Lista modelo de medicamentos esenciales de la OMS

La Organización Mundial de la Salud (OMS) publicó la “Lista Modelo OMS de Medicamentos Esenciales”, siendo actualizada cada dos años por un comité de expertos, compuesto por reconocidos especialistas del mundo académico, de investigación y de las profesiones médicas y farmacéuticas. Su última actualización fue celebrada entre el 27 y el 31 de marzo del 2017, en la sede de la OMS, en Ginebra, Suiza.

Su propósito es proporcionar una guía para la priorización de los medicamentos desde un perspectiva clínica y de salud pública. El trabajo duro comienza con los esfuerzos para asegurar que los medicamentos están realmente disponibles para los pacientes.

El número total en la lista se eleva a un total de 433 medicamentos considerados esenciales para responder a las necesidades más importantes de salud pública.

Entre los últimos cambios introducidos figuran nuevas recomendaciones sobre qué antibióticos se han de utilizar contra las infecciones comunes y cuáles se deben reservar para los casos más graves. Asimismo se han añadido medicamentos contra la infección por el VIH, la hepatitis C, la tuberculosis y la leucemia.

“La seguridad y eficacia de los medicamentos son aspectos esenciales de cualquier sistema de salud. Velar porque todas las personas tengan acceso a los medicamentos que requieran, cuando y donde los necesiten, es esencial para que los países avancen hacia el logro de la cobertura sanitaria universal”.

 


WHO Model List of Essential Medicines

20th List
(March 2017)
(Amended August 2017)

1. ANAESTHETICS, PREOPERATIVE MEDICINES AND MEDICAL GASES
1.1 General anaesthetics and oxygen
1.1.1 Inhalational medicines
halothane Inhalation.
isoflurane Inhalation.
nitrous oxide Inhalation.
oxygen Inhalation (medical gas).
1.1.2 Injectable medicines
ketamine Injection: 50 mg (as hydrochloride)/ mL in 10- mL vial.
propofol* Injection: 10 mg/ mL; 20 mg/ mL.

* Thiopental may be used as an alternative depending on local availability and cost.

1.2 Local anaesthetics
o bupivacaine Injection: 0.25%; 0.5% (hydrochloride) in vial.

Injection for spinal anaesthesia: 0.5% (hydrochloride) in 4- mL ampoule to be mixed with 7.5% glucose solution.

o lidocaine Injection: 1%; 2% (hydrochloride) in vial.

Injection for spinal anaesthesia: 5% (hydrochloride) in 2- mL ampoule to be mixed with 7.5% glucose solution.

Topical forms: 2% to 4% (hydrochloride).

lidocaine + epinephrine (adrenaline) Dental cartridge: 2% (hydrochloride) + epinephrine 1:80 000.

Injection: 1%; 2% (hydrochloride or sulfate) + epinephrine 1:200 000 in vial.

Complementary List
ephedrine Injection: 30 mg (hydrochloride)/ mL in 1- mL ampoule.

(For use in spinal anaesthesia during delivery, to prevent hypotension).

1.3 Preoperative medication and sedation for short-term procedures
atropine Injection: 1 mg (sulfate) in 1- mL ampoule.
o midazolam Injection: 1 mg/ mL.

Oral liquid: 2 mg/ mL [c].

Tablet: 7.5 mg; 15 mg.

morphine Injection: 10 mg (sulfate or hydrochloride) in 1- mL ampoule.
1.4 Medical gases
oxygen* Inhalation

For use in the management of hypoxaemia.

*No more than 30% oxygen should be used to initiate resuscitation of neonates less than or equal to 32 weeks of gestation.

2. MEDICINES FOR PAIN AND PALLIATIVE CARE
2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs)
acetylsalicylic acid Suppository: 50 mg to 150 mg.

Tablet: 100 mg to 500 mg.

ibuprofen a Oral liquid: 200 mg/5 mL.

Tablet: 200 mg; 400 mg; 600 mg.

a Not in children less than 3 months.

paracetamol* Oral liquid: 120 mg/5 mL; 125 mg/5 mL.

Suppository: 100 mg.

Tablet: 100 mg to 500 mg.

* Not recommended for anti-inflammatory use due to lack of proven benefit to that effect.

2.2 Opioid analgesics
codeine Tablet: 30 mg (phosphate).
fentanyl* Transdermal patch: 12 micrograms/hr; 25 micrograms/hr; 50

micrograms/hr; 75 micrograms/hr; 100 micrograms/hr

*for the management of cancer pain

o morphine* Granules (slow-release; to mix with water): 20 mg –200 mg (morphine sulfate).

Injection: 10 mg (morphine hydrochloride or morphine sulfate) in 1- mL ampoule.

Oral liquid: 10 mg (morphine hydrochloride or morphine sulfate)/5 mL.

Tablet (slow release): 10 mg–200mg (morphine hydrochloride

or morphine sulfate).

Tablet (immediate release): 10 mg (morphine sulfate).

*Alternatives limited to hydromorphone and oxycodone

Complementary list
methadone* Tablet: 5 mg; 10 mg (as hydrochloride)

Oral liquid: 5mg/ 5mL; 10mg/ 5mL (as hydrochloride)

Concentrate for oral liquid: 5 mg/ mL; 10mg/ mL (as hydrochloride)

*For the management of cancer pain.

2.3 Medicines for other common symptoms in palliative care
amitriptyline Tablet: 10 mg; 25 mg; 75 mg.
cyclizine [c] Injection: 50 mg/ mL.

Tablet: 50 mg.

dexamethasone Injection: 4 mg/ mL in 1- mL ampoule (as disodium phosphate salt).

Oral liquid: 2 mg/5 mL.

Tablet: 2 mg [c]; 4 mg.

diazepam Injection: 5 mg/ mL.

Oral liquid: 2 mg/5 mL.

Rectal solution: 2.5 mg; 5 mg; 10 mg.

Tablet: 5 mg; 10 mg.

docusate sodium Capsule: 100 mg.

Oral liquid: 50 mg/5 mL.

fluoxetine a Solid oral dosage form: 20 mg (as hydrochloride).

a >8 years.

haloperidol Injection: 5 mg in 1‐ mL ampoule.

Oral liquid: 2 mg/ mL.

Solid oral dosage form: 0.5 mg; 2mg; 5 mg.

hyoscine butylbromide Injection: 20 mg/ mL.
hyoscine hydrobromide [c] Injection: 400 micrograms/ mL; 600 micrograms/ mL.

Transdermal patches: 1 mg/72 hours.

lactulose [c] Oral liquid: 3.1–3.7 g/5 mL.
loperamide Solid oral dosage form: 2 mg.
metoclopramide Injection: 5 mg (hydrochloride)/mL in 2‐mL ampoule.

Oral liquid: 5 mg/5 mL.

Solid oral form: 10 mg (hydrochloride).

midazolam Injection: 1 mg/ mL; 5 mg/ mL.

Solid oral dosage form: 7.5 mg; 15 mg.

Oral liquid: 2mg/ mL [c].

ondansetron [c] a Injection: 2 mg base/ mL in 2- mL ampoule (as hydrochloride).

Oral liquid: 4 mg base/5 mL.

Solid oral dosage form: Eq 4 mg base; Eq 8 mg base.

a >1 month.

senna Oral liquid: 7.5 mg/5 mL.
3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS
dexamethasone Injection: 4 mg/ mL in 1- mL ampoule (as disodium phosphate salt).
epinephrine (adrenaline) Injection: 1 mg (as hydrochloride or hydrogen tartrate) in 1- mL ampoule.
hydrocortisone Powder for injection: 100 mg (as sodium succinate) in vial.
o loratadine * Oral liquid: 1 mg/ mL.

Tablet: 10 mg.

*There may be a role for sedating antihistamines for limited indications (EMLc).

o prednisolone Oral liquid: 5 mg/ mL [c].

Tablet: 5 mg; 25 mg.

4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS
4.1 Non-specific
charcoal, activated Powder.
4.2 Specific
acetylcysteine Injection: 200 mg/ mL in 10- mL ampoule.

Oral liquid: 10% [c]; 20% [c].

atropine Injection: 1 mg (sulfate) in 1- mL ampoule.
calcium gluconate Injection: 100 mg/ mL in 10- mL ampoule.
methylthioninium chloride (methylene blue) Injection: 10 mg/ mL in 10- mL ampoule.
naloxone Injection: 400 micrograms (hydrochloride) in 1- mL ampoule.
penicillamine Solid oral dosage form: 250 mg.
potassium ferric hexacyano-ferrate(II) – 2H2O(Prussian blue) Powder for oral administration.
sodium nitrite Injection: 30 mg/ mL in 10- mL ampoule.
sodium thiosulfate Injection: 250 mg/ mL in 50- mL ampoule.
Complementary List
deferoxamine Powder for injection: 500 mg (mesilate) in vial.
dimercaprol Injection in oil: 50 mg/ mL in 2- mL ampoule.
fomepizole Injection: 5 mg/ mL (sulfate) in 20- mL ampoule or 1 g/ mL (base) in 1.5- mL ampoule.
sodium calcium edetate Injection: 200 mg/ mL in 5- mL ampoule.
succimer Solid oral dosage form: 100 mg.
5. ANTICONVULSANTS/ANTIEPILEPTICS
carbamazepine Oral liquid: 100 mg/5 mL.

Tablet (chewable): 100 mg; 200 mg.

Tablet (scored): 100 mg; 200 mg.

diazepam Gel or rectal solution: 5 mg/ mL in 0.5 mL; 2- mL; 4- mL tubes.
lamotrigine* Tablet: 25 mg; 50 mg; 100 mg; 200 mg.

Tablet (chewable, dispersible): 2 mg; 5 mg; 25 mg; 50 mg; 100

mg; 200 mg.

*as adjunctive therapy for treatment-resistant partial or generalized seizures.

o lorazepam Parenteral formulation: 2 mg/ mL in 1- mL ampoule; 4 mg/ mL in 1- mL ampoule.
magnesium sulfate* Injection: 0.5g/ mL in 2- mL ampoule (equivalent to 1 g in 2 mL; 50% weight/volume); 0.5g/ mL in

10- mL ampoule (equivalent to 5 g in 10 mL; 50% weight/volume).

* For use in eclampsia and severe pre-eclampsia and not for other convulsant disorders.

midazolam Solution for oromucosal administration: 5 mg/mL; 10 mg/mL

Ampoule*: 1 mg/ mL; 10 mg/mL

*for buccal administration when solution for oromucosal administration is not available

phenobarbital Injection: 200 mg/ mL (sodium).

Oral liquid: 15 mg/5 mL.

Tablet: 15 mg to 100 mg.

phenytoin Injection: 50 mg/ mL in 5- mL vial (sodium salt).

Oral liquid: 25 mg to 30 mg/5 mL.*

Solid oral dosage form: 25 mg; 50 mg; 100 mg (sodium salt).

Tablet (chewable): 50 mg.

* The presence of both 25 mg/5 mL and 30 mg/5 mL strengths on the same market would cause confusion in prescribing and dispensing and should be avoided.

valproic acid (sodium valproate) Oral liquid: 200 mg/5 mL.

Tablet (crushable): 100 mg.

Tablet (enteric-coated): 200 mg; 500 mg (sodium valproate).

Complementary List
ethosuximide Capsule: 250 mg.

Oral liquid: 250 mg/5 mL.

valproic acid (sodium valproate) Injection: 100 mg/ mL in 4- mL ampoule; 100 mg/ mL in 10- mL ampoule.
6. ANTI-INFECTIVE MEDICINES
6.1 Anthelminthics
6.1.1 Intestinal anthelminthics
albendazole Tablet (chewable): 400 mg.
ivermectin Tablet (scored): 3 mg.
levamisole Tablet: 50 mg; 150 mg (as hydrochloride).
mebendazole Tablet (chewable): 100 mg; 500 mg.
niclosamide Tablet (chewable): 500 mg.
praziquantel Tablet: 150 mg; 600 mg.
pyrantel Oral liquid: 50 mg (as embonate or pamoate)/ mL.

Tablet (chewable): 250 mg (as embonate or pamoate).

6.1.2 Antifilarials
albendazole Tablet (chewable): 400 mg.
diethylcarbamazine Tablet: 50 mg; 100 mg (dihydrogen citrate).
ivermectin Tablet (scored): 3 mg.
6.1.3 Antischistosomals and other antitrematode medicines
praziquantel Tablet: 600 mg.
triclabendazole Tablet: 250 mg.
Complementary List
oxamniquine* Capsule: 250 mg.

Oral liquid: 250 mg/5 mL.

* Oxamniquine is listed for use when praziquantel treatment fails.

6.2  Antibacterials

To assist in the development of tools for antibiotic stewardship at local, national and global levels and to reduce antimicrobial resistance, three different categories were developed – ACCESS, WATCH and RESERVE groups.

Group 1 – KEY ACCESS ANTIBIOTICS

To improve both access and clinical outcomes antibiotics that were first or second choice antibiotics in at least one of the reviewed syndromes are designated as key ACCESS antibiotics, emphasizing their role as the antibiotics that should be widely available, affordable and quality-assured. ACCESS antibiotics are listed below. Selected ACCESS antibiotics may also be included in the WATCH group.

6.2.1 Beta-lactam medicines 6.2.2 Other antibacterials
amoxicillin cefotaxime* amikacin gentamicin
amoxicillin + clavulanic acid ceftriaxone* azithromycin* metronidazole
ampicillin cloxacillin chloramphenicol nitrofurantoin
benzathine benzylpenicillin phenoxymethylpenicillin ciprofloxacin* spectinomycin (EML only)
benzylpenicillin piperacillin + tazobactam* clarithromycin* sulfamethoxazole + trimethoprim
cefalexin procaine benzyl penicillin clindamycin vancomycin (oral)*
cefazolin meropenem* doxycycline vancomycin (parenteral)*
cefixime*

Italics = complementary list

*Watch group antibiotics included in the EML/EMLc only for specific, limited indications

The 2017 Expert Committee identified the following antibiotics or antibiotic classes that should be the subject of a specific stewardship focus. Antibiotics or antibiotic classes in these groups are designated accordingly in the EML/EMLc.  The “WATCH” and “RESERVE” stewardship groups could assist in activities such as local, national and global monitoring of use; development of guidelines and educational activities.

Group 2 – WATCH GROUP ANTIBIOTICS

This group includes antibiotic classes that have higher resistance potential and so are recommended as first or second choice treatments only for a specific, limited number of indications. These medicines should be prioritized as key targets of stewardship programs and monitoring.

This group includes most of the highest priority agents among the Critically Important Antimicrobials for Human Medicine1 and/or antibiotics that are at relatively high risk of selection of bacterial resistance.

Watch group antibiotics
Quinolones and fluoroquinolones

e.g. ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin

3rd-generation cephalosporins (with or without beta-lactamase inhibitor)

e.g. cefixime, ceftriaxone, cefotaxime, ceftazidime

Macrolides

e.g. azithromycin, clarithromycin, erythromycin

Glycopeptides

e.g. teicoplanin, vancomycin

Antipseudomonal penicillins + beta-lactamase inhibitor

e.g. piperacillin-tazobactam

Carbapenems

e.g. meropenem, imipenem + cilastatin

Penems

e.g. faropenem

1 http://apps.who.int/iris/bitstream/10665/251715/1/9789241511469-eng.pdf?ua=1

Group 3 – RESERVE GROUP ANTIBIOTICS

This group includes antibiotics that should be treated as “last resort” options that should be accessible, but whose use should be tailored to highly specific patients and settings, when all alternatives have failed (e.g., serious, life-threatening infections due to multi-drug resistant bacteria). These medicines could be protected and prioritized as key targets of national and international stewardship programs involving monitoring and utilization reporting, to preserve their effectiveness.

6.2.1 Beta-lactam medicines
Powder for oral liquid: 125 mg (as trihydrate)/5 mL; 250 mg (as trihydrate)/5 mL [c].
Solid oral dosage form: 250 mg; 500 mg (as trihydrate).
Powder for injection: 250 mg; 500 mg; 1 g (as sodium) in vial.
FIRST CHOICE SECOND CHOICE
– community acquired pneumonia (mild to – acute bacterial meningitis
amoxicillin moderate)

–  community acquired pneumonia (severe) [c]

–  complicated severe acute malnutrition [c]

– exacerbations of COPD
– lower urinary tract infections
– otitis media
–  pharyngitis

–  sepsis in neonates and children [c]

–  sinusitis

–  uncomplicated severe acute malnutrition [c]

amoxicillin + clavulanic acid Oral liquid: 125 mg amoxicillin + 31.25 mg clavulanic acid/5 mL AND 250 mg amoxicillin + 62.5 mg clavulanic acid/5 mL [c].

Tablet: 500 mg (as trihydrate) + 125 mg (as potassium salt).

Powder for injection: 500 mg (as sodium) + 100 mg (as potassium salt); 1000 mg (as sodium) + 200 mg (as potassium salt) in vial.

FIRST CHOICE

–  community acquired pneumonia (severe) [c]

–  complicated intraabdominal infections (mild to moderate)

–  exacerbations of COPD

–  hospital acquired pneumonia

–  low-risk febrile neutropenia

–  lower urinary tract infections

–  sinusitis

–  skin and soft tissue infections

SECOND CHOICE

–  bone and joint infections

–  community-acquired pneumonia (mild to moderate)

–  community acquired pneumonia (severe)

–  otitis media

ampicillin Powder for injection: 500 mg; 1 g (as sodium salt) in vial.
FIRST CHOICE

–  community acquired pneumonia (severe) [c]

–  complicated severe acute malnutrition [c]

–  sepsis in neonates and children [c]

SECOND CHOICE

– acute bacterial meningitis

benzathine benzylpenicillin Powder for injection: 900 mg benzylpenicillin (= 1.2 million IU) in 5- mL vial

[c]; 1.44 g benzylpenicillin (= 2.4 million IU) in 5- mL vial.

FIRST CHOICE

– syphilis

SECOND CHOICE
benzylpenicillin Powder for injection: 600 mg (= 1 million IU); 3 g (= 5 million IU) (sodium or

potassium salt) in vial.

FIRST CHOICE

-community acquired pneumonia (severe) [c]

–  complicated severe acute malnutrition [c]

–  sepsis in neonates and children [c]

–  syphilis

SECOND CHOICE

– acute bacterial meningitis[c]

cefalexin Powder for reconstitution with water: 125 mg/5 mL; 250 mg/5 mL (anhydrous).

Solid oral dosage form: 250 mg (as monohydrate).

FIRST CHOICE SECOND CHOICE

–  exacerbations of COPD

–  pharyngitis

–  skin and soft tissue infections

cefazolin* a Powder for injection: 1 g (as sodium salt) in vial.

* also indicated for surgical prophylaxis.

a >1 month.

FIRST CHOICE SECOND CHOICE

– bone and joint infections

cefixime WATCH GROUP Capsule or tablet: 200 mg; 400 mg (as trihydrate).

Powder for oral liquid: 100 mg /5 mL [c]

FIRST CHOICE SECOND CHOICE

–  acute invasive bacterial diarrhoea / dysentery

–  Neisseria gonorrhoeae

cefotaxime* WATCH GROUP Powder for injection: 250 mg per vial (as sodium salt)

* 3rd generation cephalosporin of choice for use in hospitalized neonates.

FIRST CHOICE

–  acute bacterial meningitis

-community acquired pneumonia (severe)

–  complicated intraabdominal infections (mild to moderate)

–  complicated intrabdominal infections (severe)

–  hospital acquired pneumonia

-pyelonephritis or prostatitis (severe)

SECOND CHOICE

– bone and joint infections

-pyelonephritis or prostatitis (mild to moderate)

sepsis in neonates and children [c]

ceftriaxone* a

WATCH GROUP

Powder for injection: 250 mg; 1 g (as sodium salt) in vial.

* Do not administer with calcium and avoid in infants with hyperbilirubinaemia.

a >41 weeks corrected gestational age.

FIRST CHOICE

–  acute bacterial meningitis

-community acquired pneumonia (severe)

–  complicated intraabdominal infections (mild to moderate)

–  complicated intrabdominal infections (severe)

–  hospital acquired pneumonia

–  Neisseria gonorrhoeae

-pyelonephritis or prostatitis (severe)

SECOND CHOICE

–  acute invasive bacterial diarrhoea / dysentery

–  bone and joint infections

–  pyelonephritis or prostatitis (mild to moderate)

–  sepsis in neonates and children [c]

o cloxacillin* Capsule: 500 mg; 1 g (as sodium salt).

Powder for injection: 500 mg (as sodium salt) in vial.

Powder for oral liquid: 125 mg (as sodium salt)/5 mL.

*cloxacillin, dicloxacillin and flucloxacillin are preferred for oral administration due to better bioavailability.

FIRST CHOICE

–  bone and joint infections

–  skin and soft tissue infections

SECOND CHOICE

– sepsis in neonates and children [c]

phenoxymethylpenicillin Powder for oral liquid: 250 mg (as potassium salt)/5 mL.

Tablet: 250 mg (as potassium salt).

FIRST CHOICE

–  community acquired pneumonia (mild to moderate)

–  pharyngitis

SECOND CHOICE
piperacillin + tazobactam WATCH GROUP Powder for injection: 2 g (as sodium salt) + 250 mg (as sodium salt); 4 g (as sodium salt) + 500 mg (as sodium salt) in vial
FIRST CHOICE

–  complicated intraabdominal infections (severe)

–  high-risk febrile neutropenia

–  hospital acquired pneumonia

SECOND CHOICE
procaine benzylpenicillin* Powder for injection: 1 g (=1 million IU); 3 g (=3 million IU) in vial.

* Procaine benzylpenicillin is not recommended as first-line treatment for neonatal sepsis except in settings with high neonatal mortality, when given by trained health workers in cases where hospital care is not achievable.

FIRST CHOICE

– syphilis [c]

SECOND CHOICE

– syphilis

Complementary List
ceftazidime

WATCH GROUP

Powder for injection: 250 mg or 1 g (as pentahydrate) in vial.
meropenem* a

WATCH GROUP

Powder for injection: 500 mg (as trihydrate); 1 g (as trihydrate) in vial

a >3 months.

*imipenem + cilastatin is an alternative except for acute bacterial meningitis where meropenem is preferred.

FIRST CHOICE SECOND CHOICE

–  acute bacterial meningitis in neonates [c]

–  complicated intraabdominal infections (severe)

–  high-risk febrile neutropenia

Complementary List RESERVE GROUP
aztreonam Powder for injection: 1 g; 2 g in vial
fifth generation cephalosporins

(with or without beta-lactamase inhibitor) e.g, ceftaroline

Powder for injection: 400 mg; 600 mg (as fosamil) in vial
fourth generation cephalosporins

(with or without beta-lactamase inhibitor) e.g., cefepime

Powder for injection: 500 mg; 1g; 2g (as hydrochloride) in vial
6.2.2 Other antibacterials
amikacin Injection: 250 mg (as sulfate)/mL in 2- mL vial
FIRST CHOICE

-pyelonephritis or prostatitis (severe)

SECOND CHOICE

–  high-risk febrile neutropenia

–  sepsis in neonates and children [c]

azithromycin* WATCH GROUP Capsule: 250 mg; 500 mg (anhydrous).

Oral liquid: 200 mg/5 mL.

* also listed for single-dose treatment of trachoma and yaws.

FIRST CHOICE

Chlamydia trachomatis

–  cholera [c]

–  Neisseria gonorrhoeae

SECOND CHOICE

–  acute invasive bacterial diarrhoea / dysentery

–  Neisseria gonorrhoeae

chloramphenicol Capsule: 250 mg.

Oily suspension for injection*: 0.5 g (as sodium succinate)/ mL in 2- mL ampoule.

* Only for the presumptive treatment of epidemic meningitis in children older than 2 years and in adults.

Oral liquid: 150 mg (as palmitate)/5 mL.

Powder for injection: 1 g (sodium succinate) in vial.

FIRST CHOICE SECOND CHOICE

– acute bacterial meningitis

ciprofloxacin WATCH GROUP Oral liquid: 250 mg/5 mL (anhydrous) [c].

Solution for IV infusion: 2 mg/ mL (as hyclate) [c].

Tablet: 250 mg (as hydrochloride).

FIRST CHOICE

–  acute invasive bacterial diarrhoea / dysentery

–  low-risk febrile neutropenia

–  pyelonephritis or prostatitis (mild to moderate)

SECOND CHOICE

-cholera

– complicated intraabdominal infections (mild to moderate)

clarithromycin*† WATCH GROUP Solid oral dosage form: 500 mg.

Powder for oral liquid: 125 mg/5 mL; 250 mg/5 mL

Powder for injection: 500 mg in vial

*erythromycin may be an alternative.

†clarithromycin is also listed for use in combination regimens for eradication of

H. pylori in adults.

FIRST CHOICE

-community acquired pneumonia (severe)

SECOND CHOICE

– pharyngitis

clindamycin Capsule: 150 mg (as hydrochloride).

Injection: 150 mg (as phosphate)/ mL.

Oral liquid: 75 mg/5 mL (as palmitate) [c].

FIRST CHOICE SECOND CHOICE

– bone and joint infections

doxycycline a Oral liquid: 25 mg/5 mL [c]; 50 mg/5 mL (anhydrous) [c].

Solid oral dosage form: 50 mg [c]; 100 mg (as hyclate).

Powder for injection: 100 mg in vial

a Use in children <8 years only for life-threatening infections when no alternative exists.

FIRST CHOICE

Chlamydia trachomatis

– cholera

SECOND CHOICE

–  cholera [c]

-community acquired pneumonia (mild to moderate)

–  exacerbations of COPD

gentamicin Injection: 10 mg; 40 mg (as sulfate)/ mL in 2- mL vial.
FIRST CHOICE

–  community acquired pneumonia (severe)

[c]

–  complicated severe acute malnutrition [c]

–  sepsis in neonates and children [c]

SECOND CHOICE

– Neisseria gonorrhoeae

metronidazole Injection: 500 mg in 100- mL vial.

Oral liquid: 200 mg (as benzoate)/5 mL.

Suppository: 500 mg; 1 g.

Tablet: 200 mg to 500 mg.

FIRST CHOICE

–  C. difficile infection

–  complicated intraabdominal infections (mild to moderate)

–  complicated intrabdominal infections (severe)

–  Trichomonas vaginalis

SECOND CHOICE

– complicated intraabdominal infections (mild to moderate)

nitrofurantoin Oral liquid: 25 mg/5 mL [c].

Tablet: 100 mg.

FIRST CHOICE

– lower urinary tract infections

SECOND CHOICE
spectinomycin Powder for injection: 2 g (as hydrochloride) in vial.
FIRST CHOICE SECOND CHOICE

– Neisseria gonorrhoeae

sulfamethoxazole + trimethoprim* Injection:

80 mg + 16 mg/ mL in 5- mL ampoule; 80 mg + 16 mg/ mL in 10- mL ampoule.

Oral liquid: 200 mg + 40 mg/5 mL.

Tablet: 100 mg + 20 mg; 400 mg + 80 mg; 800 mg + 160 mg.

*single agent trimethoprim may be an alternative for lower urinary tract infection.

FIRST CHOICE

– lower urinary tract infections

SECOND CHOICE

– acute invasive diarrhoea / bacterial dysentery

vancomycin WATCH GROUP Capsule: 125 mg; 250 mg (as hydrochloride).
SECOND CHOICE

– C. difficile infection

Complementary List
vancomycin WATCH GROUP Powder for injection: 250 mg (as hydrochloride) in vial.
FIRST CHOICE SECOND CHOICE

-high-risk febrile neutropenia

Complementary List RESERVE GROUP
daptomycin Powder for injection: 350 mg; 500 mg in vial
fosfomycin Powder for injection: 2 g; 4 g (as sodium) in vial
oxazolindinones e.g., linezolid Injection for intravenous administration: 2 mg/ mL in 300 mL bag.

Powder for oral liquid: 100 mg/5 mL.

Tablet: 400 mg; 600 mg.

polymyxins

e.g., colistin

Powder for injection: 1 million I.U. (as colistemethate sodium) in vial
tigecycline Powder for injection: 50 mg in vial
6.2.3 Antileprosy medicines
Medicines used in the treatment of leprosy should never be used except in combination. Combination therapy is essential to prevent the emergence of drug resistance. Colour-coded blister packs (MDT blister packs) containing standard two-medicine (paucibacillary leprosy) or three-medicine (multibacillary leprosy) combinations for adult and childhood leprosy should be used. MDT blister packs can be supplied free of charge through WHO.
clofazimine Capsule: 50 mg; 100 mg.
dapsone Tablet: 25 mg; 50 mg; 100 mg.
rifampicin Solid oral dosage form: 150 mg; 300 mg.
6.2.4 Antituberculosis medicines

WHO recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations, including modified dosage forms, non-refrigerated products and paediatric dosage forms of assured pharmaceutical quality.

ethambutol Oral liquid: 25 mg/ mL [c].

Tablet: 100 mg to 400 mg (hydrochloride).

ethambutol + isoniazid Tablet: 400 mg + 150 mg.
ethambutol + isoniazid + pyrazinamide + rifampicin Tablet: 275 mg + 75 mg + 400 mg + 150 mg.
ethambutol + isoniazid + rifampicin Tablet: 275 mg + 75 mg + 150 mg.
isoniazid Oral liquid: 50 mg/5 mL [c].

Tablet: 100 mg to 300 mg.

Tablet (scored): 50 mg.

isoniazid + pyrazinamide + rifampicin Tablet:

75 mg + 400 mg + 150 mg.

150 mg + 500 mg + 150 mg (For intermittent use three times weekly).

Tablet (dispersible): 50 mg + 150 mg + 75 mg [c].

isoniazid + rifampicin Tablet:

75 mg + 150 mg; 150 mg + 300 mg.

60 mg + 60 mg (For intermittent use three times weekly).

150 mg + 150 mg (For intermittent use three times weekly). Tablet (dispersible): 50 mg + 75 mg [c].

pyrazinamide Oral liquid: 30 mg/ mL [c].

Tablet: 400 mg.

Tablet (dispersible): 150 mg.

Tablet (scored): 150 mg.

rifabutin Capsule: 150 mg.*

* For use only in patients with HIV receiving protease inhibitors.

rifampicin Oral liquid: 20 mg/ mL [c].

Solid oral dosage form: 150 mg; 300 mg.

rifapentine* Tablet: 150 mg

*For treatment of latent TB infection (LTBI) only

Complementary List
Reserve second-line drugs for the treatment of multidrug-resistant tuberculosis (MDR-TB) should be used in specialized centres adhering to WHO standards for TB control.
amikacin Powder for injection: 100 mg; 500 mg; 1 g (as sulfate) in vial.
bedaquiline Tablet: 100 mg.
capreomycin Powder for injection: 1 g (as sulfate) in vial.
clofazimine Capsule: 50 mg; 100 mg.
cycloserine* Solid oral dosage form: 250 mg.

*Terizidone may be an alternative

delamanid a Tablet: 50 mg.

a >6 years

ethionamide* Tablet: 125 mg; 250 mg.

*Protionamide may be an alternative.

kanamycin Powder for injection: 1 g (as sulfate) in vial.
levofloxacin Tablet: 250mg; 500 mg; 750 mg.
linezolid Injection for intravenous administration: 2 mg/ mL in 300 mL bag.

Powder for oral liquid: 100 mg/5 mL.

Tablet: 400 mg; 600 mg.

moxifloxacin Tablet: 400 mg.
p-aminosalicylic acid Granules: 4 g in sachet.

Tablet: 500 mg.

streptomycin [c] Powder for injection: 1 g (as sulfate) in vial.
6.3 Antifungal medicines
amphotericin B Powder for injection: 50 mg in vial (as sodium deoxycholate or

liposomal complex).

clotrimazole Vaginal cream: 1%; 10%.

Vaginal tablet: 100 mg; 500 mg.

fluconazole Capsule: 50 mg.

Injection: 2 mg/ mL in vial.

Oral liquid: 50 mg/5 mL.

flucytosine Capsule: 250 mg.

Infusion: 2.5 g in 250 mL.

griseofulvin Oral liquid: 125 mg/5 mL [c].

Solid oral dosage form: 125 mg; 250 mg.

itraconazole* Capsule: 100 mg.

Oral liquid: 10 mg/mL.

* For treatment of chronic pulmonary aspergillosis, histoplasmosis, sporotrichosis, paracoccidiodomycosis, mycoses caused by T. marneffei and chromoblastomycosis; and prophylaxis of histoplasmosis and infections caused by T. marneffei in AIDS patients.

nystatin Lozenge: 100 000 IU.

Oral liquid: 50 mg/5 mL [c]; 100 000 IU/ mL [c].

Pessary: 100 000 IU.

Tablet: 100 000 IU; 500 000 IU.

voriconazole* Tablet: 50 mg; 200 mg

Powder for injection: 200 mg in vial

Powder for oral liquid: 40 mg/mL

*For treatment of chronic pulmonary aspergillosis and acute invasive aspergillosis.

Complementary List
potassium iodide Saturated solution.
6.4 Antiviral medicines
6.4.1 Antiherpes medicines
o aciclovir Oral liquid: 200 mg/5 mL [c].

Powder for injection: 250 mg (as sodium salt) in vial.

Tablet: 200 mg.

6.4.2 Antiretrovirals
Based on current evidence and experience of use, medicines in the following three classes of antiretrovirals are included as essential medicines for treatment and prevention of HIV (prevention of mother-to-child transmission, pre-exposure prophylaxsis (where indicated) and post-exposure prophylaxis). WHO emphasizes the importance of using these products in accordance with global and national guidelines. WHO recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations, including modified dosage forms, non-refrigerated products and paediatric dosage forms of assured pharmaceutical quality.

Scored tablets can be used in children and therefore can be considered for inclusion in the listing of tablets, provided that adequate quality products are available.

6.4.2.1 Nucleoside/Nucleotide reverse transcriptase inhibitors
abacavir (ABC) Tablet: 300 mg (as sulfate).

Tablet (dispersible, scored): 60 mg (as sulfate) [c].

lamivudine (3TC) Oral liquid: 50 mg/5 mL [c].

Tablet: 150 mg.

tenofovir disoproxil fumarate† (TDF) Tablet: 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil).

†also indicated for pre-exposure prophylaxis.

zidovudine (ZDV or AZT) Capsule: 250 mg.

Oral liquid: 50 mg/5 mL.

Solution for IV infusion injection: 10 mg/ mL in 20- mL vial.

Tablet: 300 mg.

Tablet (dispersible, scored): 60 mg [c].

6.4.2.2 Non-nucleoside reverse transcriptase inhibitors
efavirenz (EFV or EFZ) a Tablet: 200 mg (scored); 600 mg.

a >3 years or >10 kg weight.

nevirapine (NVP) a Oral liquid: 50 mg/5 mL.

Tablet: 50 mg (dispersible); 200 mg.

a> 6 weeks

6.4.2.3 Protease inhibitors
Selection of protease inhibitor(s) from the Model List will need to be determined by each country after consideration of international and national treatment guidelines and experience. Ritonavir is recommended for use in combination as a pharmacological booster, and not as an antiretroviral in its own right. All other protease inhibitors should be used in boosted forms (e.g. with ritonavir).
atazanavir a Solid oral dosage form: 100 mg; 300 mg (as sulfate).

a >25 kg.

atazanavir + ritonavir Tablet (heat stable): 300 mg (as sulfate) + 100 mg.
darunavir a Tablet: 75 mg; 400 mg; 600 mg; 800 mg

a >3 years

lopinavir + ritonavir (LPV/r) Oral liquid: 400 mg + 100 mg/5 mL.

Tablet (heat stable): 100 mg + 25 mg; 200 mg + 50 mg.

Capsule containing oral pellets: 40 mg + 10 mg [c].

ritonavir Oral liquid: 400 mg/5 mL.

Tablet (heat stable): 25 mg; 100 mg.

6.4.2.4 Integrase inhibitors
dolutegravir Tablet: 50 mg
raltegravir* Tablet (chewable): 25 mg; 100 mg.

Tablet: 400 mg

*for use in pregnant women and in second-line regimens in accordance with WHO treatemnt guidelines.

FIXED-DOSE COMBINATIONS
abacavir + lamivudine Tablet (dispersible, scored): 60 mg (as sulfate) + 30 mg; 120 mg (as sulfate) + 60 mg.
efavirenz + emtricitabine* + tenofovir Tablet: 600 mg + 200 mg + 300 mg (disoproxil fumarate equivalent to 245 mg tenofovir disoproxil).

*Emtricitabine (FTC) is an acceptable alternative to 3TC, based on knowledge of the pharmacology, the resistance patterns and clinical trials of antiretrovirals.

efavirenz + lamivudine + tenofovir Tablet: 400 mg + 300 mg + 300 mg (disoproxil fumarate equivalent to 245 mg tenofovir disoproxil)
emtricitabine* + tenofovir† Tablet: 200 mg + 300 mg (disoproxil fumarate equivalent to 245 mg tenofovir disoproxil).

*Emtricitabine (FTC) is an acceptable alternative to 3TC, based on knowledge of the pharmacology, the resistance patterns and clinical trials of antiretrovirals.

† combination also indicated for pre-exposure prophylaxis

lamivudine + nevirapine + zidovudine Tablet: 30 mg + 50 mg + 60 mg [c]; 150 mg + 200 mg + 300 mg.
lamivudine + zidovudine Tablet: 30 mg + 60 mg [c]; 150 mg + 300 mg.
6.4.2.5 Medicines for prevention of HIV-related opportunistic infections
isoniazid + pyridoxine + sulfamethoxazole + trimethoprim Tablet (scored): 300 mg + 25 mg + 800 mg + 160 mg
6.4.3 Other antivirals
ribavirin* Injection for intravenous administration: 800 mg and 1 g in 10- mL phosphate buffer solution.

Solid oral dosage form: 200 mg; 400 mg; 600 mg.

* For the treatment of viral haemorrhagic fevers

valganciclovir* Tablet: 450 mg.

*For the treatment of cytomegalovirus retinitis (CMVr).

Complementary list
oseltamivir* Capsule: 30 mg; 45 mg; 75 mg (as phosphate).

Oral powder: 12 mg/ mL.

* severe illness due to confirmed or suspected influenza virus infection in critically ill hospitalized patients

6.4.4 Antihepatitis medicines
6.4.4.1 Medicines for hepatitis B
6.4.4.1.1 Nucleoside/Nucleotide reverse transcriptase inhibitors
entecavir Oral liquid: 0.05 mg/ mL

Tablet: 0.5 mg; 1 mg

tenofovir disoproxil fumarate (TDF) Tablet: 300 mg (tenofovir disoproxil fumarate – equivalent to 245 mg tenofovir disoproxil).
6.4.4.2 Medicines for hepatitis C
Based on current evidence, medicines in the following classes of direct acting antiviral medicines are included as essential medicines for treatment of hepatitis C virus infection. WHO guidelines recommend specific combination therapy utilizing medicines from different classes.
6.4.4.2.1 Nucleotide polymerase inhibitors
sofosbuvir Tablet: 400 mg
6.4.4.2.2 Protease inhibitors
simeprevir Capsule 150 mg
6.4.4.2.3 NS5A inhibitors
daclatasvir Tablet: 30 mg; 60 mg (as hydrochloride)
6.4.4.2.4 Non-nucleoside polymerase inhibitors
dasabuvir Tablet: 250 mg
6.4.4.2.5 Other antivirals
ribavirin* Injection for intravenous administration: 800 mg and 1 g in 10- mL phosphate buffer solution.

Solid oral dosage form: 200 mg; 400 mg; 600 mg.

* For the treatment of hepatitis C, in combination with peginterferon and/or direct acting anti-viral medicines

Complementary List
pegylated interferon alfa (2a or 2b) * Vial or prefilled syringe:

180 micrograms (peginterferon alfa-2a),

80 microgram, 100 microgram (peginterferon alfa-2b).

* To be used in combination with ribavirin.

FIXED-DOSE COMBINATIONS

Alternative combinations of DAAs from different pharmacological classes are possible.

ledipasvir + sofosbuvir Tablet: 90 mg + 400 mg.
ombitasvir + paritaprevir + ritonavir Tablet: 12.5 mg + 75 mg + 50 mg
sofosbovir + velpatasvir Tablet: 400 mg + 100 mg
6.5 Antiprotozoal medicines
6.5.1 Antiamoebic and antigiardiasis medicines
diloxanide a Tablet: 500 mg (furoate).

a >25 kg.

o metronidazole Injection: 500 mg in 100- mL vial.

Oral liquid: 200 mg (as benzoate)/5 mL.

Tablet: 200 mg to 500 mg.

6.5.2 Antileishmaniasis medicines
amphotericin B Powder for injection: 50 mg in vial (as sodium deoxycholate or

liposomal complex).

miltefosine Solid oral dosage form: 10 mg; 50 mg.
paromomycin Solution for intramuscular injection: 750 mg of paromomycin

base (as the sulfate).

sodium stibogluconate or meglumine antimoniate Injection: 100 mg/ mL, 1 vial = 30  mL or 30%, equivalent to approximately 8.1% antimony (pentavalent) in 5- mL ampoule.
6.5.3 Antimalarial medicines
6.5.3.1 For curative treatment
Medicines for the treatment of P. falciparum malaria cases should be used in combination. The list currently recommends combinations according to treatment guidelines. WHO recognizes that not all of the fixed dose combinations (FDCs) in the WHO treatment guidelines exist, and encourages their development and rigorous testing. WHO also encourages development and testing of rectal dosage formulations.
amodiaquine* Tablet: 153 mg or 200 mg (as hydrochloride).

* To be used in combination with artesunate 50 mg.

artemether* Oily injection: 80 mg/ mL in 1- mL ampoule.

* For use in the management of severe malaria.

artemether + lumefantrine* Tablet: 20 mg + 120 mg.

Tablet (dispersible): 20 mg + 120 mg [c].

* Not recommended in the first trimester of pregnancy or in children below 5 kg.

artesunate* Injection: ampoules, containing 60 mg anhydrous artesunic acid with a separate ampoule of 5% sodium bicarbonate solution.

For use in the management of severe malaria.

Rectal dosage form: 50 mg [c]; 100 mg [c]; 200 mg capsules (for pre-referral treatment of severe malaria only; patients should be taken to an appropriate health facility for follow-up care) [c].

Tablet: 50 mg.

* To be used in combination with either amodiaquine, mefloquine or sulfadoxine + pyrimethamine.

artesunate + amodiaquine* Tablet: 25 mg + 67.5 mg; 50 mg + 135 mg; 100 mg + 270 mg.

* Other combinations that deliver the target doses required such as 153 mg or 200 mg (as hydrochloride) with 50 mg artesunate

can be alternatives.

artesunate + mefloquine Tablet: 25 mg + 55 mg; 100 mg + 220 mg.
artesunate + pyronaridine tetraphosphate a Tablet: 60 mg + 180 mg

Granules: 20 mg + 60 mg [c]. a > 5 kg

chloroquine* Oral liquid: 50 mg (as phosphate or sulfate)/5 mL.

Tablet: 100 mg; 150 mg (as phosphate or sulfate).

* For use only for the treatment of P.vivax infection.

dihydroartemisinin + piperaquine phosphate

a

Tablet: 20 mg + 160 mg; 40 mg + 320 mg

a > 5 kg

doxycycline* Capsule: 100 mg (as hydrochloride or hyclate).

Tablet (dispersible): 100 mg (as monohydrate).

* For use only in combination with quinine.

mefloquine* Tablet: 250 mg (as hydrochloride).

* To be used in combination with artesunate 50 mg.

primaquine* Tablet: 7.5 mg; 15 mg (as diphosphate).

* Only for use to achieve radical cure of P.vivax and P.ovale

infections, given for 14 days.

quinine* Injection: 300 mg quinine hydrochloride/ mL in 2- mL ampoule.

Tablet: 300 mg (quinine sulfate) or 300 mg (quinine bisulfate).

* For use only in the management of severe malaria, and should be used in combination with doxycycline.

sulfadoxine + pyrimethamine* Tablet: 500 mg + 25 mg.

* Only in combination with artesunate 50 mg.

6.5.3.2 For prophylaxis
chloroquine* Oral liquid: 50 mg (as phosphate or sulfate)/5 mL.

Tablet: 150 mg (as phosphate or sulfate).

* For use only in central American regions, for P.vivax infections.

doxycycline a Solid oral dosage form: 100 mg (as hydrochloride or hyclate).

a >8 years.

mefloquine a Tablet: 250 mg (as hydrochloride).

a >5 kg or >3 months.

proguanil* Tablet: 100 mg (as hydrochloride).

* For use only in combination with chloroquine.

6.5.4 Antipneumocystosis and antitoxoplasmosis medicines
pyrimethamine Tablet: 25 mg.
sulfadiazine Tablet: 500 mg.
sulfamethoxazole + trimethoprim Injection:

80 mg + 16 mg/ mL in 5- mL ampoule; 80 mg + 16 mg/ mL in 10- mL ampoule.

Oral liquid: 200 mg + 40 mg/5 mL [c].

Tablet: 100 mg + 20 mg; 400 mg + 80 mg [c].

Complementary List
pentamidine Tablet: 200 mg; 300 mg (as isethionate).
6.5.5 Antitrypanosomal medicines
6.5.5.1 African trypanosomiasis
Medicines for the treatment of 1st stage African trypanosomiasis
pentamidine* Powder for injection: 200 mg (as isetionate) in vial.

* To be used for the treatment of Trypanosoma brucei gambiense

infection.

suramin sodium* Powder for injection: 1 g in vial.

* To be used for the treatment of the initial phase of

Trypanosoma brucei rhodesiense infection.

Medicines for the treatment of 2nd stage African trypanosomiasis
eflornithine* Injection: 200 mg (hydrochloride)/ mL in 100- mL bottle.

* To be used for the treatment of Trypanosoma brucei gambiense

infection.

melarsoprol Injection: 3.6% solution, 5- mL ampoule (180 mg of active

compound).

nifurtimox* Tablet: 120 mg.

* Only to be used in combination with eflornithine, for the treatment of Trypanosoma brucei gambiense infection.

Complementary List [c]
melarsoprol Injection: 3.6% solution in 5- mL ampoule (180 mg of active compound).
6.5.5.2 American trypanosomiasis
benznidazole Tablet: 12.5 mg [c];100 mg.

Tablet (scored): 50 mg.

nifurtimox Tablet: 30 mg; 120 mg; 250 mg.
7. ANTIMIGRAINE MEDICINES
7.1 For treatment of acute attack
acetylsalicylic acid Tablet: 300 mg to 500 mg.
ibuprofen [c] Tablet: 200 mg; 400 mg.
paracetamol Oral liquid: 120 mg/5 mL [c]; 125 mg/5 mL [c].

Tablet: 300 mg to 500 mg.

7.2 For prophylaxis
o propranolol Tablet: 20 mg; 40 mg (hydrochloride).
8. ANTINEOPLASTICS AND IMMUNOSUPPRESSIVES

Medicines listed below should be used according to protocols for treatment of the diseases.

8.1 Immunosuppressive medicines
Complementary List
azathioprine Powder for injection: 100 mg (as sodium salt) in vial.

Tablet (scored): 50 mg.

ciclosporin Capsule: 25 mg.

Concentrate for injection: 50 mg/ mL in 1- mL ampoule for organ transplantation.

8.2 Cytotoxic and adjuvant medicines
Complementary List
all-trans retinoid acid (ATRA) Capsule: 10 mg.

–   Acute promyelocytic leukaemia.

allopurinol [c] Tablet: 100 mg; 300 mg.
asparaginase Powder for injection: 10 000 IU in vial.

–   Acute lymphoblastic leukaemia.

bendamustine Injection: 45 mg/0.5 mL; 180 mg/2 mL.

–   Chronic lymphocytic leukaemia

–   Follicular lymphoma

bleomycin Powder for injection: 15 mg (as sulfate) in vial.

–   Hodgkin lymphoma

–   Kaposi sarcoma

–   Ovarian germ cell tumour

–   Testicular germ cell tumour

calcium folinate Injection: 3 mg/ mL in 10- mL ampoule.

Tablet: 15 mg.

–   Early stage colon cancer

–   Early stage rectal cancer

–   Gestational trophoblastic neoplasia

–   Metastatic colorectal cancer

–   Osteosarcoma

–   Burkitt lymphoma

capecitabine Tablet: 150 mg; 500 mg.

–    Early stage colon cancer

–    Early stage rectal cancer

–   Metastatic breast cancer

–    Metastatic colorectal cancer

carboplatin Injection: 50 mg/5 mL; 150 mg/15 mL; 450 mg/45 mL; 600 mg/60 mL.

–   Early stage breast cancer

–   Epithelial ovarian cancer

–   Nasopharyngeal cancer

–   Non-small cell lung cancer

–   Osteosarcoma

–   Retinoblastoma

chlorambucil Tablet: 2 mg.

–   Chronic lymphocytic leukaemia.

cisplatin Injection: 50 mg/50 mL; 100 mg/100 mL.

–   Cervical cancer (as a radio-sensitizer)

–   Head and neck cancer (as a radio-sensitizer)

–   Nasopharyngeal cancer (as a radio-sensitizer)

–   Non-small cell lung cancer

–   Osteosarcoma

–   Ovarian germ cell tumour

–   Testicular germ cell tumour

cyclophosphamide Powder for injection: 500 mg in vial.

Tablet: 25 mg.

–   Chronic lymphocytic leukaemia

–   Diffuse large B-cell lymphoma

–   Early stage breast cancer

–   Gestational trophoblastic neoplasia

–   Hodgkin lymphoma

–   Follicular lymphoma

–   Rhabdomyosarcoma

–   Ewing sarcoma

–   Acute lymphoblastic leukaemia

–   Burkitt lymphoma

–   Metastatic breast cancer.

cytarabine Powder for injection: 100 mg in vial.

–   Acute myelogenous leukaemia

–   Acute lymphoblastic leukaemia

–   Acute promyelocytic leukaemia

–   Burkitt lymphoma.

dacarbazine Powder for injection: 100 mg in vial.

–   Hodgkin lymphoma

dactinomycin Powder for injection: 500 micrograms in vial.

–   Gestational trophoblastic neoplasia

–   Rhabdomyosarcoma

–   Wilms tumour

dasatinib Tablet: 20 mg; 50 mg; 70 mg; 80 mg; 100 mg; 140 mg.

–   Imatinib-resistant chronic myeloid leukaemia

daunorubicin Powder for injection: 50 mg (hydrochloride) in vial.

–   Acute lymphoblastic leukaemia

–   Acute myelogenous leukaemia

–   Acute promyelocytic leukaemia

docetaxel Injection: 20 mg/ mL; 40 mg/ mL.

–   Early stage breast cancer

–   Metastatic breast cancer

–   Metastatic prostate cancer

doxorubicin Powder for injection: 10 mg; 50 mg (hydrochloride) in vial.

–   Diffuse large B-cell lymphoma

–   Early stage breast cancer

–   Hodgkin lymphoma

–   Kaposi sarcoma

–   Follicular lymphoma

–   Metastatic breast cancer

–   Osteosarcoma

–   Ewing sarcoma

–   Acute lymphoblastic leukaemia

–   Wilms tumour

–   Burkitt lymphoma

etoposide Capsule: 100 mg.

Injection: 20 mg/ mL in 5- mL ampoule.

–   Testicular germ cell tumour

–   Gestational trophoblastic neoplasia

–   Hodgkin lymphoma

–   Non-small cell lung cancer

–   Ovarian germ cell tumour

–   Retinoblastoma

–   Ewing sarcoma

–   Acute lymphoblastic leukaemia

–   Burkitt lymphoma

filgrastim Injection: 120 micrograms/0.2 mL; 300 micrograms/0.5 mL; 480 micrograms/0.8 mL in pre-filled syringe 300 micrograms/mL in 1- mL vial, 480 mg/1.6 mL in 1.6- mL vial.

–   Primary prophylaxis in patients at high risk for developing febrile neutropenia associated with myelotoxic chemotherapy.

–   Secondary prophylaxis for patients who have experienced neutropenia following prior myelotoxic chemotherapy

–   To facilitate administration of dose dense chemotherapy regimens

fludarabine Powder for injection: 50 mg (phosphate) in vial.

Tablet: 10 mg

–   Chronic lymphocytic leukaemia.

fluorouracil Injection: 50 mg/ mL in 5- mL ampoule.

–   Early stage breast cancer

–   Early stage colon cancer

–   Early stage rectal cancer

–   Metastatic colorectal cancer

–   Nasopharyngeal cancer.

gemcitabine Powder for injection: 200 mg in vial, 1 g in vial.

–   Epithelial ovarian cancer

–   Non-small cell lung cancer

hydroxycarbamide Solid oral dosage form: 200 mg; 250 mg; 300 mg; 400 mg; 500 mg;

1 g.

–   Chronic myeloid leukaemia.

ifosfamide Powder for injection: 500 mg vial; 1-g vial; 2-g vial.

–   Testicular germ cell tumour

–   Ovarian germ cell tumour

–   Osteosarcoma

–   Rhabdomyosarcoma

–   Ewing sarcoma

imatinib Tablet: 100 mg; 400 mg.

–   Chronic myeloid leukaemia

–   Gastrointestinal stromal tumour

irinotecan Injection: 40 mg/2 mL in 2- mL vial; 100 mg/5 mL in 5- mL vial; 500 mg/25 mL in 25- mL vial.

–   Metastatic colorectal cancer.

mercaptopurine Tablet: 50 mg.

–   Acute lymphoblastic leukaemia

–   Acute promyelocytic leukaemia.

mesna Injection: 100 mg/ mL in 4- mL and 10- mL ampoules.

Tablet: 400 mg; 600 mg.

–   Testicular germ cell tumour

–   Ovarian germ cell tumour

–   Osteosarcoma

–   Rhabdomyosarcoma

–   Ewing sarcoma.

methotrexate Powder for injection: 50 mg (as sodium salt) in vial.

Tablet: 2.5 mg (as sodium salt).

–   Early stage breast cancer

–   Gestational trophoblastic neoplasia

–   Osteosarcoma

–   Acute lymphoblastic leukaemia

–   Acute promyelocytic leukaemia

nilotinib Capsule: 150 mg; 200 mg.

–   Imatinib-resistant chronic myeloid leukaemia

oxaliplatin Injection: 50 mg/10 mL in 10- mL vial; 100 mg/20 mL in 20- mL vial; 200 mg/40 mL in 40- mL vial.

Powder for injection: 50 mg, 100 mg in vial.

–   Early stage colon cancer

–   Metastatic colorectal cancer

paclitaxel Powder for injection: 6 mg/ mL.

–   Epithelial ovarian cancer

–   Early stage breast cancer

–   Metastatic breast cancer

–   Kaposi sarcoma

–   Nasopharyngeal cancer

–   Non-small cell lung cancer

–   Ovarian germ cell tumour

procarbazine Capsule: 50 mg (as hydrochloride).
rituximab Injection: 100 mg/10 mL in 10- mL vial; 500 mg/50 mL in 50- mL vial.

–   Diffuse large B-cell lymphoma

–   Chronic lymphocytic leukaemia

–   Follicular lymphoma.

tioguanine [c] Solid oral dosage form: 40 mg.

–  Acute lymphoblastic leukaemia.

trastuzumab Powder for injection: 60 mg; 150 mg; 440 mg in vial

–   Early stage HER2 positive breast cancer

–   Metastatic HER2 positive breast cancer.

vinblastine Powder for injection: 10 mg (sulfate) in vial.

–   Hodgkin lymphoma

–   Kaposi sarcoma.

–   Testicular germ cell tumour

–   Ovarian germ cell tumour

vincristine Powder for injection: 1 mg; 5 mg (sulfate) in vial.

–   Diffuse large B-cell lymphoma

–   Gestational trophoblastic neoplasia

–   Hodgkin lymphoma

–   Kaposi sarcoma

–   Follicular lymphoma

–   Retinoblastoma

–   Rhabdomyosarcoma

–   Ewing sarcoma

–   Acute lymphoblastic leukaemia

–   Wilms tumour

–   Burkitt lymphoma.

vinorelbine Injection: 10 mg/mL in 1- mL vial; 50 mg/5 mL in 5- mL vial.

–   Non-small cell lung cancer

–   Metastatic breast cancer

zoledronic acid Concentrate solution for infusion: 4 mg/5 mL in 5- mL vial.

Solution for infusion: 4 mg/100 mL in 100- mL bottle.

–   Malignancy-related bone disease

8.3 Hormones and antihormones
Complementary List
o anastrozole Tablet: 1 mg.

–   Early stage breast cancer

–   Metastatic breast cancer.

o bicalutamide Tablet: 50 mg.

–   Metastatic prostate cancer.

dexamethasone Injection: 4 mg/ mL in 1- mL ampoule (as disodium phosphate salt).

Oral liquid: 2 mg/5 mL [c].

–   Acute lymphoblastic leukaemia.

o leuprorelin Dose form

–   Early stage breast cancer

–   Metastatic prostate cancer

hydrocortisone Powder for injection: 100 mg (as sodium succinate) in vial.

–   Acute lymphoblastic leukaemia.

methylprednisolone [c] Injection: 40 mg/ mL (as sodium succinate) in 1- mL single-dose vial and

5-   mL multi-dose vials; 80 mg/ mL (as sodium succinate) in 1- mL single-dose vial.

–        Acute lymphoblastic leukamia.

o prednisolone Oral liquid: 5 mg/ mL [c].

Tablet: 5 mg; 25 mg.

–   Chronic lymphocytic leukaemia

–   Diffuse large B-cell lymphoma

–   Hodgkin lymphoma

–   Follicular lymphoma

–   Acute lymphoblastic leukaemia

–   Burkitt lymphoma

tamoxifen Tablet: 10 mg; 20 mg (as citrate).

–   Early stage breast cancer

–   Metastatic breast cancer

9. ANTIPARKINSONISM MEDICINES
o biperiden Injection: 5 mg (lactate) in 1- mL ampoule.

Tablet: 2 mg (hydrochloride).

levodopa + o carbidopa Tablet: 100 mg + 10 mg; 100 mg + 25 mg; 250 mg + 25 mg
10. MEDICINES AFFECTING THE BLOOD
10.1 Antianaemia medicines
ferrous salt Oral liquid: equivalent to 25 mg iron (as sulfate)/ mL.

Tablet: equivalent to 60 mg iron.

ferrous salt + folic acid Tablet: equivalent to 60 mg iron + 400 micrograms folic acid (nutritional supplement for use during pregnancy).
folic acid Tablet: 400 micrograms*; 1 mg; 5 mg.

*periconceptual use for prevention of first occurrence of neural tube defects

hydroxocobalamin Injection: 1 mg (as acetate, as hydrochloride or as sulfate) in 1- mL ampoule.
Complementary List
o erythropoiesis-stimulating agents* Injection: pre-filled syringe

1000IU/ 0.5 mL; 2000IU/ 0.5 mL; 3000IU/ 0.3 mL; 4000IU/ 0.4 mL;

5000IU/ 0.5 mL; 6000IU/ 0.6 mL; 8000IU/ 0.8mL; 10 000IU/ 1 mL;

20 000IU/ 0.5 mL; 40 000IU/ 1 mL

* the square box applies to epoetin alfa, beta and theta, darbepoetin alfa, methoxy polyethylene glycol-epoetin beta,and their respective biosimilars.

10.2 Medicines affecting coagulation
o enoxaparin* Injection: ampoule or pre-filled syringe

20 mg/0.2 mL; 40 mg/0.4 mL; 60 mg/0.6 mL; 80 mg/0.8 mL; 100 mg/1 mL; 120 mg/0.8 mL; 150 mg/1 mL

*Alternatives are limited to nadroparin and dalteparin

heparin sodium Injection: 1000 IU/ mL; 5000 IU/ mL; 20 000 IU/ mL in 1- mL ampoule.
phytomenadione Injection: 1 mg/ mL [c]; 10 mg/ mL in 5- mL ampoule.

Tablet: 10 mg.

protamine sulfate Injection: 10 mg/ mL in 5- mL ampoule.
tranexamic acid Injection: 100 mg/ mL in 10- mL ampoule.
o warfarin Tablet: 1 mg; 2 mg; 5 mg (sodium salt).
Complementary List [c]
desmopressin Injection: 4 micrograms/ mL (as acetate) in 1- mL ampoule.

Nasal spray: 10 micrograms (as acetate) per dose

heparin sodium Injection: 1000 IU/ mL; 5000 IU/ mL in 1- mL ampoule.
protamine sulfate Injection: 10 mg/ mL in 5- mL ampoule.
o warfarin Tablet: 0.5 mg; 1 mg; 2 mg; 5 mg (sodium salt).
10.3 Other medicines for haemoglobinopathies
Complementary List
deferoxamine* Powder for injection: 500 mg (mesilate) in vial.

* Deferasirox oral form may be an alternative, depending on cost and availability.

hydroxycarbamide Solid oral dosage form: 200 mg; 500 mg; 1 g.
11. BLOOD PRODUCTS OF HUMAN ORIGIN AND PLASMA SUBSTITUTES
11.1 Blood and blood components
In accordance with the World Health Assembly resolution WHA63.12, WHO recognizes that achieving self- sufficiency, unless special circumstances preclude it, in the supply of safe blood components based on voluntary, non-remunerated blood donation, and the security of that supply are important national goals to prevent blood shortages and meet the transfusion requirements of the patient population. All preparations should comply with the WHO requirements.
fresh–frozen plasma
platelets
red blood cells
whole blood
11.2 Plasma-derived medicines
All human plasma-derived medicines should comply with the WHO requirements.
11.2.1 Human immunoglobulins
anti-D immunoglobulin Injection: 250 micrograms in single-dose vial.
Anti-rabies immunoglobulin Injection: 150 IU/ mL in vial.
Anti-tetanus immunoglobulin Injection: 500 IU in vial.
Complementary List
normal immunoglobulin Intramuscular administration: 16% protein solution.*

Intravenous administration: 5%; 10% protein solution.**

Subcutaneous administration: 15%; 16% protein solution.*

* Indicated for primary immune deficiency.

**Indicated for primary immune deficiency and Kawasaki disease.

11.2.2 Blood coagulation factors
Complementary List
o coagulation factor VIII Powder for injection: 500 IU/vial.
o coagulation factor IX Powder for injection: 500 IU/vial, 1000 IU/vial.
11.3 Plasma substitutes
o dextran 70* Injectable solution: 6%.

* Polygeline, injectable solution, 3.5% is considered as equivalent.

12. CARDIOVASCULAR MEDICINES

Fixed-dose combinations for non-communicable diseases may have advantages over the single medicines given concomitantly, including increased adherence and reduced pill burden. The potential value of fixed-dose combinations of currently listed essential medicines, with regulatory approval and demonstrated bioavailability for the management of chronic non-communicable diseases, is recognized.

12.1 Antianginal medicines
o bisoprolol* Tablet: 1.25 mg; 5 mg.

* o includes metoprolol and carvedilol as alternatives.

glyceryl trinitrate Tablet (sublingual): 500 micrograms.
o isosorbide dinitrate Tablet (sublingual): 5 mg.
verapamil Tablet: 40 mg; 80 mg (hydrochloride).
12.2 Antiarrhythmic medicines
o bisoprolol* Tablet: 1.25 mg; 5 mg.

* o includes metoprolol and carvedilol as alternatives.

digoxin Injection: 250 micrograms/ mL in 2- mL ampoule.

Oral liquid: 50 micrograms/ mL.

Tablet: 62.5 micrograms; 250 micrograms.

epinephrine (adrenaline) Injection: 100 micrograms/ mL (as acid tartrate or

hydrochloride) in 10- mL ampoule.

lidocaine Injection: 20 mg (hydrochloride)/ mL in 5- mL ampoule.
verapamil Injection: 2.5 mg (hydrochloride)/ mL in 2- mL ampoule.

Tablet: 40 mg; 80 mg (hydrochloride).

Complementary List
amiodarone Injection: 50 mg/ mL in 3- mL ampoule (hydrochloride).

Tablet: 100 mg; 200 mg; 400 mg (hydrochloride).

12.3 Antihypertensive medicines
o amlodipine Tablet: 5 mg (as maleate, mesylate or besylate).
o bisoprolol* Tablet: 1.25 mg; 5 mg.

* includes atenolol, metoprolol and carvedilol as alternatives. Atenolol should not be used as a first-line agent in uncomplicated hypertension in patients >60 years

o enalapril Tablet: 2.5 mg; 5 mg (as hydrogen maleate).
hydralazine* Powder for injection: 20 mg (hydrochloride) in ampoule.

Tablet: 25 mg; 50 mg (hydrochloride).

* Hydralazine is listed for use only in the acute management of severe pregnancy-induced hypertension. Its use in the treatment of essential hypertension is not recommended in view of the evidence of greater efficacy and safety of other medicines.

o hydrochlorothiazide Oral liquid: 50 mg/5 mL.

Solid oral dosage form: 12.5 mg; 25 mg.

methyldopa* Tablet: 250 mg.

* Methyldopa is listed for use only in the management of pregnancy-induced hypertension. Its use in the treatment of essential hypertension is not recommended in view of the evidence of greater efficacy and safety of other medicines.

o losartan Tablet: 25 mg; 50 mg; 100 mg.
Complementary List
sodium nitroprusside Powder for infusion: 50 mg in ampoule.
12.4 Medicines used in heart failure
o bisoprolol* Tablet: 1.25 mg; 5 mg.

*o includes metoprolol and carvedilol as alternatives.

digoxin Injection: 250 micrograms/ mL in 2- mL ampoule.

Oral liquid: 50 micrograms/ mL.

Tablet: 62.5 micrograms; 250 micrograms.

o enalapril Tablet: 2.5 mg; 5 mg (as hydrogen maleate).
o furosemide Injection: 10 mg/ mL in 2- mL ampoule.

Oral liquid: 20 mg/5 mL [c].

Tablet: 40 mg.

o hydrochlorothiazide Oral liquid: 50 mg/5 mL.

Solid oral dosage form: 25 mg.

o losartan Tablet: 25 mg; 50 mg; 100 mg
spironolactone Tablet: 25 mg.
Complementary List
dopamine Injection: 40 mg/ mL (hydrochloride) in 5- mL vial.
12.5 Antithrombotic medicines
12.5.1 Anti-platelet medicines
acetylsalicylic acid Tablet: 100 mg.
clopidogrel Tablet: 75 mg; 300 mg
12.5.2 Thrombolytic medicines
Complementary List
streptokinase Powder for injection: 1.5 million IU in vial.
12.6 Lipid-lowering agents
o simvastatin* Tablet: 5 mg; 10 mg; 20 mg; 40 mg.

* For use in high-risk patients.

13. DERMATOLOGICAL MEDICINES (topical)
13.1 Antifungal medicines
o miconazole Cream or ointment: 2% (nitrate).
selenium sulfide Detergentbased suspension: 2%.
sodium thiosulfate Solution: 15%.
terbinafine Cream: 1% or Ointment: 1% terbinafine hydrochloride.
13.2 Anti-infective medicines
mupirocin Cream (as mupirocin calcium): 2%.

Ointment: 2%.

potassium permanganate Aqueous solution: 1:10 000.
silver sulfadiazine a Cream: 1%.

a >2 months.

13.3 Anti-inflammatory and antipruritic medicines
o betamethasone a Cream or ointment: 0.1% (as valerate).

a Hydrocortisone preferred in neonates.

o calamine Lotion.
o hydrocortisone Cream or ointment: 1% (acetate).
13.4 Medicines affecting skin differentiation and proliferation
benzoyl peroxide Cream or lotion: 5%.
coal tar Solution: 5%.
fluorouracil Ointment: 5%.
o podophyllum resin Solution: 10% to 25%.
salicylic acid Solution: 5%.
urea Cream or ointment: 5%; 10%.
13.5 Scabicides and pediculicides
o benzyl benzoate a Lotion: 25%.

a >2 years.

permethrin Cream: 5%.

Lotion: 1%.

14. DIAGNOSTIC AGENTS
14.1 Ophthalmic medicines
fluorescein Eye drops: 1% (sodium salt).
o tropicamide Eye drops: 0.5%.
14.2 Radiocontrast media
o amidotrizoate Injection: 140 mg to 420 mg iodine (as sodium or meglumine salt)/ mL in 20- mL ampoule.
barium sulfate Aqueous suspension.
o iohexol Injection: 140 mg to 350 mg iodine/ mL in 5- mL; 10- mL; 20- mL ampoules.
Complementary List
barium sulfate [c] Aqueous suspension.
o meglumine iotroxate Solution: 5 g to 8 g iodine in 100 mL to 250 mL.
15. DISINFECTANTS AND ANTISEPTICS
15.1 Antiseptics
o chlorhexidine Solution: 5% (digluconate).
o ethanol Solution: 70% (denatured).
o povidone iodine Solution: 10% (equivalent to 1% available iodine).
15.2 Disinfectants
alcohol based hand rub Solution: containing ethanol 80% volume /volume

Solution: containing isopropyl alcohol 75% volume/volume

o chlorine base compound Powder: (0.1% available chlorine) for solution.
o chloroxylenol Solution: 4.8%.
glutaral Solution: 2%.
16. DIURETICS
amiloride Tablet: 5 mg (hydrochloride).
o furosemide Injection: 10 mg/ mL in 2- mL ampoule.

Oral liquid: 20 mg/5 mL [c].

Tablet: 10 mg [c]; 20 mg [c]; 40 mg.

o hydrochlorothiazide Solid oral dosage form: 25 mg.
mannitol Injectable solution: 10%; 20%.
spironolactone Tablet: 25 mg.
Complementary List [c]
o hydrochlorothiazide Tablet (scored): 25 mg.
mannitol Injectable solution: 10%; 20%.
spironolactone Oral liquid: 5 mg/5 mL; 10 mg/5 mL; 25 mg/5 mL.

Tablet: 25 mg.

17. GASTROINTESTINAL MEDICINES
Complementary List [c]
o pancreatic enzymes Age-appropriate formulations and doses including lipase, protease and amylase.
17.1 Antiulcer medicines
o omeprazole Powder for injection: 40 mg in vial

Powder for oral liquid: 20 mg; 40 mg sachets.

Solid oral dosage form: 10 mg; 20 mg; 40 mg.

o ranitidine Injection: 25 mg/ mL (as hydrochloride) in 2- mL ampoule.

Oral liquid: 75 mg/5 mL (as hydrochloride).

Tablet: 150 mg (as hydrochloride).

17.2 Antiemetic medicines
dexamethasone Injection: 4 mg/ mL in 1- mL ampoule (as disodium phosphate salt).

Oral liquid: 0.5 mg/5 mL; 2 mg/5 mL.

Solid oral dosage form: 0.5 mg; 0.75 mg; 1.5 mg; 4 mg.

metoclopramide a Injection: 5 mg (hydrochloride)/ mL in 2- mL ampoule.

Oral liquid: 5 mg/5 mL [c].

Tablet: 10 mg (hydrochloride).

a Not in neonates.

ondansetron a Injection: 2 mg base/ mL in 2- mL ampoule (as hydrochloride).

Oral liquid: 4 mg base/5 mL.

Solid oral dosage form: Eq 4 mg base; Eq 8 mg base; Eq 24 mg base.

a >1 month.

17.3 Anti-inflammatory medicines
o sulfasalazine Retention enema. Suppository: 500 mg.

Tablet: 500 mg.

Complementary List
o hydrocortisone Retention enema.

Suppository: 25 mg (acetate).

(the o only applies to hydrocortisone retention enema).

17.4 Laxatives
o senna Tablet: 7.5 mg (sennosides) (or traditional dosage forms).
17.5 Medicines used in diarrhoea
17.5.1 Oral rehydration
oral rehydration salts Powder for dilution in 200 mL; 500 mL; 1 L.

glucose:                                    75 mEq

sodium:                                    75 mEq or mmol/L

chloride:                                  65 mEq or mmol/L

potassium:                               20 mEq or mmol/L

citrate:                                      10 mmol/L

osmolarity:                               245 mOsm/L

glucose:                                    13.5 g/L

sodium chloride:                        2.6 g/L

potassium chloride:                    1.5 g/L trisodium citrate dihydrate*:                     2.9 g/L

*trisodium citrate dihydrate may be replaced by sodium hydrogen carbonate (sodium bicarbonate) 2.5 g/L. However, as the stability of this latter formulation is very poor under tropical conditions, it is recommended only when manufactured for immediate use.

17.5.2 Medicines for diarrhoea
zinc sulfate* Solid oral dosage form: 20 mg.

* In acute diarrhoea zinc sulfate should be used as an adjunct to oral rehydration salts.

18. HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES
18.1 Adrenal hormones and synthetic substitutes
fludrocortisone Tablet: 100 micrograms (acetate).
hydrocortisone Tablet: 5 mg; 10 mg; 20 mg.
18.2 Androgens
Complementary List
testosterone Injection: 200 mg (enanthate) in 1- mL ampoule.
18.3 Contraceptives
18.3.1 Oral hormonal contraceptives
o ethinylestradiol + o levonorgestrel Tablet: 30 micrograms + 150 micrograms.
o ethinylestradiol + o norethisterone Tablet: 35 micrograms + 1 mg.
levonorgestrel Tablet: 30 micrograms; 750 micrograms (pack of two); 1.5 mg.
ulipristal Tablet: 30 mg (as acetate)
18.3.2 Injectable hormonal contraceptives
estradiol cypionate + medroxyprogesterone acetate Injection: 5 mg + 25 mg.
medroxyprogesterone acetate Injection (intramuscular): 150 mg/ mL in 1- mL vial.

Injection (subcutaneous): 104 mg/0.65 mL in pre-filled syringe or single-dose injection delivery system.

norethisterone enantate Oily solution: 200 mg/ mL in 1- mL ampoule.
18.3.3 Intrauterine devices
copper-containing device
levonorgestrel-releasing intrauterine system Intrauterine system with reservoir containing 52 mg of levonorestrel
18.3.4 Barrier methods
condoms
diaphragms
18.3.5 Implantable contraceptives
etonogestrel-releasing implant Single-rod etonogestrel-releasing implant, containing 68 mg of etonogestrel.
levonorgestrel-releasing implant Two-rod levonorgestrel-releasing implant, each rod containing 75 mg of levonorgestrel (150 mg total).
18.3.6 Intravaginal contraceptives
progesterone vaginal ring* Progesterone-releasing vaginal ring containing 2.074 g of micronized progesterone.

*For use in women actively breastfeeding at least 4 times per day

18.4 Estrogens
18.5 Insulins and other medicines used for diabetes
o gliclazide* Solid oral dosage form: (controlled-release tablets) 30 mg; 60 mg;

80 mg.

* glibenclamide not suitable above 60 years.

glucagon Injection: 1 mg/ mL.
insulin injection (soluble) Injection: 40 IU/ mL in 10- mL vial; 100 IU/ mL in 10- mL vial.
intermediate-acting insulin Injection: 40 IU/ mL in 10- mL vial; 100 IU/ mL in 10- mL vial (as compound insulin zinc suspension or isophane insulin).
metformin Tablet: 500 mg (hydrochloride).
Complementary List [c]
metformin Tablet: 500 mg (hydrochloride).
18.6 Ovulation inducers
Complementary List
clomifene Tablet: 50 mg (citrate).
18.7 Progestogens
o medroxyprogesterone acetate Tablet: 5 mg.
18.8 Thyroid hormones and antithyroid medicines
levothyroxine Tablet: 25 micrograms [c]; 50 micrograms; 100 micrograms (sodium salt).
potassium iodide Tablet: 60 mg.
o propylthiouracil Tablet: 50 mg.
Complementary List [c]
Lugol’s solution Oral liquid: about 130 mg total iodine/ mL.
potassium iodide Tablet: 60 mg.
propylthiouracil Tablet: 50 mg.
19. IMMUNOLOGICALS
19.1 Diagnostic agents
All tuberculins should comply with the WHO requirements for tuberculins.
tuberculin, purified protein derivative (PPD) Injection.
19.2 Sera and immunoglobulins
All plasma fractions should comply with the WHO requirements.
Anti-venom immunoglobulin* Injection.

* Exact type to be defined locally.

diphtheria antitoxin Injection: 10 000 IU; 20 000 IU in vial.
19.3 Vaccines
WHO immunization policy recommendations are published in vaccine position papers on the basis of recommendations made by the Strategic Advisory Group of Experts on Immunization (SAGE).

WHO vaccine position papers are updated three to four times per year. The list below details the vaccines for which there is a recommendation from SAGE and a corresponding WHO position paper as at 10 February 2017. The most recent versions of the WHO position papers, reflecting the current evidence related to a specific vaccine and the related recommendations, can be accessed at any time on the WHO website at:

http://www.who.int/immunization/documents/positionpapers/en/index.html.

Vaccine recommendations may be universal or conditional (e.g., in certain regions, in some high-risk populations or as part of immunization programmes with certain characteristics). Details are available in the relevant position papers, and in the Summary Tables of WHO Routine Immunization Recommendations available on the WHO website at:

http://www.who.int/immunization/policy/immunization_tables/en/index.html.

Selection of vaccines from the Model List will need to be determined by each country after consideration of international recommendations, epidemiology and national priorities.

All vaccines should comply with the WHO requirements for biological substances. WHO noted the need for vaccines used in children to be polyvalent.

Recommendations for all
BCG vaccine
diphtheria vaccine
Haemophilus influenzae type b vaccine
hepatitis B vaccine
HPV vaccine
measles vaccine
pertussis vaccine
pneumococcal vaccine
poliomyelitis vaccine
rotavirus vaccine
rubella vaccine
tetanus vaccine
Recommendations for certain regions
Japanese encephalitis vaccine
yellow fever vaccine
tick-borne encephalitis vaccine
Recommendations for some high-risk populations
cholera vaccine
hepatitis A vaccine
meningococcal meningitis vaccine
rabies vaccine
typhoid vaccine
Recommendations for immunization programmes with certain characteristics
influenza vaccine (seasonal)
mumps vaccine
varicella vaccine
20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) AND CHOLINESTERASE INHIBITORS
o atracurium Injection: 10 mg/ mL (besylate).
neostigmine Injection: 500 micrograms in 1- mL ampoule; 2.5 mg (metilsulfate) in 1- mL ampoule.

Tablet: 15 mg (bromide).

suxamethonium Injection: 50 mg (chloride)/ mL in 2- mL ampoule.

Powder for injection (chloride), in vial.

o vecuronium [c] Powder for injection: 10 mg (bromide) in vial.
Complementary List
pyridostigmine Injection: 1 mg in 1- mL ampoule.

Tablet: 60 mg (bromide).

o vecuronium Powder for injection: 10 mg (bromide) in vial.
21. OPHTHALMOLOGICAL PREPARATIONS
21.1 Anti-infective agents
aciclovir Ointment: 3% W/W.
azithromycin Solution (eye drops): 1.5%.
erythromycin* Ointment: 0.5% [c]

*Infections due to Chlamydia trachomatis or Neisseria gonorrhoea.

o gentamicin Solution (eye drops): 0.3% (sulfate).
natamycin Suspension: (eye drops): 5%
o ofloxacin Solution (eye drops): 0.3%.
o tetracycline Eye ointment: 1% (hydrochloride).
21.2 Anti-inflammatory agents
o prednisolone Solution (eye drops): 0.5% (sodium phosphate).
21.3 Local anaesthetics
o tetracaine a Solution (eye drops): 0.5% (hydrochloride).

a Not in preterm neonates.

21.4 Miotics and antiglaucoma medicines
acetazolamide Tablet: 250 mg.
latanoprost Solution (eye drops): latanoprost 50 micrograms/mL
o pilocarpine Solution (eye drops): 2%; 4% (hydrochloride or nitrate).
o timolol Solution (eye drops): 0.25%; 0.5% (as hydrogen maleate).
21.5 Mydriatics
atropine* a Solution (eye drops): 0.1%; 0.5%; 1% (sulfate).

* [c] Or homatropine (hydrobromide) or cyclopentolate (hydrochloride).

a >3 months.

Complementary List
epinephrine (adrenaline) Solution (eye drops): 2% (as hydrochloride).
21.6 Anti-vascular endothelial growth factor (VEGF) preparations
Complementary List
bevacizumab Injection: 25 mg/ mL.
22. OXYTOCICS AND ANTIOXYTOCICS
22.1 Oxytocics
o ergometrine Injection: 200 micrograms (hydrogen maleate) in 1- mL ampoule.
misoprostol Tablet: 200 micrograms.

–   Management of incomplete abortion and miscarriage;

–   Prevention and treatment of postpartum haemorrhage where oxytocin is not available or cannot be safely used

Vaginal tablet: 25 micrograms.*

* Only for use for induction of labour where appropriate facilities are available.

oxytocin Injection: 10 IU in 1- mL.
Complementary List
mifepristone* misoprostol*

Where permitted under national law and where culturally acceptable.

Tablet 200 mg tablet 200 micrograms.

* Requires close medical supervision.

22.2 Antioxytocics (tocolytics)
nifedipine Immediate-release capsule: 10 mg.
23. PERITONEAL DIALYSIS SOLUTION
Complementary List
intraperitoneal dialysis solution (of appropriate composition) Parenteral solution.
24. MEDICINES FOR MENTAL AND BEHAVIOURAL DISORDERS
24.1 Medicines used in psychotic disorders
o chlorpromazine Injection: 25 mg (hydrochloride)/ mL in 2- mL ampoule.

Oral liquid: 25 mg (hydrochloride)/5 mL.

Tablet: 100 mg (hydrochloride).

o fluphenazine Injection: 25 mg (decanoate or enantate) in 1- mL ampoule.
o haloperidol Injection: 5 mg in 1- mL ampoule.

Tablet: 2 mg; 5 mg.

risperidone Solid oral dosage form: 0.25 mg to 6.0 mg.
Complementary List
chlorpromazine [c] Injection: 25 mg (hydrochloride)/ mL in 2- mL ampoule.

Oral liquid: 25 mg (hydrochloride)/5 mL.

Tablet: 10 mg; 25 mg; 50 mg; 100 mg (hydrochloride).

clozapine Solid oral dosage form: 25 to 200 mg.
haloperidol [c] Injection: 5 mg in 1- mL ampoule.

Oral liquid: 2 mg/ mL.

Solid oral dosage form: 0.5 mg; 2 mg; 5 mg.

24.2 Medicines used in mood disorders
24.2.1 Medicines used in depressive disorders
o amitriptyline Tablet: 25 mg; 75mg. (hydrochloride).
fluoxetine Solid oral dosage form: 20 mg (as hydrochloride).
Complementary List [c]
fluoxetine a Solid oral dosage form: 20 mg (as hydrochloride).

a >8 years.

24.2.2 Medicines used in bipolar disorders
carbamazepine Tablet (scored): 100 mg; 200 mg.
lithium carbonate Solid oral dosage form: 300 mg.
valproic acid (sodium valproate) Tablet (enteric-coated): 200 mg; 500 mg (sodium valproate).
24.3 Medicines for anxiety disorders
o diazepam Tablet (scored): 2 mg; 5 mg.
24.4 Medicines used for obsessive compulsive disorders
clomipramine Capsule: 10 mg; 25 mg (hydrochloride).
24.5 Medicines for disorders due to psychoactive substance use
nicotine replacement therapy (NRT) Chewing gum: 2 mg; 4 mg (as polacrilex).

Transdermal patch: 5 mg to 30 mg/16 hrs; 7 mg to 21 mg/24 hrs.

Complementary List
o methadone* Concentrate for oral liquid: 5 mg/ mL; 10 mg/ mL (hydrochloride).

Oral liquid: 5 mg/5 mL; 10 mg/5 mL (hydrochloride).

* The square box is added to include buprenorphine. The medicines should only be used within an established support programme.

25. MEDICINES ACTING ON THE RESPIRATORY TRACT
25.1 Antiasthmatic and medicines for chronic obstructive pulmonary disease
o beclometasone Inhalation (aerosol): 50 micrograms (dipropionate) per dose; 100 micrograms (dipropionate) per dose (as CFC free forms).
o budesonide [c] Inhalation (aerosol): 100 micrograms per dose; 200 micrograms per dose.
o budesonide + formoterol Dry powder inhaler: 100 micrograms + 6 micrograms per dose; 200 micrograms + 6 micrograms per dose
epinephrine (adrenaline) Injection: 1 mg (as hydrochloride or hydrogen tartrate) in 1- mL ampoule.
ipratropium bromide Inhalation (aerosol): 20 micrograms/metered dose.
o salbutamol Inhalation (aerosol): 100 micrograms (as sulfate) per dose.

Injection: 50 micrograms (as sulfate)/ mL in 5- mL ampoule.

Metered dose inhaler (aerosol): 100 micrograms (as sulfate) per dose.

Respirator solution for use in nebulizers: 5 mg (as sulfate)/ mL.

26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID–BASE DISTURBANCES
26.1 Oral
oral rehydration salts See section 17.5.1.
potassium chloride Powder for solution.
26.2 Parenteral
glucose Injectable solution: 5% (isotonic); 10% (hypertonic);

50% (hypertonic).

glucose with sodium chloride Injectable solution: 4% glucose, 0.18% sodium chloride (equivalent to Na+ 30 mmol/L, Cl- 30 mmol/L).

Injectable solution: 5% glucose, 0.9% sodium chloride (equivalent to Na+ 150 mmol/L and Cl- 150 mmol/L); 5% glucose, 0.45% sodium chloride (equivalent to Na+ 75 mmol/L and Cl- 75 mmol/L) [c].

potassium chloride Solution: 11.2% in 20- mL ampoule

(equivalent to K+ 1.5 mmol/ mL, Cl- 1.5 mmol/ mL).

Solution for dilution: 7.5% (equivalent to K 1 mmol/ mL and Cl 1 mmol/ mL) [c]; 15% (equivalent to K 2 mmol/ mL and Cl

2 mmol/ mL) [c].

sodium chloride Injectable solution: 0.9% isotonic (equivalent to Na+ 154 mmol/L, Cl- 154 mmol/L).
sodium hydrogen carbonate Injectable solution: 1.4% isotonic (equivalent to Na+ 167 mmol/L, HCO3– 167 mmol/L).

Solution: 8.4% in 10- mL ampoule (equivalent to Na+ 1000 mmol/L, HCO3-1000 mmol/L).

o sodium lactate, compound solution Injectable solution.
26.3 Miscellaneous
water for injection 2- mL; 5- mL; 10- mL ampoules.
27. VITAMINS AND MINERALS
ascorbic acid Tablet: 50 mg.
calcium Tablet: 500 mg (elemental).
colecalciferol [c] Oral liquid: 400 IU/ mL.

Solid oral dosage form: 400 IU; 1000 IU.

* Ergocalciferol can be used as an alternative.

o ergocalciferol Oral liquid: 250 micrograms/ mL (10 000 IU/ mL).

Solid oral dosage form: 1.25 mg (50 000 IU).

iodine Capsule: 200 mg.

Iodized oil: 1 mL (480 mg iodine); 0.5 mL (240 mg iodine) in ampoule (oral or injectable); 0.57 mL (308 mg iodine) in dispenser bottle.

o nicotinamide Tablet: 50 mg.
pyridoxine Tablet: 25 mg (hydrochloride).
retinol Capsule: 50 000 IU; 100 000 IU; 200 000 IU (as palmitate).

Oral oily solution: 100 000 IU (as palmitate)/ mL in multidose dispenser.

Tablet (sugar-coated): 10 000 IU (as palmitate).

Water-miscible injection: 100 000 IU (as palmitate) in 2- mL ampoule.

riboflavin Tablet: 5 mg.
sodium fluoride In any appropriate topical formulation.
thiamine Tablet: 50 mg (hydrochloride).
Complementary List
calcium gluconate Injection: 100 mg/ mL in 10- mL ampoule.
28. EAR, NOSE AND THROAT MEDICINES [c]
acetic acid Topical: 2%, in alcohol.
o budesonide Nasal spray: 100 micrograms per dose.
o ciprofloxacin Topical: 0.3% drops (as hydrochloride).
o xylometazoline a Nasal spray: 0.05%.

a Not in children less than 3 months.

29. SPECIFIC MEDICINES FOR NEONATAL CARE
29.1 Medicines administered to the neonate [c]
caffeine citrate Injection: 20 mg/ mL (equivalent to 10 mg caffeine base/ mL).

Oral liquid: 20 mg/ mL (equivalent to 10 mg caffeine base/ mL).

chlorhexidine Solution or gel: 7.1% (digluconate) delivering 4% chlorhexidine (for umbilical cord care) [c].
Complementary List
o ibuprofen Solution for injection: 5 mg/ mL.
o prostaglandin E Solution for injection:

Prostaglandin E1: 0.5 mg/ mL in alcohol.

Prostaglandin E 2: 1 mg/ mL.

surfactant Suspension for intratracheal instillation: 25 mg/ mL or  80 mg/ mL.
29.2 Medicines administered to the mother
dexamethasone Injection: 4 mg/ mL dexamethasone phosphate (as disodium salt)
30. MEDICINES FOR DISEASES OF JOINTS
30.1 Medicines used to treat gout
allopurinol Tablet: 100 mg.
30.2 Disease-modifying agents used in rheumatoid disorders (DMARDs)
chloroquine Tablet: 100 mg; 150 mg (as phosphate or sulfate).
Complementary List
azathioprine Tablet: 50 mg.
hydroxychloroquine [c] Solid oral dosage form: 200 mg (as sulfate).
methotrexate Tablet: 2.5 mg (as sodium salt).
penicillamine Solid oral dosage form: 250 mg.
sulfasalazine Tablet: 500 mg.
30.3 Juvenile joint diseases
acetylsalicylic acid* (acute or chronic use) Suppository: 50 mg to 150 mg.

Tablet: 100 mg to 500 mg.

* For use for rheumatic fever, juvenile arthritis, Kawasaki disease.

Table 1.1: Medicines with age or weight restrictions

 

artesunate + pyronaridine tetraphosphate > 5 kg
atazanavir >25 kg
atropine >3 months
benzyl benzoate >2 years
betamethasone topical preparations hydrocortisone preferred in neonates
cefazolin >1 month
ceftriaxone >41 weeks corrected gestational age
darunavir > 3 years
delamanid > 6 years
dihydroartemisinin + piperaquine phosphate > 5 kg
diloxanide >25 kg
doxycycline >8 years (except for serious infections e.g. cholera)
efavirenz >3 years or >10 kg
fluoxetine >8 years
ibuprofen >3 months (except IV form for patent ductus arteriosus)
mefloquine >5 kg or >3 months
metoclopramide Not in neonates
nevirapine > 6 weeks
ondansetron >1 month
silver sulfadiazine >2 months
tetracaine Not in preterm neonates
trimethoprim >6 months
xylometazoline >3 months

Table 1.2: Explanation of dosage forms

 

A.  Principal dosage forms used in EML – oral administration

 

 

Term

 

Definition

 

 

 

 

Solid oral dosage form

Refers to tablets or capsules or other solid dosage forms such as ‘melts’ that are immediate-release preparations. It implies that there is no difference in clinical efficacy or safety between the available dosage forms, and countries should therefore choose the form(s) to be listed depending on quality and availability.

 

The term ‘solid oral dosage form’ is never intended to allow any type of modified-release tablet.

 

 

 

 

 

 

 

Tablets

Refers to:

 

·        uncoated or coated (film-coated or sugar-coated) tablets that are intended to be swallowed whole;

·        unscored and scored*;

·        tablets that are intended to be chewed before being swallowed;

·        tablets that are intended to be dispersed or dissolved in water or another suitable liquid before being swallowed;

·        tablets that are intended to be crushed before being swallowed.

 

The term ‘tablet’ without qualification is never intended to allow any type of modified-release tablet.

 

 

 

 

 

 

 

 

 

Tablets (qualified)

Refers to a specific type of tablet:

chewable – tablets that are intended to be chewed before being swallowed;

dispersible – tablets that are intended to be dispersed in water or another suitable liquid before being swallowed;

soluble – tablets that are intended to be dissolved in water or another suitable liquid before being swallowed;

crushable – tablets that are intended to be crushed before being swallowed;

scored – tablets bearing a break mark or marks where sub-division is intended in order to provide doses of less than one tablet;

sublingual – tablets that are intended to be placed beneath the tongue.

 

The term ‘tablet’ is always qualified with an additional term (in parentheses) in entries where one of the following types of tablet is intended: gastro-resistant (such tablets may sometimes be described as enteric-coated or as delayed-release), prolonged-release or another

modified-release form.

 

 

* Scored tablets may be divided for ease of swallowing, provided that dose is a whole number of tablets.

Capsules Refers to hard or soft capsules.

The term ‘capsule’ without qualification is never intended to allow any type of modified-release capsule.

Capsules (qualified) The term ‘capsule’ with qualification refers to gastro-resistant (such capsules may sometimes be described as enteric-coated or as delayed- release), prolonged-release or another modified-release form.
Granules Preparations that are issued to patient as granules to be swallowed without further preparation, to be chewed, or to be taken in or with water or another suitable liquid.

The term ‘granules’ without further qualification is never intended to allow any type of modified-release granules.

Oral powder Preparations that are issued to patient as powder (usually as single- dose) to be taken in or with water or another suitable liquid.
Oral liquid Liquid preparations intended to be swallowed i.e. oral solutions, suspensions, emulsions and oral drops, including those constituted from powders or granules, but not those preparations intended for oromucosal administration e.g. gargles and mouthwashes.

Oral liquids presented as powders or granules may offer benefits in the form of better stability and lower transport costs. If more than one type of oral liquid is available on the same market (e.g. solution, suspension, granules for reconstitution), they may be interchanged and in such cases should be bioequivalent. It is preferable that oral liquids do not contain sugar and that solutions for children do not contain alcohol.

B.  Principal dosage forms used in EML – parenteral administration

 

Term Definition
Injection Refers to solutions, suspensions and emulsions including those

constituted from powders or concentrated solutions.

Injection (qualified) Route of administration is indicated in parentheses where relevant.
Injection (oily) The term `injection’ is qualified by `(oily)’ in relevant entries.
Intravenous infusion Refers to solutions and emulsions including those constituted from

powders or concentrated solutions.

  1. Other dosage forms

 

Mode of

administration

Term to be used
To the eye Eye drops, eye ointments.
Topical For liquids: lotions, paints.

For semi-solids: cream, ointment.

Rectal Suppositories, gel or solution.
Vaginal Pessaries or vaginal tablets.
Inhalation Powder for inhalation, pressurized inhalation, nebulizer.
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