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Mesalamine (Asacol Hd)

Trade Name : Asacol HD

Allergan, Inc.

TABLET, DELAYED RELEASE

Strength 800 mg/1

MESALAMINE Aminosalicylate [EPC],Aminosalicylic Acids [CS]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Mesalamine (Asacol Hd) which is also known as Asacol HD and Manufactured by Allergan, Inc.. It is available in strength of 800 mg/1 per ml. Read more

Mesalamine (Asacol Hd) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Asacolu00ae HD is indicated for the treatment of moderately active ulcerative colitisu00a0in adults.
  • Limitations of Use
  • Asacolu00a0HDu00a0isu00a0anu00a0aminosalicylateu00a0indicatedu00a0foru00a0theu00a0treatmentu00a0ofu00a0moderately activeu00a0ulcerativeu00a0colitisu00a0inu00a0adults.u00a0()
  • u00a0u00a0u00a0u00a0
  • Safetyu00a0andu00a0effectivenessu00a0ofu00a0Asacolu00a0HDu00a0beyondu00a06u00a0weeks haveu00a0notu00a0beenu00a0establishedu00a0()
  • nttu00a0u00a0u00a0u00a0u00a0nt
  • Asacolu00a0HDu00a0delayed-releaseu00a0tablets:u00a0800u00a0mgu00a0(red-brown,u00a0capsule-shapedu00a0andu00a0imprintedu00a0withu00a0u201cWCu00a0800u201du00a0in black).
  • Delayed-releaseu00a0tablets:u00a0800u00a0mgu00a0()
  • Asacolu00a0HDu00a0isu00a0contraindicatedu00a0inu00a0patientsu00a0withu00a0knownu00a0or suspected hypersensitivityu00a0tou00a0salicylatesu00a0oru00a0aminosalicylatesu00a0oru00a0tou00a0anyu00a0ofu00a0theu00a0ingredientsu00a0ofu00a0Asacolu00a0HDu00a0n n n n n n n n n n .
  • Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Asacol HD tablets (, )
  • No data
  • Renal Impairment
  • Mesalamine-induced Acute Intolerance Syndrome
  • Hypersensitivity Reactionsn- , including Myocarditis and Pericarditis
  • Hepatic Failure
  • Theu00a0mostu00a0seriousu00a0adverseu00a0reactionsu00a0seenu00a0inu00a0Asacolu00a0HDu00a0clinicalu00a0trialsu00a0oru00a0withu00a0otheru00a0productsu00a0thatu00a0contain mesalamineu00a0oru00a0areu00a0metabolizedu00a0to mesalamineu00a0were:
  • Theu00a0mostu00a0commonu00a0adverseu00a0reactionsu00a0(u22652%)u00a0areu00a0headache,u00a0nausea,u00a0nasopharyngitis,u00a0abdominalu00a0pain,u00a0and worseningu00a0ofu00a0ulcerativeu00a0colitisu00a0()
  • No data
  • Nephrotoxic Agents including NSAIDs
  • Azathioprine or 6-n- Mn- ercaptopurine
  • Geriatric Patients
  • 8.5
  • Thereu00a0isu00a0nou00a0specificu00a0antidoteu00a0foru00a0mesalamineu00a0overdoseu00a0andu00a0treatmentu00a0foru00a0suspectedu00a0acuteu00a0severeu00a0toxicity withu00a0Asacolu00a0HDu00a0shouldu00a0beu00a0symptomaticu00a0andu00a0supportive.u00a0Thisu00a0mayu00a0includeu00a0preventionu00a0ofu00a0further gastrointestinalu00a0tractu00a0absorption,u00a0correctionu00a0ofu00a0fluidu00a0electrolyteu00a0imbalance,u00a0andu00a0maintenanceu00a0ofu00a0adequate renalu00a0function.u00a0Asacolu00a0HDu00a0isu00a0au00a0pHu00a0dependentu00a0delayed-releaseu00a0productu00a0andu00a0thisu00a0factoru00a0shouldu00a0be consideredu00a0whenu00a0treatingu00a0au00a0suspectedu00a0overdose.
  • Singleu00a0oralu00a0dosesu00a0ofu00a05000u00a0mg/kgu00a0mesalamineu00a0suspensionu00a0in miceu00a0(approximatelyu00a04.2u00a0timesu00a0the recommendedu00a0humanu00a0doseu00a0ofu00a0Asacolu00a0HDu00a0basedu00a0onu00a0bodyu00a0surfaceu00a0area),u00a04595u00a0mg/kgu00a0inu00a0rats (approximatelyu00a07.8u00a0timesu00a0theu00a0recommendedu00a0humanu00a0doseu00a0ofu00a0Asacolu00a0HDu00a0basedu00a0onu00a0bodyu00a0surfaceu00a0area)u00a0andu00a03000u00a0mg/kgu00a0inu00a0cynomolgusu00a0monkeysu00a0(approximatelyu00a010u00a0timesu00a0theu00a0recommendedu00a0humanu00a0doseu00a0ofu00a0Asacolu00a0HDu00a0basedu00a0onu00a0bodyu00a0surfaceu00a0area)u00a0wereu00a0lethal.
  • Eachu00a0Asacolu00a0HDu00a0delayed-releaseu00a0tabletu00a0foru00a0oralu00a0administrationu00a0containsu00a0800u00a0mgu00a0of mesalamine,u00a0an aminosalicylate.u00a0Asacolu00a0HDu00a0delayed-releaseu00a0tabletsu00a0haveu00a0anu00a0outeru00a0protectiveu00a0coatu00a0consistingu00a0ofu00a0a combinationu00a0ofu00a0acrylicu00a0basedu00a0resins,u00a0Eudragitu00a0Su00a0(methacrylicu00a0acidu00a0and methyl methacrylate copolymeru00a0(1:2),u00a0NF)u00a0andu00a0Eudragitu00a0L (methacrylicu00a0acidu00a0and methyl methacrylate copolymeru00a0(1:1),u00a0NF).u00a0Theu00a0inneru00a0coatu00a0consistsu00a0ofu00a0anu00a0acrylicu00a0basedu00a0resin,u00a0Eudragitu00a0S,u00a0which dissolvesu00a0atu00a0pHu00a07u00a0oru00a0greater,u00a0releasingu00a0mesalamineu00a0inu00a0theu00a0terminalu00a0ileumu00a0andu00a0beyondu00a0foru00a0topicalu00a0anti- inflammatoryu00a0actionu00a0inu00a0theu00a0colon.u00a0Mesalamineu00a0(alsou00a0referredu00a0tou00a0asu00a05-aminosalicylicu00a0acidu00a0oru00a05-ASA)u00a0has the chemicalu00a0name 5-amino-2-hydroxybenzoicu00a0acid;u00a0itsu00a0structuralu00a0formulau00a0is:
  • Inactive Ingredients:
  • No data
  • No data
  • The efficacy of Asacol HD at 4.8 grams per day was studied in a six-week, randomized, double-blind, active-controlled study in 772 patients with moderately active ulcerative colitis (UC). Moderately active UC was defined as a Physicianu2019s Global Assessment (PGA) score of 2; the PGA is a four-point scale (0 to 3) that encompasses the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy findings.
  • Patientsu00a0wereu00a0randomizedu00a01:1u00a0tou00a0theu00a0Asacolu00a0HDu00a04.8u00a0grams per dayu00a0groupu00a0(twou00a0Asacolu00a0HDu00a0tabletsu00a0threeu00a0timesu00a0a day)u00a0oru00a0theu00a0mesalamine delayed-releaseu00a02.4u00a0grams per dayu00a0groupu00a0(twou00a0mesalamine delayed-releaseu00a0400u00a0mgu00a0tabletsu00a0threeu00a0timesu00a0au00a0day).u00a0
  • Patientsu00a0characteristicallyu00a0hadu00a0au00a0historyu00a0ofu00a0previousu00a0useu00a0ofu00a0oralu00a05-ASAsu00a0(86%),u00a0steroidsu00a0(41%), andu00a0rectalu00a0therapiesu00a0(49%),u00a0andu00a0demonstratedu00a0clinicalu00a0symptomsu00a0ofu00a0threeu00a0or moreu00a0stools overu00a0normalu00a0peru00a0dayu00a0(87%)u00a0andu00a0obviousu00a0bloodu00a0inu00a0theu00a0stoolu00a0mostu00a0oru00a0allu00a0ofu00a0theu00a0timeu00a0(70%).u00a0The studyu00a0populationu00a0wasu00a0primarilyu00a0Caucasianu00a0(97%),u00a0hadu00a0au00a0meanu00a0ageu00a0ofu00a043u00a0yearsu00a0(8%u00a0agedu00a065 yearsu00a0oru00a0older),u00a0andu00a0includedu00a0slightlyu00a0moreu00a0malesu00a0(56%)u00a0thanu00a0femalesu00a0(44%).
  • Theu00a0primaryu00a0endpointu00a0wasu00a0treatmentu00a0successu00a0definedu00a0asu00a0improvementu00a0fromu00a0baselineu00a0tou00a0Weeku00a06u00a0basedu00a0on theu00a0PGA.u00a0Treatmentu00a0successu00a0ratesu00a0wereu00a0similaru00a0inu00a0theu00a0twou00a0groups:u00a070%u00a0inu00a0theu00a0Asacolu00a0HDu00a0groupu00a0andu00a066%u00a0inu00a0theu00a0Asacolu00a0groupu00a0(difference:u00a05%;u00a095%u00a0CI:u00a0[-1.9%,u00a011.2%]).
  • Au00a0secondu00a0controlledu00a0studyu00a0supportedu00a0theu00a0efficacyu00a0ofu00a0Asacolu00a0HDu00a0atu00a04.8u00a0grams per day.u00a0Treatmentu00a0successu00a0wasu00a072%u00a0inu00a0patientsu00a0withu00a0moderatelyu00a0activeu00a0UCu00a0treatedu00a0withu00a0Asacolu00a0HD.
  • Asacoln HDu00a0(mesalamine)u00a0delayed-releaseu00a0tabletsu00a0areu00a0availableu00a0asu00a0red-brown,u00a0capsule-shapedu00a0tablets containingu00a0800u00a0mg mesalamineu00a0andu00a0imprintedu00a0withu00a0u201cWCu00a0800u201du00a0inu00a0black.
  • Nn- DCn- u00a0n- u00a0
  • Protect from moisture. Tablets can be dispensed without desiccant for up to 6 weeks.
  • Storeu00a0atu00a0controlledu00a0roomu00a0temperature,u00a020u00b0u00a0tou00a025u00b0u00a0C (68u00b0u00a0tou00a077u00b0u00a0F);u00a0excursionsu00a0areu00a0permittedu00a015u00b0u00a0tou00a030u00b0u00a0C (59u00b0u00a0tou00a086u00b0u00a0F).u00a0[Seeu00a0USPu00a0Controlledu00a0Roomu00a0Temperature]
  • Administrationn- u00a0n- [see n- Arrayn- ]
  • u00a0n
  • Mesalamine-Induced Acute Intolerance Syndrome
  • Hypersensitivity Reactions
  • Hepatic Failure
  • Blood Disorders
  • Distributed by:Allergan USA, Inc.Madison, NJ 07940
  • u00a9 2018u00a0Allergan. All rights reserved.
  • Patented.u00a0 See
  • Asacolu00ae is a registered trademark of Medeva Pharma Suisse AG, licensed to Allergan Pharmaceuticals International Limited.
  • Principal Display Panel

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