Koact Co amoxiclav Tablets

KOACT

Co-amoxiclav Tablets BP 250-125 mg, 500-125 mg and 875-125 mg

Rx Only

 

NAME OF DRUG PRODUCT

Co-amoxiclav Tablets BP 250-125 mg

Co-amoxiclav Tablets BP 500-125 mg

Co-amoxiclav Tablets BP 875-125 mg

 

(TRADE) NAME OF PRODUCT

KOACT 375

KOACT 625

KOACT 1000

 

STRENGTH

375 mg, 625 mg and 1000 mg.

 

PHARMACEUTICAL DOSAGE FORM

Tablet

 

QUALITATIVE AND QUANTITATIVE COMPOSITIONS

Co-amoxiclav Tablets BP 375 mg

Each film-coated tablet contains:

Amoxicillin Trihydrate Ph.Eur. equivalent to Amoxicillin 250 mg and Potassium

Clavulanate Ph.Eur. equivalent to Clavulanic Acid 125 mg.

 

Co-amoxiclav Tablets BP 625 mg

Each film-coated tablet contains:

Amoxicillin Trihydrate Ph.Eur. equivalent to Amoxicillin 500 mg and Potassium

Clavulanate Ph.Eur. equivalent to Clavulanic Acid 125 mg.

 

Co-amoxiclav Tablets BP 1000 mg

Each film-coated tablet contains:

Amoxicillin Trihydrate Ph.Eur. equivalent to Amoxicillin 875 mg and Potassium

Clavulanate Ph.Eur. equivalent to Clavulanic Acid 125 mg.

 

PHARMACEUTICAL FORM

Co-amoxiclav Tablets BP 375 mg: White oval shaped film coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side.

Co-amoxiclav Tablets BP 625 mg: White oval shaped film coated tablets, debossed with ‘A’ on one side and ‘64’ on the other side.

Co-amoxiclav Tablets BP 1000 mg: White colored capsule shaped film coated tablets, debossed with ‘A’ on one side and with a score line in between ‘6’ and ‘5’ on the other side.

 

CLINICAL PARTICULARS

Therapeutic indications

Co-amoxiclav is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The β-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other β-lactam antibiotics.

Co-amoxiclav oral preparations are indicated for short-term treatment of bacterial infections at the following sites when amoxicillin resistant β-lactamase-producing strains are suspected as the cause. In other situations, amoxicillin alone should be considered.

– Upper Respiratory Tract Infections (including ENT) in particular sinusitis, otitis media, recurrent tonsillitis. These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae*, Moraxella catarrhalis* and Streptococcus pyogenes.

– Lower Respiratory Tract Infections in particular acute exacerbations of chronic bronchitis (especially if considered severe), bronchopneumonia. These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae* and Moraxella catarrhalis*.

– Genito-urinary Tract and Abdominal Infections in particular cystitis (especially when recurrent or complicated – excluding prostatitis), septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis. These infections are often caused by Enterobacteriaceae* (mainly Escherichia coli*), Staphylococcus saprophyticus, Enterococcus species.*

– Skin and Soft Tissue Infections in particular cellulitis, animal bites and severe dental abscess with spreading cellulitis. These infections are often caused by Staphylococcus aureus*, Streptococcus pyogenes and Bacteroides species*.

* Some members of these species of bacteria produce b-lactamase, rendering them insensitive to amoxicillin alone.

Mixed infections caused by amoxicillin-susceptible organisms in conjunction with Co-amoxiclav-susceptible 3-lactamase-producing organisms may be treated with Co-amoxiclav. These infections should not require the addition of another antibiotic resistant to β-lactamases.

 

Posology and method of administration

Since both the 375 mg and 625 mg tablets of Co-amoxiclav contain the same amount of Clavulanic acid (125 mg, as the potassium salt), two 375mg tablets of Co-amoxiclav are not equivalent to one 625 mg tablet of Co-amoxiclav; therefore, two 375 mg tablets of Co-amoxiclav should not be substituted for one 625 mg tablet of Co-amoxiclav.

 

Adults

The usual adult dose is one 625 mg tablet of Co-amoxiclav every 12 hours or one 375 mg tablet of Co-amoxiclav every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 1000 mg tablet of Co-amoxiclav every 12 hours or one 625 mg tablet of Co-amoxiclav every 8 hours.

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min should not receive the 100 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 625 mg or 375 mg every 12 hours, depending on the severity of the infection.

Patients with a less than 10 mL/min glomerular filtration rate should receive 625 or 375 every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 625 mg or 375 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

 

Pediatric Patients

Pediatric patients weighing 40 kg or more should be dosed according to the adult recommendations.

Due to the different amoxicillin to Clavulanic acid ratios in the 375 mg tablet of Co-amoxiclav (250/125) versus the 250 mg chewable tablet of Co-amoxiclav (250/62.5), the 375 mg tablet of Co-amoxiclav should not be used until the pediatric patients weighs at least 40 kg or more.

 

Administration

Co-amoxiclav may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Co-amoxiclav is administered at the start of a meal.

To minimize the potential for gastrointestinal intolerance, Co-amoxiclav should be taken at the start of a meal.

 

Contraindications

Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other β-lactam antibiotics, e.g. cephalosporins.

A previous history of Co-amoxiclav or penicillin-associated jaundice/hepatic dysfunction.

 

Special Warnings and Precautions for use

Changes in liver function may occur in some patients receiving Co-amoxiclav. The clinical significance of these changes is uncertain but Co-amoxiclav should be used with caution in patients with evidence of hepatic dysfunction.

Cholestatic jaundice, which may be severe, but is usually reversible, may occur rarely. Signs and symptoms may not become apparent for several weeks after treatment has ceased.

In patients with renal impairment, dosage should be adjusted according to the degree of impairment.

In patients with reduced urine output, crystalluria may occur very rarely, predominately with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions may occur in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity.

Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

 

Interaction with other drugs and other forms of interactions

Prolongation of bleeding time and prothrombin time may occur in some patients receiving Co-amoxiclav. Co-amoxiclav should be used with care in patients on anti-coagulation therapy.

In common with other broad-spectrum antibiotics, Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

 

Use in pregnancy and lactation

Treatment with Co-amoxiclav may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential bsç the physician. Co-amoxiclav may be administered during the period of lactation. With the exception of the risk of sensitisation, associated with the excretion of trace quantities in breast milk, there are no known detrimental effects for the breast-fed infant.

 

Effects on ability to drive and use machines

None Known.

 

Undesirable effects

Side effects are uncommon and mainly of a mild and transitory nature.

 

Gastrointestinal reactions

Diarrhoea, indigestion, nausea, vomiting, and mucocu-taneous candidiasis may occur. Antibiotic-associated colitis (including pseudomembranous. colitis and haemorrhagic colitis) may occur rarely. Nausea, although uncommon, is more often associated with higher oral dosages. If gastrointestinal side effects occur with oral therapy they may be reduced by taking Co-amoxiclav at the start of meals.

Superficial tooth discolouration may occur rarely, mostly with the suspension. It can usually be removed by brushing.

 

Renal and urinary tract disorders

Crystalluria occurs very rarely.

 

Genito-urinary effects

Vaginal itching, soreness and discharge may occur.

 

Hepatic effects

Moderate and asymptomatic rises in AST and/or ALT and alkaline phosphatases occurs occasionally. Hepatitis and cholestatic jaundice occurs rarely. These hepatic reactions occurs more commonly with Co-amoxiclav than with other penicillins.

After Co-amoxiclav hepatic reactions occurs more frequently in males and elderly patients, particularly those over 65 years. The risk increases with duration of treatment longer than 14 days. These reactions may occur very rarely in children.

Signs and symptoms usually occur during or shortly after treatment but in some cases may not occur until several weeks after treatment has ended. Hepatic reactions are usually reversible but they may be severe and very rarely, deaths occurs.

 

Hypersensitivity reactions

Urticarial and erythematous skin rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP), serum sickness-like syndrome and hypersensitivity vasculitis occurs. Treatment should be discontinued if one of these disorders occurs. In common with other β-lactam antibiotics angioedema and anaphylaxis occurs. Interstitial nephritis can occur rarely.

 

Haematological effects

As with other β-lactams transient leucopenia (including neutropenia and agranulocytosis), thrombocytopenia and haemolytic anaemia occurs rarely.

Prolongation of bleeding time and prothrombin time also occurs rarely.

 

CNS effects

CNS effects occurs very rarely. These include reversible hyperactivity, dizziness, headache and convulsions. Convulsions may occur with impaired renal function or in those receiving high doses.

 

Overdosage

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically with attention to the water electrolyte balance. Co-amoxiclav may be removed from the circulation by haemodialysis.

Amoxicillin crystalluria, in some cases leading to renal failure, may occur.

 

PHARMACOLOGICAL PROPERTIES

Pharmacokinetic properties

The pharmacokinetics of the two components of Co-amoxiclav is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal. Both clavulanate and amoxicillin have low levels of serum binding: about 70% remains free in the serum.

Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.

 

Pharmacodynamic properties

Bacterial enzymes that destroy the antibiotic before it can act on the pathogen cause resistance to many antibiotics. The clavulanate in Co-amoxiclav anticipates this defence mechanism by blocking the β-lactamase enzymes, thus rendering the organisms sensitive to amoxicillin’s rapid bactericidal effect at concentrations readily attainable in the body.

Clavulanate by itself has little antibacterial activity; however, in association with amoxicillin as Co-amoxiclav, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.

 

Gram-positive

Aerobes: Enterococcus faecalis*, Enterococcus faecium*, Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus varidans, Staphylococcus aureus*, Coagulase negative staphylococci* (including Staphylococcus epidermis*), Coryne-bacterium species, Bacillus anthracis*, Listeria monocytogenes.

Anaerobes: Clostridium species, Peptococcus species, Peptostrptococcus.

 

Gram-negative

Aerobes: Haemophilus influenza*, Moraxella catarrhalis* (Branhamella catarrhalis), Escherichia coli*, Proteus mirabilis*, Proteus vulgaris*, Klebsiella species*, Salmonella species*, Shigella species*, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae*, Neisseria meningitides*, Vibrio cholerae, Pasteurella multocida.

Anaerobes: Bacteroides species* including B. fragilis.
Some members of these species of bacteria produce beta-lactamase, rendering them insensitive to amoxicillin alone.

 

PHARMACEUTICAL PARTICULARS

List of Excipients

Cellulose, Microcrystalline, Purified Water, Sodium Starch Glycolate, Silica, Colloidal anhydrous, Magnesium Stearate, Opadry white, lsopropyl alcohol and Methylene chloride.

 

Incompatibilities

None.

 

Shelf-life

24 months.

 

Special precautions for storage

Store in a dry place at or below 30°C. Protect from moisture.

Keep out of the reach of children.

 

Authorisation Numbers

KOACT 375

TFDA. Reg. No: TAN 07,138 J01C AUR

NAFDAC. Reg. No: A4-3715

Zambia. Reg. No: 127/068

 

KOACT 625

TFDA. Reg. No: TAN 07, 266 J01C AUR

NAFDAC Reg. No: A4-4185

Zambia Reg. No: 127/069

 

KOACT 1000

TFDA. Reg. No: TZ 15 H 0245

Zambia Reg. No: 127/070

 

Nature and contents of container

KOACT 375, KOACT 625 and KOACT 1000: Blister of 5 tablets.

HDPE Container Pack:

KOACT 375 and KOACT 625: 100 and 500 tablets.

KOACT 1000: 60 Tablets.

 

MARKETING AUTHORIZATION HOLDER

Aurobindo Pharma Ltd.,

Plot No.: 2, Maitrivihar,

Ameerpet, Hyderabad-500 038,

Telangana State, India.

 

DATE OF PREPARATION OF THIS LEAFLET

April 2016.

Advertisements