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COLESEVELAM HYDROCHLORIDE powder, for suspension


  1. Hypertriglyceridemia And Pancreatitis:
  2. Gastrointestinal:
  3. Drug And Vitamin Interactions:
  4. Hypertriglyceridemia And Cardiovascular Disease:
  5. Females Of Reproductive Potential:
  6. Distributed By:
  7. For Oral Suspension:
  8. Manufactured By:
  9. Manufactured For:

Hypertriglyceridemia And Pancreatitis: 


Inform patients that colesevelam hydrochloride may increase their serum triglycerides which can lead to hypertriglyceridemia and pancreatitis. Instruct patients to discontinue colesevelam hydrochloride and seek prompt medical attention if the symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting)[see Warnings and Precautions (5.1)]

Gastrointestinal: 


Inform patients that colesevelam hydrochloride may cause bowel obstruction. Instruct patients to promptly discontinue colesevelam hydrochloride and seek medical attention if severe abdominal pain or severe constipation occurs[see Warnings and Precautions (5.2)].

Drug And Vitamin Interactions: 


Advise patients that colesevelam hydrochloride has drug interactions and colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins A, D, E, and K. Instruct patients to take oral vitamins at least 4 hours prior to colesevelam hydrochloride. Instruct patients to inform their physician about all the drugs and vitamins that they are prescribed or take over the counter[see Warnings and Precautions (5.3) and Drug Interactions (7)].

Hypertriglyceridemia And Cardiovascular Disease: 


Inform patients that colesevelam hydrochloride may increase serum triglycerides and that the long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain[see Warnings and Precautions (5.1)]

Administration [see Dosage and Administration (2.4)]:
Tablets: Advise patients to take colesevelam hydrochloride tablets with a meal and liquid. Inform patients that colesevelam hydrochloride tablets can be taken as 6 tablets once daily or 3 tablets twice daily

Females Of Reproductive Potential: 


Advise females of reproductive potential that colesevelam hydrochloride may reduce the effectiveness of oral contraceptives, and to take oral contraceptives at least 4 hours before taking colesevelam hydrochloride[see Drug Interactions (7) and Use in Specific Populations (8.3)].


cole-logo

Manufactured in India by:
Alkem Laboratories Limited
H.O.: ALKEM HOUSE,
Senapati Bapat Marg, Lower Parel,
Mumbai 400 013, INDIA

Distributed By: 


Ascend Laboratories, LLC
Parsippany, NJ 07054

Revised: July, 2019

PT 2768-01

For Oral Suspension: 

Instruct patients to empty the entire contents of one packet into a glass or cup and add 1 cup (8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink. Advise patients to take colesevelam hydrochloride oral suspension with meals. Advise patient to not take colesevelam hydrochloride oral suspension in its dry form.

Manufactured By: 

Glenmark Pharmaceuticals Limited

Plot No S-7, Colvale Industrial Estate,

Colvale-Bardez, Goa - 403 513,

India

Manufactured For: 

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

USA

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

July 2019



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