®BUPROPION, ZYBUTRIN
Zybutrin 150 Extended Release
Bupropion Hydrochloride
Antidepressant, Smoking cessation adjunct
(±)-2-(tert-butylamino)-3'-chloripropiophenone hydrochloride
C13H18ClNOHCl=276.2
Bupropion is presumed to be mediated to noradrenergic and/or dopaminergic effects. Bupropion is a weak inhibitor of the neuronal uptake of norepinephrine, serotonin. Bupropion does not inhibit monoamine oxidase.
Indications:
Bupropion hydrochloride is indicated for the treatment of major depressive disorder
Contraindication:
1-Exept under special circumstances, this medication should not be used when the following medical problems exist:
Abrupt discontinuation of alcohol or sedatives, anorexia nervosa or history of, bulimia or history of, hypersensitivity to bupropion or its component, seizure disorder.
2-The use of MAOIs concomitantly with bupropion hydrochloride or within 14 days of discontinuing treatment with bupropion hydrochloride is contraindicated.
Warnings & Precautions:
1-Risk-benefit should be considered when the following medical problems exist: Bipolar disorder or risk of, CNS tumor, Head trauma, Neurologic impairment, History of spontaneous seizures, heart disease, hepatic function impairment, renal function
impairment, hypertension, depressed psychosis especially schizoaffective disorder.
2-White blood cell count may be decreased by 10 to 14% during the first 2 monthes of therapy
3-Careful supervision of depressed patients including those with: Abnormal behaviors (i.e,agitation, panic attacks, hostility) good patient management is recommended to decrease the risk of overdose; consideration should be given to
changing the therapeutic regimen, including possibly discontinuing the medicine, in patients whose depression is persistently worse or whose emergent sociality or other symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
4-Monitoring Blood pressure recommended in patients who are using a nicotine transdermal system concurrently with bupropion and in patients with baseline hypertension.
Pregnancy:
FDA Pregnancy Category B
Bupropion hydrochloride should be used during pregnancy only if clearly needed.
Breast feeding:
Bupropion accumulates in breast milk, and the potential exists for serious adverse reaction in the infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance
of the drug to the mother.
Drug interactions:
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance Alcohol, Hepatic cytochrome P450 enzyme
Inducers, Hepatic cytochrome P450 enzyme inhibitors, levodopa, MOA inhibitors, Nicotine, Ritonavir seizure threshold lowering medications such as tricyclic antidepressants.
Adverse Reactions:
Those indicating need for medical attention: agitation, anxiety, severe headache, skin rash, hives, itching, tinnitus those indicating need for medical attention only if
they continue or bothersome: Abdominal pain, anorexia, constipation, dizziness, dryness of mouth, insomnia, excessive sweating, nausea/vomiting, tremor, myalgia,
pharyngitis, unusual weight loss, blurred vision, palpitation, taste perversion, unusual feeling of well-being, urinary frequency
Over dosage:
Seizure; hallucinations, loss of consciousness, sinus tachycardia, nausea and vomiting.
Dosage & Administration:
• Usual adult and adolescent dose:
Depression (treatment)
Initial dose: 150 mg orally once a day in the morning, increase if necessary after 4 days to 300 mg orally once a day. Max dose: 450 mg orally once a day For Smoking Cessation: Initial dose: 150 mg orally once a day for 3 days, increased to 150 mg orally twice a day Maximum dose: Maximum total daily dose should not exceed
300 mg; maximum single dose should not exceed 150 mg
Usual pediatric dose:
Safety and efficacy have not been established in children younger than 18 years of age.
Storage:
Store at controlled room temperature ,below 30°C, protect from humidity and direct light.
How supplied:
This medicine is an extended release tablet of 150 mg Bupropion Hydrochloride
Release