Medication info
NicotinPion Sustained Release Tablet 150 mg (Bupropion Hydrochloride)

NicotinPion Sustained Release Tablet 150 mg (Bupropion Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Bupropion Hydrochloride›150mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
A white, round film-coated tablet that is convex on both sides
Packaging
60 tablets/box (10 tablets/PTPX6)
Approval status
Active

MFDS item code 200801900 · Approved 2008.02.18 · Insurance code 643504100

Summary

Main use
Adjunctive treatment of nicotine dependence during smoking cessation; treatment of depression
Who takes it
Adults · Children
Adult dose
This drug should be swallowed whole; do not crush, split, or chew it. Doing so may increase the risk of adverse reactions, including seizures. - Short-term adjunctive treatment for nicotine dependence when stopping smoking 1. Adults Start this drug while the patient is still smoking. It is recommended that the "target quit date" be set within the first 2 weeks after starting this drug, most often in the second week. The initial dose is 150mg once daily for 6 days, then increase to 150mg twice daily. Doses must be separated by at least 8 hours. The maximum single dose should not exceed 150mg, and the total daily dose should not exceed 300mg. Patients should be treated with this drug for at least 7 weeks. If the patient has not made significant progress toward quitting by week 7 of treatment, they are unlikely to stop smoking during that quit attempt, and discontinuation of this drug should be considered. ·Combination therapy of this drug with a nicotine patch No dosage adjustment is necessary when this drug is used in combination with a nicotine patch to treat nicotine dependence. Combination therapy with the nicotine patch should begin on the target quit date. Before combination treatment, the physician should be thoroughly familiar with the prescribing information for this drug and the nicotine patch. - Depression 1. Initial dose The target usual dose of this drug 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 doses separated by at least 8 hours. 2. Increasing the dose to 300mg/day or higher As with other antidepressants, the antidepressant effect of this drug may not become clearly apparent for 4 weeks or longer. For patients whose symptoms have not improved after several weeks at a dose of 300mg/day, an increase to a maximum of 400mg/day (200mg twice daily) may be considered. 3. Maintenance dose It is generally accepted that pharmacotherapy for an acute episode of depression should continue for several months or longer after treatment of the acute episode. Long-term efficacy was demonstrated in a randomized study of patients with recurrent major depression who had responded to 8 weeks of acute treatment with this drug and were given either placebo or the same dose of this drug (150mg twice daily) as maintenance therapy for 44 weeks. The limited results of this study do not establish whether the dose of this drug required for maintenance therapy is the same as that needed to achieve the initial response. Therefore, patients should be reassessed regularly to determine whether maintenance therapy is needed and what dose is appropriate. ·Patients with hepatic impairment Use this drug with extreme caution in patients with severe cirrhosis; in these patients, the dose should not exceed 100mg daily or 150mg every other day. This drug should be used with caution in patients with hepatic impairment (including mild to moderate cirrhosis). In patients with mild to moderate cirrhosis, a reduction in dosing frequency and/or dose should be considered. ·Patients with renal impairment This drug should be used with caution in patients with renal impairment; a reduction in dosing frequency and/or dose should be considered.
Child dose
The safety and efficacy of this drug in patients under 18 years of age have not yet been established.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment of nicotine dependence during smoking cessation; treatment of depression

  • Nicotine dependence
  • depression
View approved original text

This medication is used to help quit smoking and overcome nicotine dependence. It also aids in the treatment of depression. In other words, it is used for smoking cessation assistance and depression treatment.

How to take

Adult dose

This drug should be swallowed whole; do not crush, split, or chew it. Doing so may increase the risk of adverse reactions, including seizures. - Short-term adjunctive treatment for nicotine dependence when stopping smoking 1. Adults Start this drug while the patient is still smoking. It is recommended that the "target quit date" be set within the first 2 weeks after starting this drug, most often in the second week. The initial dose is 150mg once daily for 6 days, then increase to 150mg twice daily. Doses must be separated by at least 8 hours. The maximum single dose should not exceed 150mg, and the total daily dose should not exceed 300mg. Patients should be treated with this drug for at least 7 weeks. If the patient has not made significant progress toward quitting by week 7 of treatment, they are unlikely to stop smoking during that quit attempt, and discontinuation of this drug should be considered. ·Combination therapy of this drug with a nicotine patch No dosage adjustment is necessary when this drug is used in combination with a nicotine patch to treat nicotine dependence. Combination therapy with the nicotine patch should begin on the target quit date. Before combination treatment, the physician should be thoroughly familiar with the prescribing information for this drug and the nicotine patch. - Depression 1. Initial dose The target usual dose of this drug 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 doses separated by at least 8 hours. 2. Increasing the dose to 300mg/day or higher As with other antidepressants, the antidepressant effect of this drug may not become clearly apparent for 4 weeks or longer. For patients whose symptoms have not improved after several weeks at a dose of 300mg/day, an increase to a maximum of 400mg/day (200mg twice daily) may be considered. 3. Maintenance dose It is generally accepted that pharmacotherapy for an acute episode of depression should continue for several months or longer after treatment of the acute episode. Long-term efficacy was demonstrated in a randomized study of patients with recurrent major depression who had responded to 8 weeks of acute treatment with this drug and were given either placebo or the same dose of this drug (150mg twice daily) as maintenance therapy for 44 weeks. The limited results of this study do not establish whether the dose of this drug required for maintenance therapy is the same as that needed to achieve the initial response. Therefore, patients should be reassessed regularly to determine whether maintenance therapy is needed and what dose is appropriate. ·Patients with hepatic impairment Use this drug with extreme caution in patients with severe cirrhosis; in these patients, the dose should not exceed 100mg daily or 150mg every other day. This drug should be used with caution in patients with hepatic impairment (including mild to moderate cirrhosis). In patients with mild to moderate cirrhosis, a reduction in dosing frequency and/or dose should be considered. ·Patients with renal impairment This drug should be used with caution in patients with renal impairment; a reduction in dosing frequency and/or dose should be considered.

Child dose

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

Precautions

This medication may increase the risk of suicidal thoughts or behavior when treating psychiatric disorders, so caution should be exercised by the doctor when administering it, especially to young patients aged 18 to 24. Patients should be monitored frequently during treatment for signs of worsening depression or unusual behaviors such as suicidal thoughts or aggression. The use of this medication is not approved for children and adolescents, so patients under 18 years of age should not take it. Patients taking this medication for smoking cessation may also experience serious psychiatric symptoms such as depression or suicidal thoughts; if these symptoms occur, consult a physician immediately. This medication carries a risk of seizures, so patients with a history of seizures or risk factors for seizures must consult a doctor before use and should not exceed the recommended dosage. Patients with impaired liver or kidney function may have increased risk of side effects due to difficulty in metabolism and excretion of this medication, thus requiring careful monitoring and dosage adjustments. Patients with cardiovascular disease should also exercise caution while taking this medication and report any unusual symptoms to their doctor immediately. This medication can cause allergic reactions, so if symptoms such as hypersensitivity, itching, rash, or difficulty breathing occur while taking it, immediately discontinue use and consult a physician. Judgment and motor skills may be impaired, hence caution is required while driving or operating machinery during treatment. This medication should not be crushed or chewed, and it should be swallowed whole, taken in two divided doses daily, with dosage increases done gradually to reduce the risk of seizures. It should not be taken in conjunction with other bupropion-containing medications, as there may be drug interaction potential, and if taking other medications, the doctor must be informed. Women who are pregnant or planning to become pregnant should consult a physician prior to taking this medication, and nursing mothers should either discontinue breastfeeding or consider stopping the medication since it can be transmitted through breast milk. Overdosage can lead to seizures, loss of consciousness, and other serious side effects; therefore, the prescribed dosage must be strictly adhered to, and if an overdose is suspected, immediate medical attention is required. This medication should be kept out of reach of children, and it is safest not to transfer it to other containers.

Side effects

Suicidal thoughts, suicidal ideation, suicidal behavior, depression, hostility, aggression, anger, depressed mood, anxiety, insomnia, dream disturbances, anxiety, attention deficit, dizziness, irritability, tremors, discomfort, rhinitis, increased cough, pharyngitis, sinusitis, shortness of breath, nasal bleeding, reaction at the patch application site, rash, itching, urticaria, taste disturbances, tinnitus, nausea, dry mouth, constipation, diarrhea, loss of appetite, oral ulcers, thirst, abdominal pain, myalgia, arthralgia, headache, infection, weakness, chest pain, pain, fever, flushing, tachycardia, elevated blood pressure, orthostatic hypotension, vasodilation, syncope, hypotension, abnormal dreams, memory impairment, paresthesia, anxiety, restlessness, confusion, delusions, paranoid thinking, hallucinations, irritability, depersonalization, Parkinsonism, dystonia, ataxia, convulsions, coordination difficulties, blood sugar disorders, weight loss, elevated liver enzyme levels, jaundice, hepatitis, frequent urination, urinary retention, angioedema, shortness of breath, bronchospasm, anaphylactic shock, visual disturbances, vaginal bleeding, urinary tract infection, 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, petechial hemorrhage, anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia, petechial papular rash, alopecia, dermatitis, hirsutism, pupillary abnormality, dry eye, hearing loss, double vision, increased intraocular pressure, pupillary dilation, chills, musculoskeletal chest pain, photophobia, fatigue, orthostatic hypotension, stroke, complete heart block, ectopic beats, myocardial infarction, phlebitis, pulmonary edema, liver dysfunction, bruxism, gastroesophageal reflux, gingivitis, glossitis, increased salivation, gastritis, tongue swelling, colitis, esophagitis, gastrointestinal bleeding, gingival bleeding, liver damage, pancreatitis, gastric ulcer, leg cramps, muscle rigidity, rhabdomyolysis, muscle weakness, coordination abnormality, decreased libido, discomfort, emotional instability, hyperactivity, excessive muscle tension, sensory loss, suicidal ideation, dizziness, amnesia, ataxia, derealization, hypomania, abnormal EEG, inability to move, aphasia, coma, suicide, delirium, dysarthria, movement disorders, muscle tone abnormalities, relief, extrapyramidal syndrome, reduced physical activity, increased libido, manic response, neuralgia, neuropathy, paranoid thinking, suicide attempts, tardive dyskinesia, bronchospasm, pneumonia, bipolar disorder, confusion, drowsiness, muscle rigidity, seizures, coma, movement disorders, paralysis, vomiting, diabetes, fractures, shortness of breath, menorrhagia, alcohol addiction, skin diseases, insomnia, headache, dizziness, weakness, dyspepsia, dream disturbances, palpitations, irritability, delirium, muscle rigidity, hallucinations, confusion, diarrhea, erectile dysfunction, discomfort, anxiety, vomiting, chest pain, pharyngitis, visual disturbances, weight loss

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

Storage

This medication should be stored in a tightly sealed container that blocks light, and the temperature should be maintained below 25 degrees Celsius. Storing it this way helps maintain its effectiveness.

Appearance and packaging

Appearance

A white, round film-coated tablet that is convex on both sides

Package unit

60 tablets/box (10 tablets/PTPX6)

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

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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.