Normaclin: composition and pharmaceutical form
One gram of Normaclin gel contains 10 mg of clindamycin as clindamycin phosphate. Besides the antibiotic, the composition includes allantoin, whose job is to soften the irritation caused by the treatment itself, and that detail matters: topical acne products almost always dry and sting the skin, while the course here lasts for months.
The other components of the base matter too. Propylene glycol is capable of irritating the skin, and methyl parahydroxybenzoate of causing allergic reactions, which may moreover appear not at once but with a delay. The gel has a specific smell and an unpleasant taste: the taste is mentioned in the leaflet for a reason, because the product is applied to the face and some of it inevitably ends up near the lips.
How Normaclin works
The pack contains not clindamycin itself but its phosphate. On the skin this compound is hydrolysed and passes into the active form — clindamycin, an antibiotic of the lincosamide group, which suppresses protein assembly in the bacterial cell by binding to the 50S subunit of its ribosome. And here the interesting part begins: the gel is applied to the surface, yet it has to act inside a closed plug. Studies have shown that after application to acne-affected skin, clindamycin is detected in the contents of comedones in concentrations sufficient against most strains of Propionibacterium acnes, one of the contributors to acne vulgaris.
The product has a second, non-antibacterial effect as well: it lowers the content of free fatty acids on the skin surface, and after that the lesions themselves begin to clear. In most patients skin changes resolve within six weeks. The reverse side is resistance: prolonged application of clindamycin to the skin may lead to resistant bacteria, which is why treatment is not turned into endless skincare.
Indications
The indication is set out in the leaflet in a single line: topical treatment of acne vulgaris. There is no grading by severity in that wording, yet the choice still belongs to the doctor — a topical antibiotic makes sense where there are inflammatory lesions, that is, a bacterial component, and not merely blocked pores.
The age limit is built straight into the indication: safety and efficacy in children under 12 have not been established and the product is not intended for them. Adolescents from 12 years and adults are prescribed it in the same way.
Method of use and dosage
The gel is applied twice a day — spot-wise, in a thin layer or sprayed onto the affected skin, depending on how many lesions there are and how scattered they are. It does not need to be rubbed in: the product should stay on the surface and in the pore openings rather than being driven into the skin by mechanical pressure. After application the hands are washed thoroughly.
The pump pack has to be primed before first use: take off the cap, point the nozzle in a safe direction and press the buttons several times until the first spray comes out. After that the waiting begins, and it is worth being ready for it: the optimal result of treatment appears after 8-12 weeks of use. The first changes show earlier, but judging the effect by the first week makes no sense.
Contraindications
The product is not used in case of hypersensitivity to the active substance or to any excipient of the gel, nor in case of hypersensitivity to lincosamide antibiotics — clindamycin and lincomycin. These two substances are structurally related, so a reaction to one of them also rules out the other.
The third contraindication is age under 12 years. It rests not on proven harm but on the absence of data: safety and efficacy studies in this age group were not carried out, and acne in younger children calls for a different explanation and a different approach.
Special warnings and precautions
The gel is intended solely for application to the skin. Contact with the eyes, mucous membranes and damaged skin must be avoided, and if it does occur, these areas are rinsed with cool water. Skin irritation is an expected reaction rather than an exceptional one, and its likelihood grows if the product ends up under an occlusive dressing: the propylene glycol in the base acts the more aggressively the less the skin can breathe. Methyl parahydroxybenzoate in the composition may give an allergic reaction, including a delayed-type one, that is, appearing several days after the start of treatment. On the ability to drive and operate machinery the product has no effect.
Separate caution is needed in people with inflammatory bowel disease, Crohn's disease, ulcerative colitis, antibiotic-associated colitis and a history of myasthenia. The reason is that taking clindamycin orally or parenterally, like many other antibiotics, is associated with the risk of severe pseudomembranous colitis; with application to the skin that likelihood is small but not zero. The colitis develops because of toxins of the bacterium Clostridium difficile and presents with persistent severe diarrhoea and cramping abdominal pain. Diagnosis uses endoscopy, bacteriological stool testing for C. difficile and a test for its enterotoxins, and treatment includes, among other things, antibiotic therapy with vancomycin; in milder cases good results come from cholestyramine, which binds the enterotoxins, with at least two hours left between vancomycin and cholestyramine. The practical conclusion for the patient is simpler than this whole picture: any diarrhoea during treatment is a reason to stop applying the gel immediately and see a doctor to establish the cause.
Drug interactions
Two prohibitions are stated outright. The first is muscle relaxants: clindamycin itself suppresses neuromuscular transmission and is capable of enhancing their action, so the product is not used together with them. The second is lincomycin, erythromycin and other macrolide antibiotics: microorganisms show cross-resistance to clindamycin and to these antibiotics, and the combination does not strengthen the treatment but empties it of meaning.
The third rule concerns not medicines but timing. If another topical product has been prescribed in parallel, it must not be applied at the same time as the gel — the applications are separated in time. This applies to any local preparation, including those that look like harmless cosmetics.
Pregnancy and breastfeeding
There are no data on the safety of topical clindamycin during pregnancy. The leaflet's wording is cautious: in this period the product may be used only in case of undoubted necessity, that is, when the doctor regards treating acne as a task that cannot be postponed. There is also no information on the effect of clindamycin on fertility.
With breastfeeding the situation is similar: there are no data on the safety of topical use, and of clindamycin taken orally or given parenterally it is known that it crosses the placental barrier and passes into milk. Whether it passes into milk after application to the skin is unknown; the bioavailability of clindamycin phosphate applied topically is about 1.7%, but even that figure does not remove the question. Therefore, during treatment with the product breastfeeding should be avoided.
Adverse reactions
Most reactions arise where the gel was applied. From the skin and subcutaneous tissue, excessive dryness, burning, itching, redness, contact dermatitis, increased skin oiliness, inflammation of the hair follicles, skin irritation and irritation of the skin around the eyes are possible, as well as allergic reactions, including delayed-type ones. The combination of dryness with increased oiliness looks contradictory, but both reactions really are described: the skin responds differently to the antibiotic and to the gel base.
The second group concerns the stomach and the intestine: loose stools, abdominal pain, bloating, dyspepsia. Taking clindamycin orally or parenterally, like other antibiotics, may be associated with the risk of severe pseudomembranous colitis. After applying the gel to the skin, general reactions occurred very rarely, but they are described: diarrhoea, including severe diarrhoea with blood and mucus, and colitis. That is exactly why intestinal symptoms with a topical product cannot be written off as coincidence.
Overdose
With a topical product, overdose is measured not in milligrams but in surface area. Clindamycin phosphate applied to the skin, especially over large areas, may be absorbed in amounts sufficient to produce a general effect on the body.
The practical meaning of this warning is that «spreading on more and covering the whole face with the neck and back at once» does not speed up treatment but opens the way to systemic reactions, including intestinal ones. The application schedule is set by the doctor and it is not worth widening it on your own.
How to get a prescription for Normaclin online
The course with this gel is long: the optimal result is assessed after 8-12 weeks, and prolonged application of clindamycin to the skin leads to bacterial resistance. That is why the decision about duration and about what to continue or supplement the treatment with stays with the doctor, and in the questionnaire it is worth stating how long the lesions have lasted, what has already been used on them and whether there are bowel diseases or myasthenia.
Normaclin is a prescription medicine, and a prescription at e-zdrowie.com can be arranged remotely: you fill in a medical questionnaire, the doctor studies the answers and issues an electronic prescription, the code arrives by message, and the medicine is dispensed at any Polish pharmacy.
