Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
Powder and solvent for IM solution for injection
Box of 1 Bottle of powder + 5 ml solvent ampoule
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 exacerbations of chronic bronchitis,
· ENT (otitis, sinusitis, angina) and stomatological infections,
· Urinary tract infections
· Male genital infections and gynecological infections,
· Digestive and biliary infections,
· Endocarditis, septicemia,
· Lyme disease: treatment of the primary phase (chronic erythema migrans) and the primary-secondary 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 AMOXICILLIN PANPHARMA 1 g / 5 mL Powder and solvent for solution for injection IM Box of 1 vial of powder + ampoule of solvent 5 ml
This presentation contains benzyl alcohol in the solvent and should only be used for the intramuscular route.
In the subject 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:
· Adults: 2 g / day, 1 injection of 1 g twice daily.
· Children and infants: 50 mg / kg / day.
· Adults: 2 g to 12 g / day.
· Children and infants (1 month to 15 years): 100 mg / kg / day to 200 mg / kg / day.
· Newborns (0 to 1 month) premature or term:
0 to 7 days
100 mg / kg / day
direct intravenous route in 3 to 4 minutes
7 to 30 days
100 to 150 mg / kg / day
Newborns at term
0 to 7 days
100 to 150 mg / kg / day
7 to 30 days
100 to 200 mg / kg / day
Special cases :
· In Lyme disease:
§ strictly isolated migrating chronic erythema: 4 g / day,
§ in case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, the dosage may be increased up to 6 g / day.
§ strictly isolated chronic migrating erythema: 50 mg / kg / day,
§ in case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, the dosage may be increased up to 100 mg / kg / day.
The duration of treatment will be 15 to 21 days.
· Prophylaxis of bacterial endocarditis:
o Adults: 2 g IV (30 min infusion) in the hour before the risky procedure followed by 1 g administration 6 hours later.
o Children: 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.
In patients with renal insufficiency:
Clearance of creatinine
Between 30 and 60 ml / min
2 to 4 g / day - Maximum dosage: 4 g / day in 2 administrations.
Between 10 and 30 ml / min
1 g then 500 mg every 12 hours.
Less than 10 ml / min
1 g then 500 mg every 24 hours.
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.
Do not use intravenously the solvent for the intramuscular route.
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.
In infants and children under 3 years, do not use the ampoule of IM solvent (see Contraindications) but 5 ml of water for injections.
Method of preparation
See section Special precautions for disposal and other handling - Instructions for use, handling and disposal.
This medicine MUST NEVER BE USED in case of allergy to antibiotics of the beta-lactam family (penicillins and cephalosporins) or to any of the other ingredients.
Due to the presence of benzyl alcohol, the IM solvent ampoule should NOT be used in children under 3 years of age.
This medicine SHOULD NOT BE USED in combination with methotrexate (see Interactions with other medicinal products and other forms of interaction ).
Adverse effects Amoxicillin Panpharma
The classification of adverse reactions used is as follows:
· Very common: ³ 1/10
· Frequent: ³ 1/100; <1/10
· Infrequent: ³ 1/1000; <1/100
· Rare: ³ 1/10000; <1/1000
· Very rare: <1/10000
· Frequency not known: can not be estimated on the basis of available data
Blood and lymphatic system disorders
Very rare: leukopenia, neutropenia, agranulocytosis, thrombocytopenia and reversible haemolytic anemia.
Not known: eosinophilia.
Nervous system disorders
Very rare: convulsions.
Not known: vertigo, headache.
Common: diarrhea, nausea
Very rare: pseudomembranous colitis, hemorrhagic colitis.
Renal and urinary disorders
Not known: acute interstitial nephritis and crystalluria.
Skin and subcutaneous tissue disorders
Uncommon: urticaria and pruritus.
Very rare: erythema multiforme, Stevens Johnson syndrome, Lyell syndrome, bullous or exfoliative dermatitis. These skin manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or evolving lymphoid leukemia. Generalized acute exanthematous pustulosis (see Special warnings and precautions for use).
Infections and infestations
Common: cutaneous and mucosal candidiasis
Immune system disorders
Very rare: anaphylaxis (including anaphylactic shock), serum sickness and hypersensitivity vasculitis (see Special warnings and precautions for use).
Not known: allergic manifestations, including urticaria, angioedema, respiratory discomfort.
Very rare: hepatitis, cholestatic jaundice.
Not known: moderate and transient increase in serum transaminases (ALT and / or ASAT).