Medication info
Exeliba Capsule 4.5 mg (Rivastigmine Tartrate)

Exeliba Capsule 4.5 mg (Rivastigmine Tartrate)

Prescription medicationHard capsuleOral
Ingredient · strength
Rivastigmine Tartarate›7.2mg / 1 capsule
Manufacturer / importer
Daewoong Bio Co., Ltd.
Appearance
A hard capsule with white-yellowish powder inside, red in the lower part.
Packaging
28 capsules (14 capsules/PTP X 2)
Approval status
Active

MFDS item code 201805127 · Approved 2018.12.17 · Insurance code 694002080

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 and administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day, and the dose should be increased at intervals of at least 2 weeks for each patient to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6mg per day and higher, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine 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 occur, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the last well-tolerated dose. 2. Treatment of symptoms 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 3~12mg per day in two divided doses. (1.5~6mg per dose twice daily.). The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between doses, and according to the patient's tolerability, the dose may then be increased consecutively to 3mg twice daily, followed by 4.5mg twice daily, and then to 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (for example, tremor) occur during treatment, withholding one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the last well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg of this medicine orally twice daily. 4. Re-administration The incidence 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.
Child dose
This medicine has not been studied in children; therefore, its use in children is not recommended.

Ingredients

Manufacturer
Daewoong Bio 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
  • Parkinson's-related dementia symptoms
View approved original text

This medication is used for the treatment of symptoms of mild to moderate Alzheimer's type dementia and Parkinson's-related dementia.

How to take

Adult dose

Dosage and administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day, and the dose should be increased at intervals of at least 2 weeks for each patient to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6mg per day and higher, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine 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 occur, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the last well-tolerated dose. 2. Treatment of symptoms 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 3~12mg per day in two divided doses. (1.5~6mg per dose twice daily.). The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between doses, and according to the patient's tolerability, the dose may then be increased consecutively to 3mg twice daily, followed by 4.5mg twice daily, and then to 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (for example, tremor) occur during treatment, withholding one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the last well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg of this medicine orally twice daily. 4. Re-administration The incidence 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.

Child dose

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

Precautions

This medication contains the ingredient Rivastigmine and should not be administered to certain patients. For example, patients with allergies to this medication, those with severe liver dysfunction, or those with a history of skin allergic reactions during the use of this medication's patch should avoid its use. It should be used with caution in patients with heart disease, peptic ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders, as these patients require special attention. This medication can cause side effects such as gastrointestinal disturbances, dizziness, headache, drowsiness, tremors, cardiac abnormalities, skin rashes, and fatigue. Especially, gastrointestinal symptoms such as nausea, vomiting, and diarrhea are commonly reported, and in some patients, serious problems such as severe ulcer or pancreatitis may occur. When starting treatment or increasing dosage, side effects may be more pronounced, so dosage should be adjusted slowly. Furthermore, in patients with dementia related to Parkinson's disease, motor symptoms may worsen, so close observation is necessary. This medication may have interactions when used with other cholinergic or anticholinergic drugs, so consult a doctor or pharmacist before co-administration. Special caution is needed especially when used with anesthetics, beta-blockers, and drugs that prolong the QT interval. For women who are pregnant or breastfeeding, safety has not been adequately established for this medication, so it should be decided cautiously after consulting with a doctor if necessary. It is also not recommended for children. In case of overdose, severe vomiting, bradycardia, confusion, and seizures may occur, and immediate medical attention should be sought for appropriate treatment. This medication should be kept out of reach of children, and it is advisable not to transfer it to another container. During treatment, it is important to regularly monitor the patient's weight and adverse reactions.

Side effects

  • nausea
  • vomiting
  • urinary tract infection
  • agitation
  • confusion
  • nightmares
  • anxiety
  • insomnia
  • depression
  • hallucinations
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  • dizziness
  • headache
  • drowsiness
  • tremors
  • fainting
  • seizures
  • extrapyramidal symptoms
  • angina
  • myocardial infarction
  • deep vein thrombosis
  • 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
  • weight loss
  • abnormal liver function test results
  • Stevens-Johnson syndrome
  • tremors
  • bradykinesia
  • dyskinesia
  • cogwheel rigidity
  • exercise intolerance
  • bradycardia
  • atrial fibrillation
  • heart block
  • decreased appetite
  • dehydration
  • increased perspiration
  • gait disturbance
  • hypertension
  • hypotension
  • incontinence
  • cerebrovascular accident
  • delirium
  • erythema
  • hives
  • blisters
  • allergic dermatitis
  • tremor
  • somnolence
  • confusional state
  • saliva secretion
  • hypotension
  • respiratory depression
  • muscle weakness
  • fainting
  • lethargy
  • aggressiveness
  • restlessness
  • motor function deficiency syndrome
  • hepatitis
  • allergic dermatitis
  • sensory disturbance
  • personality disorder
  • inability to sit still
  • confusion
  • stupor
  • pneumonia
  • sepsis

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is recommended to be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer duration.

Appearance and packaging

Appearance

A hard capsule with white-yellowish powder inside, red in the lower part.

Package unit

28 capsules (14 capsules/PTP X 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.