Registered Kenya · PPB

UNISTEN COMBI-PACK

CLOTIMAZOLE VAGINAL TABLET CLOTIMAZOLE CREAM

What it does

Clotrimazole is an antifungal medication used to treat infections caused by fungi.

Commonly used for: fungal skin infections, athlete's foot (tinea pedis), ringworm (tinea corporis), thrush (oral candidiasis)

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

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Registration & product details

Registration no.
H2010/19224/836
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
CLOTIMAZOLE VAGINAL TABLET CLOTIMAZOLE CREAM
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Regal Pharmaceuticals
Applicant / LTR
-
Country of origin
LOCAL
Manufacturer location
Road 1, off Baba dogo Road, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 21:49:47 · updated 2026-03-23 04:34:52

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

About clotimazole

Clotrimazole is an antifungal medication used to treat infections caused by fungi.

What it treats

  • fungal skin infections
  • athlete's foot (tinea pedis)
  • ringworm (tinea corporis)
  • thrush (oral candidiasis)

How it works

Clotrimazole works by stopping the growth of fungi, helping to clear up infections.

Who it's for

Clotrimazole is suitable 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 vaginal

Vaginal medications are treatments applied inside the vagina to address various conditions.

What it treats

  • vaginal infections
  • yeast infections (candidiasis)
  • bacterial vaginosis
  • hormone replacement therapy

How it works

These medications work by targeting specific issues within the vagina, such as infections or hormonal imbalances.

Who it's for

Vaginal medications are for anyone experiencing vaginal conditions or symptoms.

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

Clinical monograph: clotimazole

Clotrimazole is an antifungal medication that belongs to the imidazole class. It is used for the treatment of various fungal infections by inhibiting the growth of fungi. Clotrimazole is primarily applied topically in the form of creams, ointments, and solutions, though it can also be found in oral formulations for the treatment of oral thrush. The drug is effective against dermatophytes and yeasts, including Candida species.

Indications

  • Topical treatment of dermatophyte infections
  • Vulvovaginal candidiasis
  • Oral candidiasis (thrush)
  • Tinea corporis (ringworm)
  • Tinea pedis (athlete's foot)
  • Tinea cruris (jock itch)

Dosage

Children: Dosage for children should be determined based on the specific condition and formulation. Refer to paediatric dosing guidelines for accurate dosing information.

Adults: Dosage varies depending on the specific formulation and condition being treated. Refer to product-specific guidelines for detailed dosing information.

Mechanism of action

Clotrimazole exerts its antifungal activity by inhibiting the enzyme lanosterol 14-alpha-demethylase, which is crucial in the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to a decrease in ergosterol levels, resulting in increased membrane permeability and ultimately cell death.

Pharmacodynamics

Clotrimazole demonstrates a fungistatic effect at lower concentrations, inhibiting fungal growth, while at higher concentrations, it may exhibit fungicidal activity. The drug's efficacy is influenced by the concentration of the drug at the site of infection and the susceptibility of the fungal organism. It is generally well-tolerated with a low incidence of systemic side effects when used topically.

Pharmacokinetics

Clotrimazole is poorly absorbed from the gastrointestinal tract when taken orally, which limits systemic exposure. Topically applied clotrimazole penetrates the skin and reaches therapeutic concentrations in the stratum corneum. The systemic absorption is minimal, and it undergoes hepatic metabolism. The elimination half-life varies depending on the formulation and route of administration.

Adverse effects

  • Local irritation
  • Burning sensation
  • Erythema
  • Pruritus

Precautions

  • Avoid contact with eyes
  • Use with caution in individuals with hypersensitivity to imidazole antifungals

Pregnancy

Clotrimazole is categorized as Pregnancy Category C. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Clotrimazole is excreted in breast milk; caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Topical cream
  • Vaginal cream
  • Vaginal tablets

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: vaginal

Vaginal drugs refer to medications administered via the vaginal route for the treatment of various conditions, including infections, hormonal imbalances, and contraceptive purposes. This route allows for localized effects with reduced systemic absorption, making it suitable for certain therapeutic applications. Common forms include creams, gels, tablets, and suppositories, which can provide targeted action while minimizing systemic side effects.

Indications

  • Bacterial vaginosis
  • Candidiasis (yeast infection)
  • Trichomoniasis
  • Hormonal replacement therapy
  • Contraception
  • Local treatment of vulvovaginal atrophy

Dosage

Children: Refer to specific product guidelines and consult pediatric dosing references, as dosing for children may differ significantly from adults.

Adults: Refer to specific product guidelines for dosing instructions, as vaginal drug dosages can vary widely based on the formulation and indication.

Mechanism of action

Vaginal medications typically exert their effects locally at the site of application. For instance, antifungal agents work by disrupting the cell membrane of fungi, leading to cell death. Hormonal treatments may act by binding to specific receptors, modulating local tissue responses. The specific mechanism varies by drug class, with some agents enhancing local immune responses or altering the vaginal microbiota.

Pharmacodynamics

The pharmacodynamics of vaginal medications depend on their formulation and active ingredients. Antifungals such as clotrimazole alter fungal cell membrane permeability, while hormonal preparations like estrogen can promote tissue regeneration and maintain vaginal pH. The local environment, including the presence of vaginal flora and pH, can significantly influence the efficacy of these medications.

Pharmacokinetics

Pharmacokinetics of vaginal drugs vary widely. Local absorption into the systemic circulation is generally low, which minimizes systemic side effects. However, some drugs may still be absorbed, leading to systemic effects. The onset of action is typically rapid due to the rich vascular supply of the vaginal mucosa. Factors such as formulation, dosage, and individual patient characteristics can affect the pharmacokinetic profile.

Pregnancy

Vaginal medications should be used during pregnancy only if clearly needed. Consult healthcare provider for specific advice.

Breast-feeding

Consult healthcare provider before using vaginal medications while breastfeeding.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

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

This drug in other countries

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