National drug formulay Ethiopia

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NATIONAL DRUG FORMULARY OF ETHIOPIA

Drug Administration and Control Authority of Ethiopia September 2007

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ACKNOWLEDGMENT

The Drug Administration and Control Authority (DACA) of Ethiopia would live to extend its gratitude to the World Health Organization (WHO) for meeting all the financial expenses associated with the workshop conducted on the draft formulary and the printing of this formulary. It also thanks all participantsof the workshop for their

valuable contribution.

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CONTENTS

ACKNOWLEDGMENT--------------------------------------------------------------i INTRODUCTION ------------------------------------------------------------------- vi GENERAL ADVICE TO PRESCRIBERS AND DISPENSERS ----------- viii 1. DRUGS ACTING ON THE GASTROINTESTINAL SYSTEM----------- 1 1.1. Antacids ------------------------------------------------------------------------------------------------1 1.2. Anti-ulcer Agents -----------------------------------------------------------------------------------4 1.3. Antispasmodics/spasmolytic Analgesics ------------------------------------------------ 11 1.4. Antiemetics------------------------------------------------------------------------------------------ 14 1.5. Cathartics and Laxative ------------------------------------------------------------------------ 19 1.6. Agents used in Diarrhea ----------------------------------------------------------------------- 25 1.7. Antiflatulants --------------------------------------------------------------------------------------- 27 1.8. Digestants-------------------------------------------------------------------------------------------- 28 1.9. Antihaemorrhoidal Agents-------------------------------------------------------------------- 28 2. CARDIOVASCULAR DRUGS ------------------------------------------------31 2.1. Drugs used for Congestive Cardiac failure---------------------------------------------- 31 2.2. Antiarrhythmics ----------------------------------------------------------------------------------- 36 2.3. Antilipemic agents-------------------------------------------------------------------------------- 43 2.4. Drugs used for angina /ischemic heart disease --------------------------------------- 46 2.5. Antihypertensives--------------------------------------------------------------------------------- 51 2.6. Diuretics---------------------------------------------------------------------------------------------- 64 2.7. Sclerosing Agents --------------------------------------------------------------------------------- 70 2.8. Drugs used in vascular shock ---------------------------------------------------------------- 71 2.9. Thrombolytic agent ------------------------------------------------------------------------------ 75 3. RESPIRATORY DRUGS--------------------------------------------------------77 3.1. Antitussives/Expectorants -------------------------------------------------------------------- 77 3.2. Bronchodilators /Antiasthmatics----------------------------------------------------------- 79 4. CENTRAL NERVOUS SYSTEM DRUGS -----------------------------------90 4.1. Analgesics / Antipyretics---------------------------------------------------------------------- 90 4.2. Anxiolytics Sedatives, Hypnotics and Antipsychotics---------------------------- 102 4.3. Antidepressants---------------------------------------------------------------------------------- 116 4.4. Anticonvulsants --------------------------------------------------------------------------------- 123 4.5. Antiparkinson Agents------------------------------------------------------------------------- 132 4.6. CNS Stimulant----------------------------------------------------------------------------------- 136 5. DRUGS USED IN ANESTHESIA ------------------------------------------- 137 5.1. General Anesthetics --------------------------------------------------------------------------- 137 5.2. Neuromuscular Blockers--------------------------------------------------------------------- 143 5.3. Anesthetic Adjuncts and Adjuvants ----------------------------------------------------- 147 5.4. Local Anesthetics ------------------------------------------------------------------------------- 152 6. DRUGS USED IN MUSCLOSKELETAL AND JOINT DISEASE ---- 156 6.1. Antirheumatics ---------------------------------------------------------------------------------- 156 6.2. Drugs used for gout ---------------------------------------------------------------------------- 162 6.3. Skeletal Muscle Relaxants------------------------------------------------------------------- 165

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6.4. Cholinergic and Anticholinesterase Agents-------------------------------------------168 6.5. Drugs for the relief of soft tissue inflammation --------------------------------------171 7. ANTI-INFECTIVE ------------------------------------------------------------- 172 7.1. Antibacterials -------------------------------------------------------------------------------------172

7.1.1. Penicillins -------------------------------------------------------------------------------172 7.1.2. Other Antibacterials-----------------------------------------------------------------182 7.1.3. Antituberculars------------------------------------------------------------------------209 7.1.4. Antileprotics----------------------------------------------------------------------------218 7.2. Antifungals ----------------------------------------------------------------------------------------220 7.3. Antivirals -------------------------------------------------------------------------------------------227 7.3.1. Anti-Retroviral (ARV) Agents --------------------------------------------------227 7.3.2. Other Antivirals-----------------------------------------------------------------------238 7.4. Antiprotozoals------------------------------------------------------------------------------------240 7.4.1 Antimalarials----------------------------------------------------------------------------240 7.4.2. Amoebicides and Antigiardial Agents ---------------------------------------249 7.4.3. Leshmaniacides -----------------------------------------------------------------------252 7.4.4. Trypanocides---------------------------------------------------------------------------254 7.4.5. Drugs for Toxoplasmosis----------------------------------------------------------255 7.5. Anthelmintics-------------------------------------------------------------------------------------258 7.5.1. Filaricides -------------------------------------------------------------------------------258 7.5.2. Schistosomicides----------------------------------------------------------------------260 7.5.3. Other Anthelmintics ----------------------------------------------------------------262 8. DRUGS USED IN ENDOCRINE DISORDERS AND CONTRACEPTIVES -------------------------------------------------------------- 267 8.1. Pituitary Hormone Preparations ----------------------------------------------------------267 8.2. Corticosteroidal Preparations---------------------------------------------------------------268 8.3. Thyroid Hormones and Antithyroid Agents------------------------------------------273 8.4. Insulin and oral antidiabetic agents ------------------------------------------------------276 8.6. Male sex hormone Preparations-----------------------------------------------------------290 8.7. Contraceptives------------------------------------------------------------------------------------291 8.7.1. Combined Oral Contraceptives -------------------------------------------------294 8.7.2. Progestogen - only contraceptives ---------------------------------------------295 8.7.3. Contraceptive Devices, Barriers, and Spermicides ----------------------297 8.8. Drugs affecting Gonadotrophins ----------------------------------------------------------300 8.9. Drugs used for impotence--------------------------------------------------------------------300 8.10. Drug used in benign prostatic hyperplasia-------------------------------------------301 9. OBSTETRIC AND GYNAECOLOGICAL MEDICATIONS ---------- 303 10. ANTINEOPLASTIC AND RELATED AGENTS--------------------------------314 11. BLOOD PRODUCTS AND DRUGS AFFECTING THE BLOOD--- 333 11.1. Anticoagulants----------------------------------------------------------------------------------333 11.2. Hemostatic Agents ----------------------------------------------------------------------------335 11.3. Antianemic Agents ---------------------------------------------------------------------------336 11.4. Blood Substitutes and Plasma Expanders--------------------------------------------341 12. DRUGS FOR CORRECTING WATER, ELECTROLYTE AND ACIDBASE DISTURBANCES---------------------------------------------------------- 345

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12.1. Oral------------------------------------------------------------------------------------------------- 345 12.2 Parenteral ----------------------------------------------------------------------------------------- 349 13.VITAMINS ---------------------------------------------------------------------- 354 13.1. Vitamins, single-------------------------------------------------------------------------------- 355 13.2. Vitamins, Combinations ------------------------------------------------------------------- 364

13.2.1. Vitamin B complex preparations--------------------------------------------- 364 13.2.2. Multivitamin preparations------------------------------------------------------ 364 13.2.3. Multivitamin with minerals and/or extracts ---------------------------- 364 14. ANTIHISTAMINES AND ANTIALLERGICS -------------------------- 365 14.1. Antihistamines --------------------------------------------------------------------------------- 365 14.2. Drugs used in Allergic Emergencies --------------------------------------------------- 370 15. OPHTHALMIC AGENTS --------------------------------------------------- 372 15.1. Antiglaucoma ---------------------------------------------------------------------------------- 372 15.2. Mydriatics/Cycloplegics ------------------------------------------------------------------- 377 15.3. Anti-infectives, Ophthalmic--------------------------------------------------------------- 380 15.3.1. Antibacterials ------------------------------------------------------------------------ 380 15.3.2. Antivirals------------------------------------------------------------------------------ 383 15.3.3. Antifungal----------------------------------------------------------------------------- 384 15.4. Anti-inflammatories-------------------------------------------------------------------------- 385 15.5. Anti-infective/Anti-inflammatory combination. --------------------------------- 387 15.6. Anesthetics, Local ---------------------------------------------------------------------------- 387 15.7. Antiallergics, Diagnostics and Miscellaneous Agents -------------------------- 389 16. EAR, NOSE, AND THROAT PREPARATIONS------------------------ 392 16.1. Nasal and Oropharyngeal, Preparations --------------------------------------------- 392 16.2. Otic Agents -------------------------------------------------------------------------------------- 397 17. DERMATOLOGIC AGENTS ---------------------------------------------- 401 17.1. Anti-infective, Topical ---------------------------------------------------------------------- 401 17.2. Anti-Inflammatories, Topical ------------------------------------------------------------ 412 17.3. Anti-infective/Anti-inflammatory Combinations -------------------------------- 415 17.4. Keratolytics/Caustics and Antiacne Agents---------------------------------------- 416 17.5. Drugs for Psoriasis and Eczema--------------------------------------------------------- 419 17.6. Antiprurities------------------------------------------------------------------------------------- 421 17.7. Pigmenting Agents --------------------------------------------------------------------------- 421 17.8. Dermatological, systemic ------------------------------------------------------------------ 422 17.9. Skin Disinfecting Agents ------------------------------------------------------------------- 425 17.10. Dermatologicals, Others------------------------------------------------------------------ 427 18. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONING429 19. IMMUNOLOGICAL PREPARATIONS---------------------------------- 440 20. MISCELLANEOUS ----------------------------------------------------------- 488 APPENDIXES ---------------------------------------------------------------------- 492 GLOSSARY------------------------------------------------------------------------- 548 INDEX ------------------------------------------------------------------------------- 550

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INTRODUCTION

In places where health and communication infrastructures are at low level the opportunity of availing and accessing drug and health related information is scanty. In such circumstances promotion of rational use of drugs is at stake, which eventually shall harm the health of indivuduals and affect the overall health-care delivery service.

In Ethiopia, as the health service expands quite rapidly, in principle drug information resources need to be made available and accessible at equal pace. However, except the few promising efforts in availing some drug information materials, the gap between the demand and supply is still wide enough.

In relation to this the Drug Administration and Control Authority of Ethiopia recognizing the unmet need on drug information has been striving to develop and make accessible some information materials including, catagorized drug formularies and standard treatment guidelines, leaflets in variuos issues and bulletin.

To widen the scope of the content and to provide maximum information from single source, a draft national drug formulary has been prepared by the Authority and after incorporation of the comments from workshop participnats, the final draft is now ready for use.

The Formulary aims to provide standard information on drugs. And it targets all health professionals involved in patient care, training and research and others. Therefore the over all goal of the formularly is to help health professionals base their practice on solid information and knowledge to promote rational use of drugs. .

While developing the formulary the "World Health Organization (WHO) Model Drug Formulary" has been used as a guiding tool and the pharmacotherapeutic classification is based on the list of drugs for Ethiopia (LIDE) and its supplement list. To accommodate as much information as possible on each drug, formularies of other countries (eg.South Africa) and standard text books of pharmacy, pharmacology and therapeutics has also been used. The District Hospital formulary has also been extensively refered.

The formulary contains detailed information on each pharmaco-therapeutic class of drugs and specific information for each drugs including indication, caution, drug interaction, side effect, contraindication, dose and administration and information on storage condition. The formulary also contains general

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notes on good prescribing and dispensing practices, and supplementary information as appendixes. The formulary is designed as a digest for rapid reference and it may not always include all the information necessary for prescribing and dispensing. And by no means it does substitute standard treatment guidelines. We hope, that this formulary will be of assistance in providing useful information to the health workers and in promoting the rational use of drugs and as result proviosn of quality health services. It is also hoped that the formulary will be of particular use to those health professionals working at the periphery who have no access to adequate and up to date information. The Authority will continuously update the formularly and would like to invite readers to share their expertise in the field and provide comments to the following adderess:

Planning and Drug information establsihment and dissemination Department Drug Administration and ccontrol Authority Addis Ababa, Ethiopia, fax 251 - 1 - 5521395, P.O.Box 5681, E-mail-daca@.et

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GENERAL ADVICE TO PRESCRIBERS AND DISPENSERS

RATIONAL APPROACH TO THERAPEUTICS

Drugs should only be prescribed when they are necessary, and in all cases the benefit of administering the medicine should be considered in relation to the risks involved. Bad prescribing habits lead to ineffective and unsafe treatment, exacerbation or prolongation of illness, distress and harm to the patient, and higher cost.

Therefore Good Prescribing Practice (GPP) is prescribing the right drug at the right time, in the right dosage of the right formulation and for the right length of time.

The following steps will help to remind prescribers of the rational approach to therapeutics.

1. Define the patient's problem Whenever possible, making the right diagnosis is based on integrating many pieces of information: the complaint as described by the patient; a detailed history; physical examination; laboratory tests; X-rays and other investigations. This will help in rational prescribing, always bearing in mind that diseases are evolutionary processes.

2. Specify the therapeutic objective Doctors must clearly state their therapeutic objectives based on the pathophysiology underlying the clinical situation. Very often physicians must select more than one therapeutic goal for each patient.

3. Select therapeutic strategies The selected strategy should be agreed with the patient; this agreement on outcome, and how it may be achieved, is termed concordance.

The selected treatment can be non-pharmacological and/or pharmacological; it also needs to take into account the total cost of all therapeutic options.

a. Non-pharmacological treatment

It is very important to bear in mind that the patient does not always need a drug for treatment of the condition. Very often, health problems can be resolved by a change in life style or diet, use of physiotherapy or exercise, provision of adequate psychological support, and other non?pharmacological treatments;

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