Novamentine Amoxicillin and Potassium Clavulanate Tablets

Novamentine375/625/1000

Amoxicillin and Potassium Clavulanate Tablets BP

 

COMPOSITION

Novamentine 375

Amoxicillin and Potassium Clavulanate Tablets BP

Each film-coated tablet contains:

Amoxicillin Trihydrate BP

equivalent to Amoxicillin 250 mg

Clavulanate Potassium BP

(as Diluted Potassium Clavulanate BP)

equivalent to Clavulanic Acid 125mg

 

Novamentine 625

Amoxicillin and Potassium Clavulanate Tablets BP

Each film-coated tablet contains:

Amoxicillin Trihydrate BP

equivalent to Amoxicillin 500mg

Clavulanate Potassium BP

(as Diluted Potassium Clavulanate BP)

equivalent to Clavulanic Acid 125 mg

 

Novamentine 1000

Amoxicillin and Potassium Clavulanate Tablets BP

Each film-coated tablet contains:

Amoxicillin Trihydrate BP

equivalent to Amoxicillin 875mg

Clavulanate Potassium BP

(as Diluted Potassium Clavulanate BP)

Equivalent to Clavulanic Acid 125mg

 

CHEMISTRY

Amoxicillin Trihydrate:(2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p- hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1 – azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.

Clavulanate Potassium: Potassium (Z )-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo- 4- oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate.

 

PHARMACOLOGY

Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by β-lactamases; and therefore, the spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a β-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of β-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance.

 

Pharmacokinetics

Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Amoxicillin and Clavulanate Potassium Tablets. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. The half-life of amoxicillin after the oral administration of Amoxicillin and Clavulanate Potassium Tablets is 1.3 hours and that of clavulanic acid is 1.0 hour. Approximately 50% to 70% of the amoxicillin and approximately 25% to 40% of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration of a single Amoxicillin and Clavulanate Potassium tablet 250 mg/125 mg or 500 mg/125 mg. Clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid.

 

INDICATIONS

Amoxicillin and Clavulanate Potassium Tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower Respiratory Tract Infections – caused by β-Iactamase-producing strains of H. influenzae and M. catarrhalis.

Otitis Media – caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.

Sinusitis – caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections – caused by β-lactamase-producing strains of S. aureus, E. coli, and Kiebsiella spp.

Urinary Tract Infections – caused by β-lactamase-producing strains of E. coli, Kiebsiella spp., and Enterobacter spp.

 

RECOMMENDED DOSE

Adults

The usual adult dose is one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 250 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium every 12 hours or one 500 mg/125 mg tablet of Amoxicillin and Clavulanate Potassium 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 875 mg / 125 mg tablet. Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

Amoxicillin and Clavulanate Potassium Tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets should be taken at the start of a meal.

 

MODE OF ADMINISTRATION

Oral.

 

CONTRAINDICATIONS

Amoxicillin and Clavulanate Potassium Tablets are contraindicated in patients with a history of allergic reactions to any penicillin. It is also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium Tablets.

 

WARNINGS AND PRECAUTIONS

Serious and occasionally fatal hypersensitivity 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/or a history of sensitivity to multiple allergens.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amoxicillin and Clavulanate Potassium Tablets, and may range in severity from mild diarrhea to fatal colitis. Amoxicillin and Clavulanate Potassium Tablets should be used with caution in patients with evidence of hepatic dysfunction. Periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash.

Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis. Prescribing Amoxicillin and Clavulanate Potassium Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

 

INTERACTIONS WITH OTHER MEDICAMENTS

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxicillin and Clavulanate Potassium Tablets may result in increased and prolonged blood levels of amoxicillin. Co administration of probenecid cannot be recommended.

The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Amoxicillin and Clavulanate Potassium Tablets and allopurinoI administered concurrently. In common with other broad-spectrum antibiotics, Amoxicillin and Clavulanate Potassium Tablets may reduce the efficacy of oral contraceptives.

 

PREGNANCY AND LACTATION

There are no adequate and well-controlled studies in pregnant women. Hence, this drug should be used during pregnancy only if clearly needed. Ampicillin-class antibiotics are excreted in the milk; therefore, caution should be exercised when Amoxicillin and Clavulanate Potassium Tablets are administered to a nursing woman.

 

UNDESIRABLE EFFECTS

Amoxicillin and Clavulanate Potassium Tablets are generally well tolerated. The majority of side effects are mild and transient. The most frequently reported adverse effects were diarrhea/loose stools, nausea, skin rashes and urticaria, vomiting and vaginitis. Other adverse events reported are vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, angioedema, serum sickness-like reactions, erythema multiforme, moderate rise in AST (SGOT) and/or ALT (SGPT), interstitial nephritis and hematuria, anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis, Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, tooth discoloration etc.

 

OVERDOSAGE AND TREATMENT

Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In the case of overdosage, discontinue Amoxicillin and Clavulanate Potassium Tablets, treat symptomatically, and institute supportive measures as required. Adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.

 

STORAGE CONDITION

Store below 30°C. Keep out from the reach of children.

 

DATE OF PUBLICATION

February 2011.

 

Novamentine 375 : NAFDAC Reg. No.: A4-8592

Novamentine 625 : NAFDAC Reg. No.: A4-9070

Novamentine 1000: NAFDAC Reg. No.: A4-8574

 

Manufactured by

MICRO LABS LIMITED

Plot No. 16, Veerasandra Industrial Area,

Anekal Taluk, Bangalore-560 100. INDIA.