Phytoral Lotion 75ml

Uses of Phytoral Lotion 75ml

Ketoconazole is used to treat certain serious fungal infections in the body.

Side Effects of Phytoral Lotion 75ml

Adrenal insufficiency; GI disturbances (e.g. abdominal pain, nausea, vomiting); rash, irritation, dermatitis, burning sensation, pruritus, urticaria, angioedema, anaphylaxis; alopecia, headache, dizziness, somnolence, fever and chills; thrombocytopenia, paraesthesia; menstrual irregularities, oligospermia, adrenal cortex supression, gynaecomastia, impotence; raised intracranial pressure; photophobia, photosensitivity; asymptomatic, transient elevations in LFTs. Potentially Fatal: Hepatotoxicity.

Drug Interactions

Reduced absorption w/ antimuscarinics, antacids, H2-blockers, PPIs, sucralfate. Reduced plasma concentrations w/ rifampicin, isoniazid, efavirenz, nevirapine, phenytoin. May also reduce concentrations of isoniazid and rifampicin. May reduce efficacy of oral contraceptives. May increase serum levels of CYP3A4 substrates e.g. digoxin, oral anticoagulants, sildenafil, tacrolimus. Potentially Fatal: May potentiate and prolong sedative and hypnotic effects of midazolam and triazolam. Increased plasma levels and prolonged QT intervals of astemizole, cisapride, dofetilide, pimozide, quinidine and terfenadine which may lead to torsade de pointes. Increased risk of myopathy w/ HMG-CoA reductase inhibitors (e.g. lovastatin, simvastatin). Markedly increased plasma levels of nisoldipine. Increased risk of hyperkalaemia and hypotension w/ eplerenone. Increased risk of vasospasm potentially leading to cerebral ischaemia w/ ergot alkaloids (e.g. ergotamine, dihydroergotamine).

Contraindications

Hypersensitivity; preexisting liver disease. Concurrent use w/ CYP3A4 substrates e.g. HMG-CoA reductase inhibitors (e.g. lovastatin, simvastatin), midazolam, triazolam, cisapride, dofetilide, eplerenone, nisoldipine, pimozide, quinidine, terfenadine, astemizole, ergot alkaloids (e.g. ergotamine, dihydriergotamine).

Mechanism of Action

Ketoconazole interferes w/ biosynthesis of triglycerides and phopholipids by blocking fungal CYP450, thus altering cell membrane permeability in susceptible fungi. It also inhibits other fungal enzymes resulting in the accumulation of toxic concentrations of hydrogen peroxide. Absorption: Variably absorbed from the GI tract, may be increased w/ decreasing gastric pH. Minimally absorbed systemically (topical). Time to peak plasma concentration: Approx 2 hr (oral). Distribution: Widely distributed, CSF (poor penetration); enters breast milk. Plasma protein binding: >90% (mainly albumin). Metabolism: Partially hepatic via CYP3A4 converted to inactive metabolites. Excretion: Via faeces (57%); urine (13%). Half-life: Initial (2 hr), terminal (approx 8 hr).

Special Precautions

Predisposition to adrenocortical insufficiency. Admin w/ acidic drink in patients w/ achlorhydria. Pregnancy, lactation. Monitoring Parameters Assess liver status prior to therapy and monitor serum ALT during treatment. Discontinue if there is persistent or worsening of liver enzyme elevation. Monitor adrenal function in patients w/ adrenal insufficiency or w/ borderline adrenal function and in patients under prolonged periods of stress (e.g. major surgery, intensive care).

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

Content Disclaimer

This content is for educational purposes only. Please consult your doctor before use.