Budeson rectal foam

/ Rafa

Adults aged > 18 years
One actuation of 2 mg budesonide daily.
Method of administration
This medical product can be applied in the morning or evening.
The canister is first fitted with an applicator and then shaken for about 15 seconds before the applicator is inserted into the rectum as far as comfortable. Note that the dose is only sufficiently accurate when the pump dome is held downwards as vertically as possible. To administer a dose of this medical product, the pump dome is fully pushed down and very slowly released. Following the activation the applicator should be held in position for 10 – 15 seconds before being withdrawn from the rectum.
The best results are obtained when the intestine is evacuated prior to administration.
Duration of treatment
An acute episode generally subsides after 6 to 8 weeks. This medical product should not be used after this period of time.

Treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon.

* Hypersensitivity to the active substance or to any of the excipients
* Hepatic cirrhosis

* Treatment with this medicl product results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy with systemically acting corticoids. Transfer from other glucocorticosteroid therapy may result in reappearance or recurrence of symptoms relating to the change in systemic steroid levels.
* Caution is required in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma, or any other condition in which glucocorticosteroids may have undesirable effects.
* Systemic effects of glucocorticosteroids may occur, particularly when prescribed at high doses and for prolonged periods. Such effects may include Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric/behavioural effects.
Infection
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticosteroid treatment should be carefully considered. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked, and therefore may reach an advanced stage before being recognised.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
* This medicinal product contains 600.3 mg propylene glycol in each actuation. Propylene glycol may cause skin irritation.
* Cetyl alcohol and cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
See prescribing information for full details.

Common: Cushing’s syndrome, Dyspepsia, Increased risk of infection, Muscle and joint pain, Muscle weakness and twitching, Osteoporosis, Headache, Depression, Irritability, Euphoria, Allergic exanthema, Petechiae, Delayed wound healing, Contact dermatitis, Burning in the rectum and pain.
See prescribing information for full details.

Pharmacodynamic interactions
Cardiac glycosides
The action of the glycoside can be potentiated by potassium deficiency.
Saluretics
Potassium excretion can be enhanced.
Pharmacokinetic interactions
CYP3A4 inhibitors
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
CYP3A4 inducers
Compounds or drugs such as carbamazepine and rifampicin, which induce CYP3A4, might reduce the systemic but also the local exposure of budesonide at the gut mucosa. An adjustment of the budesonide dose might be necessary.
CYP3A4 substrates
Compounds or drugs which are metabolized by CYP3A4 might be in competition with budesonide. This might lead to an increased budesonide plasma concentration if the competing substance has a stronger affinity to CYP3A4, or – if budesonide binds stronger to CYP3A4 – the competing substance might be increased in plasma and a dose adaption/reduction of this drug might be required.
Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives, but this has not been observed with oral low dose combination contraceptives.
Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).

Pregnancy: Administration during pregnancy should be avoided unless there are compelling reasons for therapy. There are few data of pregnancy outcomes after oral administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with this medical product compared to inhaled budesonide.
Lactation: Budesonide is excreted in human milk (data on excretion after inhalative use is available). However, only minor effects on the breast-fed child are anticipated after application of this medical product within the therapeutic range. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

To date, no cases of overdose with budesonide are known.

After first opening: 4 weeks.
1 pressurised container, contains at least 14 doses of 1.2 g rectal foam each.