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QUESTION 7
Topic: Medicines Interactions Written response required: NO
Scenario: A call comes through from a community pharmacist. They have a patient with oral thrush and would like to recommend miconazole oral gel. The patient is currently also prescribed rosuvastatin.
Enquiry: Can miconazole oral gel be used in a patient taking rosuvastatin regularly?
Additional questions for enquirer that may help provide a more complete/ detailed response:
If they female, are they pregnant?
How old are the patient? Weight?
Is the patient are using frequent antiobiotic any antibiotic?
Doeas the patient are using any corticosteroid inhaler?
Does the patient has immunocomprimised disease?
Does the patient using Dentures?
What is the cause of oral thrush?
Does the patient has any syndrome that cause the mouth dry?
Does the patient are using antipsychotic or chemotherapy drugs?
Doeas the patient has diabetes or lack of vitamin B12, iron, folic acid
Are you smoker?
Once you prevent the causes it will reduce the subtipility to get oral thrush
Do they have thyroid disorder (e.g: Hypothyrodism)
Do they drink excessive amount of alcohol and how many per week?
Does the patient has any blood disorder, liver and muscle disorders , renal dysfunction ?
Does the patient use or any anticoagulant therapy such as warfarin?
Do they have allergy in general and specifically to Azoles goroup
When do you got oral thrush
What is the dose of rousvastain?
Anticipated additional question(s):
What is the Signs of rhabdomyolysis include muscle pain and weakness and reddish-brown urine (myoglobinuria). 2
liver toxicity; when do we do liver function test and does it to do for the entire duration of the treatment?
Search strategy/ information obtained from resources:
Response:
You should take daktarin oral gel until the symprtoms are clear
MIMISà Dose Drop gel on tongue; keep in mouth for as long as possible before swallowing; treat for greater than or equal to 1 wk after symptoms have cleared. Infants, younger children: divide dose into several portions and place into front of mouth. Adults, children greater than or equal to 2 yrs: 1/2 spoonful using provided measuring spoon 4 times daily; infants 6-24 mths: 1/4 spoonful using provided measuring spoon 4 times daily; elderly with dentures: also apply to dentures overnight, wash off before replacing dentures in morning
eTGà identification of underlying predisposing factors and local precipitating factors, such as ill-fitting dentures, and prevented
eTGà miconazole 2% gel 2.5 mL (child 6 months to 2 years: 1.25 mL) topically (then swallowed), 4 times daily, after food, for 7 to 14 days (measuring spoon supplied with pack). Place directly in the mouth and on the tongue [Note 2]
Continue treatment for several days after symptoms resolve. Advise denture wearers to apply the antifungal to the cleaned fitting surface of the dentures before inserting them.
Reference sources used to answer enquiry:
References
1-Stockleyà Raised statin concentrations are known to be associated with the development of myopathy and rhabdomyolysis
2-Australian medicine handbook (AMH)/ Warfarin+miconazoleàmay increase its anticoagulant effect and risk of bleeding
;Monitor INR and reduce warfarin dose as needed.
AMH/ For most drug interactions it is appropriate to temporarily stop or reduce the dose of the other drug, monitor the clinical and adverse effects and/or measure the drug concentration
AMH/ azoles + simvastatin
Azoles may increase concentration of simvastatin and increase the risk of myopathy or rhabdomyolysis; temporarily stop simvastatin while the azole is being taken or consider using pravastatin (less likely to be affected). Combinations (except with fluconazole) are contraindicated by manufacturer.
AMH/ Drug interactions may rarely occur with miconazole, as some systemic absorption of miconazole occurs from the oral gel, vaginal and topical products.
3- Stockley Drug intercationà Miconazole slightly increase rousvastatin exposure
Stockley Drug intercation à Case reports describe rhabdomyolysis associated with the use of an azole group
Stockley Drug intercation à iconazole is an inhibitor of CYP2C9 and would be expected to interact like fluconazole
Stockley Drug intercation à Just how statins cause muscle disorders is as yet unclear, although it is thought to be connected to elevated statin concentrations
Stockley Drug intercation àelevated hepatic transaminases are dose dependent, although progression to liver failure is exceedingly rare. 4 Any pharmacokinetic interaction that results in a marked rise in statin concentrations is therefore to be regarded seriously.
Stockley Drug intercation àthe overall risk of myopathy with the statins at standard therapeutic doses is quite low and commonly quoted as 0.01 to 0.1%, although in clinical studies involving patients taking statins
Stockley Drug intercation à However, it has been estimated that for every 15 million prescriptions there is only one occurrence of severe muscle damage. 7 The incidence seems to rise markedly if other interacting drugs are being taken concurrently.
4- 7- Thompson, PD, Clarkson PM, Rosenson RS; the National Lipid Association’s Muscle Safety Expert Panel. An Assessment of statin safety by muscle experts. Am J Cardiol (2006) 97 (Suppl), 69C–76C.(PubMed)
Stockley Drug intercation à the patien asked to promptly report muscle pain, tenderness, or weakness, especially if this is accompanied by malaise, fever, or dark urine. 9
5- American Jornal cardiologyàMyopathy is more likely to occur at higher statin doses than at lower doses
6-the National Lipid Association Safety Assessment Task Force 1 give some important safety recommendations, which are useful in the context of interactions:
Routine monitoring of creatine kinase is of little value in the absence of clinical symptoms.
If a patient has intolerable muscle symptoms or a creatine kinase value 10 times the upper limit of normal, and is symptomatic, statin treatment should be immediately discontinued.
If a patient has symptoms of muscle pain with a creatine kinase of up to 10 times the upper limit of normal they should be monitored closely. The statin may be continued at the same or reduced doses and symptoms and creatine kinase concentrations can be used as the clinical guide to stop or continue treatment.
If progressive creatine kinase elevations occur consider a dose reduction or temporary discontinuation of the statin.
Liver transaminase concentrations should be obtained during routine general evaluation of patients being considered for a statin.
Liver enzyme values of up to 3 times the upper limit of normal do not represent a contraindication to treatment but patients should be carefully monitored.
7-McKenney JM, Davidson MH, Jacobson TA, Guyton JR. Final conclusions and recommendations of the National Lipid Association Statin Safety Assessment Task Force. Am J Cardiol (2006) 97 (Suppl), 89C–94C.(PubMed)
Stockley Drug intercation à (b) Pharmacokinetics
1. Cytochrome P450 isoenzymes
Lovastatin and simvastatin are extensively metabolised by CYP3A4, and drugs that inhibit this isoenzyme can cause marked rises in blood statin concentrations. Atorvastatin is also metabolised by CYP3A4, but to a lesser extent than lovastatin or simvastatin. Some of the statins are not metabolised by this isoenzyme so they interact differently. Fluvastatin is metabolised primarily by CYP2C9 (with a minor contribution from other isoenzymes, including CYP3A4), only 10% of rosuvastatin is metabolised, and the isoenzymes involved appear to be CYP2C9 and CYP2C19,
Stokleyà rosuvastatin seem to have no effect P-glycoprotein substrates, and inhibitors of this carrier might therefore interact resulting in altered oral bioavailability
8-BNF April 2016 update Fungal infections of the mouth are usually caused by Candida spp. (candidiasis or candidosis). Different types of oropharyngeal candidiasis are managed as follows:
Thrush
Acute pseudomembranous candidiasis (thrush), is usually an acute infection but it may persist for months in patients receiving inhaled corticosteroids, cytotoxics or broad-spectrum antibacterials. Thrush also occurs in patients with serious systemic disease associated with reduced immunity such as leukaemia, other malignancies, and HIV infection. Any predisposing condition should be managed appropriately. When thrush is associated with corticosteroid inhalers, rinsing the mouth with water (or cleaning a child’s teeth) immediately after using the inhaler may avoid the problem. Treatment with nystatin or miconazole may be needed.Fluconazole is effective for unresponsive infections or if a topical antifungal drug cannot be used or if the patient has dry mouth. Topical therapy may not be adequate in immunocompromised patients and an oral triazole antifungal is preferred.
Electronic therapeutic guideline (eTG)à identification of underlying predisposing factors and local precipitating factors, such as ill-fitting dentures, and prevented
Electronic therapeutic guideline (eTG)à miconazole 2% gel 2.5 mL (child 6 months to 2 years: 1.25 mL) topically (then swallowed), 4 times daily, after food, for 7 to 14 days (measuring spoon supplied with pack). Place directly in the mouth and on the tongue [Note 2]
Continue treatment for several days after symptoms resolve. Advise denture wearers to apply the antifungal to the cleaned fitting surface of the dentures before inserting them.
9- MIMS Online
MIMS Onlineà says miconazole is contraindicated in HMG-CoA reductase inhibitors (eg simvastatin, lovastatin) but not with Rousvastain
Dose Drop gel on tongue; keep in mouth for as long as possible before swallowing; treat for greater than or equal to 1 wk after symptoms have cleared. Infants, younger children: divide dose into several portions and place into front of mouth. Adults, children greater than or equal to 2 yrs: 1/2 spoonful using provided measuring spoon 4 times daily; infants 6-24 mths: 1/4 spoonful using provided measuring spoon 4 times daily; elderly with dentures: also apply to dentures overnight, wash off before replacing dentures in morning
