DOCSLIB.ORG

Mebhydrolin/Methdilazine 585

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Mebhydrolin/Methdilazine 585 Mebhydrolin/Methdilazine 585 Pharmacopoeias. In Chin. and Eur. (see p.vii). Mepyramine Hydrochloride (BANM, rINNM) Symptom Menstrual; Midol Pre-Menstrual Syndrome; Myci-Spray; MyHist- US specifies the monohydrate. DM; MyHist-PD; Nalex-A 12; ND-Gesic; P-Hist; P-Tanna; Pamprin; Poly- Hidrocloruro de mepiramina; Mépyramine, Chlorhydrate de; Histine†; Premsyn PMS; Pro-Red; Pyrlex CB; R-Tanna; R-Tannamine; R-Tan- Ph. Eur. 6.2 (Meclozine Hydrochloride). A yellow or yellowish- Mepyramini Hydrochloridum; Pyranisamine Hydrochloride; Py- nate; R-Tannic-S†; Rectagene Medicated Rectal Balm; Resperal; Rhinatate; white, crystalline powder. Slightly soluble in water; soluble in al- Robitussin Night Relief; Ryna-12; Soothaderm; Tanoral; Tri-Tannate; Tri- cohol and in dichloromethane. Store in airtight containers. rilamine Hydrochloride. codene Cough & Cold; Triotann; Triplex AD; Tritan; Tussi-12 D; Tussi-12D USP 31 (Meclizine Hydrochloride). The monohydrate is white or Мепирамина Гидрохлорид S; Tussplex; Viravan; Viravan-DM; Z-Xtra; Venez.: Fesanol†; Metilcodin†; Metilfedrin†; Pi-Fedrin; Pinazo. slightly yellowish crystalline powder that has a slight odour. C17H23N3O,HCl = 321.8. Practically insoluble in water and in ether; freely soluble in chlo- CAS — 6036-95-9. roform, in pyridine, and in acid-alcohol-water mixtures; slightly ATC — D04AA02; R06AC01. soluble in dilute acids and in alcohol. Store in airtight containers. ATC Vet — QD04AA02; QR06AC01. Mequitazine (BAN, rINN) LM-209; Mekitatsiini; Mekitazin; Mequitazina; Méquitazine; Adverse Effects and Precautions Mepyramine Maleate (BANM, rINNM) Mequitazinum. 10-(Quinuclidin-3-ylmethyl)phenothiazine. As for the sedating antihistamines in general, p.561. Maleato de mepiramina; Mepiramin Maleat; Mepiramin-maleát; Мехитазин For reports of the use of antihistamines, including Mepiramino maleatas; Mepyramiinimaleaatti; Mepyramin C20H22N2S = 322.5. meclozine, in pregnancy, see p.563. maleinát; Mépyramine, maléate de; Mepyramini maleas; CAS — 29216-28-2. Mepyraminmaleat; Pyranisamine Maleate; Pyrilamine Maleate. ATC — R06AD07. Interactions Mepyramine hydrogen maleate. ATC Vet — QR06AD07. As for the sedating antihistamines in general, p.563. Мепирамина Малеат C17H23N3O,C4H4O4 = 401.5. Uses and Administration CAS — 59-33-6. Meclozine hydrochloride, a piperazine derivative, is a ATC — D04AA02; R06AC01. N sedating antihistamine with antimuscarinic and moder- ATC Vet — QD04AA02; QR06AC01. ate sedative properties. It is mainly used for its an- Pharmacopoeias. In Eur. (see p.vii) and US. N tiemetic action, which may last for up to 24 hours. Ph. Eur. 6.2 (Mepyramine Maleate). A white or slightly yellow- ish, crystalline powder. Very soluble in water; freely soluble in Meclozine hydrochloride is used in the prevention and alcohol. M.p. 99° to 103°. A 2% solution in water has a pH of 4.9 treatment of nausea and vomiting associated with a va- to 5.2. Protect from light. S riety of conditions including motion sickness (p.564) USP 31 (Pyrilamine Maleate). A white crystalline powder usual- and for the symptomatic treatment of vertigo (p.565) ly having a faint odour. Soluble 1 in 0.5 of water, 1 in 3 of alco- Pharmacopoeias. In Jpn. caused by Ménière’s disease and other vestibular disor- hol, 1 in 15 of dehydrated alcohol, and 1 in 2 of chloroform; Adverse Effects and Precautions slightly soluble in ether and in benzene. Its solutions are acid to As for the sedating antihistamines in general, p.561. ders. Meclozine hydrochloride has also been used for litmus. Store in airtight containers. Protect from light. the symptomatic relief of hypersensitivity reactions Sedation. For discussion of the sedative effects of antihista- and pruritic skin disorders (p.565). Adverse Effects and Precautions mines, see p.562. When mequitazine is given in the recommend- ed dosage of 5 mg twice daily the incidence of sedation appears The usual oral dose of meclozine hydrochloride for As for the sedating antihistamines in general, p.561. comparable with that of terfenadine. Sedation has, however, oc- motion sickness is 25 to 50 mg taken about one hour curred after doses of 10 mg twice daily. before travelling and repeated every 24 hours if neces- Interactions Interactions sary; up to 100 mg daily in divided doses has been giv- As for the sedating antihistamines in general, p.563. As for the sedating antihistamines in general, p.563. en for the treatment of vertigo and vestibular disorders. Antibacterials. For a report of torsade de pointes in a patient In the prevention and treatment of motion sickness in Uses and Administration taking spiramycin and mequitazine, see Cytochrome P450 children aged 6 to 12 years, 12.5 mg is given once dai- Mepyramine, an ethylenediamine derivative, is a se- Isoenzymes under Interactions of Spiramycin, p.333. ly; for children aged 2 to 6 years the dose is 6.25 mg dating antihistamine with antimuscarinic and sedative Pharmacokinetics once daily. properties. Mepyramine maleate is used for the symp- After absorption from the gastrointestinal tract, mequitazine is Both meclozine hydrochloride and meclozine base tomatic relief of hypersensitivity reactions and in pru- metabolised. Unchanged drug and metabolites are excreted prin- cipally in the bile. have been given by the rectal route; doses are similar to ritic skin disorders (p.565). Mepyramine maleate is those given orally. also a common ingredient of compound preparations Uses and Administration for the symptomatic treatment of coughs and the com- Mequitazine, a phenothiazine derivative, is a sedating antihista- Preparations mon cold (p.564). mine with antimuscarinic and mild sedative properties. USP 31: Meclizine Hydrochloride Tablets. Mequitazine is used for the symptomatic relief of allergic condi- Mepyramine maleate has been given in an oral dose of tions including urticaria (p.565), rhinitis (p.565) and conjunctivi- Proprietary Preparations (details are given in Part 3) 50 mg at night as a hypnotic in the short-term manage- tis (p.564), and in pruritic skin disorders (p.565). It has been giv- Belg.: Agyrax; Postafene; Braz.: Meclin; Canad.: Bonamine; Chile: Bon- amina; Cz.: Postafen†; Denm.: Postafen; Fin.: Postafen; Fr.: Agyrax; Ger.: ment of insomnia (p.564). en in usual oral doses of 5 mg twice daily. Peremesin N†; Peremesin†; Postadoxin N; Postafen†; Gr.: Emetostop; Preparations Postafene†; Hong Kong: Postafene; Mex.: Chiclida; Marenin; Neth.: Su- A cream containing 2% mepyramine maleate is used primal; Norw.: Peremesin; Postafen; NZ: Sea-Legs; Philipp.: Bonamine; locally for insect bites or stings, and for hypersensitiv- Proprietary Preparations (details are given in Part 3) Postadoxine; Port.: Navicalm; Rus.: Bonine (Бонин); Spain: Chiclida; Arg.: Primalan; Chile: Mircol; Fr.: Primalan; Quitadrill; Ger.: Metaplexan; Dramine; Navicalm†; Swed.: Postafen; Switz.: Duremesan; Turk.: Posta- ity and pruritic skin conditions but, as with any antihis- Ital.: Primalan†; Mex.: Primalan; Philipp.: Primalan; Port.: Primalan; Rus.: doxine; UK: Sea-Legs; USA: Antivert; Antrizine; Bonine; Dizmiss; tamine, there is a risk of sensitisation. It has also been Primalan (Прималан); Spain: Mircol. Dramamine II; Meni-D; Vergon†. used in eye drops. Multi-ingredient: Austria: Contravert B ; Diligan; Ger.: Diligan†; Hong Kong: Navidoxine; India: Diligan; Pregnidoxin; Malaysia: Becoloxin†; In some countries mepyramine maleate is available for Navidoxine†; Mex.: Bonadoxina; Bonalen; Bonazin; Emediba; Liatriz; Mecl- Methdilazine (BAN, rINN) ifar; Meclison; Pidoxina; Vo-Remi; Neth.: Emesafene; Port.: Diligan†; parenteral use. Mepyramine hydrochloride has also S.Afr.: Geratar; Singapore: Navidoxine†; Switz.: Duremesan; Itinerol B ; been given parenterally or by the rectal route. Metdilatsiini; Metdilazin; Metdilazina; Methdilazinum; Metodilazi- UK: Traveleeze; Venez.: Bonadoxina; Etizil†; Mebax†. Mepyramine tannate and mepyramine acefyllinate na. 10-(1-Methylpyrrolidin-3-ylmethyl)phenothiazine. have been used orally. Метдилазин C18H20N2S = 296.4. Preparations CAS — 1982-37-2. Mepyramine (BAN, rINN) BP 2008: Mepyramine Tablets; ATC — R06AD04. Mepiramina; Mepyramiini; Mepyramin; Mépyramine; Mepyrami- USP 31: Pyrilamine Maleate Tablets. ATC Vet — QR06AD04. num; Pyranisamine; Pyrilamine. 2-(N-p-Anisyl-N-2-pyridylami- Proprietary Preparations (details are given in Part 3) no)ethyldimethylamine. Austral.: Relaxa-Tabs; Braz.: Alergitanil; Hong Kong: Anthisan; Irl.: An- thisan; NZ: Anthisan; S.Afr.: Anthisan; Antihist; Mepyraderm; Mepyrimal; Мепирамин Spain: Fluidasa; UK: Anthisan; USA: Pyrlex. N C H N O = 285.4. Multi-ingredient: Arg.: Bajumol†; Drynisan; Everfem; Fadanasal; Piracala- 17 23 3 CH3 CAS — 91-84-9. mina; Polipectol†; Rynatanic†; Austral.: Neo-Diophen†; Belg.: Nortussine; Braz.: Alergitrat†; Alergo Glucalbet†; Beclase; Benistina†; Benzomel†; Co- N ATC — D04AA02; R06AC01. nidrin; Expectussin†; Ginometrim Oral†; Gripanil†; Gripsay; Killgrip†; Narid- ATC Vet — QD04AA02; QR06AC01. rin; Nariflux; Nasogrip; Posdrink; Canad.: Extra Strength Multi-Symptom PMS Relief†; Hycomine; Jack and Jill; Midol Extra Strength; Midol PMS Extra Strength; Pamprin; Prefrin A; ratio-Theo-Bronc; Relievol PMS; Trendar S PMS†; Tylenol Menstrual; Chile: Alerzona; Kitadol Periodo Menstrual; Min- faden; Predual; Rinolergan; Tapsin Periodo Menstrual; Fr.: Nortussine; N Hong Kong: Easiko†; Israel: Aforinol; Alnase; Phenyphrine-Azol†; Ital.: Balsamina Kroner; Triaminic; Vasofen; Malaysia: Prefrin A†; Mex.: Femse- Methdilazine Hydrochloride (BANM, rINNM) din Kutz; Lentostamin; Pol.: Kato-Nasal; Pro-Miss;
Load more

Recommended publications
  • (12) Patent Application Publication (10) Pub. No.: US 2010/0221245 A1 Kunin (43) Pub
    US 2010O221245A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0221245 A1 Kunin (43) Pub. Date: Sep. 2, 2010 (54) TOPICAL SKIN CARE COMPOSITION Publication Classification (51) Int. Cl. (76) Inventor: Audrey Kunin, Mission Hills, KS A 6LX 39/395 (2006.01) (US) A6II 3L/235 (2006.01) A638/16 (2006.01) Correspondence Address: (52) U.S. Cl. ......................... 424/133.1: 514/533: 514/12 HUSCH BLACKWELL SANDERS LLP (57) ABSTRACT 4801 Main Street, Suite 1000 - KANSAS CITY, MO 64112 (US) The present invention is directed to a topical skin care com position. The composition has the unique ability to treat acne without drying out the user's skin. In particular, the compo (21) Appl. No.: 12/395,251 sition includes a base, an antibacterial agent, at least one anti-inflammatory agent, and at least one antioxidant. The (22) Filed: Feb. 27, 2009 antibacterial agent may be benzoyl peroxide. US 2010/0221 245 A1 Sep. 2, 2010 TOPCAL SKIN CARE COMPOSITION stay of acne treatment since the 1950s. Skin irritation is the most common side effect of benzoyl peroxide and other anti BACKGROUND OF THE INVENTION biotic usage. Some treatments can be severe and can leave the 0001. The present invention generally relates to composi user's skin excessively dry. Excessive use of some acne prod tions and methods for producing topical skin care. Acne Vul ucts may cause redness, dryness of the face, and can actually garis, or acne, is a common skin disease that is prevalent in lead to more acne. Therefore, it would be beneficial to provide teenagers and young adults.
    [Show full text]
  • Rhinitis - Allergic (1 of 15)
    Rhinitis - Allergic (1 of 15) 1 Patient presents w/ signs & symptoms of rhinitis 2 • Consider other classifi cations of rhinitis DIAGNOSIS No - Please see Rhinitis Is allergic rhinitis - Nonallergic disease confi rmed? management chart Yes 3 ASSESS DURATION & SEVERITY OF ALLERGIC RHINITIS A Non-pharmacological therapy • Allergen avoidance • Patient education VAS <5 VAS ≥5 B Pharmacological therapy B Pharmacological therapy • Antihistamines (oral/nasal), &/or • Corticosteroids (nasal), w/ or without • Corticosteroids (nasal), or • Antihistamines (nasal), or • Cromone (nasal), or • LTRA • Leukotriene receptor antagonists (LTRA)MIMS TREATMENT © See next page Specifi cally for patients w/ asthma Not all products are available or approved for above use in all countries. Specifi c prescribing information may be found in the latest MIMS. B167 © MIMS Pediatrics 2020 Rhinitis - Allergic (2 of 15) Previously treated symptomatic Previously treated symptomatic patient (VAS <5) on antihistamines patient (VAS ≥5) on intensifi ed (oral/nasal) &/or corticosteroids (nasal) therapy w/ corticosteroids (nasal) w/ or without antihistamines (nasal) Intermittent Persistent symptoms, symptoms or without allergen w/ allergen exposure exposure B Pharmacological therapy B Pharmacological therapy • Step down or discontinue therapy • Continue or step up therapy Untreated REASSESS DISEASE SEVERITY VAS symptomatic patient DAILY UP TO DAY 3 (VAS <5 or ≥5) 4 CONTINUE Yes THERAPY & STEP EVALUATION VAS <5 DOWN THERAPY1 Improvement of symptoms? No VAS ≥5 B Pharmacological therapy • Step-up therapy REASSESS DISEASE SEVERITY MIMSVAS DAILY UP TO DAY 7 4 Yes EVALUATION VAS <5 Improvement of symptoms? No TREATMENT © VAS ≥5 See next page Continue therapy if symptomatic; consider step-down or discontinuation of therapy if symptoms subside Not all products are available or approved for above use in all countries.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2002/0102215 A1 100 Ol
    US 2002O102215A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2002/0102215 A1 Klaveness et al. (43) Pub. Date: Aug. 1, 2002 (54) DIAGNOSTIC/THERAPEUTICAGENTS (60) Provisional application No. 60/049.264, filed on Jun. 6, 1997. Provisional application No. 60/049,265, filed (75) Inventors: Jo Klaveness, Oslo (NO); Pal on Jun. 6, 1997. Provisional application No. 60/049, Rongved, Oslo (NO); Anders Hogset, 268, filed on Jun. 7, 1997. Oslo (NO); Helge Tolleshaug, Oslo (NO); Anne Naevestad, Oslo (NO); (30) Foreign Application Priority Data Halldis Hellebust, Oslo (NO); Lars Hoff, Oslo (NO); Alan Cuthbertson, Oct. 28, 1996 (GB)......................................... 9622.366.4 Oslo (NO); Dagfinn Lovhaug, Oslo Oct. 28, 1996 (GB). ... 96223672 (NO); Magne Solbakken, Oslo (NO) Oct. 28, 1996 (GB). 9622368.0 Jan. 15, 1997 (GB). ... 97OO699.3 Correspondence Address: Apr. 24, 1997 (GB). ... 9708265.5 BACON & THOMAS, PLLC Jun. 6, 1997 (GB). ... 9711842.6 4th Floor Jun. 6, 1997 (GB)......................................... 97.11846.7 625 Slaters Lane Alexandria, VA 22314-1176 (US) Publication Classification (73) Assignee: NYCOMED IMAGING AS (51) Int. Cl." .......................... A61K 49/00; A61K 48/00 (52) U.S. Cl. ............................................. 424/9.52; 514/44 (21) Appl. No.: 09/765,614 (22) Filed: Jan. 22, 2001 (57) ABSTRACT Related U.S. Application Data Targetable diagnostic and/or therapeutically active agents, (63) Continuation of application No. 08/960,054, filed on e.g. ultrasound contrast agents, having reporters comprising Oct. 29, 1997, now patented, which is a continuation gas-filled microbubbles stabilized by monolayers of film in-part of application No. 08/958,993, filed on Oct.
    [Show full text]
  • Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
    20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0
    [Show full text]
  • 2 12/ 35 74Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 22 March 2012 (22.03.2012) 2 12/ 35 74 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/16 (2006.01) A61K 9/51 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 9/14 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/EP201 1/065959 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 14 September 201 1 (14.09.201 1) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, (25) Filing Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (26) Publication Language: English TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/382,653 14 September 2010 (14.09.2010) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, NANOLOGICA AB [SE/SE]; P.O Box 8182, S-104 20 ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, Stockholm (SE).
    [Show full text]
  • Wo 2008/127291 A2
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 23 October 2008 (23.10.2008) WO 2008/127291 A2 (51) International Patent Classification: Jeffrey, J. [US/US]; 106 Glenview Drive, Los Alamos, GOlN 33/53 (2006.01) GOlN 33/68 (2006.01) NM 87544 (US). HARRIS, Michael, N. [US/US]; 295 GOlN 21/76 (2006.01) GOlN 23/223 (2006.01) Kilby Avenue, Los Alamos, NM 87544 (US). BURRELL, Anthony, K. [NZ/US]; 2431 Canyon Glen, Los Alamos, (21) International Application Number: NM 87544 (US). PCT/US2007/021888 (74) Agents: COTTRELL, Bruce, H. et al.; Los Alamos (22) International Filing Date: 10 October 2007 (10.10.2007) National Laboratory, LGTP, MS A187, Los Alamos, NM 87545 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY,BZ, CA, CH, (30) Priority Data: CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, 60/850,594 10 October 2006 (10.10.2006) US ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (71) Applicants (for all designated States except US): LOS LR, LS, LT, LU, LY,MA, MD, ME, MG, MK, MN, MW, ALAMOS NATIONAL SECURITY,LLC [US/US]; Los MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, Alamos National Laboratory, Lc/ip, Ms A187, Los Alamos, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, NM 87545 (US).
    [Show full text]
  • 209089Orig1s000 209090Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209089Orig1s000 209090Orig1s000 CLINICAL REVIEW(S) CLINICAL REVIEW Application Type NDA (Rx to OTC switch) Application Number(s) 209-089 Xyzal Allergy 24 HR tablets 209-090 Xyzal Allergy 24 HR solution Priority or Standard Standard Submit Date(s) March 18, 2016 Received Date(s) March 31, 2016 PDUFA Goal Date January 31, 2017 Division / Office DPARP/ODE 2/OND Reviewer Name(s) Xu Wang, M.D., Ph.D. Review Completion Date December 9, 2016 Established Name Levocetirizine dihydrochloride Rx Trade Name Xyzal tablets/solution OTC Trade Name Xyzal Allergy 24HR tablets/solution Therapeutic Class Antihistamine Applicant UCB Inc. Formulation(s) tablets/solution Dosing Regimen ≥12 years: One tablet (5 mg) daily/10 mL solution (5 mg) daily; 1 6 – 11 years: /2 tablet (2.5 mg) daily/5 mL solution (2.5 mg) daily; 2 – 5 years: 2.5 mL solution (1.25 mg) daily Indication(s) Temporarily relieve these symptoms due to hay fever or other upper respiratory allergies: • running nose, • sneezing, • itchy, watering eyes, • itching of nose or throat Intended Population(s) Tablets: ≥6 years of age Solution: ≥2 years of age Template Version: March 6, 2009 Reference ID: 4025819 Clinical Review Xu Wang, M.D., Ph.D. NDA 209-089/NDA 209-090 Rx to OTC switch Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets/solution Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT .........................................4 1.1 Recommendation on Regulatory Action ............................................................. 4 1.2 Risk Benefit Assessment .................................................................................... 4 2 INTRODUCTION AND REGULATORY BACKGROUND ........................................ 4 2.1 Product Information ............................................................................................ 4 2.2 Currently Available Treatments for Proposed Indications..................................
    [Show full text]
  • Mebhydrolin (BAN, Rinn) Significant Risk of Major Congenital Malformations
    584 Antihistamines Analysis of data collected by the Swedish Medical Birth Regis- means of removing loratadine or its metabolite desloratadine mito†; Alviumthe†; Bisincof; Bramin; Bronar; Broquixol; Celestamine NS; try between 1994 and 2001 revealed 15 cases of hypospadias from the body.1 Claricort†; Clariflu; Clarifriol; Clarinase†; Clarityne D; Coricidin Expec; among a cohort of 2780 newborns exposed to loratadine during Dimegan D; Doralan-Ax; Efectine D; Farmalor; Fluxibit; Gralddep; Laritol D; 1 1. Matzke GR, et al. Pharmacokinetics of loratadine in patients Laritol Ex; Laritol G; Lertamine D; Linfarden; Lovarin P†; Lyrsedin; Neoalexil the first trimester of pregnancy. The authors noted that the indi- with renal insufficiency. J Clin Pharmacol 1990; 30: 364–71. P†; Quimtadine DSQ; Quimtafriol; Sensibit D; Sensibit XP; Sibilex; Tadinar- vidual risk for having an infant with hypospadias after loratadine C; Tamex; Tavexyl; TheraFlu 24; TheraFlu N 12; TheraFlu TD; NZ: Clari- use is small (less than 1%) and the attributive risk of extra cases nase†; Demazin Non-Drowsy†; Philipp.: Claricort; Clarinase; Rhinase; in the population is low. The US CDC has also analysed data Uses and Administration Pol.: Clarinase; Port.: Claridon; S.Afr.: Clarityne D; Demazin NS; Polara- 2 tyne D†; Singapore: Clarinase; Spain: Narine; Thai.: Clarinase; Turk.: from the National Birth Defects Prevention study; they found no Loratadine, a piperidine derivative related to azatadine, Clarinase; USA: Alavert Allergy & Sinus D; Claritin-D; Venez.: Ambroclar; increase in the risk of second- or third-degree hypospadias in the is a long-acting, non-sedating antihistamine with no Celestamincort; Claricort; Claridex; Claridexultra; Clariflu; Clarigrip; Clari- infants of women who used loratadine in early pregnancy.
    [Show full text]
  • Histamine Receptor
    Histamine Receptor Histamine Receptors are a class of G protein-coupled receptors with histamine as their endogenous ligand. There are four known histamine receptors: H1 receptor, H2 receptor, H3 receptor, H4 receptor. The H1 receptor is a histamine receptor belonging to the family of Rhodopsin-like G-protein-coupled receptors. This receptor, which is activated by the biogenic amine histamine, is expressed throughout the body, to be specific, in smooth muscles, on vascular endothelial cells, in the heart, and in the central nervous system. H2 receptors are positively coupled to adenylate cyclase via Gs. It is a potent stimulant of cAMP production, which leads to activation of Protein Kinase A. Histamine H3 receptors are expressed in the central nervous system and to a lesser extent the peripheral nervous system, where they act asautoreceptors in presynaptic histaminergic neurons, and also control histamine turnover by feedback inhibition of histamine synthesis and release. The Histamine H4 receptor has been shown to be involved in mediating eosinophil shape change and mast cell chemotaxis. www.MedChemExpress.com 1 Histamine Receptor Inhibitors & Modulators (±)-Methotrimeprazine (D6) (±)-Tazifylline (dl-Methotrimeprazine D6) Cat. No.: HY-19489S Cat. No.: HY-U00018 Bioactivity: (±)-Methotrimeprazine (D6) is the deuterium labeled Bioactivity: (±)-Tazifylline is a potent, selective and long-acting Methotrimeprazine, which is a D3 dopamine and Histamine H1 histamine H1 receptor antagonist. receptor antagonist. Purity: >98% Purity: >98% Clinical Data: No Development Reported Clinical Data: No Development Reported Size: 1 mg Size: 1 mg, 5 mg, 10 mg, 20 mg ABT-239 Acrivastine Cat. No.: HY-12195 (BW825C) Cat. No.: HY-B1510 Bioactivity: ABT-239 is a novel, highly efficacious, Bioactivity: Acrivastine (BW825C) is a short acting histamine 1 non-imidazole class of H3R antagonist and a transient receptor antagonist for the treatment of allergic rhinitis.
    [Show full text]
  • Mebhydrolin/Methdilazine 585
    Mebhydrolin/Methdilazine 585 Pharmacopoeias. In Chin. and Eur. (see p.vii). Mepyramine Hydrochloride (BANM, rINNM) Symptom Menstrual; Midol Pre-Menstrual Syndrome; Myci-Spray; MyHist- US specifies the monohydrate. DM; MyHist-PD; Nalex-A 12; ND-Gesic; P-Hist; P-Tanna; Pamprin; Poly- Hidrocloruro de mepiramina; Mépyramine, Chlorhydrate de; Histine†; Premsyn PMS; Pro-Red; Pyrlex CB; R-Tanna; R-Tannamine; R-Tan- Ph. Eur. 6.2 (Meclozine Hydrochloride). A yellow or yellowish- Mepyramini Hydrochloridum; Pyranisamine Hydrochloride; Py- nate; R-Tannic-S†; Rectagene Medicated Rectal Balm; Resperal; Rhinatate; white, crystalline powder. Slightly soluble in water; soluble in al- Robitussin Night Relief; Ryna-12; Soothaderm; Tanoral; Tri-Tannate; Tri- cohol and in dichloromethane. Store in airtight containers. rilamine Hydrochloride. codene Cough & Cold; Triotann; Triplex AD; Tritan; Tussi-12 D; Tussi-12D USP 31 (Meclizine Hydrochloride). The monohydrate is white or Мепирамина Гидрохлорид S; Tussplex; Viravan; Viravan-DM; Z-Xtra; Venez.: Fesanol†; Metilcodin†; Metilfedrin†; Pi-Fedrin; Pinazo. slightly yellowish crystalline powder that has a slight odour. C17H23N3O,HCl = 321.8. Practically insoluble in water and in ether; freely soluble in chlo- CAS — 6036-95-9. roform, in pyridine, and in acid-alcohol-water mixtures; slightly ATC — D04AA02; R06AC01. soluble in dilute acids and in alcohol. Store in airtight containers. ATC Vet — QD04AA02; QR06AC01. Mequitazine (BAN, rINN) LM-209; Mekitatsiini; Mekitazin; Mequitazina; Méquitazine; Adverse Effects and Precautions Mepyramine Maleate (BANM, rINNM) Mequitazinum. 10-(Quinuclidin-3-ylmethyl)phenothiazine. As for the sedating antihistamines in general, p.561. Maleato de mepiramina; Mepiramin Maleat; Mepiramin-maleát; Мехитазин For reports of the use of antihistamines, including Mepiramino maleatas; Mepyramiinimaleaatti; Mepyramin C20H22N2S = 322.5.
    [Show full text]
  • Medicines Regulations 1984 (SR 1984/143)
    Reprint as at 30 March 2021 Medicines Regulations 1984 (SR 1984/143) David Beattie, Governor-General Order in Council At the Government House at Wellington this 5th day of June 1984 Present: His Excellency the Governor-General in Council Pursuant to section 105 of the Medicines Act 1981, and, in the case of Part 3 of the regulations, to section 62 of that Act, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations and bodies that appeared to the Minister to be representatives of persons likely to be substantially affected, and by and with the advice and consent of the Executive Coun- cil, hereby makes the following regulations. Contents Page 1 Title and commencement 5 2 Interpretation 5 Part 1 Classification of medicines 3 Classification of medicines 9 Note Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint. Note 4 at the end of this reprint provides a list of the amendments incorporated. These regulations are administered by the Ministry of Health. 1 Reprinted as at Medicines Regulations 1984 30 March 2021 Part 2 Standards 4 Standards for medicines, related products, medical devices, 10 cosmetics, and surgical dressings 4A Standard for CBD products 10 5 Pharmacist may dilute medicine in particular case 11 6 Colouring substances [Revoked] 11 Part 3 Advertisements 7 Advertisements not to claim official approval 11 8 Advertisements for medicines 11 9 Advertisements for related products 13 10 Advertisements
    [Show full text]
  • Decongestants, Antihistamines and Nasal Irrigation for Acute Sinusitis in Children (Review)
    Decongestants, antihistamines and nasal irrigation for acute sinusitis in children (Review) Shaikh N, Wald ER This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2014, Issue 10 http://www.thecochranelibrary.com Decongestants, antihistamines and nasal irrigation for acute sinusitis in children (Review) Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 3 METHODS ...................................... 3 RESULTS....................................... 5 Figure1. ..................................... 6 DISCUSSION ..................................... 8 AUTHORS’CONCLUSIONS . 8 ACKNOWLEDGEMENTS . 8 REFERENCES ..................................... 8 CHARACTERISTICSOFSTUDIES . 12 DATAANDANALYSES. 14 APPENDICES ..................................... 14 WHAT’SNEW..................................... 17 HISTORY....................................... 17 CONTRIBUTIONSOFAUTHORS . 17 DECLARATIONSOFINTEREST . 17 SOURCESOFSUPPORT . 17 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 18 INDEXTERMS .................................... 18 Decongestants, antihistamines and nasal irrigation for acute sinusitis in children (Review) i Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention
    [Show full text]