Globaxol/Globaxol Forte

Globaxol/Globaxol Forte

sulfamethoxazole + trimethoprim

Manufacturer:

GXI

Distributor:

Metro Drug
Full Prescribing Info
Contents
Co-trimoxazole: Trimethoprim and sulfamethoxazole.
Description
Globaxol: Each 5 mL suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim, USP.
Globaxol Forte: Each forte tablet contains 800 mg sulfamethoxazole and 160 mg trimethoprim, USP.
Each 5 mL suspension contains 400 mg sulfamethoxazole and 80 mg trimethoprim, USP.
Action
Pharmacology: Pharmacodynamics: COTRIMOXAZOLE (GLOBAXOL) contains two active ingredients, sulfamethoxazole and trimethoprim acting synergistically by blockage of two enzymes that catalyze successive stages in the biosynthesis of folinic acid in the microorganisms. This mechanism usually results in bactericidal activity in vitro at concentrations which the individual components are only bacteriostatic. COTRIMOXAZOLE (GLOBAXOL) is often effective against organisms that are resistant to one of the active ingredients.
The antibacterial effect of COTRIMOXAZOLE (GLOBAXOL) covers a wide range of Gram-positive and Gram-negative organisms e.g., Streptococci, Staphylococci, Pneumococci, Neisseria, Bordetella, Salmonella, Klebsiella/Aerobacter, Shigella and Vibrio cholerae.
A particularly high degree of enhanced activity is exhibited against the problem organisms, Haemophilus influenzae, E. coli and Proteus mirabilis or vulgaris.
Pharmacokinetics: COTRIMOXAZOLE (GLOBAXOL) when given orally, plasma concentrations of trimethoprim and sulfamethoxazole are generally around the optimal ratio of 1:20, although they may vary from 1:2 to 1:30 or more. The ratio of the two drugs is usually much lower in the tissues (often around 1:2 to 1:5) since trimethoprim, the more lipophilic drug, penetrates many tissues better than sulfamethoxazole and has a much larger volume of distribution. In urine the ratio may vary from 1:1 to 1:5 depending on the pH.
Indications/Uses
Respiratory Tract Infections: Acute and chronic bronchitis, bronchiectasis, pneumonia, Pneumocystis carinii, pneumonitis, pharyngitis, tonsillitis, sinusitis and otitis media.
Genitourinary Tract Infections: Acute and chronic cystitis, pyelonephritis, urethritis, prostatitis, genital infections in both sexes including gonococcal urethritis.
Gastrointestinal Tract Infections: Typhoid, paratyphoid fever, typhoid carrier state and bacillary dysentery and cholera.
Skin and Soft Tissue Infections: Pyoderma, furuncles, abscesses and infected wounds and other bacterial infections.
Dosage/Direction for Use
See table.

Click on icon to see table/diagram/image

This standard dosage approximates to 30 mg sulfamethoxazole and 6 mg trimethoprim per Kg bodyweight per day.
In acute infections COTRIMOXAZOLE (GLOBAXOL) should be continued until the patients have been symptom-free for 2 days, the majority will require treatment for at least 5 days. If clinical improvement is not evident after 7 days therapy, the patient should be reassessed.
For severe infections, the dosage may be increased by 50%. As an alternative to standard dosage for acute, uncomplicated lower urinary tract infections, short-term treatment of 1 to 3 days duration has been shown to be effective.
NOTE: It may be preferable to take COTRIMOXAZOLE (GLOBAXOL) with some food or drink to minimize the possibility of gastrointestinal disturbances.
Contraindications
COTRIMOXAZOLE (GLOBAXOL) should not be given to patients with a history of hypersensitivity to sulfonamides or trimethoprim and its derivatives.
Warnings
Physician must first determine if the patient is hypersensitive to any of the active ingredients and its derivatives before using the drug.
Special Precautions
Treatment should be discontinued immediately at the first appearance of skin rash or any other serious adverse reactions. COTRIMOXAZOLE (GLOBAXOL) should not be given during pregnancy and to premature and newborn infants.
Special care should be exercised in treating patients with severe hepatic parenchymal damage as changes may occur in the absorption and metabolism of trimethoprim and sulfamethoxazole.
COTRIMOXAZOLE (GLOBAXOL) should not be given to infants below 6 weeks of age because of the risk of Kernicterus from the sulfonamide content.
An adequate fluid intake should be maintain to reduce the risk of crystalluria, but alkalinisation of the urine, increases urinary excretion of the sulfamethoxazole component but decreases urinary excretion of trimethoprim.
Use In Pregnancy & Lactation
Should not be given during pregnancy.
Adverse Reactions
COTRIMOXAZOLE (GLOBAXOL) is usually well tolerated at the recommended dosage. Side effects are usually mild, such as nausea, with or without vomiting and skin rashes. There have been a few reports of subjective experiences, such as headache, depression, dizziness and hallucination but their relationship to therapy remains unproven.
Storage
Store at temperatures not exceeding 30°C.
Protect from light.
ATC Classification
J01EE01 - sulfamethoxazole and trimethoprim ; Belongs to the class of combinations of sulfonamides and trimethoprim, including derivatives. Used in the systemic treatment of infections.
Presentation/Packing
Globaxol: Oral susp (light pink to pink, strawberry flavoured) 60 mL.
Globaxol Forte: Tab (white to off-white, oval, uncoated, bisected on one side) 100's. Oral susp (white to off-white, raspberry flavoured) 60 mL.
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