ALKINDI Granule in capsule Ref.[27923] Active ingredients: Hydrocortisone

Posology

Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used.

Monitoring of the clinical response is necessary and patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual responsiveness to the medicinal product, and the effect of stress (e.g. surgery, infection, trauma). During stress it may be necessary to increase the dose temporarily.

Replacement therapy in primary and secondary adrenal insufficiency

Alkindi is given as replacement therapy by oral administration of granules according to clinical practice, in a dose to be titrated against individual clinical response.

Recommended replacement doses of hydrocortisone are 8-10 mg/m²/day for patients with adrenal insufficiency alone and 10-15 mg/m²/day in patients with congenital adrenal hyperplasia (CAH), typically in three or four divided doses.

In patients with some remaining endogenous cortisol production a lower dose may be sufficient.

In situations when the body is exposed to excessive physical and/or mental stress, patients may need an increased dose, especially in the afternoon or evening.

Pre-operatively, during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenal reserve

Pre-operatively, anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids.

In less severe situations when parenteral administration of hydrocortisone is not required, for instance low grade infections, moderate fever of any aetiology and stressful situations such as minor surgical procedures, there should be high awareness of the risk of developing acute adrenal insufficiency, and the normal oral daily replacement dose should be increased temporarily; the Alkindi total daily dose should be increased by doubling or tripling the usual dose. Once the intercurrent illness episode is over, patients can return to the normal replacement dose of Alkindi.

In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment. Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia. Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis.

Changing from conventional oral glucocorticoid treatment to Alkindi

When changing patients from conventional oral hydrocortisone replacement therapy, crushed or compounded, to Alkindi, an identical total daily dose may be given. Alkindi is therapeutically equivalent to conventional oral hydrocortisone formulations. Where a patient is changed from other oral hydrocortisone formulations to Alkindi, inaccuracy in the dosing possible with other oral hydrocortisone formulations can lead to a relative fall in hydrocortisone exposure on the same nominal dose, leading to symptoms of adrenal insufficiency or crisis (see section 4.4).

Method of administration

The granules must be given orally and should not be chewed. The capsule shell must not be swallowed but carefully be opened as follows:

• The capsule is held so that the printed strength is at the top, and tapped to ensure all the granules are in the lower half of the capsule.
• The bottom of the capsule is gently squeezed.
• The top of the capsule is twisted off.
• The granules are either poured directly onto the child’s tongue, or the granules are poured onto a spoon and placed in the child’s mouth. For children who are able to take soft food, the granules may be sprinkled onto a spoonful of cold or room temperature soft food (such as yoghurt or fruit puree) and given immediately.
• Whichever method is used, the capsule is tapped to ensure all the granules are removed.

Immediately after administration a drink such as water, milk, breast-milk, or formula-milk should be given to help ensure all granules are swallowed.

If the granules are sprinkled onto a spoonful of soft food this should be given immediately (within 5 minutes) and not stored for future use.

The granules must not be added to liquid as this can result in less than the full dose being given, and may affect the taste masking which will allow the bitter taste of hydrocortisone to become apparent.

Do not administer via nasogastric tube as there is a risk of nasogastric tube blockage.

Detailed pictograms on how to administer the granules are provided in the package leaflet.

Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him/her unusually susceptible to ill effects from hydrocortisone. In which case, symptomatic treatment should be instituted as necessary.

The biological half-life of hydrocortisone is about 100 minutes.

3 years.

After first opening: 60 days.

Do not store above 30°C.

Store in the original bottle in order to protect from light.

Hard capsule for opening, containing a single dose of granules. The capsules are provided in high-density polyethylene bottles with polypropylene closure with integrated desiccant.

Pack sizes: 1 bottle containing 50 capsules.

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