page 1
CURRENT WORK PLAN New monographs for inclusion in The International Pharmacopoeia and revision of related monographs
2011
The following categories are included in this work programme: • 1. Medicines used in HIV/AIDS treatment (antiretrovirals - ARVs) • 2. Medicines used in malaria treatment • 3. Medicines used in TB treatment • 4. Anti-infectives (antibacterials, antiprotozoal, antifungal, antiviral, and antimycobacterial agents, anthelmintics) • 5. Oral rehydration therapy • 6. Other medicines (other antivirals, analgesics, antipyretics, palliative care agents, anti-epileptics, large volume parenterals, reproductive health, vitamins, cytotoxic agents, insulins )
Entries highlighted in red correspond to new additions.
Where a draft monograph has already been provided to the Secretariat for discussion , this is indicated by means of the symbol *.
page 2
1. Medicines used in HIV/AIDS treatment (antiretrovirals - ARVs)
APIs: • Atazanavir
Dosage forms:
• Emtricitabine oral solution • Ritonavir capsules • Ritonavir oral solution • Stavudine powder for oral solution • Zidovudine tablets • Atazanavir capsules
Fixed-dose combinations (FDC):
• Tenofovir and lamivudine tablets • Tenofovir, efavirenz and lamivudine tablets • Atazanavir and ritonavir tablets • Lamivudine and abacavir tablets • Lamivudine, abacavir and nevirapine tablets
• Lopinavir and ritonavir capsules • Lopinavir and ritonavir oral solution • Lamivudine and stavudine tablets • Lamivudine, stavudine and nevirapine tablets
Dosage forms, as available for: • Lamivudine + Zidovudine + Efavirenz**
** to confirm with the Disease Programme
page 3
2. Medicines used in Malaria treatment
APIs
• Piperaquine phosphate
Dosage forms
• Artesunate rectal capsules
Fixed-dose combinations (FDC):
• Artemether and lumefantrine capsules • Artemether and lumefantrine dispersible tablets • Artesunate and amodiaquine tablets • Dihydroartemisinin and piperaquine phosphate tablets
Revision • Artemisinin derivatives (APIs and dosage forms) (see http://www.who.int/medicines/publications/pharmacopoeia/mon_mal/en/index.html )
page 4
3. Medicines used in Tuberculosis (TB) treatment
APIs:
• Moxifloxacin • p-Aminosalicylic acid • Terizidone
Dosage forms:
• Moxifloxacin tablets/capsules • Ethambutol oral liquid • Pyrazinamide oral syrup
• p-Aminosalicylic acid granules • Ethionamide tablets/capsules • Protionamide tablets • Terizidone tablets/capsules
page 5
4. Anti-infectives (antibacterials, antiprotozoals, antifungals, antivirals, anthelminthics and antimycobacterial agents)
APIs • Azithromycin • Aciclovir • Cefixime • Rifabutin
• Ceftriaxone sodium • Fluconazole • Ivermectin
Dosage forms • Azithromycin capsules • Azithromycin oral liquid • Sulfadiazine tablets • Clindamycin capsules • Clindamycin injection • Clindamycin oral liquid • Aciclovir tablets • Aciclovir powder for injection • Aciclovir oral liquid • Spectinomycin powder for injection • Cefixime capsules • Rifabutin capsules
• Albendazole chewable tablets • Ceftriaxone injection • Doxycycline dispersible tablets • Fluconazole capsules • Fluconazole injection • Fluconazole oral solution/suspension • Ivermectin tablets • Pyrantel chewable tablets* • Pyrantel oral solution* • Pyrimethamine tablets
Fixed-dose combinations (FDC):
• Sulfamethoxazole and trimethoprim injection • Sulfamethoxazole and trimethoprim oral solution/suspension
page 6
5. Oral rehydration therapy
APIs • Zinc acetate • Zinc gluconate
Dosage forms • Paediatric zinc acetate tablets • Paediatric zinc acetate oral solution • Paediatric zinc gluconate oral solution • Paediatric zinc gluconate tablets
page 7
6. Other medicines (other antivirals, analgesics, antipyretics, palliative care agents, anti-epileptics, LVPs 1, reproductive health, vitamins, cytotoxic agents, insulins)
Dosage forms • Morphine oral solution • Paediatric Retinol oral solution
Antiepileptics • Carbamazepine oral liquid • Carbamazepine chewable tablets • Phenobarbital oral liquid • Phenytoin oral liquid • Phenytoin chewable tablets • Valproic acid oral liquid • Valproic acid crushable tablets
Large volume parenterals • Glucose intravenous infusion • Sodium chloride intravenous infusion • Sodium chloride and glucose intravenous infusion
Reproductive health APIs • Mifepristone • Misoprostol • Norgestrel
Dosage forms • Mifepristone tablets§ • Misoprostol tablets • Norgestrel tablets • Norethisterone tablets • Norethisterone injection
Note from Secretariat: § used in co-blisters with Misoprostol tablets
• Ethinylestradiol + levonorgestrel tablets • Medroxyprogesterone acetate (DMPA), depot injection
1 LVPs: Large Volume Parenterals
page 8
Cytotoxic medicines
• Bleomycin powder for injection • Etoposide capsules • Vinblastine powder for injection • Vincristine powder for injection • Calcium folinate tablets • Calcium folinate injection
Insulins
APIs
• Insulin, human • Insulin, bovine • Insulin, porcine
Dosage forms
• Insulin preparations - General monograph
• Insulin injection (soluble) • Insulin zinc suspension • Isophane insulin injection
• Insulin zinc suspension (amorphous)** • Insulin zinc suspension (crystalline)** • Biphasic insulin injection** • Biphasic isophane insulin injection ** • Protamine zinc insulin injection**
** to confirm with the Disease Programme
***