Medicinal Products

AMOXICILLIN MYLAN PHARMA 500 mg

Clamoxyl Generic Drug
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
laboratory: Mylan

capsule
Box of 12
All forms

Indication

They result from the antibacterial activity and the 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 ADULT AND CHILD :
- in initial treatment of:
. acute pneumopathies, . superinfections of acute bronchitis and exacerbations of chronic bronchitis,
. ENT infections (otitis, sinusitis, documented angina at beta-hemolytic streptococcus A) and stomatology,
. urinary tract infections,
. male genital infections and gynecological infections,
. digestive and biliary infections, . 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 ...), - relay treatment of the injectable route endocarditis, septicemia,
- as a prophylactic treatment of bacterial endocarditis. ON ADULTS ONLY : in combination with another antibiotic (clarithromycin or imidazole) and antisecretory agent, eradication of Helicobacter pylori in adult peptic ulcer disease. - Official recommendations regarding the proper use of antibacterials should be taken into account.

Dosage AMOXICILLIN MYLAN PHARMA 500 mg Capsule Box of 12

This form in capsule is reserved for adults and children over 6 years (see precautions for use).

There are other presentations of amoxicillin more suitable for dosages greater than 2 g per day for adults, and other presentations suitable for children under 6 years.

Dosage

In the subject with normal renal function

ADULT

The usual dosage is 1-1.5 or 2 g / day in 2 to 3 doses.

Special cases:

· 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,
or

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

Dosage scheme

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

Special cases:

· 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)

Dose

Dosage scheme

> 30

Usual dose

No adjustment needed

10-30

Usual dose

12h (corresponding to 2/3 of the dose)

<10

Usual dose

24h (corresponding to 1/3 of the dose)

Administration mode

ORAL WAY.

This medicine can be taken during or between meals.

The capsules should be swallowed without opening, with a glass of water.

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 section Interactions with other medicinal products and other forms of interaction ).

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.

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. 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.

Hepatobiliary disorders

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

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