Clamoxyl Generic Drug
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin
laboratory: Cristers
box of 12
All forms
Indication
AMOXICILLINE CRISTERS is indicated for the treatment of the following infections in adults and children (see sections 4.2 and 5.2), Dosage and Administration, Warnings and Precautions and Pharmacodynamic Properties .
· Acute bacterial sinusitis
· Acute otitis media
· Angina / documented pharyngitis with streptococcus
· Acute exacerbations of chronic bronchitis
· Community pneumonia
· Acute cystitis
· Bacteruria asymptomatic gravidarum
· Acute pyelonephritis
· Typhoid and paratyphoid fever
· Dental abscess with cellulite
· Joint infections on prostheses
· Eradication of Helicobacter pylori
· Lyme disease
AMOXICILLINE CRISTERS is also indicated for the prophylaxis of endocarditis.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Dosage AMOXICILLINE CRISTERS 500 mg Capsule box of 12
AMOXICILLINE CRISTERS is indicated for the treatment of the following infections in adults and children (see sections 4.2 and 5.2), Dosage and Administration, Warnings and Precautions and Pharmacodynamic Properties .
· Acute bacterial sinusitis
· Acute otitis media
· Angina / documented pharyngitis with streptococcus
· Acute exacerbations of chronic bronchitis
· Community pneumonia
· Acute cystitis
· Bacteruria asymptomatic gravidarum
· Acute pyelonephritis
· Typhoid and paratyphoid fever
· Dental abscess with cellulite
· Joint infections on prostheses
· Eradication of Helicobacter pylori
· Lyme disease
AMOXICILLINE CRISTERS is also indicated for the prophylaxis of endocarditis.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Against indications
Hypersensitivity to the active substance, penicillins or to any of the excipients listed under Composition .
History of severe immediate hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam (eg cephalosporin, carbapenem or monobactam).
Adverse effects Amoxicilline Cristers
The most common side effects are diarrhea, nausea and rash.
Adverse reactions identified in clinical studies and since the marketing of amoxicillin are listed below according to the MedDRA system organ classification.
The following terminology is used to classify adverse reactions according to their frequency:
· Very common (≥ 1/10)
· Common (≥ 1/100 to <1/10)
· Uncommon (≥ 1/1000 to <1/100)
· Rare (≥ 1/10 000 to <1/1000)
· Very rare (<1 / 10, 000)
· Frequency not known (can not be estimated from available data)
Infections and infestations | |
Very rare | Cutaneous and mucosal candidiasis |
Blood and lymphatic system disorders | |
Very rare | Reversible leukopenia (including agranulocytosis or severe neutropenia), reversible hemolytic anemia and thrombocytopenia. Prolongation of bleeding time and Quick time (see section Warnings and precautions for use ). |
Immune system disorders | |
Very rare | Severe allergic reactions, including angioedema, anaphylaxis, serum sickness, and hypersensitivity vasculitis (see Warnings and Precautions ) section. |
Not known frequency | Jarisch-Herxheimer reaction (see section Warnings and precautions for use ) |
Nervous system disorders | |
Very rare | Hyperkinesis, vertigo and convulsions (see Warnings and Precautions ). |
Gastrointestinal disorders | |
Clinical study data | |
*Frequent | Diarrhea and nausea |
*Rare | vomiting |
Post-marketing data | |
Very rare | Antibiotic-associated colitis (including pseudo-membranous colitis and haemorrhagic colitis, see Warnings and precautions for use ). Hairy black tongue |
Hepatobiliary disorders | |
Very rare | Hepatitis and cholestatic jaundice. Moderate increase in ASAT and / or ALAT. |
Skin and subcutaneous tissue disorders | |
Clinical study data | |
*Frequent | Skin rash |
*Rare | Urticaria and pruritus |
Post-marketing data | |
Very rare | Skin reactions such as polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, and acute generalized exanthematous pustulosis (PEAG) (see Warnings and Precautions for Use section ). |
Renal and urinary disorders | |
Very rare | Interstitial nephritis Crystalline (see sections Warnings and precautions for use and Overdose Overdose) |
* The frequency of these AEs was determined based on clinical trial data for a total of approximately 6, 000 adult and pediatric patients on amoxicillin. |
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 declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.