Pharmaceutical Form

Granules in capsules for opening. The granules are white to off-white and are available in a transparent colorless (size 00el) hard capsule.
 

• Alkindi 0.5 mg granules in capsules for opening

       The capsule is printed with "INF-0.5" in red ink.

• Alkindi 1 mg granules in capsules for opening

       The capsule is printed with "INF-1.0" in blue ink.

• Alkindi 2 mg granules in capsules for opening

       The capsule is printed with "INF-2.0" in green ink.

• Alkindi 5 mg granules in capsules for opening

       The capsule is printed with "INF-5.0" in gray ink

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Indications

Replacement therapy for adrenal insufficiency in infants, children and adolescents (from birth to <18 years). 4.2 Posology and method of administration.

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Product Information

Alkindi is an immediate-release hydrocortisone drug designed specifically to meet the dosing needs of adrenal insufficiency for which no licensed, child-friendly products are available in Europe or the United States. At present, pharmacists often mix hydrocortisone tablets into a fine powder and prepare it in individual capsules or sachets to achieve the lower doses required for children. This composition is very variable and often results in incorrect dosing2. Alkindi is manufactured using commercially proven technology in four doses: 0.5 mg, 1 mg, 2 mg and 5 mg, to give clinicians maximum flexibility in tailoring treatment to the child. Taste-masking excipients that are acceptable for pediatric use eliminate the bitter taste of hydrocortisone, potentially increasing compliance. Alkindi has a shelf life of over two years which is significantly longer than existing unlicensed hydrocortisone products.

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1.  Alkindi Summary of Product Characteristics 2. Neumann et al 2017  Quality of compounded hydrocortisone capsules used in the treatment of children.  European Journal of Endocrinology 177, 239–242

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Article Number

Alkindi 0.5 mg: 512821

Alkindi 1.0 mg: 497083

Alkindi 2.0 mg: 467473

Alkindi 5.0 mg: 582671

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ATC Code

H02AB09

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