Pencla Duo

Each 5 ml of the reconstituted suspension contains: Amoxicillin (As Trihydrate) 200 mg; Clavulanic acid (As Potassium Clavulanate) 28.5 mg.

Co-Amoxiclav is indicated for the treatment of the following infections in adults and children: Acute bacterial sinusitis (properly diagnosed); Cystitis; Pyelonephritis; Cellulitis; Animal bites; Severe dental abscess with spreading cellulitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

As directed by physician.

Before initiating therapy Co-Amoxiclav, careful attention should be taken concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs the Co-Amoxiclav therapy must be discontinued and appropriate alternative therapy instituted.
In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from Co-Amoxiclav presentation to amoxicillin in accordance with the official guidance.
This Co-Amoxiclav presentation may not suitable for use when there is a high risk that the presumptive pathogens have reduced susceptibility or resistance to the beta-lactam agents, that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid (e.g. penicillin-insusceptible S. pneumoniae).
Convulsions may occur in patients with impaired renal function or in those receiving high doses of Co-Amoxiclav.
Co-Amoxiclav should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Concomitant use with allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Prolonged use may result in an overgrowth of non-susceptible organisms.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP). This reaction requires discontinuation of Co-Amoxiclav and contra-indicates any subsequent administration of amoxicillin.
Co-Amoxiclav should be used with caution in patients with evidence of hepatic impairment.
Hepatic problems have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events are very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased, these are usually reversible. Hepatic problems may be severe and in very rare circumstances can cause death. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.
Antibiotic-associated colitis has been reported with nearly all antibacterial agents and range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibiotic-associated colitis occur, Co-Amoxiclav should be discontinued immediately, patients must be advised to contact a physician and get an appropriate therapy initiated. Anti-peristaltic medicinal products are contraindicated in this situation.
Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy.
Prolongation of prothrombin time has been rarely reported in patients taking Co-Amoxiclav. Appropriate monitoring should be carried out when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
In patients with renal impairment, the dose should be adjusted according to the degree of impairment.
In patients with a reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin it is advisable to take adequate fluids and the urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained.
During treatment with amoxicillin, enzymatic glucose oxidase methods should be used whenever testing for the presence of glucose in urine because false positive results may occur with non-enzymatic methods.
The presence of clavulanic acid in Co-Amoxiclav can cause a non-specific binding of lgG and albumin by red cell membranes leading to a false positive Coombs test.
There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients taking Co-Amoxiclav, who were subsequently found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients taking Co-Amoxiclav should be interpreted cautiously and confirmed by other diagnostic methods.

Pregnancy: Animal studies do not indicate direct/indirect harmful effects in pregnancy, embryonal/foetal development, parturition or postnatal development. Limited data on the use of Co-Amoxiclav during pregnancy in humans does not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane, it was reported that prophylactic treatment with Co-Amoxiclav may be associated with an increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless considered essential by the physician.
Lactation: Both substances are excreted into the breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant). Consequently, diarrhoea and fungus infection of the mucous membranes may be possible in the breast-fed infant, so that breast-feeding might have to be discontinued. The possibility of sensitisation should be taken into account. Co-Amoxiclav should only be used during breast-feeding if the doctor considers the benefit/risk assessment to the infant.

Shelf Life: 24 Months from manufacturing date.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

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