Update on GI Medication Management Megan Butler, M.D

Total Page:16

File Type:pdf, Size:1020Kb

Update on GI Medication Management Megan Butler, M.D Update on GI medication management Megan Butler, M.D. Pediatric Gastroenterology Duke University Objectives • Discuss common GI diseases in children • Reflux • EoE • Constipation • Functional GI disorders • Review pharmacologic and non-pharmacologic treatment for GI disorders in children • Understand adverse events associated with GI medications Reflux “Name’s Reflux. Medical condition or super power, you decide.” -Reflux ©Disney-Pixar Reflux • Gastroesophageal Reflux • Reflux ≠ Reflux • Kids are NOT just little adults • Reflux in kids can be physiologic or pathologic • 80% of babies regurgitate in the first month of life • ~10% at 1yo • Need to distinguish • Important to rule out other reasons for symptoms Reflux • Definitions • GER • Passage of gastric contents into the esophagus with or without regurgitation and vomiting • GERD • When GER leads to symptoms that affect daily functioning and/or complications • Refractory GERD • GERD not responding to optimal treatment after 8 weeks • Look for “alarm signs” Reflux - DDxs • Gastrointestinal Obstruction • Cardiac • Pyloric stenosis, Malrotation with • Heart failure, vascular ring, autonomic volvulus, Intussusception, Hirschsprung dysfunction disease, Antral/duodenal web, Incarcerated hernia, Superior mesenteric • Other GI disorders artery syndrome • Achalasia, gastroparesis, gastroenteritis, peptic ulcers, eosinophilic esophagitis, • Neurologic food allergy/intolerance, inflammatory • Hydrocephalus, Subdural hematoma, bowel disease, pancreatitis, appendicitis Intracranial hemorrhage, Intracranial mass • Infectious • Sepsis/meningitis, UTI, upper/lower • Metabolic airway infection, otitis media, hepatitis • Galactosemia, hereditary fructose intolerance, urea cycle defects, amino • Other and organic acidemias, fatty acid • Pediatric condition falsification/factitious oxidation disorders, metabolic acidosis, disorder by proxy, child neglect or abuse, congenital adrenal hyperplasia/adrenal self-induced vomiting, cyclic vomiting crisis syndrome, rumination syndrome • Toxic • Lead poisoning, other toxins Alarm signs • Weight loss • Macro/microcephaly • Lethargy • Persistent forceful vomiting • Fever • Nocturnal vomiting • Excessive irritability/pain • Bilious vomiting • Dysuria • Hematemesis • Onset >6 months or increasing >12- • Chronic diarrhea 18 months of age • Rectal bleeding • Bulging fontanel/rapidly increasing • Abdominal distention head size • Seizures Clinical management algorithms • Etiologies can differ by age • Treatment algorithms differ by age • 2018 NASPGHAN clinical guidelines • Infants < 6 months • Infants and children ≥6 months Reflux - DDxs • Gastrointestinal Obstruction • Cardiac • Pyloric stenosis, Malrotation with • Heart failure, vascular ring, autonomic volvulus, Intussusception, Hirschsprung dysfunction disease, Antral/duodenal web, Incarcerated hernia, Superior mesenteric • Other GI disorders artery syndrome • Achalasia, gastroparesis, gastroenteritis, peptic ulcers, eosinophilic esophagitis, • Neurologic food allergy/intolerance, inflammatory • Hydrocephalus, Subdural hematoma, bowel disease, pancreatitis, appendicitis Intracranial hemorrhage, Intracranial mass • Infectious • Sepsis/meningitis, UTI, upper/lower • Metabolic airway infection, otitis media, hepatitis • Galactosemia, hereditary fructose intolerance, urea cycle defects, amino • Other and organic acidemias, fatty acid • Pediatric condition falsification/factitious oxidation disorders, metabolic acidosis, disorder by proxy, child neglect or abuse, congenital adrenal hyperplasia/adrenal self-induced vomiting, cyclic vomiting crisis syndrome, rumination syndrome • Toxic • Lead poisoning, other toxins Infant with H&P Yes Alarm sign? Appropriate testing suspected GERD No Avoid overfeeding Thicken feeds Education 1st Not improved? 2-4 week trial protein hydrolysate or AA Improved? Discuss protein formula, or cow’s milk reintroduction at follow up elimination (EBF) Formula/elimination trial 2nd Not improved Medications 3rd line Consider 4-8 week trial of Pediatric GI referral acid suppression, wean if sxs improve Adapted from Rosen et al, 2018 Child with suspected H&P Yes Alarm sign? Appropriate testing GERD No Lifestyle and dietary Improved? st Continue management 1 line education Not improved Acid suppression x 4-8 Improved? nd Attempt wean 2 line weeks Not improved Symptoms recur with weaning Pediatric GI referral Adapted from Rosen et al, 2018 GERD management • Non pharmacologic • Thickened feedings • Modification of feeding volumes/intervals • Discuss overfeeding! • Infants: Milk elimination, extensively hydrolyzed formula, AA formulas • Children: discuss excessive body weight, foods that may exacerbate reflux (tomato, spicy, chocolate, citrus, peppermint) • No evidence: • Massage therapy, hypnotherapy, homeopathy, acupuncture, herbal medicine, dietary supplementation, pre- and pro-biotics Medications for GERD • Histamine-2 Receptor Antagonist • Proton pump inhibitor • Prokinetics • Antacids Histamine-2 Receptor Antagonist • Ranitidine • Tachyphylaxis • 5-10 mg/kg/day (max 300mg) • Many drug interactions • Cimetidine • cytochrome P450 • 30-40 mg/kg/day (max 800mg) • Interfere with absorption • Nizatidine • Inhibit Renal excretion • 10-20 mg/kg/day (max 300mg) • CNS • Famotidine • Confusion • 1 mg/kg/day (max 40mg) • Headache • depression • Hematologic • thrombocytopenia • CV • Related to IV administration Proton Pump Inhibitors • Omeprazole • Changes in gastric mucosa • 1-4 mg/kg/day (max 40 mg) • ↑risk of GI and respiratory infxns • Lansoprazole • Vit B12 def • 2 mg/kg/day infants (max 30 mg) • ↓Mg • Esomeprazole • 10 mg/day (< 20kg) • ↑risk of fractures • 20 mg/day (>20 kg) • Rebound hyperacidity • Pantoprazole • ↑gastric microbiota • 1-2 mg/kg/day (max 40 mg) • headache • ?CV • ?renal • ?neuro Prokinetics • Metoclopramide • AE: Neurologic • Extrapyramidal, dyskinesia, dystonia, seizures, hypertonia, tremor • AE: Cardiac • Shock, hypotension, cardiac arrest, tachycardia, bradycardia, hypertension, cardiorespiratory arrest, circulatory collapse • tachyphylaxis • Domperidone • NOT FDA approved in US • AE: Cardiac toxicity • Baclofen • AE: Muscle weakness, somnolence, muscle weakness, nausea, paresthesia Miscellaneous medications • Antacids and aglinates • Neutralize acid • Sodium/potassium bicarbonate, or Al, Mg or Ca salts • Mg alginate, sodium alginate, Ca carbonate, Al hydroxide • Unclear benefit • AE: milk alkali syndrome (↑Ca, alkalosis, renal failure), ↑serum Al • Sucralfate • Site protective agent • AE: Al toxicity, intraluminal drug binding, drug interactions • Bethanechol • Cholinergic used for urinary retention • AE: flushing, hypotension, tachycardia, colic, bronchoconstriction… When to use medicines for GERD? • Erosive esophagitis PPI 1st line • Crying/distress in infants • Regurgitation in infants • Children with symptomatic GERD (heartburn, etc) 4-8 wks H2RAs or PPI • Extraesophageal sxs (cough, asthma, wheezing) • Other medications? Rosen et al. 2018 Eosinophilic Esophagitis • Chronic condition • Immune mediated • 1 in 10,000 people • Clinically can be very similar to GERD Eosinophilic Esophagitis • Often mistaken for GERD • Vomiting, regurgitation, chest pain, dysphagia, food impactions • Needs EGD to differentiate • > 15 eos/HPF in ≥ 1 biopsy specimen • Management • Non-pharmacologic • Elimination diet • Pharmacologic • Steroids (topical and systemic) • Response to therapy • EGD!! Eosinophilic esophagitis Uptodategastro.wordpress.com University of Chicago EoE non-pharmacologic management • Multi-disciplinary approach • GI • A/I • RD • PCP • Elimination diet • 4 food/6 food • Milk, wheat, egg, soy • +/- nuts and seafood • Intact protein elimination • AA formula • May need feeding tube (NG/GT) EoE medications • Swallowed, topical corticosteroids • OVB • Budesonide slurry Nothing to eat/drink x 20 mins • Fluticasone • PPI? • AE: thrush, incorrect administration, steroid SE • Systemic steroids • Rarely required • AE: many Constipation • Common in children • 3% PCP visits • 25% Pediatric GI visits ©2019 the Awkward Store Constipation • Infrequent and/or painful bowel movements • fecal incontinence • abdominal pain • Can significantly impact quality of life and health care costs • Vast majority of children no underlying medical disease found Rome III diagnostic criteria • Need ≥ 2 in absence of organic pathology: • ≤ 2 bowel movements in the toilet per week • 1 episode fecal incontinence per week • History of excessive stool retention or retentive posturing • History of painful or hard bowel movements • Presence of large fecal mass in rectum • History or large diameter stools that may obstruct the toilet • Developmental age <4y sxs present at least 1 month • DA ≥4y, sxs present at least 2 months Hymen et al 2006 and Rasquin et al 2006 Constipation DDxs • Celiac • Anal achalasia • Hypothyroid • Colonic inertia • Electrolyte abnormalities • Anorectal malformations • Dietary protein allergy • Pelvic mass • Medications/toxins • Spinal cord anomalies • Vitamin D intoxication • Abnormal abdominal musculature • Botulism • Pseudoobstruction • Cystic fibrosis • Multiple endocrine neoplasia type • Hirschsprung disease 2B • Behavioral/anxiety Alarm signs • Onset <1 mo • Perianal fistula • Passage of meconium >48 hours • Abnormal position of anus • Family h/o HD • Absent anal or cremasteric reflex • Ribbon stools • Decreased LE strength/tone/reflex • Blood in stools (absence of anal • Tuft of hair on spine fissure) • Sacral dimple • FTT • Gluteal cleft deviation • Bilious emesis • Extreme
Recommended publications
  • What Are the Acute Treatments for Migraine and How Are They Used?
    2. Acute Treatment CQ II-2-1 What are the acute treatments for migraine and how are they used? Recommendation The mainstay of acute treatment for migraine is pharmacotherapy. The drugs used include (1) acetaminophen, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans and (5) antiemetics. Stratified treatment according to the severity of migraine is recommended: use NSAIDs such as aspirin and naproxen for mild to moderate headache, and use triptans for moderate to severe headache, or even mild to moderate headache when NSAIDs were ineffective in the past. It is necessary to give guidance and cautions to patients having acute attacks, and explain the methods of using medications (timing, dose, frequency of use) and medication use during pregnancy and breast-feeding. Grade A Background and Objective The objective of acute treatment is to resolve the migraine attack completely and rapidly and restore the patient’s normal functions. An ideal treatment should have the following characteristics: (1) resolves pain and associated symptoms rapidly; (2) is consistently effective; (3) no recurrence; (4) no need for additional use of medication; (5) no adverse effects; (6) can be administered by the patients themselves; and (7) low cost. Literature was searched to identify acute treatments that satisfy the above conditions. Comments and Evidence The acute treatment drugs for migraine generally include (1) acetaminophens, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans, and (5) antiemetics. For severe migraines including status migrainosus and migraine attacks refractory to treatment, (6) anesthetics, and (7) corticosteroids (dexamethasone) are used (Tables 1 and 2).1)-9) There are two approaches to the selection and sequencing of these medications: “step care” and “stratified care”.
    [Show full text]
  • Drugs That Can Cause Delirium (Anticholinergic / Toxic Metabolites)
    Drugs that can Cause Delirium (anticholinergic / toxic metabolites) Deliriants (drugs causing delirium) Prescription drugs . Central acting agents – Sedative hypnotics (e.g., benzodiazepines) – Anticonvulsants (e.g., barbiturates) – Antiparkinsonian agents (e.g., benztropine, trihexyphenidyl) . Analgesics – Narcotics (NB. meperidine*) – Non-steroidal anti-inflammatory drugs* . Antihistamines (first generation, e.g., hydroxyzine) . Gastrointestinal agents – Antispasmodics – H2-blockers* . Antinauseants – Scopolamine – Dimenhydrinate . Antibiotics – Fluoroquinolones* . Psychotropic medications – Tricyclic antidepressants – Lithium* . Cardiac medications – Antiarrhythmics – Digitalis* – Antihypertensives (b-blockers, methyldopa) . Miscellaneous – Skeletal muscle relaxants – Steroids Over the counter medications and complementary/alternative medications . Antihistamines (NB. first generation) – diphenhydramine, chlorpheniramine). Antinauseants – dimenhydrinate, scopolamine . Liquid medications containing alcohol . Mandrake . Henbane . Jimson weed . Atropa belladonna extract * Requires adjustment in renal impairment. From: K Alagiakrishnan, C A Wiens. (2004). An approach to drug induced delirium in the elderly. Postgrad Med J, 80, 388–393. Delirium in the Older Person: A Medical Emergency. Island Health www.viha.ca/mhas/resources/delirium/ Drugs that can cause delirium. Reviewed: 8-2014 Some commonly used medications with moderate to high anticholinergic properties and alternative suggestions Type of medication Alternatives with less deliriogenic
    [Show full text]
  • Cabergoline Patient Handout
    Cabergoline For the Patient: Cabergoline Other names: DOSTINEX® • Cabergoline (ca-BERG-go-leen) is used to treat cancers that cause the body to produce too much of a hormone called prolactin. Cabergoline helps decrease the size of the cancer and the production of prolactin. It is a tablet that you take by mouth. • Tell your doctor if you have ever had an unusual or allergic reaction to bromocriptine or other ergot derivatives, such as pergoline (PERMAX®) and methysergide (SANSERT®), before taking cabergoline. • Blood tests and blood pressure measurement may be taken while you are taking cabergoline. The dose of cabergoline may be changed based on the test results and/or other side effects. • It is important to take cabergoline exactly as directed by your doctor. Make sure you understand the directions. Take cabergoline with food. • If you miss a dose of cabergoline, take it as soon as you can if it is within 2 days of the missed dose. If it is over 2 days since your missed dose, skip the missed dose and go back to your usual dosing times. • Other drugs such as azithromycin (ZITHROMAX®), clarithromycin (BIAXIN®), erythromycin, domperidone, metoclopramide, and some drugs used to treat mental or mood problems may interact with cabergoline. Tell your doctor if you are taking these or any other drugs as you may need extra blood tests or your dose may need to be changed. Check with your doctor or pharmacist before you start or stop taking any other drugs. • The drinking of alcohol (in small amounts) does not appear to affect the safety or usefulness of cabergoline.
    [Show full text]
  • PRESCRIBED DRUGS and NEUROLOGICAL COMPLICATIONS K a Grosset, D G Grosset Iii2
    J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp.2004.045757 on 16 August 2004. Downloaded from PRESCRIBED DRUGS AND NEUROLOGICAL COMPLICATIONS K A Grosset, D G Grosset iii2 J Neurol Neurosurg Psychiatry 2004;75(Suppl III):iii2–iii8. doi: 10.1136/jnnp.2004.045757 treatment history is a fundamental part of the healthcare consultation. Current drugs (prescribed, over the counter, herbal remedies, drugs of misuse) and how they are taken A(frequency, timing, missed and extra doses), drugs tried previously and reason for discontinuation, treatment response, adverse effects, allergies, and intolerances should be taken into account. Recent immunisations may also be of importance. This article examines the particular relevance of medication in patients presenting with neurological symptoms. Drugs and their interactions may contribute in part or fully to the neurological syndrome, and treatment response may assist diagnostically or in future management plans. Knowledge of medicine taking behaviour may clarify clinical presentations such as analgesic overuse causing chronic daily headache, or severe dyskinesia resulting from obsessive use of dopamine replacement treatment. In most cases, iatrogenic symptoms are best managed by withdrawal of the offending drug. Indirect mechanisms whereby drugs could cause neurological problems are beyond the scope of the current article—for example, drugs which raise blood pressure or which worsen glycaemic control and consequently increase the risk of cerebrovascular disease, or immunosupressants
    [Show full text]
  • NEUROPHARMACOLOGICAL COMPARISON BETWEEN DOMPERIDONE and METOCLOPRAMIDE Abstract-Domperidone, a New Gastrokinetic with Potent
    In in vitro binding assays, domperidone In in vitro experiments on the isolated was found to be a potent and specific guinea-pig stomach, domperidone selectively dopamine antagonist, but ex vivo and in vivo NEUROPHARMACOLOGICAL COMPARISON BETWEEN DOMPERIDONE AND METOCLOPRAMIDE A. WAUQUIER, C.J.E. NIEMEGEERS and P.A.J. JANSSEN Department of Pharmacology, Janssen Pharmaceutica , B-2340 Beerse, Belgium Accepted October 17, 1980 Abstract-Domperidone, a new gastrokinetic with potent antiemetic properties is devoid of central effects, up to high dose levels. To assess the CNS activity of domperidone and metoclopramide, the inhibition of intracranial self-stimulation (ICS) in two different situations, and the influence on EEG in dogs were studied. The dissociation between the antiemetic and central effects of both compounds were evaluated in dogs given a stereotypogenic dose of apomorphine. A significant and dose related inhibition of ICS (conditioned situation) was obtained with 0.8 and 1.6 mg/kg i.v. domperidone and with 0.125, 0.25 and 0.50 mg/kg i.v. metoclopramide. The ED50 values were 0.79 mg/kg and 0.25 mg/kg respectively. The effect was most pronounced 4 hr after administration with domperidone and 15 min after administration with metoclopramide. In the EEG studies, no specific structure-related effects were found but the total potency was increased with domperidone 0.8 and 1.6 mg/kg i.v. and with metoclopramide 0.063, 0.125, 0.25 and 0.50 mg/kg i.v. This increase was due to a decrease in fast frequencies, an increase of slower frequencies and a slight increase of the amplitude.
    [Show full text]
  • Domperidone Packet
    Domperidone IND Packet For Sponsors Treating Patients with Gastrointestinal Disorders Last Updated February 2, 2021 Page 1 1. Domperidone Background ...................................................................................................................................................... 3 2. Obtaining an IND..................................................................................................................................................................... 3 3. Application Process ................................................................................................................................................................. 3 Single Patient IND (SPI) .............................................................................................................................................................. 4 Intermediate Size Patient Population (multi-patient) IND ........................................................................................................... 4 4. Regulatory Responsibilities as a Sponsor ............................................................................................................................... 5 5. Ordering Domperidone........................................................................................................................................................... 5 6. Financial Responsibility .........................................................................................................................................................
    [Show full text]
  • Endoscopic Treatment of Pharmacobezoar Caused by Slow-Release Clomipramine and Quetiapine Overdose
    Netherlands Journal of Critical Care Submitted August 2020; Accepted January 2021 CASE REPORT Endoscopic treatment of pharmacobezoar caused by slow-release clomipramine and quetiapine overdose S.J.P. Hiel1, A. Osinski1, J.T. Kamphuis2 1Department of Intensive Care, 2Department of Gastroenterology, Maxima Medical Center, Veldhoven, the Netherlands Correspondence S.J.P. Hiel - [email protected] Keywords - slow-release clomipramine, intoxication, pharmacobezoar, endoscopy Abstract Case report A pharmacobezoar is a rare entity characterised by an An 18-year-old female known with chronic depression was accumulation of undigested pills in the gastrointestinal tract. admitted to our hospital approximately two hours after taking It is often induced by massive drug consumption, especially an overdose of tablets. She supposedly ingested 50 tablets of slow-release tablets. We describe an 18-year-old female with slow-release clomipramine 75 mg (3.75 g total) and 100 tablets a pharmacobezoar after taking an overdose of slow-release of slow-release quetiapine 25 mg (2.5 g total). She was found clomipramine and slow-release quetiapine. Because of a in a state of reduced responsiveness by her mother who called decline in her level of consciousness, she was intubated. As the emergency services. standard treatment with activated charcoal, gastric lavage On examination at the emergency department, a very thin and laxatives was insufficiently effective, it was decided patient with a body weight of 50 kg (body mass index of 17.3 to remove the tablets endoscopically. The patient did not kg/m2) was seen. Glasgow coma scale (GCS) was E3-M5-V3. have any post-procedural complications and showed a full Her pupils were slightly, equally dilated and responsive to recovery.
    [Show full text]
  • Therapy and Symptom Management in CFS/ME
    British Association for CFS/ME: Therapy and Symptom Management in CFS/ME Aim This guide was developed through the British Association of CFS/ME (BACME), an organisation that represents health professionals working with this condition. It aims to provide information to support clinicians in their work with CFS/ME and includes both pharmacological and rehabilitative approaches. It has been developed by a group of experienced professionals both in a specially convened open workshop, held in 2014, and through circulation and consultation with the wider BACME membership, AYME (Action for Young people with ME) and service -users. This document is compiled of two major sections. These two sections are: 1. Symptom management guide. This provides information about symptoms experienced by people with CFS/ME, and if pharmacological therapy can ease these symptoms. Information on contra-indications and cautions to consider is also provided for these pharmacological treatments. 2. Guidance for therapists covering the provision of therapy for CFS/ME. This includes a list of resources (available on the website BACME.org.uk) for use in therapy, as well as guidance on support and supervision. It does not replace specialist CBT and GET training (recommended by NICE and available at www.PACEtrial.org). It represents pragmatic recommendations from experienced clinicians to guide practice when seeing adults with CFS/ME, where specialist CFS/ME CBT and GET therapists are not available/appropriate. It is informed by these approaches. The term CFS/ME has been applied throughout this guide as it is the current term used in NHS services. Other terminology may be used by some clinicians, therapists and service users A Brief History of CFS/ME services within NHS In May 2003, it was announced that a central budget of £8.5 million would be released to the NHS in two phases to allow stepped development of CFS/ ME services in England.
    [Show full text]
  • Prescriber Update Vol.36 No.1 March 2015
    Prescriber Update Vol. 36 No. 1 March 2015 www.medsafe.govt.nz ISSN 1172-5648 (print) ISSN 1179-075X (online) Contents A Topical Issue – Serious Hypersensitivity and Burning Reactions 2 Atomoxetine and Raynaud’s Phenomenon 3 Check INR after Starting Roxithromycin for Patients on Warfarin 3 Fruit Interactions with Common Medicines 4 Sexual Dysfunction Associated with Antidepressants and Antipsychotics 5 Rotavirus Vaccination – Summary of Adverse Event Reports Received in the First Six Months of Funding 8 MARC’s Remarks: December 2014 Meeting 8 Risk of Stroke with Ranibizumab (Lucentis), Bevacizumab (Avastin) and Aflibercept (Eylea), Administered by Intravitreal Injection 9 Medicine Labels – Rubbing Salt into the Wound 10 Domperidone – At the Heart of the Matter 10 Adverse Reaction Reporting in New Zealand – 2014 12 Spontaneous Reports: Seasonal Influenza Vaccination 2014 13 MEDICINES MONITORING 13 Preventing Paediatric Medication Errors 14 A Topical Issue — Serious Hypersensitivity and Burning Reactions There have been reports internationally Key Messages of chemical skin burns in premature neonates who were treated with chlorhexidine solution z Serious hypersensitivity reactions before central venous catheterisation3. This risk including anaphylaxis have been reported has been associated with both alcohol-based and following the use of topical acne products water-based solutions. that contain benzoyl peroxide or salicylic acid. According to these reports and the published literature, the risk appears to be higher z There is a risk of chemical skin burns with in premature neonates, especially those born the use of chlorhexidine solution for skin before 32 weeks of gestation and within the first disinfection in premature neonates. two weeks of life.
    [Show full text]
  • OUH Formulary Approved for Use in Breast Surgery
    Oxford University Hospitals NHS Foundation Trust Formulary FORMULARY (Y): the medicine can be used as per its licence. RESTRICTED FORMULARY (R): the medicine can be used as per the agreed restriction. NON-FORMULARY (NF): the medicine is not on the formulary and should not be used unless exceptional approval has been obtained from MMTC. UNLICENSED MEDICINE – RESTRICTED FORMULARY (UNR): the medicine is unlicensed and can be used as per the agreed restriction. SPECIAL MEDICINE – RESTRICTED FORMULARY (SR): the medicine is a “special” (unlicensed) and can be used as per the agreed restriction. EXTEMPORANEOUS PREPARATION – RESTRICTED FORMULARY (EXTR): the extemporaneous preparation (unlicensed) can be prepared and used as per the agreed restriction. UNLICENSED MEDICINE – NON-FORMULARY (UNNF): the medicine is unlicensed and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. SPECIAL MEDICINE – NON-FORMULARY (SNF): the medicine is a “special” (unlicensed) and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. EXTEMPORANEOUS PREPARATION – NON-FORMULARY (EXTNF): the extemporaneous preparation (unlicensed) cannot be prepared and used unless exceptional approval has been obtained from MMTC. CLINICAL TRIALS (C): the medicine is clinical trial material and is not for clinical use. NICE TECHNOLOGY APPRAISAL (NICETA): the medicine has received a positive appraisal from NICE. It will be available on the formulary from the day the Technology Appraisal is published. Prescribers who wish to treat patients who meet NICE criteria, will have access to these medicines from this date. However, these medicines will not be part of routine practice until a NICE TA Implementation Plan has been presented and approved by MMTC (when the drug will be given a Restricted formulary status).
    [Show full text]
  • Proposal for the Inclusion of Anti-Emetic Medications (For Children) in the Who Model List of Essential Medicines
    Second Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines Geneva, 29 September to 3 October 2008 PROPOSAL FOR THE INCLUSION OF ANTI-EMETIC MEDICATIONS (FOR CHILDREN) IN THE WHO MODEL LIST OF ESSENTIAL MEDICINES REPORT Marc Bevan, Elizabeth Seil, Robin Bell and Jane Robertson Discipline of Clinical Pharmacology School of Medicine and Public Health Faculty of Health University of Newcastle Level 5, Clinical Sciences Building, NM2 Calvary Mater Hospital Edith Street, Waratah, 2298 New South Wales AUSTRALIA Tel +61-02-49211726 Fax + 61-02-49602088 WHO EML – anti-emetics – June 2008 1. Summary statement of the proposal Anti-emetic medications (anti-histamines, dopamine antagonists and serotonin 5-HT3 antagonists) are proposed for inclusion in the World Health Organization (WHO) Model List of Essential Medicines for the management of acute gastroenteritis in children. 2. Name of focal point in WHO submitting or supporting the application 3. Name of the organisation preparing the application Discipline of Clinical Pharmacology, School of Medicine and Public Health, Faculty of Health, University of Newcastle, Level 5, Clinical Sciences Building, NM2, Calvary Mater Hospital, Edith Street, Waratah, 2298, New South Wales, Australia. 4. International Nonpropriety Name (INN, generic name) of the medicine The proposal reviews relevant data regarding four anti-emetic medications; metoclopramide and domperidone (dopamine agonists), promethazine (anti- histamine) and ondansetron (serotonin 5-HT3 antagonist). 5. Formulation considered for inclusion The formulations of metoclopramide, domperidone, promethazine and ondansetron considered for inclusion are shown in Table 1. Table 1: Formulations of ant-emetic medications considered for inclusion Formulation Comment Metoclopramide Injection or oral - Injection, tablet and oral liquid formulations are preparation (tablet, currently listed on WHO EML for children.
    [Show full text]
  • RP-HPLC Method for Determination of Several Nsaids and Their Combination Drugs
    Hindawi Publishing Corporation Chromatography Research International Volume 2013, Article ID 242868, 13 pages http://dx.doi.org/10.1155/2013/242868 Research Article RP-HPLC Method for Determination of Several NSAIDs and Their Combination Drugs Prinesh N. Patel, Gananadhamu Samanthula, Vishalkumar Shrigod, Sudipkumar C. Modh, and Jainishkumar R. Chaudhari Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Balanagar, Hyderabad, Andhra Pradesh 500037, India Correspondence should be addressed to Gananadhamu Samanthula; [email protected] Received 29 June 2013; Accepted 13 October 2013 Academic Editor: Andrew Shalliker Copyright © 2013 Prinesh N. Patel et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. An RP-HPLC method for simultaneous determination of 9 NSAIDs (paracetamol, salicylic acid, ibuprofen, naproxen, aceclofenac, diclofenac, ketorolac, etoricoxib, and aspirin) and their commonly prescribed combination drugs (thiocolchicoside, moxifloxacin, clopidogrel, chlorpheniramine maleate, dextromethorphan, and domperidone) was established. The separation was performed on ∘ Kromasil C18 (250 × 4.6 mm, 5 m) at 35 C using 15 mM phosphate buffer pH 3.25 and acetonitrile with gradient elution ata flow rate of 1.1 mL/min. The detection was performed by a diode array detector (DAD) at 230 nm with total run time of 30min. 2 Calibration curves were linear with correlation coefficients of determinationr ( ) > 0.999. Limit of detection (LOD) and Limit of quantification (LOQ) ranged from 0.04 to 0.97 g/mL and from 0.64 to 3.24 g/mL, respectively.
    [Show full text]