US FDA The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter:link

Pregnancy cat. The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast milk B1(AU For at least 40,000 years before European settlement in the late 18th century, Australia was inhabited by indigenous Australians, who belonged to one or more of the roughly 250 language groups. After sporadic visits by fishermen from the immediate north and discovery by Dutch explorers in 1606, Australia's eastern half was claimed by the British) B(US ^ b. English is the de facto language of American government and the sole language spoken at home by 80% of Americans age five and older. Spanish is the second most commonly spoken language) Legal status The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as is the case in Prescription Only (S4) The Standard for the Uniform Scheduling of Drugs and Poisons, abbreviated SUSDP, is a document used in the regulation of drugs and poisons in Australia. It is produced by the National Drugs and Poisons Scheduling Committee , a committee of the Therapeutic Goods Administration (TGA). The SUSDP contains the decisions of the NDPSC in the aim of (AU For at least 40,000 years before European settlement in the late 18th century, Australia was inhabited by indigenous Australians, who belonged to one or more of the roughly 250 language groups. After sporadic visits by fishermen from the immediate north and discovery by Dutch explorers in 1606, Australia's eastern half was claimed by the British) POM A prescription medication is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug (UK The United Kingdom of Great Britain and Northern Ireland[note 7] is a sovereign state located off the northwestern coast of continental Europe. It is an island country, spanning an archipelago including Great Britain, the northeastern part of the island of Ireland, and many small islands. Northern Ireland is the only part of the UK with a land) OTC Over-the-counter drugs are medicines that may be sold to a customer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to customers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are products that are safe and/℞-only (U.S., depending on dosage strength) Routes A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is brought into contact with the body Oral, parenteral (what is this?) (verify)

Cimetidine (INN An International Nonproprietary Name is the official non-proprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization (WHO)[citation needed]. The plethora of named proprietary preparations containing a given substance can lead to confusion about the identity of the active ingredient. INNs) (pronounced /sɨˈmɛtɨdiːn/, /saɪˈmɛtɨdiːn/) is a histamine H2-receptor antagonist The H2-receptor antagonists are a class of drugs used to block the action of histamine on parietal cells in the stomach, decreasing the production of acid by these cells. H2 antagonist are used in the treatment of dyspepsia, although they have largely been surpassed in popularity by the more effective proton pump inhibitors. In the United States, that inhibits the production of acid in the stomach In some animals, including vertebrates, echinoderms, insects and molluscs, the stomach is a muscular, hollow, dilated part of the alimentary canal which functions as the primary organ of the digestive tract. It is involved in the second phase of digestion, following mastication (chewing). The stomach is located between the esophagus and the small. It is largely used in the treatment of heartburn Heartburn, also known as pyrosis or acid indigestion is a burning sensation in the chest, just behind the breastbone or in the epigastrium. The pain often rises in the chest and may radiate to the neck, throat, or angle of the jaw and peptic ulcers A peptic ulcer, also known as ulcus pepticum, PUD or peptic ulcer disease, is an ulcer of an area of the gastrointestinal tract that is usually acidic and thus extremely painful. As many as 80% of ulcers are associated with Helicobacter pylori, a spiral-shaped bacterium that lives in the acidic environment of the stomach, however only 40% of those. It is marketed by GlaxoSmithKline GlaxoSmithKline plc is a British pharmaceutical, biological, and healthcare company. GSK is the world's fourth largest pharmaceutical company after Johnson & Johnson, Pfizer, and Roche respectively by revenue; and a research-based company with a wide portfolio of pharmaceutical products covering anti-infectives, central nervous system, under the trade name A trade name, also known as a trading name or a business name, is the name which a business trades under for commercial purposes, although its registered, legal name, used for contracts and other formal situations, may be another Tagamet (sometimes Tagamet HB or Tagamet HB200). Cimetidine was approved in the UK in 1976 and was approved in the US by the Food & Drug Administration for prescriptions starting January 1, 1979.

Contents

Clinical use

Main article: H2-receptor antagonist The H2-receptor antagonists are a class of drugs used to block the action of histamine on parietal cells in the stomach, decreasing the production of acid by these cells. H2 antagonist are used in the treatment of dyspepsia, although they have largely been surpassed in popularity by the more effective proton pump inhibitors. In the United States,

History and development

Cimetidine, approved by the FDA for inhibition of gastric acid secretion, has been advocated for a number of dermatological diseases. [1]Cimetidine was the prototypical histamine H2-receptor antagonist The H2-receptor antagonists are a class of drugs used to block the action of histamine on parietal cells in the stomach, decreasing the production of acid by these cells. H2 antagonist are used in the treatment of dyspepsia, although they have largely been surpassed in popularity by the more effective proton pump inhibitors. In the United States, from which the later members of the class were developed. Cimetidine was the culmination of a project at Smith, Kline & French (SK&F; now GlaxoSmithKline GlaxoSmithKline plc is a British pharmaceutical, biological, and healthcare company. GSK is the world's fourth largest pharmaceutical company after Johnson & Johnson, Pfizer, and Roche respectively by revenue; and a research-based company with a wide portfolio of pharmaceutical products covering anti-infectives, central nervous system,) by James W. Black Sir James Whyte Black, OM, FRS, FRSE, FRCP is a Scottish doctor and pharmacologist who invented Propranolol, synthesized Cimetidine and was awarded the Nobel Prize for Medicine in 1988 for these discoveries, C. Robin Ganellin, and others to develop a histamine receptor The histamine receptors are a class of G-protein coupled receptors with histamine as their endogenous ligand antagonist A receptor antagonist is a type of receptor ligand or drug that does not provoke a biological response itself upon binding to a receptor, but blocks or dampens agonist-mediated responses. In pharmacology, antagonists have affinity but no efficacy for their cognate receptors, and binding will disrupt the interaction and inhibit the function of an to suppress stomach acid secretion.[2] This was one of the first drugs discovered using a rational drug design approach, thanks to the efforts of medicinal chemists C. Robin Ganellin and Graham Durant and pharmacologist James Black at Smith, Kline, & French Laboratories (now GlaxoSmithKline; Sir James W. Black shared the 1988 Nobel Prize in Physiology or Medicine for the discovery of propranolol US FDA:link and also is credited for the discovery of cimetidine; actually, the medicinal chemists would have made the discovery).[3]

At the time (1964 1964 (MCMLXIV, "nineteen sixty-four", "nineteen hundred sixty-four", or "one thousand, nine hundred (and) sixty-four") was a leap year starting on Wednesday (link will display full calendar) of the Gregorian calendar) it was known that histamine Histamine is an organic nitrogen compound involved in local immune responses as well as regulating physiological function in the gut and acting as a neurotransmitter. Histamine triggers the inflammatory response. As part of an immune response to foreign pathogens, histamine is produced by basophils and by mast cells found in nearby connective could stimulate the secretion of stomach acid, but also that traditional antihistamines A histamine antagonist is an agent that inhibits action of histamine via histamine receptors. H1 antihistamines are used as treatment for symptoms of allergies such as runny nose. Allergies are caused by an excessive type 1 hypersensitivity response of the body to allergens, such as pollen released by plants. An allergic reaction, which if severe had no effect on acid production. In the process, the SK&F scientists also proved the existence of histamine H2-receptors.

The SK&F team used a rational drug-design structure starting from the structure of histamine - the only design lead, since nothing was known of the then hypothetical H2-receptor. Hundreds of modified compounds were synthesised in an effort to develop a model of the receptor. The first breakthrough was Nα-guanylhistamine, a partial H2-receptor antagonist. From this lead the receptor model was further refined and eventually led to the development of burimamide, the first H2-receptor antagonist. Burimamide, a specific competitive antagonist A competitive antagonist is a receptor antagonist that binds to a receptor but does not activate the receptor. The antagonist will compete with available agonist for receptor binding sites on the same receptor. Sufficient antagonist will displace the agonist from the binding sites, resulting in a lower frequency of receptor activation at the H2-receptor 100-times more potent than Nα-guanylhistamine, proved the existence of the H2-receptor.

Burimamide was still insufficiently potent for oral administration and further modification of the structure, based on modifying the pKa An acid dissociation constant, Ka, is a quantitative measure of the strength of an acid in solution. It is the equilibrium constant for a chemical reaction known as dissociation in the context of acid-base reactions. The equilibrium can be written symbolically as: of the compound, lead to the development of metiamide. Metiamide was an effective agent, however it was associated with unacceptable nephrotoxicity Nephrotoxicity is a poisonous effect of some substances, both toxic chemicals and medication, on the kidneys. There are various forms of toxicity. Nephrotoxicity should not be confused with the fact that some medications have a predominantly renal excretion and need their dose adjusted for the decreased renal function (e.g. heparin) and agranulocytosis Agranulocytosis, also known as agranulosis, is an acute condition involving a severe and dangerous leukopenia , most commonly of neutrophils, causing a neutropenia in the circulating blood. It represents a severe lack of one major class of infection-fighting white blood cells. People with this condition are at very high risk of serious infections[2]. It was proposed that the toxicity arose from the thiourea Thiourea is an organic compound of carbon, nitrogen, sulfur and hydrogen, with the formula C group, and similar guanidine-analogues were investigated until the ultimate discovery of cimetidine.

Cimetidine was first marketed in the United Kingdom in 1976; therefore, it took 12 years from initiation of the H2-receptor antagonist program to commercialization. The commercial name "Tagamet" was decided upon by fusing the two words"antagonist" and "cimetidine".[2] Subsequent to the introduction onto the U.S. drug market, two other H2-receptor antagonists were approved, ranitidine US FDA:link (Zantac, Glaxo Labs) and famotidine US FDA:link (Pepcid, Yamanouchi, Ltd.) Cimetidine became the first drug ever to reach more than $1 billion a year in sales, thus making it the first blockbuster drug A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.[4]

Other uses

In some studies, cimetidine has been found to reduce the debilitating pain and symptoms of herpes zoster Herpes zoster , commonly known as shingles and also known as zona, is a viral disease characterized by a painful skin rash with blisters in a limited area on one side of the body, often in a stripe. The initial infection with varicella zoster virus (VZV) causes the acute (short-lived) illness chickenpox which generally occurs in children and young, presumably by blocking the H2-receptors of T-lymphocyte suppressor cells.[5]

A number of "open label" studies showed that cimetidine was effective in the treatment of common warts, but more rigorous double-blinded clinical trials suggested it to be no more effective than a placebo. However, this study admits that their results may not be sound, due to small sample size, and did not explore higher dosing options.[6]

Another study by Yokoyama et al. used cimetidine for the treatment of chronic calcific tendinitis Calcific tendinitis (also calcific/calcifying/calcified/calcareous tenonitis/tendonitis/tendinopathy, tendinosis calcarea, hydroxyapatite deposition disease and calcific periarthritis), a form of tendinitis, is a disorder characterized by deposits of hydroxyapatite (a crystalline calcium phosphate) in any tendon of the body, but most commonly in of the shoulder.[7] The small scale study took 16 individuals with calcific tendinitis in one shoulder, all of which had previously attempted other forms of therapy including steroid injection and arthroscopic lavage. During the course of the study 10 patients reported an elimination of pain and 9 displayed a complete disappearance of Calcium deposits. With results being on a small scale, it has been recommended that Cimetidine, for the treatment of chronic calcific tendinitis of the shoulder, be opened to large scale clinical trials.[8]

Cimetidine has also been reported[9] for use in treatment of colorectal cancer - it is however not approved in the US by the FDA for cancer treatment.

Cimetidine has been reported for use as an analgesic in experimental treatments of interstitial cystitis.

Pretreatment with cimetidine improves the accuracy of measured creatinine clearance testing when using urine collection analysis.

Adverse effects and interactions

Cimetidine is a known inhibitor of many isozymes Isozymes are enzymes that differ in amino acid sequence but catalyze the same chemical reaction. These enzymes usually display different kinetic parameters (e.g. different KM values), or different regulatory properties. The existence of isozymes permits the fine-tuning of metabolism to meet the particular needs of a given tissue or developmental of the cytochrome P450 The cytochrome P450 superfamily is a large and diverse group of enzymes. The function of most CYP enzymes is to catalyze the oxidation of organic substances. The substrates of CYP enzymes include metabolic intermediates such as lipids and steroidal hormones, as well as xenobiotic substances such as drugs and other toxic chemicals enzyme system[10] (specifically CYP1A2, CYP2C9 Cytochrome P450 2C9 is a protein which in humans is encoded by the CYP2C9 gene, CYP2C19, CYP2D6 Cytochrome P450 2D6 , a member of the cytochrome P450 mixed-function oxidase system, is one of the most important enzymes involved in the metabolism of xenobiotics in the body. Whilst CYP2D6 is involved in the oxidation of a wide range of substrates of all the CYPs, there is considerable variability in its expression in the liver. The gene is, CYP2E1, and CYP3A4 Cytochrome P450 3A4 (EC 1.14.13.97), a member of the cytochrome P450 mixed-function oxidase system, is one of the most important enzymes involved in the metabolism of xenobiotics in the body. CYP3A4 is involved in the oxidation of the largest range of substrates of all the CYPs. CYP3A4 is also, correspondingly, present in the largest quantity of). This inhibition forms the basis of the numerous drug interactions A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. Typically, interaction between drugs come to mind . However, interactions may also exist between drugs & foods (drug-food interactions), as well as that occur between cimetidine and other drugs. For example, cimetidine may decrease metabolism of some drugs, such as those used in hormonal contraception Hormonal contraception refers to birth control methods that act on the endocrine system. Almost all methods are composed of steroid hormones, although in India one selective estrogen receptor modulator is marketed as a contraceptive. The original hormonal method—the combined oral contraceptive pill—was first marketed as a contraceptive in 1960. Cimetidine interferes with metabolism of the hormone estrogen Estrogens , oestrogens (BE), or œstrogens, are a group of steroid compounds, named for their importance in the estrous cycle, and functioning as the primary female sex hormone, their name comes from estrus/oistros (period of fertility for female mammals) + gen/gonos = to generate, enhancing estrogen activity. In women, this can lead to galactorrhea Galactorrhea or galactorrhoea is the spontaneous flow of milk from the breast, unassociated with childbirth or nursing, whereas in men, gynecomastia Gynecomastia, pronounced /ˌɡaɪnɨkɵˈmæstiə/, is the development of abnormally large mammary glands in males resulting in breast enlargement. The term comes from the Greek γυνή gyne meaning "woman" and μαστός mastos meaning "breast". The condition can occur physiologically in neonates (due to female hormones has been reported;[11] during postmarketing surveillance Postmarketing surveillance is the practice of monitoring a pharmaceutical drug or device after it has been released on the market. Since drugs are approved on the basis of clinical trials which involve relatively small numbers of people who have been "controlled" for this purpose - meaning that they normally do not have other medical in the 1980s, cases of male sexual dysfunction were also reported.[12][13] Cimetidine also affects the metabolism of methadone Methadone is a synthetic opioid, used medically as an analgesic, antitussive and a maintenance anti-addictive for use in patients on opioids. It was developed in Germany in 1937. Although chemically unlike morphine or heroin, methadone also acts on the opioid receptors and thus produces many of the same effects. Methadone is also used in managing, sometimes resulting in higher blood levels and a higher incidence of side effects, and may interact with the antimalarial medication hydroxychloroquine.[14]

The development of longer-acting H2-receptor antagonists with reduced adverse effects such as ranitidine proved to be the downfall of cimetidine and, though it is still used, it is no longer among the more widely used H2-receptor antagonists. Side effects can include dizziness, and more rarely, headache.

Following administration of cimetidine, the half-life and AUC of zomitriptan and its active metabolites were approximately doubled (see CLINICAL PHARMACOLOGY). See complete drug interactions for Zomig (triptan succinate used for migraine relief) in package insert: http://www1.astrazeneca-us.com/pi/Zomig.pdf

References

  1. ^ Scheinfeld N. Cimetidine: A review of the recent developments. Dermatol Online J. 2003;9(2):4.[PMID: 12639457]
  2. ^ a b c "Tagamet: A medicine that changed people's lives". American Chemical Society. 2004. http://acswebcontent.acs.org/landmarks/tagamet/tagamet.html. Retrieved 2009-09-06.
  3. ^ Silverman, Richard A. (2004). The organic chemistry of drug design and drug action. Amsterdam: Elsevier Academic Press. p. 159. ISBN 0-12-643732-7.
  4. ^ Whitney, Jake (February 2006). "Pharmaceutical Sales 101: Me-Too Drugs". Guernica. http://www.guernicamag.com/features/111/me_too_drugs/. Retrieved 2008-07-31.
  5. ^ Faloon, William; Kitchen, Kate (March 2001). "Tagemet to Treat Herpes and Shingles". Life Extension Magazine. http://www.lef.org/magazine/mag2001/mar2001_report_tagamet_1.html. Retrieved 2009-03-05.
  6. ^ Fit KE, Williams PC (Jul 2007). "Use of histamine2-antagonists for the treatment of verruca vulgaris". Ann Pharmacother 41 (7): 1222–6. doi:10.1345/aph.1H616. PMID 17535844.
  7. ^ Yokoyama M, Aono H, Takeda A, Morita K (2003). "Cimetidine for chronic calcifying tendinitis of the shoulder". Reg Anesth Pain Med 28 (3): 248–52. doi:10.1053/rapm.2003.50048. PMID 12772145.
  8. ^ "Musculoskeletal Pain". http://www.pain.com/sections/categories_of_pain/Musculoskeletal/resources/library/abstract.cfm?ID=5248&next_page=1&startrec=1&RecordDisplays=20&Search_phrase=shoulder. Retrieved 2008-10-22.
  9. ^ "Colorectal Cancer - Page 2 Of 3: Online References For Health Concerns". http://www.lef.org/protocols/cancer/colorectal_02.htm+. Retrieved 2008-10-22.
  10. ^ Levine M, Law EY, Bandiera SM, Chang TK, Bellward GD (Feb 1998). "In vivo cimetidine inhibits hepatic CYP2C6 and CYP2C11 but not CYP1A1 in adult male rats". The Journal of pharmacology and experimental therapeutics 284 (2): 493–9. PMID 9454789. http://jpet.aspetjournals.org/cgi/pmidlookup?view=long&pmid=9454789.
  11. ^ Michnovicz JJ, Galbraith RA (Feb 1991). "Cimetidine inhibits catechol estrogen metabolism in women". Metabolism: clinical and experimental 40 (2): 170–4. PMID 1988774.
  12. ^ Sawyer D, Conner CS, Scalley R (February 1981). "Cimetidine: adverse reactions and acute toxicity". Am J Hosp Pharm 38 (2): 188–97. PMID 7011006.
  13. ^ Sabesin SM (1993). "Safety issues relating to long-term treatment with histamine H2-receptor antagonists". Aliment Pharmacol Ther 7 Suppl 2: 35–40. PMID 8103374.
  14. ^ Furst DE (June 1996). "Pharmacokinetics of hydroxychloroquine and chloroquine during treatment of rheumatic diseases". Lupus 5 Suppl 1: S11–5. PMID 8803904.

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