April 30, 2017
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Forfivo XL

"April 8, 2015 -- A new study ties antidepressants to a higher risk for first-time seizures in people being treated for depression.

Older antidepressants called tricyclics were the only type not linked to the raised risk, say researchers fro"...

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Forfivo XL

Overdosage
Contraindications

OVERDOSE

Human Overdose Experience

Overdoses of up to 30 g or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG changes such as conduction disturbances or arrhythmias. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.

Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.

Overdosage Management

Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference (PDR). Call 1-800-222-1222 or refer to www.poison.org.

There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose.

CONTRAINDICATIONS

  • FORFIVO XL is contraindicated in patients with a seizure disorder [see WARNINGS AND PRECAUTIONS].
  • FORFIVO XL is contraindicated in patients treated currently with other bupropion products because the incidence of seizure is dose dependent [see WARNINGS AND PRECAUTIONS].
  • FORFIVO XL is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because a higher incidence of seizures was observed in such patients treated with bupropion [see WARNINGS AND PRECAUTIONS].
  • FORFIVO XL is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
  • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with FORFIVO XL or within 14 days of discontinuing treatment with FORFIVO XL is contraindicated. There is an increased risk of hypertensive reactions when FORFIVO XL is used concomitantly with MAOIs. The use of FORFIVO XL within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting FORFIVO XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and DRUG INTERACTIONS].
  • FORFIVO XL is contraindicated in patients with known hypersensitivity to bupropion or the other ingredients of FORFIVO XL tablets. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [see WARNINGS AND PRECAUTIONS].
This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/10/2016

Overdosage
Contraindications

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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