Information on Oral drugs presentations

Fixed-dose combinations (FDCs)

Galenic formulations presented as co-formulations contain several active pharmaceutical ingredients in the same pharmaceutical form.

These are commonly known as "fixed-dose combinations (FDCs)".

In the label, the different molecules are separated by a slash ('/').

Example: ATOVAQUONE 250mg / PROGUANIL HCl 100mg, tab., >40 kg

This means that each tablet contains both atovaquone and proguanil hydrochloride.

Co-blisters

Galenical formulations presented as co-blisters contain different medicines in separate dosage forms, combined n the same blister pack.

In the label, the different molecules are separated by a plus sign ('+'). The co-blister presentation is always mentioned in the label.

Example: SP 1 x 500/25mg + AQ 3 x eq.150-153mg base, coblister disp.tab, 9-17kg

This means that sulfadoxine/pyrimethamine (SP) and amodiaquine (AQ) are supplied together in the same blister pack, but not in the same tablet.

Paediatric formulation considerations

Some excipients should be avoided or are prohibited in paediatric medicines because of safety concerns.

Examples includes:

• Benzyl alcohol in injectable formulations.
• Ethanol in oral formulations, unless no other suitable source or formulation is available.
• Sucrose in oral paediatric medicines, which should be avoided whenever possible, especially when suitable alternatives exist.

Abbreviations, INNS and item roots

Antimalarial medicines

Antituberculosis medicines

Antiretrovirals