Clamoxyl Uses, Dosage, Side Effects, Precautions & Warnings

Clamoxyl >> Generic drug of the Therapeutic class: Infectiology – Parasitology
Active ingredients: Amoxicillin

what is clamoxyl ?

• This medicine is indicated for the treatment of bacterial infections with sensitive germs.
• It is also indicated in adults for the treatment of certain ulcers of the stomach or duodenum.

what is clamoxyl tablets used for and indication?

CLAMOXYL is indicated for the treatment of the following infections in adults and children (see sections Posology and method of administration , Warnings and precautions for use 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

CLAMOXYL is also indicated for the prophylaxis of endocarditis.

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

clamoxyl dosage

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

There are other presentations of amoxicillin more suited to doses higher than 2 g per day for adults, and other presentations suitable for children under 6 years.

Dosage :

NORMAL RENAL FUNCTION :

clamoxyl dosage adulte

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 :

• Chronic erythema migrans strictly isolated: 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.
• 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 :

• . Oral protocol: 3 g single dose, administered in the hour before the gesture at risk
• . parenteral protocol relay: 1 g per os6 hours after parenteral administration.

– Eradication of Helicobacter pylori in cases of peptic ulcer disease : The following dosage regimens are recommended

• . 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 weeks in case of progressive gastric ulcer.
•  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 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.
  

clamoxyl dosage CHILD

The usual dose is as follows:

• for children under 30 months : 50 mg / kg / day to 100 mg / kg / day in 3 divided doses at 8 hours
• for children over 30 months: 25 mg / kg / day at 50 mg / kg / day in 2 or better 3 doses without exceeding the dosage of 3 g / day.

 In other infections, the recommended dosage is 80 to 100 mg / kg / day in 3 doses.

Acute otitis media :

• If a 72-hour probabilistic treatment and bacteriological documentation of Streptococcus pneumoniaewith decreased sensitivity to penicillin G fails , the recommended dose is 150 mg / kg / day in 3 divided doses during 10 hours. days.
• Up-to-date clinical data have shown bacterial eradication at this dose for S. pneumoniae strains with amoxicillin MIC <= 2 mg / L.

Pneumonia .

• For more severe infections, as well as for endocarditis and septicemia (in relay of the injectable route): the dosage can be increased up to 150 mg / kg / day in 3 or 4 doses, without exceeding the dosage of 6 g /day.

SPECIAL CASES

•  Angina : in children older than 30 months: 50 mg / kg / day, in 2 daily doses. The treatment duration of angina is 6 days.
• Lyme Disease :. 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 without exceeding 6 g / day.

The duration of treatment will be 15 to 21 days.

Prophylaxis of bacterial endocarditis :

• . oral protocol: 75 mg / kg once taken, administered within one hour before the risky procedure;
• . parenteral protocol relay: 25 mg / kg orally 6 hours after parenteral administration.
  

INSUFFICIENT RENAL SUBJECT :

Administer a first loading dose (Do) equivalent to the dose normally prescribed and, depending on the degree of severity of the condition:

Clearance of creatinine: Dosage schedule .

• – greater than 30 ml / min: No adaptation : continue the treatment with the usual dose and the 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.
  

Mode of administration :

ORAL ROUTE.

• This medicine can be taken during or between meals.
• The capsules should be swallowed without opening, with a glass of water.

Contraindications

CONTRA-INDICATED:

• This medication MUST NEVER BE USED in case of allergy to antibiotics of the beta-lactam family (penicillins and cephalosporins) or to one of the other constituents.
• The capsule intake is contraindicated in children under 6 years of age, because it can lead to a wrong route.

ADVISED AGAINST:

• This medication SHOULD NOT GENERALLY BE USED in combination with methotrexate (see interactions).

How it works CLAMOXYL?

ABSORPTION :

• When taken orally, amoxicillin is resorbed at approximately 80 percent. This resorption is not influenced by food.
  

DISTRIBUTION :

• The peak serum, 2 hours after the intake, reaches a rate of 7 to 10 μg / ml for a dose of 500 mg and 13 to 15 μg / ml for a 1 g intake.
• Serum levels increase with the dose.
• In subjects whose renal function is normal, the half-life is 1 hour on average.
•  Diffusion in most tissues and biological media: presence of antibiotic at therapeutic rates found in bronchial secretions, sinuses, amniotic fluid, saliva, aqueous humor, CSF, serous, middle ear.
• Amoxicillin has good distribution in tonsils, depending on serum concentrations: between 1.5 and 3 hours after taking 1 gram of amoxicillin in adults, tonsil concentrations are on average 3 to 4 μg / g.
• Amoxicillin crosses the placental barrier and passes into breast milk.
•  Protein binding rate: 17 percent.
  

BIOTRANSFORMATION :

• Amoxicillin is partly transformed in the body into the corresponding penicilloic acid. Approximately 20 percent of the dose administered in this form is in the urine.
  

EXCRETION :

The absorbed part is excreted in active form:

• mainly in the urine (in about 6 hours, 70 to 80 percent of the absorbed dose),
•  in the bile (5 to 10 percent).

clamoxyl side effects

The most common side effects are diarrhea, nausea and rash.

The adverse reactions identified in the clinical studies and since the marketing of lamoxicillin are listed below according to the MedDRA system organ classification.

The following terminology is used to classify adverse reactions according to their frequency:

1. Very common (≥ 1/10)
2. Frequent (≥ 1/100 to <1/10)
3. Uncommon (≥ 1/1000 to <1/100)
4. Rare (≥ 1/10 000 to <1/1000)
5. Very rare (<1 / 10,000)

Not known (can not be estimated from the 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 4.4).
Immune system disorders
Very rare	Severe allergic reactions, including angioedema, anaphylaxis, serum sickness, and hypersensitivity vasculitis (see section 4.4).
Not known frequency	Jarisch-Herxheimer reaction (see section 4.4)
Nervous system disorders
Very rare	Hyperkinesia, dizziness and convulsions (see section 4.4).
Gastrointestinal disorders
Clinical Data
*Frequent	Diarrhea and nausea
*Rare	vomiting
Post-marketing data
Very rare	Antibiotic-associated colitis (including pseudo-membranous colitis and haemorrhagic colitis, see section 4.4). Hairy black tongue
Hepatobiliary disorders
Very rare	Hepatitis and cholestatic jaundice. Moderate increase in ASAT and / or ALAT.
Skin and subcutaneous tissue disorders
Clinical Data
*Frequent	Skin rash
*Rare	Urticaria and pruritus
Post-marketing data
Very rare	Skin reactions such as polymeric erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, and acute generalized exanthematous pustulosis (PEAG) (see section 4.4).
Renal and urinary disorders
Very rare	Interstitial nephritis Crystalline (see sections 4.4 and 4.9 Overdose)
* The frequency of these AEs was determined from clinical trial data for a total of approximately 6,000 adult and pediatric patients on amoxicillin.

CLAMOXYL Interactions

ASSOCIATION DECONSEILLEE :

Methotrexate :

• Increased effects and hematological toxicity of methotrexate by inhibition of renal tubular secretion by penicillins.
  

ASSOCIATION TO BE TAKEN INTO ACCOUNT :

Allopurinol :

• Increased risk of skin reactions.
  

SPECIAL PROBLEMS OF INR IMBALANCE :

• Many cases of increased activity of oral anticoagulants have been reported in patients receiving antibiotics. The marked infectious or inflammatory context, the age and the general state of the patient appear as risk factors.
•  In these circumstances, it appears difficult to distinguish between the infectious pathology and its treatment in the occurrence of the imbalance of the INR.
•  However, some classes of antibiotics are more involved, including fluoroquinolones, macrolides, cyclins, cotrimoxazole and some cephalosporins.

CLAMOXYL Warnings and Precautions :

Special warnings

• Any allergic manifestation (rash, itching, etc.) during treatment should be reported immediately to a physician.
• Before taking this treatment, tell your doctor if during previous antibiotic treatment (even with another family of antibiotics), an allergic reaction has occurred: hives or other skin rashes, itching, abrupt swelling of the face and neck of allergic origin (Quincke’s edema).
• The occurrence, at the beginning of treatment, of a redness generalizing to the whole body with pustules, and accompanied by fever, must make suspect a serious reaction called generalized acute exanthematous pustulosis; tell your doctor immediately as this requires stopping treatment; this reaction will contraindicate any new administration of amoxicillin alone or in combination with the same drug to another active substance.

Precautions for use

• Tell your doctor if you have known kidney failure.
• Drink plenty of fluids for the duration of the treatment.
• This medicine may interfere with some biological test results: Coombs test, blood glucose, total serum protein, urine glucose test. Tell your doctor about taking amoxicillin, if these tests are prescribed.
• High doses of beta-lactam antibiotics in patients with renal insufficiency or in patients with previous seizures, treated epilepsy or meningeal lesions may exceptionally result in seizures.
• Capsule taking is contraindicated in children under 6 years of age because they can swallow and choke.

Drive and use machines

• No studies have been conducted on the ability to drive vehicles and use machines.
• However, the occurrence of adverse effects (eg allergic reactions, dizziness, convulsions) that may affect the ability to drive or use machines is possible.

CLAMOXYL PREGNANCY / BREAST FEEDING / FERTILITY

clamoxyl during pregnancy

• Studies in animals have not shown any direct or indirect harmful effects on reproduction. Limited data on the use of amoxicillin in pregnant women do not indicate an increased risk of congenital malformations.
•  Amoxicillin may be used in pregnant women if the potential benefits outweigh the potential risks associated with the treatment.

feeding

• Amoxicillin is excreted in breast milk in small amounts with possible risk of sensitization. As a result, diarrhea and fungal infection of the mucous membranes are possible in the breastfed infant and may require cessation of breastfeeding.
• Amoxicillin can only be used during breastfeeding after the benefit / risk ratio has been evaluated by the treating physician.

Fertility

• There are no data on the effects of amoxicillin on human fertility.
•  Animal reproduction studies have shown no effect on fertility.

What should I do if I miss a dose?

Treatment should be continued normally, regardless of the missed dose. Do not take a double dose to make up for the dose you forgot to take.

What happens if I overdose from CLAMOXYL ?

Signs and symptoms of overdose

1. Gastrointestinal symptoms (such as nausea, vomiting and diarrhea) and fluid and electrolyte disturbances are possible.
2. Cases of crystalluria with lamoxicillin, leading in some cases to renal failure have been observed. Seizures may occur in patients with renal impairment or those receiving high doses.

Treatment of lintoxication

• The treatment of gastro-intestinal signs is symptomatic and involves a special monitoring of the electrolyte-electrolyte balance.
• Lamoxicillin can be removed from the bloodstream by hemodialysis.

What is  Forms and Composition?

Active substance

• Amoxicillin: 500 mg
• As amoxicillin trihydrate
• For a capsule.

Other components

Magnesium stearate.

Composition of the capsule shell:

• Head: indigotine, erythrosine, gelatin, titanium dioxide (E171).
• Body: yellow iron oxide, gelatin, titanium dioxide (E171).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.