Neuralmin hard capsules 75 Boston Pharma treat neuropathy, epilepsy, anxiety disorder (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Pregabalin

Ingredient

Composition information	Content
Pregabalin	75mg

Uses

Indications

Neuralmin 75 drugs are indicated for adults in the following cases:

Neurological pain: Treatment of peripheral neuropathy and central nerve pain.

Pregabalin has the same structure as acid - aminobutyric (GABA) (acid S - 3 - Aminomethyl - 5 - Methylhexanoic).

Mechanism of action:

Pregabalin is linked to a supporting unit (α2 - Δ protein) of calcium channel depending on the potential in the central nervous system.

pharmacokinetic

absorption

Pregabalin is quickly absorbed when drinking when hungry, the peak concentration in plasma is achieved after 1 hour when using a single or multiple dose. The oral bioavailability of Pregabalin is about 90% and does not depend on the dose. After repeated dose, the stable state of the drug is achieved for 24 - 48 hours. Pregabal absorption rules decreased when used with food, causing CMAX to decrease by about 25-30% and TMAX was extended by about 2.5 hours. However, used with food without any significant clinical effects on the absorption level of Pregabalin.

Distribution

On test animals (mice, monkeys), pregabalin can cross the brain and placenta barriers, as well as appear in milk. In humans, the distribution of pregabalin after oral use is about 0.56 l/kg. Pregabalin does not bind to plasma proteins.

Metabolism

Pregabalin is negligible in the human body. About 98% of oral doses are found in urine in constant form. Premylate derivative of Pregabalin, the main metabolite is found in the urine, accounting for only about 0.9% of the dose. In preclinical studies, there is no sign of Pregabalin racemicization.

Elimination

Pregabalin is excreted mainly through the renal in a constant form. The average deduction time is 6.3 hours. Plasma clearance and kidney clearance of pregabalin is proportional to the patient's creatinine clearance. Therefore, the dose adjustments are needed in patients with impaired renal function or hemorrhage.

linear

The pharmacokinetics of linear Pregabalin within the recommended dose range. Pharmacokinetic transformation among objects is less than 20%. Multi -dose pharmacokinetics can be predicted from data on single dose. Therefore, there is no need to regularly monitor the concentration of drugs in the blood when treated with pregabalin.

Before taking Neuralmin hard capsules 75 Boston Pharma treat neuropathy, epilepsy, anxiety disorder (2 blisters x 14 tablets)

How to use

oral, use or not with food.

Dosage

Dosage from 150 mg to 600 mg/day, divided into 2 to 3 times.

Neurological pain

The starting dose is 150 mg/day. Depending on the response and tolerance of the patient, the dose can be increased to 300 mg/day after 3-7 days, if necessary, can increase to a maximum dose of 600 mg/day after 1 week of treatment.

epilepsy

The starting dose is 150 mg/day. Depending on the response and tolerance of the patient, the dose can be increased to 300 mg/day after 1 week, if necessary, can increase to a maximum dose of 600 mg/day after 1 week of treatment.

Disseminated anxiety disorders

The starting dose is 150 mg/day. Depending on the response and tolerance of the patient, the dose can be increased to 300 mg/day after 1 week, then increasing the dose to 450 mg/day 1 week later. The maximum dose of 600 mg/day can be placed after 1 week of treatment.

Stop using Pregabalin

If you have to stop using pregabalin, the dose should be reduced slowly for a minimum of 1 week.

Patients with renal failure

Need to adjust the dose according to creatinine clearance (CLCR), specifically as follows:

Clcr (ml/minute)

Total daily pregabalin dose

Maximum doses (mg/day)

2 - 3 times/day Supplement after hemorrhage (mg)

After each 4 -hour session.

Patients with liver failure

No dose adjustment.

Elderly

may need to reduce pregabalin dose in the elderly due to impaired renal function.

Children

Safety and effectiveness of drugs for children under 18 have not been proven.

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?

Overdose

According to the experience after circulating the drug, the common side effects when overdose of pregabalin have been observed including drowsiness, confusion, agitation, no rest, epilepsy. In some rare cases, coma may also occur.

How to handle

Overdose treatment Pregabalin includes general supportive treatment and hemolysis if necessary.

What to do when forgetting 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 neuralmin 75, you may experience unwanted effects (ADR).

Frequency is classified as follows:

Very common (≥ 1/10), common (≥ 1/100 to Agency System

blood and lymphatic disorders Uncommon

neutropen leukopenia

Metabolic and nutrition disorders Common Increased appetite loss of orientation, insomnia, reduced libido. Meet out of control Sleep, headache Common loss, unusual coordination, tremor, forgetting, forgotten, memory impairment, attention disorders, abnormalities, sensory loss, body, balance disorders, libidies. Disorder, dizziness posture, tremor when moving intentionally, vibrating eyeballs, cognitive disorders, mental decline, language disorders reduced reflexes, increasing sensation, burning sensation, loss of taste, discomfort. Eye disorders Common blurred vision, Song Market Rare Loss of vision, corneal inflammation, eyeball shake, changing sense of vision in depth, dilating pupils, stretches, bright glare Vascular disorders less common lower blood pressure, hypertension, hot, flushed face, cold limbs Meet pulmonary edema, larynx stenosis Abdominal disturbance, dry mouth Uncommon increased liver enzymes (AST, ALT) rare jaundice Uncommon lumpy, urticaria, sweating, itching Pain. Cervical spasms rarely swelling, muscle pain, muscle convulsions, neck pain, stiffness Slowly, dysmenorrhea, breast pain drunk, abnormal feeling, fatigue

less common body edema, chest pain, pain, fever, thirst, chill, depression increased blood phosphokinase, blood glucose, platelet number, blood creatinin, hypokalemia, weight loss

Instructions on how to handle ADR

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

Neuralmin 75 contraindications in the following cases:

hypersensitivity to pregabalin and or any ingredients in the preparation.

Caution when using

kidneys while used in the following cases:

Diabetics.

There are hypersensitivity reactions.

Dizziness, drowsiness, loss of consciousness, confusion and mental decline.

Visual effects.

Stopped anti -epileptic drugs. kidney failure.

Cowdown syndrome.

Server congestive heart failure.

Treatment of central nerve pain due to spinal cord damage.

There are thoughts and suicide behaviors.

Reduce the function of the lower gastrointestinal tract.

wrong use, abuse or drug dependence.

Brain pathology.

Be cautious with excipients: capsules contain lactose. Do not use for patients with rare genetic problems and galactose intolerance, lactose deficiency or malpuses - galactose.

The ability to drive and operate machinery

Pregabalin can cause drowsiness, dizziness that affects light to medium impact on the ability to drive. Operate machinery. If affected, patients should not operate machinery, drive, work on high or other cases.

Pregnancy

There is no adequate data on the use of Pregabalin in pregnant women. Animal studies show that toxicity on fertility, potential risks in humans is unknown. Therefore, Neuralmin 75 is not used during pregnancy unless the benefits bring the mother more clearly more important than the risks that may occur to the fetus.

must apply contraception for women of reproductive age.

Breastfeeding period

Pregabalin can be secreted through breast milk. It is unclear whether the drug effect for babies. Need to consider carefully before deciding to stop the drug or stop breastfeeding.

Medicinal interaction

Because Pregabalin is excreted mainly through urine in the form of unprovered ( In Vivo studies do not observe the clinical pharmacokinetic interaction between pregabalin and phenytoin, carbamazepin, valproic acid, lamotrigin, gabapentin, lorazepam, oxycodon or ethanol. Pharmacokinetic assessments on autonomous groups have shown that oral diabetes treatment drugs, diuretics, insulin, phenobarbital, Tiagabin and Topiramat have no significant clinical influence on pregabalin clearance.

Shared Pregabalin with oral contraceptives orally, Norethisteron and Ethinyl Estradiol does not affect pharmacokinetics in a stable state of both drugs.

Pregabalin may increase the effects of ethanol and Lorazepam. In control clinical trials, the oral multi -dose pregabalin is used in combination with Oxycodon, Lorazepam, or ethanol, which does not cause any important clinical effects on the breathing. In the reports after the circulation of the drug, there are records of respiratory failure and coma in patients taking pregabalin and other central neurological inhibitors. Pregabalin seems to aggravate the decline in cognitive and coarse movement function caused by Oxycodon.

Elderly: There are no specific pharmacological interaction studies conducted on the elderly volunteer.

Storage

Store in a dry place, below 30 ° C, avoid light.

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