Inn Drugs in Bangladesh
CHAPTER-01
Pharmacy
The mortar and pestle, an internationally recognized symbol to represent the pharmacy profession
Pharmacy (from the Greek ???????? ‘pharmakon’ = drug) is the health profession that links the health sciences with the chemical sciences, and it is charged with ensuring the safe and effective use of medication. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing medications, and it also includes more modern services related to patient care, including clinical services, reviewing medications for safety and efficacy, and providing drug information. Pharmacists, therefore, are the experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes. The term is also applied to an establishment used for such purposes. The first pharmacy in Europe (still working) was opened in 1241 in Trier, Germany.
The word pharmacy is derived from its root word pharma which was a term used since the 1400–1600’s. In addition to pharma responsibilities, the pharma offered general medical advice and a range of services that are now performed solely by other specialist practitioners, such as surgery and midwifery. The pharma (as it was referred to) often operated through a retail shop which, in addition to ingredients for medicines, sold tobacco and patent medicines. The pharmas also used many other herbs not listed.
In its investigation of herbal and chemical ingredients, the work of the pharma may be regarded as a precursor of the modern sciences of chemistry and pharmacology, prior to the formulation of the scientific method.
Disciplines
Pharmacy, tacuinum sanitatis casanatensis (XIV century)The field of Pharmacy can generally be divided into three primary disciplines:
The boundaries between these disciplines and with other sciences, such as biochemistry, are not always clear-cut; and often, collaborative teams from various disciplines research together.
Pharmacology is sometimes considered a fourth discipline of pharmacy. Although pharmacology is essential to the study of pharmacy, it is not specific to pharmacy. Therefore it is usually considered to be a field of the broader sciences.
Other specializations in pharmacy practice recognized by the Board of Pharmaceutical Specialties include: cardiovascular, infectious disease, oncology, pharmacotherapy, nuclear, nutrition, and psychiatry. The Commission for Certification in Geriatric Pharmacy certifies pharmacists in geriatric pharmacy practice. The American Board of Applied Toxicology certifies pharmacists and other medical professionals in applied toxicology.
Pharmacists
Pharmacists are highly-trained and skilled healthcare professionals who perform various roles to ensure optimal health outcomes for their patients. Many pharmacists are also small-business owners, owning the pharmacy in which they practice.
Pharmacists are represented internationally by the International Pharmaceutical Federation (FIP). They are represented at the national level by professional organisations such as the Royal Pharmaceutical Society of Great Britain (RPSGB), the Pharmacy Guild of Australia (PGA), the Pakistan Pharmacists Society(PPS) and the American Pharmacists Association (APhA). See also: List of pharmacy associations.
In some cases, the representative body is also the registering body, which is responsible for the ethics of the profession. Since the Shipman Inquiry, there has been a move in the UK to separate the two roles.
History of pharmacy
Paleopharmacological studies attest to the use of medicinal plants in pre-history.
The earliest known compilation of medicinal substances was the Sushruta Samhita, an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to the 3rd or 4th century AD.
Many Sumerian (late 6th millennium BC – early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine.
Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC.
The earliest known Chinese manual on materia medica is the Shennong Bencao Jing (The Divine Farmer’s Herb-Root Classic), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong. Earlier literature included lists of prescriptions for specific ailments, exemplified by a manuscript “Recipes for 52 Ailments”, found in the Mawangdui tomb, sealed in 168 BC. Further details on Chinese pharmacy can be found in the Pharmacy in China article.
The Greek physician Pedanius Dioscorides is famous for writing a five volume book in his native Greek ???? ???? ???????? in the 1st century AD. The Latin translation De Materia Medica (Concerning medical substances) was used a basis for many medieval texts, and was built upon by many middle eastern scientists during the Islamic Golden Age. The title coined the term materia medica.
In Japan, at the end of the Asuka period (538-710) and the early Nara period (710-794), the men who fulfilled roles similar to those of modern pharamacists were highly respected. The place of pharmacists in society was expressly defined in the Taih? Code (701) and re-stated in the Y?r? Code (718). Ranked positions in the pre-Heian Imperial court were established; and this organizational structure remained largely intact until the Meiji Restoration (1868). In this highly stable hierarchy, the pharmacists — and even pharmacist assistants — were assigned status superior to all others in health-related fields such as physicians and acupuncturists. In the Imperial household, the pharmacist was even ranked above the two personal physicians of the Emperor.
In Baghdad the first pharmacies were established in 754under the Abbasid Caliphate during the Islamic Golden Age. By the 9th century, these pharmacies were state-regulated.
The advances in made in the Middle East in botany and chemistry led medicine in medieval Islam substantially to develop pharmacology. Muhammad ibn Zakar?ya R?zi (Rhazes) (865-915), for instance, acted to promote the medical uses of chemical compounds. Abu al-Qasim al-Zahrawi (Abulcasis) (936-1013) pioneered the preparation of medicines by sublimation and distillation. His Liber servitoris is of particular interest, as it provides the reader with recipes and explains how to prepare the `simples’ from which were compounded the complex drugs then generally used. Sabur Ibn Sahl (d 869), was, however, the first physician to initiate pharmacopoedia, describing a large variety of drugs and remedies for ailments. Al-Biruni (973-1050) wrote one of the most valuable Islamic works on pharmacology entitled Kitab al-Saydalah (The Book of Drugs), where he gave detailed knowledge of the properties of drugs and outlined the role of pharmacy and the functions and duties of the pharmacist. Ibn Sina (Avicenna), too, described no less than 700 preparations, their properties, mode of action and their indications. He devoted in fact a whole volume to simple drugs in The Canon of Medicine. Of great impact were also the works by al-Maridini of Baghdad and Cairo, and Ibn al-Wafid (1008-1074), both of which were printed in Latin more than fifty times, appearing as De Medicinis universalibus et particularibus by `Mesue‘ the younger, and the Medicamentis simplicibus by `Abenguefit’. Peter of Abano (1250-1316) translated and added a supplement to the work of al-Maridini under the title De Veneris. Al-Muwaffaq’s contributions in the field are also pioneering. Living in the 10th century, he wrote The foundations of the true properties of Remedies, amongst others describing arsenious oxide, and being acquainted with silicic acid. He made clear distinction between sodium carbonate and potassium carbonate, and drew attention to the poisonous nature of copper compounds, especially copper vitriol, and also lead compounds. He also describes the distillation of sea-water for drinking.
In Europe pharmacy-like shops began to appear during the 12th century. In 1240 emperor Frederic II issued a decree by which the physician´s and the apothecary´s professions were separated.
Types of pharmacy practice areas
Pharmacists practice in a variety of areas including retail, hospitals, clinics, nursing homes, drug industry, and regulatory agencies. Pharmacists can specialize in various areas of practice including but not limited to: hematology/oncology, infectious diseases, ambulatory care, nutrition support, drug information, critical care, pediatrics, etc.
Community pharmacy
A pharmacy (commonly the chemist in Australia, New Zealand and the UK; or drugstore in North America; retail pharmacy in industry terminology; or Apothecary, historically) is the place where most pharmacists practice the profession of pharmacy. It is the community pharmacy where the dichotomy of the profession exists—health professionals who are also retailers.
Community pharmacies usually consist of a retail storefront with a dispensary where medications are stored and dispensed. The dispensary is subject to pharmacy legislation; with requirements for storage conditions, compulsory texts, equipment, etc., specified in legislation. Where it was once the case that pharmacists stayed within the dispensary compounding/dispensing medications; there has been an increasing trend towards the use of trained pharmacy technicians while the pharmacist spends more time communicating with patients.
All pharmacies are required to have a pharmacist on-duty at all times when open. In many jurisdictions, it is also a requirement that the owner of a pharmacy must be a registered pharmacist (R.Ph.). This latter requirement has been revoked in many jurisdictions, such that many retailers (including supermarkets and <href=”#Discount_department_store” title=”Department store”>mass merchandisers) now include a pharmacy as a department of their store.
Likewise, many pharmacies are now rather grocery store-like in their design. In addition to medicines and prescriptions, many now sell a diverse arrangement of additional household items such as cosmetics, shampoo, office supplies, confectionary, and snack foods.
Hospital pharmacy
Pharmacies within hospitals differ considerably from community pharmacies. Some pharmacists in hospital pharmacies may have more complex clinical medication management issues whereas pharmacists in community pharmacies often have more complex business and customer relations issues.
Because of the complexity of medications including specific indications, effectiveness of treatment regimens, safety of medications (i.e., drug interactions) and patient compliance issues ( in the hospital and at home) many pharmacists practicing in hospitals gain more education and training after pharmacy school through a pharmacy practice residency and sometimes followed by another residency in a specific area. Those pharmacists are often referred to as clinical pharmacists and they often specialize in various disciplines of pharmacy. For example, there are pharmacists who specialize in haematology/oncology, HIV/AIDS, infectious disease, critical care, emergency medicine, toxicology, nuclear pharmacy, pain management, psychiatry, anticoagulation clinics, herbal medicine, neurology/epilepsy management, paediatrics, neonatal pharmacists and more.
Hospital pharmacies can usually be found within the premises of the hospital. Hospital pharmacies usually stock a larger range of medications, including more specialized medications, than would be feasible in the community setting. Most hospital medications are unit-dose, or a single dose of medicine. Hospital pharmacists and trained pharmacy technicians compound sterile products for patients including total parenteral nutrition (TPN), and other medications given intravenously. This is a complex process that requires adequate training of personnel, quality assurance of products, and adequate facilities. Several hospital pharmacies have decided to outsource high risk preparations and some other compounding functions to companies who specialize in compounding.
Clinical pharmacy
Clinical pharmacists provide a direct patient care service that optimizes the use of medication and promotes health, wellness, and disease prevention. Clinical pharmacists care for patients in all health care settings but the clinical pharmacy movement initially began inside Hospitals and clinics. Clinical pharmacists often collaborate with Physicians and other healthcare professionals to improve pharmaceutical care. Clinical pharmacists are now an integral part of the interdisciplinary approach to patient care. They work collaboratively with physicians, nurses and other healthcare personnel in various medical and surgical areas. They often participate in patient care rounds and drug product selection. In most hospitals in the United States, potentially dangerous drugs that require close monitoring are dosed and managed by clinical pharmacists.
Compounding pharmacy
Compounding is the practice of preparing drugs in new forms. For example, if a drug manufacturer only provides a drug as a tablet, a compounding pharmacist might make a medicated lollipop that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead.
Compounding pharmacies specialize in compounding, although many also dispense the same non-compounded drugs that patients can obtain from community pharmacies.
Consultant pharmacy
Consultant pharmacy practice focuses more on medication regimen review (i.e. “cognitive services”) than on actual dispensing of drugs. Consultant pharmacists most typically work in nursing homes, but are increasingly branching into other institutions and non-institutional settings.<href=”#cite_note-9″ title=””>[10] Traditionally consultant pharmacists were usually independent business owners, though in the United States many now work for several large pharmacy management companies (primarily Omnicare, Kindred Healthcare and PharMerica). This trend may be gradually reversing as consultant pharmacists begin to work directly with patients, primarily because many elderly people are now taking numerous medications but continue to live outside of institutional settings. Some community pharmacies employ consultant pharmacists and/or provide consulting services.
The main principle of consultant pharmacy is Pharmaceutical care developed by Hepler and Strand in 1990.
Internet pharmacy
Since about the year 2000, a growing number of Internet pharmacies have been established worldwide. Many of these pharmacies are similar to community pharmacies, and in fact, many of them are actually operated by brick-and-mortar community pharmacies that serve consumers online and those that walk in their door. The primary difference is the method by which the medications are requested and received. Some customers consider this to be more convenient and private method rather than traveling to a community drugstore where another customer might overhear about the drugs that they take. Internet pharmacies (also known as Online Pharmacies) are also recommended to some patients by their physicians if they are homebound.
While most Internet pharmacies sell prescription drugs and require a valid prescription, some Internet pharmacies sell prescription drugs without requiring a prescription. Many customers order drugs from such pharmacies to avoid the “inconvenience” of visiting a doctor or to obtain medications which their doctors were unwilling to prescribe. However, this practice has been criticized as potentially dangerous, especially by those who feel that only doctors can reliably assess contraindications, risk/benefit ratios, and an individual’s overall suitability for use of a medication. There also have been reports of such pharmacies dispensing substandard products.
Of particular concern with internet pharmacies is the ease with which people, youth in particular, can obtain controlled substances (e.g., Vicodin, generically known as hydrocodone) via the internet without a prescription issued by a doctor/practitioner who has an established doctor-patient relationship. There are many instances where a practitioner issues a prescription, brokered by an internet server, for a controlled substance to a “patient” s/he has never met. In the United States, in order for a prescription for a controlled substance to be valid, it must be issued for a legitimate medical purpose by a licensed practitioner acting in the course of legitimate doctor-patient relationship. The filling pharmacy has a corresponding responsibility to ensure that the prescription is valid. Often, individual state laws outline what defines a valid patient-doctor relationship.
Canada is home to dozens of licensed Internet pharmacies, many which sell their lower-cost prescription drugs to U.S. consumers, who pay one of the world’s highest drug prices.[citation needed] In recent years, many consumers in the US and in other countries with high drug costs, have turned to licensed Internet pharmacies in India, Israel and the UK, which often have even lower prices than in Canada.
In the United States, there has been a push to legalize importation of medications from Canada and other countries, in order to reduce consumer costs. While in most cases importation of prescription medications violates Food and Drug Administration (FDA) regulations and federal laws, enforcement is generally targeted at international drug suppliers, rather than consumers. There is no known case of any U.S. citizens buying Canadian drugs for personal use with a prescription, who has ever been charged by authorities.
Veterinary pharmacy
Veterinary pharmacies, sometimes called animal pharmacies may fall in the category of hospital pharmacy, retail pharmacy or mail-order pharmacy. Veterinary pharmacies stock different varieties and different strengths of medications to fulfill the pharmaceutical needs of animals. Because the needs of animals as well as the regulations on veterinary medicine are often very different from those related to people, veterinary pharmacy is often kept separate from regular pharmacies.
Nuclear pharmacy
Nuclear pharmacy focuses on preparing radioactive materials for diagnostic tests and for treating certain diseases. Nuclear pharmacists undergo additional training specific to handling radioactive materials, and unlike in community and hospital pharmacies, nuclear pharmacists typically do not interact directly with patients.
Military pharmacy
Military pharmacy is an entirely different working environment due to the fact that technicians perform most duties that in a civilian sector would be illegal. State laws of Technician patient counseling and medication checking by a pharmacist do not apply.
Pharmacy informatics
Pharmacy informatics is the combination of pharmacy practice science and applied information science. Pharmacy informaticists work in many practice areas of pharmacy, however, they may also work in information technology departments or for healthcare information technology vendor companies. As a practice area and specialist domain, pharmacy informatics is growing quickly to meet the needs of major national and international patient information projects and health system interoperability goals. Pharmacists are well trained to participate in medication management system development, deployment and optimization.
Issues in pharmacy
Separation of prescribing from dispensing
In most jurisdictions (such as the United States), pharmacists are regulated separately from physicians. Specifically, the legislation stipulates that the practice of prescribing must be separate from the practice of dispensing. These jurisdictions also usually specify that only pharmacists may supply scheduled pharmaceuticals to the public, and that pharmacists cannot form business partnerships with physicians or give them “kickback” payments. However, the American Medical Association (AMA) Code of Ethics provides that physicians may dispense drugs within their office practices as long as there is no patient exploitation and patients have the right to a written prescription that can be filled elsewhere. 7 to 10 percent of American physicians practices reportedly dispense drugs on their own.
In other jurisdictions (particularly in Asian countries such as China, Hong Kong, Malaysia, and Singapore), doctors are allowed to dispense drugs themselves and the practice of pharmacy is sometimes integrated with that of the physician, particularly in traditional Chinese medicine.
In Canada it is common for a medical clinic and a pharmacy to be located together and for the ownership in both enterprises to be common, but licensed separately.
The reason for the majority rule is the high risk of a conflict of interest. Otherwise, the physician has a financial self-interest in “diagnosing” as many conditions as possible, and in exaggerating their seriousness, because he or she can then sell more medications to the patient. Such self-interest directly conflicts with the patient’s interest in obtaining cost-effective medication and avoiding the unnecessary use of medication that may have side-effects. This system reflects much similarity to the checks and balances system of the U.S. and many other governments.
A campaign for separation has begun in many countries and has already been successful (like in Korea). As many of the remaining nations move towards separation, resistance and lobbying from dispensing doctors who have pecuniary interests may prove a major stumbling block (e.g. in Malaysia).
The future of pharmacy
In the coming decades, pharmacists are expected to become more integral within the health care system. Rather than simply dispensing medication, pharmacists will be paid for their patient care skills.
This shift has already commenced in some countries; for instance, pharmacists in Australia receive remuneration from the Australian Government for conducting comprehensive Home Medicines Reviews. In the United Kingdom, pharmacists (and nurses) who undertake additional training are obtaining prescribing rights. They are also being paid for by the government for medicine use reviews. In the United States, pharmaceutical care or Clinical pharmacy has had an evolving influence on the practice of pharmacy. Moreover, the Doctor of Pharmacy (Pharm.D.) degree is now required before entering practice and many pharmacists now complete one or two years of residency or fellowship training following graduation. In addition, consultant pharmacists, who traditionally operated primarily in nursing homes are now expanding into direct consultation with patients, under the banner of “senior care pharmacy.
Symbols
Bowl of Hygeia The red stylized “A” used in Germany Caduceus (used erroneously)
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CHAPTER-02
INTRODUCTION OF INN
International Nonproprietary Names (INN) identifies pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.
Guidelines on the Use of INNs for Pharmaceutical Substances (1997)
The INN system as it exists today was initiated in 1950 by a World Health Assembly resolution WHA3.11 and began operating in 1953, when the first list of International Nonproprietary Names for pharmaceutical substances was published. The cumulative list of INN now stands at some 7000 names designated since that time, and this number is growing every year by some 120-150 new INN.
Since its inception, the aim of the INN system has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances, in the form of INN, is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.
As unique names, INN have to be distinctive in sound and spelling, and should not be liable to confusion with other names in common use. To make INN universally available they are formally placed by WHO in the public domain, hence their designation as “nonproprietary”. They can be used without any restriction whatsoever to identify pharmaceutical substances.
Another important feature of the INN system is that the names of pharmacologically-related substances demonstrate their relationship by using a common “stem”. By the use of common stems the medical practitioner, the pharmacist, or anyone dealing with pharmaceutical products can recognize that the substance belongs to a group of substances having similar pharmacological activity.
The extent of INN utilization is expanding with the increase in the number of names. Its wide application and global recognition are also due to close collaboration in the process of INN selection with numerous national drug nomenclature bodies. The increasing coverage of the drug-name area by INN has led to the situation whereby the majority of pharmaceutical substances used today in medical practice are designated by an INN. The use of INN is already common in research and clinical documentation, while their importance is growing further due to expanding use of generic names for pharmaceutical products.
EXECUTIVE SUMMERY
Recommendations from the INN Ad-Hoc Meeting on Biologicals,
Geneva, 23-24 April 2007
The objective of this meeting, which brought together representatives from various national nomenclature institutions, from the innovator and generics industry, from the INN Biological Advisers and from the INN Expert Group, was to discuss and review in-depth the INN policies for naming and defining biological medicinal substances, and to submit recommendations to be discussed by the full INN Expert Group during the 44th INN Consultation in May 2007.
Following is the outcome of the discussions:
1. INN Policies on post-translational modifications of proteins:
• Existing INN definitions of glycoproteins are inadequate and should be reviewed in terms of current knowledge and consistency of application.
• More information should be requested at the time of application for an INN.
• Arguments were made for and against the present practice of including specific Greek letters to differentiate different glycoforms of a given molecular entity (e.g. epoetin). In view of the lack of consensus, no change in the INN nomenclature policy pertaining to post-translational modifications is recommended at this time. The proposal of eliminating the Greek letter therefore should not be considered, even in a prospective manner.
• Consideration should be given as to how much information should be included in the name and how much in the definition, bearing in mind that there are protein modifications other than glycosylation (e.g. phosphorylation, lipidation).
• Consideration should also be given to drawing up a list of internationally agreed codes to reflect different production processes (such as E. coli, yeast, CHO cells etc). The use of such codes would not be part of the INN but discretionary, and used in labeling when regulatory authorities wished to distinguish different production systems.
2. INN Policies for Monoclonal Antibodies
• The nomenclature rules for monoclonal antibodies are complex. Current developments in the use of different antibody types (e.g. IgG 1, 2) with different functions, antibody fragments and “glyco-engineering” is adding to this complexity. Consideration should be given to establishing a small expert group to review these developments and to make specific recommendations on INN policy for monoclonal antibodies.
3. INN Policies on Vaccines and Gene, Cell and Tissue Therapies Vaccines
• No major changes are foreseen in the policies for naming vaccines, which are a diverse group of biologicals.
• The WHO Expert Committee on Biological Standardization should continue to assign international and proper names to prophylactic vaccines. Consideration should be given to reviewing current inconsistencies in nomenclature and to extending the scheme to all prophylactic vaccines, as well as to developing internationally agreed abbreviations.
• Some small peptides used in the treatment of cancers should be considered as therapeutic immunostimulants rather than vaccines and be given INNs.
• Close liaison between the INN Expert Group and the Expert Committee on Biological Standardization should be established to monitor nomenclature policies in this evolving field and to consider appropriate policy on specialized issues, such as viral vectors for use as cancer vaccines. Gene, Cell and Tissue Therapy.
• No change in the INN policy for gene, cell and tissue therapies is recommended for the time being.
• Cells and tissues, including stem cells, are considered to be outside the remit of the INN system.
• The Expert Committee on Biological Standardization should consider developing guidelines for the quality control and safety evaluation of stem cells and tissue engineered medicinal products.
4. INN Policies on Blood Products
• No changes should be made to existing policies since these were already well established.
• Recombinant DNA-derived substances should therefore continue to be assigned INNs but the complexities already referred to with respect to post translational modification of proteins, as well as intended modifications, need to be taken into account.
• All naturally-derived blood products should still be considered to be outside the remit of the INN system.
• Nomenclature policies in this evolving field should be monitored through close liaison between the INN Expert Group and the Expert Committee on Biological Standardization, who consults with the International Society on Thrombosis and Haemostasis as well as the Blood Regulators Network.
5. INN Policies on Transgenic Products and Enzymes Transgenic Products
• It is recommended that there be no separate policy for products derived from transgenic animals or plants.
• The codes developed to reflect different manufacturing processes mentioned above should include transgenic systems. Enzymes
• No changes are proposed in the policy for assigning INNs to naturally-derived or biotechnology-derived enzymes. However this position may need review in future.
USE OF INN
Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by national or, as in the case of the European Community, by international legislation. As a result of ongoing collaboration, national names such as British Approved Names (BAN), Dénominations Communes Françaises (DCF), Japanese Adopted Names (JAN) and United States Accepted Names (USAN) are nowadays, with rare exceptions, identical to the INN.
Some countries have defined the minimum size of characters in which the generic nonproprietary name must be printed under the trade-mark labelling and advertising. In several countries the generic name must appear prominently in type at least half the size of that used for the proprietary or brand-name. In some countries it has to appear larger than the trade-mark name. Certain countries have even gone so far as to abolish trade-marks within the public sector.
To avoid confusion, which could jeopardize the safety of patients, trade-marks cannot be derived from INN and, in particular, must not include their common stems. As already mentioned the selection of further names within a series will be seriously hindered by the use of a common stem in a brand-name.
SELECTION OF INN
The names which are given the status of an INN are selected by the World Health Organization on the advice of experts from the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. The process of INN selection follows three main steps:
– a request/application is made by the manufacturer or inventor; – after a review of the request a proposed INN is selected and published for comments; – after a time-period for objections has lapsed, the name will obtain the status of a recommended INN and will be published as such if no objection has been raised.
INN is selected in principle only for single, well-defined substances that can be unequivocally characterized by a chemical name (or formula). It is the policy of the INN programme not to select names for mixtures of substances, while substances that are not fully characterized are included in the INN system in exceptional cases only. INN is not selected for herbal substances (vegetable drugs) or for homoeopathic products. It is also the policy of the INN programme not to select names for those substances that have a long history of use for medical purposes under well-established names such as those of alkaloids (e.g. morphine, codeine), or trivial chemical names (e.g. acetic acid).
An INN is usually designated for the active part of the molecule only, to avoid the multiplication of entries in cases where several salts, esters, etc. are actually used. In such cases, the user of the INN has to create a modified INN (INNM) himself; mepyramine maleate (a salt of mepyramine with maleic acid) is an example of an INNM. When the creation of an INNM would require the use of a long or inconvenient name for the radical part of the INNM, the INN programme will select a short name for such a radical (for example, mesilate for methanesulfonate).
In the process of INN selection, the rights of existing trade-mark owners are fully protected. If in the period of four months following the publication of a proposed INN, a formal objection is filed by an interested person who considers that the proposed INN is in conflict with an existing trade-mark, WHO will actively pursue an arrangement to obtain a withdrawal of such an objection or will reconsider the proposed name. As long as the objection exists, WHO will not publish it as a recommended INN.
CHAPTER-03
IRBESARTAN
DESCRIPTION
Arbit contains Irbesartan INN which is a antihypertensive drug. It antagonizes angiotensin II receptor.
INDICATIONS.
Arbit is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
DOSAGE AND ADMINISTRATION.
The recommended initial dose of arbit is 150 mg once daily. Patients requiring further reduction in blood pressure should be treated with 300 mg once daily. Arbit may be administered with or without food.
CONTRAINDICATION
Arbit is contraindicated in patients who are hypersensitive to any component of this product.
DRUG INTERACTIONS.
No significant drug interaction has been found in studies with Hydrochlorothiazide, Digoxin, Warfarin, and Nifedipine.
SIDE EFFECTS.
In placebo-controlled clinical trials the adverse event, which occurred in at least 1% of patients treated with irbesartan and at a higher incidence versus placebo, included diarrhoea, dyspepsia, trauma, fatigue, and upper respiratory infection. Irbesartan use was not associated with an increased incidence of dry cough, as is trpically associated with ACE inhibitor use.
USE IN SPECIAL POPULATIONS.
Paediatric: There is no data on safety and effectiveness of Irbesartan in children.
Geriatric: In elderly subjects (age 65-80 years), on dosage adjustment is necessary.
Commercial Packs
Arbit® 75 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Irbesartan INN 75 mg.
Arbit® 150 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Irbesartan INN 150 mg.
LANSOPRAZOLE
DESCRIPTION
The active ingredient in Lansoprazole Delayed-Release Capsules, Lansoprazole for Delayed-Release Oral Suspension and Lansoprazole SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure:
INDICATIONS
Lansoprazole Delayed-Release Capsules, Lansoprazole SoluTab Delayed-Release Orally Disintegrating Tablets and Lansoprazole For Delayed-Release Oral Suspension are indicated for:
Short-Term Treatment of Active Duodenal Ulcer
Lansoprazole is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.
DOSAGE AND ADMINISTRATION
Lansoprazole is available as a capsule, orally disintegrating tablet and oral suspension, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole should be taken before eating. Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with Lansoprazole.
HOW SUPPLIED
Lansoprazole Delayed-Release Capsules, 15 mg, are opaque, hard gelatin, colored pink and green with the TAP logo and “Lansoprazole 15” imprinted on the capsules. The 30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and “PREVACID 30” imprinted on the capsules.
SIDE EFFECTS
Clinical
Worldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. The adverse reaction profiles for Lansoprazole Delayed-Release Capsules and Lansoprazole for Delayed-Release Oral Suspension are similar. In general, Lansoprazole treatment has been well-tolerated in both short-term and long-term trials
Incidence of Possibly or Probably Treatment-Related Adverse Events in Short-Term, Placebo-Controlled Lansoprazoled Studies
| Body as a Whole | ||
| Abdominal Pain | 2.1 | 1.2 |
| Digestive System | ||
| Constipation | 1.0 | 0.4 |
| Diarrhea | 3.8 | 2.3 |
| Nausea | 1.3 | 1.2 |
DRUG INTERACTIONS
Lansoprazole causes a profound and long-lasting inhibition of gastric acid secretion; therefore, it is theoretically possible that lansoprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, digoxin).
CONTRAINDICATIONS.
Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation of Lansoprazole.
Amoxicillin is contraindicated in patients with a known hypersensitivity to any penicillin.
Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, and any of the macrolide antibiotics.
TEGASEROD
DESCRIPTION
DRUG CLASS AND MECHANISM: Tegaserod is an oral medication for the treatment of constipation and constipation–predominant irritable bowel syndrome (IBS) in women. IBS is a chronic gastrointestinal disorder characterized by recurrent abdominal pain or discomfort and altered bowel function which may be either constipation or diarrhea. As many as 20% of American adults may suffer from IBS.
PREPARATIONS
White, round tablets of 2 and 6 mg.
STORAGE
Tegaserod tablets should be stored at room temperature, 59–86°F (15–30°C).
PRESCRIBED FOR
Tegaserod is used for the short–term treatment of women with IBS whose primary bowel symptom is constipation. It also is approved for the treatment of chronic, idiopathic constipation in men and women less than 65 years of age.
DOSING
The usual dose of tegaserod is 6 mg twice daily, most frequently for 4 to 12 weeks. Tegaserod can be taken with or without food. Older persons do not require lower doses than younger persons.
DRUG INTERACTIONS
There are no known drug interactions with tegaserod. Other drugs that increase intestinal contractions will likely lead to more diarrhea if used together with tegaserod.
PREGNANCY
No ill effects were seen in the fetuses of pregnant rats given 15 times the human dose and rabbits given 50 times the human dose of tegaserod (on a per–weight basis). Nevertheless, there are no adequate studies of tegaserod in pregnant women. Therefore, physicians must weight the potential benefit of giving tegaserod during pregnancy against the unknown risk.
NURSING MOTHERS
Tegaserod is secreted into the breast milk of nursing rats. Very high doses of tegaserod in mice cause tumors. Due to the demonstration of these tumors and the lack of safety data in children, physicians must weigh the potential benefit of giving tegaserod to nursing women against the unknown risk to the infant.
SIDE EFFECTS
Tegaserod is well tolerated in most patients. The most commonly reported side effects are headache (1 in 6 patients), abdominal pain (1 in 8), and diarrhea (1 in 11). Only diarrhea has been reported substantially more frequently than with placebo treatment (sugar pill). Rarely the diarrhea is severe, leading to hospitalization for dehydration and requiring intravenous fluids. Ischemic colitis has been seen rarely in patients taking tegaserod although it is not clear if there is a causal relationship. Patients who develop signs of ischemic colitis––worsening abdominal pain, bloody diarrhea––should stop taking tegaserod and contact their physicians.
ROSUVASTATIN CALCIUM
DESCRIPTION
Rosuvastatin Calcium is a synthetic lipid-lowering agent. Rosuvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.
INDICATIONS
Rosuvastatin Calcium is indicated
1. As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidemia (Fredrickson Type IIa and IIb);
2. As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);
3. To reduce LDL-C, total-C, and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Therapy in Different Risk Categories
| CHDa or CHD Risk Equivalent
(10-year risk > 20% |
< 100 mg/dL | ? 100 mg/dL | ? 130 mg/dL
(100-129 mg/dL:drug optional)b |
| 2+ Risk Factors
(10-year risk ? 20%) |
< 130 mg/dL | ? 130 mg/dL | ? 130 mg/dL
10-year risk 10-20% ? 160 mg/dL 10-year risk < 10% |
| 0-1 Risk Factors | < 160 mg/dL | ? 160 mg/dL | ? 190 mg/dL (160-189 mg/dL)
(LDL-lowering drug optional) |
| a CHD = coronary heart disease.
b Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C < 100 mg/dL cannot be achieved by TLC. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. c Almost all people with 0-1 risk factor have 10-year risk < 10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. |
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DOSAGE AND ADMINISTRATION
The patient should be placed on a standard cholesterol-lowering diet before receiving Rosuvastatin Calcium and should continue on this diet during treatment. Rosuvastatin Calcium can be administered as a single dose at any time of day, with or without food.
Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
The dose range for Rosuvastatin Calcium is 5 to 40 mg once daily. Therapy with Rosuvastatin Calcium should be individualized according to goal of therapy and response. The usual recommended starting dose of Rosuvastatin Calcium is 10 mg once daily. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions, who have predisposing factors for myopathy, and as noted below for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency (see CLINICAL PHARMACOLOGY, Race, and Renal Insufficiency, and Drug Interactions). For patients with marked hypercholesterolemia (LDL-C > 190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. After initiation and/or upon titration of Rosuvastatin Calcium, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
HOW SUPPLIED
Rosuvastatin Calcium Tablets are supplied as:
5 mg tablets: Yellow, round, biconvex, coated tablets identified as “Rosuvastatin Calcium” and “5” debossed on one side and plain on the other side of the tablet.
STORAGE
Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from moisture.
SIDE EFFECTS
Rosuvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. In clinical studies of 10,275 patients, 3.7% were discontinued due to adverse experiences attributable to rosuvastatin. The most frequent adverse events thought to be related to rosuvastatin were myalgia, constipation, asthenia, abdominal pain, and nausea.
DRUG INTERACTIONS
Cyclosporine
When rosuvastatin 10 mg was coadministered with cyclosporine in cardiac transplant patients, rosuvastatin mean Cmax and mean AUC were increased 11-fold and 7-fold, respectively, compared with healthy volunteers. These increases are considered to be clinically significant and require special consideration in the dosing of rosuvastatin to patients taking concomitant cyclosporine (see WARNINGS, Myopathy/Rhabdomyolysis, and DOSAGE AND ADMINISTRATION).
CONTRAINDICATIONS
Rosuvastatin is contraindicated in patients with a known hypersensitivity to any component of this product.
Rosuvastatin is contraindicated in patients with active liver disease or with unexplained persistent elevations of serum transaminases (see WARNINGS, Liver Enzymes).
EFAVIRENZ
DESCRIPTION
Efavirenz (brand names Sustiva® and Stocrin®) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1.
For HIV infection that has not previously been treated, the United States Department of Health and Human Services Panel on Antiretroviral Guidelines currently recommends the use of efavirenz in combination with lamivudine/zidovudine or tenofovir/emtricitabine as the preferred NNRTI-based regimens in adults and adolescents.
Indications
Efavirenz is used to treat HIV infection. It is never used alone and is always given in combination with other drugs. The decision on when to start treatment should take into account CD4 count, HIV viral load, treatment history, resistance profiles and patient preference.
Since the preliminary publication of the results of the ACTG 5142 trial in 2006 which compared efavirenz against lopinavir, efavirenz has been used as first line treatment in preference to the protease inhibitors. The ACTG 5095 trial showed that the potency of efavirenz is maintained at all CD4 counts and HIV viral loads.
Dosing
The usual adult dose of efavirenz is 600mg per day (usually given at bedtime); or 800mg daily when given concurrently with rifampicin as part of treatment of co-infection with tuberculosis.
Drug interactions
• Efavirenz is metabolized in the liver, and possesses both inhibitory and inducing effects on the 3A4 isoform of the cytochrome P450 system. This means efavirenz may interact with other drugs metabolized in the liver, requiring either increased or decreased dosages.
• Efavirenz lowers blood levels of most protease inhibitors. Dosages of amprenavir, atazanavir, or indinavir may need to be increased. The blood levels of saquinavir are dramatically lowered, so that the two drugs cannot be used simultaneously.
• St John’s wort and garlic supplements may decrease efavirenz blood levels.
Adverse effects
• Psychiatric symptoms, including insomnia, confusion, memory loss, and depression, are common.
• Rash, nausea, dizziness and headache may occur.
• Efavirenz can cause birth defects and should not be used in women who might become pregnant.
• Safety in children has not been established.
• Use of efavirenz can produce a false positive result in some urine tests for marijuana.
• Abuse of efavirenz for supposed hallucinogenic and dissociative effects ha
