharma® 450 mg film-coated tablets
Clindamycin - 1 A Pharma® 600 mg film-coated tablets
Clindamycin - 1 A Pharma® 450 mg film-coated tablets
Clindamycin - 1 A Pharma® 600 mg film-coated tablets
Clindamycin - 1 A Pharma 450 mg film-coated tablets
One film-coated tablet contains 488.7 mg clindamycin hydrochloride (equivalent to 450 mg clindamycin).
Clindamycin - 1 A Pharma 600 mg film-coated tablets
One film-coated tablet contains 651.5 mg clindamycin hydrochloride (equivalent to 600 mg clindamycin).
Excipient with known effect: lactose
For a full list of excipients, see section 6.1
White, oval, film-coated tablet with a score line The score line is only used to divide the tablet to make it easier to swallow and not to be divided into equal doses.
4.1 Areas of application
Clindamycin is used for infections caused by bacteria sensitive to clindamycin (see section 5.1), such as:
• Upper respiratory tract infections such as chronic or recurrent tonsillitis, pharyngitis, sinusitis, otitis media, and scarlet fever when treatment with primary antibiotics is unsuccessful or impossible
• Lower respiratory tract infections such as acute bacterial exacerbation of chronic bronchitis (adequately diagnosed), pneumonia, empyema, and lung abscess
• Difficult-to-treat skin and soft tissue infections such as acne, furunculosis, cellulitis, impetigo, abscesses, wound infections, erysipelas and nail fold infections
• Infections of the bones and joints such as osteomyelitis and septic arthritis
• Gynecological infections such as endometritis, tubo-ovarian abscess, salpingitis, infections of the cervix and inflammatory diseases in the pelvic region in combination with an antibiotic that is effective against gram-negative aerobic bacteria.
At through Chlamydia trachomatis Cervicitis caused by clindamycin can be given as monotherapy.
• Intra-abdominal infections such as peritonitis and abdominal abscesses in combination with an antibiotic that is effective against Gram-negative aerobic bacteria
• Dental infections such as periodontal abscess and periodontal disease
In the case of severe clinical pictures, intravenous therapy is preferable to oral therapy.
Clindamycin is effective in many anaerobic infections (see section 5.1). For aerobic infections, clindamycin is an alternative when other antibiotics are ineffective or contraindicated. The generally recognized guidelines for the appropriate use of antimicrobial agents must be taken into account when using Clindamycin - 1 A Pharma.
4.2 Dosage and method of application
Adults, adolescents from 14 years and older patients
Depending on the severity of the infection, 600 - 1800 mg clindamycin daily. The daily intake is divided into 3 - 4 equal individual revenues.
For doses that cannot be achieved with Clindamycin -1 A Pharma 450 mg or -600 mg film-coated tablets, other, lower-dosed dosage forms are available.
Clindamycin - 1 A Pharma film-coated tablets are not suitable for children who cannot swallow them whole. Clindamycin - 1 A Pharma film-coated tablets do not allow the exact mg / kg / body weight dosages, so a more suitable dosage form should be used if necessary.
Patients with liver disease
The elimination half-life of clindamycin is increased in patients with moderate to severe liver disease. A dose reduction is usually not necessary if clindamycin film-coated tablets are given every 8 hours. However, clindamycin plasma levels should be monitored in patients with severe hepatic insufficiency. Depending on the results of this measure, it may be necessary to reduce the dose or to extend the dosing interval.
Kidney disease patients
A prolonged elimination half-life of clindamycin has been observed in patients with impaired renal function. However, a dose reduction is not necessary in the case of mild to moderate impairment of kidney function.
However, plasma levels should be monitored in patients with severe renal impairment or anuria. Depending on the results of this measure, a dose reduction or, alternatively, a longer dosing interval of 8 or even 12 hours may be necessary.
Dosage for hemodialysis
Clindamycin is not hemodialysable. No additional dose is therefore required before or after dialysis.
type of application
To protect the esophagus, the film-coated tablets should always be taken with a full glass of water!
For infections caused by beta-hemolytic streptococci, treatment should last at least 10 days.
Hypersensitivity to clindamycin or lincomycin or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Serious hypersensitivity reactions, including severe skin reactions such as: B. Drug rash with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalizing pustular rash (AGEP). If hypersensitivity or severe skin reactions occur, treatment with clindamycin should be discontinued and appropriate treatment instituted (see sections 4.3 and 4.8).
The occurrence of virtually all antibiotics, including clindamycin, has been reported Clostridium difficileassociated diarrhea (CDAD) has been reported. In terms of severity, these ranged from mild diarrhea to colitis with a fatal outcome. A therapy with antibiotics changes the normal intestinal flora, which leads to an overgrowth with C. difficile can lead. C. difficile produces toxins A and B, which contribute to the development of CDAD and are a major cause of "antibiotic-associated colitis". Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality, since such infections can be resistant to antibiotic therapy and may necessitate a colectomy. CDAD should be considered in all patients with diarrhea after antibiotic treatment. A careful medical history should be taken, as CDAD can occur up to 2 months after antibiotic therapy has been carried out. This can develop into colitis, including pseudomembranous colitis (see section 4.8), which can range in severity from mild to fatal. If antibiotic-associated diarrhea or colitis is suspected, or if antibiotic-associated diarrhea or antibiotic-associated colitis is confirmed, antibiotic treatment, including clindamycin, should be discontinued immediately and appropriate therapeutic measures initiated. In this situation, peristalsis inhibitors are contraindicated.
Clindamycin should only be used with special caution in patients with
• impaired liver function
• Disorders of neuromuscular transmission (myasthenia gravis, Parkinson's disease; see also sections 4.5 and 4.8)
• A history of gastrointestinal disorders (e.g. previous inflammation of the colon)
• allergies and asthma
Anaphylactic reactions including angioedema have been reported for clindamycin. Anaphylactic reactions can progress to life-threatening shock, even after initial use. In these cases, clindamycin must be discontinued immediately and appropriate treatment (e.g. treatment for shock) instituted.
Clindamycin should be prescribed with caution to patients with a history of gastrointestinal disease - especially colitis.
Because clindamycin does not cross the blood-brain barrier in sufficient quantities, it should not be used to treat meningitis.
Clindamycin should not be used for acute respiratory infections caused by viruses.
Caution should be exercised when using clindamycin in atopic patients.
The use of clindamycin can lead to superinfection or colonization with resistant germs, especially fungi.
With long-term therapy (treatment longer than 10 days) the blood count as well as liver and kidney function should be checked at regular intervals.
Clindamycin treatment is a possible alternative treatment for penicillin allergies.
A cross allergy between clindamycin and penicillin is not known and, due to the structural differences between the substances, is not to be expected. In individual cases, however, there is information about anaphylaxis against clindamycin in people with a pre-existing penicillin allergy. This should be taken into account when treating patients with penicillin allergy during clindamycin treatment.
Clindamycin should be used with caution in patients with allergies or asthma.
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4.5 Interactions with other medicinal products and other forms of interaction
In vitro an antagonistic effect between clindamycin and erythromycin was observed, which could be clinically significant. Therefore, these two active ingredients should not be used at the same time.
The pathogens are cross-resistant to clindamycin and lincomycin.
Neuromuscular blocking substances
It has been found that, due to its neuromuscular blocking properties, clindamycin can increase the effects of other neuromuscular blocking substances (e.g. ether, tubocurarine, pancuronium halide). Therefore, clindamycin should be used with caution in patients receiving such drugs.
Unexpected life-threatening reactions can occur during an operation.
Vitamin K antagonists
Increased blood coagulation values (PT / INR) and / or bleeding have been reported in patients receiving clindamycin with vitamin K antagonists (e.g. warfarin, acenocoumarol, fluindione).
The blood coagulation values should therefore be monitored closely in patients treated with vitamin K antagonists.
Clindamycin is primarily metabolised via cytochrome CYP3A4 and to a small extent via cytochrome CYP3A5 to the main metabolite clindamycin sulfoxide and the minor metabolite N-desmethylclindamycin. Therefore, inhibitors of CYP3A4 and CYP3A5 can reduce the clearance of clindamycin and inducers of these isoenzymes increase the clearance of clindamycin. If strong CYP3A4 inducers such as rifampicin are administered concomitantly, monitoring for loss of efficacy should be performed.
In vitroStudies indicate that clindamycin does not inhibit the isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Therefore, clinically meaningful interactions between clindamycin and co-administered drugs that are metabolized by these isoenzymes are unlikely.
4.6 Fertility, pregnancy and lactation
Reproductive toxicity studies in rats and rabbits with oral and subcutaneous administration gave no indications of impairment of fertility or damage to the fetus by clindamycin, except at maternally toxic doses. Animal reproduction studies cannot always be applied to humans.
Clindamycin crosses the placenta barrier in humans. After multiple doses, the concentration in the amniotic fluid is around 30% of that in the maternal blood.
Clinical studies in pregnant women did not reveal an increased incidence of congenital malformations with systemic administration of clindamycin during the second and third trimesters of pregnancy. There are insufficient and well-controlled studies in pregnant women in the first trimester of pregnancy.
Clindamycin must therefore not be used during pregnancy unless clearly necessary.
Orally and parenterally applied clindamycin was found in breast milk in concentrations of 0.7 to 3.8 μg / ml. Because of the risk of serious side effects in the breast-fed infant, clindamycin should not be used during breast-feeding.
Fertility studies in rats after oral administration of clindamycin showed no effects on fertility or childbearing potential.
4.7 Effects on ability to drive and use machines
Clindamycin has minor or moderate influence on the ability to drive and use machines. Some side effects (e.g. dizziness, drowsiness, see section 4.8) may impair the ability to concentrate and react and limit the ability to drive and use machines.
4.8 Side effects
In Table 1 the side effects reported in clinical trials and in the post-marketing setting are listed by organ class and frequency. The frequency information is based on the following convention:
Very common (≥ 1/10)
Common (≥ 1/100 to <1/10)
Uncommon (≥ 1/1000 to <1/100)
Rare (≥ 1/10000 to <1/1000)
Very rare (<1/10000)
Not known (frequency cannot be estimated from the available data)
Within each frequency group, the side effects are listed in descending order of severity.
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