Novale Bar 75gm

INTRODUCTION

NOVALE BAR contains Ketoconazole which belongs to the group of medicines called Antifungals. It is used to treat various fungal infections of the skin such as ringworm, athlete’s foot and dermatitis associated with such infections.

NOVALE BAR can also be used to treat other fungal infections like candida paronychia (fungal infection around nails), cutaneous candidiasis (fungal infection of the skin), and pityriasis versicolor (characterized by the development of hyper-pigmented patches on the trunk that may/may not spread to arms and shoulders).

Before using NOVALE BAR, inform your doctor if you have any allergies or pre-existing conditions, or if you are taking any other medicines. NOVALE BAR should be used cautiously in pregnant and breastfeeding women. The safety and effectiveness of NOVALE BAR in children (less than 12 years of age) have not been established so, consult your child’s doctor for advice.

The most common side effects associated with NOVALE BAR are skin dryness, itching, redness or burning sensation. It is recommended to consult the doctor if any of the symptoms worsen.

USES OF NOVALE BAR

Treats various fungal infections of the skin such as:

• ringworm, athlete’s foot and dermatitis associated with such infections
• candida paronychia
• cutaneous candidiasis
• pityriasis versicolor

HOW NOVALE BAR WORKS

NOVALE BAR clears the infection by causing holes in the fungal cell membranes, thus killing the fungi.

DIRECTIONS FOR USE

Always apply NOVALE BAR as directed by your physician. It is for external use only. Apply NOVALE BAR on the affected area. It can be applied on the body and scalp. Wash and rinse thoroughly with water after applying NOVALE BAR. Avoid contact of NOVALE BAR with the nose, mouth or eyes.

If NOVALE BAR accidentally gets in your eye, gently rinse your eyes with cold water. Your doctor will decide the right dose and duration of therapy for you according to your age, body weight and disease condition.

SIDE EFFECTS OF NOVALE BAR

HOW TO MANAGE SIDE EFFECTS

Itching, dryness and burning sensation of skin:

Try to avoid the urge to scratch as it may lead to further damage. Keep your nails trimmed and clean. Use a gentle cleanser to wash the skin to avoid dirt and bacterial build-up. Do not rub the area roughly with a harsh cloth as it may cause more itching. Instead, let the area air-dry. Cover with a generous layer of moisturizer and stay hydrated. Applying ice packs may provide relief to the burning sensation of the skin. Consult your doctor if any of the symptoms remain or worsen.

WARNING & PRECAUTIONS

PREGNANCY

NOVALE BAR should be used with caution in pregnant women as it is not known if this medicine will harm your unborn baby. Consult your doctor before using it.

BREASTFEEDING

NOVALE BAR should be used with caution in breastfeeding women as it is not known if this medicine passes into your breast milk. Consult your doctor before using it.

ALLERGY

Do not use NOVALE BAR if you are allergic to Ketoconazole or any of the other ingredients of this medicine.

INTERACTIONS

A. Drug-Drug Interactions

Before using NOVALE BAR, inform your doctor if you are taking, have taken, or might take any other medicine, including prescription, non-prescription or herbal medicine.

Overdosage:

If you or anyone else accidentally use too much of NOVALE BAR, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep NOVALE BAR out of reach of children
• Do not store above 25°C

FAQs ABOUT NOVALE BAR

Can NOVALE BAR be used on infants?

The safety and effectiveness of NOVALE BAR in children (less than 12 years of age) have not been established. Consult your child’s doctor for advice. The doctor will determine an appropriate dose or select a suitable alternative treatment for your child.

What if NOVALE BAR accidentally gets into my eyes, mouth or nose?

Avoid getting NOVALE BAR into your eyes, mouth, or nose. In case it comes in contact with these areas accidentally, wash it with water thoroughly. Call your doctor if any discomfort occurs.

Can NOVALE BAR be used by elderly people?

NOVALE BAR is not recommended to be used by elders above the age of 65, due to lack of safety data. For patients below that age, it is recommended to be used only after consultation by a doctor.

Can NOVALE BAR be used by pregnant women?

NOVALE BAR should be used with caution in pregnant women as it is unknown if this medicine will harm your unborn baby. If you are pregnant, think you may be pregnant or are planning to get pregnant, consult your doctor before taking it.

Can I take other medicines with NOVALE BAR?

Before using NOVALE BAR, inform your doctor if you are taking, have taken, or might take any other medicine, including prescription, over the counter or any herbal medicine, as these might lead to serious side effects by interacting with each other.

REFERENCES

1. KD. Tripathi. Antifungal Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 791, 792.Raviteja Innamuri, Sudhir Nayak UK, Shrutakirthi D Shenoi. Open comparative study of efficacy and safety of ketoconazole soap and oral ketoconazole in tinea versicolor. Journal of Pakistan Association of Dermatologists. 2014. [Accessed on 11th October 2022] https://applications.emro.who.int/imemrf/J_Pak_Assoc_Dermatol/J_Pak_Assoc_Dermatol_2014_24_1_63_67.pdf

2. C.A. Green, P. M. Farr. S. Shuster. Treatment of seborrhoeic dermatitis with ketoconazole: II. Response of seborrhoeic dermatitis of the face, scalp and trunk to topical ketoconazole. BJD. British Journal of Dermatology. February 1987. [Accessed on 11th October 2022] https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2133.1987.tb05815.x

3. Padagis Israel Pharmaceuticals Ltd. Ketoconazole- ketoconazole aerosol, foam. [Revised in September 2022] [Accessed on 11th October 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9b65f632-a98d-400e-9ec3-84dea581d6a3&type=display   

4. VKAN Healthcare. Vabderm-K (Ketoconazole 1% soap). [Accessed on 14th October 2022] http://www.vkanhealthcare.com/ketoconazole-soap-4779042.html

5. Integrated Labortaries. Inte- Ket Soap (Ketoconazole 2%). [Accessed on 11th October 2022] https://integratedlaboratories.in/ketoconazole-2-inte-ket-soap/

AUTHOR DETAILS

Written By Dr. Jeenal Rajani, Pharm.D.
Last updated on 27 Oct 2022 | 03:52 PM(IST)