Nivalin 5mg Sopharma tablets treat intellectual dementia, Alzheimer (1 blister x 20 tablets)

Dosage form Box of 1 blister x 20 tablets
Specifications Galantamin HBr

Ingredient

Composition information	Content
Galantamin HBr	5mg

Uses

Indications

Nivalin 5mg drugs are indicated in the following cases: Treatment of mild to medium dementia in Alzheimer's disease.

Pharmacokology

galantamin is an acetylcholininininin inhibitor that is competitive and recovered. Galantamin is inversely attached and active acetylcholininininininisterase, thus inhibiting acetylcholin hydrolysis, increasing acetylcholin levels at Synap Cholinergic. In addition, the drug also increases the activity of acetylcholin on nicotinic receptors.

The lack of acetycholin in the cerebral cortex, fillings and horses is considered one of the premature pathological characteristics of Alzheimer, causing dementia of wisdom and cognitive impairment. Anti -cholinesterase such as galantamin increases acetycholin content, which reduces the development of the disease. The effects of galantamin may decrease as the disease progresses and only a few acetycholin secretions are still active.

pharmacokinetic

galantamin is absorbed quickly and completely. The use of the drug when used by oral is about 90%. Food does not affect the area under the curve (AUC) but the maximum concentration (CMAX) decreased by about 25% and the time of achieving the concentration of the communal house (TMAX) is about 1.5 hours behind. The drug reaches the top concentration after 1 hour.

galantamin binds to low plasma proteins, about 18%. The average distribution of the drug is 175L.

galantamin metabolizes in the liver through cytochrom P450 (mainly due to isenzyme 2D6 and 3A4) and glucuronic complex.

About 20% galantamin eliminates the kidneys in a constant form within 24 hours in people with normal kidney function (indicating the renal clearance of 65ml/minute), about 20-25% of the whole blood removal is 300ml/min. The half -life of Galantamin is 5 - 7 hours.

Hepatic failure

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

kidney failure

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

Elderly

Galantamin concentration is higher than healthy people 30-40%.

Before taking Nivalin 5mg Sopharma tablets treat intellectual dementia, Alzheimer (1 blister x 20 tablets)

How to use

Use Nivalin 5mg Oral.

Dosage

daily dose 1 tablet/time x 2 times/day, preferably at breakfast and dinner. Maintain for 4 weeks, then the dose may increase to 2 tablets/time x 2 times/day. The increased dose depends on the response of each patient. Increase the dose only when the doctor is indicated.

For people with an average level of liver failure

Do not use exceeding 3 tablets/day. Do not use for severe liver failure.

For patients with renal impairment average

Do not use exceed 3 nivalin 5mg/day. Do not use for patients with severe renal failure.

Treatment time

The treatment time varies within a few weeks to several years depending on the condition and the patient's tolerance. In the case of side effects, the dose should be reduced or stop treatment with nivalin for 2-3 days and then start again with lower dose. If the nivalin is stopped for a long time, when the treatment should be started, it should start at the lowest dose and then increase gradually to reach the optimal maintenance dose.

Should consult your doctor if you have stopped with nivalin for a long time.

Note: Nivalin 5mg 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 using nivalin overdose 5mg?

Symptoms

Nausea, vomiting, gastrointestinal spasms, diarrhea, increased secretion (watery eyes, runny nose, increased salivation, sweat), slow heart rate, hypotension, convulsions, muscle paralysis, or muscle spasms, respiratory failure and can be fatal.

Handling

Detoxification specific with anti -cholinergic drugs such as intravenous atropine starts from 0.5 to 1.0mg, until the response. At the same time, use treatments to support common poisoning. It is unknown whether galantamin and metabolites are removed by zero fertilizer (abdominal, artificial kidney).

What to do when forgetting a dose?

When you forget to use the drug, you should use that dose as soon as you remember. However, if you are close to the next dose time, you should skip the forgotten dose and continue to use according to the normal course.

Side Effects

When using nivalin, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nausea, vomiting, diarrhea, anorexia, weight loss, abdominal pain, indigestion.

Uncommon, 1/1000

Cardiovascular: Slow heart rate, posture hypotension, heart failure, atrial block, suspense, atrial fibrillation, extended QT interval, branch block, tachycular, fainting.

Gastrointestinal: indigestion, gastritis - intestines, gastrointestinal bleeding, difficulty swallowing, increased secretion of saliva, hiccups.

Central nervous system: dizziness, fatigue, headache, tremor, muscle jerky, convulsions, depression, insomnia, sleep, confusion, psychotic syndrome.

Urinary urinary: Unable to restrain, urinate many times, urinate at night, urinate, urinary tract infection, urinary retention, kidney stones.

Metabolism: hyperglycemia, alkaline phosphatase.

Other: Anemia, bleeding, erythema, nosebleeds, thrombocytopenia, rhinitis.

Rare, ADR

perforation of the esophagus.

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.

Warnings

Before using Nivalin 5mg, you need to read the instructions carefully and refer to the information below.

Contraindicated

Nivalin drugs contraindicated in the following cases:

Sensitive to any ingredients of the drug.

Severe liver failure (Child - Pugh> 9).

Severe kidney failure (Creatinin bar below 9ml/minute).

Do not use for children because they have not yet determined the effective safety dose.

Patients simultaneously impaired many liver and kidney functions.

Be cautious when using

as well as other cholinergic stimulants, need to be carefully used galantamin on the following objects:

On the cardiovascular system: The drug causes a slow heart rate, atrial atrial block, so it is necessary to be especially cautious for people with arrhythmia on ventricular and people who are taking drugs that slow heart rate. Unwanted effect on the heart should be cautious with any object.

On the digestive system: The drug increases gastric secretion, should be used cautiously on high -risk subjects such as people with a history of stomach -duodenal ulcer, who are taking nonsteroidal anti -inflammatory drugs (NSAIDs).

On the urinary system: Due to the impact on the cholinergic system, the drug can cause urination.

On the nervous system: The drug has the ability to increase the risk of seizures, secondary epilepsy due to the stimulation of the cholinergic system.

On the respiratory system: The drug causes an impact on the cholinergic system, so it must be cautious for people with a history of asthma or chronic obstructive pulmonary disease.

Be cautious when using galantamin for people with liver failure or mild to moderate kidney failure.

Be cautious when anesthesia uses Succinylcholin and other neuropectory medications in people who are taking galantamin because this drug can increase the effects of muscle relaxants.

The ability to drive and operate machinery

Precautions when used for operators of machinery, train driving, higher working people and other cases because the drug can cause dizziness, drowsiness.

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

When anesthesia: Galantamin is similar to the Succinylcholin muscle relaxants used in surgery.

anti -cholinergic drugs: antagonistic to the effect of galantamin.

Cholinergic stimulants (Cholinergic owner or cholinergic inhibitors): The synonymous effect when used simultaneously.

Non -steroid anti -inflammatory drugs (NSAIDS): Galantamin causes increased gastrointestinal secretion of NSAIDs, increasing the risk of gastrointestinal bleeding.

Medications that slow heart rate like digoxin and beta inhibitors: There is likely to interact with galantamin.

Pharmacokinetic interaction

Cytochrom P450 induction or inhibition may change galantamin metabolism, causing pharmacokinetic interaction.

cimetidin, paroxetin: increase the area under the concentration curve- time of galantamin.

Amitriptylin, fluoxetin, fluvoxamine, quininin: reducing galantamin clearance.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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