PANAMOXY 1000
-
Chemical Name:
Amoxicillin (Sodium) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Penicillin -
Pharmaceutical Form:
Vial -
Composition:
Amoxicillin (Sodium) 1000mg
PANAMOXY
For Injection (Vial)
Amoxicillin (Sodium)
Broad Spectrum Antibiotic
1-PHARMACOLOGY:
Amoxicillin is a semi-synthetic aminopenicillin of the beta-lactam group of antibiotics. It has a broad spectrum of antibacterial rapidly bactericidal activity against many gram-positive and gram-negative micro-organisms, acting through the inhibition of biosynthesis of cell wall mucopeptide.
Strains of the following organism are generally sensitive to the bactericidal action of Amoxicillin in vitro :
Gram-positive micro-organisms:
Aerobes: Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, penicillin-sensitive Staphylococcus aureus, Corynebacterium species, Bacillus anthracis, Listeria monocytogenes.
Anaerobes: Clostridium species.
Gram-negative micro-organisms:
Aerobes: Haemophilus influenzae, Eschericia coli, Proteus mirabilis, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella septica, Vibrio cholerae.
2-PHARMACOKINETICS:
Amoxicillin gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic. Peak plasma concentration of administration of 500mg Amoxicillin sodium is 14 mg/ml, 1 hour after intramuscular injection.
Amoxicillin is not highly protein bound: approximately 18% of total plasma drug content is bound to protein. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid, however it has weak permeability to the uninflammed meningesis, but inflammation generally increases the permeability of the meninges to penicillins and this may apply to Amoxicillin .
The elimination half-life is approximately 1 hour. The major route of elimination for Amoxicillin is via the kidney. Approximately 60-70% of Amoxicillin is excreted unchanged in urine by glomerular filtration and tubular secretion during the first 6 hours after administration of a standard dose.
Amoxicillin is also partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to 10-25% of the initial dose and exists in high concentration in gall bladder.
3-INDICATIONS:
PANAMOXY is indicated for :
-Upper respiratory tract infections: nose and throat infections, otitis media.
-Lower respiratory tract infections: acute exacerbations of chronic bronchitis, lobar and bronchopneumonia.
-Gastrointestinal tract infections: typhoid and parathyroid fever.
-Genito-urinary tract infections: cystitis, urethritis, pyelonephritis, becteriuria in pregnancy, septic abortion, puerperal sepsis.
-Skin and soft tissue infections
-Billiary tract infections
-Bone infections
-Pelvic infections
-Gonorrhoea (non-penicillinase producing strains)
-Septicaemia
-Endocarditis
-Meningitis
-Peritonitis
-Dental abscess (as an adjunct to surgical management)
-Prophylaxis of endocarditis: PANAMOXY may be used for the prevention of bacteraemia associated with procedures such as dental extraction, in patients at risk of developing of endocarditis.
4-CONTRA INDICATIONS:
Hyperallergic reactions to any penicillin.
5-PRECAUTIONS:
It should preferably not be given to patients with infectious mononucleosis and with lymphatic leukemia.
Caution must be done in case of a history of allergic reaction to any of the cephalosporins.
6-Pregnancy and Lactation:
Pregnancy: Category B. As directed by the physician. Bearing in mind that Amoxicillin crosses the placenta and milk barrier.
7-SIDE EFFECTS :
Amoxicillin is well tolerated. The majority of the observed side effects were mild and of transitory nature.
Hypersensitivity Reactions: rashes- erythema multiforme- Stevens-Johnson Syndrome- urticaria.
NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to penicillin therapy. Serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids.
Gastrointestinal: Glossitis, stomatitis, nausea, vomiting, diarrhea (these reactions are usually associated with oral dosage forms of amoxicillin).
Hemic and Lymphatic Systems: Anemia, thrombocytopenia, eosinophilia, leucopenia, agranulocytosis. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioral changes, dizziness.
8-DRUG INTERACTIONS:
-Probenecid: reduces the excretion of Amoxicillin.
-An increased frequency of skin rashes in patients receiving Amoxicillin with allopurinol.
-Amoxicillin may decrease the efficacy of oestrogen-containing oral contraceptives.
9-DOSAGE & ADMINISTRATION:
Adults:
Intramuscularly 2g daily.
Intravenously 2g to 12g daily.
Slow intravenous injection or intravenous infusion for 30 to 60 minutes can be applied.
Children and infants:
Intramuscularly 50 mg/kg daily.
Intravenously 100 mg to 200 mg/kg daily.
Slow intravenous injection or intravenous infusion for 30 to 60 minutes can be applied.
New-born from birth to 1 month:
By intravenous infusion. The dosage of each administration should not exceed 50 mg/kg.
| Premature | 0 – 7 days | 100 mg/kg/day |
| 7 – 30 days | 100 – 150 mg/kg/day | |
| New-born at term | 0 – 7 days | 100 – 150 mg/kg/day |
| 7 – 30 days | 100 – 200 mg/kg/day |
In renal insufficiency; according to creatinine clearance as follows:
| 30 – 60 ml/min | 2 – 4g/day (maximal dose: 4 g/day in two administrations) |
| 10 – 30 ml/min | 1g followed by 500 mg each 12 hours |
| Less than 10 ml/min | 1g followed by 500 mg each 24 hours |
In severe infections, the above dosage could be increased if needed.
Dosage & administration in special cases:
Prophylaxis of endocarditis:
Adults: 2g in 30 minutes by intravenous infusion before the intervention, followed by 1g after 6 hours.
Children: 50mg/kg in 30 minutes by intravenous infusion before the intervention, followed by 25mg/kg after 6 hours.
AMOX CAN BE DISSOLVED IN STERILE WATER FOR INJECTION OR IN 1% OF LIDOCAINE.
10-PACKAGING & COMPOSITION:
-PANAMOXY 250 – For Injection: A pack of 1 or 100 vials. Each vial contains sterile Amoxicillin Sodium equivalent to 250 mg Amoxicillin.
-PANAMOXY 500 – For Injection: A pack of 1,10 or 100 vials. Each vial contains sterile Amoxicillin Sodium equivalent to 500 mg Amoxicillin.
-PANAMOXY 1000 – For Injection: A pack of 1 or 100 vials. Each vial contains sterile Amoxicillin Sodium equivalent to 1000 mg Amoxicillin.
11-STORAGE CONDITIONS:
Store PANAMOXY– For Injection at temperature below 25°C.
Related Products
