Medication info
Monsti Capsule 1.5 mg (Rivastigmine Tartrate)

Monsti Capsule 1.5 mg (Rivastigmine Tartrate)

Prescription medicationHard capsuleOral
Ingredient · strength
Rivastigmine Tartarate›2.4mg / 1 capsule
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
A yellow hard capsule containing white to off-white powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201606084 · Approved 2016.10.14 · Insurance code 653005870

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
Administration: Rivastigmine is administered orally twice daily with breakfast and the evening meal. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer's type The initial dose is 3 mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Since this medicine showed greater efficacy at doses of 6 mg per day and higher in clinical trials, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration After administering 1.5 mg per dose twice daily for at least 2 weeks, the dose may be increased to 3 mg per dose twice daily if well tolerated. Subsequent increases may be made to 4.5 mg per dose twice daily, followed by 6 mg per dose twice daily after at least 2 weeks if well tolerated. 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 dementia associated with Parkinson's disease In a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12 mg per day in 2 divided doses (1.5~6 mg per dose twice daily). The initial dose is 1.5 mg per dose twice daily. At intervals of at least 4 weeks between dose levels, the dose may subsequently be increased in succession according to patient tolerability to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and then 6 mg per dose 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, omitting one or several doses 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 6 mg per dose orally twice daily. 4. Restarting treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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 medicine has not been studied in children; therefore, its use is not recommended in children.

Ingredients

Manufacturer
Korea Pharma Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat symptoms of mild to moderate Alzheimer's type dementia and dementia symptoms related to Parkinson's disease.

How to take

Adult dose

Administration: Rivastigmine is administered orally twice daily with breakfast and the evening meal. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer's type The initial dose is 3 mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Since this medicine showed greater efficacy at doses of 6 mg per day and higher in clinical trials, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration After administering 1.5 mg per dose twice daily for at least 2 weeks, the dose may be increased to 3 mg per dose twice daily if well tolerated. Subsequent increases may be made to 4.5 mg per dose twice daily, followed by 6 mg per dose twice daily after at least 2 weeks if well tolerated. 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 dementia associated with Parkinson's disease In a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12 mg per day in 2 divided doses (1.5~6 mg per dose twice daily). The initial dose is 1.5 mg per dose twice daily. At intervals of at least 4 weeks between dose levels, the dose may subsequently be increased in succession according to patient tolerability to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and then 6 mg per dose 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, omitting one or several doses 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 6 mg per dose orally twice daily. 4. Restarting treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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 medicine has not been studied in children; therefore, its use is not recommended in children.

Precautions

This medication should not be used in patients with allergies to certain components. It should be avoided in patients with severely impaired liver function as safety has not been established. Patients with a history of skin allergic reactions to the patch form of this medication should also avoid its use. Patients with heart disease or conditions such as peptic ulcer, asthma, obstructive pulmonary disease, urinary retention, seizures, and extrapyramidal disorders should use this medication with caution. This medication can commonly cause gastrointestinal side effects such as nausea, vomiting, and diarrhea; therefore, caution is needed during the initial stage of treatment and when increasing the dosage. Neuropsychiatric adverse reactions such as dizziness, drowsiness, headache, and tremors may also occur, so caution is required when driving or operating machinery. In Parkinson's disease patients, motor symptoms may worsen, and consultation with a physician is necessary if such symptoms occur. Weight loss may occur during treatment, thus regular monitoring of weight changes is important. This medication may interact with other cholinergic drugs, so it is essential to inform healthcare providers about concomitant medications. Pregnant or breastfeeding women should consult with a physician before taking this medication as its safety has not been fully established. Not recommended for children, and in cases of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, requiring immediate medical attention. This medication should be stored out of reach of children and not transferred to other containers for safety.

Side effects

  • Nausea
  • vomiting
  • urinary tract infection
  • agitation
  • confusion
  • nightmares
  • anxiety
  • insomnia
  • depression
  • hallucinations
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  • dizziness
  • headache
  • drowsiness
  • tremors
  • syncope
  • seizures
  • extrapyramidal symptoms
  • angina
  • myocardial infarction
  • deep vein thrombosis
  • hypertension
  • diarrhea
  • loss of appetite
  • abdominal pain
  • dyspepsia
  • gastric ulcer
  • duodenal ulcer
  • gastrointestinal bleeding
  • pancreatitis
  • esophageal rupture
  • increased sweating
  • rash
  • itching
  • fatigue
  • weakness
  • lethargy
  • falls
  • weight loss
  • abnormal liver function test results
  • Stevens-Johnson syndrome
  • tremors
  • hypersomnia
  • hypokinesia
  • movement disorders
  • cogwheel rigidity
  • bradykinesia
  • bradycardia
  • atrial fibrillation
  • heart block
  • decreased appetite
  • dehydration
  • increased perspiration
  • gait disturbance
  • hypertension
  • hypotension
  • incontinence
  • cerebrovascular accident
  • delirium
  • erythema
  • urticaria
  • blisters
  • allergic dermatitis
  • tremors
  • headache
  • hypersomnia
  • confusion
  • lethargy
  • saliva secretion
  • sweating
  • hypotension
  • respiratory depression
  • muscle weakness
  • syncope
  • aggression
  • restlessness
  • dysautonomia
  • hepatitis
  • allergic dermatitis
  • sensory disturbances
  • personality disorder
  • inability to sit still
  • delirium
  • confusion
  • pneumonia
  • sepsis

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be kept between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

A yellow hard capsule containing white to off-white powder

Package unit

30 capsules/bottle, 100 capsules/bottle

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.