Deruff 4mg Davipharm treat mild to medium dementia (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Galantamin
Ingredient
| Composition information | Content |
| Galantamin | 4mg |
Uses
Indications
Deruff - 4 is indicated in the following cases:
In addition, the drug also increases the activity of acetylcholin on nicotinic receptors. The deficiency of acetylcholin in the cerebral cortex, fillings and horses is considered one of the premature pathological characteristics of Alzheimer's disease, causing dementia and cognitive impairment. Anti -cholinesterase such as galantamin increases acetylcholin content, which reduces the development of the disease. The effect of galantamin may decrease as the disease progresses and only few acetylcholine neurons are still active.
pharmacokinetics
galantamin is an alkaline compound with a liveli electric constant pKa = 8.2. Galantamin steam body oil and distribution coefficient (log p) between n - octanol/buffer solution pH 12 is 1.09. Galantamin's water solubility (pH 6) is 31mg/ml. Galantamin has 3 carbon opposite. Form S, R, S are natural forms. Galantamin is partially metabolized by cytochrom, mainly CYP2D6 and CYP3A4. Some metabolites formed during the galantamin recession shows in vitro activity but does not have the important activity in vivo.
absorption
Galantamin absorbs fast, with TMAX about 1 hour after drinking. The bioavailability of galantamin is high, in the range of 88.5 ± 5.4%. Using drugs with food reduces the absorption rate of the drug and reduces CMAX about 25%, but does not affect the absorption level (AUC).
Distribution
The average distribution volume is 175L. The drug is less associated with plasma proteins, the rate is 18%.
Metabolism
About 75% of galantamin dose is eliminated in the form of metabolites. In vitro research shows that CYP2D6 plays a role in the formation of O-Desmethylgalantamin and CYP3A4 plays a role in the formation of N-Oxyd-Galantamin. The total level of radioactive isotope is eliminated in feces and urine is not different between people with metabolism through CYP2D6 small and high.
In the plasma of people with metabolism through CYP2D6 small and high, galantamin is in a constant form and its glucuronid form occupies most of the radioactive marks. No metabolites have any activity (Norgalantamin, O-Desmethylgalantamin and Odesmethyl-Norgalantamin) can be detected in non-conjugated plasma forms in people with metabolic people in CYP2D6 small and more after single dose.
Norgalantamin was discovered in plasma in patients after repeated dose, but did not account for more than 10% of galantamin concentration. Nghiên cứu in vitro cho thấy khả năng ức chế của galantamin với các dạng chính của cytochrom P450 ở người là rất thấp.
Elimination
Galantamin plasma concentration decreases according to level 2 function, with a half -life of 7-8 hours in healthy objects. The clearance of oral use in patients is about 200ml/minute with the difference between the objects is 30%. Seven days after taking a single dose of 4mg 3H -Galantamin, 90 - 97% of the radioactive dose found in the urine and 2.2 - 6.3% were found in feces.
After intravenous and oral injection, 18-22% of the dose is eliminated in the form of galantamin constant in urine for 24 hours, with renal clearance of 68.4 ± 22.0ml/min, showing 20-25% of the total plasma clearance.
Before taking Deruff 4mg Davipharm treat mild to medium dementia (3 blisters x 10 tablets)
How to use
galantamin is used by oral, twice a day, preferably at breakfast and dinner. Need to ensure adequate use of water during treatment.
Dosage
Adults/Elderly
Before the beginning of treatment: The diagnosis of the type of intellectual dementia due to Alzheimer may occur should be fully determined according to the current clinical instructions.
Starting dose: The recommended starting dose is 8mg/day (4mg used 2 times/day) for 4 weeks.
Maintenance dose: Galantamin tolerance and dose should be re -evaluated regularly, preferably within 3 months after the beginning of treatment. After that, the clinical benefit of Galantamin and the patient's treatment tolerance should be re -evaluated regularly based on current clinical guidelines.
Maintenance treatment can continue as long as the benefits are still good and the patient is tolerated with galantamin treatment. Galantamin should be considered when there is no effect on treatment or patients are no longer tolerated with treatment. The starting dose is 16mg (8mg used 2 times/day) and should hold this dose for at least 4 weeks.
Should consider increasing maintenance dose to 24mg/day (12mg used 2 times/day) in specific cases after fully evaluated including clinical benefits and tolerance.
In patients who do not have an increase in response or in tolerance of 24mg/day, should consider reducing the dose to 16mg/day.
Stop drugs: There is no response reaction after stopping the drug suddenly (such as when preparing surgery).
Patients with renal failure
Galantamin plasma concentration may increase in patients with medium to severe renal failure.
In patients with creatinine clearance ≥ 9ml/min, no need to adjust the galantamin dose.
Contraindicated to use galantamin in patients with creatinine clearance
Patients with liver failure
Galantamin plasma concentrations may increase in medium to severe liver failure patients. In patients with medium -sized liver function (Child -Pugh 7 - 9), based on the pharmacokinetic model, it is recommended that the starting dose is 4mg used once a day, it is best to use in the morning, at least 1 week. After that, the dose should be increased to 4mg used 2 times/day for at least 4 weeks. In these patients, daily dose should not exceed 8mg of use 2 times/day.
In patients with severe liver failure (Child-Pugh> 9), contraindicated use of galantamin. No need to adjust the dose for patients with mild liver failure. Combination treatment in patients treated with strong inhibitors CYP2D6 or CYP3A4, may consider reducing galantamin dose.
Children
galantamin is not specified for children.
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? These effects generally have the participation of the central nervous system, sympathetic nervous system, and the following nervous - muscle.
In addition to myastal or local vibration, there may be some or all signs of cholinergic attacks with symptoms: severe nausea, vomiting, abdominal pain, increased salivation, tearing, urination, defecation, sweating, slow heartbeat, hypotension, stroke and convulsions. Increasing muscle weakness and bronchospasm can lead to serious airway damage.
There was a report after bringing the drug to the market in case of torsion, extending the QT range, slow heart rate, ventricular fastness and loss of consciousness due to the inadvertent of the overdose of Galantamin.
Handling
As other cases of overdose, general support measures should be taken. In severe cases, cholinergic anti -atropine can be used as general antidote for drugs that are similar to cholin. Starting recommendations at a dose of 0.5 - 1mg intravenously, and then adjust the dose by clinical response.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Deruff - 4, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Uncommon, 1/1000 Rare, 1/10,000 ≤ ADR Hepatitis: Hepatitis. Skin and subcutaneous tissue: Stevens-Johnson syndrome, acute, diverse bodyburges. Instructions on how to handle ADR Unwanted effects on the gastrointestinal tract (vomiting, nausea, diarrhea, anorexia, weight loss) are most common and increased by the dose. To reduce these unwanted effects, galantamin should be used at meals, using anti -vomiting drugs, drinking enough water. The drug can cause other unwanted effects, advising patients to notify unwanted effects when taking the drug. When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Deruff - 4 contraindications in the following cases:
Contraindicated galantamin in patients with significant liver and kidney dysfunction.
Precautions when using
Memory loss types
galantamin is indicated for patients with dementia due to mild to severe alzheimer. The benefits of galantamin on the form of intellectual dementia or other memory impairment have not been determined. In 2 clinical trials that lasted for 2 years in patients with mild impaired consciousness (a form of lighter memory impairment, not in the scope of dementia due to Alzheimer), Galantamin does not show any benefits in reducing consciousness or clinical progress to memory loss.
Galantamin mortality rate is significantly higher than the placebo group. The cause of death is very diverse. About 50% of death from galantamin is due to the result of blood vessels (myocardial infarction, stroke and sudden death). It is unclear related to these results for treatment in patients with dementia caused by Alzheimer.
There is no increase in the death rate in the group using galantamin in a long -term, random, placebo -control study in patients with mild to medium alzheimer. The mortality rate in the placebo group is significantly higher than the galantamin group.
Memorial diagnosis should be diagnosed by Alzheimer under the current instructions. Galantamin treatment should be performed under the supervision of a doctor and should only be started if the patient has a caregator who can regularly monitor the patient's medication.
Serious skin reaction
Serious skin reaction (Stevens-Johnson syndrome and acute bodyburges) have been reported in patients using galantamin. Patients should be advised to notify the signs of serious skin reactions and stop taking galantamin as soon as there are signs of first leather rash.
weight monitoring
Patients with Alzheimer lost weight. Treatment with anti -cholinesterase, including galantamin, can cause weight loss in these patients. The patient's weight should be monitored.
Causes need to be cautious
As drugs have other cholin -like effects, should be cautious when taking galantamin in patients with the following conditions:
cardiovascular disorders
Due to its pharmacological effects, the drugs that have the same effect as cholin may have a sympathetic effect on the heartbeat (such as slow heart rate). This effect may be particularly important in patients with sinus syndrome or transmission disorders on the ventricle of other heart or in patients who use with drugs that can significantly reduce heart rate, such as Digoxin and beta blockers or in patients with untreated electrolytes (such as hyperkalemia, hypotension).
Therefore should be cautious when taking galantamin in patients with cardiovascular disease, such as the stage after the heart attack, the new atrial start, the heart block level 2 or higher, unstable angina, or congestive heart failure, especially NYHA level III - IV.
In a mesmerized control study in patients with dementia because Alzheimer is treated with Galantamin, there is an increase in unwanted effect rate on the heart.
Gastrointestinal disorders
Patients with high risk of gastrointestinal ulcers, such as patients with a history of ulcerative disease or patients who are susceptible to this disease, including patients who are being used with nonsteroidal anti -inflammatory drugs (NSAID), should be monitored. It is not recommended to use galantamin in patients with stomach - intestinal obstruction or recovery after stomach -intestinal surgery.
neurological disorders
There have been epilepsy reports when using galantamin. Epilepsy can also be a manifestation of Alzheimer's disease. In rare cases, the increase in the tone of Cholinergic can worsen Parkinson's symptoms. In an analysis of a placebarbaremical control study in patients with dementia treated by Alzheimer with Galantamin, the event on cerebral vascular is rarely seen. Galantamin may be considered in patients with cerebrovascular disease.
respiratory disorders, chest and mediastinum
Be careful when taking the drug that is like cholin in patients with a history of severe bronchial asthma or obstructive pulmonary obstruction or active lung infection (such as pneumonia).
Kidney and urinary disorders
It is not recommended to use galantamin in patients with urinary tract blockages or recovering after bladder surgery.
Surgery
galantamin, as well as drugs that are similar to cholin, often increases the sucinylcholin -style muscle relaxation during anesthesia, especially in the case of a deficiency of pseudocholinesterase.
Autodity warning
Deruff - 4 contains polysorbat 80 that can cause allergies and castor oil can cause nausea, vomiting, abdominal pain, diarrhea. Deruff contains erythrosin color, Sunset Yellow, Brilliant Blue color can cause allergies.
The ability to drive and operate machinery
galantamin has mild to moderate influence on the ability to drive and operate machinery. Symptoms include dizziness and drowsiness, especially in the first week of treatment.
Pregnancy
There is no research on pregnancy. Animal research shows that galantamin slows down the development of fetuses and newborn animals. Be careful when used for pregnant people.
Breastfeeding period
whether or not galantamin has not yet been breastfeeding. However, do not only only use drugs for women during breastfeeding or when using galantamin should not breastfeed.
Drug interaction
Pharmacological interaction
Because of its acting mechanism, Galantamin should not be used with other drugs that are similar to Cholin (such as Ambenonium, Donepezil, Neostigmin, Pyridostigmin, Rivastigmin or Pilocarpin for body use). Galantamin has the ability to fight the effect of anti -cholinergic drugs. If the anti -cholinergic drug is discontinued like a sudden atropine, there is a risk of galantamin that may flare up.
Similar to drugs that are similar to Cholin, Galantamin can interact with pharmacological energy with drugs that significantly reduce heart rate such as digoxin, beta blockers, some calcium and amiodaron channel blockers. Should be cautious when used with drugs that can cause torsion. In these cases, you should consider monitoring the electrocardiogram. Galantamin, as well as other cholin -like drugs, often cause Succinylcholin -style muscle relaxation during anesthesia, especially in the case of pseudocholininesterase deficiency.
Pharmacokinetic interaction
Galantamin elimination has the participation of many different metabolic paths and excreted through the kidneys. The ability to interact with low clinical significance. However, significant interaction may occur in some patients. Sharing galantamin with food slows down the absorption speed but does not affect the level of absorption. It is recommended to use galantamin with food to minimize the unexpected effect of Cholinergic.
Other drugs affect Galantamin metabolism
Official drug interaction research shows that Galantamin bioavailability is about 40% when used with paroxetin (CYP2D6 strong inhibitor), 30% and 12% when used with ketoconazol and erythromycin (CYP3A4 inhibitors). Therefore, the beginning of treatment with strong inhibitors CYP2D6 (such as Quinidin, Paroxetin or Fluoxetin) or CYP3A4 inhibitors (such as ketoconazole or ritonavir) while taking Galantamin, patients may have an increase in unwanted effects of Cholinergic, mainly nausea and vomiting. In these cases, based on tolerance, it is possible to consider reducing galantamin maintenance dose.
Memantin, a N-Methyl-D-Aspartat receptor antagonist (NMDA), at a dose of 10mg used 1 time/day for 2 days and then increases to 10mg used 2 times/day for 12 days, does not affect the pharmacokinetics of Galantamin in a stable state.
The effect of galantamin on the metabolism of other drugs
galantamin at 24mg treatment dose/day does not affect Digoxin's dynamics, although it may still occur pharmacological interactions.
galantamin at the dose of 24mg treatment/day does not affect Warfarin kinetics and prothrombin time.
Storage
Temperature does not exceed 30 ° C.
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