AMOCLAV Co-Amoxiclav 312.5mg / 5mL Powder for Oral Suspension 60mL Tutti-Fruiti
RXDRUG-DRP-1614-04
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Features
Brand
Amoclav
Full Details
Dosage Strength
312.5mg per 5ml
Drug Ingredients
- Co-Amoxiclav
Drug Packaging
Powder for Oral Suspension 60ml
Generic Name
Co-Amoxiclav
Drug Flavor
Tutti Frutti
Dosage Form
Powder for Oral Suspension
Registration Number
DRP-1614-04
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For the treatment of the following infections caused by susceptible microorganisms: Upper respiratory tract infections (including ENT infections): Tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections: Acute and chronic bronchitis, pneumonia, lung abscess.
Genito-urinary tract and abdominal infections: Cystitis, urethritis, pyelonephritis, female genital infections, septic abortion, pelvic or puerperal sepsis, intra-abdominal sepsis.
Skin and skin structure infections: Furuncle and abscess, cellulitis, wound infections.
Bone and joint infections: Osteomyelitis.
Dental infection: Dentoalveolar abscess.
Other infections: Septicemia, peritonitis, post-surgical infections.
Step down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral Co-amoxiclav.
Lower respiratory tract infections: Acute and chronic bronchitis, pneumonia, lung abscess.
Genito-urinary tract and abdominal infections: Cystitis, urethritis, pyelonephritis, female genital infections, septic abortion, pelvic or puerperal sepsis, intra-abdominal sepsis.
Skin and skin structure infections: Furuncle and abscess, cellulitis, wound infections.
Bone and joint infections: Osteomyelitis.
Dental infection: Dentoalveolar abscess.
Other infections: Septicemia, peritonitis, post-surgical infections.
Step down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral Co-amoxiclav.
Dosage/Direction for Use
Administer Co-amoxiclav at the start of a meal to minimize potential gastrointestinal intolerance and to optimize absorption.
Drink plenty of water to ensure proper state of hydration and adequate urinary output.
Treatment should not exceed 14 days without first re-evaluating the patient.
Usual Oral Dosage in Children up to 12 years old: Co-amoxiclav is dosed based on the amoxicillin component and is given in divided doses every 12 hours.
Children below 1 year old: 30 mg/kg body weight/day.
For Mild to Moderate Infections: 25 mg/kg body weight/day.
For Severe Infections: 45 mg/kg body weight/day. (See Tables 3 and 4.)
Drink plenty of water to ensure proper state of hydration and adequate urinary output.
Treatment should not exceed 14 days without first re-evaluating the patient.
Usual Oral Dosage in Children up to 12 years old: Co-amoxiclav is dosed based on the amoxicillin component and is given in divided doses every 12 hours.
Children below 1 year old: 30 mg/kg body weight/day.
For Mild to Moderate Infections: 25 mg/kg body weight/day.
For Severe Infections: 45 mg/kg body weight/day. (See Tables 3 and 4.)
Dosage in Children up to 12 years old on Hemodialysis: 15 mg/kg body weight once daily. Patients should receive an additional dose of 15 mg/kg body weight both during and at the end of dialysis.
Dosage in Children up to 12 years old with Hepatic Impairment: Dose with caution and monitor hepatic function regularly.
DIRECTIONS FOR RECONSTITUTION: (See Table 5.)
Dosage in Children up to 12 years old with Hepatic Impairment: Dose with caution and monitor hepatic function regularly.
DIRECTIONS FOR RECONSTITUTION: (See Table 5.)
Overdosage
Clinical features of overdosage with Co-amoxiclav may include gastrointestinal symptoms, fluid and electrolyte imbalance. Amoxicillin crystalluria, leading to renal failure, has also been observed in some cases.
Symptomatic treatment is recommended. Co-amoxiclav can be removed by hemodialysis.
Symptomatic treatment is recommended. Co-amoxiclav can be removed by hemodialysis.
Administration
May be taken with or without food: Preferably taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications
Known hypersensitivity to penicillin or any ingredient in this product.
Cross-sensitivity with other β-lactam antibiotics, e.g., cephalosporins.
Patients with a previous history of jaundice/liver impairment associated with Co-amoxiclav or penicillin.
Patients with glandular fever or lymphatic lymphoma should not be given Co-amoxiclav as the amoxicillin component is likely to cause a maculopapular rash.
Cross-sensitivity with other β-lactam antibiotics, e.g., cephalosporins.
Patients with a previous history of jaundice/liver impairment associated with Co-amoxiclav or penicillin.
Patients with glandular fever or lymphatic lymphoma should not be given Co-amoxiclav as the amoxicillin component is likely to cause a maculopapular rash.
Special Precautions
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Careful inquiry should be made concerning previous hypersensitivity to penicillins, cephalosporins, or other drugs before initiating therapy with Co-amoxiclav. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be instituted.
Clostridium difficile: associated diarrhea and colitis have been reported with nearly all antibacterial agents, and may range in severity from mild to life-threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
Since hepatic toxicity has been associated with Co-amoxiclav therapy, the drug should be used with caution in patients with evidence of hepatic dysfunction.
In patients with renal impairment, the dose of Co-amoxiclav should be adjusted based on the degree of impairment (see Dosage & Administration).
During administration of high doses of amoxicillin, it is recommended to maintain adequate fluid intake and urinary output in order to reduce the possibility of crystalluria associated with amoxicillin therapy.
Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly with Co-amoxiclav since prolongation of prothrombin time has been reported rarely in patients receiving Co-amoxiclav.
Although Co-amoxiclav has a low toxicity profile, the renal, hepatic, and hematopoietic status of patients undergoing prolonged treatment with the drug should be evaluated periodically.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Use in Pregnancy: (Pregnancy Category B). There are no adequate or controlled studies in pregnant women and safe use in pregnancy has not been definitely established. However, oral Co-amoxiclav has been administered to pregnant women, particularly in the treatment of urinary tract infections, without evidence of adverse effects to the fetus.
Use in Lactation: Since Co-amoxiclav is distributed in human milk, use with caution when breastfeeding.
Use in children: Children weighing over 40 kg should be dosed based on recommended dosing in adult patients. The safety and efficacy of Co-amoxiclav tablets in children weighing less than 40 kg have not been established.
Use in elderly patients: Since elderly patients have increased risk of renal impairment, dose adjustment and renal function monitoring may be necessary.
Clostridium difficile: associated diarrhea and colitis have been reported with nearly all antibacterial agents, and may range in severity from mild to life-threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
Since hepatic toxicity has been associated with Co-amoxiclav therapy, the drug should be used with caution in patients with evidence of hepatic dysfunction.
In patients with renal impairment, the dose of Co-amoxiclav should be adjusted based on the degree of impairment (see Dosage & Administration).
During administration of high doses of amoxicillin, it is recommended to maintain adequate fluid intake and urinary output in order to reduce the possibility of crystalluria associated with amoxicillin therapy.
Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly with Co-amoxiclav since prolongation of prothrombin time has been reported rarely in patients receiving Co-amoxiclav.
Although Co-amoxiclav has a low toxicity profile, the renal, hepatic, and hematopoietic status of patients undergoing prolonged treatment with the drug should be evaluated periodically.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Use in Pregnancy: (Pregnancy Category B). There are no adequate or controlled studies in pregnant women and safe use in pregnancy has not been definitely established. However, oral Co-amoxiclav has been administered to pregnant women, particularly in the treatment of urinary tract infections, without evidence of adverse effects to the fetus.
Use in Lactation: Since Co-amoxiclav is distributed in human milk, use with caution when breastfeeding.
Use in children: Children weighing over 40 kg should be dosed based on recommended dosing in adult patients. The safety and efficacy of Co-amoxiclav tablets in children weighing less than 40 kg have not been established.
Use in elderly patients: Since elderly patients have increased risk of renal impairment, dose adjustment and renal function monitoring may be necessary.
Use In Pregnancy & Lactation
Pregnancy: (Pregnancy Category B). There are no adequate or controlled studies in pregnant women and safe use in pregnancy has not been definitely established. However, oral Co-amoxiclav has been administered to pregnant women, particularly in the treatment of urinary tract infections, without evidence of adverse effects to the fetus.
Lactation: Since Co-amoxiclav is distributed in human milk, use with caution when breastfeeding.
Lactation: Since Co-amoxiclav is distributed in human milk, use with caution when breastfeeding.
Adverse Reactions
Dermatologic and Hypersensitivity Reactions: Angioneurotic edema, anaphylaxis, serum sickness-like syndrome, fever, hypersensitivity vasculitis, skin rash, pruritus, urticaria, angioedema, erythema multiforme (rarely Stevens-Johnson syndrome), toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP).
Gastrointestinal Effects: Abdominal discomfort, anorexia, and flatulence, dyspepsia, diarrhea/loose stools, nausea, vomiting, indigestion, Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis), gastritis, stomatitis, glossitis, black "hairy" tongue, mucocutaneous candidiasis, enterocolitis.
Hematologic Effects: Reversible leukopenia (including neutropenia) and thrombocytopenia, thrombocytopenic purpura, reversible agranulocytosis, anemia (including hemolytic anemia), slight thrombocytosis, eosinophilia, abnormal platelet aggregation, prolonged bleeding time and prothrombin time.
Nervous System Effects: Dizziness, headache, reversible hyperactivity and convulsions particularly in patients with impaired renal functions or those receiving high doses, agitation, anxiety, behavioral changes, confusion, insomnia.
Hepatic Effects: A moderate rise in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), serum bilirubin and/or alkaline phosphatase, hepatitis, cholestatic jaundice, acute hepatic dysfunction.
Renal and Genitourinary Effects: Acute interstitial nephritis, crystalluria, vaginal itching, soreness and discharge.
Other Effects: Superficial tooth discoloration (brown, yellow, or gray staining).
Gastrointestinal Effects: Abdominal discomfort, anorexia, and flatulence, dyspepsia, diarrhea/loose stools, nausea, vomiting, indigestion, Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis), gastritis, stomatitis, glossitis, black "hairy" tongue, mucocutaneous candidiasis, enterocolitis.
Hematologic Effects: Reversible leukopenia (including neutropenia) and thrombocytopenia, thrombocytopenic purpura, reversible agranulocytosis, anemia (including hemolytic anemia), slight thrombocytosis, eosinophilia, abnormal platelet aggregation, prolonged bleeding time and prothrombin time.
Nervous System Effects: Dizziness, headache, reversible hyperactivity and convulsions particularly in patients with impaired renal functions or those receiving high doses, agitation, anxiety, behavioral changes, confusion, insomnia.
Hepatic Effects: A moderate rise in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), serum bilirubin and/or alkaline phosphatase, hepatitis, cholestatic jaundice, acute hepatic dysfunction.
Renal and Genitourinary Effects: Acute interstitial nephritis, crystalluria, vaginal itching, soreness and discharge.
Other Effects: Superficial tooth discoloration (brown, yellow, or gray staining).
Drug Interactions
(See Table 6.)
Interference with Laboratory Tests: High urine concentrations of ampicillin may result in false-positive reactions when testing for urinary glucose using cupric sulfate (e.g., Clinitest, Benedict's Solution). Since this effect may also occur with amoxicillin, glucose oxidase methods (e.g., Clinistix) should be used when urinary glucose determinations are indicated in patients receiving Co-amoxiclav.
Although not reported to date with Co-amoxiclav, positive direct antiglobulin (Coombs') test results have been reported in patients who received ticarcillin and clavulanic acid and appear to be caused by clavulanic acid. This reaction may interfere with hematologic studies or transfusion cross-matching procedures and therefore should be considered in patients receiving Co-amoxiclav.
Although not reported to date with Co-amoxiclav, positive direct antiglobulin (Coombs') test results have been reported in patients who received ticarcillin and clavulanic acid and appear to be caused by clavulanic acid. This reaction may interfere with hematologic studies or transfusion cross-matching procedures and therefore should be considered in patients receiving Co-amoxiclav.
Storage
Store in a dry place at temperatures not exceeding 25°C.
Action
Pharmacology: Pharmacodynamics: Amoxicillin (an aminopenicillin antibiotic) and potassium clavulanate (a β-lactamase inhibitor) [Co-amoxiclav] is usually bactericidal in action. Concurrent administration of clavulanic acid does not alter the mechanism of action of amoxicillin. However, because clavulanic acid has a high affinity for and binds to certain β-lactamases that generally inactivate amoxicillin by hydrolyzing its β-lactam ring, concurrent administration of the drug with amoxicillin results in synergistic bactericidal effect which expands amoxicillin's spectrum of activity against many strains of β-lactamase-producing bacteria resistant to amoxicillin alone.
Antimicrobial Spectrum of Activity: In vitro and clinical studies have demonstrated the susceptibility of the following microorganisms to Co-amoxiclav: (See Table 1.)
Antimicrobial Spectrum of Activity: In vitro and clinical studies have demonstrated the susceptibility of the following microorganisms to Co-amoxiclav: (See Table 1.)
Although most strains of Enterobacter species are resistant in vitro, clinical efficacy has been demonstrated with Co-amoxiclav in urinary tract infections caused by these organisms.
Co-amoxiclav has demonstrated in vitro activity against most strains of the following microorganisms; however, clinical significance is unknown: (See Table 2.)
Co-amoxiclav has demonstrated in vitro activity against most strains of the following microorganisms; however, clinical significance is unknown: (See Table 2.)
Pharmacokinetics: Co-amoxiclav is stable in the presence of acidic gastric secretions and is well absorbed following oral administration. Peak serum concentrations of amoxicillin and of clavulanic acid are generally attained within 1 to 2.5 hours after oral administration.
In a study in children 2 to 5 years old with urinary tract infections who received a single oral dose of 125 mg of amoxicillin and 31.75 mg of clavulanic acid suspension, the mean serum concentrations (Cmax) of amoxicillin were 9.4, 9.7, and 6.5 µg/mL and of clavulanic acid were 2.1, 4.4, and 2.5 µg/mL at 30, 60, and 90 minutes, respectively, after the dose.
In a study in fasting children who received a single amoxicillin dose of 35 mg/kg given as Co-amoxiclav oral suspension, concentrations of amoxicillin and of clavulanic acid in middle ear effusions averaged 3 and 0.5 µg/mL, respectively, 2 hours after the dose.
When a single 5 mL oral dose of Co-amoxiclav 457 mg/5 mL suspension was administered in healthy male and female subjects (fasted state), pharmacokinetic parameters reached were: Cmax 5.789 µg/mL, Tmax 1.164 hours, AUC0-t 12.21 µg/mL•hr and AUC0-∞12.855 µg/mL•hr for amoxicillin, and 1.379 µg/mL, 1.039 hours, 2.492 µg/mL•hr and 2.727 µg/mL•hr, respectively, for clavulanic acid.
Therapeutic concentrations of both amoxicillin and clavulanic acid have been found in the gall bladder, abdominal tissue, skin, fat, and muscle tissues; the synovial and peritoneal fluids, bile and pus. Animal studies show no evidence that either component may accumulate in any organ.
Neither amoxicillin nor clavulanic acid is highly protein-bound; studies show that about 13% to 25% of total plasma drug concentration of each compound is protein-bound.
Both Co-amoxiclav components readily cross the placenta. Only small amounts of amoxicillin and clavulanic acid are distributed in human milk.
Serum concentrations of amoxicillin and clavulanic acid both decline in a biphasic manner and their half-lives are similar. Approximately 50 to 73% of amoxicillin and 25 to 45% of clavulanic acid are excreted unchanged in urine within 6 to 8 hours following oral administration of a single dose of Co-amoxiclav in adults with normal renal function.
In a study in children 2 to 15 years old, the elimination half-lives of amoxicillin and clavulanic acid averaged 1.2 and 0.8 hours, respectively.
Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of Co-amoxiclav has not been evaluated in long-term animal studies.
The mutagenic potential of the drug has been investigated in vitro using the Ames test, a human lymphocyte cytogenic assay, a yeast test and a mouse lymphoma forward mutation assay, and in vivo using mouse micronucleus tests and a dominant lethal test. Results were negative for all tests except for the in vitro mouse lymphoma assay where weak activity was found at very high, cytotoxic concentrations.
Oral doses of Co-amoxiclav up to 1,200 mg/kg/day (5.7 times the maximum human dose) were found to have no effect on fertility and reproductive performance in rats dosed with a 2:1 ratio formulation of amoxicillin: clavulanic acid.
In a study in children 2 to 5 years old with urinary tract infections who received a single oral dose of 125 mg of amoxicillin and 31.75 mg of clavulanic acid suspension, the mean serum concentrations (Cmax) of amoxicillin were 9.4, 9.7, and 6.5 µg/mL and of clavulanic acid were 2.1, 4.4, and 2.5 µg/mL at 30, 60, and 90 minutes, respectively, after the dose.
In a study in fasting children who received a single amoxicillin dose of 35 mg/kg given as Co-amoxiclav oral suspension, concentrations of amoxicillin and of clavulanic acid in middle ear effusions averaged 3 and 0.5 µg/mL, respectively, 2 hours after the dose.
When a single 5 mL oral dose of Co-amoxiclav 457 mg/5 mL suspension was administered in healthy male and female subjects (fasted state), pharmacokinetic parameters reached were: Cmax 5.789 µg/mL, Tmax 1.164 hours, AUC0-t 12.21 µg/mL•hr and AUC0-∞12.855 µg/mL•hr for amoxicillin, and 1.379 µg/mL, 1.039 hours, 2.492 µg/mL•hr and 2.727 µg/mL•hr, respectively, for clavulanic acid.
Therapeutic concentrations of both amoxicillin and clavulanic acid have been found in the gall bladder, abdominal tissue, skin, fat, and muscle tissues; the synovial and peritoneal fluids, bile and pus. Animal studies show no evidence that either component may accumulate in any organ.
Neither amoxicillin nor clavulanic acid is highly protein-bound; studies show that about 13% to 25% of total plasma drug concentration of each compound is protein-bound.
Both Co-amoxiclav components readily cross the placenta. Only small amounts of amoxicillin and clavulanic acid are distributed in human milk.
Serum concentrations of amoxicillin and clavulanic acid both decline in a biphasic manner and their half-lives are similar. Approximately 50 to 73% of amoxicillin and 25 to 45% of clavulanic acid are excreted unchanged in urine within 6 to 8 hours following oral administration of a single dose of Co-amoxiclav in adults with normal renal function.
In a study in children 2 to 15 years old, the elimination half-lives of amoxicillin and clavulanic acid averaged 1.2 and 0.8 hours, respectively.
Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of Co-amoxiclav has not been evaluated in long-term animal studies.
The mutagenic potential of the drug has been investigated in vitro using the Ames test, a human lymphocyte cytogenic assay, a yeast test and a mouse lymphoma forward mutation assay, and in vivo using mouse micronucleus tests and a dominant lethal test. Results were negative for all tests except for the in vitro mouse lymphoma assay where weak activity was found at very high, cytotoxic concentrations.
Oral doses of Co-amoxiclav up to 1,200 mg/kg/day (5.7 times the maximum human dose) were found to have no effect on fertility and reproductive performance in rats dosed with a 2:1 ratio formulation of amoxicillin: clavulanic acid.
MedsGo Class
Penicillins
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