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

Fluocinolone Acetonide Shampoo

SEBOWASH Shampoo

Qualitative and Quantitative Composition

SEBOWASH Shampoo

Fluocinolone Acetonide IP …………....0.01% w/v

Dosage Form and Strength

Shampoo, 0.01% w/v

Clinical Particulars

Therapeutic Indications

SEBOWASH Shampoo is indicated for the treatment of seborrhoeic dermatitis of the scalp. This product has not been proven effective in other corticosteroid-responsive dermatoses

Posology and Method of Administration

The SEBOWASH Shampoo bottle should be shaken well prior to use. The required amount of SEBOWASH Shampoo should be applied to the scalp area once daily, massaged until it lathers, and then allowed to remain on the scalp for approximately 5 minutes. The hair and scalp should then be rinsed thoroughly with water.

Contraindications

SEBOWASH Shampoo is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Special Warnings and Precautions for Use

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticoid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycaemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary-free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

If irritation develops, SEBOWASH Shampoo should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favourable response does not occur promptly, use of SEBOWASH Shampoo should be discontinued until the infection has been adequately controlled.

Use in Special Population

Pregnant Women

Pregnancy Category C      

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women or teratogenic effects from fluocinolone acetonide shampoo. Therefore, SEBOWASH Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Lactating Women

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are secreted in human milk, caution should be exercised when SEBOWASH Shampoo is administered to a nursing woman.

Pediatric Patients 

Safety and effectiveness in children and infants have not been established. Because of a higher ratio of skin surface area to body mass, paediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore, also at a greater risk of glucocorticoid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilloedema.

Undesirable Effects

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning, itching, irritation, and hypopigmentation.

In case your patient experiences any side-effect/s, write to drugsafety@cipla.com. You can also report side-effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product.

Overdose

Topically applied fluocinolone acetonide shampoo can be absorbed in sufficient amounts to produce systemic effects (See Special Warnings and Precautions for Use).

Pharmacological Properties

Pharmacodynamic Properties

Fluocinolone acetonide (6 alpha, 9-Difluro-11 beta, 16 alpha, 17,21 -tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16,17-acetal with acetone) is a synthetic fluorinated corticosteroid for topical dermatologic use. Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Fluocinolone acetonide has low to medium potency, compared to other topical corticosteroids.

Pharmacokinetics Properties

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin while inflammation and/or other disease processes in the skin increase percutaneous absorption.

Fluocinolone acetonide shampoo is in the low to medium range of potency as compared with other topical corticosteroids.

Nonclinical Properties

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Fluocinolone acetonide Shampoo.

Description

SEBOWASH Shampoo contains the synthetic fluorinated corticosteroid fluocinolone acetonide for topical use.

Pharmaceutical Particulars

Shelf-Life

See on Pack

Packaging Information

SEBOWASH Shampoo……………..bottle of 125 mL

Storage and Handling Instructions

Store below 25⁰C and dry place. Keep the bottle tightly closed.

Keep out of reach of children.

Patient Counselling Information

What is SEBOWASH Shampoo?

SEBOWASH Shampoo is a prescription medicine used on the scalp to treat a skin condition called seborrheic dermatitis. It is not known if SEBOWASH Shampoo is safe and effective in children and infants.

How should I use SEBOWASH Shampoo?

• Use SEBOWASH Shampoo exactly as your doctor tells you to use it.
• SEBOWASH Shampoo is for use on your scalp only (topical).
• Shake the SEBOWASH Shampoo bottle well before using.
• Wet the hair and scalp thoroughly, apply sufficient amount of SEBOWASH Shampoo, and massage into the scalp. (Please note that this product does not contain drying detergents and, therefore, produces minimal lathering.)
• Allow the shampoo to remain on the scalp for 5 minutes. (Note: This is necessary for effective treatment.)
• Rinse your hair and scalp well with water.
• Repeat the above instructions daily for 2 weeks.
• Avoid getting SEBOWASH Shampoo in your eyes. If you get SEBOWASH Shampoo in your eyes, rinse your eyes well with water.
• Do not bandage or cover your head after using SEBOWASH Shampoo unless your doctor tells you to.
• Tell your doctor if you develop irritation where you apply SEBOWASH Shampoo, or if your seborrheic dermatitis is not getting better with SEBOWASH Shampoo.

Who should not use SEBOWASH Shampoo?

Do not use SEBOWASH Shampoo if you are allergic to any of its ingredients.

Before using SEBOWASH Shampoo, tell your doctor about all of your medical conditions, including if you:

• have a scalp infection. You may need medicine to treat the scalp infection before you use SEBOWASH Shampoo.
• are pregnant or plan to become pregnant. It is not known if SEBOWASH Shampoo can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if SEBOWASH Shampoo passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed you baby if you use SEBOWASH Shampoo.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Do not use other products containing a corticosteroid medicine with SEBOWASH Shampoo without talking to your doctor first.

What are the possible side effects of SEBOWASH Shampoo?

SEBOWASH Shampoo can pass through your s kin.

The side effects of corticosteroids medicines used on the skin (topical) include:

• dry, itchy, and reddened skin
• burning or stinging at application site
• inflamed hair follicle
• acne
• thinning of skin
• loss of skin color

These are not all the possible side effects of fluocinolone acetonide shampoo. For more information, ask your doctor.

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side-effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product.

How should I store SEBOWASH Shampoo?

• Store below 25⁰C and dry place.
• Keep the bottle tightly closed.
• Keep SEBOWASH Shampoo out of reach of children.

General information about SEBOWASH Shampoo

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SEBOWASH Shampoo for a condition for which it was not prescribed. Do not give SEBOWASH Shampoo to other people, even if they have the same symptoms you have. It may harm them.

Details of Manufacturer

M/s Golden Cross Pharma Ltd,

Tarpin Block, Rorathang, Sikkim - 737133

Details of Permission or Licence Number with Date

M/481/08 dated 05/01/2023

Date of Revision

15/05/2023