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 BETA-LACTAMASE RESISTANT AMINOPENICILLINS (CLAVOMED) – DRUG OF CHOICE IN TREATMENT OF SINUSITIS 
NUGZAR UBERI, Doctor of Medicine, M.D.
TSMU, Associated Professor
 
Sinusitis is quite widespread disease in adults and children which is accompanied with serious complications. There are two forms of sinusitis: viral and bacterial. Usually common cold is accompanied with viral self limited rhinosinusitis. 2% of upper respiratory infections are complicated with bacterial sinusitis. Some children may have chronic form of the disease which is not represented as infection process. Main aspects of treatment and diagnosis of sinusitis are still controversial. Only ethmoidal and maxillary sinuses are present at birth, although pneumatization process is completed only in ethmoidal sinus. The same process is completed in age 4 in maxillary sinuses. Sphenoid sinus forms from age 5, development of frontal sinus begins from 7-8 years of age and completes in adulthood. The exit canals of sinuses are very narrow and they drain in middle nasal meatus. Due to mucocilliary clearance of covering epithelium, paranasal sinuses are normally sterile.
Etiology:
The main bacterial pathogens causing sinusitis in adult and children are: Streptococcus pneumoniae (approximately 30%), Haemophilus influenzae (approximately 20%) and Moraxella catarrhalis (approximately 20%). 50% of Heamophilus spaces and 100% of Moraxella spaces are beta-lactamase positive. 25% of Streptococcal pathogens are penicillin resistant. Staphylococcus aureus, other streptococci and anaerobes rarely cause bacterial sinusitis in children. The pathogens frequently revealed in chronic sinusitis are: H.influenzae, A group beta-hemolytic streptococcus, M.catarrhalis, S.pneumoniae and coagulase-negative staphylococcus.
Epidemiology:
Acute bacterial sinusitis occurs in voluntary age. The contributory factors are: viral infections of upper respiratory tract, allergic rhinitis, cigarette smoking. Chronic sinusitis may occur in children with immunodeficiency, cystic fibrosis, cilliar disfunction, pathology of phagocytic system, gastro-oesophageal reflux, anatomical defect (palate crack), nasal polips and foreign matter in nose.
 Pathogenesis:
Typically acute bacterial sinusitis develops as complication of upper respiratory infection. Initially viral rhinosinusitis develops. Bacterial flora may get from nasal cavity into sinuses, but with normal clearance of mucosa they are quickly eliminated. Due to inflammation and swelling, there are obstructed exit canal of the sinuses and decreased bacterial clearance during viral rhinosinusitis. Mentioned condition is favorable for replication of microflora and bacterial colonization in high titers.
Clinical picture:
Adults and children with sinusitis may have such nonspecific complains as nasal congestion, nasal discharge (unilateral or bilateral), fever and cough. Rare symptoms are: bad breath (halitosis), decrease in sensation of taste and smell, periorbital oedema. Face- and headache in children are comparably rare. There may be found mild erythema and swelling of nasal mucosa with discharge on physical examination. There may be face tenderness in the projection of inflamed sinus in adolescent and adult patients.
Diagnosis:
Diagnosis of acute bacterial sinusitis is mainly based on clinical anamnesis. Persistent symptoms of upper respiratory infection, including nasal discharge, cough which lasts for 10-14 days without visible improvement, severe respiratory symptoms with fever at or over 39°C, purulent nasal discharge for 3-4 days, correspond with complicated acute sinusitis. Bacteria are cultured from maxillary sinus aspirate in 70 % of children with described condition. Children with chronic sinusitis have history of persistent respiratory symptoms with cough, nasal discharge and nasal congestion lasting for more than 90 days period. The most accurate diagnostic method for sinusitis is aspiration of sinus contents, but it is not used routinely. The sinus fluid level can be detected by transilumination, but it is impossible to differentiate viral or bacterial origin of infection by this method. To use transilumination method in children is technically sufficiently difficult. There are opacification, swelling of mucosa, gas and fluid level on X-ray. These mentioned X-ray signs are not sufficiently specific. Based on these signs we can set inflammation of sinus, but it is impossible to conduct differential diagnosis with viral, bacterial and allergic inflammations. Based on nonspecific clinical picture of this disease, differential diagnosis should be conducted with upper respiratory infection, allergic rhinitis, non-allergic rhinitis and foreign matter in nose. Upper respiratory infection is characterized by nasal discharge, cough and fever in the initial stage. Allergic rhinitis may be seasonal and eosinophilia is revealed in nasal discharge.
Treatment:
It is not finally proved which antibacterial preparation is most effective for the treatment of sinusitis. According to recommendations of Pediatric Academy of USA, antibacterial preparations should be used in the treatment of acute sinusitis to stimulate recovery process and decrease development of complications. Amoxicillin application (dose 45mg/kg/daily) for the treatment of initial stage of uncomplicated sinusitis is adequate. Alternative treatments for children with penicillin allergy are cefuroxime acetyl, clarithromycine, azythromycine. The drug of choice for antibiotic resistant spaces is classic representative of ,,protected“ aminopenicillins - suspension of Clavomed. Clavomed is the combination of beta-lactam antibiotic (amoxicillin) and irreversible inhibitor of beta-lactamase (clavulanic acid the same potassium clavulanate). Empirical choice of Clavomed is based on etiologic factors of sinusitis: all mentioned causative pathogens produce beta-lactamase. Clavulanic acid content of Clavomed ensures protection of amoxicillin from beta-lactamase. Besides this, clavulanic acid itself has weak antibacterial effect and increases antimicrobial immunity of the organism. Tested dosage form is Clavomed - pediatricoral suspension (312, 5 mg/5ml - 80 ml).
 
The recommended scheme for the treatment of bacterial sinusitis is:
40-45 mg/kg daily divided in 3 doses
age
dose
0-3 months
0,75 ml 2-3 times a day
3-12 months
¼ of measuring cup (2,5 ml) 3 times a day
1-7 years
½ of measuring cup (5 ml) 3 times a day
7-14 years
One measuring cup (10ml) 3 times a day.
 
The advantage of Clavomed is its wide spectrum of antimicrobial coverage. That’s why its application is recommended for empirical treatment of sinusitis. Clavomed has high biopenetration (reaches high concentration in tissues of accessory nasal sinuses and fluids). It is excreted from the body in almost unchanged form, this fact shows non-hepatotoxic and non-nephrotoxic nature of Clavomed and proves its safety. And finally, good organoleptic characteristics of Clavomed: its nice cherry taste and homogenic consistency makes Clavomed comfortable medicine for application in children.
In the case of ineffectiveness of described treatment, consultation of otorhinolaryngologist is necessary and aspiration of sinus contents and bacterial antibiotic sensitivity test may be needed. The length of treatment is not strict and should be defined individually. But in general it is recommended to give treatment for 7 days after the symptoms end.
The inflammation of frontal sinus may progress to intracranial complications. Because of this the treatment should be begun with parenteral antibiotic (ceftriaxone), until the condition is stabilized. After that the treatment should be continued with per oral antibiotics, with Clavomed for example. Usage of decongestants, antihistaminic preparations, mucolitics and intranasal corticosteroids is not fully studied, and it is better to avoid them. In contrast wash of nasal cavity with saline water may stimulate secret excretion and act as mild vasoconstrictor; although effects of the mentioned issue are badly studied in children.
Complications:
Bacterial sinusitis may be accompanied by serious complication. This is conditioned by their proximity to orbit and brain. From orbital complications we should mention orbital and periorbital cellulitis. Intracranial complications are meningitis, cavernous sinus thrombosis, subdural empyema, epidural abscess and brain abscess. Children with changed mental status, neck muscle rigidity or symptoms of intracranial hypertension (headache, vomiting) should be evaluated by X-ray of brain, orbit and sinuses to exclude intracranial complications of acute bacterial sinusitis. Before the bacterial antibiotic sensitivity test gives results, treatment should be started with wide spectrum antibiotics (usually cafotaxime or ceftriaxone in combination with vancomycin). Surgical intervention may be needed for abscess treatment. Other complication of sinusitis are: frontal bone osteomyelitis, which is represented with swelling of frontal area; mucocele, which is chronic inflammation process localized in frontal sinus, but it may extend and cause orbit dislocation and diplopia. Surgical treatment is needed for this complication.
Prophylaxis:
Prevention measures of the disease include: keeping self hygiene such as frequent hand wash and avoidance of persons with influenza virus infection, because bacterial sinusitis is it's common complication. Besides, it is necessary to receive anti-influenza vaccination on every season of flu. Immunization and chemoprophylaxis with antiviral preparations may greatly decrease development of viral infection and consequently associated complications. Although it should be mentioned that influenza virus is not the only causative of common cold.