Ftoroderm (Ointment) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

D07AB09 (Triamcinolone)

Active Substance

Triamcinolone acetonide (BAN)

Dosage Form

Ftoroderm

Ointment for external use 0.1%: tubes from 10 g to 200 g

Dosage Form, Packaging, and Composition

Ointment for external use white or almost white, homogeneous, practically odorless or with a faint characteristic odor.

Excipients: methylparahydroxybenzoate – 0.2 g, stearic acid – 2.5 g, polysorbate 60 – 3.5 g, cetyl alcohol – 6 g, liquid paraffin – 12 g, glycerol – 18 g, purified water – 57.7 g.

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
45 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
55 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
65 g – aluminum tubes (1) – cardboard packs.
70 g – aluminum tubes (1) – cardboard packs.
75 g – aluminum tubes (1) – cardboard packs.
80 g – aluminum tubes (1) – cardboard packs.
85 g – aluminum tubes (1) – cardboard packs.
90 g – aluminum tubes (1) – cardboard packs.
95 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
110 g – aluminum tubes (1) – cardboard packs.
120 g – aluminum tubes (1) – cardboard packs.
130 g – aluminum tubes (1) – cardboard packs.
140 g – aluminum tubes (1) – cardboard packs.
150 g – aluminum tubes (1) – cardboard packs.
160 g – aluminum tubes (1) – cardboard packs.
170 g – aluminum tubes (1) – cardboard packs.
180 g – aluminum tubes (1) – cardboard packs.
190 g – aluminum tubes (1) – cardboard packs.
200 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids; corticosteroids with moderate activity (group II)

Pharmacological Action

Corticosteroid. Suppresses the functions of leukocytes and tissue macrophages. Limits the migration of leukocytes to the area of inflammation. Impairs the ability of macrophages to phagocytose and to form interleukin-1. Promotes stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of inflammation. Reduces capillary permeability caused by the release of histamine. Suppresses fibroblast activity and collagen formation.

Inhibits the activity of phospholipase A₂, leading to suppression of prostaglandin and leukotriene synthesis. Suppresses the release of COX (mainly COX-2), which also contributes to reduced prostaglandin production.

Reduces the number of circulating lymphocytes (T- and B-cells), monocytes, eosinophils, and basophils due to their movement from the vascular bed into lymphoid tissue; suppresses antibody formation.

Suppresses the release of ACTH and β-lipotropin by the pituitary gland but does not reduce the level of circulating β-endorphin. Inhibits the secretion of TSH and FSH.

When applied directly to blood vessels, it has a vasoconstrictive effect.

It has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins, and fats. Stimulates gluconeogenesis, promotes the uptake of amino acids by the liver and kidneys, and increases the activity of gluconeogenesis enzymes. In the liver, it enhances glycogen storage by stimulating the activity of glycogen synthase and the synthesis of glucose from protein metabolism products. The increase in blood glucose levels stimulates insulin secretion.

Inhibits glucose uptake by fat cells, which leads to activation of lipolysis. However, due to increased insulin secretion, lipogenesis is stimulated, which promotes fat accumulation.

It has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, skin, and bone tissue.

Osteoporosis and Cushing’s syndrome are the main factors limiting long-term corticosteroid therapy. As a result of the catabolic effect, growth suppression in children is possible.

In high doses, it may increase the excitability of brain tissue and contribute to a lowering of the seizure threshold. Stimulates excessive production of hydrochloric acid and pepsin in the stomach, which contributes to the development of peptic ulcers.

When used systemically, therapeutic activity is due to anti-inflammatory, anti-allergic, immunosuppressive, and anti-proliferative effects.

When used externally and locally, the therapeutic activity of triamcinolone acetonide is due to anti-inflammatory, anti-allergic, and anti-exudative (due to the vasoconstrictive effect) actions.

In terms of anti-inflammatory activity, Triamcinolone acetonide is 6 times more potent than hydrocortisone. Triamcinolone acetonide has practically no mineralocorticoid activity.

Pharmacokinetics

When used systemically, it is metabolized mainly in the liver and partially in the kidneys. The main metabolic pathway is 6-β-hydroxylation. T_1/2 – 3.5 h. Excreted by the kidneys.

Indications

For systemic use: bronchial asthma, chronic bronchitis with broncho-obstructive syndrome, pemphigoid, psoriasis, dermatitis.

Intra-articular administration: chronic inflammatory joint diseases, exudative arthritis, gout, joint hydrops, shoulder joint block, chronic inflammation of the inner layer of the joint capsule.

For external use: eczema, psoriasis, neurodermatitis, various types of dermatitis, and other inflammatory and allergic skin diseases of non-microbial etiology (as part of complex therapy).

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin areas two to three times daily.

Gently rub the ointment into the skin until fully absorbed.

The duration of treatment is determined by the physician based on the disease severity and therapeutic response.

Limit continuous use to a maximum of two weeks unless directed by a physician.

For occlusive dressing therapy, apply a thin layer and cover only as prescribed for severe, resistant lesions.

Use occlusive dressings intermittently and for short durations; avoid in pediatric patients.

Discontinue treatment gradually upon improvement to prevent symptom recurrence.

Do not apply to large surface areas, broken skin, or under tight diapers in infants.

Avoid contact with eyes and mucous membranes.

If no improvement is observed within one week, re-evaluate the diagnosis.

If signs of skin atrophy or secondary infection appear, discontinue use and institute appropriate therapy.

Adverse Reactions

From the endocrine system redistribution of adipose tissue, menstrual cycle disorders, increased blood glucose levels, suppression of adrenal function, “moon face”, striae, hirsutism, acne.

From the metabolism edema, electrolyte imbalance, negative nitrogen balance, growth retardation in children.

From the digestive system steroid gastric ulcer, erosive and ulcerative lesions of the gastrointestinal tract, acute pancreatitis.

From the CNS convulsions, sleep disorders, mental disorders, headaches and dizziness, weakness.

From the musculoskeletal system myopathy, osteoporosis.

From the cardiovascular system arterial hypertension.

From the blood coagulation system thromboembolism.

From the organ of vision visual disturbances, posterior subcapsular cataract, increased intraocular pressure or exophthalmos, anaphylactic reactions.

Reactions due to immunosuppressive action exacerbation of infectious diseases.

With intra-articular administration joint pain, irritation at the injection site, depigmentation, sterile abscess, skin atrophy may occur; with doses exceeding 40 mg, resorptive side effects are possible.

With external use itching, skin irritation, late eczematous-type reactions, steroid acne, purpura may occur. With prolonged use of the ointment, the development of secondary infectious lesions and atrophic skin changes is possible.

Contraindications

History of acute psychoses, active form of tuberculosis, myasthenia, metastatic neoplasms, diverticulitis, gastric and duodenal ulcer disease, arterial hypertension, Cushing’s syndrome, renal failure, history of thrombosis and embolism, osteoporosis, diabetes mellitus, latent foci of infection, amyloidosis, syphilis, fungal diseases, viral infections (including those caused by Herpes simplex and Varicella zoster), amoebic infections, poliomyelitis (except for the bulbar-encephalitic form), gonococcal or tuberculous arthritis, vaccination period, lymphadenitis after BCG vaccination, glaucoma, infected skin lesions.

Use in Pregnancy and Lactation

If use during pregnancy (especially in the first trimester) and during lactation is necessary, the expected benefit to the mother and the risk of side effects in the fetus or child should be assessed.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Parenteral use in children under 6 years of age is not recommended; in children aged 6-12 years – only for strict indications.

Long-term external use in children of any age should be avoided.

Special Precautions

Not intended for intravenous administration.

Use with caution and under strict medical supervision in cases of edematous syndrome, obesity, mental illness, and gastrointestinal diseases. During treatment, it is recommended to take vitamin D and consume foods rich in calcium.

For external use, to prevent local infectious complications, it is recommended to use in combination with antimicrobial agents.

Parenteral use in children under 6 years of age is not recommended; in children aged 6-12 years – only for strict indications.

Long-term external use in children of any age should be avoided.

Drug Interactions

When used concomitantly with anabolic steroids, androgens, the risk of peripheral edema and acne increases.

When used concomitantly with antithyroid drugs and thyroid hormones, thyroid function may be altered.

When used concomitantly with histamine H₁-receptor blockers, the effect of triamcinolone is reduced; with hormonal contraceptives – the effect of triamcinolone is potentiated.

Hypocalcemia associated with the use of triamcinolone may lead to an increase in the duration of neuromuscular blockade caused by depolarizing muscle relaxants when used concomitantly.

When used concomitantly with immunosuppressants, the risk of bacterial and viral infections increases.

When used concomitantly with potassium-sparing diuretics, hypokalemia is possible.

Concomitant use may reduce the effectiveness of indirect anticoagulants, heparin, streptokinase, urokinase, and increase the risk of erosive and ulcerative lesions and gastrointestinal bleeding.

When used concomitantly with NSAIDs (including acetylsalicylic acid), the risk of erosive and ulcerative lesions and gastrointestinal bleeding increases.

Concomitant use weakens the effect of oral hypoglycemic agents, insulin; with laxatives – hypokalemia is possible; with cardiac glycosides – the risk of cardiac rhythm disturbances and other toxic effects of glycosides increases.

When used concomitantly with tricyclic antidepressants, mental disorders associated with triamcinolone use may be enhanced.

Storage Conditions

Store at 8°C (46°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.