What is Amoxiclav Forte?
Amoxicillin (Amoxiclav Forte) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Amoxiclav Forte) fights bacteria in the body.
Clavulanate potassium is a form of Clavulanic Acid (Amoxiclav Forte), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.
The combination of Amoxicillin (Amoxiclav Forte) 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 (Amoxiclav Forte) and clavulanate potassium may also be used for purposes not listed in this medication guide.
Amoxiclav Forte indications
Amoxiclav Forte-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 (Amoxiclav Forte). Amoxiclav Forte-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 Amoxiclav Forte-600 and other antibacterial drugs, Amoxiclav Forte-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.
Amoxiclav Forte description
Each film-coated tablet contains Amoxicillin (Amoxiclav Forte) trihydrate equivalent to Amoxicillin (Amoxiclav Forte) 500 mg, and potassium clavulanate equivalent to Clavulanic Acid (Amoxiclav Forte) 125 mg, respectively.
Each vial contains Amoxicillin (Amoxiclav Forte) sodium equivalent to Amoxicillin (Amoxiclav Forte) 1000 mg and clavulanate potassium equivalent to Clavulanic Acid (Amoxiclav Forte) 200 mg, respectively.
Amoxiclav Forte 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.
Amoxiclav Forte is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Amoxiclav Forte) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic Acid (Amoxiclav Forte)). Amoxicillin (Amoxiclav Forte) 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 (Amoxiclav Forte) 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 (Amoxiclav Forte): Clavulanic Acid (Amoxiclav Forte) 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 (Amoxiclav Forte) 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.
Amoxiclav Forte dosage
Tablet: Tablets should be taken immediately before a meal.
General Information: For infections caused by Amoxicillin (Amoxiclav Forte)-sensitive organisms, the dosage is that approved for Amoxicillin (Amoxiclav Forte) as the Clavulanic Acid (Amoxiclav Forte) component does not contribute to the therapeutic effect.
Adults: 1 or 2 Amoxiclav Forte 375 mg tab 8 hourly or 1 Amoxiclav Forte 625 mg tab 8 hourly for more severe infections and infections of the respiratory tract.
For Amoxicillin (Amoxiclav Forte)-resistant organisms, the dosage of Amoxiclav Forte tablets are as follows:
Since both Amoxiclav Forte 375 mg and 625 mg contain the same amount of Clavulanic Acid (Amoxiclav Forte) (125 mg, as the potassium salt), 2 Amoxiclav Forte 375 mg are not equivalent to 1 Amoxiclav Forte 625 mg. Therefore, 2 Amoxiclav Forte 375 mg should not be substituted for 1 Amoxiclav Forte 625 mg for treatment of more severe infections.
Renal Failure: Both Amoxicillin (Amoxiclav Forte) and Clavulanic Acid (Amoxiclav Forte) 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 (Amoxiclav Forte) and Clavulanic Acid (Amoxiclav Forte) 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 (Amoxiclav Forte), 1 part Clavulanic Acid (Amoxiclav Forte) preparations (which corresponds to a daily dosage of the equivalent of Amoxicillin (Amoxiclav Forte) 20-40 mg/kg and Clavulanic Acid (Amoxiclav Forte) 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: Amoxiclav Forte may be administered by the IV routes.
Amoxiclav Forte 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.
Amoxiclav Forte interactions
See also:
What other drugs will affect Amoxiclav Forte?
Probenecid decreases the renal excretion of Amoxicillin (Amoxiclav Forte). Concurrent use with Amoxiclav Forte may result in increased and prolonged blood levels of Amoxicillin (Amoxiclav Forte).
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.
Amoxiclav Forte should not be co-administrated with disulfiram.
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Amoxiclav Forte. Thus, Amoxiclav Forte should be used with care in patients on anticoagulation therapy.
Amoxiclav Forte may reduce the effect of oral contraceptives and the caution should be given to patients.
Laboratory Test Interactions: Amoxiclav Forte 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.
Amoxiclav Forte side effects
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What are the possible side effects of Amoxiclav Forte?
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 (Amoxiclav Forte) is required, consideration should be given to administering the additional Amoxicillin (Amoxiclav Forte) separately.
Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Amoxiclav Forte) and Clavulanic Acid (Amoxiclav Forte); the Clavulanic Acid (Amoxiclav Forte) component has been implicated. The events associated with Amoxiclav Forte 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 Amoxiclav Forte, the significance of these findings is unknown.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Amoxiclav Forte.
Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Amoxiclav Forte at the start of a meal.
Amoxicillin (Amoxiclav Forte) 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, Amoxiclav Forte 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 Amoxiclav Forte. Prolongation of bleeding time and prothrombin time have also been reported less frequently.
Amoxicillin (Amoxiclav Forte) alone or in combination with Clavulanic Acid (Amoxiclav Forte) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Amoxiclav Forte)-Clavulanic Acid (Amoxiclav Forte)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Amoxiclav Forte) 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.
Amoxiclav Forte contraindications
Hypersensitivity to the Amoxicillin (Amoxiclav Forte)/clavulanate potassium to any of the penicillins or to any of the excipients of Amoxiclav Forte.
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 Amoxiclav Forte.
Active ingredient matches for Amoxiclav Forte:
List of Amoxiclav Forte substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Amoxiclav-VMD 50mg voor honden en katten (Netherlands) | |
| AmoxiClavulan (Austria) | |
| AmoxiClavulan 1A Pharma (Austria) | |
| Amoxiclin-CL (Peru) | |
| Amoxiclin-CL 12h (Peru) | |
| Amoxicomp (Austria) | |
| Amoxicomp Genericon (Austria) | |
| Amoxicomp Genericon 1g (Austria) | |
| Amoxicure-C (India) | |
| Amoxicure-C Amoxicillin trihydrate 500 mg, Clavulanate potassium 125 mg. TAB / 6 (Balsons (Best Cure)) | $ 1.08 |
| 6's (Balsons (Best Cure)) | $ 1.08 |
| AMOXICURE-C tab 6's (Balsons (Best Cure)) | $ 1.08 |
| Amoxidal Plus (Paraguay, Uruguay) | |
| Amoxidin CL (Peru) | |
| Amoxidura plus (Germany) | |
| Tablet, Film-Coated; Oral; Amoxicillin Trihydrate 500 mg; Clavulanic Acid / Clavulanate Potassium 125 mg (Merck dura) | |
| Tablet, Film-Coated; Oral; Amoxicillin Trihydrate 875 mg; Clavulanic Acid / Clavulanate Potassium 125 mg (Merck dura) | |
| Amoxigard (Bulgaria) | |
| Amoxigrand Compuesto (Argentina) | |
| Amoxiland Plus (Paraguay) | |
| Amoxilanic (Egypt) | |
| Amoxilanico (Peru) | |
| Amoxilanico Duo (Peru) | |
| Amoxilite Plus (Pakistan) | |
| Amoxillat-Clav (Germany) | |
| Tablet, Film-Coated; Oral; Amoxicillin Trihydrate 500 mg; Clavulanic Acid / Clavulanate Potassium 125 mg (Azupharma) | |
| Tablet, Film-Coated; Oral; Amoxicillin Trihydrate 875 mg; Clavulanic Acid / Clavulanate Potassium 125 mg (Azupharma) | |
| AMOXIMENTIN | |
| AMOXIMENTIN 500MG/125MG TABLET 1 strip / 6 tablets each (PCI Pharmaceuticals) | $ 0.83 |
| Amoximentin 500 mg/125 mg Tablet (PCI Pharmaceuticals) | $ 0.14 |
| Amoxin Comp (Finland) | |
| Amoxiplus (Romania) | |
| Amoxiplus 1.2g (Serbia) | |
| Amoxiplus ratiopharm (Austria) | |
| Amoxiplus ratiopharm 156,25 mg/5 ml (Austria) | |
| Amoxiplus ratiopharm 1g (Austria) | |
| Amoxiplus ratiopharm 625 mg (Austria) | |
| Amoxiplus ratiopharm forte (Austria) | |
| Amoxiplus ratiopharm forte 312,5 mg/5 ml (Austria) | |
| Amoxistad plus (Austria) | |
| Amoxistad plus 875 mg/125 mg (Austria) | |
| Amoxitenk (Argentina) | |
| Amoxitenk Plus (Argentina) | |
| Amoxitenk Plus Pediátrica (Argentina) | |
| AMOXRAG (India) | |
| 1's (Auriga) | $ 1.45 |
| 6's (Auriga) | $ 2.17 |
See 7042 substitutes for Amoxiclav Forte | |
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
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Information checked by Dr. Sachin Kumar, MD Pharmacology
