Oral solution 4mg CPC1HN to treat peripheral neuropathy (4 blisters x 5 tubes)

ATC code: n06da04.

galantamin, an alkaloid is a selective and reversible inhibitor of acetylcholininesterase. In addition, galantamin enhances acetylcholin activities on nicotinic receptors, which can be linked to a receptor site. Thus, the increase in activity in the cholinergic system is associated with improving cognitive function that can be achieved in patients with dementia of Alzheimer diseases.

pharmacokinetics

galantamin absorbs quickly and completely. The use of the drug when used by oral is about 90%. The bioavailability of tablets is like the bioavailability of oral solution. Food does not affect the area under the curve (AUC) but the maximum concentration (CMAX) decreased by about 25% and the time of reaching the peak concentration (TMAX) is about 1.5 hours behind. The drug achieves the peak concentration after 1 hour.

galantamin binds to low plasma proteins, about 18%. Brain concentration in the brain is 2-3 times higher in plasma.

galantamin metabolizes in the liver through cytochrom P450 (mainly due to isenzyme CYP2D6 and CYP3A4) and glucuronic complex. The half -life of galantamin is 7 - 8 hours. After 7 days, most of the oral dose is found in urine, about 6% is found in feces, about 20-30% of the dose excreted through urine in the form of unchanged.

Hepatic failure: In medium liver failure people, after taking a dose of galantamin, galantamin clearance is reduced by 25% compared to normal people.

Renal failure: After a single dose of 8 mg, AUC increased by about 37% in medium renal failure and 67% in people with severe renal failure compared to normal people.

Elderly: Galantamin concentration in plasma is 30-40%higher than healthy people.

recommended starting dose: 4 mg/time x 2 times/day, within 4 weeks.

Maintenance dose

During the drug, it is necessary to regularly evaluate the dose, tolerance and clinical benefits of the drug, preferably within 3 months after the beginning of treatment. Continue to maintain treatment if the drug has a good effect and a good tolerance with galantamin. Consider stopping the drug if not effective on patients.

Starting dose: 8 mg/time x 2 times/day, should be maintained for at least 4 weeks.

Then, consider increasing the treatment dose to maintain 12 mg/time x 2 times/day after the clinical response and patient tolerance.

For patients who do not see increased response or tolerance when increasing the dose of 24 mg/day (12 mg/time x 2 times/day), the decrease of the dose up to 16 mg/day (8 mg/time x 2 times/day) should be considered.

For patients with liver failure:

In general, the level of doses for patients with average liver failure (Child -Pugh 7 - 9) should not exceed 16 mg/day.

It is not recommended to use in patients with severe liver failure (Child -Pugh 10 - 15).

For patients with renal failure:

Dosage for patients with medium renal failure should not exceed 16 mg/day. Not recommended in patients with severe renal failure (CLCR

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Symptoms

Nausea, vomiting, gastric spasms, saliva secretion, watery eyes, urination, defecation, sweating, slow heartbeat, hypotension, vascular collapse and convulsions, bronchospasm, torsion, extension of QT, slow heartbeat, ventricular tachycardia and temporary loss of consciousness.

Management

As in any case of overdose, general support measures should be used. In severe cases, anti -cholinergic drugs as atropine can be used as an antidote. The starting dose of 0.5 - 1.0 mg intravenously, with the next dose based on clinical response.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Notify the physician with unwanted effects when using the drug.

Be cautious when using

Please see more information about the drug in the instruction sheet of the use of the drug attached.

Heart disorders

Patients with sinus syndrome or heart -transmitting disorders on ventricular or in users of drug products that reduce heart rate such as digoxin and beta blockers or patients with electrolyte disorders.

Be careful when taking galantamin for patients with cardiovascular disease, such as the first stage after myocardial infarction, atrial fibrillation, unstable angina, or congestive heart failure, especially NYHA III - IV.

Gastrointestinal disorders

It is necessary to monitor symptoms for patients at high risk of peptic ulcer, such as people with a history of disease or high -risk subjects, including nonsteroidal anti -inflammatory drug users (NSAIDs).

It is not recommended to use in patients with gastritis or after stomach surgery.

Nervous system disorders

Galantamin can cause seizures and worsen the symptoms of Parkinson's disease.

It is necessary to consider carefully before taking galantamin for patients with stroke.

Respiratory, chest and mediastinum disorders

Special monitoring must be monitored when taking galantamin for patients with a history of severe asthma or obstructive pulmonary disease or active lung infection (such as pneumonia).

Kidney and urinary disorders

Galantamin's use is not recommended in patients with urine obstruction or recovery after bladder surgery.

Surgery

galantamin has the ability to increase the activity of Succinyl Cholin causing muscle dilatation during anesthesia, especially in the case of lack of pseudocholines-ASE.

Authority warning:

The drug uses sorbitol, patients with rare genetic disorders in fructose tolerance should not be used.

In the ingredient that uses sodium methyl paraben and sodium propyl paraben can cause allergic reactions.

Monitoring the patient's weight: Patients treated with cholinesterase inhibitors, including galantamin, may lose weight. Therefore, it is necessary to monitor the weight of the patient during treatment.

The effect of the drug on the ability to drive and operate machinery

The drug affects the ability to drive and operate machinery because it can cause dizziness, rare can cause visual and hearing hallucinations.

Use drugs for women during pregnancy and lactation

Pregnant women

There is no information on using galantamin in pregnant women. Animal research shows reproductive toxicity. Be careful when using galantamin for pregnant women.

breastfeeding women

There is no research on whether Galantamin is excreted in breast milk or not. So women use galantamin should not breastfeed.

Drug interaction

should not use galantamin simultaneously with other drugs that have another choline (cholinimetic) effect such as Ambenonium, Donepezil, Neostigmin, Pyridostigmin, Rivastigmin or Pilocarpin have systemic effects.

galantamin has the ability to fight the effect of anti -cholinergic drugs. Therefore, the sudden stopping of anticholinergic drugs such as atropin will cause the potential risk of galantamin's side effects. Pharmaceutical interaction with drugs may significantly reduce heart rate such as digoxin, beta blockers, calcium channel blocking agents.

Caution with drugs capable of causing torsion.

Galantamin's bioavailability increases by about 40% when used simultaneously with paroxetin (a powerful CYP2D6 inhibitor) and 30% and 12% in treatment with ketoconazol and erythromycin (both CYP3A4 inhibitors). Therefore, when starting treatment with strong CYP2D6 inhibitors (such as Quinidin, paroxetin, or Fluowetin) or CYP3A4 (such as ketoconazol or ritonavir), patients may increase the rate of cholinergic adverse reactions, mainly nausea and vomiting. In this case, based on tolerance, galantamin dose reduction should be adjusted accordingly.