Amoxil/Amoxil Forte

Amoxil/Amoxil Forte

amoxicillin

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Full Prescribing Info
Contents
Amoxicillin.
Description
Each Amoxil capsules contains amoxicillin 250 or 500 mg.
Each 5 mL of Amoxil and Amoxil Forte oral suspension contains amoxicillin 125 mg and 250 mg, respectively.
Each mL of Amoxil oral drops contain amoxicillin 100 mg.
Powder for Oral Suspension/Oral Drops: Bottles of white powder (for reconstitution) with yellowish grains and a characteristic fruity odor. When reconstituted, a lemon-peach-strawberry flavored suspension is formed.
Action
Pharmacology: Pharmacodynamics: Amoxil is a semisynthetic aminopenicillin of the β-lactam group of antibiotics. It has a broad-spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms, acting through the inhibition of biosynthesis of cell wall mucopeptide. Amoxicillin is however, susceptible to degradation by β-lactamases and therefore, the spectrum of activity does not include organisms which produce these enzymes including resistant staphylococci and all strains of Pseudomonas, Klebsiella and Enterobacter.
It is rapidly bactericidal and possesses the safety profile of a penicillin.
The prevalence of acquired resistance is geographically and time dependent and for select species may be very high. Local information on resistance is durable, particularly when treating severe infections. (See Table 1).

Click on icon to see table/diagram/image

Pharmacokinetics: Amoxil/Amoxil Forte is well absorbed. Oral administration, usually at convenient 3 times daily dosage produces high serum levels independent of the time at which food is taken. It gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.
Amoxicillin is not highly protein bound, approximately 18% of total plasma drug content is bound to protein. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid. Inflammation generally increases the permeability of the meninges to penicillins and this may apply to amoxicillin.
The major route of elimination for amoxicillin is via the kidney. Approximately 60-70% of Amoxil/Amoxil Forte is excreted unchanged in the urine during the first 6 hrs after administration of a standard dose. The elimination half-life (t½) is approximately 1 hr. Amoxil/Amoxil Forte is also partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to 10-25% of the initial dose.
Concurrent administration of probenecid delays amoxicillin excretion.
Small amounts of amoxicillin are also excreted in feces and bile.
Indications/Uses
Treatment of commonly occurring bacterial infections eg, upper respiratory tract infections (eg, ear, nose and throat infections, otitis media); lower respiratory tract infections (eg, acute exacerbations of chronic bronchitis, lobar and bronchopneumonia); gastrointestinal tract infections (eg, typhoid and paratyphoid fever); genitourinary tract infections (eg, cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, septic abortion, puerperal sepsis); other infections including borreliosis (Lyme disease; Borrelia burgdorferi); skin and soft tissue infections; biliary tract infections; bone infections; pelvic infections; gonorrhea (non penicillinase-producing strains); septicemia; endocarditis; meningitis; peritonitis; dental abscess (as an adjunct to surgical management); Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.
Infections eg, septicemia, endocarditis and meningitis due to susceptible organisms should be treated initially with high doses of a parenteral therapy and where appropriate, in combination with another antibiotic.
Prophylaxis of Endocarditis: Amoxil may be used for the prevention of bacteremia associated with procedures eg, dental extraction, in patients at risk of developing endocarditis (see Dosage & Administration).
Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing where necessary (see Pharmacology: Microbiology under Actions).
Dosage/Direction for Use
Adults and Children >40 kg: Standard Dose: 250 mg 3 times daily, increasing to 500 mg 3 times daily for more severe infections.
High Dosage Therapy (Maximum Recommended Oral Dosage 6 g Daily in Divided Doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
Short Course Therapy: Simple Acute Urinary Tract Infection: Two 3-g doses with 10-12 hrs between the doses. Dental Abscess: Two 3-g doses with 8 hrs between the doses. Gonorrhea: 3 g as a single dose.
Helicobacter Pylori Eradication in Peptic (Duodenal and Gastric) Ulcer Disease: 750 mg-1 g twice daily in combination with a proton-pump inhibitor (eg, omeprazole, lansoprazole) and another antibiotic (eg, clarithromycin, metronidazole) for 7 days.
Children <40 kg: Standard Dose: 125 mg 3 times daily, increasing to 250 mg 3 times daily for more severe infections. Amoxil drops is recommended for children <6 months.
Acute Otitis Media: 750 mg twice daily for 2 days may be used as an alternative course of treatment.
Renal Impairment: In renal impairment, the excretion of the antibiotic will be delayed and depending on the degree of impairment, it may be necessary to reduce the total daily dosage according to the following scheme: Adults and Children >40 kg: Mild Impairment [creatinine clearance (CrCl >30 mL/min)]: No change in dosage. Moderate Impairment (CrCl 10-30 mL/min): 500 mg twice daily maximum. Severe Impairment (CrCl <10 mL/min): 500 mg/day maximum.
Children <40 kg: Mild Impairment (CrCl >30 mL/min): No change in dosage. Moderate Impairment (CrCl 10-30 mL/min): 15 mg/kg twice daily (500 mg twice daily maximum). Severe Impairment (CrCl <10 mL/min): 15 mg/kg once daily (500 mg maximum).
Patients Receiving Peritoneal Dialysis: 500 mg/day maximum. Dosing as for patients with severe renal impairment (CrCl <10 mL/min). Amoxicillin is not removed by peritoneal dialysis.
Patients Receiving Hemodialysis: Dosing as for patients with severe renal impairment (CrCl <10 mL/min).
Amoxicillin is removed from the circulation by hemodialysis. Therefore, 1 additional dose (500 mg for adults or 15 mg/kg for children <40 kg) may be administered during dialysis and at the end of each dialysis.
Prophylaxis of Endocarditis: See Table 2.

Click on icon to see table/diagram/image

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.
Overdosage
Gastrointestinal effects eg, nausea, vomiting and diarrhea may be evident, and symptoms of water/electrolyte imbalance should be treated symptomatically.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Precautions).
Amoxil can be removed from the circulation by hemodialysis.
Contraindications
Amoxicillin (Amoxil) is a penicillin and should not be given to patients w/ history of hypersensitivity to β-lactam antibiotics (eg, penicillins, cephalosporins).
Special Precautions
Before initiating therapy with Amoxil/Amoxil Forte, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins or cephalosporins. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to β-lactam antibiotics (see Contraindications). If an allergenic reaction occurs, Amoxil/Amoxil Forte should be discontinued and appropriate alternative therapy instituted. Serious anaphylactic reactions may require immediate emergency treatment with adrenaline. Oxygen, IV steroids and airway management, including intubation, may also be required.
Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may also occasionally result in overgrowth of nonsusceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhea during or after antibiotic use. If prolonged or significant diarrhea occurs, or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Dosage should be adjusted in patients with renal impairment (see Dosage & Administration).
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Overdosage).
Abnormal prolongation of prothrombin time [increased international normalized ratio (INR)] has been reported rarely in patients receiving Amoxil/Amoxil Forte and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Amoxil/Amoxil Forte Oral Suspension and Drops: Contain sodium benzoate which is a mild irritant to the skin, eyes and mucus membrane. It may increase the risk of jaundice in newborn babies. May contain aspartame which is a source of phenylalanine and should be used with caution in patients with phenylketonuria.
May contain sorbitol. If the patient have been told by the physician that the patient have an intolerance to some sugars, contact physician before taking Amoxil/Amoxil Forte.
Effects on the Ability to Drive or Operate Machinery: Adverse effects on the ability to drive or operate machinery have not been observed.
Use in Pregnancy & Lactation: The safety of Amoxil/Amoxil Forte for use in human pregnancy has not been established by well-controlled studies in pregnant women. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and these studies have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. Amoxil may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Amoxil may be given during lactation. With the exception of the risk of sensitization associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breastfed infant.
Use In Pregnancy & Lactation
The safety of Amoxil/Amoxil Forte for use in human pregnancy has not been established by well-controlled studies in pregnant women. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and these studies have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. Amoxil may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Amoxil may be given during lactation. With the exception of the risk of sensitization associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breastfed infant.
Adverse Reactions
The following convention has been utilized for the classification of adverse effects: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000).
The majority of the adverse effects listed as follows are not unique to amoxicillin and may occur when using other penicillins.
Unless otherwise stated, the frequency of adverse events has been derived from >30 years of post-marketing reports.
Blood and Lymphatic System Disorders: Very Rare: Reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia; prolongation of bleeding time and prothrombin time.
Immune System Disorders: Very Rare: As with other antibiotics, severe allergic reactions, including angioneurotic edema, anaphylaxis (see Precautions), serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued (see also Skin and Subcutaneous Tissue Disorders as follows).
Nervous System Disorders: Very Rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Infections and Infestations: Very Rare: Mucocutaneous candidiasis.
Gastrointestinal Disorders: #Common: Diarrhea and nausea. #Uncommon: Vomiting. Very Rare: Antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis); black hairy tongue. Superficial tooth discoloration has been reported in children. Good oral hygiene may help prevent tooth discoloration as it can usually be removed by brushing (for Amoxil 100 mg/mL oral drops, Amoxil 125 mg/5 mL and Amoxil Forte powder for oral suspension only).
Hepatobiliary Disorders: Very Rare: Hepatitis and cholestatic jaundice. A moderate rise in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT). The significance of a rise in AST and/or ALT is unclear.
Skin and Subcutaneous Tissue Disorders: #Common: Skin rash. #Uncommon: Urticaria and pruritus. Very Rare: Skin reactions eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, and acute generalized exanthematous pustulosis (AGEP) (see also Immune System Disorders in previous texts).
Renal and Urinary Tract Disorders: Very Rare: Interstitial nephritis, crystalluria (see Overdosage).
#The incidence of these adverse events was derived from clinical studies involving a total of approximately 6,000 adult and pediatric patients taking amoxicillin.
Drug Interactions
Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with Amoxil/Amoxil Forte may result in increased and prolonged blood levels of amoxicillin.
In common with other antibiotics, Amoxil/Amoxil Forte may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives.
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false-positive readings are common with chemical methods.
In the literature, there are rare cases of increased INR in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or INR should be carefully monitored with the addition or withdrawal of Amoxil/Amoxil Forte.
Caution For Usage
Instructions for Use and Handling: Directions for Making Up the Suspension (Reconstitution): Check cap seal is intact before use. Invert and shake bottle to loosen powder. Fill the bottle with water to just below the mark on bottle label. Invert and shake well, then top up with water to the mark. Invert and shake again. Shake well before taking each dose.
Amoxil 100 mg/mL Oral Drops: To make up to 20 mL reconstituted suspension, loosen the powder by shaking. Add water up to 2/3 of level indicated by the mark on the label. Shake well for 1 min and then let it stand for 1 min. Then add water up to the mark on the label and shake well for 30 sec. Shake well before use.
Amoxil 125 mg/5 mL Powder for Oral Suspension and Amoxil Forte 250 mg/5 mL Powder for Oral Suspension: To make up to 60 mL reconstituted suspension, loosen the powder by shaking. Add water up to 2/3 of level indicated by the mark on the label. Shake well for 1 min and then let it stand for 1 min. Then add water up to the mark on the label and shake well for 30 sec. Shake well before use.
Storage
Store in a dry place at temperatures not exceeding 25°C.
The reconstituted Amoxil 100 mg/mL oral drops, 125 mg/5 mL powder for oral suspension and Amoxil Forte 250 mg/5 mL powder for oral suspension will retain its potency for 7 days when stored at refrigerated temperatures (between 2-8°C).
MIMS Class
Penicillins
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Presentation/Packing
Amoxil: Cap 250 mg (yellow opaque body and red opaque cap, printed with GS LEX in white ink, white to off white powd) x 100's. 500 mg (yellow opaque body and red opaque cap, printed with GS JVL in white ink, white to off white powd) x 100's. Powd for oral susp 125 mg/5 mL x 60 mL. Oral drops 100 mg/mL x 20 mL. Amoxil Forte: Powd for oral susp 250 mg/5 mL x 60 mL.
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