Pedi-AG Uses

• Pedi-AG indications
• Pedi-AG description
• Pedi-AG dosage
• Pedi-AG interactions
• Pedi-AG side effects
• Pedi-AG contraindications

What is Pedi-AG?

Amoxicillin (Pedi-AG) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Pedi-AG) fights bacteria in the body.

Clavulanate potassium is a form of Clavulanic Acid (Pedi-AG), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.

The combination of Amoxicillin (Pedi-AG) 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 (Pedi-AG) and clavulanate potassium may also be used for purposes not listed in this medication guide.

Pedi-AG indications

Pedi-AG-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 (Pedi-AG). Pedi-AG-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 Pedi-AG-600 and other antibacterial drugs, Pedi-AG-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.

Pedi-AG description

Each film-coated tablet contains Amoxicillin (Pedi-AG) trihydrate equivalent to Amoxicillin (Pedi-AG) 500 mg, and potassium clavulanate equivalent to Clavulanic Acid (Pedi-AG) 125 mg, respectively.

Each vial contains Amoxicillin (Pedi-AG) sodium equivalent to Amoxicillin (Pedi-AG) 1000 mg and clavulanate potassium equivalent to Clavulanic Acid (Pedi-AG) 200 mg, respectively.

Pedi-AG 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.

Pedi-AG is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Pedi-AG) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic Acid (Pedi-AG)). Amoxicillin (Pedi-AG) 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 (Pedi-AG) 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 (Pedi-AG): Clavulanic Acid (Pedi-AG) 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 (Pedi-AG) 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.

Pedi-AG dosage

Tablet: Tablets should be taken immediately before a meal.

General Information: For infections caused by Amoxicillin (Pedi-AG)-sensitive organisms, the dosage is that approved for Amoxicillin (Pedi-AG) as the Clavulanic Acid (Pedi-AG) component does not contribute to the therapeutic effect.

Adults: 1 or 2 Pedi-AG 375 mg tab 8 hourly or 1 Pedi-AG 625 mg tab 8 hourly for more severe infections and infections of the respiratory tract.

For Amoxicillin (Pedi-AG)-resistant organisms, the dosage of Pedi-AG tablets are as follows:

Since both Pedi-AG 375 mg and 625 mg contain the same amount of Clavulanic Acid (Pedi-AG) (125 mg, as the potassium salt), 2 Pedi-AG 375 mg are not equivalent to 1 Pedi-AG 625 mg. Therefore, 2 Pedi-AG 375 mg should not be substituted for 1 Pedi-AG 625 mg for treatment of more severe infections.

Renal Failure: Both Amoxicillin (Pedi-AG) and Clavulanic Acid (Pedi-AG) are excreted by the kidneys and the serum t_½ 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 (Pedi-AG) and Clavulanic Acid (Pedi-AG) and an additional dose should be administered at the end of dialysis.

Oral Suspension:

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 (Pedi-AG), 1 part Clavulanic Acid (Pedi-AG) preparations (which corresponds to a daily dosage of the equivalent of Amoxicillin (Pedi-AG) 20-40 mg/kg and Clavulanic Acid (Pedi-AG) 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: Pedi-AG may be administered by the IV routes.

Pedi-AG 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.

Pedi-AG interactions

See also:
What other drugs will affect Pedi-AG?

Probenecid decreases the renal excretion of Amoxicillin (Pedi-AG). Concurrent use with Pedi-AG may result in increased and prolonged blood levels of Amoxicillin (Pedi-AG).

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.

Pedi-AG should not be co-administrated with disulfiram.

Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Pedi-AG. Thus, Pedi-AG should be used with care in patients on anticoagulation therapy.

Pedi-AG may reduce the effect of oral contraceptives and the caution should be given to patients.

Laboratory Test Interactions: Pedi-AG 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.

Pedi-AG side effects

See also:
What are the possible side effects of Pedi-AG?

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 (Pedi-AG) is required, consideration should be given to administering the additional Amoxicillin (Pedi-AG) separately.

Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Pedi-AG) and Clavulanic Acid (Pedi-AG); the Clavulanic Acid (Pedi-AG) component has been implicated. The events associated with Pedi-AG 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 Pedi-AG, the significance of these findings is unknown.

The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Pedi-AG.

Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Pedi-AG at the start of a meal.

Amoxicillin (Pedi-AG) 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, Pedi-AG 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 Pedi-AG. Prolongation of bleeding time and prothrombin time have also been reported less frequently.

Amoxicillin (Pedi-AG) alone or in combination with Clavulanic Acid (Pedi-AG) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Pedi-AG)-Clavulanic Acid (Pedi-AG)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Pedi-AG) 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.

Pedi-AG contraindications

Hypersensitivity to the Amoxicillin (Pedi-AG)/clavulanate potassium to any of the penicillins or to any of the excipients of Pedi-AG.

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 Pedi-AG.

Active ingredient matches for Pedi-AG:

Amoxicillin/Clavulanic Acid

References

1. 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).
2. PubChem. "CLAVULANIC ACID". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. PubChem. "amoxicillin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology