Clamoxyl Generic Drug
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
Powder for oral suspension
Bottle of reconstituted suspension of 60 ml
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:
In adults and children:
· In initial treatment of:
o acute pneumonitis,
o superinfections of acute bronchitis and exacerbations of chronic bronchitis,
o ENT infections (otitis, sinusitis, documented angina at beta-hemolytic streptococcus A) and stomatology,
o urinary infections,
o male genital infections and gynecological infections,
o digestive and biliary infections,
o 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 ...),
· In relay treatment of the injectable route of endocarditis, septicemia,
· As a prophylactic treatment for bacterial endocarditis.
In adults only:
· In combination with another antibiotic (clarithromycin or imidazole) and antisecretory agent, eradication of Helicobacter pylori in adult peptic ulcer disease.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Dosage AMOXICILLIN MYLAN PHARMA 125 mg / 5 mL Powder for oral suspension 60 ml reconstituted suspension bottle
A measuring spoon (5 ml) contains 125 mg of amoxicillin.
There are other presentations of amoxicillin that are more suitable for adults and other presentations more appropriate in some cases to the child (large doses, older children).
In the subject with normal renal function
The usual dosage is 1-1.5 or 2 g / day in 2 to 3 doses.
· Angina: 2 g / day in 2 daily doses.
The treatment duration of angina is 6 days.
· Acute pneumopathies: 3 g / day, ie 1 g every 8 hours,
· Lyme disease:
o strictly isolated chronic migrating erythema: 4 g / day.
o in case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, the dosage may be increased up to 6 g / day.
The duration of treatment will be 15 to 21 days.
· Endocarditis and septicemia (relay of the injectable route): the dosage can be increased up to 6 g per 24 hours in at least three doses.
· Prophylaxis of bacterial endocarditis:
o oral protocol: 3 g taken once a day, administered within one hour before the risky procedure,
o parenteral protocol relay: 1 g per os 6 hours after parenteral administration.
· Eradication of Helicobacter pylori in case of peptic ulcer disease: the following dosing regimens are recommended:
o amoxicillin 1 g morning and evening, combined with clarithromycin 500 mg morning and evening and omeprazole 20 mg morning and evening for 7 days, then 20 mg omeprazole daily for 3 additional weeks in case of progressive duodenal ulcer or 3 to 5 additional weeks in case of progressive gastric ulcer,
o amoxicillin 1 g morning and evening, combined with clarithromycin 500 mg morning and evening and lansoprazole 30 mg morning and evening, for 7 days, then 30 mg lansoprazole daily for 3 additional weeks in case of progressive duodenal ulcer or 3 to 5 additional weeks in case of progressive gastric ulcer.
The effectiveness of the treatment depends on compliance with the dosing regimen, including the taking of triple therapy during the first 7 days.
In patients with renal insufficiency
Administer a first loading dose (Do) equivalent to the dose normally prescribed and, depending on the degree of severity of the pathology:
Clearance of creatinine
greater than 30 ml / min.
No adaptation: continue treatment with usual dose and recommended frequency
from 10 to 30 ml / min.
Do / 2, every 12 hours
less than 10 ml / min.
Do / 2, every 24 hours
Hemodialysis: Do then Do / 2 a day. On days of dialysis, administer Do / 2 after the dialysis session.
CHILDREN UNDER 40 KG
The daily dose for children is 40 to 90 mg / kg / day in 2 or 3 doses * (not to exceed 3 g / day) depending on the indication, the severity of the infection and the sensitivity of the bacteria (see section specific cases below and sections Warnings and Precautions, Pharmacodynamic Properties and Pharmacokinetic Properties ).
* The pharmacokinetic and pharmacodynamic data indicate that administration in 3 daily doses allows a better efficiency. Administration in 2 daily doses is therefore only recommended for the highest doses.
Children over 40 kg should be given the adult dosage
· Angina: 50 mg / kg / day in 2 daily doses.
· Acute otitis media: in areas with a high prevalence of pneumococci with reduced susceptibility to penicillins, the dosage should be in accordance with national recommendations.
· Lyme disease at an early stage (isolated chronic erythema migrans): 50 mg / kg / day in 3 daily doses for 14 to 21 days.
· Prophylaxis of bacterial endocarditis: 50 mg / kg once taken, administered within one hour before the risky procedure.
Dosage in children with renal impairment
The dosage should be reduced in patients with severe renal impairment. In patients with creatine clearance less than 30 mL / min, an increase in the time interval between 2 doses is recommended, as well as a decrease in the daily dose (see Warnings and Precautions sections). and pharmacokinetic properties ).
Children under 40 kg with kidney failure
Creatine Clearance (mL / min)
No adjustment needed
12h (corresponding to 2/3 of the dose)
24h (corresponding to 1/3 of the dose)
This medicine can be taken during or between meals.
Use the measuring spoon provided with the bottle.
This medicine MUST NEVER BE USED:
· If you are allergic to antibiotics of the beta-lactam family (penicillins and cephalosporins) or any of the other ingredients.
This medicine SHOULD NOT BE USED in combination with methotrexate (see section Interactions with other medicinal products and other forms of interaction ).
Due to the presence of aspartame (8.5 mg per measuring spoon), this drug is contraindicated in cases of phenylketonuria.
Adverse effects Amoxicillin Mylan Pharma
The classification of adverse reactions used is as follows:
· Very common: ≥1 / 10
· Frequent: ≥1 / 100; <1/10
· Uncommon: ≥1 / 1000; <1/100
· Rare: ≥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.
Not known: superficial tooth staining in children, usually reversible after brushing teeth.
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. Acute generalized exanthematous pustulosis (see 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 Warnings and precautions for use section ).
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).
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions
via the national declaration system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr