Trientine Tetrahydrochloride
Generic Name: trientine tetrahydrochloride
Brand Names:
Cuvrior
11 DESCRIPTION CUVRIOR contains trientine tetrahydrochloride which is a salt of trientine, a copper chelator. The structural formula of trientine tetrahydrochloride is: Molecular Formula C 6 H 22 Cl 4 N 4 Molecular Weight 292.08 g mol -1 CUVRIOR (trientine tetrahydrochloride) tablets are for oral administration and contain 300 mg of trientine tetrahydrochloride (equivalent to 150 mg trientine).
Overview
11 DESCRIPTION CUVRIOR contains trientine tetrahydrochloride which is a salt of trientine, a copper chelator. The structural formula of trientine tetrahydrochloride is: Molecular Formula C 6 H 22 Cl 4 N 4 Molecular Weight 292.08 g mol -1 CUVRIOR (trientine tetrahydrochloride) tablets are for oral administration and contain 300 mg of trientine tetrahydrochloride (equivalent to 150 mg trientine).
Uses
1 INDICATIONS AND USAGE CUVRIOR is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. CUVRIOR is a copper chelator indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Recommended Dosage and Administration Starting total daily dosage of CUVRIOR in adults is 300 mg up to 3,000 mg orally in divided doses (2 times daily). See full prescribing information for recommended conversion table when switching from penicillamine to CUVRIOR. ( 2.1 ) Total daily dosage of CUVRIOR should not exceed 3,000 mg. ( 2.1 ) If the number of CUVRIOR tablets prescribed per day cannot be equally divided among doses, then divide total daily dosage such that the higher number of tablets is taken with the first daily dose. ( 2.1 ) Take CUVRIOR on an empty stomach. ( 2.2 ) Swallow tablets without crushing, chewing, or dissolving tablets.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Potential for Worsening of Clinical Symptoms at Initiation of Therapy [see Warnings and Precautions (5.1) ] Copper Deficiency [see Warnings and Precautions (5.2) ] Iron Deficiency [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (>5%) are abdominal pain, change of bowel habits, rash, alopecia, and mood swings. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orphalan at 1-800-961-8320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Mineral Supplements (e.g. iron, zinc, calcium, magnesium): Avoid concomitant use. If concomitant use is unavoidable ( 2.2 , 7.1 ): Iron : Take CUVRIOR at least 2 hours before or 2 hours after iron. Other Mineral Supplements : Take CUVRIOR at least 1 hour before or 2 hours after other mineral supplements. Other Drugs for Oral Administration : Take CUVRIOR at least 1 hour apart from any other oral drug. ( 2.2 , 7.1 ) 7.1 Mineral Supplements and Other Oral Drugs CUVRIOR has the potential to chelate non-copper cations in mineral supplements and other oral drugs, and could be rendered ineffective prior to systemic absorption.
Warnings
5 WARNINGS AND PRECAUTIONS Potential for Worsening of Clinical Symptoms at Initiation of Therapy : May include neurological deterioration. Adjust dosage or discontinue CUVRIOR if clinical condition worsens. ( 5.1 ) Copper Deficiency : Periodic monitoring is required. ( 5.2 ) Iron Deficiency : If iron deficiency develops, a short course of iron supplementation may be given. ( 5.3 , 7.1 ) Hypersensitivity Reactions : If rash or other hypersensitivity reaction occurs, consider discontinuing CUVRIOR. ( 5.4 ) 5.1 Potential for Worsening of Clinical Symptoms at Initiation of Therapy Worsening of clinical symptoms, including neurological deterioration, may occur at the beginning of CUVRIOR therapy due to mobilization of excess stores of copper. 4 CONTRAINDICATIONS CUVRIOR is contraindicated in patients with hypersensitivity to trientine or to any of the excipients in CUVRIOR [see Warnings and Precautions (5.4) ] . Hypersensitivity to trientine or to any of the excipients in CUVRIOR. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience over several decades with use of trientine for the treatment of Wilson's disease have not identified any drug-associated risks for major birth defects, miscarriages, or other adverse maternal or fetal outcomes. Untreated Wilson's disease may result in worsening disease symptoms during pregnancy and increase the risk of miscarriages in some symptomatic patients (see Clinical Considerations ) .
Storage
Store at a controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) are permitted [see USP Controlled Room Temperature] .
Frequently Asked Questions
What is Trientine Tetrahydrochloride used for?▼
1 INDICATIONS AND USAGE CUVRIOR is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. CUVRIOR is a copper chelator indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. ( 1 )
What are the side effects of Trientine Tetrahydrochloride?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Potential for Worsening of Clinical Symptoms at Initiation of Therapy [see Warnings and Precautions (5.1) ] Copper Deficiency [see Warnings and Precautions (5.2) ] Iron Deficiency [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (>5%) are abdominal pain, change of bowel habits, rash, alopecia, and mood swings. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orphalan at 1-800-961-8320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Trientine Tetrahydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience over several decades with use of trientine for the treatment of Wilson's disease have not identified any drug-associated risks for major birth defects, miscarriages, or other adverse maternal or fetal outcomes. Untreated Wilson's disease may result in worsening disease symptoms during pregnancy and increase the risk of miscarriages in some symptomatic patients (see Clinical Considerations ) .
What are the important warnings for Trientine Tetrahydrochloride?▼
5 WARNINGS AND PRECAUTIONS Potential for Worsening of Clinical Symptoms at Initiation of Therapy : May include neurological deterioration. Adjust dosage or discontinue CUVRIOR if clinical condition worsens. ( 5.1 ) Copper Deficiency : Periodic monitoring is required. ( 5.2 ) Iron Deficiency : If iron deficiency develops, a short course of iron supplementation may be given. ( 5.3 , 7.1 ) Hypersensitivity Reactions : If rash or other hypersensitivity reaction occurs, consider discontinuing CUVRIOR. ( 5.4 ) 5.1 Potential for Worsening of Clinical Symptoms at Initiation of Therapy Worsening of clinical symptoms, including neurological deterioration, may occur at the beginning of CUVRIOR therapy due to mobilization of excess stores of copper. 4 CONTRAINDICATIONS CUVRIOR is contraindicated in patients with hypersensitivity to trientine or to any of the excipients in CUVRIOR [see Warnings and Precautions (5.4) ] . Hypersensitivity to trientine or to any of the excipients in CUVRIOR. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.