(Film coated Tablets & Powder For Oral Suspension)
Composition:
Composition

Reconstituted Suspension

Tablets

15
6.25
mg /5 ml

230
mg/5ml

31
2.5
mg / 5 ml 460
mg/5ml
375
mg/ tablet

625
mg/tablet

1
gm/tablet
Amoxycillin
(As trihydrate)

125 mg

200 mg

250 mg 400 mg
250 m

500 mg

875 mg
Clavulanic acid
(as potassium salt)

3
1.25 mg

30 mg

6
2.5 mg 60 mg
125 mg

125 mg

125 mg
Magnabiotic 460 mg / 5 ml (Powder for suspension)Inactive Ingredients:
Film coated tablets:
Colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and microcrystalline cellulose.
Powder for oral suspension:
Sodium saccharine, sodium benzoate, citric acid anhydrous,sodium citrate anhydrous, microcrystalline cellulose, xanthan gum, silicon dioxide, silicic anhydride colloidal, cherry flavor powder & manthol.
Pharmacological actions:
Magnabiotic is an anti-bacterial combination of amoxycillin and clavulinic acid.
Amoxycillin:
Is a semi-synthetic penicillin with a broad spectrum against Gram+ve & Gram-ve micro-organisms.
Clavulanic acid:
Is a B-lactam structurally related to Penicillins that inactivate B-lactamase enzymes commonly found in micro-organisms resistant to penicillin .
The combination of Amoxycillin / Clavulanic acid extends the antibiotic spectrum of Amoxycillin to include bacteria normally resistant to Amoxycillin & other B-lactam antibiotics.

Magnabiotic is well absorbed from G.I.T after oral administration, stable in the presence of gastric acid & may be administered with out regard to to meals.
About 50-70 % of Magnabiotic is excreted unchanged in urine during the first 6 hours after oral administration .
It diffuses readily into most body tissues & fluids & can be detected in middle ear effusion .

Pharmacokinetics:
After oral administration of Magnabiotic, approximately 50%-70% of amoxicillin & 25%-40% of the clavulanic acid is excreted unchanged in urine during first sic hours.
It diffuses readily into most of body tissues & fluids and can be detected in middle ear effusion.

Indications:
Upper respiratory tract & E.N.T infections :
Sinusitis, tonsillitis, pharyngitis , laryngitis, otitis media,etc...
Lower respiratory tract infections :
Bronchitis, pneumonia, emphysema, lung abscess etc....
Gastrointestinal infections :
Enteritis, billary tract infection.
Genito-urinary tract infections :
Cystitis, urethritis, gonorrhea etc...
Skin & soft tissue infections :
Cellulitis, erysipelas, boils, carbuncles ,etc...
others : Septicemia, osteomyelitis, etc...
Contraindications:
A history of allergic reactions to any Penicillin is a contraindication.


Method of reconstitution & administration:
Oral suspension:
The suspension should reconstituted just before use.
Add water to the content till the mark in 2 portions and shake well after each addition.
It should be administrated within 7 days of reconstitution.
Shake well before taking each time.
The reconstituted powder should be stored at the refrigerator.

Dosage & route of administration & duration:
Doses are administrated under medical advice according to case severity and patient's response.
Oral suspension & film coated tablets:
Adults & children over 12 years old:
Mild & moderate infections:
Magnabiotic 460 mg: 2 teaspoonfuls (10 ml) every 12 hours.
Or: one film coated tablet of Magnabiotic 375 mg every 8 hours.
Or: One film coated tablet of Magnabiotic 1 gm every 12 hours.
Severe infections:
One film coated tablet of Magnabiotic 625 mg every 8 hours.
Or: One film coated tablet of 1 gm every 8 hours.
Children:
9 months - 2 years :1/2 teaspoonful Magnabiotic 15
6.25 mg every 8 hours .
Or: Half teaspoonful (
2.5 ml) of Magnabiotic 230 mg every 12 hours.
2 - 7 years :1 teaspoonful Magnabiotic 15
6.25 mg every 8 hours .
or: One teaspoonful (5 ml) of Magnabiotic 230 mg every 12 hours.
7 - 12 years : 2 teaspoonful Magnabiotic 15
6.25 mg every 8 hours .
Or: One teaspoonful of Magnabiotic 31
2.5 mg every 8 hours .
Or: One teaspoonful of Magnabiotic 460 mg every 12 hours.
In severe infections, these dosages may be doubled.
I.V.
injection or infusion:
Adults and children over 12 years : 1200 mg every 8 hours.
In serious infections : 1200 mg every 6 hours.
Children:
3 months - 12 years: 30 mg/kg every 8 hours.
In more serious infections : 30 mg/kg every 6 hours.
Children less than 3 months :30 mg/kg every 12 hours (In premature infants and in full term infants during the prenatal period)increasing to 8 hourly intervals there after.

Side effects:
Magnabiotic is generally well tolerated.
The majority of side effects are mild & transient and consist mainly of diarrhea, nausea, abdominal discomfort, skin rashes & urticaria which disappear upon discontinuation of therapy.


Drug interactions:
Probencid decreases the renal tubular secretion of Amoxycillin.
Concurrent use with amoxicillin/clavulanate potassium may result in increased and prolonged blood levels of amoxicillin.
Co administration of probencid cannot be recommended.
The concurrent administration of Allopurinol and Ampicillin increase the substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone.
It is not know whether this potentiation of ampicillin rashes is due to allopurinol or to the hyperuricemia presents in those patients.
There are no data with amoxicillin/clavulanate potassium administrated concurrently.
In common with other brad-spectrum antibiotics; amoxicillin/clavulanate potassium may reduce the efficacy of oral contraceptive.

Pregnancy & lactation:
- Magnabiotic should be avoided during pregnancy especially during the first trimester.
-During lactation; traces quantities of penicillin can be detected in breast milk.


Precautions & Warnings:
-Intravenous Magnabiotic should be used with caution in patients with evidence of severe hepatic dysfunction.
-Magnabiotic dosage should be adjusted for patients with severe or moderate renal impairement.

Storage:
1-Film coated tablets:
-For 375 mg & 1gm:
Keep film coated tablets in a dry place at temperature not exceeding than 30ºC.
-For 625 mg:
Keep film coated tablets in a dry place at temperature not exceeding than 25ºC.

2-Powder for oral suspension:
-Before reconstitution: Store at temperature not exceeding than 30ºC in a dry place.
-After reconstitution: Store at 2º-8ºC for 7 days.

Packages:
Film coated tablets:
375 mg/tablets: 10 film coated tablets packed in one hard aluminum metallic sheet PA,AL/PVC strip inside hard aluminum pouch, packed in a carton box with pamphlet.
625 mg/tablets: 8 film coated tablets packed in one hard aluminum metallic sheet PA,AL/PVC strip inside hard aluminum pouch, packed in a carton box with pamphlet.
Or: 8 film coated tablets packed in an amber glass bottle (30 ml) type 3 with white plastic cap with red ring in a carton box and pamphlet.
1 gm tablet: 10 (white to off white , oval , biconvex) film coated tablets packed in an amber glass bottle (30 ml) type 3 with white plastic cap with red ring in a carton box and pamphlet.
Powder for suspension:
(15
6.25 mg/5ml),(230 mg/5ml),(31
2.5 mg/5ml) or (460 mg/5ml):
A carton box (type 3) containing bottle of 60 or 80 ml after reconstitution with distilled water, closed by pilfer proof plastic cap with indication sealing pamphlet.
Instruction for patients:
Patients should be counseled that antibacterial drugs including amoxicillin/clavulanate potassium, should be used to treat bacterial infections.
They don't treat viral infections (e.g.
the common cold).
When amoxicillin/clavulanate potassium prescribed to treat bacterial infections, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may:
1-Decrease the effectiveness of the immediate treatment.
2-Increase the like hood that bacteria will develop resistance and will not be treatable by amoxicillin/clavulanate potassium or other antibacterial drugs in the future.

Magna-Biotic 1gm tablets
Magna-Biotic Vials