DOCSLIB.ORG

Cimetidine Reduces Weight and Improves Metabolic Control in Overweight Patients with Type 2 Diabetes

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Cimetidine Reduces Weight and Improves Metabolic Control in Overweight Patients with Type 2 Diabetes International Journal of Obesity (1998) 22, 1041±1045 ß 1998 Stockton Press All rights reserved 0307±0565/98 $12.00 http://www.stockton-press.co.uk/ijo Cimetidine reduces weight and improves metabolic control in overweight patients with Type 2 diabetes G Stùa-Birketvedt*1, PN Paus3, R Ganss3, OC Ingebretsen2 and J Florholmen1 1Laboratory of Gastroenterology, Institute of Clinical Medicine, University of Tromsù, Tromsù; 2Biochemical Department, University Hospital of Tromsù, Tromsù; and 3Medical Department, Central Hospital of Akershus, Nordbyhagen, Norway OBJECTIVE: To investigate the weight-reducing effect of cimetidine in overweight patients with Type 2 diabetes. DESIGN: A 12-week clinical intervention study of 400 mg cimetidine prescribed three times daily in a randomised, double-blind, placebo-controlled design. SUBJECTS: Forty-three overweight patients with Type 2 diabetes (age 18±65 y, body mass index (BMI) 27.2± 48.2 kg=m2). MEASUREMENTS: Body weight, BMI, body fat, waist and hip circumference, waist=hip ratio, blood pressure, fasting blood glucose, HbA1c, plasma concentrations of insulin, insulin=glucose ratio and lipids at the start and after 12 weeks, and daily recordings of appetite. RESULTS: Subjects given cimetidine (n 19) and placebo (n 24) lost 5.0Æ 2.2 kg (meanÆ s.d.) and 1.3Æ 1.1 kg, respectively. Signi®cant reductions were observed in appetite, body fat (29.9Æ 6.6% to 25.3Æ 7.4%), waist circumfer- ence (111.5Æ 10.3 cm to 107.4Æ 10.6 cm), waist=hip ratio (0.96Æ 0.08 to 0.94 Æ 0.08), and systolic and diastolic blood pressure (reductions of 6.9Æ 11.4 mm Hg and 6.0Æ 6.6 mm Hg, respectively) in cimetidine group only. Signi®cant decreases in fasting concentrations of blood glucose, HbA1c, plasma insulin, insulin=glucose ratio, plasma triglycerides and a signi®cant increase in plasma high-density lipoprotein cholesterol were observed in the cimetidine group only. CONCLUSIONS: Cimetidine reduces appetite and body weight, and improves metabolic control in overweight subjects with Type 2 diabetes. Keywords: H2-receptor antagonist; hyperlipidemia; insulin resistance; obesity; weight reduction Introduction heterogeneous pathogenesis, with interactions at least between visceral obesity and genetic factors.11 We have previously reported that the H -receptor According to previous reports, there is a high pre- 2 antagonist, cimetidine, reduces weight in healthy valence of Type 2 diabetes among obese subjects.1,2 overweight subjects.12 The mechanism of this effect Hyperinsulinism and insulin resistance are character- is unknown. In rats, H -receptor antagonists reduce istic features of both Type 2 diabetes and obesity (for 2 appetite and weight gain by a non-gastric acid related review, see Ref. 3). In obese subjects the insulin mechanism.13 We have shown that cholecystokinin resistance is highly correlated to the mass of visceral (CCK) is a candidate mediator of this effect on fat.4,5 However, it remains controversial whether satiety.14 obesity is the major and=or an independent contributor The objective of this study was to investigate the to the insulin resistance in Type 2 diabetes.6,7 effect of cimetidine on body weight and metabolic It is well recognized that weight reduction is pro®le in overweight patients with Type 2 diabetes in associated with bene®cial effects on metabolic con- a randomized, double blind, placebo-controlled study. trol.8 A modest weight reduction may strongly improve the metabolic pro®le.9 Weight reduction induces improved glycemic control, reduced hepatic glucose output, increased insulin action in the liver and the peripheral tissue, and improved insulin secre- Materials and methods tion.10 However, a weight reduction to normalcy elicits a complete normalization of the peripheral insulin action in only few patients.10 This implies a Subjects Sixty-two patients with Type 2 diabetes were recruited from the outpatient ®les of two Norwegian hospitals. The inclusion criteria were age 18±65 y and *Correspondence: Dr Grethe Stùa-Birketvedt, University of body mass index (BMI) > 25 kg=m2. Patients with Pennsylvania, 3600 Market Street, Suite 732, 19104 PA, USA. Received 11 September 1997; revised 21 May 1998; accepted serious cardial, renal or hepatic diseases were 26 May 1998 excluded. Patients treated with antacids, gastric acid Cimetidine reduces weight G Stùa-Birketvedt et al 1042 antisecretory agents, insulin or corticosteroids were Ethics also excluded. The study was conducted according to the Helsinki declarations and with the approval of the Ethical Committee of The Health Region V, Norway. Study design The patients were randomized into two groups accord- Statistical analysis ing to BMI: the ®rst group, cimetidine (400 mg): Statistical analysis was performed in those patients (Nycomed, Oslo, Norway) and the second group who ful®lled the study according to the protocol. placebo (identical in taste and appearance as cimeti- Differences in consecutive weight changes between dine) (Pharmaceutical Department, University Hospi- the cimetidine and placebo group were evaluated tal of Tromsù, Tromsù, Norway), prescribed three using repeated measures multivariate analysis of var- times daily, 30 min before meals. Patients were told iance (RM MANOVA). Loss in appetite was de®ned to follow their own diet or eat less if not hungry, to as a decrease of > 10% in the mean visual analogue perform their regular exercise program and not change scale (VAS) during treatment of an individual patient. their smoking habits during the study. The cimetidine Signi®cance between the treatment groups was tested dose was twice as high as that used in the former by comparing the fraction of patients with loss in 12 study as it seemed to induce a stronger feeling of appetite in each group by using Fisher-Irwin exact satiety (unpublished observation). This dose also test. In the remaining parameters, the signi®cance was 14 increases the postprandial CCK response. tested for within-group comparison by paired Stu- At the start, a physical examination was performed, dent's t test, and for between-group comparison by including sitting blood pressure, height, weight, unpaired t tests. The signi®cance level was set at abdominal circumference (umbilical level), and hip P < 0.05. circumference (tuberculum majus). BMI was calcu- lated as kg=m2. Body fat % was measured with near infrared technique (Futrex 5000: Futrex Corp., Gaithersburg, MA) as previously described.15 These Results procedures were repeated at the end of the study. Duration of the study was 12 weeks, with clinic visits scheduled at the same time each week. Subjects Subjects were weighed each week, side effects were recorded Of the 62 subjects (31 in each group) randomized to and the average degree of hunger before breakfast, active and placebo treatment, 60 subjects (31=29, in lunch and supper during the previous week was the cimetidine and placebo group, respectively) recorded on a 10 cm visual analogue scale. Compli- entered the study, that is, two patients were lost at ance with the drug treatment was checked by the inclusion due to reasons unknown (Table 1). Five of returned dose packets; 80% compliance was consid- the patients were not included due to sudden events ered acceptable. between the randomization and the start. Twelve subjects were excluded, four subjects due to side effects (one placebo subject with diarrhoea and three cimetidine subjects, one each with arthralgia, abdom- Laboratory tests inal pain and vomiting). After termination of the Blood samples were drawn after an overnight fast at treatment all subjects recovered completely. In the the start and after 12 weeks. The blood samples were remaining patients the medication was well tolerated. withdrawn into vacutainer tubes containing EDTA The remaining 43 subjects (19=24), 14 women and 29 (1 mg=ml, ®nal concentration), and centrifuged at men, completed the study according to the protocol. 1000 g for 10 min at 4C. Blood glucose was mea- sured by a glucose analyzer (Model 2300 STAT, Yellow Springs Instrument Co., Inc., Yellow Springs, Table 1 Patients included and excluded OH). The rest of the plasma was immediately frozen Cimetidine Placebo Total (727 C) and stored for later measurements. HbA1c was measured by the Diamat TM system from Bio-Rad Randomized 31 31 62 Failed to initiate the study 0 2 2 Laboratories GmbH (Munich, Germany). Insulin was Lack of ful®lling the inclusion criteria 4 1 5 measured by a radioimmunoassay (RIA) method.16 Initiated the study 27 28 55 Plasma concentrations of cholesterol and triglycerides Excluded due to Side effects 3 1 4 were measured using Hitachi 917 Automatic Analyzer Withdrawals not related to 3 1 4 from Boehringer Mannheim (Mannheim, Germany). treatment Reagents, calibrators and controls were purchased Changes in smoking habits 1 1 Immobilization (bone fracture) 1 1 from the manufacturer. High-density lipoprotein Use of antacids 1 1 (HDL) cholesterol concentrations in plasma were Start of peroral antidiabetic agents 1 1 measured after preparation of HDL according to the Total of excluded patients 8 4 12 Total of evaluable patients 19 24 43 method described by Burstein et al.17 Cimetidine reduces weight G Stùa-Birketvedt et al 1043 Characteristics of patients plasma concentrations of insulin and insulin=glucose Characteristics of the patients are shown in Table 2. ratio (Table 4). In the cimetidine group there were At the start of the study there were no signi®cant signi®cant reductions in the levels of HbA1c, insulin differences between age, gender, duration of Type 2 and insulin=glucose ratio, but no signi®cant changes diabetes, patients on peroral antidiabetic medication, in the placebo group were observed. body weight, BMI, fat %, waist and hip circumfer- There were no signi®cant differences in baseline ences or waist=hip ratio (WHR). plasma levels of cholesterol, triglycerides and HDL During the ®rst week of treatment, appetite mea- cholesterol between the two groups (Table 4).
Load more

Recommended publications
  • Drug-Induced Sexual Dysfunction in Men and Women
    VOLUME 36 : NUMBER 2 : APRIL 2013 ARTICLE Drug-induced sexual dysfunction in men and women Helen M Conaglen whether the clinician is willing to ask about sexual Clinical psychologist and SUMMARY issues and does so in a sensitive way.7,8 Senior research fellow Many medical conditions and their treatments Patients on long-term medications may not be John V Conaglen aware that their sexual problems have developed Endocrinologist and contribute to sexual dysfunction. as a result of their treatment. Conversely some may Associate professor in Commonly implicated drugs include Medicine blame their drugs for sexual problems which are due Sexual Health Research Unit antihypertensives, antidepressants, to relationship difficulties or other stressors. Some Waikato Clinical School antipsychotics and antiandrogens. doctors consider that asking patients if they had Faculty of Medical and Understanding the potential for drug-induced noticed any sexual adverse effects from their drugs Health Sciences University of Auckland sexual problems and their negative impact may ‘suggest’ them to the patient, and possibly result on adherence to treatment will enable the in non-adherence. Patients attributing their sexual clinician to tailor treatments for the patient problems to their drugs are less likely to continue the Key words treatment even when necessary for their health.9 The antidepressants, and his or her partner. consultation should include discussion of the patient’s antihypertensives, Encouraging a discussion with the patient sexual issues so these can be considered in treatment antipsychotics, arousal, about sexual function and providing erectile dysfunction, decisions. hypoactive sexual desire strategies to manage the problem are critical disorder, male impotence, to good clinical care.
    [Show full text]
  • Dative Metabolism of Cortisol in Humans Kunihi
    臨 床 薬 理JPn J Clin Pharmacol Ther 18 (3) Sept 1987 509 Comparison of the Inhibitory Effects of Famotidine and Cimetidine on Hepatic Oxi- dative Metabolism of Cortisol in Humans Kunihiko MORITA* Hiroki KONISHI* Takeshi ONO* and Harumi SHIMAKAWA* (Receivedon Dec.19, 1986) * Hospital Pharmacy, Shiga Universityof Medical Science, Tsukinowa-cho,Seta, Ohtsu520-21, Japan The inhibitory effect of famotidine, a new H2-receptor antagonist, on hepatic oxidative metabolism of cortisol in six healthy volunteers was compared with that of cimetidine by monitoring the change in urinary 6ƒÀ-hydroxycortisol (6ƒÀ-OHF), an oxidative metabolite of cortisol. The ratio of 6ƒÀ-OHF to 17-hydroxycorticosteroids (17-OHCS) in urine was measured before, during, and after treatment with famotidine and cimetidine for 3 days in a cross-over study. The ratio was decreased by 25% -35% of the original level after 1-3 days of oral treatment with cimetidine (800 mg, b. i. d.). The reduction vanished within 2 days after the last dose of cimetidine. The ratio was not significantly changed during oral treatment with famotidine (40 mg, b. i. d.). These findings indicate that famotidine, in contrast to cimetidine, does not affect the hepatic oxidative metabolism of cortisol in man, and it is suggested that famotidine does not affect the hepatic drug-metabolizing capacity in humans. Key words: famotidine, cimetidine, H2-receptor antangonist, 6ƒÀ-hydroxycortisol, enzyme inhibition been shown to inhibit the hepatic elimination of a Introduction number of drugs coadministred.1-4) A number of Cimetidine, a histamine H2-receptor antagonist studies have demonstrated that this inhibitory widely used for the treatment of peptic ulcer, has action of cimetidine is based on its high affinity for cytochrome P-450 in hepatic microsomes *滋 賀医科大学医学部附属病院薬剤部 arising from imidazole and cyano groups.5-7) 〓520-21滋 賀県大津市瀬田月輪町 Ranitidine, an H2-receptor antagonist developed 510 hospital pharmacists, aged 24 to 35 years old (mean 28), participated in the study.
    [Show full text]
  • Auspar Attachment 1. Product Information for Mifepristone
    Attachment 1: Product information for AusPAR MS-2 Step mifepristone/misoprostol MS Health Pty Ltd PM-2013-01037-1-5 Final 13 October 2014. This Product Information was approved at the time this AusPAR was published. PRODUCT INFORMATION - MS-2 StepÔ It is very important that all patients receiving these medications are followed up by a medical practitioner, preferably the prescriber, to ensure that the medication has been effective. Even if no adverse events have occurred all patients must receive follow-up 14 to 21 days after taking mifepristone. Read the SPECIAL WARNINGS AND PRECAUTIONS FOR USE carefully. This document refers to the use of MS-2 StepÔ, which consists of Mifepristone Linepharma 200 mg tablet and GyMiso® misoprostol 200 microgram tablets in combination. These medicines are indicated in females of childbearing age for the medical termination of a developing intrauterine pregnancy, up to 63 days of gestation. The Mifepristone Linepharma 200 mg tablet component of this therapy is also used to treat another condition. For information about the treatment of the other condition, refer to the full Product Information for Mifepristone Linepharma 200 mg tablet individual product (AUST R 175671). NAME OF THE MEDICINE MS-2 StepÔ is a composite pack containing Mifepristone Linepharma 200 mg tablet and GyMiso® misoprostol 200 microgram tablets. Mifepristone Australian Approved Name (AAN): Mifepristone Chemical Structure: CH3 N CH 3 OH CH H CH3 3 H H O Molecular formula: C29H35NO2 Molecular weight: 429.6 Version:22May2014 [63days] Page 1 of 23 Attachment 1: Product information for AusPAR MS-2 Step mifepristone/misoprostol MS Health Pty Ltd PM-2013-01037-1-5 Final 13 October 2014.
    [Show full text]
  • 2021 Formulary List of Covered Prescription Drugs
    2021 Formulary List of covered prescription drugs This drug list applies to all Individual HMO products and the following Small Group HMO products: Sharp Platinum 90 Performance HMO, Sharp Platinum 90 Performance HMO AI-AN, Sharp Platinum 90 Premier HMO, Sharp Platinum 90 Premier HMO AI-AN, Sharp Gold 80 Performance HMO, Sharp Gold 80 Performance HMO AI-AN, Sharp Gold 80 Premier HMO, Sharp Gold 80 Premier HMO AI-AN, Sharp Silver 70 Performance HMO, Sharp Silver 70 Performance HMO AI-AN, Sharp Silver 70 Premier HMO, Sharp Silver 70 Premier HMO AI-AN, Sharp Silver 73 Performance HMO, Sharp Silver 73 Premier HMO, Sharp Silver 87 Performance HMO, Sharp Silver 87 Premier HMO, Sharp Silver 94 Performance HMO, Sharp Silver 94 Premier HMO, Sharp Bronze 60 Performance HMO, Sharp Bronze 60 Performance HMO AI-AN, Sharp Bronze 60 Premier HDHP HMO, Sharp Bronze 60 Premier HDHP HMO AI-AN, Sharp Minimum Coverage Performance HMO, Sharp $0 Cost Share Performance HMO AI-AN, Sharp $0 Cost Share Premier HMO AI-AN, Sharp Silver 70 Off Exchange Performance HMO, Sharp Silver 70 Off Exchange Premier HMO, Sharp Performance Platinum 90 HMO 0/15 + Child Dental, Sharp Premier Platinum 90 HMO 0/20 + Child Dental, Sharp Performance Gold 80 HMO 350 /25 + Child Dental, Sharp Premier Gold 80 HMO 250/35 + Child Dental, Sharp Performance Silver 70 HMO 2250/50 + Child Dental, Sharp Premier Silver 70 HMO 2250/55 + Child Dental, Sharp Premier Silver 70 HDHP HMO 2500/20% + Child Dental, Sharp Performance Bronze 60 HMO 6300/65 + Child Dental, Sharp Premier Bronze 60 HDHP HMO
    [Show full text]
  • Cimetidine Tablets 200Mg, 400Mg and 800Mg
    PACKAGE LEAFLET: INFORMATION FOR THE USER Cimetidine Tablets 200mg, 400mg and 800mg [Cimetidine] Read all of this leaflet carefully before you start ! Are taking other medicines (see Section 'Other taking this medicine because it contains medicines and Cimetidine Tablets '). important information for you. ! Keep this leaflet. You may need to read it again. Other medicines and Cimetidine Tablets ! If you have any further questions, ask your doctor or pharmacist or nurse. Tell your doctor or pharmacist if you are taking, have ! This medicine has been prescribed for you only. recently taken or might take any other medicines. Do not pass it on to others. It may harm them, In particular tell your doctor if you are taking any of even if their signs of illness are the same as the following: yours. ! Anticoagulants to thin your blood e.g. warfarin ! If you get any side effects, talk to your doctor, or ! Anticonvulsants to prevent fits e.g. phenytoin pharmacist or nurse. This includes any possible ! Bronchodilators for breathing difficulties e.g. side effects not listed in this leaflet. See section 4. theophylline ! Anti-arrhythmics to slow heart rate e.g. lidocaine, What is in this leaflet: propranolol 1. What Cimetidine Tablets are and what they ! Antidepressants to treat anxiety e.g. diazepam are used for ! Immunosuppresants to prevent organ rejection 2. What you need to know before you take or rheumatism (e.g. ciclosporin) Cimetidine Tablets ! Medicines that cause a fall in blood cell count 3. How to take Cimetidine Tablets ! Antifungals used to treat fungal infections (e.g. 4.
    [Show full text]
  • Complete Inhibition of Food-Stimulated Gastric Acid Secretion by Combined Application of Pirenzepine and Ranitidine*
    Gut: first published as 10.1136/gut.22.7.542 on 1 July 1981. Downloaded from Gut, 1981, 22, 542-548 Complete inhibition of food-stimulated gastric acid secretion by combined application of pirenzepine and ranitidine* W LONDONG,t V LONDONG, C RUTHE, AND P WEIZERT From the Medizinische Klinik Innenstadt, University ofMunich, Munich, W Germany SUMMARY In a double-blind, placebo controlled and randomised secretory study the effectiveness of pirenzepine, ranitidine, and their combination was compared intraindividually in eight healthy subjects receiving intravenous bolus injections. Pirenzepine (0.15 mg/kg) plus ranitidine (0-6 mg/kg) suppressed peptone-stimulated gastric acid secretion from 69±11 to 2±0-4 mmol H+/3 h; the mean percentage inhibition was 97%. Postprandial gastrin was unaffected. There were only minor side-effects in a few experiments (reduction of salivation, brief blurring of vision), but no prolactin stimulation after ranitidine or ranitidine plus pirenzepine. The combined application of ranitidine and pirenzepine inhibited meal-stimulated acid secretion more effectively and produced fewer side-effects than the combination of cimetidine plus pirenzepine studied previously. The combined application ofclassical anticholinergics Methods and H2-receptor antagonists inhibits basal and http://gut.bmj.com/ stimulated gastric acid secretion in man more than Each subject had four tests which had to be carried either drug alone.' In double-blind, placebo con- out within a fortnight; the interval between two tests trolled and randomised investigations we have was at least three days. On separate days each subject demonstrated79 that combined intravenous bolus received pirenzepine, ranitidine, pirenzepine plus injections ofthe antimuscarinic drug pirenzepine with ranitidine, and placebo in random order by slow cimetidine suppressed peptone-stimulated acid out- intravenous bolus on a double-blind basis according put more effectively (on average by 90%) than either to a predetermined randomisation code.
    [Show full text]
  • These Highlights Do Not Include All the Information Needed to Use PRASTERA® Safely and Effectively
    PRASTERA- prasterone and ibuprofen Health Science Funding, LLC Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PRASTERA® safely and effectively. See full prescribing information for PRASTERA® . PRASTERA® prasterone oral softgels 200mg are for oral use only. Initial U.S. Approval INDICATIONS AND USAGE PRASTERA® prasterone 200 mg oral softgels is indicated in female patients with mild to moderate, active (SLEDAI ≥2) systemic lupus erythematosus (SLE) to restore serum 5-dehydroandrosterone sulfate to levels typical of women without SLE. In Phase III clinical trials in female patients with mild to moderate active SLE, prasterone 200 mg was associated with reduced risk of auto-immune flare, reduced risk of breast cancer and reduced risk of death from any cause. (§§1, 6.2, 6.4, 6.5) DOSAGE AND ADMINISTRATION The recommended dose is one (1) softgel daily. (§2) DOSAGE FORMS AND STRENGTHS 200mg oral softgel capsules supplied in a convenience package with ibuprofen oral tablets 400mg. (§3) CONTRAINDICATIONS Known hypersensitivity to any of its ingredients. (§4) Undiagnosed abnormal genital bleeding. (§4) Known, suspected or history of breast cancer. (§4, §6.5) History of, or known, deep vein thrombosis, pulmonary embolism, arterial thromboembolic disease (e.g., stroke, myocardial infarction). (§4) Hypercholesterolemia or ischemic heart disease. (§4, §7.2.4) Hepatic or renal impairment (pharmacokinetic data lacking). (§4, §7.2) Breast-feeding or known or suspected pregnancy.
    [Show full text]
  • 14 LETTERS to the EDITORS 565 EFFECT of CIMETIDINE on GONADAL FUNCTION in MAN We Were Interested to Read the Paper by Wang Et Al
    Br. J. clin. Pharmac. (1982), 14 LETTERS TO THE EDITORS 565 EFFECT OF CIMETIDINE ON GONADAL FUNCTION IN MAN We were interested to read the paper by Wang et al. dine being an antiandrogen in man and this is sup- (1982) which showed that treatment of male patients ported by the finding that cimetidine competes with suffering from duodenal ulcer with cimetidine was androgens for binding to androgen receptors in associated with a significant rise in serum testosterone human skin fibroblasts (Sultan et al., 1980) as it also levels. We are aware of four other published studies does in mouse kidney preparations (Funder & on this topic (including one cited by Wang et al., 1982 Mercer, 1979). (van Thiel et al., 1979)) in patients being treated for Since cimetidine but not ranitidine has this effect acid peptic disorders with cimetidine (Carlson et al., then it is not a function of H2-receptor blockade 1981; Peden et al., 1981; Spona et al., 1981). (Peden et al., 1981). The clinical relevance of this All of these studies showed that treatment with recently became apparent to us when we were cimetidine was associated with a modest rise in basal referred a 50 year old man who had received testosterone levels although this rise was statistically cimetidine 1g/day continuously for 18 months for a significant in only two of the papers (Peden et al., stomal ulcer. He had gynaecomastia and complained 1981; van Thiel et al., 1979). Two of the studies were of impotence. Measurements of serum prolactin, prospective and comparative. That of Carlson et al.
    [Show full text]
  • PACKAGE LEAFLET – INFORMATION for the USER Cimetidine
    PACKAGE LEAFLET – INFORMATION FOR THE USER Cimetidine 200mg Tablets Cimetidine 400mg Tablets Cimetidine 800mg Tablets (Cimetidine) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet: 1. What Cimetidine tablets are and what they are used for 2. What you need to know before you take Cimetidine tablets 3. How to take Cimetidine tablets 4. Possible side effects 5. How to store Cimetidine tablets 6. Contents of the pack and other information 1. What Cimetidine tablets are and what they are used for Cimetidine belongs to a group of medicines called Histamine H2 receptor antagonists and is used as an anti-ulcer drug. It works by reducing the amount of acid in your stomach. Cimetidine is used to treat and relieve the following conditions: Ulcers in the stomach (gastric ulcer) and in upper part of the intestine (duodenum ulcer). Recurrent or stomac ulcers (ulcers that keep coming back or which have occurred following stomach surgery). Ulcers in the stomach or duodenum which may be caused by non-steroidal anti- inflammatory drugs (NSAIDs, often used to reduce pain, fever and inflammation) Acid from the stomach escaping into the food pipe causing pain, inflammation and heartburn (oesophageal reflux).
    [Show full text]
  • Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
    Updated June 07, 2021 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List1 • Add the following entry to category 2 due to serious safety concerns of mutagenicity, cytotoxicity, and possible carcinogenicity when quinacrine hydrochloride is used for intrauterine administration for non- surgical female sterilization: 2,3 o Quinacrine Hydrochloride for intrauterine administration • Revision to category 1 for clarity: o Modify the entry for “Quinacrine Hydrochloride” to “Quinacrine Hydrochloride (except for intrauterine administration).” • Revision to category 1 to correct a substance name error: o Correct the error in the substance name “DHEA (dehydroepiandosterone)” to “DHEA (dehydroepiandrosterone).” 1 For the purposes of the substance names in the categories, hydrated forms of the substance are included in the scope of the substance name. 2 Quinacrine HCl was previously reviewed in 2016 as part of FDA’s consideration of this bulk drug substance for inclusion on the 503A Bulks List. As part of this review, the Division of Bone, Reproductive and Urologic Products (DBRUP), now the Division of Urology, Obstetrics and Gynecology (DUOG), evaluated the nomination of quinacrine for intrauterine administration for non-surgical female sterilization and recommended that quinacrine should not be included on the 503A Bulks List for this use. This recommendation was based on the lack of information on efficacy comparable to other available methods of female sterilization and serious safety concerns of mutagenicity, cytotoxicity and possible carcinogenicity in use of quinacrine for this indication and route of administration.
    [Show full text]
  • Study Protocol and Statistical Analysis Plan
    ECOG-ACRIN Operations Office – Boston Frontier Science 900 Commonwealth Avenue Boston, MA 02215 (617) 632-3610 Fax: (617) 632-2990 Randomization: (617) 632-2022 Group Chair: Robert L. Comis, M.D. and Mitchell Schnall, M.D. Jean MacDonald, Director of Research Operations Group Statistician: Robert Gray, Ph.D. and Constantine Gatsonis, Ph.D. Mary Steele, Director of Group Administration July 31, 2014 Martha Kruhm, MS RAC Head, Protocol and Information Office Quality Assurance Section CTEP, DCT, NCI 6130 Executive Blvd, EPN Room 7000 Bethesda, MD 20892 Dear Ms. Kruhm: Enclosed is Addendum #9 to E2809, Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy. The following revisions to E2809 protocol have been made in this addendum: Section Change 1. Cover Page Updated the version date. Inserted into the first and second bullet points the phrase "confirmed on 2. Section 6.1.4 two consecutive additional determinations taken at least 4 weeks apart," to more clearly define undetectable PSA. The following revisions to E2809 Informed Consent Document have been made in this addendum: Section Change 1. Cover Page Updated the version date. "What side effects or Updated the risk section language to correspond with the condensed 2. risks can I expect from risk lists format. being in the study?" "What side effects or 3. risks can I expect from Inserted condensed risk list for Bicalutamide. being in the study?" If you have any questions regarding this addendum, please contact [email protected] or 617-632-3610.
    [Show full text]
  • An Investigation Into the Effects and Possible
    AN INVESTIGATION INTO THE EFFECTS AND POSSIBLE MECHANISMS OF ACTION OF CIMETIDINE AND RANITIDINE ON THE SEXUAL BEHAVIOUR OF MALE RATS BY ROOPRAM BADRI Dip.Med.Tech. (Clin Path); Dip.Med.Tech. (Histopath) Submitted in part fulfilment of the requirements for the degree of Master of Medical Science in the Department of Pharmacology in the Faculty of Health Sciences at the University of Durban-Westville. Supervisor: Professor AL du Preez Joint-Supervisor: Mrs MJ du Preez Date Submitted: June 1985 ACKNOWLEDGEMENTS It is a special pleasure to thank Professor AL du Preez, Rector of Technikon, Natal, (former Head of Pharmacology Department, University of Durban-Westville), who conceived the idea for ' this investigation and offered excellent guidance and constructive criticisms during the course of this study. I am grateful to Mrs MJ du Preez for her encouragement and many valuable suggestions while supervising this research. My sincere thanks are extended to Professor AM Veltman for his kindness and constant encouragement; the late Mr RD Ramkisson for statistical assistance; Professor R Miller and the Pharmacology staff for their assistance in various ways; Mr S Baboolal for writing statistical programs; Mr AI Vawda for assistance with anti androgen studies; Miss I Venkatas for help on use of word processor: and to many colleagues at the University of Ourban-Westville for their generous help. My sincere appreciation goes to Mr HJ Klomfass, Natal Institute of Immunology, for assistance with techniques in ovariectomy and cardiac puncture; Or RH Scott (Department of Pathology), Addington Hospital, for assistance with histology of testes; Or RJ Norman (Department of Chemical Pathology), University of Natal Medical School, for radioimmunoassay of serum testosterone; Mr S Tejram and Mr P Naicker (Department of Medical Illustration), University of Natal Medical School, for photographic assistance.
    [Show full text]