Generic drug of Adult Augmentin
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin + clavulanic acid
laboratory: Teva Sante
in sachet-dose (ratio amoxicillin / clavulanic acid: 8/1) sachets-dose box of 12
All forms
Indication
AMOXICILLIN / CLAVULANIC ACID TEVA is indicated for the treatment of the following infections in adults and children (see section 4.2 Posology and method of administration, Warnings and precautions for use, and Pharmacodynamic properties ). :
· Acute bacterial sinusitis (diagnosed appropriately),
· Acute otitis media,
· Exacerbation of chronic bronchitis (diagnosed appropriately),
· Acute community pneumonia,
· Cystitis,
· Pyelonphritis,
· Infections of the skin and soft tissues, especially cellulitis, animal bites, severe dental abscesses with spread of cellulite,
· Infections of bones and joints, especially osteomyelitis.
Official recommendations regarding the appropriate use of antibacterials should be taken into account.
Dosage AMOXICILLIN / CLAVULANIC ACID TEVA 1 g / 125 mg ADULTS powder for oral suspension in sachet-dose (amoxicillin / clavulanic acid ratio: 8/1) sachets-dose box of 12
AMOXICILLIN / CLAVULANIC ACID TEVA is indicated for the treatment of the following infections in adults and children (see section 4.2 Posology and method of administration, Warnings and precautions for use, and Pharmacodynamic properties ). :
· Acute bacterial sinusitis (diagnosed appropriately),
· Acute otitis media,
· Exacerbation of chronic bronchitis (diagnosed appropriately),
· Acute community pneumonia,
· Cystitis,
· Pyelonphritis,
· Infections of the skin and soft tissues, especially cellulitis, animal bites, severe dental abscesses with spread of cellulite,
· Infections of bones and joints, especially osteomyelitis.
Official recommendations regarding the appropriate use of antibacterials should be taken into account.
Against indications
· Hypersensitivity to the active substances, penicillins or any of the excipients.
 · Previous serious hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam (eg, cephalosporin, carbamphenol) Or a monobactam).
 · History of jaundice / hepatitis related to amoxicillin / clavulanic acid (see section Unnecessary effects ).
Adverse effects Amoxicil / ac Clav Teva Ad
The most common untoward effects are diarrhea, nausea and vomiting.
The adverse effects identified in the clinical studies and post-marketing of AMOXICILLIN / CLAVULANIC ACID are listed below according to the MedDRA system-organ classification.
The following terminology is used to classify the undesirable effects according to their frequency:
Very frequent (³ 1/10)
Frequent (³ 1/100 to <1/10)
Not very frequent (³ 1/1 000 to <1/100)
Rare (³ 1/10 000 to <1/1000)
Very rare (<1 / 10, 000)
Unlimited frequency (can not be estimated based on available data)
Infections and infestations | |
Skin and mucous membrane candidiasis | Frà © Quent |
Excessive development of non-susceptible organisms | Unconditional frequency |
Hematologic and lymphatic system disorders | |
Reversible leukopenia (including neutropenia) | Rare |
Thrombocytopà © nie | Rare |
Reversible agranulocytosis | Unconditional frequency |
Hemolytic anemia | Unconditional frequency |
Prolongation of bleeding time and Quick 1 time | Unconditional frequency |
Immune system disorders 10 | |
Angels of Quincke | Unconditional frequency |
anaphylaxis | Unconditional frequency |
Serial sickness | Unconditional frequency |
Hypersensitivity vasculitis | Unconditional frequency |
Nervous system disorders | |
à ‰ dizziness | Not very frequent |
CÃ © Phala © es | Not very frequent |
Reversible hyperactivity | Unconditional frequency |
Convulsions 2 | Unconditional frequency |
Aseptic meningitis | Unconditional frequency |
Gastrointestinal disorders | |
Diarrhea | Very frequent |
Nausea 3 | Frà © Quent |
vomiting | Frà © Quent |
Indigestion | Not very frequent |
Colitis associated with antibiotics 4 | Unconditional frequency |
Glossophytie | Unconditional frequency |
Hereditary conditions | |
ASAT and / or ALAT 5 elevations | Not very frequent |
Hepatitis 6 | Unconditional frequency |
Cholestatic Icarus 6 | Unconditional frequency |
Skin and subcutaneous tissue disorders 7 | |
Skin rash | Not very frequent |
itching | Not very frequent |
Urticaria | Not very frequent |
Polymorphic rhythm | Rare |
Stevens-Johnson Syndrome | Unconditional frequency |
Epidermolysis necrotizing hyperacute | Unconditional frequency |
Bullous dermatitis or exfoliator | Unconditional frequency |
Acute Generalized Exanthematous Pustulosis (PEAG) 9 | Unconditional frequency |
Renal and urinary disorders | |
Interstitial nephritis | Unconditional frequency |
Crystalline 8 | Unconditional frequency |
1 See Warnings and Precautions section 2 See Warnings and Precautions section 3 Nausea is more often associated with higher oral doses. Gastrointestinal manifestations may be alleviated by taking AMOXICILLIN / CLAVULANIC ACID TEVA at the beginning of a meal. 4 Including pseudomembranous colitis and hemorrhagic colitis (see Warnings and Precautions ) 5 A moderate increase in ASAT and / or ALT levels has been noted in patients treated with antibiotics in the beta-lactam family, but significance of these increases is unknown. 6 These effects have been observed with other penicillins and cephalosporins (see Warnings and Precautions ). 7 In the event of hypersensitivity dermatitis, treatment should be discontinued (see Warnings and Precautions ). 8 See Overdose section 9 See Warnings and Precautions section 10 See sections Contraindications and Warnings and Precautions | |
Declaration of suspected untoward effects
The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals should report any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (Ansm) and Ree Bucket of the Regional Centers for Pharmacovigilance - Website: // www.ansm.sante.fr.
