Medication info

Rivawins Capsule 1.5 mg (Rivastigmine Tartrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Rivastigmine Tartarate›Strength being verified
Manufacturer / importer
Cosmax Pharma Co., Ltd.
Appearance
A hard capsule of white to pale yellow powder, with a yellow lower part.
Packaging
28 capsules (2 PTP of 14 capsules each)
Approval status
Approval withdrawn

MFDS item code 201902392 · Approved 2019.04.17

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of symptoms of mild to moderate Alzheimer-type dementia and Parkinson's disease-related dementia
Who uses it
Adults · Children
Adult dosage
Dosage and administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer-type dementia The initial dose is 3 mg of rivastigmine daily, and the dose should be increased at intervals of at least 2 weeks for each patient to the highest tolerated dose or the maximum recommended dose of 12 mg daily. Since this medicine showed greater efficacy at doses of 6 mg daily and higher in clinical trials, a target dose range of 6~12 mg daily is recommended for most patients. Recommended dose titration After administering 1.5mg of this medicine twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. Subsequent increases may be made by administering 4.5mg twice daily and, if well tolerated for at least 2 weeks, increasing 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, the daily dose should be reduced to the dose that was previously well tolerated. 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, 3~12mg of rivastigmine daily was administered twice daily. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg of this medicine twice daily, and at intervals of at least 4 weeks between doses, the dose may subsequently be increased sequentially according to the patient's tolerability to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight loss, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, omitting one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reducing the daily dose to the previously well-tolerated dose or discontinuing treatment may be considered. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Reinitiation of treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart treatment 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.
Children's dosage
This medicine has not been studied in children; therefore, its use in children is not recommended.

Ingredients

Manufacturer
Cosmax Pharma Co., Ltd.

Efficacy & effects

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

  • Mild Alzheimer-type dementia symptoms
  • moderate Alzheimer-type dementia symptoms
  • mild dementia symptoms related to Parkinson's disease
  • moderate dementia symptoms related to Parkinson's disease.
View approved original text

This medication is used to treat mild to moderate symptoms of Alzheimer-type dementia. It is also effective for symptoms of dementia that occur in patients with mild to moderate Parkinson's disease. By treating these two major dementia symptoms, it helps improve patients' cognitive function and quality of daily life. Therefore, it is used to alleviate symptoms of dementia associated with Alzheimer's and Parkinson's disease.

Dosage and Administration

Adult dosage

Dosage and administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer-type dementia The initial dose is 3 mg of rivastigmine daily, and the dose should be increased at intervals of at least 2 weeks for each patient to the highest tolerated dose or the maximum recommended dose of 12 mg daily. Since this medicine showed greater efficacy at doses of 6 mg daily and higher in clinical trials, a target dose range of 6~12 mg daily is recommended for most patients. Recommended dose titration After administering 1.5mg of this medicine twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. Subsequent increases may be made by administering 4.5mg twice daily and, if well tolerated for at least 2 weeks, increasing 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, the daily dose should be reduced to the dose that was previously well tolerated. 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, 3~12mg of rivastigmine daily was administered twice daily. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg of this medicine twice daily, and at intervals of at least 4 weeks between doses, the dose may subsequently be increased sequentially according to the patient's tolerability to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight loss, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, omitting one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reducing the daily dose to the previously well-tolerated dose or discontinuing treatment may be considered. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Reinitiation of treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart treatment 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.

Children's dosage

This medicine has not been studied in children; therefore, its use in children is not recommended.

Precautions

This medication should not be used in patients who are allergic to the active ingredient, Rivastigmine, or any other component. It should not be administered to patients with severely impaired liver function due to lack of experience with its use in such cases. Patients who experienced allergic contact dermatitis with the transdermal patch form of this medication should not use this drug. Caution should be exercised in patients with a history of heart disease, peptic ulcers, duodenal ulcers, asthma, obstructive pulmonary diseases, urinary retention, seizures, or extrapyramidal disorders. Gastrointestinal side effects can occur frequently with this medication, and extra caution is especially needed when initiating treatment or adjusting dosages. Women may experience gastrointestinal side effects and weight loss more frequently. Neurological and psychiatric adverse reactions such as dizziness, headache, drowsiness, tremors, anxiety, insomnia, depression, and hallucinations can occur. Cardiac side effects including bradycardia, angina pectoris, myocardial infarction, and arrhythmias have been rarely reported. Gastrointestinal issues such as nausea, vomiting, diarrhea, loss of appetite, abdominal pain, dyspepsia, peptic ulcers, and gastrointestinal bleeding may occur. Skin reactions such as increased sweating, rashes, and itching can also appear. This medication may have enhanced effects or interactions when used with other cholinergic drugs, requiring caution. It is particularly necessary to discontinue the medication for a period before anesthesia, and using it with beta-blockers can increase the risk of bradycardia. The safety of this medication during pregnancy has not been sufficiently established, so it should only be used when the benefits outweigh the potential risks to the fetus. During breastfeeding, it is recommended to discontinue breastfeeding due to the possibility of this drug being excreted in breast milk. Safety and efficacy in children have not been established, so the use of this medication in children is not recommended. Overdosage can result in symptoms such as nausea, vomiting, diarrhea, dizziness, tremors, headache, bradycardia, and confusion, which may require immediate medical treatment if severe. This medication should be kept out of the reach of children and should not be transferred to other containers for safety. Regular monitoring of the patient's weight, cardiac status, and gastrointestinal symptoms during treatment is important.

Side effects

  • Nausea
  • vomiting
  • dizziness
  • headache
  • drowsiness
  • tremor
  • agitation
  • confusion
  • anxiety
  • insomnia
Show 66 more
  • depression
  • hallucination
  • fainting
  • convulsion
  • angina pectoris
  • myocardial infarction
  • bradycardia
  • atrioventricular block
  • atrial fibrillation
  • tachycardia
  • hypertension
  • diarrhea
  • loss of appetite
  • abdominal pain
  • indigestion
  • gastric ulcer
  • duodenal ulcer
  • gastrointestinal bleeding
  • pancreatitis
  • esophageal rupture
  • increased sweating
  • rash
  • itching
  • fatigue
  • weakness
  • lethargy
  • falls
  • abnormal liver function test values
  • mucocutaneous syndrome
  • bradykinesia
  • dyskinesia
  • cogwheel rigidity
  • hypokinesia
  • decreased appetite
  • dehydration
  • increased perspiration
  • gait disturbance
  • urinary incontinence
  • cerebrovascular accident
  • delirium
  • erythema
  • hives
  • blisters
  • allergic dermatitis
  • constipation
  • inability to sit cross-legged
  • sensory disturbances
  • confusion
  • stupor
  • pneumonia
  • sepsis
  • aggression
  • restlessness
  • dissociative syndrome
  • hepatitis
  • salivary gland secretion
  • sialorrhea
  • muscle tone abnormalities
  • muscle rigidity
  • balance disorder
  • musculoskeletal rigidity
  • stiffness
  • movement disorders
  • antiemetic
  • hypersomnia
  • confusional state

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and the storage temperature should be maintained between 1 to 30 degrees Celsius to preserve its effectiveness.

Appearance and packaging

Appearance

A hard capsule of white to pale yellow powder, with a yellow lower part.

Package unit

28 capsules (2 PTP of 14 capsules each)

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.