AMOXIL Amoxicillin 100mg / mL Powder for Suspension Oral Drops 20mL

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.

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.

 

Overdosage

May be taken with or without food: May be taken w/ meals for better absorption & to reduce GI discomfort.

 

Amoxicillin (Amoxil) is a penicillin and should not be given to patients w/ history of hypersensitivity to β-lactam antibiotics (eg, penicillins, cephalosporins).

 

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 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.

 

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

Storage

Action

Penicillins