hiconcil Uses, Dosage, Side Effects, Precautions & Warnings

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

HICONCIL 500 mg, capsule, box of 12 Medicinal product withdrawn from the market on 02/10/2008

what is hiconcil 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, exacerbation of chronic bronchitis
  • ENT infections (otitis, sinusitis, angina) and stomatological
  • Urinary 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 of endocarditis, septicemia.
  
• as a prophylactic treatment for bacterial endocarditis.
  

IN ADULTS ONLY :

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

hiconcil Dosage

• One measuring spoon (5 ml) contains 125 mg of amoxicillin.
• For adults and in certain cases in children (large doses, older children), other presentations of amoxicillin are more suitable.
  

Dosage of oral amoxicillin

IN SUBJECT WITH NORMAL RENAL FUNCTION :

ADULTS :

• The usual dosage of amoxicillin is 1-1.5 or 2 g / day in 2 to 3 doses.
  

Special cases :

• angina : 500 mg every 12 hours, for 10 days.
• In acute strep throat, a 6-day treatment at a dose of 2 g / day in 2 doses ensures eradication of the streptococcus.
  
• acute pneumonia: 3 g / day, or 1 g every 8 hours.
  
• Lyme disease :
  • chronic migrant strictly isolated erythema: 4 g / 24 hours
  • in the event of systemic manifestations suggesting a hematogenous dissemination of Borrelia burgdorferi , the doses may be increased up to 6 g / 24 h.
  • 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 as a single dose, administered within one hour of the risky procedure,
  • relay of the parenteral protocol: 1 g per os 6 hours after parenteral administration.
    

Helicobacter pylori eradication in case of peptic ulcer disease in adults , the following 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 doses at 8 hours
    
  • or children over 30 months: 25 to 50 mg / kg / day in 2 or better 3 doses without exceeding the dosage of 3 g / day.
•  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 :

• Lyme Disease :
  • Chronic erythema migrant strictly isolated: 50 mg / kg / 24 h
  • in the event of systemic manifestations suggesting a hematogenous dissemination of Borrelia burgdorferi , the doses may be increased up to 6 g / 24 h.
  • The duration of treatment will be 15 to 21 days.
    
• prophylaxis of bacterial endocarditis:
  • Oral protocol: 75 mg / kg single dose, administered in the hour before the gesture at risk
  • relay of the parenteral protocol: 25 mg / kg per os 6 hours after parenteral administration.
    
• angina : in acute strep throat in the over 30 month old child, a 6-day treatment at a dose of 50 mg / kg / day in 2 divided doses ensures the eradication of streptococci.
  

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.
•  Use the measuring spoon supplied with the bottle.

hiconcil 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.
• Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.

ADVISED AGAINST:

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

how does hiconcil work?

ABSORPTION : When

• taken orally, amoxicillin is approximately 80 percent absorbed.
• This absorption is not influenced by food.
  

DISTRIBUTION :

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

BIOTRANSFORMATION :

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

EXCRETION :

The absorbed part is excreted in active form:

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

hiconcil Side Effects

The classification of undesirable effects used is as follows :

• very common:> = 1/10.
• common:> = 1/100; <1/10.
• uncommon:> = 1/1000; <1/100.
• rare:> = 1/10000; <1/1000.
• very rare: <1/10000.

not known: frequency cannot be estimated from the available data.

Blood and lymphatic system disorders :

• Very rare: reversible leukopenia, neutropenia, agranulocytosis, thrombocytopenia and hemolytic anemia.
• Not known: eosinophilia.

Nervous system :

• Very rare: convulsions.
• Not known: dizziness, headache.

Gastrointestinal disorders :

• Common: diarrhea, nausea.
• Uncommon: vomiting.
• Very rare: pseudomembranous colitis, hemorrhagic colitis.
• Not known: superficial tooth staining in children, usually reversible after brushing teeth.

Kidney and urinary tract disorders :

• Not known: acute interstitial nephritis and crystalluria.

Skin and subcutaneous tissue disorders :

• Common: rash.
• Uncommon: urticaria and pruritus.
• Very rare: erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome, bullous or exfoliative dermatitis. These skin manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or active lymphoid leukemia. Acute generalized exanthematous pustulosis (see warnings and precautions for use).

Infections and infestations :

• Frequent: mucocutaneous candidiasis.

mmune system :

• Very rare: anaphylaxis (including anaphylactic shock), serum sickness and hypersensitivity vasculitis (see warnings and precautions for use).
•  Not known: allergic manifestations, including urticaria, angioedema, respiratory discomfort.

Hepatobiliary disorders :

• Very rare: hepatitis, cholestatic jaundice.
• Frequency not known: moderate and transient increase in serum transaminases (ALT and / or ASAT).

hiconcil Interactions

• Increase in the effects and hematological toxicity of methotrexate by inhibition of renal tubular secretion by penicillins.

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 general condition of the patient appear to be risk factors. Under these circumstances, it appears difficult to distinguish between the infectious pathology and its treatment in the occurrence of the INR imbalance. However, certain classes of antibiotics are more involved: these include fluoroquinolones, macrolides, cyclins, cotrimoxazole and certain cephalosporins.
• Not applicable.

Warnings and Precautions

• The occurrence of any allergic manifestation requires the discontinuation of treatment, and the establishment of an appropriate treatment.
• Severe and sometimes fatal hypersensitivity reactions (anaphylaxis) have been observed exceptionally in patients treated with beta-lactams.
• Their administration therefore requires an examination.
• Given a history of typical allergy to these products, the contraindication is definite.
• The penicillin allergy is crossed with the cephalosporin allergy in 5 to 10% of cases. This leads to the proscription of penicillins when the subject is known to be allergic to cephalosporins.
•  In the event of renal insufficiency, adjust the dosage according to the creatinine clearance or the creatinine level (see dosage and method of administration).
• In the event of administration of high doses of amoxicillin, sufficient fluid intake should be ensured to reduce the risk of crystalluria.
• A positive direct Coombs test was obtained during treatment with beta-lactams. This could also occur in subjects treated with amoxicillin.

At very high concentrations, tends to amoxicillin:

• • reduce assay results in blood glucose
  • interfere in the determinations of the total protein level of the serum by color reaction,
  • give a false positive color reaction in glycosuria assays by the semi-quantitative colorimetric method.
• Treatment of Lyme disease: Jarisch-Herxheimer reactions may occur.
• This medicinal product contains 5.7 mg of sodium per measuring spoon: take this into account only in children on a strict sodium diet.
  
• Due to the presence of sucrose , this medication is contraindicated in cases of fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency.
• This medicine contains 2.2 g of sucrose per measuring spoon: take this into account in the daily ration.
• Breast-feeding: there is little passage into breast milk and the quantities ingested are much lower than the therapeutic doses. As a result, breast-feeding is possible while taking this antibiotic. However, discontinue breast-feeding (or medication) if diarrhea, candidiasis, or rash occurs in the infant.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• Studies in animals have not produced any evidence of teratogenic effects. In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, the substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies on two species.
• Clinically, analysis of a high number of exposed pregnancies apparently revealed no specific malformative or foetotoxic effects of amoxicillin. However, only epidemiological studies would make it possible to verify the absence of risk.
• Therefore, amoxicillin can be prescribed during pregnancy if needed.
• The passage of amoxicillin in breast milk is low and the amounts ingested are much lower than the therapeutic doses. As a result, breast-feeding is possible while taking this antibiotic.
• However, stop breast-feeding (or the medication) if diarrhea, candidiasis or rash occurs in the infant.

What happens if I overdose from hiconcil ?

•  The manifestations of overdose can be neuropsychic, renal (crystalluria – see warnings and precautions for use) and gastrointestinal.
• Treatment is symptomatic, particularly monitoring the fluid and electrolyte balance.
• Amoxicillin can be removed by hemodialysis.

What is  Forms and Composition ?

Appearance and shape

Active ingredient	Capsule
Amoxicillin	500 mg *

* per unit dose

Active ingredients: Amoxicillin

Excipients with known effects ? : Lactose monohydrate

Other excipients: Magnesium stearate, Colloidal anhydrous silica, Head: Gelatin, Erythrosine, Iron oxide yellow, Titanium dioxide, Body: Gelatin, Titanium dioxide

NOT’s

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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.