Medicinal Products

AMOXICILLIN SANDOZ 1 g

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

Dispersible tablet
Box of 14
All forms

Indication

AMOXICILLIN SANDOZ 1 g, dispersible tablet is indicated for the oral treatment of the following bacterial infections caused by amoxicillin-sensitive organisms (see section 5.1 ).

· High respiratory infections, including ENT infections: acute otitis media, acute sinusitis, and Group A beta-hemolytic streptococci, documented.

· Low respiratory infections: acute exacerbation of chronic bronchitis, community-acquired pneumonia

· Infections of the lower urinary tract: cystitis

· Prevention of endocarditis.

· Treatment of early Lyme disease with erythema migrans (stage 1).

· Eradication of Helicobacter pylori : in appropriate combination with another anti-bacterial and an adequate anti-ulcer agent in adult patients also with H. peylori peptic ulcer .

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AMOXICILLINE SANDOZ 1 g Dispersible tablet Box of 14

There are other presentations of amoxicillin for dosages less than 2 g per day and more child-friendly forms.

The dosage of amoxicillin depends on the age, weight and renal function of the patient, the severity and location of the infection, and the suspected or proven nature of the causative organism. The tablets can be used in two ways: they can either be dispersed in water and then drink the liquid, or take them directly with water. They can be broken to facilitate their swallowing.

AMOXICILLIN SANDOZ 1 g, dispersible tablet can be taken before, during or after meals.

Dosage:

In general, it is necessary to continue the treatment during 2 to 3 days after the disappearance of the symptoms. In case of infection with beta-hemolytic streptococci, the treatment should last 10 days to ensure the eradication of the germ.

Parenteral therapy is indicated if oral administration is considered impossible or inappropriate, especially for the emergency treatment of serious infections.

Adults and children over 12 years old

The usual daily dose is between 750 mg and 3 g of amoxicillin in 2 to 3 doses.

Specific dosages

Angina: 1g twice a day. The duration of treatment is 6 days.

Acute exacerbation of chronic bronchitis in adults: 1 g twice daily.

Acute pneumopathies: 1g three times daily (ie 1g every 8 hours).

Lyme disease (chronic migrating erythema strictly isolated): 500 mg to 1g three times daily, the duration of treatment is 14 to 21 days.

Eradication of Helicobacter pylori : amoxicillin 1g twice daily, clarithromycin 500 mg twice daily and omeprazole 20 mg or lansoprazole 30 mg twice daily for 7-14 days. Alternative treatment should be considered for populations with more than 20% resistance to clarithromycin.

Elderly patients

Same dosage as in adults, except in cases of renal failure.

Dosage in case of renal failure

The dose should be reduced in case of severe renal impairment. When renal clearance is less than 30 ml / min, it is recommended to prolong the interval between doses or to reduce the doses (see Warnings and Precautions ).

In case of renal insufficiency, a brief treatment with a single dose of 3 g is not possible.

Adults (including elderly patients):

Creatinine clearance (ml / min)

Dose

Interval between takes

> 30

No adjustment needed

10 - 30

Half of the usual dose

12 hours

<10

Half of the usual dose

24 hours

In case of hemodialysis, give 500 mg at the end of the hemodialysis.

Prevention of endocarditis

Administration of 2 to 3 g of oral amoxicillin in the hour before surgery.

For more details (post-surgical antibiotic coverage, for example) and a description of patients at risk, refer to the official guidelines in effect regarding the prevention of endocarditis.

Against indications

The use of AMOXICILLIN SANDOZ 1 g, dispersible tablet is contraindicated in the following cases:

· Hypersensitivity to penicillin; consider the possibility of cross-reactivity with beta-lactams such as cephalosporins.

· Hypersensitivity to any of the excipients of the product.

Adverse effects Amoxicillin Sandoz

In this section, the frequency of adverse events is defined as follows:

Frequency: (≥1 / 100, <1/10)

Uncommon: (≥1 / 1, 000, <1/100)

Rare: (≥1 / 10, 000, <1/1000)

Very rare: (<1 / 10, 000)

indeterminate frequency (can not be estimated from available data)

Infections and infestations

Rare :

Overinfections and colonization by resistant germs or yeasts, eg oral or vaginal candidiasis after prolonged and repeated use of amoxicillin .

Blood and lymphatic system disorders

Rare

Eosinophilia and hemolytic anemia.

Very rare

Leukopenia, neutropenia, granulopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, prolongation of bleeding time and prolongation of prothrombin time. All these phenomena were reversible after stopping treatment.

Immune system disorders

Rare

Laryngeal edema, serum sickness, allergic vasculitis and anaphylactic shock.

Nervous system disorders

Rare

CNS effects, including hyperkinesia, dizziness and convulsions. Seizures are possible in case of renal insufficiency, epilepsy, meningitis or treatment with high doses.

Gastrointestinal disorders

Frequent

Gastric disorders, nausea, anorexia, vomiting, flatulence, loose stools, diarrhea, enanthemas (especially in the mouth area), dryness of mouth, taste abnormalities. These gastrointestinal effects are usually mild and often disappear during treatment or very soon after the end of treatment. Taking amoxicillin during meals usually reduces the frequency of these side effects.

Rare

An abnormal superficial staining of the teeth (especially with the suspension) is possible, but rare. In general, the brushing of the teeth makes it possible to eliminate this abnormal coloring.

Very rare

If severe and persistent diarrhea develops, consideration should be given to the possibility - very rare - of pseudomembranous colitis. Drugs that inhibit peristalsis are contraindicated.

Appearance of a black language.

Hepatobiliary disorders

Rare

Moderate and transient increase in liver enzymes

Rare

Hepatitis and cholestatic jaundice.

Skin and subcutaneous tissue disorders

Frequent

Skin reactions such as exanthema, pruritus, urticaria; typical morbilliform exanthema occurs 5 - 11 days after the start of treatment. The immediate appearance of an urticaria indicates an allergic reaction to amoxicillin and requires discontinuation of treatment.

Rare (see also section Warnings and precautions for use )

Angioneurotic edema (Quincke's edema), erythema multiforme, acute generalized exanthematous pustulosis, Lyell's syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and bullous and exfoliative dermatitis.

Kidney disorders

Rare

Acute interstitial nephritis. Crystalluria.

General disorders and administration site conditions

Rare

Medicated fever.

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