Medicinal Products

AMODEX Ge 1 g / 5 ml

Generic Clamoxyl 1G Drug
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
laboratory: Bouchara-Recordati

Powder and solvent for IM solution for injection
Box of 1 Bottle of powder + 5 ml solvent ampoule
All forms

Indication

They arise from the antibacterial activity and pharmacokinetic characteristics of amoxicillin. They take into account both the clinical studies that gave rise to this drug and its place in the range of antibacterial products currently available.
They are limited to infections due to germs defined as sensitive:
- acute pneumonitis,
- superinfections of acute bronchitis and exacerbation of chronic bronchitis,
- ENT (otitis, sinusitis, angina) and stomatological infections,
- urinary infections,
- male genital infections and gynecological infections,
- digestive and biliary infections,
- endocarditis, septicemia,
- meningitis,
- Lyme disease: treatment of the primary phase (chronic erythema migrans) and the primosecondary phase (chronic erythema migrans associated with general signs: asthenia, headache, fever, arthralgia ...),
- prophylaxis of bacterial endocarditis.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AMODEX Ge 1 g / 5 ml Powder and solvent for solution for injection IM Box of 1 vial of powder + ampoule of solvent of 5 ml

This presentation containing benzyl alcohol in the solvent should only be used for the intramuscular route.
Posology of injectable amoxicillin :
Dosage in subjects with normal renal function:
The dosage depends on the indication, the severity and location of the infection, the sensitivity of the germ in question, and the weight of the subject:
- intramuscularly :
. Adult: 2 g / 24 h, 1 injection of 1 g twice a day.
. Infant and child: 50 mg / kg / 24 h.
- Intravenously :
. Adults: 2 to 12 g / 24 h.
. Children and infants (1 month to 15 years): 100 to 200 mg / kg / 24 h.
. Newborns (0 to 1 month) premature or full-term intravenous infusion in 3 to 4 minutes:
. Premature 0 to 7 days: 100 mg / kg / 24 h.
. Premature 7 to 30 days: 100 to 150 mg / kg / 24 h.
. 0 to 7 day term neonates: 100 to 150 mg / kg / 24 h.
. Newborns at term of 7 to 30 days: 100 to 200 mg / kg / 24 h.
Special cases :
- In Lyme disease :
- Adult :
. Chronic erythema migrans strictly isolated: 4 g / 24 h,
. in case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, the dosage may be increased up to 6 g / 24 h.
- Child:
. strictly isolated chronic migrating erythema: 50 mg / kg / 24 h,
. in case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, the dosage may be increased up to 100 mg / kg / 24 h.
The duration of treatment will be 15 to 21 days.
- Prophylaxis of bacterial endocarditis :
Parenteral Protocol:
. Adult: 2 g IV (30 min infusion) in the hour before the risky procedure followed by 1 g administration 6 hours later.
. Child: 50 mg / kg IV (30 min infusion) in the hour before the risky procedure followed by oral administration of 25 mg / kg 6 hours later.
Dosage in patients with renal insufficiency:
- Creatinine clearance between 30 and 60 ml / min: 2 to 4 g / 24 h. Maximum dosage: 4 g / 24 h in 2 administrations.
- clearance of creatinine between 10 and 30 ml / min: 1 g then 500 mg every 12 hours.
- creatinine clearance less than 10 ml / min: 1 g then 500 mg every 24 h.
In severe infections, this dosage may be insufficient. It is advisable to check the serum levels, and possibly meningeal, of amoxicillin for a possible adjustment of doses.
Mode of administration :
INTRAMUSCULAR PATH.
Do not use the intramuscular solvent intravenously .
Do not inject more than 1 g of amoxicillin at a time in adults.
Do not inject more than 25 mg / kg at a time in children.
The solvent used makes the injection painless.
Method of preparation: see handling methods.
In infants and children under 3 years old, do not use the ampoule of IM solvent (see contraindications), but 5 ml of water for injection.

Against indications

CONTRAINDICATED:
This medicine MUST NOT BE USED in case:
- allergy to antibiotics of the beta-lactam family (penicillins and cephalosporins), or to any of the other constituents,
- infectious mononucleosis (increased risk of cutaneous phenomena).
Because of the presence of benzyl alcohol, the solvent ampoule should NOT be used in children under 3 years of age.
NOT RECOMMENDED :
This medicine SHOULD NOT BE USED in combination with methotrexate (see interactions).

Adverse effects Amodex GE

- Allergic manifestations, including urticaria, eosinophilia, angioedema, difficulty breathing, exceptionally anaphylactic shock.
- Maculopapular rashes of allergic origin or not. Exceptionally, some cases of Stevens Johnson syndrome, erythema multiforme, and bullous or exfoliative dermatitis.
- Digestive disorders: nausea, vomiting, diarrhea, candidiasis.
- Other manifestations of immunoallergic origin have been reported more rarely:
. moderate and transient increase in serum transaminases,
. anemia, leukopenia, reversible thrombocytopenia,
. acute interstitial nephritis.
- Some cases of pseudomembranous colitis after amoxicillin administration have been reported.
- The administration of high doses of beta-lactams, particularly in patients with renal insufficiency, can lead to encephalopathies (disorders of consciousness, abnormal movements, seizures).

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