Celestoderm-b® with garamycin

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

Composition:

Active substances: betamethasone, gentamicin;

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

Excipients: mineral oil, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: homogeneous ointment of almost white to light yellow color, free from foreign particles.

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

ATC code D07CC01.

Pharmacological properties.

Pharmacodynamics.

Celestoderm-B® with Garamycin combines the prolonged anti-inflammatory, antipruritic, 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 to be 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.

The medicinal product is contraindicated in patients with hypersensitivity to the active substances or to any other component of the preparation, as well as in patients with hypersensitivity to other glucocorticoids or aminoglycoside antibiotics.

Celestoderm-V® with Garamycin, ointment, must not be used in the presence of skin diseases predominantly caused by viral or bacterial infections.

Celestoderm-V® with Garamycin, oint游戏副本, must not be used during the first trimester of pregnancy due to the presence of betamethasone valerate in the formulation.

Celestoderm-V® with Garamycin, ointment, 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 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 Garamycin, ointment, 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 under occlusive dressings should be avoided.

Interaction with other medicinal products and other forms of interaction.

Celestoderm-V® with Garamycin must not be used simultaneously with other topical dermatological medicinal products due to possible 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 systemic use of 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 glucocorticoid doses, prolonged duration of treatment, and larger treated body surface area. Therefore, patients using high doses of potent glucocorticoids such as betamethasone valerate over large areas of the body should be closely and regularly monitored for signs of hypothalamic-pituitary-adrenal (HPA) axis suppression. If suppression occurs, Celestoderm-V® with Gramicidin, ointment, should be discontinued or the frequency of application reduced, or the patient should be switched to a less potent glucocorticoid. HPA axis function usually recovers completely after discontinuation of the drug. In rare cases, withdrawal symptoms may develop, requiring supplementation with systemic glucocorticoids.

When using corticosteroids of systemic and local action (including intranasal, inhaled, and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual disturbances develop, the patient should undergo an ophthalmological examination to evaluate possible causes of visual impairment, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported following use of corticosteroids of systemic and local action.

Medicinal products such as Celestoderm-V® with Gramicidin, ointment, containing gentamicin, should be used with caution for specific therapy. They should only be applied if there is no rapid response to antiseptic measures, if such response is inadequate, or if antiseptic therapy is contraindicated.

Cross-allergic reactions with aminoglycoside antibiotics have been observed.

Allergy to gentamicin arising from topical use of gentamicin-containing products (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 microorganisms, including fungi. In such cases, and in the event of skin irritation, sensitization, or superinfection, treatment with the drug should be discontinued and appropriate therapy initiated.

Systemic absorption of gentamicin following topical application may be higher when treating large body surface areas, especially with prolonged use or in the presence of skin damage. In such cases, adverse effects associated with systemic use 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.

Because of the presence of soft white paraffin and mineral oil in the formulation, application of Celestoderm-V® with Gramicidin ointment to the anogenital area may damage the structure of latex condoms and reduce their safety during use while undergoing treatment.

Celestoderm-V® with Gramicidin, ointment, should not be applied to wounds or leg ulcers.

Use during pregnancy or breastfeeding

Pregnancy

There are insufficient data on the use of Celestoderm-V® with Gramicidin ointment in pregnant women. Reproductive toxicity was observed in animal studies using the active substances of Celestoderm-V® with Gramicidin ointment. Celestoderm-V® with Gramicidin, ointment, should not be used during the first trimester of pregnancy.

The use of Celestoderm-V® with Gramicidin ointment may be considered only in later stages of pregnancy if the expected benefit outweighs the potential risk. Medicinal products of this class should not be used over large areas, in large quantities, or for prolonged periods during pregnancy.

Breastfeeding

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

Ability to influence reaction speed when driving or operating machinery

The medicinal product does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Apply a thin layer of the ointment to the entire affected skin area twice daily – in the morning and evening.

The frequency of application is determined individually by a 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 reevaluated.

Children

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

Since children have a higher surface area to body weight ratio compared to adults, systemic absorption of the drug is more pronounced. Therefore, children are more susceptible to developing suppression of the hypothalamic-pituitary-adrenal (HPA) axis and experiencing exogenous corticosteroid effects following topical corticosteroid use.

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

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

Overdose

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

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

Symptoms of overdose

With prolonged or excessive use of topical glucocorticoids, suppression of the pituitary-adrenal function may occur, leading to secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's disease.

Other signs of gentamicin toxicity due 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

Patients should seek immediate medical advice if they accidentally ingest Celestoderm-V® with Gramicidin ointment, or if the ointment has been used in excess or for a prolonged period.

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

Side effects.

Side effects during treatment with Celestoderm-V® with Gramicidin are very rare and include increased sensitivity, rash, and changes in skin pigmentation.

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

Celestoderm-V® with Garamycin, cream, is generally well tolerated. Very rarely, skin irritation may occur, which could be related to individual hypersensitivity to gentamicin.

Local application of gentamicin may delay 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.

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

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after the medicinal product has been authorized. This enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to 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 tubes. 1 tube in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

Organon Heist bv, Belgium
Organon Heist bv, Belgium

Manufacturer's address and place of business.

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