| a) Generic Name |
Fluconazole INN
|
| b) Trade/Brand Name |
To be submitted at the time of inclusion.
|
| a) Presentation |
Capsule
Each Capsule contains Fluconazole INN 150 mg
|
| b) Indications |
1. Superficial candidal infections such as oral or vaginal thrush
2. Esophagitis caused by candida or other susceptible species
3. Maintenance therapy of cryptococcal meningitis
4. Disseminated candidiasis
5. Acute treatment of systemic fungal infections.
6. Dermatophyte and candida skin infections
7. Fungal urinary tract infections
|
| d) Side effects |
Therapy with Fluconazole is well tolerated
The most common adverse effects are related to the gastrointestinal system such as
Nausea, Abdominal pain, Vomiting, Diarrhoea, Headache and skin rash are also common
|
| e) Precautions and
Warnings
|
Caution should be taken in
- Renal impairment
- Pregnancy
- Breast-feeding women
- Raised liver enzyme
Contraindications: Known hypersensitivity
Advanced liver disease
Co-administration with terfenadine or cisapride
|
| f) Contraindications
|
Fluconazole should not be used in patients with known hypersensitivity to fluconazole or to related azole compounds.
|
| g) Over dose |
If there is any overdose, supportive measure and gastric lavage should be instituted according to the patient's clinical conditions. As fluconazole is excreted largely in urine volume, diuresis would probably increase elimination rate. A three hour session of haemodialysis decreases plasma levels approximately 50%.
|
| h) Drug Interactions |
Fluconazole increases the prothrombin time after warfarin administration in healthy males. It has been shown to prolong the serum half life of concomitantly asministered oral sulphonyureas. Co-administration of multiple dose-hydrochlorothiazide to healthy volunteers receiving fluconazole increased plasma concentrations of fluconazole by 40%. Concomtant administration of fluconazole and phenytoin may increase the level of phenytoin to a clinically significant degree. Concomitant administration of fluconazole and rifampicin decreases availability of fluconazole. Concomitant administration of fluconazole and theophyline
decreases the availability of the later. Fluconazole increases plasma concentration of celecoxibe (dose should be reduces to halve), zidorudine (increased risk of toxicity), midazolam (prolonged sedative effect), bosentan ( avoid concomitant use) and tacrolimus. Effect of acenocounazole is enhanced by fluconazole.
pre-existing asthma.
|
| i) Storage Conditions |
• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.
|
| j) Package Quantity |
To be submitted at the time of inclusion.
|
