Medication info
Osgmin Capsule 1.5mg (Rivastigmine Tartrate)

Osgmin Capsule 1.5mg (Rivastigmine Tartrate)

Prescription medicationHard capsuleOral
Ingredient · strength
Rivastigmine Tartarate›2.4mg / 1 capsule
Manufacturer / importer
Os Korea Pharmaceutical Co., Ltd.
Appearance
Hard capsule containing white to pale yellow powder with yellow upper and lower parts
Packaging
28 capsules/box [(14 capsules/PTP*2)]
Approval status
Active

MFDS item code 201901785 · Approved 2019.03.26

Summary

Main use
Treatment of symptoms of mild to moderate Alzheimer-type dementia and dementia associated with Parkinson's disease
Who takes it
Adults · Children
Adult dose
Dosage: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Because this drug showed greater efficacy in clinical trials at doses of 6mg per day and above, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration Administer 1.5mg of this drug twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg twice daily and, if well tolerated, after at least 2 weeks, to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss are observed, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previously well-tolerated dose. 2. Treatment of mild to moderate symptoms of dementia associated with Parkinson's disease In a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day, divided into 2 daily doses (1.5~6mg twice daily). The initial dose is 1.5mg of this drug twice daily. Depending on the patient's tolerability, subsequent doses may be increased at intervals of at least 4 weeks, first to 3mg twice daily, then to 4.5mg twice daily, and then to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, interrupting administration once or several times may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the previously well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6mg of this drug orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.
Child dose
○ Children: This medication has not been studied in children; therefore, its use in children is not recommended.

Ingredients

Manufacturer
Os Korea Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of mild to moderate Alzheimer-type dementia and dementia associated with Parkinson's disease

  • Symptoms of Alzheimer's type dementia
  • dementia symptoms related to Parkinson's disease
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's type dementia and dementia symptoms related to Parkinson's disease that are classified as mild to moderate.

How to take

Adult dose

Dosage: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Because this drug showed greater efficacy in clinical trials at doses of 6mg per day and above, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration Administer 1.5mg of this drug twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg twice daily and, if well tolerated, after at least 2 weeks, to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss are observed, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previously well-tolerated dose. 2. Treatment of mild to moderate symptoms of dementia associated with Parkinson's disease In a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day, divided into 2 daily doses (1.5~6mg twice daily). The initial dose is 1.5mg of this drug twice daily. Depending on the patient's tolerability, subsequent doses may be increased at intervals of at least 4 weeks, first to 3mg twice daily, then to 4.5mg twice daily, and then to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, interrupting administration once or several times may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the previously well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6mg of this drug orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

○ Children: This medication has not been studied in children; therefore, its use in children is not recommended.

Precautions

This drug contains rivastigmine as the active ingredient and should not be administered to certain patients. For example, it should not be used in patients with hypersensitivity to this drug, severe liver impairment, or those who previously developed allergic dermatitis from the transdermal patch of this drug. In addition, patients with a history of heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should use this drug cautiously. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea can commonly occur when taking this medication, particularly during the period of adjusting the dosage. Mental and neurological abnormal reactions such as dizziness, headache, drowsiness, anxiety, depression, and hallucinations have also been reported, so if any of these symptoms occur, immediate consultation with a medical professional is necessary. Care should be taken as motor symptoms may worsen in patients with Parkinson's disease. This drug should be used with caution when combined with other cholinergic medications or anticholinergics, especially because it is recommended to discontinue it for a certain period before anesthesia. Furthermore, since it can affect heart rhythm, additional caution is required for patients with heart-related diseases. Pregnant or nursing women should only use this drug under the judgment of a specialist as its safety has not been fully confirmed; it is better to avoid use during breastfeeding. In case of overdose, symptoms such as vomiting, dizziness, bradycardia, and confusion may occur, and emergency treatment may be necessary in severe cases. Therefore, it is essential to strictly adhere to the prescribed dosage and method of administration. While taking this medication, the patient's condition should be regularly monitored, especially regarding weight loss or cardiovascular symptoms, skin reactions, etc. It is also not recommended for use in children. Lastly, this medication should be stored out of reach of children and not be transferred to other containers for safety.

Side effects

  • area
  • vomiting
  • urinary tract infection
  • agitation
  • confusion
  • nightmares
  • anxiety
  • insomnia
  • depression
  • hallucinations
Show 74 more
  • dizziness
  • headache
  • drowsiness
  • tremors
  • syncope
  • seizures
  • extrapyramidal symptoms
  • angina
  • myocardial infarction
  • deep vein thrombosis
  • bradycardia
  • heart block
  • atrial fibrillation
  • tachycardia
  • hypertension
  • diarrhea
  • loss of appetite
  • abdominal pain
  • dyspepsia
  • gastric ulcer
  • duodenal ulcer
  • gastrointestinal hemorrhage
  • pancreatitis
  • esophageal rupture
  • increased sweating
  • rash
  • itching
  • fatigue
  • weakness
  • lethargy
  • falling
  • weight loss
  • abnormal liver function test values
  • Stevens-Johnson syndrome
  • tremors
  • hypokinesia
  • dyskinesia
  • cogwheel rigidity
  • bradyphrenia
  • decreased appetite
  • dehydration
  • increased perspiration
  • gait disturbance
  • muscular hypertonia
  • hypertension
  • hypotension
  • urinary incontinence
  • cerebrovascular accident
  • delirium
  • erythema
  • hives
  • blisters
  • allergic dermatitis
  • tremor
  • drowsiness
  • confusion
  • salivation
  • hypotension
  • respiratory depression
  • muscle weakness
  • stupor
  • pneumonia
  • sepsis
  • aggression
  • restlessness
  • dysautonomia
  • hepatitis
  • allergic skin dermatitis
  • sensory disturbances
  • personality disorder
  • inability to sit still
  • upper respiratory infection
  • constipation
  • delirium

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

Storage

Store this medication in a tightly sealed container to protect it from air or moisture, ideally at a temperature between 1 and 30 degrees Celsius. By doing so, the efficacy of the medication can be well maintained.

Appearance and packaging

Appearance

Hard capsule containing white to pale yellow powder with yellow upper and lower parts

Package unit

28 capsules/box [(14 capsules/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

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

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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.