Registered Kenya · PPB

DACINAZOLE CREAM

MICONAZOLE NITRATE

H2010/19996/037 MICONAZOLE (NITRATE) 2% W/W alimentary tract and metabolism INN generic

What it does

Miconazole is an antifungal medication used to treat fungal infections on the skin and in the mouth.

Commonly used for: fungal infections of the skin, oral thrush (fungal infection in the mouth)

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Hard to find? We help patients in Kenya source rare medicines. We don't sell or dispense medicines - licensed pharmacies do.

Source this medicine

Registration & product details

Registration no.
H2010/19996/037
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
MICONAZOLE NITRATE
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
A01AB - Antiinfectives and antiseptics for local oral treatment
RxNorm RxCUI
6932
Manufacturer / MAH
Dawa
Applicant / LTR
-
Country of origin
LOCAL
Manufacturer location
Baba Dogo Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 22:01:14 · updated 2026-03-23 04:46:28

Drug Interactions

44
Check interactions

Severe (5)

Antihistamines,non-Sedating - increases exposure

Miconazole is predicted to increase the exposure to antihistamines, non-sedating (mizolastine). Avoid.

Severe Theoretical

Ergometrine - increases exposure

Miconazoleispredictedtoincreasetheexposureto ergometrine.Avoid.oTheoretical

Severe Theoretical

Ergotamine - increases exposure

Miconazoleispredictedtoincreasetheexposureto ergotamine.Avoid.oTheoretical

Severe Theoretical

Mizolastine - increases exposure

Miconazole is predicted to increase the exposure to antihistamines, non-sedating (mizolastine). Avoid.

Severe Theoretical

Oral Benzodiazepines - increases exposure

Miconazole is predicted to increase the exposure to oral benzodiazepines (midazolam). Avoid.

Severe Theoretical

Moderate (33)

Alfentanil - increases exposure

Miconazole is predicted to increase the exposure to opioids (alfentanil). Use with caution and adjust dose.

Moderate Theoretical

Alkylating Agents - increases concentration

Miconazole is predicted to increase the concentration of alkylating agents (busulfan). Use with caution and adjust dose.

Moderate Theoretical

Alprazolam - increases exposure

Miconazole is predicted to increase the exposure to benzodiazepines (alprazolam). Use with caution and adjust dose.

Moderate Theoretical

Amlodipine - increases exposure

Miconazole is predicted to increase the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine, verapamil). Use with caution and a

Moderate Theoretical

Antiarrhythmics - increases exposure

Miconazole is predicted to increase the exposure to antiarrhythmics (disopyramide). Use with caution and adjust dose.

Moderate Theoretical

Unknown (6)

Aminoglycosides - decreases exposure

Miconazole potentially decreases the exposure to aminoglycosides (tobramycin).

Unknown Anecdotal

Cobimetinib - increases exposure

Miconazoleispredictedtoincreasetheexposureto cobimetinib.rTheoretical

Unknown Theoretical

Diltiazem - increases exposure

Miconazole is predicted to increase the exposure to calcium channel blockers (diltiazem).

Unknown Theoretical

Phenindione - increases anticoagulant effect

Miconazolegreatlyincreasestheanticoagulanteffectof phenindione.rTheoretical

Unknown Theoretical

Pimozide - increases exposure

Miconazoleispredictedtoincreasetheexposuretopimozide. Avoid.oTheoretical

Unknown Theoretical

Tobramycin - decreases exposure

Miconazole potentially decreases the exposure to aminoglycosides (tobramycin).

Unknown Anecdotal

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Miconazole is an antifungal medication used to treat fungal infections on the skin and in the mouth.

What it treats

  • fungal infections of the skin
  • oral thrush (fungal infection in the mouth)

How it works

It works by stopping the growth of fungi, helping to clear the infection.

Who it's for

This medication is for adults and children who have fungal infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Miconazole

BNF-referenced

Miconazole is an azole antifungal agent utilized for the treatment of various fungal infections, particularly those caused by Candida species. It acts primarily by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes, thereby compromising the integrity and function of the fungal cell. Miconazole can be administered topically, orally, or intravaginally, making it versatile for treating conditions such as oropharyngeal candidiasis, vaginal candidiasis, and superficial skin infections.

Indications

  • Vaginal candidiasis
  • Oropharyngeal candidiasis
  • Vulvovaginal infections
  • Superficial fungal infections

Dosage

Adults: For vaginal candidiasis, miconazole cream is typically applied twice daily, using 5 g inserted into the vagina for 7 days. For oropharyngeal candidiasis, the oral gel is usually administered as 2.5 mL four times a day.

Mechanism of action

Miconazole primarily acts through the inhibition of the CYP450 14α-lanosterol demethylase enzyme, leading to disrupted ergosterol production in fungal cell membranes. This disruption results in increased cell membrane permeability and leakage of essential cellular constituents. Additionally, miconazole inhibits fungal peroxidase and catalase, increasing the production of reactive oxygen species (ROS) which contribute to fungal cell death. Miconazole also elevates intracellular levels of farnesol, which disrupts quorum sensing in Candida, preventing the transition to more virulent forms.

Pharmacodynamics

Miconazole is predominantly applied topically, leading to minimal systemic absorption. Its primary adverse reactions are usually localized to hypersensitivity reactions, with the potential for anaphylaxis in rare cases. Patients using intravaginal miconazole are advised to avoid reliance on other contraceptive methods and not to use tampons simultaneously due to the risk of altered vaginal flora.

Pharmacokinetics

Miconazole is poorly absorbed when applied topically or intravaginally, resulting in low systemic exposure. The pharmacokinetics of miconazole can vary based on the route of administration, but systemic absorption is generally low, thus limiting systemic side effects and interactions. Miconazole is extensively metabolized in the liver, and its metabolites are excreted primarily through the urine.

Contra-indications

  • Hypersensitivity to miconazole or any of its excipients
  • Recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
  • Undiagnosed vaginal bleeding
  • Oestrogen-dependent tumors (e.g. breast cancer in first-degree relatives)
  • Acute porphyrias
  • Severe diabetes (increased risk of heart disease)

Adverse effects

  • Dysmenorrhoea
  • Skin reactions
  • Increased risk of gallbladder disease
  • Migraine or migraine-like headaches
  • Abdominal pain
  • Dysuria
  • Nausea
  • Pelvic cramps
  • Vaginal hemorrhage
  • Angioedema

Interactions

  • Miconazole + antihistamines (non-sedating): Severe (increases exposure)
  • Miconazole + mizolastine: Severe (increases exposure)
  • Miconazole + oral benzodiazepines: Severe (increases exposure)
  • Miconazole + ergometrine: Severe (increases exposure)
  • Miconazole + ergotamine: Severe (increases exposure)
  • Miconazole + alkylating agents: Moderate (increases concentration)
  • Miconazole + busulfan: Moderate (increases concentration)
  • Miconazole + antiarrhythmics: Moderate (increases exposure)
  • Miconazole + disopyramide: Moderate (increases exposure)
  • Miconazole + benzodiazepines: Moderate (increases exposure)

Precautions

  • Caution in patients with history of breast cancer
  • Monitor breast status regularly in women on oestrogen therapy
  • Risk of endometrial cancer with prolonged use of oestrogens
  • Risk of ovarian cancer with long-term use of combined HRT
  • Increased risk of venous thromboembolism in women using combined or oestrogen-only HRT

Pregnancy

Pregnant women may require a longer duration of treatment, usually about 7 days, to clear the infection. Caution is advised.

Breast-feeding

Manufacturer advises caution; no specific information available.

BNF 85 (British National Formulary) p.930 BNF 85 (British National Formulary) p.1356 BNF 85 (British National Formulary) p.1371 BNF for Children 2019-2020 p.756 BNF for Children 2019-2020 p.771 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Miconazole

PubChem CID 4189

Molecular formula: C18H14Cl4N2O

Mechanism of action

Miconazole is an azole antifungal used to treat a variety of conditions, including those caused by _Candida_ overgrowth. Unique among the azoles, miconazole is thought to act through three main mechanisms. The primary mechanism of action is through inhibition of the CYP450 14α-lanosterol demethylase enzyme, which results in altered ergosterol production and impaired cell membrane composition and permeability, which in turn leads to cation, phosphate, and low molecular weight protein leakage. In addition, miconazole inhibits fungal peroxidase and catalase while not affecting NADH oxidase activity, leading to increased production of reactive oxygen species (ROS). Increased intracellular ROS leads to downstream pleiotropic effects and eventual apoptosis. Lastly, likely as a result of lanosterol demethylation inhibition, miconazole causes a rise in intracellular levels of farnesol. This molecule participates in quorum sensing in _Candida_, preventing the transition from yeast to mycelial forms and thereby the formation of biofilms, which are more resistant to antibiotics. In addition, farnesol is an inhibitor of drug efflux ABC transporters, namely _Candida_ CaCdr1p and CaCdr2p, which may additionally contribute to increased effectiveness of azole drugs.

Pharmacodynamics

Miconazole is an azole antifungal that functions primarily through inhibition of a specific demethylase within the CYP450 complex. As miconazole is typically applied topically and is minimally absorbed into the systemic circulation following application, the majority of patient reactions are limited to hypersensitivity and cases of anaphylaxis. Patients using intravaginal miconazole products are advised not to rely on contraceptives to prevent pregnancy and sexually transmitted infections, as well as not to use tampons concurrently.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.