Medication info
Well Sustained Release Tablet (Bupropion Hydrochloride)

Well Sustained Release Tablet (Bupropion Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Bupropion Hydrochloride›150mg / 1 tablet
Manufacturer / importer
Unimed Pharmaceutical Co., Ltd.
Appearance
Round, white, film-coated tablets with a convex surface on both sides
Packaging
28 tablets (14 tablets/PTP × 2)
Approval status
Active

MFDS item code 201605178 · Approved 2016.08.30 · Insurance code 649507320

Summary

Main use
Treatment of depression; short-term adjunctive treatment of nicotine dependence during smoking cessation
Who takes it
Adults · Children
Adult dose
Swallow this medication whole. Do not crush, split, or chew it. Doing so may increase the risk of adverse reactions, including seizures. - Short-term adjunctive treatment of nicotine dependence during smoking cessation Administer 150mg once daily for 6 days as the initial dose, then increase to 150mg twice daily. Doses should be taken at least 8 hours apart. The maximum dose per administration should not exceed 150mg, and the total daily dose should not exceed 300mg. Patients should receive this medication for at least 7 weeks. Combination therapy with this medication and a nicotine patch No dosage adjustment is necessary when this medication is coadministered with a nicotine patch to treat nicotine dependence. - Depression 1. Initial dose The usual target dose of this medication in adults is 150mg twice daily (300mg/day). Administer 1 tablet once in the morning (150mg/day, 150mg once daily) for at least 4 days. If the patient tolerates it adequately, increase to 1 tablet twice daily (300mg/day, 150mg twice daily), with at least 8 hours between doses. 2. Dose increases above 300mg/day For patients whose symptoms have not improved after several weeks at 300mg/day, an increase to a maximum of 400mg/day (200mg twice daily) may be considered. 3. Maintenance dose Long-term efficacy was demonstrated in a study in which patients with recurrent major depression who responded to 8 weeks of acute treatment with this medication were randomized to placebo or the same dose of this medication (150mg twice daily) as maintenance therapy for 44 weeks. ·Patients with hepatic impairment Use this medication with extreme caution in patients with severe cirrhosis, and do not exceed 100mg per day or 150mg every 2 days in these patients. Use this medication with caution in patients with hepatic impairment (including mild to moderate cirrhosis); in patients with mild to moderate cirrhosis, consider reducing the frequency and/or dose. ·Patients with renal impairment Use this medication with caution in patients with renal impairment, and consider reducing the frequency and/or dose.
Child dose
The safety and efficacy of this medication in patients under 18 years of age have not been established.

Ingredients

Manufacturer
Unimed Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of depression; short-term adjunctive treatment of nicotine dependence during smoking cessation

  • Nicotine dependence
  • depression
View approved original text

This medication is used as an adjunctive treatment for nicotine dependence in individuals who are trying to quit smoking, as well as for the treatment of depression. It primarily alleviates the physical and psychological symptoms related to smoking cessation, contributing to increased success rates in quitting. Thus, it is effective for overcoming withdrawal symptoms and improving mood in individuals attempting to quit smoking. For these reasons, it is used in the treatment of smoking cessation and depression.

How to take

Adult dose

Swallow this medication whole. Do not crush, split, or chew it. Doing so may increase the risk of adverse reactions, including seizures. - Short-term adjunctive treatment of nicotine dependence during smoking cessation Administer 150mg once daily for 6 days as the initial dose, then increase to 150mg twice daily. Doses should be taken at least 8 hours apart. The maximum dose per administration should not exceed 150mg, and the total daily dose should not exceed 300mg. Patients should receive this medication for at least 7 weeks. Combination therapy with this medication and a nicotine patch No dosage adjustment is necessary when this medication is coadministered with a nicotine patch to treat nicotine dependence. - Depression 1. Initial dose The usual target dose of this medication in adults is 150mg twice daily (300mg/day). Administer 1 tablet once in the morning (150mg/day, 150mg once daily) for at least 4 days. If the patient tolerates it adequately, increase to 1 tablet twice daily (300mg/day, 150mg twice daily), with at least 8 hours between doses. 2. Dose increases above 300mg/day For patients whose symptoms have not improved after several weeks at 300mg/day, an increase to a maximum of 400mg/day (200mg twice daily) may be considered. 3. Maintenance dose Long-term efficacy was demonstrated in a study in which patients with recurrent major depression who responded to 8 weeks of acute treatment with this medication were randomized to placebo or the same dose of this medication (150mg twice daily) as maintenance therapy for 44 weeks. ·Patients with hepatic impairment Use this medication with extreme caution in patients with severe cirrhosis, and do not exceed 100mg per day or 150mg every 2 days in these patients. Use this medication with caution in patients with hepatic impairment (including mild to moderate cirrhosis); in patients with mild to moderate cirrhosis, consider reducing the frequency and/or dose. ·Patients with renal impairment Use this medication with caution in patients with renal impairment, and consider reducing the frequency and/or dose.

Child dose

The safety and efficacy of this medication in patients under 18 years of age have not been established.

Precautions

This drug may increase the risk of suicidal thoughts or behaviors in young individuals with major depressive disorder or psychiatric illnesses; therefore, physicians must carefully assess the need and risks of treatment. Patients of all ages taking this medication should be closely monitored for changes in behavior such as worsening depression, suicidal tendencies, or aggression, and family members or caregivers should be advised to closely observe the patient's condition. This drug is not approved for use in children and adolescents. Even when used for smoking cessation, serious psychiatric adverse events such as depression, suicidal thoughts, and suicide attempts have been reported; therefore, careful observation of changes in patient behavior is essential. This drug should not be co-administered with other bupropion-containing products and should be used with caution or avoided in patients with a history of seizures or a high risk of seizures. Patients with impaired liver or kidney function may experience elevated drug concentrations; thus, dose adjustments and close monitoring are needed. Caution is also necessary when administering to patients with cardiovascular diseases. If an allergic reaction occurs during treatment, use should be immediately discontinued and a physician consulted. This medication can cause a variety of side effects, including insomnia, anxiety, restlessness, headache, dizziness, nausea, loss of appetite, rash, tremors, tinnitus, and others, so if any unusual symptoms appear, consultation with healthcare professionals is advised. Minimizing or avoiding alcohol consumption during treatment is recommended, and any concurrent medications should be discussed with a healthcare provider to consider potential interactions. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and it is advised to avoid this drug while breastfeeding. This drug may affect judgment or motor skills, so caution should be exercised during driving or operating machinery. In case of overdose, serious side effects such as seizures, loss of consciousness, and arrhythmias may occur; thus, adherence to prescribed dosages is crucial. Keep out of reach of children and avoid transferring to other containers.

Side effects

Suicidal impulses, suicidal thoughts, suicide attempts, depression, anxiety, hostility, aggression, anger, worsened nicotine withdrawal symptoms, nausea, dry mouth, constipation, diarrhea, loss of appetite, oral ulcers, thirst, muscle pain, joint pain, insomnia, abnormal dreams, anxiety, concentration difficulties, dizziness, irritability, tremors, discomfort, rhinitis, increased cough, pharyngitis, sinusitis, shortness of breath, nosebleed, patch site reactions, rash, itching, urticaria, dysgeusia, tinnitus, frequent urination, headache, infection, lethargy, chest pain, pain, fever, flushing, tachycardia, increased blood pressure, orthostatic hypotension, vasodilation, fainting, hypotension, abnormal dreams, memory impairment, paresthesia, headache, anxiety, restlessness, confusion, delusions, paranoid thinking, hallucinations, irritability, depersonalization, Parkinsonism, dystonia, ataxia, spasms, inability to coordinate, blood sugar disorders, weight loss, elevated liver enzyme levels, jaundice, hepatitis, angioedema, bronchospasm, anaphylactic shock, joint pain, fever, erythema multiforme, Stevens-Johnson syndrome, visual impairment, vaginal bleeding, urgent urination, urinary tract infection, migraine, injury from accidents, acne, increased appetite, low back pain, bronchitis, dysmenorrhea, dyspepsia, intestinal gas retention, influenza symptoms, hypertension, neck pain, weight gain, dysphagia, vomiting, spasms, drowsiness, hypersensitivity, decreased memory, central nervous system stimulation, paranoid thinking, irritability, drowsiness, delirium, muscle rigidity, depression, hallucinations, confusion, diarrhea, erectile dysfunction, discomfort, vomiting, chest pain, shortness of breath, pharyngitis, weight loss, chills, facial swelling, musculoskeletal chest pain, photophobia, fatigue, postural hypotension, stroke, complete atrioventricular block, ectopic beats, myocardial infarction, thrombophlebitis, pulmonary edema, hepatic dysfunction, bruxism, gastroesophageal reflux, gingivitis, stomatitis, increased saliva secretion, tongue swelling, colitis, esophagitis, gastrointestinal bleeding, gum bleeding, liver damage, pancreatitis, gastric ulcer, leg cramps, muscle rigidity, rhabdomyolysis, muscle weakness, coordination problems, decreased libido, discomfort, emotional instability, hyperactivity, excessive muscle tension, sensory loss, suicidal thoughts, dizziness, memory loss, ataxia, derealization, hypomania, abnormal EEG, motor impairment, aggression, aphasia, coma, suicide, delirium, delusions, dysarthria, movement disorders, dystonia, relief of tension, extrapyramidal syndrome, hypokinesia, increased libido, manic reactions, neuralgia, neuropathy, restlessness, suicide attempts, tardive dyskinesia, bronchospasm, pneumonia, erectile dysfunction, polyuria, prostate disorders, ejaculation abnormalities, cystitis, dyspareunia, dysuria, gynecomastia, menopause, pain during erection, salpingitis, urinary incontinence, urinary retention, vaginitis, hyperglycemia, hypoglycemia, inappropriate antidiuretic hormone symptoms, edema, peripheral edema, diabetes, petechiae, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia, bleeding, thrombotic complications, papular rash, alopecia, angioedema, exfoliative dermatitis, hypertrichosis, pupillary control disturbances, dry eyes, hearing loss, diplopia, increased intraocular pressure, mydriasis, insomnia, headache, dizziness, nausea, dry mouth, tremors, anxiety, agitation, loss of appetite, abdominal pain, palpitations, pharyngitis, sweating, tinnitus, frequent urination, schizophrenic reactions, Parkinsonism, depersonalization, pancreatitis, complications of intracranial injury, fractures, prostate abnormalities, schizophrenic reactions, communication disorders, complications of intracranial injury, increased sputum, hemoptysis, sleep apnea, skin disorders, dermatitis, decreased urine flow, cerebral hemorrhage, bipolar disorder, pneumonia, alcohol dependence, drowsiness, skin disorders, seizures, coma, movement disorders, paralysis, vomiting, rash, diabetes, shortness of breath

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a special container that does not allow light in. It is also important to keep it at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Round, white, film-coated tablets with a convex surface on both sides

Package unit

28 tablets (14 tablets/PTP × 2)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.