OGMENTININE
( Film Coated Tablets & Dry Powder for oral Suspension )
(Amoxicillin + Clavulanic acid )
 

PROPERTIES AND INDICATIONS:
OGMENTININE Is an antibacterial combination consisting of the semisynthetic antibiotic Amoxicillin and the B-lactamase inhibitor, Clavulanate potassium (the potassium salt of clavulanic acid). Clavulanic acid is produced by the fermentation of streptomyces clavuligerus.
It is b - lactam structurally related to the penicillins, and possesses the ability to inactivate a wide variety of b- lactamases by blocking the active sites of the enzymes responsible for transferred drug resistance to penicillins and cephalosporins.
Amoxycillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms.
OGMENTININE `S spectrum includes: 1. Gram-positive bacteria : Aerobes and Anaerobes,
2- Gram-negative bacteria:
Aerobes and Anaerobes. Including all B - lactamase producing bacteria.
OGMENTININE is well absorbed from the gastro intestinal tract after oral administration , and is stable in the presence of gastric acid , and may be given without regards to meals . Approximately 50-70% of the amoxicillin and approximately 25 % to 40 % of the clavulanic acid are excreted unchanged in urine during the first 6 hours after administration .
OGMENTININE diffuses readily into most body tissues and fluids, and its concentrations can be detected in middle ear effusions.
 

INDICATIONS AND USAGE
OGMENTININE is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
-Lower Respiratory Tract Infections : caused by (beta)-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
-Otitis Media :caused by (beta)-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
-Sinusitis: caused by (beta)-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
-Skin and Skin Structure Infections : caused by (beta)-lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp.
-Urinary Tract Infections : caused by (beta)-lactamase-producing strains of Escherichia coli, Klebsiella spp. and Enterobacter spp.
 

CONTRAINDICATIONS:

Ogmentinine is contraindicated in patients with a history of allergic reactions to any penicillin. It is contraindicated in patients with a previous history of Ogmentinine associated hepatic dysfunction .

PRECAUTIONS:
While Ogmentinine possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system function, including renal, hepatic and hematopoietic functionm is advisable during prolonged therapy .
Ampicillin class antibiotics should not be administrated to patients with mononucleosis.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy.
 

DRUG INTERACTIONS:
Concurrent administration of probenicid with OGMENTININE increases and prolongs blood levels of Amoxycillin . There are no data with OGMENTININE and allopurinol administered concurrently .
OGMENTININE may reduce the efficacy of oral contraceptives and patients should be warned accordingly .
 

USAGE IN PREGNANT & NURSING MOTHERS:
OGMENTININE should be used during pregnancy only if clearly needed .
Nursing Mothers : Ampicillin class antibiotics are excreted in the milk : therefore, caution should be exercised when OGMENTININE is administered to a nursing mother .
 

SIDE EFFECTS:
OGMENTININE is generally well tolerated. The majority of side effects are of mild and transient nature. They consist of diarrhoea, nausea, abdominal discomfort, vomiting , skin rashes, urticaria and vaginitis. These side effects disappear upon discontinuation of the therapy.
Hemic and lymphatic systems: Anemia, including hemolytic anemia , thrombocytopenia, thrombocytopenic purpera, eosinophilia ,leukopenia and agranulocytosis have been reported during therapy with penicillin.
Central Nervous System: agitation , anxiety, behavioral changes, confusion , convulsion , dizziness and insomenia have been reported rarely.
 

WARNINGS:
Before initiating therapy with OGMENTININE , careful inquiry should be made concerning hypersensitivity reactions to penicillins , cephalosporins or other allergies . if an allergic reactions occurs, OGMENTININE should be discontinued and the appropriate therapy instituted .
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia . Studies indicate that a toxin produced by Closrtridium defficile is one primary cause of "antibiotic associated colitis.
With patients who suffer from liver insufficiency : hepatic dysfunction , including increases in serum trans-aminases , serum bilirubin and/or alkaline phosphatase ,has been infrequently reported with OGMENTININE.
 

DOSAGE & ADMINISTRATION:
1-Neonates and infants aged <12 weeks (3 month)
Due to incompletely developed renal function affecting elimination of amoxicillin in this age group , the recommended dose of OGMENTININE 30 mg/kg/day devided q 12 hours ,based on the amoxicillin component. Clavulanate elimination is unaltered in this age group.
2- Patients aged 12 weeks and older
Otitis media, sinusitis, lower respiratory tract infections, and more severe infections:
OGMENTININE 457 Dry syrup : 45 mg/kg/day q 12h
OGMENTININE 312 Dry syrup: 45 mg/kg/day q 12h or 40 mg/kg/day q 8h
OGMENTININE 156 Dry syrup : 40 mg/kg/day q 8h
Less severe infection :
OGMENTININE 457 Dry syrup : 25 mg/kg/day q 12h
OGMENTININE 312 Dry syrup : 25 mg/kg/day q 12h or 20 mg/kg/day q 8h
OGMENTININE 156 Dry syrup : 20 mg/kg/day q 8h
3- Adults and pediatrics weighting 40 kg and more :
Usual dose:
OGMENTININE TABLET 625 mg q 12h or 375 mg q 8h.
For more severe infections and infections of the respiratory tract :
OGMENTININE TABLET 1000 mg q 12h or 625 mg q 8h.
 

OVERDOSAGE:
They may be treated symptomatically with attention to water electrolyte balance. OGMENTININE may be removed from the circulation by haemodialysis.
PACKAGES & COMPOSITION OGMENTININE 1000 : 6 film coated tablets , each tablet contains :
Amoxycillin 875 mg. ( as trihydrate ) + Clavulanic acid 125 mg. ( as potassium salt )
OGMENTININE 625 : 10 film coated tablets , each tablet contains :
Amoxycillin 500 mg. ( as trihydrate ) + Clavulanic acid 125 mg. ( as potassium salt )
OGMENTININE 375 : 30 film coated tablets , each tablet contains :
Amoxycillin 250 mg. ( as trihydrate ) + Clavulanic acid 125 mg. ( as potassium salt )
OGMENTININE 457 : Dry powder for oral suspension , bottle of 60 ml , each 5 ml of the reconstituted suspension contains:
Amoxycillin 400 mg. ( as trihydrate ) + Clavulanic acid 57 mg. ( as potassium salt )
OGMENTININE 312 : Dry powder for oral suspension , bottle of 60 ml , each 5 ml of the reconstituted suspension contains:
Amoxycillin 250 mg. ( as trihydrate ) + Clavulanic acid 62.5 mg. ( as potassium salt )
OGMENTININE 156 : Dry powder for oral suspension , bottle of 60 ml , each 5 ml of the reconstituted suspension contains:
Amoxycillin 125 mg. ( as trihydrate ) + Clavulanic acid 31.25 mg. ( as potassium salt )
After reconstitution, store the product below 25ْ C. and throw away after 10 days .
 

STORAGE:
Store at room temperature away of moisture and heat .
Keep away of the reach of children .
RECONSTITUTION FOR ORAL SUSPENSION
Invert bottle and tab to loosen the powder. Add water, until the reconstituted suspension is at level with the mark on the bottle.
Following reconstitution the suspension is stable for 7 days at room temperature, or 14 days under refrigerator, (2-4C).
keep container tightly closed. Shake well before using.