Suspension Clamox 312mg 

Clamox^® (Amoxicillin /Clavulanate potassium)

Description

Clamox^® is an oral antibacterial combination consisting of semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium. Clinical pharmacology

The formulation of amoxicillin and clavulanic acid in Clamox^® protects amoxicillin from degradation by β-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin to include many bactria normally resistant to amoxicillin and other β-lactam antibiotics. Thus Clamox^® possesses the distinctive properties of a broad-spectrum antibiotic and a β -lactamase inhibitor. Antibacterial activity

Gram-Positive Aerobes:

Staphylococcus aureus(beta-lactamase and non –beta- lactamase-producing ), Staphylococci which are resistant to methicillin/oxacillin should be considered as resistant to Clamox^®. Gram-Negative Aerobes: Enterobacter species (Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonsrated with Clamox^® are resistant in vitro, clinical efficacy has been demonstrated with Clamox^® in urinary tract infections causedby these organisms.) Escherichia coli (beta-lactamase- and non –beta- lactanase-producing), Haemophilus influenzae (beta-lactamase- and non –beta- lactamase-producing,) Klebsiella species (all known strains are beta- lactamase producing), -Moraxella catarrehalis(beta-lactamase- and non –beta- lactamase-producing) .

Pharmacokinetics Oral absorption well absorbed Presystemic metabolism ----

Plasma half – life range 1.3 h

Volume of distribution 0.36 L.kg^-1

Plasma protein binding

Amoxicillin ~ 18%

Clavulanic acid ~ 25%

Indication

1- Lower respiratory tract infections

2- Urinary tract infection

3- Skin and skin structure infections

4- Sinusitis

5- Otitis media

Contraindication

Clamox^® is contraindicated for patients known to have hypersensitivity to any of the penicillins and in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Clamox^®

Precaution

· The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Clamox^® should be discontinued and appropriate therapy instituted.

· Prescribing Clamox^® 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.

· As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy.

· Periodic monitoring of hepatic function and renal function is advisable during prolonged therapy.

Pregnancy

Pregnancy category B.

Adequate and well-controlled studies in humans have not been done; this drug should be used during pregnancy only if clearly needed.

Breast feeding

Clamox^® is secreted in human milk. Caution should be exercised when Clamox^® is administered to a nursing mother.

Dosage

Usual adult and adolescent dose

Antibacterial-

Pneumonia and other severe infections- oral, 875 mg of amoxicillin and 125 mg of clavulanic acid every twelve hours or 500 mg of amoxicillin and 125 mg of clavulanic acid every eight hours.

Other infections-

Oral , 500 mg of amoxicillin and 125 mg of clavulanic acid every twelve hours or 250 mg of amoxicillin and 125 mg of clavulanic acid every eight hours.

Note: adults who have difficulty swallowing may be given the 125 mg /5 ml or the 250 mg/5 ml formulation of oral suspension in place of the 500 mg tablet.

Usual pediatric dose

Antibacterial-

Dosage is based on the amoxicillin component.

Neonates and infants up to 12 weeks (3 months) of age-

Oral, 15 mg of amoxicillin per kg of body weight every twelve hours.

Infants 3 months of age and older and children up to 40 kg of body weight-

Otitis media, acute, pneumonia, sinusitis, other severe infections: oral, 13.3 mg of amoxicillin per kg of body weight every eight hours (using the formulation containing either 125 mg of amoxicillin per 5 ml or 250 mg of amoxicillin per 5 ml).

Less severe infections –

6.7 mg of amoxicillin per kg of body weight every eight hours (using the formulation containing either 125 mg of amoxicillin per 5 ml or 250 mg of amoxicillin per 5 ml).

Children weighing more than 40 kg of body weight-

See usual adult and adolescent dose.

Patient consultation

· Consult with your physician if you have sensitivity to Amoxicillin, Penicillim, Cephalosporins , or any other medications

· Clamox^® should only be used to treat bacterial infection. They don’t treat viral infection (e.g., the common cold).

· If you missed a dose, take it as soon as possible, don't take if it is almost time for next dose, don’t double dose.

· Continue medicine for full time of treatment.

· Check with your physician if condition does not improve or worsens.

Warning

· Before initiating therapy with Clamox^®, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Clamox^® should be discontinued and appropriate therapy instituted.

· pseudomembranous colitis has been reported with nearly all antibacterial agents, including Clamox^®, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Interaction

· Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of Clamox^® and Probenecid may result in increased and prolonged blood levels of amoxicillin.

· Clamox^® may reduce the efficacy of oral contraceptives. Laboratory value alteration

High urine concentrations of Ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using clinitest®, benedict's solution or fehling's solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as clinistix®) be used.

· Following administration of Ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with Clamox^®. adverse reactions 

Those indicating need for medical attention

Incidence less frequent

Allergic reaction, specifically anaphylaxis (fast or irregular breathing, puffiness or swelling around face, shortness of breath, sudden ,severe decrease in blood pressure),elevated liver function tests, oral candidiasis (sore mouth or tongue), serum sickness-like reactions ( skin rash, joint pain, fever) , skin rash , hives, or itching,

Incidence rare

Chest pain, clostridium difficile colitis (severe abdominal or stomach cramps and pain, abdominal tenderness, watery and severe diarrhea, fever), dysuria or urinary retention (trouble in urinating), edema (swelling of face, fingers, lower legs or feet, weight gain),erythema multiforme or stevens- Johnson syndrome, hepatic dysfunction, including cholestatic hepatitis(abdominal pain, nausea or vomiting, yellow eyes or skin), glossitis (redness, swelling, or soreness of tongue), leukopemia or neutropenia( sore throat and fever), proteinuria or pyuria, seizures, toxic epidermal necrolysis.

Those indicating need for medical attention only if they continue or are bothersome

Incidence more frequent

Gastrointestinal reactions (mild diarrhea, nausea or v