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Dexafort (dexamethasone)

Dexafort has a relatively narrow registered footprint, marketed in eight countries — primarily across Western and Northern Europe, with additional presence in Australia and South Africa. Its active ingredient is dexamethasone, a long-established glucocorticoid classified within the corticosteroid family and used systemically as well as in dermatological and ophthalmic preparations.

Dexamethasone is one of the most versatile corticosteroids in clinical use, and the indications registered for Dexafort reflect that breadth. They span respiratory conditions such as asthma, bronchospasm, and bronchitis; dermatological conditions including pemphigus and eczema; certain infections including tuberculosis where corticosteroid support is indicated; and haematological use in leukaemia. The drug's profile combines anti-inflammatory, immunosuppressive, antiallergic, desensitising, and anti-shock activity, which explains why it appears across so many therapeutic areas.

Travellers and expatriates familiar with the Dexafort brand from countries such as France, Australia, Sweden, South Africa, or Belgium are unlikely to encounter the exact same brand outside this small registered footprint. Dexamethasone itself, however, is registered in essentially every regulated pharmaceutical market in the world, sold under a wide variety of brand names and in multiple formulations — oral, injectable, ophthalmic, and topical — depending on the indication.

Other glucocorticoid corticosteroids exist internationally and are used in overlapping clinical settings, although molecules within the class differ in potency, duration, and route of administration and are not freely interchangeable. A local pharmacist can usually identify a regionally available dexamethasone product or an appropriate alternative within the corticosteroid class. Because corticosteroid therapy is highly individualised and often part of a wider treatment plan, any decision to start, stop, or substitute Dexafort belongs with the prescribing healthcare provider.

Countries
Australia Belgium France Ireland Poland South Africa Sweden Switzerland
Diseases
Asthma Bronchospasm Infection Leukemia Bronchitis Pemphigus Tuberculosis Eczema Abscess Bacterial Meningitis Fever Meningitis Agranulocytosis Hypercalcemia Colitis Arthritis,Osteoarthritis Rheumatoid Arthritis Bursitis Osteoarthritis Edema Tenosynovitis Crush Injury Allergic Reactions Shock Allergic Conjunctivitis Synovitis Nephrotic Syndrome Lupus Inflammatory conditions Discoid lupus erythematosus Iridocyclitis Iritis Keratitis Shingles Cerebral edema Purpura Rheumatic fever Burns Pink eye Systemic lupus erythematosus Typhoid Blepharitis Blepharoconjunctivitis Keratoconjunctivitis Cold sore Pemphigus vulgaris Episcleritis Brain abscess Secondary adrenal insufficiency Golfer's elbow Adrenogenital syndrome Autoimmune disease Neurosurgery Acute asthma Steroid responsive inflammatory conditions Cyclitis Scleritis Asthma with status asthmaticus Keloids Encephalitis
Ingredients
Dexamethasone
Drug Actions
Antiallergic Antiexudative Anti-inflammatory Ophthalmologicals Corticosteroids, dermatological preparations Glucocorticoid Immunosuppressive Desensitizing Anti-shock Corticosteroids for systemic use
How does this drug class actually work?
Read the plain-language explainer in Pharmacology Academy (H1 antihistamines) →

Drugs with the same active ingredients

Aibrex Alergi Alergi (chlorphenamine,dexamethasone) Bicrinol Bideon biotic plus Biocort Biocort (antibacterials_corticosteroid) Ciloxadex Ciprocort Ciprocort (antihistaminices) Ciprofloxacina d dorf Cirflox Decadron Decadron con ciprofloxacina Decadron con neomicina Decadron(corticosteroids) Dexa-rhinospray Dexa-teosona Dexalaf Dexalergin

Incompatibilities

None known.

Preclinical safety data

Eye drops; Eye suspension; Injection; Pills; Solution for intravenous and intramuscular injection; Substance-powderCoated tablet; Intravitreal implant in applicator; Имплантат для интравитреального введенияEye ointment

Acute toxicity:

In mice and rats, the LD50 for Dexafort (Dexamethasone) after a single oral dose is 16 g/kg body and over 3 g/kg body weight, respectively, within the first 7 days. Following a single subcutaneous dose, the LD50 in mice is more than 700 mg/kg body weight and in rats about 120 mg/kg body weight, within the first 7 days.

Over a period of 21 days, these values become lower, which is interpreted as a consequence of serious infectious diseases caused by the hormone-induced immunosuppression.

Chronic toxicity:

There are no data on chronic toxicity in humans and animals. Corticoid-induced intoxications are not known. In longer-term treatment with doses above 1.5 mg/day, pronounced undesirable effects can be expected.

Mutagenic and tumorigenic potential:

The available study findings for glucocorticoids show no evidence of clinically relevant genotoxic properties.

Reproductive toxicity:

In animal studies, cleft palate was observed in rats, mice, hamsters, rabbits, dogs and primates; not in horses and sheep. In some cases these divergences were combined with defects of the central nervous system and of the heart. In primates, effects in the brain were seen after exposure. Moreover, intrauterine growth can be delayed. All these effects were seen at high dosages.

Effects in non-clinical studies were observed only at doses considered sufficiently in excess of the maximum dose for human indicating little relevance to clinical use.

No mutagenicity, carcinogenicity, reproductive or developmental toxicity data are available for OZURDEX. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application.

Dexamethasone exposure to the healthy/untreated eye via contralateral diffusion has been observed in rabbits following delivery of the implant to the posterior segment of the eye.

Repeat dose topical ocular safety studies with dexamethasone in rabbits have shown systemic corticosteroid effects. Such effects are considered to be unlikely when Dexafort (Dexamethasone) is used as recommended.

Dexamethasone was clastogenic in the in vitro human lymphocyte assay and in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional carcinogenicity studies with Dexafort (Dexamethasone) have not been performed.

Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.

There are no other preclinical data of relevance to the prescriber which are additional to that included in other sections of the SPC.

Pharmacotherapeutic group

Eye drops; Eye suspension; Injection; Pills; Solution for intravenous and intramuscular injection; Substance-powderCoated tablet; Intravitreal implant in applicator; Имплантат для интравитреального введенияEye ointmentcorticosteroids for systemic use, glucocorticoids, ATC code: H02AB02.Ophthalmologicals, antiinflammatory agents, ATC code: S01BA01Ophthalmologicals: Anti-inflammatory Agents.

Pharmacokinetic properties

Eye drops; Eye suspension; Injection; Pills; Solution for intravenous and intramuscular injection; Substance-powderCoated tablet; Intravitreal implant in applicator; Имплантат для интравитреального введенияEye ointment

Absorption and distribution

After oral administration, Dexafort (Dexamethasone) is rapidly and almost completely absorbed in the stomach and small intestine. Its bioavailability is 80-90%. Maximum blood levels are reached between 60 and 120 minutes. The binding of Dexafort (Dexamethasone) to plasma albumins is dose-dependent. At very high doses, the largest portion circulates freely in the blood. In hypoalbuminaemia the proportion of the unbound (active) corticoid rises.

Biotransformation

The average (serum) elimination half-life of Dexafort (Dexamethasone) in adults is 250 minutes (+ 80 minutes). Due to its long biological half-life of more than 36 hours, daily continuous administration of Dexafort (Dexamethasone) can lead to accumulation and overdosing.

Elimination

The elimination is largely renal in the form of free Dexafort (Dexamethasone) alcohol. Dexafort (Dexamethasone) is partly metabolised, the metabolites are excreted as glucuronates or sulfates, also mainly by the kidneys.

Renal and hepatic impairment

Renal function impairment has no relevant effect on the clearance of Dexafort (Dexamethasone). However, the elimination half-life is prolonged in severe liver disease.

Plasma concentrations were obtained from a subset of 21 patients in the two RVO, 6-month efficacy studies prior to dosing and on days 7, 30, 60 and 90 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone. Ninety-five percent of the plasma dexamethasone concentration values for the 350 µg dose group and 86% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL). The highest plasma concentration value of 0.094 ng/mL was observed in one subject from the 700 µg group. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.

Plasma concentrations were obtained from a subgroup of patients in the two DME pivotal studies prior to dosing and on days 1, 7, and 21, and months 1.5 and 3 following intravitreal injection of a single intravitreal implant containing 350 µg or 700 µg dexamethasone. One hundred percent of the plasma dexamethasone concentration values for the 350 µg dose group and 90% for the 700 µg dose group were below the lower limit of quantitation (0.05 ng/mL). The highest plasma concentration value of 0.102 ng/mL was observed in 1 subject from the 700 µg group. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.

In a 6-month monkey study following a single intravitreal injection of OZURDEX the dexamethasone vitreous humour Cmax was 100 ng/mL at day 42 post-injection and 5.57 ng/mL at day 91. Dexamethasone remained detectable in the vitreous at 6 months post-injection. The rank order of dexamethasone concentration was retina > iris > ciliary body > vitreous humour > aqueous humour > plasma.

In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humour, and sclera tissues for 18 hours, no metabolites were observed. This is consistent with results from rabbit and monkey ocular metabolism studies.

Dexamethasone is ultimately metabolised to lipid and water soluble metabolites that can be excreted in bile and urine.

The OZURDEX matrix slowly degrades to lactic acid and glycolic acid through simple hydrolysis, then further degrades into carbon dioxide and water.

Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. In plasma dexamethasone protein binding is less than for most other corticosteroids. Corticosteroids diffuse into tissue fluids and cerebrospinal fluid but transplacental diffusion in significant amounts has not been demonstrated. Corticosteroids are metabilised in the liver the kidney and excrete in the urine. Metabolism is similar to other corticosteroids. Intraocular penetration occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.

Special precautions for disposal and other handling

Eye drops; Eye suspension; Injection; Pills; Solution for intravenous and intramuscular injection; Substance-powderCoated tablet; Intravitreal implant in applicator; Имплантат для интравитреального введенияEye ointment

No special requirements for disposal.

OZURDEX is for single use only.

Each applicator can only be used for the treatment of a single eye.

If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used. Once the foil pouch is opened the applicator should be used immediately.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Do not touch dropper tip to any surface as this may contaminate the contents.

If the drop of medication is not retained in the eye upon dosing for any reason then instill another drop.

Frequently asked questions

What conditions does Dexafort treat?

Dexafort is prescribed across a broad range of inflammatory, allergic, and immune-related conditions, reflecting the wide therapeutic role of corticosteroids in general. Registered uses include asthma and bronchospasm, certain infections such as tuberculosis when used as adjunctive therapy, dermatological conditions including pemphigus and eczema, and haematological conditions such as leukaemia. The structured indication block further down this page lists each registered use in detail.

Which active substance is in Dexafort?

The active ingredient in Dexafort is dexamethasone, a glucocorticoid corticosteroid with anti-inflammatory, immunosuppressive, antiallergic, and anti-shock properties. Dexamethasone is one of the most widely used corticosteroids in the world and circulates internationally under a number of different brand names and formulations, including oral, injectable, ophthalmic, and topical presentations depending on the market.

In how many countries is Dexafort available?

Dexafort is registered in eight countries, with its footprint concentrated in Western and Northern Europe and extending to Australia and South Africa. Examples include France, Australia, Sweden, South Africa, Belgium, and Poland. If your country is not on this list, dexamethasone itself is almost certainly available locally under a different brand name, and a pharmacist can confirm what equivalent products are stocked.

Are there other medications with the same active ingredient as Dexafort?

Dexamethasone is sold under many brand names worldwide and in several different formulations, since it has been a mainstay of corticosteroid therapy for decades. The broader corticosteroid class also includes a number of other glucocorticoid molecules used in overlapping clinical settings, although they are not freely interchangeable. To identify a local dexamethasone-containing product, search the active ingredient on Pill2Trip or ask a pharmacist.

Should I consult a doctor before taking Dexafort?

Yes. Systemic corticosteroid therapy is highly individualised and is calibrated to the underlying condition, the patient's broader medical history, and concurrent treatments. Prescription requirements, available formulations, and brand names vary considerably between countries, which matters for travellers and people relocating across borders. Any decision to start, stop, switch, or substitute a dexamethasone product should be made with a healthcare provider rather than at a pharmacy counter.

Dexafort (dexamethasone)

Available in 8 countries