Individual generic drug information

miconazole

Reference monograph

Part of registered formulation

BECLOMETHASON E+MICONAZOLE+ NEOMYCIN

Reference record: Miconazole
Source: BNF 80 (2020–2021)
Printed source pages: 1305, 1306
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Miconazole only.

Indications And Dose

Oral candidiasis ▶BY MOUTH USING ORAL GEL ▶Child 2–17 years: 2.5 mL 4 times a day treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared, to be administered after meals, retain near oral lesions before swallowing (dental prostheses and orthodontic appliances should be removed at night and brushed with gel) ▶Adult: 2.5 mL 4 times a day treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared, to be administered after meals, retain near oral lesions before swallowing (dental prostheses and orthodontic appliances should be removed at night and brushed with gel) Intestinal candidiasis ▶BY MOUTH USING ORAL GEL ▶Child 4 months–17 years: 5 mg/kg 4 times a day (max. per dose 250 mg) treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared ▶Adult: 5 mg/kg 4 times a day (max. per dose 250 mg) treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared Prevention and treatment of oral candidiasis (dose approved for use by community practitioner nurse prescribers) ▶BY MOUTH USING ORAL GEL ▶Child 4–23 months: 1.25 mL 4 times a day treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared, to be smeared around the inside of the mouth after feeds ▶Child 2–17 years: 2.5 mL 4 times a day treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared, to be administered continued → after meals, retain near oral lesions before swallowing (dental prostheses and orthodontic appliances should be removed at night and brushed with gel) ▶Adult: 2.5 mL 4 times a day treatment should be continued for at least 7 days after lesions have healed or symptoms have cleared, to be administered after meals, retain near oral lesions before swallowing (dental prostheses and orthodontic appliances should be removed at night and brushed with gel) l UNLICENSED USE Not licensed for use in children under 4 months of age or during ﬁrst 5–6 months of life of an infant born pre-term.

Source pages 1305, 1306

Contra Indications

Infants with impaired swallowing reﬂex

Source page 1306

Cautions

Avoid in Acute porphyrias p. 1120

Source page 1306

Prescribing And Dispensing Information

Flavours of oral gel may include orange.

Source page 1306

Exceptions To Legal Category

15-g tube of oral gel can be sold to the public.

Source page 1306

Safety

Extracted information for Miconazole only.

Interactions

→Appendix 1: antifungals, azoles

Source page 1306

Side Effects

Ear, nose and oropharynx ▶Common or very common Skin reactions ▶Frequency not known Angioedema

Source page 1306

Pregnancy

Manufacturer advises avoid if possible— toxicity at high doses in animal studies.

Source page 1306

Breast Feeding

Manufacturer advises caution—no information available.

Source page 1306

Hepatic Impairment

Manufacturer advises avoid.

Source page 1306

Dose and formulations

Extracted information for Miconazole only.

Directions For Administration

Oral gel should be held in mouth, after food.

Source page 1306

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Oromucosal gel CAUTIONARY AND ADVISORY LABELS 9 ▶Daktarin (Johnson & Johnson Ltd, Janssen-Cilag Ltd) Miconazole 20 mg per 1 gram Daktarin 20mg/g oromucosal gel sugar-free | 15 gram p £4.01 DT = £4.01 sugar-free | 80 gram P £4.38 DT = £4.38 ANTIFUNGALS › POLYENE ANTIFUNGALS

Source page 1306

Clinical care

Extracted information for Miconazole only.

Patient And Carer Advice

Patients or carers should be given advice on how to administer miconazole oromucosal gel. l PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary Miconazole Oromucosal Gel may be prescribed.

Source page 1306

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Children

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Adults

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Children

First line only; read the complete Indications and dose section above.

5 mg/kg 4 times a day (max. per

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Adults

First line only; read the complete Indications and dose section above.

5 mg/kg 4 times a day (max. per dose 250 mg)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Children

First line only; read the complete Indications and dose section above.

1.25 mL 4 times a day treatment

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Children

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Adults

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1306

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

miconazole

Reference monograph

Part of registered formulation

BECLOMETHASON E+MICONAZOLE+ NEOMYCIN

Reference record: Miconazole
Source: BNF 80 (2020–2021)
Printed source pages: 1305, 1306
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Miconazole only.

Indications And Dose

Source pages 1305, 1306

Contra Indications

Infants with impaired swallowing reﬂex

Source page 1306

Cautions

Avoid in Acute porphyrias p. 1120

Source page 1306

Prescribing And Dispensing Information

Flavours of oral gel may include orange.

Source page 1306

Exceptions To Legal Category

15-g tube of oral gel can be sold to the public.

Source page 1306

Safety

Extracted information for Miconazole only.

Interactions

→Appendix 1: antifungals, azoles

Source page 1306

Side Effects

Ear, nose and oropharynx ▶Common or very common Skin reactions ▶Frequency not known Angioedema

Source page 1306

Pregnancy

Manufacturer advises avoid if possible— toxicity at high doses in animal studies.

Source page 1306

Breast Feeding

Manufacturer advises caution—no information available.

Source page 1306

Hepatic Impairment

Manufacturer advises avoid.

Source page 1306

Dose and formulations

Extracted information for Miconazole only.

Directions For Administration

Oral gel should be held in mouth, after food.

Source page 1306

Medicinal Forms

Source page 1306

Clinical care

Extracted information for Miconazole only.

Patient And Carer Advice

Source page 1306

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Children

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Adults

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Children

First line only; read the complete Indications and dose section above.

5 mg/kg 4 times a day (max. per

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Adults

First line only; read the complete Indications and dose section above.

5 mg/kg 4 times a day (max. per dose 250 mg)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Children

First line only; read the complete Indications and dose section above.

1.25 mL 4 times a day treatment

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Children

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1305

Adults

First line only; read the complete Indications and dose section above.

2.5 mL 4 times a day treatment should be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1306

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.