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BACLOFEN injection, solution

  1. Patient Information
  2. Manufactured For:
  3. Manufactured By:

Patient Information 

Risks Related to Sudden Withdrawal of Baclofen

Advise patients and caregivers that sudden withdrawal of baclofen, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death. Inform patients that early symptoms of baclofen withdrawal may include increased spasticity, itching, and tingling of extremities. If baclofen withdrawal or a pump malfunction is suspected, patients should be brought immediately to a hospital for assessment and treatment.

Inform patients and caregivers that sudden withdrawal occurs most frequently due to a delivery problem with the catheter or the pump, or failure to refill the pump on schedule. Advise patients and their caregivers to pay careful attention to infusion system alarms. Instruct patients and caregivers that if they miss their scheduled pump refill, they should immediately contact their physician to reschedule the refill before the pump runs out of drug.

Baclofen Overdose

Inform patients and their caregivers that baclofen overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma. If an overdose appears likely, patients should be brought immediately to a hospital for assessment and possible emptying of the pump.

Operation of Automobiles and Other Dangerous Machinery

Advise patients that baclofen may cause drowsiness, and that they should exercise caution regarding the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness.

Increased Risk of Drowsiness with Alcohol and Other CNS Depressants

Inform patients and their caregivers that the drowsiness associated with baclofen use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their physician about all prescription and nonprescription drugs they may use.

SynchroMed is a trademark of Medtronic, Inc.

Manufactured For: 

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Manufactured By: 

Mylan Laboratories Limited

Bangalore, India

MAY 2018

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