Globantin

Globantin

amoxicillin + clavulanic acid

Manufacturer:

Zhuhai United

Distributor:

Global Pharmatrade
Full Prescribing Info
Contents
Co-amoxiclav (amoxicillin and clavulanic acid).
Description
Each vial contains: Amoxicillin (as sodium) 500 mg, Clavulanate Potassium 100 mg.
Each vial contains: Amoxicillin (as sodium) 1 g, Clavulanate Potassium 200 mg.
Each Clavulanate Potassium & Amoxicillin Injection 0.6 g vial contains 0.5 mmol of potassium and 1.4 mmol of sodium.
Each Clavulanate Potassium & Amoxicillin Injection 1.2 g vial contains 1.0 mmol of potassium and 2.8 mmol of sodium.
Action
Pharmacology: Pharmacokinetics: Amoxicillin is given by injection as the sodium salt and, in general, similar concentration are achieved with intramuscular as with oral administration. About 20% is bound to plasma proteins in the circulation and plasma half-lives of 1 to 5 hours have been reported. The half-life maybe in longer in neonates and the elderly; in renal failure the half-life may be 7 to 20 hours. Amoxicillin is widely distributed at varying concentrations in body tissues and fluids. It crosses the placenta; small amounts are distributed into breast milk. Little amoxicillin passes into the CSF unless the meninges are inflamed.
Amoxicillin is metabolized to a limited extent to penicilloic acid which is excreted in the urine. About 60% of an oral dose of amoxicillin is excreted unchanged in the urine in 6 hours by glomerular filtration and tubular secretion. Urinary concentrations above 300 μg per mL have been reported after a dose of 250 mg. Probenecid retards renal excretion. Amoxicillin is removed by haemodialysis. High concentrations have been reported in bile; some may be excreted in the feces.
Bacteriology: Spectrum: Clavulanate Potassium and Amoxicillin is the group name for formulations containing 2, 4, and 5 parts of a broad spectrum penicillin, Amoxicillin and 1 part of potassium clavulanate. Potassium clavulanate has been shown in vitro to be an irreversible inhibitor of β-lactamase produced by: Staphylococcus aureus, Escherichia, Klebsiella pneumonia, Proteus mirabilis, Proteus vulgaris, Haemophilus influenzae, Neisseria gonorrhea and Bacteroides fragilis. Potassium clavulanate does not inactivate the chromosomally mediated (Sykes Type 1 Cephalosporinase) β-lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, Indole positive Proteus, Providencia species and Serratia marcescens. In vitro the formulation showed synergism against Amoxicillin-resistant organisms, with no evidence of antagonism and the activity was not reduced in the presence of serum.
(In vitro activity does not necessarily imply in vivo efficacy.)
Bactericidal action: The Amoxicillin component of the formulations exert a bactericidal action against many strains of Gram-positive and Gram-negative organisms. The clavulanic acid component has very little bactericidal action. It does however, by inactivation of susceptible β-lactamases, protect Amoxicillin from degradation by a large number of β-lactometers enzymes produced by penicillin resistant strains of organisms.
Absorption: The pharmacokinetics of Amoxicillin and clavulanic acid are closely allied. Doubling the dose virtually doubles the peak serum level.
Indications/Uses
Clavulanate Potassium and Amoxicillin formulations are indicated for the treatment of infections caused by Amoxicillin resistant producing β-lactamases sensitive to clavulanic acid; Upper respiratory tract, such as sinusitis, otitis media, tonsillitis.
Lower respiratory tract, such as bronchitis (caused by Amoxicillin resistant β-lactamases producing Escherichia coli, Haemophilus influenzae and Haemophilus para-influenzae) pneumonia. Urinary tract infections, such as cystitis, urethritis, pyelonephritis. Skin and soft tissues. Clavulanate Potassium and Amoxicillin formulations will also be effective in the treatment of infections caused by Amoxicillin sensitive organisms at the appropriate Amoxicillin dosage since in this situation the clavulanic acid component does not contribute to the therapeutic effect.
Dosage/Direction for Use
Clavulanate Potassium and Amoxicillin 1.2 g powder for injection can be reconstituted by dissolving 20 mL Water for Injection BP. When a diluent is added a transient ink coloration or slight opalescence will be observed where after, a pale yellow fluid. For intravenous infusion, the reconstituted vial should be further diluted with the desired volume of a suitable infusion fluid. (See Table 1.)

Click on icon to see table/diagram/image

Clavulanate Potassium and Amoxicillin vials should not be reconstituted or mixed with: Dextrose solution, Sodium bicarbonate solution for injection, Protein hydrolysates or other proteinaceous fluids, Blood or plasma, Intravenous lipids.
However, the reconstituted solution may be injected into the drip tubing of infusion fluids containing glucose, bicarbonate and dextran over a period of 3-4 minutes.
Note: Clavulanate Potassium and Amoxicillin vials are not suitable for intramuscular or subcutaneous administration. The reconstituted vials can be administered intravenously by injection (2 minutes) or slow intravenous infusion (30 minutes).
DOSAGES: Adult (Intravenous): For severe infections of the respiratory tract, urinary tract and skin and soft tissue requiring parenteral therapy initially 1 Clavulanate Potassium and Amoxicillin 1.2 g vial containing the equivalent of 1000 mg of AMOXICILLIN and 200 mg clavulanic acid can be administered intravenously 6 to 8 hourly by intravenous injection (2 minutes) or intravenous infusion (30 minutes) until condition settles followed by oral therapy Clavulanate Potassium and Amoxicillin 375 tablets at the recommended dose. If no response has occurred within 48 hours therapy must be reviewed.
Intravenous treatment with Clavulanate Potassium and Amoxicillin should not extend beyond 10 days without review and the total daily administration of clavulanic acid should not exceed 800 mg. Treatment can be continued with Clavulanate Potassium and Amoxicillin 375 tablets orally where appropriate after a satisfactory therapeutic response has been obtained.
Adult: See Table 2.

Click on icon to see table/diagram/image

Children: Insufficient evidence exists at present to recommend an intravenous dosage in children.
Or as prescribed by the physician.
Special Precautions
Clavulanate Potassium and Amoxicillin should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to Amoxicillin induced skin rashes. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the agent should be discontinued and/or appropriate therapy instituted.
Impaired hepatic function: Changes in liver function tests have been observed in some patients receiving Clavulanate Potassium and Amoxicillin. It should be used with care in patients with evidence of severe hepatic dysfunction.
Impaired renal function: In patients with moderate or severe renal impairment Clavulanate Potassium and Amoxicillin dosage should be adjusted.
Adverse Reactions
The most frequently reported adverse effects are diarrhea, nausea, vomiting, abdominal pain, skin rashes, urticaria, and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes. Hepatitis and cholestatic jaundice have been reported. The events 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. A moderate rise in Aspartate transaminase and/or Alanine transaminase has been noted in patients treated with Clavulanate Potassium and Amoxicillin. The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Clavulanate Potassium and Amoxicillin.
Gastro-Intestinal: gastritis, stomatitis, glossitis, black "hairy" tongue, enterocolitis and pseudomembranous colitis.
Hypersensitivity: skin rashes, urticaria, erythema multiforme, rare cases of Stevens-Johnson syndrome and less frequently exfoliate dermatitis and toxic epidermal necrolysis have been reported. Whenever such reactions occur Clavulanate Potassium and Amoxicillin 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 penicillin. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted less than 1% of the patients treated with Clavulanate Potassium and Amoxicillin. Prolongation of bleeding time and prothrombin time have been reported less frequently.
Drug Interactions
Probenecid decreases the renal tubular secretion of Amoxicillin but does not affect Clavulanate acid excretion. Concurrent use with Clavulanate Potassium and Amoxicillin may result in increase and prolonged blood levels of Amoxicillin but not clavulanic acid.
The concurrent administration of allopurinol and ampicillin substantially increases the incidence of rashes in patients receiving both agents as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. The ingestion of alcohol while being treated with some other β-lactam antibiotics has precipitated disulfiram (Antabuse) like reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with Clavulanate Potassium and Amoxicillin.
Clavulanate Potassium and Amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Storage
Store at a temperatures not exceeding 25°C. Protect from light. Do not freeze.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
1 g/200 mg powd for inj (vial) 10's. 500 mg/100 mg powd for inj (vial) 10's.
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