What is Amoxitenk Plus Pediátrica?
Amoxicillin (Amoxitenk Plus Pediátrica) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Amoxitenk Plus Pediátrica) fights bacteria in the body.
Clavulanate potassium is a form of Clavulanic Acid (Amoxitenk Plus Pediátrica), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.
The combination of Amoxicillin (Amoxitenk Plus Pediátrica) and clavulanate potassium is used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.
Amoxicillin (Amoxitenk Plus Pediátrica) and clavulanate potassium may also be used for purposes not listed in this medication guide.
Amoxitenk Plus Pediátrica indications
Amoxitenk Plus Pediátrica-600 is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors:
- antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
- age ≤ 2 years
- daycare attendance
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with Amoxicillin (Amoxitenk Plus Pediátrica). Amoxitenk Plus Pediátrica-600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL.
Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the β-lactamase–producing organisms listed above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxitenk Plus Pediátrica-600 and other antibacterial drugs, Amoxitenk Plus Pediátrica-600 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxitenk Plus Pediátrica description
Each film-coated tablet contains Amoxicillin (Amoxitenk Plus Pediátrica) trihydrate equivalent to Amoxicillin (Amoxitenk Plus Pediátrica) 500 mg, and potassium clavulanate equivalent to Clavulanic Acid (Amoxitenk Plus Pediátrica) 125 mg, respectively.
Each vial contains Amoxicillin (Amoxitenk Plus Pediátrica) sodium equivalent to Amoxicillin (Amoxitenk Plus Pediátrica) 1000 mg and clavulanate potassium equivalent to Clavulanic Acid (Amoxitenk Plus Pediátrica) 200 mg, respectively.
Amoxitenk Plus Pediátrica tablets also contains the following excipients: Microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, povidone (K30), eudragit E 100, isopropyl alcohol, magnesium stearate, white opadryl 03B58965, PEG400, methylene chloride.
Amoxitenk Plus Pediátrica is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Amoxitenk Plus Pediátrica) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic Acid (Amoxitenk Plus Pediátrica)). Amoxicillin (Amoxitenk Plus Pediátrica) is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Its molecular formula is C16H19N305S3H20 and the molecular weight is 419.46. Chemically, Amoxicillin (Amoxitenk Plus Pediátrica) is (2S, 5R, 6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl) acetamido]-3, 3-dimethyl-7-oxo-4-1-azabicyclo[3.2.1] heptane-2-carboxylic acid trihydrate.
Amoxicillin (Amoxitenk Plus Pediátrica): Clavulanic Acid (Amoxitenk Plus Pediátrica) is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic Acid (Amoxitenk Plus Pediátrica) is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KN05 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R, 5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate.
Amoxitenk Plus Pediátrica dosage
Tablet: Tablets should be taken immediately before a meal.
General Information: For infections caused by Amoxicillin (Amoxitenk Plus Pediátrica)-sensitive organisms, the dosage is that approved for Amoxicillin (Amoxitenk Plus Pediátrica) as the Clavulanic Acid (Amoxitenk Plus Pediátrica) component does not contribute to the therapeutic effect.
Adults: 1 or 2 Amoxitenk Plus Pediátrica 375 mg tab 8 hourly or 1 Amoxitenk Plus Pediátrica 625 mg tab 8 hourly for more severe infections and infections of the respiratory tract.
For Amoxicillin (Amoxitenk Plus Pediátrica)-resistant organisms, the dosage of Amoxitenk Plus Pediátrica tablets are as follows:
Since both Amoxitenk Plus Pediátrica 375 mg and 625 mg contain the same amount of Clavulanic Acid (Amoxitenk Plus Pediátrica) (125 mg, as the potassium salt), 2 Amoxitenk Plus Pediátrica 375 mg are not equivalent to 1 Amoxitenk Plus Pediátrica 625 mg. Therefore, 2 Amoxitenk Plus Pediátrica 375 mg should not be substituted for 1 Amoxitenk Plus Pediátrica 625 mg for treatment of more severe infections.
Renal Failure: Both Amoxicillin (Amoxitenk Plus Pediátrica) and Clavulanic Acid (Amoxitenk Plus Pediátrica) are excreted by the kidneys and the serum t½ of each increases in patients with renal failure. Therefore, the dose may need to be reduced or the interval extended. The following schedule in the dosage is proposed:
Haemodialysis decreases serum concentrations of both Amoxicillin (Amoxitenk Plus Pediátrica) and Clavulanic Acid (Amoxitenk Plus Pediátrica) and an additional dose should be administered at the end of dialysis.
Oral Suspension:
Suspensions should be taken immediately before a meal.Reconstitution: For reconstitution to 30 mL, add water till the mark, invert the bottle and shake well until all the powder is dispersed.
Children: 25-50 mg/kg/day of the 4 parts Amoxicillin (Amoxitenk Plus Pediátrica), 1 part Clavulanic Acid (Amoxitenk Plus Pediátrica) preparations (which corresponds to a daily dosage of the equivalent of Amoxicillin (Amoxitenk Plus Pediátrica) 20-40 mg/kg and Clavulanic Acid (Amoxitenk Plus Pediátrica) 5-10 mg/kg) to be taken in divided doses every 8 hrs at the start of a meal.
Dosage Guide:
To correspond to a dosage of 25-50 mg/kg/day.
To correspond to a dosage of 50 mg/kg/day.
IV/IM: Amoxitenk Plus Pediátrica may be administered by the IV routes.
Amoxitenk Plus Pediátrica is administered by IM or slow IV injection in doses of 500 mg every 8 hrs.
Severe Infections: 1 g every 6 hrs by slow IV injection over 3-4 min or by infusion over 30-60 min.
Children ≤10 years: 50-100 mg/kg body weight daily by injection in divided doses.
Amoxitenk Plus Pediátrica interactions
See also:
What other drugs will affect Amoxitenk Plus Pediátrica?
Probenecid decreases the renal excretion of Amoxicillin (Amoxitenk Plus Pediátrica). Concurrent use with Amoxitenk Plus Pediátrica may result in increased and prolonged blood levels of Amoxicillin (Amoxitenk Plus Pediátrica).
The concurrent administration of allopurinol and ampicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. But it is not known whether this potentiation of ampicillin rash is due to allopurinol or the hyperuricemia present in these patients.
Amoxitenk Plus Pediátrica should not be co-administrated with disulfiram.
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Amoxitenk Plus Pediátrica. Thus, Amoxitenk Plus Pediátrica should be used with care in patients on anticoagulation therapy.
Amoxitenk Plus Pediátrica may reduce the effect of oral contraceptives and the caution should be given to patients.
Laboratory Test Interactions: Amoxitenk Plus Pediátrica results in high urine concentration. High urine concentration of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict or Fehling's solution.
Amoxitenk Plus Pediátrica side effects
See also:
What are the possible side effects of Amoxitenk Plus Pediátrica?
The most frequently reported adverse effects were diarrhoea, nausea, vomiting, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes. The incidence and severity of adverse effects, particularly nausea and diarrhoea, increased with the higher recommended dose and can be minimised by administering the agent at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these GI symptoms occur and a higher concentration of Amoxicillin (Amoxitenk Plus Pediátrica) is required, consideration should be given to administering the additional Amoxicillin (Amoxitenk Plus Pediátrica) separately.
Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Amoxitenk Plus Pediátrica) and Clavulanic Acid (Amoxitenk Plus Pediátrica); the Clavulanic Acid (Amoxitenk Plus Pediátrica) component has been implicated. The events associated with Amoxitenk Plus Pediátrica may be severe and occur predominantly in adult or elderly patients. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased. The hepatic events are usually reversible. However, in extremely rare circumstances, death has been reported. These have almost always been cases associated with serious underlying disease or concomitant medication.
A moderate rise in aspartate transaminase and/or alanine transaminase has been noted in patients treated with Amoxitenk Plus Pediátrica, the significance of these findings is unknown.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Amoxitenk Plus Pediátrica.
Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Amoxitenk Plus Pediátrica at the start of a meal.
Amoxicillin (Amoxitenk Plus Pediátrica) causes hypersensitivity reactions similar to those induced by penicillin G and ampicillin, including rashes and fever. The incidence of these reaction is probably no higher than with other penicillins. Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or uticaria. Hypersensitivity reactions include skin rashes, urticaria, erythema multiforme, rare cases of Stevens-Johnson syndrome and less frequently exfoliative dermatitis and toxic epidermal necrolysis have been reported. Whenever such reactions occur, Amoxitenk Plus Pediátrica should be discontinued. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin.
Haematopoietic and Lymphatic: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in patients treated with Amoxitenk Plus Pediátrica. Prolongation of bleeding time and prothrombin time have also been reported less frequently.
Amoxicillin (Amoxitenk Plus Pediátrica) alone or in combination with Clavulanic Acid (Amoxitenk Plus Pediátrica) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Amoxitenk Plus Pediátrica)-Clavulanic Acid (Amoxitenk Plus Pediátrica)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Amoxitenk Plus Pediátrica) alone). Risks were increased in patients receiving >1 course and in older recipients.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes and/or dizziness have also been reported. Depression, seizures or hallucinations.
Amoxitenk Plus Pediátrica contraindications
Hypersensitivity to the Amoxicillin (Amoxitenk Plus Pediátrica)/clavulanate potassium to any of the penicillins or to any of the excipients of Amoxitenk Plus Pediátrica.
History of a severe immediate hypersensitivity reaction (eg, anaphylaxis) to another β-lactam agent (eg, a cephalosporin, carbapenem or monobactam).
History of cholestatic jaundice/hepatic dysfunction due to Amoxitenk Plus Pediátrica.
Active ingredient matches for Amoxitenk Plus Pediátrica:
Amoxicillin/Clavulanic Acid in Argentina.
List of Amoxitenk Plus Pediátrica substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Amoxitenk Plus (Argentina) | |
| AMOXRAG (India) | |
| 1's (Auriga) | $ 1.45 |
| 6's (Auriga) | $ 2.17 |
| Amoxrag Amoxicillin 1 g, clavulanicacid 0.2 g. POWD / 1 (Auriga) | $ 1.45 |
| Amoxrag Amoxicillin 250 mg, clavulanicacid 125 mg. TAB / 6 (Auriga) | $ 1.59 |
| Amoxrag Amoxicillin 500 mg, clavulanicacid 125 mg. TAB / 6 (Auriga) | $ 2.17 |
| AMOXRAG tab 6's (Auriga) | $ 2.17 |
| Amoxrag Amoxicillin 1 g, clavulanicacid 0.2 g. POWD / 1 (Auriga) | $ 1.45 |
| Amoxrag Amoxicillin 250 mg, clavulanicacid 125 mg. TAB / 6 (Auriga) | $ 1.59 |
| Amoxrag Amoxicillin 500 mg, clavulanicacid 125 mg. TAB / 6 (Auriga) | $ 2.17 |
| Amoxrag Syr (India) | |
| Amoxrag Syr Amoxicillin 200 mg, clavulanicacid 28.5 mg/5 mL. DRY-SYR / 30ml (Auriga) | $ 0.84 |
| AMOXRAG SYR dry syr 30ml (Auriga) | $ 0.84 |
| Amoxtacim (South Korea) | |
| Amoxtal-CA (India) | |
| Amoxtal-CA Amoxicillin 500 mg, Clavulanicacid 125 mg. TAB / 6 (Talson) | $ 3.60 |
| 6's (Talson) | $ 3.60 |
| AMOXTAL-CA tab 6's (Talson) | $ 3.60 |
| Amoxy + Clav Potas Com | |
| Amoxy Clav | |
| AMOXY PLUS | |
| AMOXY PLUS 200 MG/28.5 MG DRY SYRUP 1 bottle / 30 ML dry syrup each (Symbiosis Lab) | $ 0.71 |
| AMOXY PLUS 500 MG/125 MG TABLET 1 strip / 10 tablets each (Symbiosis Lab) | $ 0.82 |
| Amoxy Plus 500 mg/125 mg Tablet (Symbiosis Lab) | $ 0.08 |
| AMOXY(SYMBIOSIS) | |
| AMOXY PLUS CV 500 MG/125 MG TABLET 1 strip / 6 tablets each (Symbiosis Lab) | $ 1.77 |
| AMOXYCILLIN 250MG+POTASSIUM CLAVULANATE 125MG | |
| AMOXYCILLIN 250MG+POTASSIUM CLAVULANATE 125MG TABLET 1 strip / 6 tablets each (Jan Aushadhi) | $ 0.36 |
| Amoxycillin; Clavulanic Acid | |
| Amoxyclav (Australia, Georgia) | |
| Injectable; Injection; Amoxicillin Sodium 1000 mg; Clavulanic Acid / Clavulanate Potassium 200 mg (Abbott) | |
| Amoxyclav Amoxicillin 1 g, clavulanatepotassium 0.2 g. POWD / 1 (Abbott) | $ 2.16 |
| AMOXYCLAV 1000 MG/200 MG INJECTION 1 vial / 1 injection each (Abbott) | $ 0.68 |
| AMOXYCLAV 500 MG/125 MG TABLET 1 strip / 6 tablets each (Abbott) | $ 1.23 |
| Amoxyclav 1000 mg/200 mg Injection (Abbott) | $ 0.72 |
| Amoxyclav 250mg/125mg Tablet (Abbott) | $ 0.10 |
| Amoxyclav 500 mg/125 mg Tablet (Abbott) | $ 0.21 |
| Amoxyclav 200 (Australia) | |
| Amoxyclav 250 (Australia) | |
| Amoxyclav 50 (Australia) | |
| Amoxyclav 500 (Australia) | |
| Amoxyclav AN (Australia) | |
| Amoxyclav Generichealth (Australia) | |
| AmoxyClav GH (Australia) | |
| AmoxyClav RBX (Australia) | |
| Amoxyplus (Spain) | |
| Amoxytek (India) | |
| Amoxytek Amoxicillin 500 mg, Clavulanicacid 125 mg. TAB (Arunabh) | |
| Amoxytek Amoxicillin 250 mg, Clavulanicacid 125 mg. TAB (Arunabh) | |
See 7042 substitutes for Amoxitenk Plus Pediátrica | |
References
- DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "CLAVULANIC ACID". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "amoxicillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Amoxitenk Plus Pediátrica are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Amoxitenk Plus Pediátrica. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yetConsumer reported age
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
