INTRODUCTION

ULTIDERM CS LOTION contains Fluocinolone which belongs to the group of medicines called Corticosteroids. It is indicated for the relief of the inflammatory and pruritic (irritating, itchy) symptoms of corticosteroid-responsive dermatoses (skin conditions that can be treated with corticosteroid medicines).

Before using ULTIDERM CS LOTION, inform your doctor if you have any skin infections or if you are using any other medicines. ULTIDERM CS LOTION should be used in pregnancy only if the potential benefit justifies the potential risk to the baby and should be used with caution in breastfeeding women.

Caution should be exercised while using ULTIDERM CS LOTION in children so, consult your child’s doctor for advice. Patients may experience local reactions like burning, itching, irritation, dryness, etc. Contact your doctor if any of the symptoms worsen over time.

USES OF ULTIDERM CS LOTION

• Used to relieve the inflammatory and pruritic symptoms of corticosteroid-responsive dermatoses

HOW ULTIDERM CS LOTION WORKS

ULTIDERM CS LOTION reduces the swelling and constriction of the blood vessels by inhibiting the factors that cause swelling and inflammation. It also blocks the pathway of certain substances that cause inflammation (prostaglandins).

DIRECTIONS FOR USE

Always apply ULTIDERM CS LOTION as directed by your physician. Apply a thin film of ULTIDERM CS LOTION over the affected area. It is for external use only. Avoid applying this medicine around your eyes, including eyelids, nose and mouth.

In hairy sites, the hair should be parted to allow direct contact with the affected area. Wash hands before and after the application of ULTIDERM CS LOTION. Your doctor will decide the right dose and duration of ULTIDERM CS LOTION treatment depending on your age, weight and disease condition.

SIDE EFFECTS OF ULTIDERM CS LOTION

HOW TO MANAGE SIDE EFFECTS

Skin irritation:

Pat or tap your skin rather scratching it and hold something cool on your skin, like a damp towel. Have cool or warm baths or showers. Keep your nails clean, short and smooth and wear loose cotton clothing. If symptom persists, contact your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug – Drug Interactions:

Before using ULTIDERM CS LOTION, inform your doctor if you are using, have used or might use any other medicine, including prescription, non-prescription or any herbal medicine.

Overdosage:

If you or anyone else accidentally use too much of ULTIDERM CS LOTION, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose include Cushing’s syndrome (extreme tiredness, muscle weakness, headaches), hyperglycaemia or glucosuria (increased thirst and frequency of urination, dry mouth, blurred vision, tiredness).

SYNOPSIS

MORE INFORMATION

• Keep ULTIDERM CS LOTION out of reach of children
• Store between 15°C - 25°C

FAQs ABOUT ULTIDERM CS LOTION

What if I forget to apply a dose of ULTIDERM CS LOTION?

If you forget to apply a dose of ULTIDERM CS LOTION, do it as soon as you remember. However, omit that dose if it's almost time for the next one. Do not apply a double quantity of ULTIDERM CS LOTION to make up for the missed dose.

What if ULTIDERM CS LOTION accidentally gets into my eyes, mouth or nose?

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

Can ULTIDERM CS LOTION affect overall health?

Patients receiving a large dose of ULTIDERM CS LOTION either by applying to a large area or having covered dressings can absorb the medicine in a sufficient amount which can cause HPA axis suppression, Cushing's syndrome and intracranial hypertension, for which you will be evaluated periodically.

Can ULTIDERM CS LOTION be used by pregnant and breast-feeding women?

ULTIDERM CS LOTION should be used in pregnancy only if the potential benefit justifies the potential risk to the baby and should be used with caution in breastfeeding women. Consult your doctor before using it.

Can ULTIDERM CS LOTION be used in children?

ULTIDERM CS LOTION should be used with caution in children. Parents of children should not use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Consult your child’s doctor for advice.

REFERENCES

1. KD. Tripathi. Drugs Acting on Skin and Mucous Membranes. Essentials of medical pharmacology. Eighth edition. 2019. Page – 895.

2. PubChem Compound Summary for CID 6215, Fluocinolone acetonide. National Center for Biotechnology Information. PubChem. [Accessed on 16th June 2022]. https://pubchem.ncbi.nlm.nih.gov/compound/Fluocinolone-acetonide#section=Mechanism-of-Action

3. KANEE B. Clinical studies with topical fluocinolone acetonide in the treatment of various dermatoses. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. May 1963. [Accessed on 16th June 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1921315/pdf/canmedaj00996-0011.pdf

4. IGI Laboratories, Inc. U.S. Food & Drug Administration. [Revised in November 2012] [Accessed on 16th June 2022]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf

5. Teligent Pharma, Inc. Fluocinolone Acetonide Topical Solution USP, 0.01%. Dailymed. [Revised in June 2018]. [Accessed on 16th June 2022]. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b859bc63-a9e3-4a6d-a3f7-711b4eeaba63&type=display#pediatric

6. E. FOUGERA & CO. FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%. Dailymed. [Revised in September 2020] [Accessed on 16th June 2022]. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=49552e29-7813-4726-b15d-63bd975b6588&type=display

USEFUL DIAGNOSTIC TESTS

• Urinary free cortisol test
• ACTH stimulation test