Celestoderm-v® with garamycin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CELESTODERM-V® WITH GARAMYCIN®

Composition:

Active substances: betamethasone, gentamycin;

1 g of cream contains 1 mg of betamethasone (as 17-valerate) and 1 mg of gentamicin (as sulfate);

Excipients: chlorocresol, sodium dihydrogen phosphate dihydrate, diluted phosphoric acid, mineral oil, cetylstearyl alcohol, polyethylene glycol cetylstearyl ether, soft white paraffin, sodium hydroxide, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream without foreign inclusions.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Corticosteroids combined with antibiotics. Betamethasone and antibiotics.

ATC code D07X C01.

Pharmacological properties.

Pharmacodynamics.

Celestoderm-B® with Garamycin combines the prolonged anti-inflammatory, anti-pruritic, and vasoconstrictive effects of betamethasone valerate with the broad-spectrum antibacterial activity of gentamicin sulfate. It is active against Staphylococcus aureus (coagulase-positive, coagulase-negative, and some penicillinase-producing strains) and Gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, and Klebsiella pneumoniae.

Pharmacokinetics.

Data on the pharmacokinetics of Celestoderm-B® with Garamycin are not available.

Clinical characteristics.

Indications.

Dermatoses amenable to treatment with glucocorticosteroids, complicated or suspected of being complicated by secondary infection caused by gentamicin-sensitive microorganisms: eczema (atopic, infantile, nummular), anogenital and senile pruritus, contact dermatitis, seborrheic dermatitis, neurodermatitis, intertriginous dermatitis, solar dermatitis, exfoliative dermatitis, stasis dermatitis, and psoriasis.

Contraindications.

Celestoderm-V® with Gentamicin is contraindicated in patients with hypersensitivity to the active substances or to any other component of the medicinal product, as well as in patients with hypersensitivity to other glucocorticoids or aminoglycoside antibiotics.

Celestoderm-V® with Gentamicin cream is also contraindicated in patients with hypersensitivity to chlorocresol.

Celestoderm-V® with Gentamicin cream should not be used in the presence of skin disorders predominantly caused by viral or bacterial infections.

Celestoderm-V® with Gentamicin cream should not be used during the first trimester of pregnancy due to the presence of betamethasone valerate in the formulation.

Celestoderm-V® with Gentamicin cream is also contraindicated in the following conditions:

• viral infections, including post-vaccination reactions and varicella;
• cutaneous tuberculosis and syphilis;
• viral skin infections (e.g. herpes simplex, herpes zoster);
• acne vulgaris and rosacea-like dermatitis;
• dermatomycoses;
• concomitant systemic therapy with aminoglycoside antibiotics – due to the risk of achieving toxic plasma levels;
• progressive renal insufficiency;
• children under 1 year of age.

Celestoderm-V® with Gentamicin cream is not intended for application into the auditory canal, eyes, or onto mucous membranes.

Due to the potential for systemic absorption of the active ingredient, prolonged treatment, application over large skin areas, and/or use with occlusive dressings should be avoided.

Interaction with other medicinal products and other forms of interaction.

Celestoderm-V® with Gentamicin cream should not be used simultaneously with other topical dermatological medicinal products due to the possibility of mutual inactivation.

Gentamicin is incompatible with amphotericin B, heparin, sulfadiazine, and beta-lactam antibiotics (e.g. cephalosporins).

Special precautions for use.

Any adverse effects observed during the use of systemic glucocorticoids, including suppression of adrenal cortex function, may also occur with topical glucocorticoids following systemic absorption, particularly in children.

Systemic absorption of topical glucocorticoids generally increases with higher corticosteroid doses, longer duration of treatment, and larger treated body surface area. Therefore, patients using high doses of potent glucocorticoids such as betamethasone valerate on extensive body areas should be closely and regularly monitored for signs of hypothalamic-pituitary-adrenal (HPA) axis suppression. If suppression occurs, the medication should be discontinued or the frequency of application reduced, or the patient should be switched to a less potent glucocorticoid.

HPA axis function usually fully recovers after discontinuation of the drug. In rare cases, withdrawal symptoms may develop, requiring the addition of systemic glucocorticoid therapy.

Visual disturbances may occur with both systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should undergo ophthalmological examination to evaluate possible causes of visual impairment, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, reported after use of both systemic and topical corticosteroids.

Medicinal products containing gentamicin, such as Celestoderm-V® with Garacyn, cream, should be used with caution for specific therapy. They should only be applied if antiseptic measures do not produce a rapid response, the response is inadequate, or antiseptic therapy is contraindicated.

Cross-allergic reactions with aminoglycoside antibiotics have been observed.

Allergy to gentamicin occurring during topical use of gentamicin-containing preparations (such as creams/ointments) precludes subsequent use of gentamicin and other aminoglycosides, for example, in infusion form.

Prolonged topical use of antibiotics may occasionally lead to overgrowth of resistant microflora, including fungi. In such cases, as well as in the event of skin irritation, sensitization, or superinfection, treatment with the drug should be discontinued and appropriate therapy initiated.

Systemic absorption of gentamicin during topical application may be higher when treating large body surfaces, especially with prolonged use or in the presence of skin damage. In such cases, adverse effects associated with systemic absorption of gentamicin may occur. The drug should therefore be used with caution under these conditions, particularly in children.

Due to the potential for neuromuscular blockade with systemically absorbed aminoglycosides, the medicinal product should be used with caution in patients with myasthenia gravis, Parkinson's disease, other conditions associated with muscle weakness, and in patients concurrently receiving other medicinal products that may cause neuromuscular blockade.

Due to the presence of soft white paraffin and mineral oil in the formulation, application of Celestoderm-V® with Garacyn cream to the anogenital area may damage the structure of latex condoms and reduce their safety during treatment.

Celestoderm-V® with Garacyn, cream, should not be applied to wounds or ulcers on the legs.

Celestoderm-V® with Garacyn, cream, contains cetostearyl alcohol. Cetostearyl alcohol may cause local skin irritation (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

Pregnancy

There are insufficient data on the use of Celestoderm-V® with Garacyn cream in pregnant women. Reproductive toxicity was observed in animal studies using the active ingredients of Celestoderm-V® with Garacyn cream. Celestoderm-V® with Garacyn, cream, should not be used during the first trimester of pregnancy. The cream may be prescribed only at later stages of pregnancy if the expected benefit outweighs the potential risk. Medicinal products of this group should not be used on large areas, in large amounts, or for prolonged periods during pregnancy.

Breastfeeding

There is no information available on whether betamethasone passes into breast milk. Other glucocorticoids and gentamicin are known to pass into breast milk. Therefore, Celestoderm-V® with Garacyn, cream, may be used during breastfeeding only if the expected benefit outweighs the potential risk. Medicinal products of this group should not be used on large areas, in large amounts, or for prolonged periods, and contact between the infant and the skin area treated with the cream should be avoided.

Ability to affect reaction speed when driving or operating machinery.

The medicinal product usually does not affect reaction speed when driving or operating machinery.

Method of Administration and Dosage

Apply the cream as a thin layer over the entire affected skin area twice daily – in the morning and evening.

The frequency of application is determined individually by the physician depending on the severity of the disease. In mild cases, once daily application may be sufficient; in more severe cases, more frequent application may be required.

The duration of treatment depends on the size and location of the lesion, as well as the patient's response to therapy. However, if clinical improvement is not observed within 3–4 weeks, the diagnosis should be reconsidered.

Children

There are no clinical data on the use of this medicinal product in children; therefore, its use is not recommended in this age group.

Since children have a higher surface area to body weight ratio compared to adults, more active absorption of the drug may occur. Therefore, children are more susceptible to developing suppression of the hypothalamic-pituitary-adrenal (HPA) axis and exogenous corticosteroid effects due to corticosteroid use.

In children receiving topical corticosteroids, adrenal suppression, Cushing's syndrome, growth retardation, inadequate weight gain, and increased intracranial pressure have been reported.

Signs of adrenal cortex suppression include low plasma cortisol levels and lack of response to adrenal stimulation tests using adrenocorticotropic hormone (ACTH) preparations. Increased intracranial pressure may present as bulging fontanelle, headache, and bilateral optic disc swelling.

Overdose

Celestoderm-V® with Gramicidin, cream, should be used only at the recommended doses.

If the patient forgets to apply the cream, it should be applied as soon as possible, after which the patient should continue following the usual dosing schedule.

Symptoms of overdose

Prolonged or excessive use of topical glucocorticosteroids may lead to suppression of pituitary-adrenal function, resulting in secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's disease.

Other signs of gentamicin toxicity related to overdose are not expected, since only minimal amounts of gentamicin are absorbed.

Excessive or prolonged topical use of gentamicin may lead to overgrowth of fungi and antibiotic-resistant bacteria.

Treatment

The patient should seek immediate medical advice if the Celestoderm-V® with Gramicidin cream is accidentally ingested, or if excessive amounts are applied or the cream is used for prolonged periods.

Symptoms of acute hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance should be performed. In cases of chronic toxic effects, gradual withdrawal of glucocorticoids is recommended. In case of overgrowth of resistant microorganisms, discontinuation of Celestoderm-V® with Gramicidin cream is advised, and appropriate therapy should be initiated.

Side effects

When treating with Celestoderm-V® with Garamycin cream, adverse reactions are very rare and include increased sensitivity, rash, and skin discoloration.

The following adverse reactions have been reported with the use of topical corticosteroids, particularly under occlusive dressings.

Celeston Derm-V® with Gramicidin, cream, is generally well tolerated. In very rare cases, skin irritation may occur, which could be related to individual hypersensitivity to gentamicin.

Local application of gentamicin may prolong wound healing. In addition, topical use of gentamicin may occasionally cause ototoxicity, vestibular toxicity, and nephrotoxicity, particularly when gentamicin is repeatedly applied to large wounds.

Celeston Derm-V® with Gramicidin, cream, contains excipients such as chlorocresol and cetyl stearyl alcohol. Chlorocresol may cause allergic reactions. Hypersensitivity reactions to these substances have been reported only in rare cases.

In such cases, treatment with Celeston Derm-V® with Gramicidin cream should be discontinued.

Cases of blurred vision have been reported (see also section "Special precautions for use") during corticosteroid therapy (frequency unknown).

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after marketing authorization of the medicinal product. This allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

Shelf life. 3 years.

Storage conditions. Store out of reach of children at a temperature not exceeding 25 °C.

Packaging. 30 g in aluminum tubes. 1 tube per cardboard box.

Prescription status. Prescription only.

Manufacturer.

Organon Heist bv, Belgium.

Manufacturer's address and location of operations.

Industriepark 30, 2220, Heist-op-den-Berg, Belgium.