Forexine

Forexine

cefalexin

Manufacturer:

GXI

Distributor:

Metro Drug
Full Prescribing Info
Contents
Cefalexin monohydrate.
Description
Each capsule contains 500 mg Cefalexin (as monohydrate).
Each 5 mL of reconstituted suspension contains 250 mg Cefalexin (as monohydrate).
Forexine is a brand of Cefalexin, a first-generation cephalosporin antibiotic having the highest degree of activity against gram-positive bacteria including beta-hemolytic Streptococci, Staphylococci (coagulase-positive, coagulase-negative, and penicillinase-producing strains), Streptococcus (Diplococcus) pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella sp., Neisseria catarrhalis and Haemophilus influenzae.
In vitro test shows that the cephalosporins are bactericidal because they inhibit cell wall synthesis.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Cefalexin is an oral broad-spectrum antibiotic. In adequate concentrations, it is bactericidal for sensitive proliferating microorganisms by inhibiting the biosynthesis of the cell wall.
Pharmacokinetics: Cefalexin is almost completely absorbed from the gastrointestinal tract and produces a peak plasma concentration of about 18 micrograms/mL 1 hour after a 500 mg oral dose.
Indications/Uses
For the treatment of the following infections when caused by susceptible strains of the designated microorganisms.
Respiratory tract infections: Acute and chronic bronchitis and infected bronchiectasis caused by S. pneumoniae and a group Streptococci; bacterial sinusitis caused by Streptococci, S. pneumoniae and S. aureus (methicillin-sensitive only).
Ear, nose and throat infections: Otitis media, mastoiditis, follicular tonsillitis and pharyngitis due to S. pneumoniae, H. influenzae, Staphylococci, Streptococci and N. catarrhalis.
Genito-urinary tract infections: Acute and chronic pyelonephritis, cystitis including acute prostatitis caused by E. coli, P. mirabilis and Klebsiella sp.
Skin and soft tissue infections: Caused by Staphylococci and/or Streptococci.
Bones and joint infections: Caused by Staphylococci and/or P. mirabilis.
Dental infections: Caused by Staphylococci and/or Streptococci.
Note: Appropriate culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
Dosage/Direction for Use
Cefalexin suspension or Cefalexin capsule is administered orally. The adult dosage ranges from 1 to 6 grams daily in divided doses.
The usual adult dose is 1 to 2 grams daily given in divided doses at 6, 8, or 12-hour intervals or as directed by the physician.
For streptococcal pharyngitis or tonsillitis, mild, uncomplicated urinary tract infections, and skin and soft tissue infections, a dosage of 500 mg may be administered every 12 hours.
For more severe infections or those caused by less susceptible organism, larger doses may be needed.
If daily doses of Cefalexin require greater than 4 grams, parenteral cephalosporins in appropriate doses should be prescribed.
Usual Dose in Children is 25 to 50 mg/kg body weight in divided doses. To be taken every 6 hours: See Table 1.

Click on icon to see table/diagram/image

For Streptococcal pharyngitis in children over 1 year of age, mild, uncomplicated urinary tract infections, and skin and soft tissue infections, the total daily dose may be divided; and administered and taken every 12 hours. (See Table 2.)

Click on icon to see table/diagram/image

In severe infections, the dosage may be doubled.
In the therapy of otitis media, a dosage of 75 to 100 mg per kg body weight per day in 4 divided doses is needed.
In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of Cefalexin should be administered for a minimum of 10 days.
Contraindications
Cefalexin is contraindicated in patients with previous allergic reactions to penicillins, penicillin derivatives, penicillamine, or cephalosporins.
Warnings
Before using the medication, the physician must determine if patient is hypersensitive to Cephalosporins, Penicillins and derivatives.
Cephalosporins should not be given to patients taking other medications especially alcohol, anticoagulants, heparin, thrombolytic agents, platelet aggregation inhibitors, or probenecid to avoid unfavorable drug interaction.
Note: Cefalexin may be taken on a full or empty stomach. Compliance with full course of therapy especially in streptococcal infections is highly recommended.
Special Precautions
Precautions should be considered to patients with history of bleeding disorders since cephalosporins may cause hypoprothrombinemia and potentially bleeding, gastrointestinal disease especially ulcerative colitis, hepatic function impairment. In patients with renal function impairment, a reduced dosage of Cefalexin is recommended.
Use In Pregnancy & Lactation
Pregnancy: Cephalosporins cross the placenta. Adequate and well controlled studies in humans have not been done. However, studies in animals have not shown that these cephalosporins cause adverse effects on the fetus. Cefalexin may be used during pregnancy only if clearly necessary.
Side Effects
Symptoms of potential side effects include pseudomembranous colitis, allergic reactions, hypoprothrombinemia, oral candidiasis, seizures, hypersensitivity reactions, gastrointestinal reactions, serum sickness-like reactions, vaginitis, thrombophlebitis, biliary "sludge", and pseudolithiasis. These effects are rarely if not less frequently reported being experienced by some patients.
Drug Interactions
The renal excretion of cefalexin, and many other cephalosporins, is delayed by probenecid.
Storage
Store at a temperature not exceeding 30°C. Protect from light.
Suspension: Shake Well Before Use.
After reconstitution, Cefalexin suspensions retain their potency for 14 days if refrigerated.
MIMS Class
ATC Classification
J01DB01 - cefalexin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Cap 500 mg (white, crystalline powder in a yellow opaque, size 0) x 21's (treatment pack), 100's. Oral susp 250 mg/5 mL (granules, orange in color and orange-flavored) x 70 mL.
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