amoxicillin teva Uses, Dosage, Side Effects, Precautions & Warnings

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

what is amoxicillin teva ?

AMOXICILLIN TEVA 500 MG: GENERAL INFORMATION

• This medication is indicated for the treatment of bacterial infections caused by susceptible germs.
• It is also indicated in adults for the treatment of certain ulcers of the stomach or duodenum.

PRESENTATION (S) AVAILABLE FOR AMOXICILLIN TEVA 500 MG

PVC PVDC aluminum blister pack (s) of 12 capsule (s)

FEATURE	DESCRIPTION
Pharmaceutical class	systemic antibacterials
Active substance (s)	per capsule: amoxicillin trihydrate (574.00 mg)
General medicine	Yes
Pharmaceutical form	capsule
Route (s) of administration	oral
Social security reimbursement rate	65%
Laboratory (s)	TEVA CLASSICS
Conditions of issue	available by simple prescription

what is amoxicillin teva medication used for and indication?

They derive from the antibacterial activity and the pharmacokinetic characteristics of amoxicillin. They take into account both the clinical studies to which this drug has given rise and its place in the range of antibacterial products currently available.

They are restricted to infections susceptible to germs defined as:

ADULTS AND CHILDREN :

• in initial treatment of :
  • acute pneumonia,
  • secondary infections of acute bronchitis and exacerbations of chronic bronchitis
  • ENT infections (otitis, sinusitis, tonsillitis documented streptococcus beta-hemolytic) and Dental,
  • urinary tract infections,
  • male genital infections and gynecological infections
  • digestive infections and bile,
  • Lyme disease: treatment of the primary phase (chronic erythema migrans) and the primary phase (chronic erythema migrans associated with general signs: asthenia, headache, fever, arthralgia, etc.),
• as a relay treatment for the injectable route endocarditis, septicemia,
• as a prophylactic treatment for bacterial endocarditis.

IN ADULTS ONLY :

• in combination with another antibiotic (clarithromycin or imidazole) and an antisecretory agent, eradication of Helicobacter pylori in the event of peptic ulcer disease in adults.
• Consideration should be given to official recommendations regarding the appropriate use of antibacterials.

amoxicillin teva Dosage

This capsule form is reserved for adults and children over 6 years old (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 of age.

Dosage

IN 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 intakes.
• The duration of treatment for angina is 6 days.
  
• Acute lung disease : 3 g / day, or 1 g every 8 hours.
  
• Lyme Disease :
  • Strictly isolated chronic migrant erythema: 4 g / day.
  • in the event of systemic manifestations suggesting hematogenous dissemination of Borrelia burgdorferi , the doses 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
  • relay of the parenteral protocol: 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 active duodenal ulcer or 3 to 5 weeks additional in case of progressive gastric ulcer,or
  • 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 of lansoprazole per day for 3 additional weeks in case of active duodenal ulcer or 3 to 5 weeks additional in case of progressive gastric ulcer.
    The effectiveness of the treatment depends on compliance with the dosage regimen, in particular on taking the triple therapy during the first 7 days.
    

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 to 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 divided doses.
  

Acute otitis media :

• in the event of failure of a 72-hour probabilistic treatment and bacteriological documentation of Streptococcus pneumoniae with reduced sensitivity to penicillin G, the recommended dosage is 150 mg / kg / day in 3 doses for 10 days. Up-to-date clinical data have shown bacterial eradication at this dosage for S. pneumoniae strains with an amoxicillin MIC <= 2 mg / L.
  
• Pneumonia .
  • For more severe infections, as well as for endocarditis and septicemia (relaying the injection 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 over 30 months: 50 mg / kg / day, in 2 daily doses. The duration of treatment for angina is 6 days.
    
• Lyme Disease :
  • Strictly isolated chronic migrant erythema: 50 mg / kg / day,.
  • in the event of systemic manifestations suggesting hematogenous dissemination of Borrelia burgdorferi , the doses 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 as a single dose, administered within one hour of the risky procedure;
  • relay of the parenteral protocol: 25 mg / kg per os 6 hours after parenteral administration.
    

IN THE SUBJECT WITH RENAL INSUFFICIENCY :

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

Creatinine clearance: Dosage schedule .

• greater than 30 ml / min: No adaptation : continue 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 per day. On dialysis days, administer Do / 2 after the dialysis session.
  

Method of administration :

ORAL.

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

amoxicillin teva 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 To Take amoxicillin teva ?

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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.

• Swallow with water without opening the capsule.
• Distribute the catches evenly throughout the day, they should be spaced at least 4 hours apart.

How To Store amoxicillin teva ?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blisters. The expiry date refers to the last day of that month.
• Store in the original packaging in order to protect from moisture.
• Store at a temperature not exceeding 25 ° C.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

amoxicillin teva Side Effects

Like all medicines, Amoxicillin Teva 500 mg hard capsule can cause side effects, although not everybody gets them.

Effects commonly seen in less than 1 in 10 patients and more than 1 in 100 patients

• Nausea, diarrhea. In case of diarrhea occurring during treatment, seek prompt advice from your doctor. NEVER TAKE ANTI-DIARRHEA TREATMENT WITHOUT MEDICAL PRESCRIPTION.
• Skin rash.
• Candidiasis of the skin or mucous membranes (infection caused by certain microscopic fungi).

Uncommon effects seen in less than 1 in 100 patients and in more than 1 in 1000 patients

• Vomiting.
• Hives and pruritus (itching).

Very rarely seen in less than 1 in 10,000 people

• Leukopenia (more or less drop in the number of white blood cells), neutropenia (drop in certain white blood cells: neutrophils in the blood), agranulocytosis (large drop in the number of certain white blood cells: neutrophils), thrombocytopenia (drop in the number of platelets) , reversible hemolytic anemia (destruction of red blood cells).
• Generalized allergy (including allergic shock), serum sickness (rash with fever and joint pain), allergic vasculitis (inflammation of small blood vessels).
• Convulsions.
• Pseudomembranous colitis (inflammation of the intestine with diarrhea and / or abdominal pain), hemorrhagic colitis (inflammation of the intestine with diarrhea and / or bleeding).
• Hepatitis (inflammation of the liver), jaundice.
• Skin rash, Stevens-Johnson syndrome, Lyell syndrome (peeling of the skin that can quickly spread very seriously throughout the body), bullous or exfoliative dermatitis (inflammation of the skin with bubbles).
• Acute generalized exanthemous pustulosis (redness spreading throughout the body with pustules and accompanied by fever).

Effects for which the frequency is not known

• Allergies which can manifest themselves in a more or less serious way: angioedema (sudden swelling of the face and neck), respiratory discomfort, urticaria.
• Eosinophilia (an increase in certain white blood cells in the blood).
• Dizziness.
• Interstitial nephritis (inflammatory disease of the kidneys), crystalluria (presence of crystals in the urine).
• Moderate, transient increase in the level of transaminases (liver enzymes) in the blood.

If you experience any side effects not listed in this leaflet, or if you experience any of the side effects listed as serious, please inform your doctor or pharmacist.

Keep out of the reach and sight of children.

amoxicillin teva Interactions

• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including methotrexate, even if they are obtained without a prescription.

Drive and use machines

• AMOXICILLIN Teva 500 mg hard capsules may cause side effects (such as allergic reactions, dizziness and seizures) which may reduce your ability to drive.
• Don’t drive or use machines unless you feel well.

Warnings and Precautions

Special warnings

• Any allergic manifestation (rash, itching, etc.) during treatment should be reported immediately to a doctor.
• 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 rashes, itching, sudden swelling of the face and of the neck of allergic origin (angioedema).
• The occurrence, at the start of treatment, of a redness generalizing to the whole body with pustules, and accompanied by fever, should raise suspicion of a serious reaction called acute generalized exanthemous pustulosis; tell your doctor immediately as this means that you have to stop taking it; this reaction will contraindicate any further administration of amoxicillin alone or combined in the same drug with another active substance.

Precautions for use

• Tell your doctor if you have known renal impairment.
• Drink abundantly during the treatment.
• This medication may falsify certain biological analysis results: Coombs test, glycemia, total serum proteins, detection of glucose in the urine. Tell your doctor about taking amoxicillin if you are prescribed these tests.
• The administration of high doses of beta-lactams in patients with renal impairment or in patients who have had previously convulsions, for example treated epilepsy or meningeal attacks, may exceptionally lead to convulsions.
• Taking the capsule is contraindicated in children before 6 years of age because they can swallow askew and choke.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• If needed, this medicine can be taken during pregnancy.
• Ask your doctor or pharmacist for advice before taking any medicine.

Feeding with milk

• Breast-feeding is possible while taking this medicine.
• If the newborn baby has problems such as diarrhea, rash on the skin, candidiasis ( infection due to certain microscopic fungi ), immediately tell your doctor who will advise you on what to do as these effects on your child may be due. to this drug.
• Ask your doctor or pharmacist for advice before taking any medicine.

What happens if I overdose from amoxicillin teva ?

• Immediately consult your doctor or pharmacist.
• If you take too much Amoxicillin Teva 500 mg hard capsules, it may cause stomach pain (nausea, vomiting or diarrhea) or crystals in the urine making it cloudy or painful when passing urine. See your doctor as soon as possible. Bring the medicine to show your doctor.

What should I do if I miss a dose?

• If you forgot to take a dose, take it as soon as you remember.
• Do not take the next dose too soon; wait about 4 hours before taking the next dose
• Do not take a double dose to make up for the dose you forgot to take.
• If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.

What is  Forms and Composition ?

WHAT AMOXICILLIN TEVA 500 MG CONTAINS  

The active substance is:

Amoxicillin …………. 500.00 mg

In the form of amoxicillin trihydrate

For a capsule.

· The other ingredients are:

• Magnesium stearate.
• Composition of the capsule shell : gelatin, indigotine (E132), yellow iron oxide (E172), titanium dioxide (E171).

WHAT IS AMOXICILLIN TEVA 500 MG HARD CAPSULE AND CONTENTS OF THE OUTER CARTON  

• This medication is in the form of a capsule, box of 12.

MARKETING AUTHORIZATION HOLDER

MAKER

BTT LABORATORIES

• ZI DE KRAFFT
• 67150 ERSTEIN

or

• TEVA SANTE
• RUE BELLOCIER
• 89107 SENS CEDEX

NAMES OF THE DRUG IN THE MEMBER STATES OF THE EUROPEAN ECONOMIC AREA  

• Not applicable.

THE LAST DATE ON WHICH THIS LEAFLET WAS REVISED IS:  

• [to be completed later by the holder]

AMOXICILLIN TEVA 500 MG: COMPOSITION

Active substance

Amoxicillin: 500.00 mg

In the form of amoxicillin trihydrate

For a capsule.

Other components

• Magnesium stearate.
• Composition of the capsule shell: gelatin, indigotine (E132), yellow iron oxide (E172), 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.