DOCSLIB.ORG

Triptans: Almotriptan, Amerge®, Axert®, Frova®, Imitrex® and Sumatriptan Tablets/Nasal Spray/Injection, Maxalt/MLT®, Naratriptan, Onzetra™

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Triptans: Almotriptan, Amerge®, Axert®, Frova®, Imitrex® and Sumatriptan Tablets/Nasal Spray/Injection, Maxalt/MLT®, Naratriptan, Onzetra™ Drug Therapy Guidelines Triptans: almotriptan, Amerge®, Axert®, Frova®, Imitrex® and sumatriptan tablets/nasal spray/injection, Maxalt/MLT®, naratriptan, Onzetra™ Xsail™, Relpax® and eletriptan tablets, rizatriptan/ODT, Sumavel®, Tosymra™, Treximet®, Zembrace™ SymTouch™, zolmitriptan/ODT tablets, Applicable Zomig/ZMT® tablets/nasal spray Medical Benefit Effective: 5/28/2021 Pharmacy- Formulary 1 x Next Review: 3/22 Pharmacy- Formulary 2 x Date of Origin: 8/29/06 Pharmacy- Formulary 3/Exclusive x Review Dates: 8/06, 11/07, 12/08, 12/09, 6/10, 3/11, 3/12, 3/13, Pharmacy- Formulary 4/AON x 3/14, 3/15, 3/16, 3/17, 3/18, 3/19, 3/20, 2/21, 3/21 I. Medication Description Serotonin receptor agonists are used to treat (not prevent) acute attacks of migraine headaches. These medications work by binding to specific serotonin receptors in the brain which in turn decreases the release of chemicals responsible for the vasodilation of cerebral blood vessels, decreases the activity of pain signaling neurons, and reduces inflammation. II. Position Statement For all lines of business, coverage is provided immediately, without requiring prior authorization, for preferred/formulary medications with associated quantity limit restrictions. Quantity limitations criteria do not apply when the medication is requested by a neurologist. Coverage is determined through a prior authorization process with supporting clinical evidence for all other requests for members aged 18 and older. III. Policy Formulary 1: See Sections B and C Formulary 2: See Sections A and C Formulary 3/Exclusive: See Sections A and C Formulary 4/AON: See Sections A and C A. Non-preferred medications: Amerge, Axert, Frova, Imitrex, Maxalt, Onzetra, Relpax, Tosymra, Treximet, Zembrace, Zomig, Zolmitriptan nasal spray Plan-preferred medications: eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan tablets, zolmitriptan oral disintegrating tablets B. Non-preferred medications: Amerge, Axert, Frova, Imitrex, Maxalt, Onzetra, Relpax, Tosymra, Zembrace, Zomig, Zolmitriptan nasal spray Plan-preferred medications: eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan tablets, zolmitriptan oral disintegrating tablets C. Coverage will be provided as follows: Page 1 of 5 Drug Therapy Guidelines Triptans Last Review Date: 3/2021 When requesting coverage of a brand medication for which a plan-preferred A/B rated generic is available, coverage will be provided when there is sufficient evidence that the use of the A/B rated generic equivalent has resulted in inadequate results AND Coverage of any non-preferred medication will be provided when the patient has experienced intolerance or therapeutic failure with at least one plan-preferred medication first OR when at least ONE of the following criteria is met: o The plan-preferred medications are contraindicated or will likely cause an adverse reaction by or physical or mental harm to the member. o The plan-preferred medications are expected to be ineffective based on the known clinical history and conditions of the member and the member’s prescription drug regimen. o The member has tried the plan-preferred medications or another prescription drug in the same pharmacologic class or with the same mechanism of action and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event. o The member is stable on the medication selected by their healthcare professional for the medical condition under consideration (where “stable” is defined as receiving the medication for an adequate period of time, have achieved optimal response, and continued favorable outcomes are expected UNLESS the medication was initially selected due to the availability of a drug sample or a coupon card). o The plan-preferred medication is not in the best interest of the member because it will likely cause a significant barrier to the member’s adherence or to compliance with the member’s plan of care, will likely worsen a comorbid condition of the member, or will likely decrease the member’s ability to achieve or maintain reasonable functional ability in performing daily activities. IV. Quantity Limitations Medication Covered per 30 days Covered per 90 days Imitrex/sumatriptan 25mg, 50mg tablets 18 36 100mg tablets 9 27 4mg injection doses 12 36 6mg injection doses 8 24 Nasal spray 5mg or 20mg 12 24 Sumavel 4mg injection 12 36 Sumavel 6mg injection 8 24 Tosymra 10mg Nasal spray 12 36 Treximet 9 27 Axert/almotriptan 6.25mg tablets 12 36 12.5mg tablets 8 24 Relpax/eletriptan 20mg tablets 12 36 40mg tablets 8 24 Page 2 of 5 Drug Therapy Guidelines Triptans Last Review Date: 3/2021 Frova 2.5mg tablets 12 36 Amerge/naratriptan 1mg tablets 12 36 2.5mg tablets 9 27 Maxalt/Maxalt MLT/rizatriptan 5mg, 10mg tablets 12 36 Zomig/Zomig ZMT/zolmitriptan 2.5mg tablets 12 36 5mg tablets 8 24 Nasal spray 12 24 Zembrace Symtouch (per dose) 8 24 Onzetra Xsail (per dose) 8 24 Coverage for a greater quantity of triptans is determined through a prior authorization process with the following criteria: o Medication must be prescribed by (or in consultation with) a neurologist OR o When prescribed by other providers: . Member must be experiencing a greater number of headaches per month than what the general covered quantity can treat AND . Member must be receiving preventative therapy for migraine headaches. VI. Coverage Duration Coverage is approved indefinitely for the life of this policy once coverage criteria are met for non-preferred medications. Duration of coverage for increased quantities will be limited to 12 months. VII. Coverage Renewal Criteria n/a X. Billing/Coding Information Please see individual prescribing information for products. XII. Summary of Policy Changes 6/1/11: Addition of naratriptan (generic Amerge) to the preferred medications in this class; Removal of Maxalt/Maxalt MLT from preferred products; Clarification of coverage of Axert in treatment of migraine in adolescent members (12 to 17 years); Change in quantity limit for naratriptan to 9 tablets/30 days, 27 tablets/90 days to reflect packaging in units of 9 tablets. 11/2011: Sumavel no longer targeted medication, quantity limits remain in place 6/15/12: addition of Alsuma to policy, extended authorization duration 6/15/13: rizatriptan/rizatriptan ODT and Zecuity added to policy; Typo re: quantity of Sumavel covered per month fixed; Brands with available generics are now non-preferred Page 3 of 5 Drug Therapy Guidelines Triptans Last Review Date: 3/2021 6/2013: added zolmitriptan/ODT to policy 5/14/14: zolmitriptan and rizatriptan considered preferred for both Exchange and Commercial 6/15/14: simplified increased quantity coverage criteria; clarified quantity limits via mail order 6/15/15: no policy changes 7/1/15: formulary distinctions made 5/16/16: Zembrace quantity limits added 5/26/16: Onzetra quantity limits added 6/10/16: Onzetra considered non-preferred 6/15/16: no policy changes 6/16/16: Zembrace considered non-preferred 4/5/17: removed Zecuity due to no availability 5/1/17: step therapy criteria added 8/21/17: addition of eletriptan to preferred medications; removal of Relpax from preferred medications 9/20/17: updated duration of coverage for increased quantities 1/31/18: updated criteria concerning requests from neurologists 5/1/18: removed Alsuma as product is off-market 5/15/19: added Tosymra to policy; updated quantity limitations 5/1/20: no policy changes 2/5/21: moved zolmitriptan nasal spray to non-preferred 2/10/21: formulary distinctions made 5/28/21: no policy changes XIII. References 1. Clinical Pharmacology (search for various serotonin receptor agonists). Accessed 1/2021. 2. Comparison of available triptans. Pharmacist’s Letter/Prescriber’s Letter 2009; May 2009. 3. Product Information: Sumatriptan/naproxen (Treximet® – GlaxoSmithKline). Revised 5/2016. 4. Product Information: Naratriptan (Amerge® - GlaxoSmithKline). Revised 12/2016. 5. Product Information: Rizatriptan (Maxalt®, Maxalt-MLT® - Merck). Revised 3/2015. 6. Product Information: Sumatriptan nasal spray (Imitrex® NS –GlaxoSmithKline). Revised 12/2017. 7. Product Information: Sumatriptan tablets (Imitrex® - GlaxoSmithKline). Revised 12/2017. 8. Product Information: Sumatriptan injection (Imitrex® Injection -GlaxoSmithKline). Revised 12/2017. 9. Product Information: Zolmitriptan tablets (Zomig®, Zomig-ZMT®- IMPAX). Revised September 2012. 10. Product Information: Zolmitriptan nasal spray (Zomig® Nasal Spray – IMPAX). Revised 11/2016. 11. Product Information: Almotriptan (Axert®– Janssen). Revised 5/2017. 12. Product Information: Frovatriptan (Frova®– Endo). Revised 8/2018. 13. Product Information: Eletriptan (Relpax®- Pfizer). Revised 11/2013. 14. Product Information: sumatriptan iontophoretic transdermal system (Zecuity® - NuPath Inc). Revised 2/2016. 15. Product Information: sumatriptan injection (Sumavel® DosePro® - Endo). Revised 6/2016. 16. Product information: sumatriptan injection (Alsuma® - Pfizer). Revised 4/2014. 17. Product Information: OnzetraTM XsailTM. Revised 1/2016. 18. Product Information: ZembraceTM SymTouchTM. Revised 1/2016. 19. Dowson A. Eur Neurol 1996;36(suppl 2):28-31 20. Eur Neurol 1996;32(suppl 2):24-7 Page 4 of 5 Drug Therapy Guidelines Triptans Last Review Date: 3/2021 21. Fletcher PE, et al. Headache Treatment: Trial Methodology and New Drugs. Lippincott-Raven Publishers, 1997 22. Lipton RB et al. Prevalence and Burden of Migraine in the United States: Data from the American Migraine Study
Load more

Recommended publications
  • ERJ-01090-2018.Supplement
    Shaheen et al Online data supplement Prescribed analgesics in pregnancy and risk of childhood asthma Seif O Shaheen, Cecilia Lundholm, Bronwyn K Brew, Catarina Almqvist. 1 Shaheen et al Figure E1: Data available for analysis Footnote: Numbers refer to adjusted analyses (complete data on covariates) 2 Shaheen et al Table E1. Three classes of analgesics included in the analyses ATC codes Generic drug name Opioids N02AA59 Codeine, combinations excluding psycholeptics N02AA79 Codeine, combinations with psycholeptics N02AA08 Dihydrocodeine N02AA58 Dihydrocodeine, combinations N02AC04 Dextropropoxyphene N02AC54 Dextropropoxyphene, combinations excluding psycholeptics N02AX02 Tramadol Anti-migraine N02CA01 Dihydroergotamine N02CA02 Ergotamine N02CA04 Methysergide N02CA07 Lisuride N02CA51 Dihydroergotamine, combinations N02CA52 Ergotamine, combinations excluding psycholeptics N02CA72 Ergotamine, combinations with psycholeptics N02CC01 Sumatriptan N02CC02 Naratriptan N02CC03 Zolmitriptan N02CC04 Rizatriptan N02CC05 Almotriptan N02CC06 Eletriptan N02CC07 Frovatriptan N02CX01 Pizotifen N02CX02 Clonidine N02CX03 Iprazochrome N02CX05 Dimetotiazine N02CX06 Oxetorone N02CB01 Flumedroxone Paracetamol N02BE01 Paracetamol N02BE51 Paracetamol, combinations excluding psycholeptics N02BE71 Paracetamol, combinations with psycholeptics 3 Shaheen et al Table E2. Frequency of analgesic classes prescribed to the mother during pregnancy Opioids Anti- Paracetamol N % migraine No No No 459,690 93.2 No No Yes 9,091 1.8 Yes No No 15,405 3.1 No Yes No 2,343 0.5 Yes No
    [Show full text]
  • Antimigraine Agents, Triptans Review 07/21/2008
    Antimigraine Agents, Triptans Review 07/21/2008 Copyright © 2004 - 2008 by Provider Synergies, L.L.C. All rights reserved. Printed in the United States of America. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage and retrieval system without the express written consent of Provider Synergies, L.L.C. All requests for permission should be mailed to: Attention: Copyright Administrator Intellectual Property Department Provider Synergies, L.L.C. 5181 Natorp Blvd., Suite 205 Mason, Ohio 45040 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended
    [Show full text]
  • Frovatriptan Versus Zolmitriptan for the Acute Treatment of Migraine: a Double-Blind, Randomized, Multicenter, Italian Study
    Neurol Sci (2010) 31 (Suppl 1):S51–S54 DOI 10.1007/s10072-010-0273-x SYMPOSIUM: NEWS IN TREATMENT OF MIGRAINE ATTACK Frovatriptan versus zolmitriptan for the acute treatment of migraine: a double-blind, randomized, multicenter, Italian study Vincenzo Tullo • Gianni Allais • Michel D. Ferrari • Marcella Curone • Eliana Mea • Stefano Omboni • Chiara Benedetto • Dario Zava • Gennaro Bussone Ó The Author(s) 2010. This article is published with open access at Springerlink.com Abstract The objective of this study is to assess patients’ of PF episodes at 2 h was 26% with F and 31% with Z satisfaction with migraine treatment with frovatriptan (F) (p = NS). PR episodes at 2 h were 57% for F and 58% for or zolmitriptan (Z), by preference questionnaire. 133 sub- Z(p = NS). Rate of recurrence was 21 (F) and 24% jects with a history of migraine with or without aura (IHS (Z; p = NS). Time to recurrence within 48 h was better for criteria) were randomized to F 2.5 mg or Z 2.5 mg. The F especially between 4 and 16 h (p \ 0.05). SPF episodes study had a multicenter, randomized, double-blind, cross- were 18 (F) versus 22% (Z; p = NS). Drug-related adverse over design, with each of the two treatment periods lasting events were significantly (p \ 0.05) less under F (3 vs. 10). no more than 3 months. At the end of the study, patients In conclusion, our study suggests that F has a similar were asked to assign preference to one of the treatments efficacy of Z, with some advantage as regards tolerability (primary endpoint).
    [Show full text]
  • APPENDIX a Scoping Letter, NOP, and NOP Comments
    APPENDIX A Scoping Letter, NOP, and NOP Comments THE CITY OF SAN DIEGO PLANNING DEPARTMENT Date of Notice: November 24, 2014 PUBLIC NOTICE OF THE PREPARATION OF A PROGRAM ENVIRONMENTAL IMPACT REPORT AND A SCOPING MEETING INTERNAL ORDER No. 21003411 PUBLIC NOTICE: The City of San Diego as the Lead Agency has determined that the project described below will require the preparation of a Program Environmental Impact Report (PEIR) in compliance with the California Environmental Quality Act (CEQA). This Notice of Preparation of a PEIR and Scoping Meeting was publicly noticed and distributed on November 24, 2014. This notice was published in the SAN DIEGO DAILY TRANSCRIPT and placed on the City of San Diego website at: http://www.sandiego.gov/city-clerk/officialdocs/notices/index.shtml SCOPING MEETING: Two public scoping meetings will be held by the City of San Diego's Planning Department one on Tuesday, December 9, 2014 from 5:30 p.m. to 7:30 PM at the South Bay Recreation Center located at 1885 Coronado Avenue, San Diego CA 92154, and one on Thursday, December 11, 2014 from 6:00 PM to 8:00 PM at the Public Utilities Department Metropolitan Operations Complex located at 9192 Topaz Way, San Diego CA 92123. Please note that depending on the number of attendees, the meeting could end earlier than the end times noted above. Verbal and written comments regarding the scope and alternatives of the proposed EIR will be accepted at the meeting. Please send in written/mail-in comments may also be sent to the following address: Myra Herrmann, Environmental Planner, City of San Diego Development Services Center, 1222 First Avenue, MS 501, San Diego, CA 92101 or e-mail your comments to [email protected] with the Project Name and Number in the subject line Number in the subject line within 30 days of the receipt of this notice/date of the Public Notice above.
    [Show full text]
  • Triptans Step Therapy/Quantity Limit Criteria
    Triptans Step Therapy/Quantity Limit Criteria Program may be implemented with the following options 1) step therapy 2) quantity limits or 3) step therapy with quantity limits For Blue Cross and Blue Shield of Illinois Option 1 (step therapy only) will apply. Brand Generic Dosage Form Amerge® naratriptan tablets Axert® almotriptan tablets Frova® frovatriptan tablets Imitrex® sumatriptan injection*, nasal spray, tablets* Maxalt® rizatriptan tablets Maxalt-MLT® rizatriptan tablets Relpax® eletriptan tablets Treximet™ sumatriptan and naproxen tablets Zomig® zolmitriptan tablets, nasal spray Zomig-ZMT® zolmitriptan tablets * generic available and included as target agent in quantity limit edit FDA APPROVED INDICATIONS1-7 The following information is taken from individual drug prescribing information and is provided here as background information only. Not all FDA-approved indications may be considered medically necessary. All criteria are found in the section “Prior Authorization Criteria for Approval.” Amerge® Tablets1, Axert® Tablets2, Frova® Tablets3,Imitrex® injection4, Imitrex Nasal Spray5, Imitrex Tablets6, Maxalt® Tablets7, Maxalt-MLT® Tablets7, Relpax® Tablets8, Treximet™ Tablets9, Zomig® Tablets10, Zomig-ZMT® Tablets10, and Zomig® Nasal Spray11 Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan), Maxalt (rizatriptan), Maxalt-MLT (rizatriptan orally disintegrating), Relpax (eletriptan), Treximet (sumatriptan/naproxen), Zomig (zolmitriptan), and Zomig-ZMT (zolmitriptan orally disintegrating) tablets, and Imitrex (sumatriptan) and Zomig (zolmitriptan) nasal spray are all indicated for the acute treatment of migraine attacks with or without aura in adults. They are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of all of these products have not been established for cluster headache, which is present in an older, predominantly male population.
    [Show full text]
  • Zomig and Zomig Rapimelt Are Trade Marks of the Astrazeneca Group of Companies
    AUSTRALIAN PRODUCT INFORMATION Zomig® and Zomig Rapimelt® (zolmitriptan) 1 NAME OF THE MEDICINE Zolmitriptan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zomig is presented as round, yellow (2.5 mg) or pink (5 mg), biconvex film-coated intagliated (with a ‘Z’ on one side) tablets containing 2.5 mg or 5 mg zolmitriptan. The 2.5 mg tablets are 7.4 mm in diameter and are compressed to a weight of 122 mg. The 5 mg tablets are 8.6 mm in diameter and are compressed to a weight of 244 mg. Zomig Rapimelt is presented as orally dispersible white round uncoated orange flavoured tablets containing 2.5 mg zolmitriptan. The tablets are 6.4 mm in diameter, flat-faced with a bevelled edge and intagliated with ‘Z’ on one side. The tablets are compressed to a weight of 100 mg. Excipient(s) with known effect: lactose monohydrate (Zomig), aspartame (Zomig Rapimelt). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM • Tablet, film-coated • Tablet, dispersible (oral) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zomig is indicated for the acute treatment of migraine with or without aura. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended initial dose of Zomig to treat a migraine attack is 2.5 mg. The Zomig conventional tablet should be swallowed whole with water. The Zomig Rapimelt orally dispersible tablet rapidly dissolves when placed on the tongue and is swallowed with the patient’s saliva. A drink of water is not required when taking the Zomig Rapimelt orally dispersible tablet.
    [Show full text]
  • Zolmitriptan Intranasal Spanlastics for Enhanced Migraine Treatment; Formulation Parameters Optimized Via Quality by Design Approach
    Scientia Pharmaceutica Article Zolmitriptan Intranasal Spanlastics for Enhanced Migraine Treatment; Formulation Parameters Optimized via Quality by Design Approach Asmaa Saleh 1, Maha Khalifa 2 , Seham Shawky 2, Amjaad Bani-Ali 3 and Heba Eassa 2,* 1 Department of Pharmaceutical Sciences, College of Pharmacy, Princess Nourah bint Abdulrahman University, Riyadh 11671, Saudi Arabia; [email protected] 2 Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University, Cairo 11651, Egypt; [email protected] (M.K.); [email protected] (S.S.) 3 Pharmacy Practice Department, College of Pharmacy, Princess Nourah bint Abdulrahman University, Riyadh 11671, Saudi Arabia; [email protected] * Correspondence: [email protected]; Tel.: +20-114-261-2925 Abstract: Zolmitriptan is a potent second-generation triptan prescribed for migraine attacks. It suffers low bioavailability (40%) after oral administration due to the hepatic first-pass metabolism. Spanlastics are surfactant-based elastic vesicular drug carrier systems. This study aimed to design and optimize intranasal spanlastic formulations as an alternative approach that directly targets brain delivery, enhancing its bioavailability and avoiding the first-pass effect. The quality by design approach was applied to correlate the formulation parameters (Span 60 and Tween 80 concentrations) and critical quality attributes (entrapment efficiency (EE%) and particle size). Spanlastic formulations Citation: Saleh, A.; Khalifa, M.; were designed based on response surface central composite design and prepared via an ethanol injec- Shawky, S.; Bani-Ali, A.; Eassa, H. tion method. Designed formulations were characterized by EE% and particle size measurements to Zolmitriptan Intranasal Spanlastics select the optimized formula (with a combination of small particle size and high EE%).
    [Show full text]
  • RELPAX® (Eletriptan Hydrobromide) Tablets
    RELPAX® (eletriptan hydrobromide) Tablets DESCRIPTION RELPAX® (eletriptan) Tablets contain eletriptan hydrobromide, which is a selective 5­ hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H­ indole monohydrobromide, and it has the following chemical structure: CH OO OO 3 N S . HBr N H The empirical formula is C22H26N2O2S . HBr, representing a molecular weight of 463.40. Eletriptan hydrobromide is a white to light pale colored powder that is readily soluble in water. Each RELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients microcrystalline cellulose NF, lactose NF, croscarmellose sodium NF, magnesium stearate NF, titanium dioxide USP, hypromellose, triacetin USP and FD&C Yellow No. 6 aluminum lake. CLINICAL PHARMACOLOGY Mechanism of Action: Eletriptan binds with high affinity to 5-HT1B, 5-HT1D and 5-HT1F receptors, has modest affinity for 5-HT1A, 5-HT1E, 5-HT2B and 5-HT7 receptors, and little or no affinity for 5-HT2A, 5-HT2C, 5-HT3, 5-HT4, 5-HT5A and 5-HT6 receptors. Eletriptan has no significant affinity or pharmacological activity at adrenergic alpha1, alpha2, or beta; dopaminergic D1 or D2; muscarinic; or opioid receptors. Two theories have been proposed to explain the efficacy of 5-HT receptor agonists in migraine. One theory suggests that activation of 5-HT1 receptors located on intracranial blood vessels, including those on the arteriovenous anastomoses, leads to vasoconstriction, which is correlated with the relief of migraine headache.
    [Show full text]
  • Summary of Product Characteristics
    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Name to be completed nationally] 2.5 mg film-coated tablets [Name to be completed nationally] 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.5 mg Each film-coated tablet contains 2.5 mg zolmitriptan Excipient: Lactose, anhydrous 102.50 mg per tablet 5 mg Each film-coated tablet contains 5.0 mg zolmitriptan Excipient: Lactose, anhydrous 205.00 mg per tablet For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 2.5 mg Yellow coloured, round, biconvex film-coated tablets debossed with 497 on one side and deep break line on other side (diameter approximately: 7 mm). The tablet can be divided into equal halves. 5 mg Pink coloured, round, biconvex film-coated tablets debossed with 498 on one side and plain on other side (diameter approximately: 8.5 mm). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zolmitriptan is indicated for the acute treatment of migraine headache with or without aura. It is not indicated for prophylaxis. 4.2 Posology and method of administration The recommended dose of zolmitriptan to treat a migraine attack is 2.5 mg. It is advisable that [Name to be completed nationally] is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a second dose is required, it should not be taken within 2 hours of the initial dose.
    [Show full text]
  • Ergomar (Ergotamine) P&T Approval Date 4/2017, 6/2017, 3/2018, 3/2019, 1/2020, 1/2021 Effective Date 4/1/2021; Oxford Only: 4/1/2021
    UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2021 P 2125-6 Program Prior Authorization/Medical Necessity Medication Dihyroergotamine nasal spray (Migranal)*, Ergomar (ergotamine) P&T Approval Date 4/2017, 6/2017, 3/2018, 3/2019, 1/2020, 1/2021 Effective Date 4/1/2021; Oxford only: 4/1/2021 1. Background: Migranal (dihydroergotamine) nasal spray is indicated for the acute treatment of migraine headaches with or without aura. Migranal nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine. Ergomar is indicated to abort or prevent vascular headache, for example, migraine, migraine variants or a so-called "histaminic cephalalgia”. Ergomar should not be used for chronic daily administration. The U.S. Headache Consortium guidelines offer a general strategy based on expert consensus. Nonsteroidal anti-inflammatory drugs (NSAIDs) or caffeine-containing combination analgesics may be first-line treatment for mild to moderate migraine, or severe migraine that has previously responded to these agents. Triptans are considered first-line abortive treatment of moderate to severe migraine, or mild attacks that have not responded to nonprescription medicines. Ergotamine-containing compounds may also be reasonable in this situation. This program requires a member to try one oral triptan and one nasal triptan prior to receiving coverage for brand or generic Migranal or two oral triptans prior to receiving coverage of Ergomar. 2. Coverage Criteriaa: A. Dihydroergotamine Nasal Spray (Migranal*) will be approved based on all of the following criteria: 1. Diagnosis of moderate to severe migraine headaches with or without aura. -AND- 2. History of failure, contraindication, or intolerance to one of the following oral triptans (Document duration of trial): a.
    [Show full text]
  • Guideline for Preoperative Medication Management
    Guideline: Preoperative Medication Management Guideline for Preoperative Medication Management Purpose of Guideline: To provide guidance to physicians, advanced practice providers (APPs), pharmacists, and nurses regarding medication management in the preoperative setting. Background: Appropriate perioperative medication management is essential to ensure positive surgical outcomes and prevent medication misadventures.1 Results from a prospective analysis of 1,025 patients admitted to a general surgical unit concluded that patients on at least one medication for a chronic disease are 2.7 times more likely to experience surgical complications compared with those not taking any medications. As the aging population requires more medication use and the availability of various nonprescription medications continues to increase, so does the risk of polypharmacy and the need for perioperative medication guidance.2 There are no well-designed trials to support evidence-based recommendations for perioperative medication management; however, general principles and best practice approaches are available. General considerations for perioperative medication management include a thorough medication history, understanding of the medication pharmacokinetics and potential for withdrawal symptoms, understanding the risks associated with the surgical procedure and the risks of medication discontinuation based on the intended indication. Clinical judgement must be exercised, especially if medication pharmacokinetics are not predictable or there are significant risks associated with inappropriate medication withdrawal (eg, tolerance) or continuation (eg, postsurgical infection).2 Clinical Assessment: Prior to instructing the patient on preoperative medication management, completion of a thorough medication history is recommended – including all information on prescription medications, over-the-counter medications, “as needed” medications, vitamins, supplements, and herbal medications. Allergies should also be verified and documented.
    [Show full text]
  • Zolmitriptan (Zolmig) COMPLEX CHRONIC DISEASES PROGRAM Medication Handout Date: May 15, 2018
    Zolmitriptan (Zolmig) COMPLEX CHRONIC DISEASES PROGRAM Medication Handout Date: May 15, 2018 Medication: Zolmitriptan (Zomig) 2.5 mg or 5 mg What is Zolmitriptan: Zolmitriptan is a type of medication called “triptans” which is used to treat acute migraine headaches. Migraine symptoms may be caused by swollen blood vessels in the head. Zolmitriptan is thought to reduce the swelling of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound. Zolmitriptan works only when a migraine attack has started. It will not stop you from getting an attack Expected Benefit: Relief should occur within 1 – 2 hrs Watch for possible side effects: This list of side effects is important for you to be aware of however, it is also important to remember that not all side effects happen to all people. If you have problems with these side effects talk with your doctor or pharmacist Heaviness of the arms and legs Flushing Sensation of pins and needles Tightness in the chest, neck, or throat These side effects can be reduced or avoided with a smaller dose or trying a different triptan (e.g., rizatriptan) If you develop muscle spasms and fever, stop the medication and let the clinic know Stopping the medication: There should be no withdrawal effect when stopping the medication as the medication is not taken regularly. How to use and store this medication: Take this medication with or without food Most effective if taken at
    [Show full text]