Chemical formula: C₁₈H₁₄Cl₄N₂O Molecular mass: 416.129 g/mol PubChem compound: 4189
Miconazole interacts in the following cases:
Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects. If necessary, their dosage should be reduced and, where appropriate, plasma levels monitored.
In patients using certain oral hypoglycaemics such as sulphonylureas, an enhanced therapeutic effect leading to hypoglycaemia may occur during concomitant treatment with miconazole and appropriate measures should be considered.
Bleeding events, some with fatal outcomes, have been reported with concurrent use of miconazole oral gel and warfarin. If the concomitant use of miconazole with an oral anticoagulant such as warfarin is planned, caution should be excercised and the anticoagulant effect must be carefully monitored and titrated.
Patients should be advised that if they experience unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit, to stop treatment with miconazole and seek medical advice.
It is advisable to monitor miconazole and phenytoin levels, if these two drugs are used concomitantly.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin and with other miconazole formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.
In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown.
Only small amounts of miconazole nitrate are absorbed following topical administration.
However, as with other imidazoles, miconazole should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits.
Although intravaginal absorption is limited, miconazole vaginal cream should be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks.
It is not known whether miconazole is excreted in human milk. Caution should be exercised when prescribing miconazole oral gel to nursing mothers.
Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.
When using miconazole vaginal cream during breastfeeding, caution should be exercised.
Miconazole should not affect alertness or driving ability.
The safety of miconazole oral gel was evaluated in 111 patients with oral candidiasis or oral mycoses who participated in 5 clinical trials. Of these 111 patients, 88 were adults with oral candidiasis or oral mycoses who participated in 1 randomised, active-controlled, double-blind clinical trial and 3 open-label clinical trials. The other 23 patients were paediatric patients with oral candidiasis who participated in 1 randomised, active-controlled, open-label clinical trial in paediatric patients (aged ≤1 month to 10.7 years). These patients took at least one dose of miconazole oral gel and provided safety data.
Based on the pooled safety data from these 5 clinical trials (adult and paediatric), the most commonly reported (≥1% incidence) adverse reactions were nausea (6.3%), product taste abnormal (3.6%), vomiting (3.6%), oral discomfort (2.7%), regurgitation (1.8%), and dry mouth (1.8%). Dysgeusia was reported in 0.9% of patients.
Based on the pooled safety data from the 4 clinical trials in adults, common adverse reactions reported included nausea (4.5%), product taste abnormal (4.5%), oral discomfort (3.4%), dry mouth (2.3%), dysgeusia (1.1%), and vomiting (1.1%).
In the 1 paediatric clinical trial, the frequency of nausea (13.0%) and vomiting (13.0%) was very common, and regurgitation (8.7%) was common. As identified through post-marketing experience, choking may occur in infants and young children. The frequency, type, and severity of other adverse reactions in children are expected to be similar to that in adults.
Increases in INR and bleeding events such as epistaxis, contusion, haematuria, melaena, haematemesis, haematoma and haemorrhages have been reported in patients treated with oral anticoagulants such as warfarin in association with miconazole oral gel. Some events had fatal outcomes.
The following list includes all identified adverse reactions, including those that that have been reported from post-marketing experience.
The frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).
Not Known: Anaphylactic reaction, Hypersensitivity
Uncommon: Dysgeusia
Not Known: Choking
Common: Dry mouth, Nausea, Oral discomfort, Vomiting, Regurgitation
Not Known: Diarrhoea, Stomatitis, Tongue discolouration
Not Known: Hepatitis
Not Known: Angioedema, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Urticaria, Rash, Acute generalised exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms
Common: Product taste abnormal
Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in the list below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with miconazole that meet threshold criteria are included in the list.
The adverse drug reactions are ranked by frequency, using the following convention: Very common ≥1/10, Common ≥1/100 and <1/10, Uncommon ≥1/1,000 and <1/100, Rare ≥1/10,000 and <1/1,000, Very rare <1/10,000, including isolated reports.
Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.
Not known: Anaphylactic reaction
Hypersensitivity
Uncommon: Skin burning sensation, Skin inflammation, Skin hypopigmentation
Not known: Angioedema, Urticaria, Contact dermatitis, Rash, Erythema, Pruritus
Uncommon: Application site irritation, Application site burning, Application site pruritus, Application site reaction NOS, Application site warmth
The safety of miconazole vaginal cream was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g. vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. Adverse reactions reported by ≥1% of miconazole-treated subjects in these trials are shown in List 1.
In the list, the frequencies are provided according to the following convention: Very common ≥1/10, Common ≥1/100 and <1/10, Uncommon ≥1/1,000 and <1/100, Rare ≥1/10,000 and <1/1,000, Very rare <1/10,000.
List 1. Adverse Reactions Reported by Miconazole-treated Subjects in 2 Single Blind Clinical Trials:
Common: Rash
Uncommon: Rash pruritic, urticaria
Very common: Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort
Common: Dysmenorrhoea
A range of additional reactions were reported during the clinical trials, such as: vaginal discharge, vaginal haemorrhage, vaginal pain, headache, dysuria, urinary tract infection, abdominal pain, rosacea, swelling of the face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.
List 2. Adverse Reactions Identified During Postmarketing Experience with Miconazole Vaginal Cream by Frequency Category Estimated from Spontaneous Reporting Rates:
Not known: Hypersensitivity including Anaphylactic and Anaphylactoid reactions
Not known: Angioedema, Pruritus
Not known: Vaginal irritation, pelvic cramps
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
