A BOOK OF ESSENTIAL DRUGS , Study notes of Pharmacy

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Essential

drugs

Practical guidelines

intended for physicians, pharmacists,

nurses and medical auxiliaries

2013 EDITION

© Médecins Sans Frontières – February 2013 All rights reserved for all countries. No reproduction, translation and adaptation may be done without the prior permission of the Copyright owner. ISBN 2-906498-91-

Preface

The 1978 Alma Ata Conference on primary health care recognized that essential drugs are

vital for preventing and treating illnesses which affect millions of people throughout the

world. Essential drugs save lives and improve health.

In 1981, the World Health Organization established the Action Programme on Essential

Drugs to support countries to implementing national drug policies and to work towards

rational use of drugs. This work was broadened in 1998 when WHO created the department

of Essential Drugs and Other Medicines (EDM), combining the responsabilities of the former

DAP with WHO's global efforts to promote quality, safety, efficacy, and accurate information

for all medicines.

EDM works with countries, international agencies, NGOs like Médecins Sans Frontières,

and other organizations to ensure that people everywhere have access to the essential drugs

they need at a price which is affordable; that the drugs are safe, effective, and of good quality;

and that they are prescribed and used rationally.

Appropriate tools are critical to the effective implementation of essential drugs policies. This

practical handbook, based on Médecins Sans Frontières' field experience, is one of the tools

which we strongly recommend.

Designed to give practical, concise infomation to physicians, pharmacists and nurses, this

“Essential drugs - practical guidelines” is an important contribution from Médecins Sans

Frontières to improve the rational use of drugs, which will be a continuing challenge in the

coming years.

Dr Jonathan D. Quick Director, Essential Drugs and Other medicines World Health Organization

Despite all efforts, it is possible that certain errors may have been overlooked in this manual. Please inform the authors of any errors detected. It is important to remember, that if in doubt, it is the responsibility of the prescribing medical professional to ensure that the doses indicated in this manual conform to the manufacturer's specifications.

The authors would be grateful for any comments or criticisms to ensure that this manual continues to evolve and remains adapted to the reality of the field.

Comments should be addressed to:

Médecins Sans Frontières - Guidelines 8 rue St-Sabin - 75011 Paris Tel.: +33.(0)1.40.21.29. Fax: +33.(0)1.48.06.68. e.mail: guide.essdrugs@msf.org

This manual is also available on the internet at www.msf.org. As treatment protocols are constantly changing, medical staff are encouraged to check this website for updates of this edition.

Use of the guide

General organisation

There are two easy ways to find information in this manual:

• A summary at the beginning of the manual lists the chapters and their corresponding pages.
• A double-entry alphabetical index at the end of the manual with international non- proprietary and proprietary names.

Nomenclature of drugs

The International Non-proprietary Names (INN) of drugs is used in this manual. Some frequently used proprietary names, followed by the symbol ®, are also given.

E.g.: amoxicillin (Amoxyl®, Clamoxyl®…)

Dosage

Prescription tables showing average dosage in drug units (tablets, ampoules etc.) according to weight or age of patients are included for the most commonly used drugs.

Dosage for children are expressed in milligrams per kilogram per day (mg/kg/day) for most drugs. For certain symptomatic drugs, dosage is expressed in milligrams per kilogram per dose (mg/kg/dose). For certain antiretrovirals, dosage is expressed in milligrams per square meter (mg/m^2 ).

Dosage for adults is expressed in grams or milligrams per day for most drugs. For certain drugs requiring a more precise dosage, doses are expressed in mg/kg/day. In malnourished patients, prescriptions should always be adapted to the patient's weight.

Symbols

This box indicates potentially toxic drugs, administered under medical prescription only in many European countries (e.g. Belgium, France, Spain, UK).

Prescription under medical supervision

Summary

PART ONE

Oral drugs (^) page 13

Injectable drugs (^) page 155

Infusion solutions (^) page 231

Vaccines, immunoglobulins and antisera (^) page 241

5 Drugs for external use, antiseptics and disinfectants^ page 259

PART TWO

• Organisation and management of a pharmacy page
• Drug quality and storage page
• Prescription, cost, compliance page
• Use of antibacterials page
• Antiseptics and disinfectants page
• WHO model list of essential medicines page
• Main references page
• Alphabetical index page
• Abacavir (ABC) Oral drugs
• Acetaminophen
• Acetylsalicylic acid (ASA)
• Aciclovir
• Albendazole
• Albuterol
• Albuterol aerosol
• Albuterol nebuliser solution
• Aluminium hydroxide
• Amitriptyline
• Amodiaquine (AQ)
• Amoxicillin
• Amoxicillin/clavulanic acid
• Artemether/lumefantrine
• Artesunate (AS)
• Artesunate/amodiaquine (AS/AS)
• Artesunate + sulfadoxine/pyrimethamine
• Ascorbic acid
• Aspirin
• Atenolol
• Azithromycin
• AZT/3TC
• AZT/3TC/NVP
• Beclometasone
• Biperiden
• Bisacodyl
• Butylscopolamine
• Calcium gluconate
• Carbamazepine
• Cefixime
• Chloramphenicol
• Chloroquine
• Chlorphenamine = chlorpheniramine
• Chlorpromazine
• Cimetidine
• Ciprofloxacin
• Clindamycin
• Clomipramine
• Cloxacillin
• Co-amoxiclav
• Coartemether
• Codeine
• Colecalciferol
• Cotrimoxazole
• d4T/3TC/NVP
• Dapsone
• Desogestrel
• Diazepam
• Didanosine (ddI)
• Diethylcarbamazine
• Digoxin
• Dihydralazine
• Dihydroartemisinin/piperaquine
• Dipyrone
• Doxycycline
• Efavirenz (EFV - EFZ)
• Enalapril
• Ergocalciferol
• Erythromycin
• Ethambutol (E)
• Ethinylestradiol/levonorgestrel
• Ferrous salts
• Ferrous salts/folic acid
• Fluconazole
• Flucytosine
• Fluoxetine
• Folic acid
• Folinic acid
• Fosfomycin tromethamine
• Furosemide = frusemide
• Glibenclamide
• Glyceryl trinitrate
• Griseofulvin
• Halofantrine
• Haloperidol
• Hydralazine
• Hydrochlorothiazide
• Hyoscine butylbromide
• Ibuprofen
• Indinavir (IDV)
• Iodized oil
• Isoniazid (H)
• Isosorbide dinitrate
• Itraconazole
• Ivermectin
• Lactulose
• Lamivudine (3TC)
• Levodopa/carbidopa
• Levonorgestrel
• Levonorgestrel (emergency)
• Loperamide
• Lopinavir/ritonavir (LPV/r)
• Mebendazole
• Mefloquine (MQ)
• Metamizole
• Methyldopa
• Metoclopramide
• Metronidazole
• Miconazole
• Mifepristone (RU486)
• Misoprostol
• Morphine immediate-release
• Morphine sustained-release
• Multivitamins
• Nalidixic acid
• Nevirapine (NVP)
• Niclosamide
• Nicotinamide
• Nifedipine
• Nitrofurantoin
• Nitroglycerin
• Noramidopyrine
• Nystatin
• Omeprazole
• Oral rehydration salts (ORS)
• Paracetamol
• Paroxetine
• Penicillin V
• Phenobarbital
• Phenoxymethylpenicillin
• Phenytoin
• Potassium chloride
• Praziquantel
• Prednisolone and prednisone
• Proguanil
• Promethazine
• Pyrantel
• Pyrazinamide (Z)
• Pyridoxine
• Pyrimethamine
• Quinine
• ReSoMal
• Retinol
• Rifampicin (R)
• Risperidone
• Ritonavir (RTV)
• Salbutamol
• Salbutamol aerosol
• Salbutamol nebuliser solution
• Saquinavir (SQV)
• Sodium valproate
• Spironolactone
• Stavudine (d4T)
• Stavudine/lamivudine/nevirapine
• Sulfadiazine
• Sulfadoxine/pyrimethamine (SP)
• Sulfamethoxazole/trimethoprim
• Thiamine
• Tinidazole
• Tramadol
• Tranexamic acid
• Triclabendazole
• Trinitrin
• Valproic acid
• Vitamin A
• Vitamin B complex
• Vitamin B1
• Vitamin B3
• Vitamin B6
• Vitamin B9
• Vitamin C
• Vitamin D2
• Vitamin D3
• Vitamin PP
• Zidovudine (AZT - ZDV)
• Zidovudine/lamivudine
• Zidovudine/lamivudine/nevirapine
• Zinc sulfate

Therapeutic action

• Analgesic, antipyretic, non steroidal anti-inflammatory (NSAID)

Indications

• Mild pain
• Fever
• Rheumatic diseases (except gout)

Presentation

• 100 mg and 500 mg tablets. Also comes in 300 mg tablets.

Dosage

• Pain and fever Child: 60 mg/kg/day in 3 or 4 divided doses Adult: 1 to 3 g/day in 3 or 4 divided doses
• Rheumatic diseases Child > 20 kg: 50 to 100 mg/kg/day in 4 divided doses Adult: 3 to 6 g/day in 4 divided doses
• Maximum dose: child: 100 mg/kg/day; adult: 6 g/day

Duration : pain and fever : 1 to 3 days; rheumatic diseases : according to clinical response.

Contra-indications, adverse effects, precautions

• Do not administer to patients with allergy to aspirin and NSAID, peptic ulcer, coagulation disorders, haemorrhage; severe renal, hepatic or cardiac impairment.
• Do not administer to children less than one year (use paracetamol).
• Administer with caution to elderly patients or patients with asthma.
• Do not exceed indicated doses, particularly in children and elderly patients. Intoxications are severe, possibly fatal.
• May cause:
  • allergic reactions, epigastric pain, peptic ulcer, haemorrhage;
  • dizziness, tinnitus (early signs of overdose). For all cases above, stop aspirin and use paracetamol.
• Do not combine with methotrexate, anticoagulants and NSAID.
• Monitor combination with insulin (increased hypoglycaemia) and corticosteroids.
• Pregnancy: not recommended during the first 5 months; CONTRA-INDICATED from the beginning of the 6th^ month (use paracetamol)
• Breast-feeding: avoid (use paracetamol)

Remarks

• In children less than 16 years, preferably use paracetamol.
• Take during meals, preferably with a lot of water.
• For the treatment of moderate pain, it is recommended to combine aspirin with codeine or tramadol.
• Aspirin may be administered for its antiplatelet effects in secondary prevention of athero- thrombosis, at a dose of 75 to 300 mg daily.
• Storage: below 25°C – Do not use if tablets have a strong smell of vinegar. A slight vinegar smell is always present.

ACETYLSALICYLIC acid = ASPIRIN = ASA

AGE

WEIGHT

0 2 months 1 year 5 years

4 kg 8 kg 15 kg 35 kg 100 mg tablet – – 1 1/2 tab x 3 3 tab x 3 – 300 mg tablet – – 1/2 tab x 3 1 tab x 3 2 tab x 3 500 mg tablet – – 1/4 tab x 3 1/2 tab x 3 1 tab x 3

ADULT

15 years

Therapeutic action

• Antiviral active against herpes simplex virus and varicella zoster virus

Indications

• Treatment of recurrent or extensive oral and oesophageal herpes in immunocompromised patients
• Treatment of herpetic kerato-uveitis
• Treatment of genital herpes
• Secondary prophylaxis of herpes in patients with frequent and/or severe recurrences
• Treatment of severe forms of zoster: necrotic or extensive forms, facial or ophthalmic zoster

Presentation

• 200 mg and 800 mg tablets Also comes in 40 mg/ml oral suspension.

Dosage and duration

• Treatment of recurrent or extensive oral and oesophageal herpes in immunocompromised patients, treatment of herpetic kerato-uveitis Child under 2 years: 200 mg 5 times per day for 7 days Child over 2 years and adult: 400 mg 5 times per day for 7 days
• Treatment of genital herpes Child over 2 years and adult: 400 mg 3 times per day for 7 days; in immunocompromised patients, continue treatment until clinical resolution
• Secondary prophylaxis of herpes in patients with frequent and/or severe recurrences Child under 2 years: 200 mg 2 times per day Child over 2 years and adult: 400 mg 2 times per day
• Treatment of severe forms of zoster Adult: 800 mg 5 times per day for 7 days

Contra-indications, adverse effects, precautions

• Do not administer to patients with hypersensitivity to aciclovir.
• May cause: headache, skin rash, allergic reactions, gastrointestinal disturbances, raised transaminases, neurologic disorders in patients with renal impairment and elderly patients; rarely, haematological disorders.
• Reduce dosage in patients with renal impairment.
• Drink a lot of liquid during treatment.
• Pregnancy: no contra-indication
• Breast-feeding: no contra-indication

Remarks

• For the treatment of herpes simplex, aciclovir should be started as soon as possible (within 96 hours) after the appearance of lesions to reduce severity and duration of infection.
• For the treatment of herpes zoster, aciclovir should be start preferably within 72 hours after the appearance of lesions. Aciclovir administration does not reduce the likelihood of developing zoster-associated pain but reduces the overall duration of this pain.
• Storage: below 25°C –

ACICLOVIR

(Zovirax®…)

Prescription under medical supervision

Therapeutic action

• Antacid

Indications

• Stomach pain associated with gastritis and peptic ulcer

Presentation

• 500 mg tablet There are numerous preparations of aluminium and/or magnesium hydroxide and different dosages.

Dosage

• Child over 5 years: rarely indicated. When necessary: half a tablet 3 times/day
• Adult: 3 to 6 tablets/day after meals or 1 tablet during painful attacks

Duration : according to clinical response

Contra-indications, adverse effects, precautions

• May cause: constipation (except when tablets contain magnesium salts or magnesium hydroxide).
• Decreases intestinal absorption of many drugs such as tetracycline, iron salts, isoniazid, ethambutol, chloroquine, atenolol, digoxin, fluoroquinolones, corticosteroids, indometacin, ketoconazole, thyroxine, etc. Do not administer simultaneously with these drugs, administer 2 hours apart.
• Pregnancy: no contra-indication
• Breast-feeding: no contra-indication

Remarks

• Chew tablets.
• Storage: no special temperature requirements

ALUMINIUM HYDROXIDE

Therapeutic action

• Tricyclic antidepressant with anxiolytic and sedative properties

Indications

• Neuropathic pain, often in combination with carbamazepine
• Major depression, especially when a sedative effect is required

Presentation

• 25 mg tablet

Dosage

• Adult:
  • Neuropathic pain : initial dose of 25 mg once daily at bedtime for one week. Increase to 50 mg once daily the following week, then 75 mg once daily at bedtime as of the third week (max. 150 mg/day).
  • Depression : the usual dose is 75 to 150 mg once daily (depending on efficacy and tolerance) at bedtime. The dose is also increased progressively but more rapidly, over 8 to 10 days.
• Reduce the dose by half in elderly patients and in patients with hepatic or renal impairment.

Duration

• Neuropathic pain : several months (3 to 6) after pain relief is obtained, then attempt to stop treatment.
• Depression : minimum 6 months. The treatment should be discontinued gradually (dose tapered over 4 weeks). If signs of relapse occur, increase the dose.

Contra-indications, adverse effects, precautions

• Do not administer to patients with recent myocardial infarction, arrhythmia, closed-angle glaucoma, prostate disorders.
• Administer with caution and carefully monitor use in patients > 60 years and in patients with epilepsy, chronic constipation, renal or hepatic impairment, history of bipolar disorders.
• May cause:
  • drowsiness (caution when driving/operating machinery), orthostatic hypotension, sexual dysfunction;
  • anticholinergic effects: dry mouth, blurred vision, constipation, tachycardia, disorders of micturition. These adverse effects are transitory or disappear with dose reduction. Treatment should be discontinued in the event of severe reactions (mental confusion, urinary retention, cardiac rhythm disorders);
  • psychic disorders: exacerbation of anxiety, possibility of a suicide attempt at the beginning of therapy, manic episode during treatment.
• Do not combine with another antidepressant.
• Monitor combination with CNS depressants (opioid analgesics, sedatives, H1 anti- histamines, etc.), drugs known to have anticholinergic effects (atropine, carbamazepine, chlorpromazine, promethazine, etc.), drugs which lower the seizure threshold (antispychotics, mefloquine, tramadol, etc.), lithium and other serotonergics.
• Avoid alcohol during treatment.
• Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, decrease the dose at the end of pregnancy to avoid gastrointestinal and neurological adverse effects in the newborn infant.
• Breast-feeding: monitor the child for excessive somnolence.

Remarks

• Sedative effect occurs following initial doses, analgesic effect is delayed for 7 to 10 days. For depression, it is necessary to wait 3 weeks before assessing therapeutic efficacy. This must be explained to the patient.
• Storage: no special temperature requirements

AMITRIPTYLINE

(Elavil®, Laroxyl®, Triptyzol®…)

Prescription under medical supervision