Ministry of Health & Population (MOHP) EGYPTIAN NATIONAL FORMULARY EGYPT 2007 Ministry of Health and Population (MOHP) Central Adm inistration of Pharm aceutical Affairs (CAPA) Training and Technical Research Departm ent Preface I have the pleasure to put at the disposal of all health pro- fessionals the Egyptian National Formulary which has been prepared by a group of prominent professors of Medicine, professors of Pharmacy, and experts of the Ministry of Health and Population (MOHP). The present work is a continuation of the efforts of MOHP to enhance rational use of drugs through encouraging the use of generic drugs by prescribers and dispensers, which leads to a better utilization of available resources and makes pharmaceutical products more affordable. We hope that the Egyptian National Formulary will be of usefulness to all. Minister of Health and Population Prof. Dr. Hatem El-Gabaly 2007 i ii Foreword The national health authorities undertake continuous en- deavours to enhance the essential drugs concept being the corner pillar in the rational use of drugs. In this frame- work the national Essential Drugs List (EDL) has been prepared and published a number of years ago. The present National Drug Formulary has been conceived to complement the national Essential Drugs List. It has been compiled by experts from MOHP, professors of Medicine and professors of Pharmacy. The present formulary offers the user valuable information on all drugs included in the EDL regarding uses, adverse effects, drug interactions, drugs used during pregnancy and lactation, pharmacogenetics, geriatric and paediatric drug use, and importance of compliance with treatment regimens. The drugs in the formulary are mentioned in their non- proprietary names (generic names). Of great value for the users is that each therapeutic group is preceded by com- mon disease states. We hope that the formulary will be a valuable contribution to Rational Use of Drugs. iii Formulation Committee Prof. Dr. Mamdoh Zaky Prof. Dr. Ez El Deen El Denshary Prof. Dr. Haidar Ghaleb Prof. Dr. Manal Nour Prof. Dr. Mohsen Fathallah Prof. Dr. Esmat Sheba Prof. Dr. Roshdy El Badrawy Prof. Dr. Taha El Shewy Prof. Dr. Zeinab Ebied Medical Editor Dr. Mohamed K. Allam Revision Committee Prof. Dr. Ahmed Abdel Salam Prof. Dr. Abdel Rahman Al-Naggar Computer Revision: Eng.Hany kamal Coordinator Prof. Dr. Zeinab Ebied Under Secratory of State Prof. Dr. Zeinab Ebied iv CONTENTS Preface i Foreword iii Abbreviations vi Abbreviations vii 1. Teratogenicity and Breast Feeding 2 2. Paediatrics 8 3. Geriatrics 13 4. Patient Compliance 19 5. Drug Interactions 22 6. Pharmacogenetics 26 7. Adverse Drug Reactions (ADR) 30 8. Gastro-Intestinal Tract Drugs 47 9. Cardiovascular System Drugs 62 10. Respiratory System Drugs 90 11. Anti-Allergic Drugs 97 12. Neuro Psychiatric Drugs 109 13. Drugs for Infectious Diseases 125 14. Endocrine Drugs 169 15. Malignant Diseases and Immunosuppressive Drugs 184 16. Nutrition and Blood Restorative Drugs 196 17. Skeletal Muscle Relaxants 207 18. Ophthalmic Preparations 216 19. Ear, Nose and Oropharynx Drugs 222 20 Dermatological Drugs 228 21. Vaccines and Sera 237 22 Anaesthetic Preparations 248 Index 257 v Abbreviations 5-HT3 - 5-Hydroxytryptamine ACE - Angiotensin converting enzyme ACh - Acetylcholine ACTH - Adrenocorticotrophic Hormone ADR(s) - Adverse drug reactions AFP - Alpha fetoprotein ALT - Alanine transferase ARF - Acute renal failure AST - Aspartate transferase ATP - Adenosine triphosphate AV - Atrio-ventricular bid - Bis In Die (Latin: Twice a day) BP - Blood pressure BSP - Bromosulphalein CCB - Calcium channel blockers CHF - Congestive heart failure CMV - Cytomegalovirus CNS - Central nervous system COP - Cardiac output CTZ - Chemoreceptor trigger zone CVS - Cardiovascular system ECG - Electro cardio gram ESR - Erythrocyte sedimentation rate GFR - Glomerular filtration rate GGT - Gama glutaryl transferase GIT - Gastrointestinal tract HB - Haemoglobin Hcl - Hydrochloric acid (gastric acid) HPF - High power field ICP - Intracranial pressure IM - Intra muscular IV - Intra venous LES - Lower oesophageal sphincter LTI - Lower urinary tract infection LVF - Left ventricular failure MAOI (s) - Monoamino oxidase inhibitor (s) NB - Nota Bene (Latin: Note Well) vi Abbreviations NSAID (s) - Non steroidal anti-inflammatory drug (s) OTC - Over the counter PO - Per Os qid - Quater In Die (Latin: Four times a day) RAA - Renin angiotensin aldosterone RBC (s) - Red blood cell (s) SC - Subcutaneous sid - Semel In Die (Latin: Once a day) SLE - Systemic lupus erythematosus STD (s) - Sexually transmitted disease (s) TCA (s) - Tricyclic antidepressant (s) TIA (s) - Transient ischemic attack (s) tid - Ter In Die (Latin: Three times a day) UTI - Upper urinary tract infection VC - Vomiting centre VMC - Vasomotor centre WBC (s) - White blood cell (s) vii viii SECTION I TERATOGENICITY AND BREAST FEEDING In this section: 1.1 Drugs in Pregnancy 2 1.2 Placental Transfer 2 1.3 Foetal Development and Drug Effects 3 1.4 Proven Human Teratogens 3 1.5 Drug Excretion in Human Milk 4 1.6 Reducing Risk of Infant Exposure to Drugs in Breast Milk 5 1.7 Drugs Contraindicated During Lactation 5 2 Teratogenicity and Breast Feeding angiomas. The malformations of little 1. Teratogenicity and medical significance are not included Breast Feeding in incidence data even if they have emotional cosmetic effects. Approxi- The use of drugs during pregnancy mately 6 newborn infants in every and lactation is controversial and pre- 100 will be with a major malforma- sents great challenge to clinicians. tion, but only 3 of these will be identi- The use of drugs during pregnancy is fied at birth or in the neonatal period. of special concern because of medi- To these, one can add an unknown cal, social, and legal implications. number of infants with mental and Congenital anomalies or birth defects physical growth retardation and those are among the leading causes of infant of minor structural anomalies. morbidity and mortality. Drug consumption during 1.1 Drugs in Pregnancy pregnancy Congenital malformation is defined as Many drugs are regularly consumed structural abnormalities of prenatal during gestation including some that origin that are present at birth that are potential teratogens. Women con- seriously interfere with viability or sume an average of 5 to 9 medica- physical well being. tions. Vitamins and iron supplements are the most commonly used followed Some drug induced defects relate to by anti-infective and analgesic antipy- changes in functions or conditions retic anti-inflammatory agents. that are not structural abnormalities e.g. mental or physical growth retar- dation, CNS depression, deafness, 1.2 Placental Transfer tumours or biochemical changes. Most medications cross the placenta Congenital anomalies i.e. birth de- to the foetus. During gestation, the fects, include both these toxicities and surface area of the placenta increases, structural changes. while the placental thickness decrea- ses to 1/5 at term. Both processes tend The prevalence of major malfor- to favour the transfer of chemicals to mations is 3% and similar rate is dis- the foetus. covered in months or years following birth. Anomalies of internal organs e.g. heart, kidneys, reproductive sys- Mechanism of placental tem and GIT may go unrecognized for transfer years or discovered only at autopsy. Drugs, nutrients and other substances cross the placenta by … Minor malformations are not included in this percentage e.g. umbilical and • Simple diffusion e.g. most drugs inguinal hernias, phimosis, external • Facilitated diffusion e.g. glucose ear, cryptorchidism, hydrocele, and Ministry of health and population Egyptian National Formulary 3 • Active transfer e.g. vitamins, amino • Interaction between hereditary ten- acids dencies and non-genetic environ- • Pinocytosis e.g. immune antibodies mental factors (20% of all defects) • Breaks between cells e.g. erythro- e.g. congenital hip dislocation cytes • Environmental factors: e.g. mater- nal infections, chemicals and drugs The last two are of no practical impor- (10% of all defects). Only 2 viruses tance in drugs transfer and a protozoan have been proven to induce malformation. Bacteria Factors influencing rate of tend to release toxins that cause ex- transfer tensive tissue damage and foetal death rather than structural anoma- • Molecular weight lies. The viruses are rubella (cata- • Lipid solubility ract, heart disease and deafness) • Uterine and umbilical blood flow and cytomegalovirus (CMV) infec- (major factor) tion (deafness, mental retardation, • Maternal diseases e.g. hyperten- microcephaly, chorioretinitis, sei- sion, diabetes zures, blindness and optic atrophy). The protozoan Toxoplasma gondii 1.3 Foetal Development (hepatosplenomegaly, jaundice, rash, chorioretinitis, cerebral calci- and Drug Effects fications and hydrocephalus or mi- Early in the embryonic period (con- crocephalus. ception to 56 days), during the pre- • Maternal infections account for 2% implantation and presomite stage (0 to and maternal diseases e.g. diabetes 14 days), exposure to a teratogenic and hyperthermia account for 1-2%. agent usually produces an “all or • Unknown causes: account for 60- none” effect on the ovum. The ovum 65% of cases. either dies from a lethal dose of a teratogenic drug or it regenerates 1.4 Proven Human Tera- completely after exposure to a sub- lethal dose. During organogenesis, togens insult with the same teratogen may Numerous drugs are associated with produce major morphologic