Amoxil (Amoxicillin). Dosage, Side Effects, Interactions
AMOXIL contains amoxicillin, a semi-synthetic antibiotic, an analogue of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms.
Chemically it is (2S,5,R,6,R)-6-[(,R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo -4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate.
The amoxicillin molecular formula is C 16 H 19 N 3 OR 5 S & bull; 3H two O and the molecular weight is 419.45.
Capsules : Each AMOXIL capsule with a royal blue opaque cap and pink opaque body contains 250mg or 500mg of amoxicillin as trihydrate. The cap and body of the 250mg capsule are imprinted with the product names AMOXIL and 250. The cap and body of the 500mg capsule are imprinted with AMOXIL and 500. Inactive Ingredients: D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Magnesium Stearate, and Titanium Dioxide.
Tablets : Each tablet contains 500 mg or 875 mg of amoxicillin as trihydrate. Each film-coated, capsule-shaped, pink tablet is embossed with AMOXIL centered over 500 and 875 respectively. The 875 mg tablet is rated on the back. Inactive Ingredients: Colloidal Silicon Dioxide, Crospovidone, Aluminum Lake FD&C Red #30, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Titanium Dioxide.
Ear, nose and throat infections
AMOXIL is indicated in the treatment of infections due to susceptible (β-lactamase negative ONLY) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp. or Haemophilus influenzae .
AMOXIL is indicated in the treatment of infections due to susceptible (β-lactamase negative ONLY) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .
Infections of the skin and skin structure
AMOXIL is indicated in the treatment of infections due to susceptible (β-lactamase negative ONLY) isolates of Streptococcus spp. (only α- and β-hemolytic isolates), Staphylococcus spp. or E. coli .
Lower respiratory tract infections
AMOXIL is indicated in the treatment of infections due to susceptible (β-lactamase negative ONLY) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp. or H. influenzae .
Helicobacter pylori infection
AMOXIL is indicated in combination with clarithromycin plus lansoprazole as triple therapy for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of duodenal ulcer) to eliminate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. Pylori with lansoprazole
AMOXIL, in combination with lansoprazole delayed-release capsules, is indicated as dual therapy for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of duodenal ulcer) who are either allergic or intolerant to clarithromycin, or who have resistance to clarithromycin is known or suspected. (See the clarithromycin package insert , Microbiology .) Eradication of H. pylori It has been shown to reduce the risk of duodenal ulcer recurrence.
To reduce the development of drug-resistant bacteria and to maintain the effectiveness of AMOXIL (amoxicillin) and other antibacterial medicines, AMOXIL should only be used to treat infections that have been proven or are strongly suspected to be caused by bacteria. If culture and susceptibility information is available, it should be considered when selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns can contribute to empirical selection of therapy.
DOSAGE AND APPLICATION
Dosage for adult and pediatric patients > 3 months old
Treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic or there is evidence of bacterial eradication. It is recommended to treat any infection caused by Streptococcus pyogenes for at least 10 days to prevent the onset of acute rheumatic fever. Some infections may require therapy for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after the end of therapy.
Table 1: Dosing recommendations for adult and pediatric patients > 3 months old
|infection||heaviness too||Usual adult dose||Usual dose for children > 3 months b|
|Throat / Nose / Throat Skin / Skin Texture Urogenital Tract||Mild / moderate||500 mg every 12 hours or 250 mg every 8 hours||25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours|
|Difficult||875 mg every 12 hours or 500 mg every 8 hours||45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours|
|Lower Airways||Mild / Medium or Heavy||875 mg every 12 hours or 500 mg every 8 hours||45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours|
|The dosing for infections caused by bacteria that are moderately susceptible to amoxicillin should follow the recommendations for severe infections.|
b The child dose is intended for people weighing less than 40 kg. Children weighing 40 kg or more should be dosed according to adult recommendations.
Dosing in newborns and infants aged & le; 12 weeks (≤ 3 months)
Treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic or there is evidence of bacterial eradication. It is recommended to treat any infection caused by Streptococcus pyogenes for at least 10 days to prevent the onset of acute rheumatic fever. Due to the incompletely developed renal function affecting the elimination of amoxicillin in this age group, the recommended upper dose of AMOXIL is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with renal impairment.
The recommended oral dose for adults is 1 gram of AMOXIL, 500 mg of clarithromycin and 30 mg of lansoprazole administered twice daily (every 12 hours) for 14 days.
The recommended oral dose for adults is 1 gram of AMOXIL and 30 mg of lansoprazole, three times a day (every 8 hours) for 14 days. Please see full prescribing information for clarithromycin and lansoprazole.
Dosage in renal dysfunction
- Patients with renal impairment generally do not require a dose reduction unless the impairment is severe.
- Severely disabled patients with a glomerular filtration rate of <30 mL/min. should not receive an 875 mg dose.
- Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours depending on the severity of the infection.
- Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours depending on the severity of the infection.
- Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. You should be given an extra dose both during and at the end of dialysis.
Instructions for mixing the oral suspension
Tap the bottle until all the powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to a wet powder. Add the rest of the water and shake vigorously again.
Table 2: Amount of water to mix the oral suspension
|Strength||bottle size||Amount of water needed for reconstitution|
|Oral suspension 125 mg / 5 ml||80ml||62ml|
|Oral suspension 200 mg / 5 ml||50ml||39ml|
|Oral suspension 250 mg / 5 ml||80ml||59ml|
|Oral suspension 400 mg / 5 ml||50ml||36ml|
After reconstitution, the required amount of suspension to be swallowed should be applied directly to the child’s tongue. Alternative methods of administration include adding the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold beverages. These preparations should then be made immediately.
NOTE: PROTECT THE ORAL SPRING BEFORE USE. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable but not required.
The following is explained in more detail in other sections of the label:
- Anaphylactic reactions
Experience in clinical trials
Because clinical trials are conducted under a wide variety of conditions, the adverse reaction rates observed in clinical trials of one drug cannot be directly compared to rates observed in clinical trials of another drug and may not reflect rates observed in practice.
The most common adverse reactions (>1%) observed in clinical trials with AMOXIL capsules, tablets or oral suspension were diarrhoea, rash, vomiting and nausea.
Triple therapy : The most commonly reported adverse events in patients receiving triple therapy (amoxicillin/clarithromycin/lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).
Dual therapy : The most commonly reported adverse events in patients receiving dual therapy with amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information about side effects with clarithromycin or lansoprazole, see the side effects section of the package leaflet.
post marketing or other experiences
In addition to adverse events reported from clinical trials, the following events have been identified during post-marketing use of penicillins. Because they are reported voluntarily from a population of unknown size, no estimates of frequency can be made. These events were selected for inclusion based on a combination of severity, frequency of reporting, or potential causal relationship to AMOXIL.
- Infections and infestations : Mucocutaneous candidiasis.
- Gastrointestinal : Black-haired tongue and hemorrhagic/pseudomembranous colitis.
Symptoms of pseudomembranous colitis may appear during or after antibacterial treatment
- Hypersensitivity reactions : anaphylaxis. Serum sickness-like reactions, erythematous maculopapular rash, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.
- Liver : A moderate increase in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice , hepatic cholestasis and acute cytolytic hepatitis have been reported.
- Kidneys : Crystalluria has been reported.
- Hemic and Lymphatic Systems : Anemia, including haemolytic anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are considered to be hypersensitivity phenomena.
- Central Nervous System : Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported
- Miscellaneous : Tooth discoloration (brown, yellow or gray tint) has been reported. Most reports have occurred in pediatric patients. In most cases, brushing or cleaning your teeth reduced or eliminated the discoloration.
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