Shampoo

 

Itching, flaking and scaling skin above the hairline can be quite common.
In its mildest form it is called dandruff. But when there is an annoying itch, extreme flaking along with inflamed greasy, scaly-looking skin above the frontal hairline or around the ears, it could be scalp Seborrheic Dermatitis (SSD).

The Latin translation of Seborrhoea means 'free flowing oil' and dermatitis means 'inflamed skin'. Seborrheic dermatitis is a non-contagious skin condition that can range in severity from a mild rash to severe redness and is often associated with itching and yellow greasy scaliness. It is a stubborn and persistent condition that can cause a great deal of discomfort. Seborrheic Dermatitis usually affects the scalp but can also occur on other parts of the face and body such as the nose, eyelids, ears, and navel as well as skin folds under the arms, breasts, groin and buttocks. Inflammation typically occurs in these areas because the skin oil glands are largely concentrated here.

Scalp Seborrheic Dermatitis (SSD) is the most common form of the condition and affects people of all ages.

First time in Bangladesh

Scalp itch can now be washed away



Seorrheic Dermatitis (SD) in Infants
When SD occurs during infancy, it is also called "cradle cap" because it usually occurs around the scalp and ears. Symptoms may also be present in the diaper region or any bent surface areas.
While the exact cause of Seborrheic Dermatitis is still unknown and may vary from infants to adults, there are various factors related to the onset of the condition that should be considered when selecting treatment. Stress, fatigue, extreme
weather conditions, oily skin, infrequent shampooing or skin cleansing, skin disorders such as Acne, Obesity, and the use of lotions that contain alcohol have all been found to increase the risk or worsen Seborrheic Dermatitis. Another cause believed to contribute to outbreaks of Seborrheic Dermatitis is related to an increase in the numbers of a fungus called Pityrosporum ovate normally present in the skin. The incidence and severity of the condition may also be influenced by a combination of genetic or hormonal factors, which might explain why it can appear in infancy and disappear before puberty.


 

Seboral Shampoo (Fluocinolone acetonide) topical shampoo, 0.01% is a unique corticosteroid treatment in a shampoo-delivery system created to effectively treat inflammatory diseases of the scalp, such as itch and dandruff associated with Seborrheic Dermatitis (SD).

Fluocinolone acetonide - the active ingredient in Seboral - is a low- to medium-potency corticosteroid specially indicated for the treatment of Seborrheic Dermatitis of the scalp.
When used every day for two weeks, Seboral Shampoo treats inflammatory diseases related to SD. Some side effects have been reported infrequently in people who have used topical steroids, such as inflammation, burning, itching and irritation.



HOW TO USE SEBOWASH SHAMPOO
1. Shake Seboral Shampoo bottle well.
2. Wet the hair and scalp thoroughly, apply sufficient amount of Seboral Shampoo, and massage into the scalp. (Please note that this product does not contain drying detergents and therefore produces minimal lathering.)
3. Allow Seboral Shampoo to remain on the scalp for five minutes. (Note: It is important to keep the shampoo on for five minutes for effective treatment).
4. Rinse thoroughly with water. Conditioner is not necessary.
5. Repeat these instructions daily for two weeks. Following the initial two weeks, one treatment per week is usually sufficient to keep the itching and flaking of dandruff from returning.


Prescribing Information
COMPOSITION
Fluocinolone acetonide...... 0.01%

DESCRIPTION
Fluocinolone acetonide (6 alpha , 9-Difluro-11 beta,
16 alpha , 17, 21 -tetrahydroxypregna-1, 4-diene-3, 20dione 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 the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively, called Lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as Prostaglandin and Leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachldonic acid is released from membrane phospholipids by phospholipase A2. Fluccinilone acetonide has low-to medium-potency as compared with other topical corticosteroids.
In vehicle-controlled studies for the treatment of Seborrheic dermatitis of the scalp, after 14 days of treatment, 84% of patients on active treatment and 29% of patients on the drug vehicle had cleared or markedly improved.


INDICATIONS
Seboral is indicated for the treatment of Sebortlieic Dermatitis of the scalp. This product has not proven effective in other corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION:
This product should be shaken well prior to use. Required amount of the medicated shampoo (no more than approximately one ounce) should be applied to the scalp area once daily, worked into a lather, and allowed to remain on the scalp for approximately 5 minutes. The hair and scalp should then be rinsed thoroughly with water.

CONTRAINDICATIONS:
Seboral is contraindicated in thosee patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS AND PRECAUTIONS:
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, hyperglycemia, 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.
If HPA axis suppression is noted, an attempt should be made to withdrew the drug, to reduce the frequency of application, or to substitute by a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids.
If irritation develops, Seboral should be discontinued and appropriate therapy instituted. Allergiccontact dermatitis with corticosteroids is usually diagnosed by e failure to heal.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Seboral should be discontinued until the infection has been adequately controlled.
Information for Patients:
1. Seboral is to be used as directed by the physician. It
is for external use only. Avoid contact with the eyes. In
case of contact, wash eyes liberally with water.
2. This medication should not be used for any disorder
other than that for which it was prescribed,
3. The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report to their physician any signs of local adverse reactions.
5. Discard contents after three (3) months.

Pregnancy:
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 of teratogenic effects from Fluocinolone acetonide stampoo.Therefore, Seboral should be used dur'n., Pregnancy only it the potential benefit justifies the risk to he foetus.

Lactation:
Systemically administered corticosteroids appear in human a: d and ccu d 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 Seboral is administered to a nursing woman.

Pediatric Use:
Safety and effectiveness in children and infants have not been established. Because of a higher ratio of skin surface area to body mass, pediatric 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 papilledema.

SIDE 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.

OVERDOSAGE
Topically applied Seboral can be absorbed in sufficient amounts to produce systemic effects.

STORAGE
Store between 15 and 30'C (59' and 86' F) in tightly closed containers.

PRESENTATION
Bottle 60 ml.
 

Sole Agent & Marketed by:
Popular Health Care
Dhaka, Bangladesh

 

Manufactured by:
Cipla Ltd.
Mumbai Central Mumbai 400 008 India

 

Home About us Products Contact