Daktarin® Gel

Declaration as user*

Please click the applicable link below

Are you a Medical Practitioner or Patient ?

*You undertake that you have provided accurate, complete and correct information to the company.

Patient

Please consult your Healthcare Professional for any drug-related information.

Medical Practitioner

For the use only of Registered Medical Practitioners or a Hospital or a Laboratory

NAME OF THE MEDICINAL PRODUCT
Daktarin® Gel

QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole Nitrate IP ………….2% w/w

PHARMACEUTICAL FORM
White homogeneous smooth gel.

CLINICAL INFORMATION
Indications
Treatment of Skin and nail infections due to dermatophytes, yeasts and other fungi such as:
• Tinea capitis, T. corporis, T. manuum, T. pedis (athlete’s foot), T. barbae, T. cruris.

Dosage and Administration
Apply some gel to the lesions twice daily. Rub the gel into the skin with your finger until it has fully penetrated.
The duration of therapy varies from 2 to 6 weeks depending on the localization and the severity of the lesions.
Treatment should be continued at least 1 week after disappearance of all signs and symptoms.
FOR EXTERNAL USE ONLY.

Contraindications
Daktarin gel is contraindicated in individuals with a known hypersensitivity to miconazole, another ingredient of the formulation, or other imidazole derivatives.

Warnings and Precautions
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin gel and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued. Daktarin gel must not come into contact with the eyes.

Interactions
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application (see Pharmacokinetic Properties), clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and the anticoagulant effect should be monitored. The effects and side effects of some other drugs (e.g., oral hypoglycemics and phenytoin), when co-administered with miconazole, can be increased and caution should be exercised.

Pregnancy and Breast-feeding
Pregnancy
Daktarin gel applied topically are minimally absorbed into the systemic circulation (bioavailability < 1%). Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing Daktarin gel during pregnancy should always be weighed against the expected therapeutic benefits.
Breast-feeding
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.

Effects on Ability to Drive and Use Machines
Not applicable.

Adverse Reactions
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of miconazole nitrate/miconazole based on the comprehensive assessment of the available adverse event information. A causal relationship with miconazole nitrate/miconazole cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical trial data
Adverse reactions reported among 834 patients who received miconazole nitrate 2% cream and/or placebo cream base in 21 double-blind clinical trials are presented in Table 1 below. Included in the table are all adverse events considered to be related to study drug. A dash indicates that the adverse reaction was not reported by patients in the specified treatment group.

Table 1: Adverse Reactions Reported by Patients in Either Treatment Group in 21 Double Blind Clinical Trials of Miconazole Nitrate 2% cream versus Placebo
System Organ Class
Adverse reaction Miconazole Nitrate 2% Cream
(n=426), % Placebo Cream Base
(n=408), %
Overall adverse reactions 1.9 1.2
Skin and subcutaneous tissue disorders
Skin burning sensation 0.2 0.7
Skin inflammation 0.2 --
Skin hypopigmentation 0.2 --
General disorders and administration site conditions
Application site irritation 0.7 0.5
Application site burning 0.2 0.2
Application site pruritus 0.2 --
Application site reaction NOS 0.2 --
Application site warmth 0.2 --
Note: Individual patients may have reported more than a single event.
Postmarketing data
In addition to the adverse reactions reported during clinical studies and listed above, the following adverse reactions have been reported during post marketing experience (Table 2). In the table, the frequencies are provided according to the following convention:

Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1000 and <1/100
Rare ≥1/10000 and <1/1000
Very rare <1/10000, including isolated reports.

In Table 2, adverse reactions are presented by frequency category based on spontaneous reporting rates.
Table 2: Adverse Reactions Identified During Postmarketing Experience with Daktarin gel by Frequency Category Estimated from Spontaneous Reporting Rates
Immune system disorders
Very rare anaphylactic reaction, hypersensitivity

Skin and subcutaneous tissue disorders
Very rare angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation

General disorders and administration site conditions
Very rare application site reactions, including application site irritation
Overdose
Symptoms
Topical use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment
Accidental ingestion: Daktarin gel is intended for topical use, not for oral use. Should accidental oral ingestion of large quantities of these products occur, an appropriate supportive care should be taken.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Pharmacotherapeutic group: Antifungals for dermatological/topical use; imidazole derivative, ATC code: D01A C02.

Mechanism of action
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.

Pharmacodynamic effects
Usually, miconazole acts very rapidly on pruritus, which frequently accompanies dermatophyte and yeast infections. This symptomatic improvement is seen before the first signs of healing are observed.

Miconazole has also been proven to be effective in secondarily infected mycoses.

Microbiology
Miconazole combines an antifungal activity against the common dermatophytes, yeasts and various other fungi with an antibacterial activity against certain gram-positive bacilli and cocci.

Pharmacokinetic Properties
Absorption
Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hours after application.

Systemic absorption has also been demonstrated after repeated application of miconazole to infants with diaper dermatitis. Plasma levels of miconazole were undetectable or low in all infants.

Distribution
Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism and Excretion
The small amount of miconazole that is absorbed is eliminated predominantly in feces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine.

NON-CLINICAL INFORMATION
Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

PHARMACEUTICAL INFORMATION
List of Excipients
The inactive ingredients are Carbomer, Triethanolamine, Benzoic Acid, Disodium Edetate, Propylene Glycol, Purified Water.

Incompatibilities
None known.

Shelf Life
See expiry date on Tube & Outer carton.

Special Precautions for Storage
Store below 300C. Do not freeze.
Replace cap tightly.
Keep out of reach of children.

Instructions for Use and Handling
To open the tube, reverse the cap and pierce the protective seal on the tube.

Nature and Contents of Container
Daktarin Gel is supplied in Aluminium tube of 40g along with Carton.

Manufactured by:
Encube Ethicals Pvt. Ltd.,
Plot No. C1, Madkaim Ind. Estate,
Madkaim, Post Mardol, Ponda,
Goa - 403 404, India.

Marketed by:
JNTL Consumer Health (India) Pvt. Ltd,
Office No. 16, Ground Floor, Admin Block,
L.B.S. Marg, Mulund (West),
Mumbai 400 080.

DATE OF REVISION OF THE TEXT
27 December 2022
Reference: Company Core Data Sheet (CCDS) dated 27 Aug 2015.