Medicinal Products

AMOXICILLIN PANPHARMA 1 g Powder for solution for injection (IM-IV) Box of 10 vials of powder of 1 g

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
laboratory: Panpharma

Powder for solution for injection (IM-IV)
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 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,

· Meningitis,

· 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 AMOXICILLINE PANPHARMA 1 g Powder for solution for injection (IM-IV) Box of 10 vials of powder of 1 g

Dosage

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:

Intravenously:

· 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:

premature

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

Intramuscularly:

· Adults: 2 g / day, 1 injection of 1 g twice daily.

· Children and infants: 50 mg / kg / day.

Special cases :

· In Lyme disease:

o Adults:

§ 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.

o Children:

§ 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:

Parenteral Protocol:

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

Dosage scheme

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.

Administration mode

INTRAVENOUS PATH or INTRAMUSCULAR PATH

Intravenously:

This medication can be administered either:

· In direct IV injection, inject slowly in 3 to 4 minutes:

o in adults, do not inject more than 1 g of amoxicillin at a time,

o in infants, infants and newborns, do not inject more than 25 mg / kg at a time;

· In rapid discontinuous perfusion: 30 to 60 minutes:

o in adults, do not inject more than 2 g of amoxicillin at a time,

o in children and infants: do not inject more than 50 mg / kg at a time;

· Continuous infusion.

Intramuscularly:

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.

Method of preparation

See Special precautions for disposal and other handling - Instructions for use, handling and disposal -

Against indications

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.

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.

Gastrointestinal disorders

Common: diarrhea, nausea

Uncommon: vomiting.

Very rare: pseudomembranous colitis, hemorrhagic colitis.

Renal and urinary disorders

Not known: acute interstitial nephritis and crystalluria.

Skin and subcutaneous tissue disorders

Common: rash

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.

Hepatobiliary disorders

Very rare: hepatitis, cholestatic jaundice.

Not known: moderate and transient increase in serum transaminases (ALT and / or ASAT).

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