Registered Tanzania · TMDA

Elica M

Miconazole Nitrate 2 w/v,Mometasone furoate 0.1 w/v

TZ 16 H 0372 Cream 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.

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

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Registration & product details

Registration no.
TZ 16 H 0372
Registration date
2021-12-04
Expiry date
2026-12-03
Status
Registered/Compliant
Active ingredient
Miconazole Nitrate 2 w/v,Mometasone furoate 0.1 w/v
Dosage form
Cream
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
A01AB - Antiinfectives and antiseptics for local oral treatment
RxNorm RxCUI
6932
Manufacturer / MAH
Jamjoom Pharmaceuticals
Country of origin
SAUDI ARABIA
Manufacturer location
Jeddah 1st Industrial City, Jeddah 21442, Saudi Arabia

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:38:35 · updated 2026-10-22 03:00:44

Drug Interactions

83
Check interactions

Severe (6)

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

Mifamurtide - decreases efficacy

Corticosteroidsarepredictedtodecreasetheefficacyof mifamurtide.Avoid.rTheoretical

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 (51)

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 (26)

Aminoglycosides - decreases exposure

Miconazole potentially decreases the exposure to aminoglycosides (tobramycin).

Unknown Anecdotal

Aspirin - decreases concentration

Corticosteroids are predicted to decrease the concentration of aspirin (high-dose) and aspirin (high-dose) increases the risk of gastrointestinal bleeding when given with corticosteroids.

Unknown Study

Choline Salicylate - decreases concentration

Corticosteroids are predicted to decrease the concentration of cholinesalicylate. Ciclesonide → see corticosteroids Ciclosporin → see TABLE 2 p. 1517 (nephrotoxicity), TABLE 16 p. 1521 (increased seru

Unknown Study

Cobimetinib - increases exposure

Miconazoleispredictedtoincreasetheexposureto cobimetinib.rTheoretical

Unknown Theoretical

Corticosteroids - increases exposure

Cobicistat is predicted to increase the exposure to corticosteroids (beclometasone) (risk with beclometasone is likely to be lower than with other corticosteroids).

Unknown Theoretical

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 Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About miconazole

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.

About mometasone

Mometasone is a corticosteroid used to reduce inflammation and treat various allergic and skin conditions.

What it treats

  • allergic rhinitis (hay fever)
  • asthma
  • skin conditions like eczema and psoriasis

How it works

It works by reducing inflammation in the body, which helps relieve symptoms.

Who it's for

It is for people suffering from allergies, asthma, or certain skin problems.

Drug class

Corticosteroids

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.

Clinical monograph: Mometasonefuroate

BNF-referenced

Mometasone furoate is a potent corticosteroid used primarily for the management of asthma, allergic rhinitis, and nasal polyps. It exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties, making it effective in reducing airway inflammation and alleviating symptoms of nasal congestion. Mometasone furoate is typically administered via inhalation or as a nasal spray, allowing for targeted delivery and minimizing systemic side effects.

Indications

  • Management of asthma in adults and adolescents not adequately controlled with inhaled corticosteroids and short-acting beta-2 agonists
  • Allergic rhinitis
  • Nasal polyps

Dosage

Children: For children aged 12-17 years, initially 400 micrograms daily in 1-2 divided doses, single dose to be inhaled in the evening, reduced to 200 micrograms once daily if control is maintained.

Adults: 1 inhalation once daily; dosage may be increased to 400 micrograms twice daily if necessary.

Mechanism of action

Mometasone furoate works by binding to glucocorticoid receptors, leading to the modulation of gene expression. This results in the inhibition of pro-inflammatory cytokines and chemokines, thereby reducing inflammation in the airways and nasal passages. It also inhibits the activation of inflammatory cells such as eosinophils and mast cells, contributing to its therapeutic effects.

Pharmacodynamics

As a corticosteroid, mometasone furoate exhibits significant anti-inflammatory effects, which are crucial in the management of asthma and allergic conditions. The drug reduces airway hyper-responsiveness and decreases mucus production, leading to improved airflow and decreased symptoms such as wheezing and shortness of breath. Its rapid onset of action is beneficial for acute symptom relief.

Pharmacokinetics

Mometasone furoate is well-absorbed when administered by inhalation or nasal spray. It undergoes extensive first-pass metabolism in the liver, resulting in low systemic bioavailability. The drug is primarily excreted via the feces, with a small percentage eliminated through the urine. The half-life of mometasone furoate is approximately 5.8 hours, allowing for once-daily dosing in many cases.

Adverse effects

  • Candida infection
  • Nasal ulceration
  • Throat irritation
  • Headache
  • Cough

Interactions

  • Corticosteroids
  • Beta2 agonists

Precautions

  • Use with caution in patients with active or quiescent tuberculosis infections
  • Monitor for signs of infection
  • Use in hepatic impairment requires caution

Pregnancy

Use only if potential benefit outweighs risk-limited information available.

Breast-feeding

Avoid-present in milk in animal studies.

Storage

Store below 30°C. Protect from light and moisture.

Formulations

  • {'form': 'Inhalation powder', 'strength': '200 micrograms per dose', 'brand': 'Asmanex Twisthaler'}
  • {'form': 'Aqueous nasal spray', 'strength': '50 micrograms per dose', 'brand': 'Flixonase'}
BNF 85 (British National Formulary) p.311 BNF 85 (British National Formulary) p.1345 BNF 85 (British National Formulary) p.1386 BNF for Children 2019-2020 p.188 BNF for Children 2019-2020 p.747 BNF for Children 2019-2020 p.785 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.

Clinical monograph: mometasone

BNF-referenced

Mometasone is a synthetic corticosteroid that exhibits medium potency and is primarily used for its anti-inflammatory, antipruritic, and vasoconstrictive properties. It is effective in the management of various inflammatory conditions, such as asthma, allergic rhinitis, and skin disorders. Mometasone works by reducing inflammation and suppressing immune responses, providing relief from symptoms associated with these conditions.

Indications

  • Asthma
  • Allergic rhinitis
  • Skin conditions (e.g., eczema, dermatitis)

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing guidelines.

Adults: Refer to the specific BNF guidelines for adult dosing, which may vary based on the condition being treated.

Mechanism of action

Mometasone exerts its anti-inflammatory effects by crossing cell membranes and binding with high affinity to specific cytoplasmic glucocorticoid receptors. This interaction diminishes the release of leukocytic acid hydrolases, prevents macrophage accumulation at inflamed sites, interferes with leukocyte adhesion to capillary walls, reduces capillary membrane permeability, and inhibits the release of histamine and kinin. Additionally, mometasone inhibits the formation of scar tissue and acts through phospholipase A2 inhibitory proteins, known as lipocortins, which control the synthesis of potent inflammatory mediators like prostaglandins and leukotrienes.

Pharmacodynamics

Mometasone demonstrates medium potency as a corticosteroid, effectively reducing inflammation without significant systemic absorption due to extensive hepatic metabolism. Its local effects are favored over systemic effects, making it suitable for chronic conditions like asthma, where immediate symptom relief is not expected. The onset of action may take 1 to 2 weeks for maximum improvement in asthma symptoms following inhalation. Discontinuation of mometasone may allow for sustained asthma stability for several days.

Pharmacokinetics

Mometasone is extensively metabolized in the liver, resulting in a low systemic bioavailability. Its pharmacokinetic profile includes rapid absorption and distribution, with a half-life that supports once-daily dosing in many cases. The lack of active metabolites contributes to its safety profile, minimizing systemic effects while providing effective local action.

Interactions

  • cobicistat+mometasone: Unknown (increases exposure)
  • idelalisib+mometasone: Unknown (increases exposure)
  • clarithromycin+mometasone: Unknown (increases exposure)

Pregnancy

Mometasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution should be exercised when administering mometasone to nursing mothers, as it is not known whether it is excreted in human milk.

Storage

Store at room temperature, away from light and moisture. Do not freeze.

Formulations

  • Mometasone furoate nasal spray
  • Mometasone furoate inhalation aerosol
  • Mometasone furoate cream
  • Mometasone furoate ointment
  • Mometasone furoate lotion

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.

Molecular reference: mometasone

PubChem CID 441335

Molecular formula: C22H28Cl2O4

Mechanism of action

Unbound corticosteroids cross cell membranes and bind with high affinity to specific cytoplasmic receptors. Inflammation is decreased by diminishing the release of leukocytic acid hydrolases, prevention of macrophage accumulation at inflamed sites, interference with leukocyte adhesion to the capillary wall, reduction of capillary membrane permeability, reduction of complement components, inhibition of histamine and kinin release, and interference with the formation of scar tissue. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A<sub>2</sub> inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Mometasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone.

Pharmacodynamics

Mometasone is a medium-potency synthetic corticosteroid with antiinflammatory, antipruritic, and vasoconstrictive properties. Studies in asthmatic patients have demonstrated that mometasone provides a favorable ratio of topical to systemic activity due to its primary local effect along with the extensive hepatic metabolism and the lack of active metabolites. Though effective for the treatment of asthma, glucocorticoids do not affect asthma symptoms immediately. Maximum improvement in symptoms following inhaled administration of mometasone furoate may not be achieved for 1 to 2 weeks or longer after starting treatment. When glucocorticoids are discontinued, asthma stability may persist for several days or longer. Mometasone has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. The clinical significance of these findings is unknown.

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.