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Bactaclav

Foundation Pharma
1, Raimi Adedokun drive, off General Hospital Road, Gbagada, Lagos
Email: foundationfam@yahoo.com
Tel: 234-709-873-2653

Brand Name

Bactaclav

Manufacturer

Manufactured in India by:

FINECURE PHARMACEUTICALS LTD. Shimla Pistaur, Malsa Road, Kichha, Udham Singh Nagar, Ultarakhand-263148, India.

Manufactured for:

ASOJ SOFT CAPS PVT. LTD. Asoj, Baroda-Halol Highway, Dist. Baroda -391 510. Gujarat. www.asojsoftcaps.com

Therapeutic Class

Antibacterial, Penicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: ): Each film coated tablet contains: Amoxicillin Trihydrate USP eq. to Amoxicillin 500 mg; Potassium Clavulanate USP eq. to Clavulanic Acid 125 mg Q.S. Excipients, Colour; Titanium Dioxide USP

Pack Size: Bactaclav-625: 2 x 7 tablets presented in a carton.

bactaclav 625

Tablet (NRN: ): Each film coated tablet contains: Amoxicillin Trihydrate USP eq. to Amoxicillin 875 mg; Potassium Clavulanate USP eq. to Clavulanic Acid 125 mg Q.S. Excipients Colour: Titanium Dioxide USP

Pack Size: Bactaclav-1000: 2 x 7 tablets presented in a carton.

bactaclav 1000

Pharmacology

MECHANISM OF ACTION:

Blisclav is a combination of Amoxicillin and Potassium Clavulanate.

The Amoxicillin component of the formulation exerts a bactericidal action against many strains of Gram-positive and Gram-negative organisms.

The Clavulanic acid component has little or no antimicrobial action.

It does, however, by inactivation of susceptible β-lactamase, protect Amoxicillin from degradation by β-lactamase enzymes produced by penicillin resistant strains of microorganisms.

Antibacterial Activity

Clavulanic acid is an irreversible inhibitor of β-lactamases produced by Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Proteus vulgaris, H. influenzae, N. gonorrhoeae and B. fragilis (In-vitro activity does not necessarily imply in-vivo efficacy). Potassium clavulanate does not inactivate the chromosomally mediated (Sykes Type 1 Cephalosporinases) β-lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, indole positive Proteus, Providencia species and Serratia marcescens.

Pharmacokinetics:

The pharmacokinetics of Amoxicillin and Clavulanic acid are closely allied and neither are adversely affected by the presence of food in the stomach, and are stable in the presence of gastric acid. The oral bioavailability of Amoxicillin and Potassium Clavulanate is approximately 90% and 75% respectively.

Peak serum levels of both occur about 1-2 hours after oral administration. Clavulanic acid has about the same plasma elimination half-life (1 hour) as that of Amoxicillin (1.3 hours). Blisclav is eliminated primarily unchanged through the renal route (glomerular filtration and tubular secretion). Approximately 50-78% of Amoxicillin and 25-40% of Clavulanic acid are excreted unchanged in urine within the first 6 hours after administration.

Indications

Blisclav is indicated for the treatment of infections caused by Amoxicillin resistant organisms producing β-lactamases sensitive to Clavulanic acid:

Upper respiratory tract infections: Otitis media, tonsillitis, sinusitis.

Lower respiratory tract infections: Pneumonia, bronchitis (caused by Amoxicillin resistant β-lactamases producing E. coli, H. influenzae and Haemophilus parainfluenza).

Urinary tract infections: Cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections: Blisclav formulations will also be effective in the treatment of infections caused by Amoxicillin sensitive organisms at the appropriate Amoxicillin dosage since in this situation the Clavulanic acid component does not contribute to the therapeutic effect

Contra-indications

Allergy to penicillins and cephalosporins.

Safety in pregnancy has not been established.

Blisclav is contraindicated in patients with a previous history of Amoxicillin and Potassium Clavulanate associated jaundice/hepatic dysfunction.

Blisclav is also contraindicated in infectious mononucleosis.

Patients with lymphatic leukemia and patients with hyperuricaemia having been treated with allopurinol may also be at an increased risk of developing skin rashes.

Precautions/Warnings

WARNINGS:

Transient hepatitis and cholestatic jaundice has been reported, hence, Blisclav should be used with caution in patients with evidence of hepatic dysfunction. Serious and occasionally fatal hypersensitivity (anaphylactic} reactions have been reported in patients on penicillin therapy.
Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins.

These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.

Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensivity reactions to penicillins, cephalosporins or other allergens. lf an allergic reaction occurs, Blisclav should be discontinued and the appropriate therapy instituted: adrenaline, corticosteroids, and antihistamines.

PRECAUTIONS

Allergic reactions may occur, usually manifesting as pruritic skin rash, an erythematous skin reaction, urticaria, angiodema, anaphylaxis or eosinophilia. Coomb's test may become positive. In this event, withdrawal of Blisclav and the administration of antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, Blisclav should be discontinued and the patient treated with the usual agents: adrenaline, corticosteroids and antihistamines.

Treatment with Blisclav may give rise to a maculopapular rash during therapy or within a few days after completion. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis and hence should be avoided. The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy. Monilial overgrowth such as vaginitis and thrush have been reported.

Treatment with Blisclav can cause gastrointestinal symptoms such as diarrhoea, nausea and vomiting which can be minimised by administering the medicine at the start of a meal. In addition, as these symptoms are especially related to the Potassium Clavulanate component, where these gastro-intestinal symptoms occur and a higher concentration of Amoxicillin is required, consideration should be given to administering the additional Amoxicillin separately.

Caution must be exercised in patients with syphilis as some patients may experience a Jarisch-Herxheimer reaction shortly after starting the treatment. Symptoms include fever, chills, headache and reactions at the site of the lesions. The reactions can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as optic atrophy. A moderate rise in aspartame transaminase/alanine transaminase has been observed in patients treated with this combination.

Impaired renal function

Renal function should be monitored in patients with moderate to severe renal impairment and Blisclav dosage should be adjusted. High dose should be avoided in patients with impaired renal function/heart failure and in patients receiving potassium sparing diuretics.

Impaired hepatic function

Blisclav should be used with caution in patients with underlying hepatic disease as hepatic and cholestatic jaundice have been reported with this combination. The condition is more predominant in adult and elderly patients.

Use in lactation

Amoxicillin is excreted in human milk but the excretion of clavulanic acid has not been studied conclusively therefore caution should be exercised when Blisclav is administered to nursing mothers.

Interactions

Concurrent use of Blisclav with probenecid may result in increased and prolonged blood levels of Amoxicillin but since the excretion of Clavulanic acid is unchanged by probenecid, its blood level remains unaffected.

Interaction of Blisclav with coumarin or indandione - derivative anticoagulants, heparin, non-steroidal anti-inflammatory drugs (NSAIDs) especially, aspirin, other platelet aggregation inhibitors or thrombolytic agents may be clinically significant.

Blisclav may decrease the efficacy of oestrogen-containing oral contraceptives.

Adverse Effects

Amoxicillin:

Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria. The hypersensitivity reactions reported are erythematous maculopapular rashes, urticaria. fever and joint pains. Anaphylactic shock may occur.

Gastrointestinal
Nausea, heartburn, vomiting and diarrhoea. Pseudomembranous colitis has been reported.

Liver
Hepatotoxicity, hepatitis, cholestatic jaundice may occur. A moderate rise in serum glutamic oxalacetic transaminase {SGOT} has been noted, but the significance of this finding is unknown.

Hemic and Lymphatic Systems
Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and granulocytopenia have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System
Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioral changes and/or dizziness have also been reported. Depression, seizures, or hallucinations.

Other
A sore mouth or tongue and a black hairy tongue have been reported. Allergic reactions which may include exfoliative dermatitis, other skin rashes, interstitial nephritis and vasculitis, may occur. Erythema multiforme (including Stevens Johnson syndrome), toxic episodes of necrolysis.

Clavulanic acid:

Gastro-intestinal: Nausea and diarrhoea

Liver: Cholestatic jaundice and hepatitis

Dosage & Administration

Tablets should be taken with meal or as directed by the physician.

Adults:

Blisclav 625: 1 Tablet every 8 hours or as directed by the physician.

Blisclav 1000: 1 Tablet every 12 hours or as directed by the physician.

Dosage in renal failure:

Both Amoxicillin and Clavulanic acid are excreted by the kidneys and the serum half-life of each increases in patients with renal failure.

Therefore, the dose may need to be reduced or the interval extended.

Known symptoms of overdosage and treatment

Nausea, vomiting and diarrhoea may occur with overdosing.

Treatment is symptomatic and supportive.

Amoxicillin and clavulanic acid may be removed from the circulation by haemodialysis.

Storage/Handling Recommendations

Keep in a cool, dry place below 25oC, protected from light.

Keep medicines out of reach of children.

Review Date

2017-05-19 03:31:04