AMORAX 250 mg/5 ml  

Amoxicillin

Suspension 250 mg/5 ml

Amorax^® (Amoxicillin)

Description

Amorax^® is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity.

Clinical pharmacology

Amorax^® is similar to ampicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. Amoxicillin has been shown to be active against most strains of the following microorganisms.

Antibacterial activity

Aerobic Gram-Positive Microorganisms:

Enterococcus faecalis Staphylococcus spp. * ((beta)-lactamase-negative strains only) Streptococcus pneumoniae Streptococcus spp. ((alpha) - and (beta)-hemolytic strains only) ^* Staphylococci which are susceptible to amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to amoxicillin.

Aerobic Gram-Negative Microorganisms:

Escherichia coli ((beta)-lactamase-negative strains only) Haemophilus influenzae ((beta)-lactamase-negative strains only) Neisseria gonorrhoeae ((beta)-lactamase-negative strains only) Proteus mirabilis ((beta)-lactamase-negative strains only)

Pharmacokinetics

Oral absorption rapidly

Presystemic metabolism ----

Plasma half – life range 61.3 min

Volume of distribution 0.31.kg^-1

Plasma protein binding ~ 20%

Indication

1- ENT infections

2- GU tract infections

3- Skin and skin structure infections

4- Lower respiratory tract infections

5- Gonorrhea

6- H.pylori infections

7- Triple therapy

8- Dual therapy

Contraindication

Amorax^® is contraindicated for patients known to have hypersensitivity to any of the penicillins.

Precaution

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

· Prescribing Amorax ^Òin 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.

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

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

· All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with amoxicillin should have a follow-up serologic test for syphilis after 3 months.

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

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

Dosage

Usual adult and adolescent dose

· Ear/Nose/Throat: Mild/Moderate, 500 mg every 12 hours or 250 mg every 8 hours.

Severe, 875 mg every 12 hours or 500 mg every 8 hours.

· Lower Respiratory Tract: Mild/Moderate/Severe, 875 mg every 12 hours or 500 mg every 8 hours.

· Skin/Skin Structure: Mild/Moderate, 500 mg every 12 hours or 250 mg every 8 hours.

Severe, 875 mg every 12 hours or 500 mg every 8 hours.

· Genitourinary Tract: Mild/Moderate, 500 mg every 12 hours or 250 mg every 8 hours.

Severe, 875 mg every 12 hours or 500 mg every 8 hours.

· Gonorrhea Acute, uncomplicated ano-genital, and urethral infections in males and females: 3 grams as single oral dose

Usual pediatric dose

· Ear/Nose/Throat: Mild/Moderate ,25 mg/kg/day in divided doses every 12 hours or 20mg/kg/day in divided doses every 8 hours.

Severe: 45 mg/kg/day in divided doses every 12 hours or 40mg/kg/day in divided doses every 8 hours

Lower Respiratory Tract: Mild/Moderate/Severe, 45 mg/kg/day in divided doses every 12 hours or 40mg/kg/day in divided doses every 8 hours

· Skin/Skin Structure: Mild/Moderate, 25 mg/kg/day in divided doses every 12 hours or 20mg/kg/day in divided doses every 8 hours.

Severe, 45 mg/kg/day in divided doses every 12 hours or 40mg/kg/day in divided doses every 8 hours

· Genitourinary Tract: Mild/Moderate, 25 mg/kg/day in divided doses every 12 hours or 20mg/kg/day in divided doses every 8 hours.

Severe, 45 mg/kg/day in divided doses every 12 hours or 40mg/kg/day in divided doses every 8 hours

· Gonorrhea Acute, uncomplicated ano-genital, and urethral infections in males and females

Prepubertal children: 50 mg/kg Amorax^®, combined with 25mg/kg probenecid as a single dose.

Note: Since probenecid is contraindicated in children under 2 years, do not use his regimen in these cases.

Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

Patient consultation

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

· Tell your doctor if you have or have ever had kidney disease, allergies, asthma, hay fever, hives, or phenylketonuria.

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

· pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, 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 amoxicillin and Probenecid may result in increased and prolonged blood levels of amoxicillin.

· Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

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 amoxicillin.

adverse reactions

· As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They 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 following adverse reactions have been reported as associated with the use of penicillins:

· Gastrointestinal:    nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.

· Hypersensitivity reactions:    serum sickness-like reactions, erythematous maculopapular rashes, erythema multiforme, stevens-johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.

· Liver:    A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.

· Hemic and Lymphatic Systems:    Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis 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, convulsions, behavioral changes, and/or dizziness have been reported rarely.

· Miscellaneous:    Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Overdose

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed.

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adults and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.

Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.

Storage and stability condition

· Stores unreconstituted powder at or below 20^oC.

· Protect from light and moisture.

· Dispense in a tight container.

· Any unused portion of the reconstituted suspention must be discarded after 14 days.

· Refrigeration is preferable but not required

· Keep out of the reach of children.

Packaging

Each bottle contains 250 or 125mg / 5ml of Amoxicillin as the trihydrate when reconstituted.