ELOSALIC 0.1% (45G OINTMENT)

769911279

New product

Mometasone Furoate + Salicylic Acid 0.1%

$23.00

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1.       Name of the Medicinal Product

Elosalic 1 mg/g + 45 mg/g ointment.

2.       Qualitative and Quantitative Composition

Each gram of ointment contains 1 mg of mometasone furoate and 45 mg of salicylic acid

Excipient: Each gram of ointment contains 20 mg of propylene glycol stearate.

 

For a full list of excipients, see section 6.1.

3.       Pharmaceutical Form

Ointment

White to off-white coloured

4.       Clinical Particulars

4.1     Therapeutic indications

Initial treatment of moderate to severe plaque psoriasis.

4.2     Posology and method of administration

Apply a thin layer to the affected skin areas once or twice daily. Maximum daily dose is 15 g, applied to no more than 30% of the body surface. A treatment duration for longer than 3 weeks has not been evaluated within the pivotal studies. As for all potent steroids it is recommended that the applications are gradually tapered down.

4.3     Contraindications

Patients with hypersensitivity to mometasone furoate, to salicylic acid or to any of the excipients.

 

As with other topical glucocorticoids, Elosalic ointment is contraindicated in patients with:

-               bacterial infection (e.g, pyodermas, syphilis, and tuberculosis),

-               viral infection (e.g., herpes simplex, varicella, herpes zoster, verrucae vulgares, condylomata acuminata, molluscum contagiosum)

-               fungal infection (dermatophytes and yeasts), and

-               parasitical infections if causal therapy is not concomitantly given.

 

Elosalic Ointment is also contraindicated in patients with postvaccination reactions, perioral dermatitis, rosacea, acne vulgaris, and skin atrophy.

 

Elosalic is contraindicated in the last trimester of pregnancy (see 4.6).

4.4     Special warnings and special precautions for use

As with all cutaneous glucocorticoid preparations, precautions should be taken when extensive body surface areas are treated.

Elosalic is not recommended for use under occlusive dressing.Elosalic is not for use on the face, groin, genital, or other intertriginous areas. Elosalic is not for ophthalmic use. When using Elosalic ointment, care must be taken to avoid contact with the eyes, mucosae and open wounds. Elosalic should not be used on ulcers, wounds, or stretch marks.

 

Elosalic is not recommended for use in pustular or psoriasis guttata.

 

If irritation, including excessive dryness, develops Elosalic should be discontinued and appropriate therapy instituted.

 

Glucocorticoids can mask, activate, or exacerbate skin infection. If concomitant skin infection develops, an appropriate antifungal or antibacterial agent should be used. If a favourable response does not occur, the use of Elosalic should be discontinued until the infection has been adequately controlled.

 

Salicylic acid may act as a sunscreen agent. Patients who combine cutaneous therapy of Elosalic with UV therapy should remove the remaining ointment and clean the treated area before the start of UV therapy to reduce the photoprotective action, and thereby reduce the risk of burning of the untreated surrounding area to a minimum. Following the UV treatment, the ointment can be reapplied.

 

Elosalic contains propylene glycol stearate which may cause skin irritation.

 

Paediatric use

The safety and efficacy of Elosalic have not been established in children below the age of 12 years.

4.5     Interaction with other medicinal products and other forms of interaction

None known.

4.6     Pregnancy and lactation

There are no clinical data from the use of mometasone furoate during pregnancy. Studies of mometasone furoate and salicylic acid in animals have shown teratogenic effects, see section 5.3. These data are not considered relevant for the cutaneous use of Elosalic ointment.

 

During the first and second trimester:

The safety of Elosalic in pregnant women has not been established. Therefore, the use of Elosalic during the first and second trimester of pregnancy should be avoided.

 

During the third trimester:

During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including salicylic acid may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged bleeding time in both mother and child may occur. Therefore, Elosalic is contraindicated during the last trimester of pregnancy (see 4.3).

It is not known whether cutaneous administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Elosalic ointment is therefore not recommended unless clearly necessary.

4.7     Effects on ability to drive and use machines

Not relevant.

4.8     Undesirable effects

Adverse reactions that have been reported with the use of cutaneous corticosteroids include:

 

Table 1:           Treatment-related adverse reactions reported by body system and frequency

Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10 000, including isolated reports)

 

Endocrine disorders

Rare:

 

Adrenal suppression.

Skin and subcutaneous tissue disorders

Common:

 

Uncommon:

 

 

Rare:

 

 

Unknown:

 

 

 

 

General disorders and administration site conditions

Common:

 

Infections and infestations

Uncommon :

 

Immune system disorders :

Rare

 

Pruritus, local skin atrophy

 

Skin striae, rosacea like dermatitis, ecchymosis, folliculitis

 

Hypertrichosis, skin hypopigmentation

 

Skin irritation, skin maceration, dry skin, dermatitis acneiform, dermatitis, dermatitis contact, skin exfoliation, telangiectasia, miliaria

 

 

 

 

Application site burning sensation

 

 

Infection

 

 

Hypersensitivity

 

 

4.9     Overdose

Excessive, prolonged use of topical corticosteroids can suppress hypothalamic-pituitary-adrenal-axis function, resulting in secondary adrenal insufficiency. If hypothalamic-pituitary-adrenal-axis suppression is noted, an attempt should be made to reduce the frequency of application or to withdraw the drug, observing the care required in these situations.

In the clinical program doses of more than the recommended maximum daily dose of 15 g/day had a transient effect on the hypothalamic-pituitary-adrenal-axis function.

5.       Pharmacological Properties

5.1     Pharmacodynamic properties

Pharmacotherapeutic group: corticosteroids, potent, other combinations; ATC-code D07XC03.

 

The pharmacodynamic activity of Elosalic is directly related to its active components, mometasone furoate and salicylic acid, and its vehicle. Mometasone is a strongly potent glucocorticoid belonging to the EU class III.

 

Like other cutaneous corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the cutaneous steroids, in general, is unclear.

 

Salicylic acid has been shown to desquamate the stratum corneum while not effecting changes in the structure of the viable epidermis. This mechanism of action has been attributed to a dissolution of the intercellular cement substance. Salicylic acid enhances the absorption of mometasone furoate through the skin layers.

5.2     Pharmacokinetic properties

The degree of absorption and systemic effects depends on:

  • ·                treated area and condition of the epidermis
  • ·                duration of treatment
  • ·                application area
  • ·                use of occlusive bandage

 

Following a single cutaneous application of a combination of 3H-mometasone furoate 0.1% and salicylic acid 5% ointmentfor 12 hours without occlusion, approximately 1.5% of the applied dose was absorbed systemically. Mean peak plasma salicylic acid level was 0.0066 mmol/l. Systemic toxic reactions to salicylic acid are usually associated with much higher plasma levels (2.17 to 2.90 mmol/l).

 

Minor effects on the hypothalamic-pituitary-adrenal-axis were observed when up to 7.5 g of Elosalic were applied twice daily at a total daily dose of 15 g for seven days to 30% of the body surface area, as indicated by the occurrence of a single below normal plasma cortisol level in one patient. The value returned to normal during continuation of therapy.

 

Following application of up to 7.5 g of Elosalic twice daily without occlusion for 3 weeks, salicylate levels in blood were <0.36 mmol/l, which is the lower limit of detection. The laboratory normal salicylate plasma concentration range seen with oral treatment giving systemic effect is 1-2 mmol/l.

 

Absorbed mometasone furoate undergoes rapid and extensive metabolism to multiple metabolites. These are not considered to have pharmacological activity. No major metabolite is formed.

 

Following a single cutaneous application (12 hours) of a combination ointment formulation of 3H-mometasone furoate 0.1% and salicylic acid 5% to patients with psoriasis, approximately 0.36% and 1.11% of the radioactivity was recovered in the urine and faeces, respectively, over a 5-day collection period. Following this same application, the effective half-life of salicylic acid is 2.8 hours.

5.3     Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety toxicology, genotoxicity and carcinogenicity (nasal administration) of mometasone furoate besides what is already known for glucocorticoids.

Studies of corticosteroids in animals have shown reproduction toxicity (cleft palate, skeletal malformations).

In reproduction toxicity studies in rats, prolonged gestation and prolonged and difficult labour was detected. Mo

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