Frego Kalbe medicine for preventive treatment migraine (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Flunarizine

Ingredient

Composition information	Content
Flunarizine	5mg

Uses

Indications

Frego 5mg drug is indicated in the following cases:

Preventive treatment of migraine in case other treatments is not effective or less tolerant.

Selective Calcium channel blockers, reduce artery and artery muscle spasms.

Mechanism of action:

The drug prevents cell calcium overload by reducing overflow of calcium over the cell membrane. Flunarizin does not prevent the normal lipstick stability of calcium in the cell. Flunarizin does not affect the contraction and myocardial transmission.

The effect of flunarizin in migraine prevention is due to the ability to reduce the frequency of migraine. Flunarizin also reduces the level of migraine but with less level, and does not affect the time of migraine.

Dynamics

Normally, Flunarizin is used by oral and it is absorbed quickly and almost completely through the digestive tract (95%). The peak concentration of serum (cmax) is 50 to 100µg/100ml after taking a single dose of 10mg achieved after 2-4 hours (TMAX) on healthy volunteers.

studies in in vitro shows that a large amount of flunarizin is connected in the blood (99%), mainly with plasma proteins (90%), the remaining amount is attached to red blood cells (9%).

Proteins mainly participate in cohesion with flunarizin are alpha and beta globulin. Although a large amount of flunarizin is connected in the blood, it also has a very large body distribution with an average distribution of 43 l/kg.

However, this volume is different in each individual, from 28 to 300 l/kg. Flunarizin's distribution volume is very high in the body indicating that a large amount of drugs is connected to tissues. The high -body integral in the body of the flunarizin is due to the prolonged half -life of the drug, approximately 18 days after taking a single dose.

Along with prolonged half -life, the concentration of the drug in plasma also achieved stability after 5-6 weeks, maybe even longer when using the dose repeated. There is a difference between individual concentrations of flunazirin in plasma: 16% of cases have a concentration of 0.02 to 0.05 mg. L1, 36% of cases have a concentration of> 0.05 to 0.1 mg. L1, 20% of cases have a concentration of> 0.1 to 0.25 mg/L1 and 4% of cases with a concentration of> 0.25 mg. L1, this figure may correspond to the difference in the process of money metabolism of the drug.

Oral absorption> 95%.

Average half -life.

DISTRIBUTION DISTRIBUTION 43 L/KG.

The ratio attached to plasma protein 90%.

flunarizin is issued mainly thanks to the liver biosynthesis, and less than 0.01% of the drug is exported in the urine in the form of unchanged within 24 hours and less than 5% of the drug in the form of unchanged in the fertilizer. The metabolites are mainly exported through bile and in the feces, which reflects a large amount of metabolites cleared through the liver, approximately 120 ml/min.

Flunarizin is exported into breast milk. However, there are no special documents about the issue of the drug in breast milk, research on dogs shows that the concentration of the drug in breast milk is higher than the serum concentration.

Age also has a little effect on the pharmacokinetics of flunarizin. The half -life of the elderly may be a bit shorter than the young, about 7.3 ± 3.3 days.

Before taking Frego Kalbe medicine for preventive treatment migraine (5 blisters x 10 tablets)

How to use

oral drugs.

Dosage

Adults ≤ 65 years old and elderly (> 65 years):

Use 5 mg/day, take it in the evening, maintain for 4 - 8 weeks.

During the treatment period, if the symptoms of depression are appeared , foreign tower or other serious adverse events, it is necessary to stop taking the drug.

If after 8 weeks of treatment without improvement, patients need to be seen as not responding to treatment and should stop taking the drug.

Treatment time does not exceed 6 months.

Recommended for patients ≤ 65 years old: If the patient's clinical manifestation shows that the response is incomplete, may increase the dose up to 10 mg/day but need to consider in the patient's tolerance capacity.

Children:

Children ≥ 12 years old, especially in the case of unexplained migraine: 5 mg/day, taken in the evening. Treatment period must not exceed 6 months.

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?

Some cases of acute overdose (dosage up to 600 mg once) have been reported and symptoms that occur including sleeping, anxiety mood and tachycardia.

Can handle acute overdose by using activated carbon, gastric lavage and supportive treatment measures.

Symptoms of foreign tapes and depression have also been reported in some cases when using the dose from 10 to 40 mg of flunarizin for 3 weeks and for 15 months.

What to do when you forget the 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 Frego 5mg, you may experience unwanted effects (ADR).

Flunarizin safety (dose of 5 to 10 mg/day) is evaluated on 247 patients treated with flunarizin participating in two clinical trials with a place of regard to a place of placebo in dizziness and migraine treatment and in 476 patients with Flunarizin treatment participated in two clinical trials comparable to dizziness and/or migraine.

Based on the safety data from these tests, the most unwanted effects (frequency occurring ≥ 4%) are: weight gain (11%), drowsiness (9%), depression (5%), increase appetite (4%), rhinitis (4%).

Includes the above -mentioned adverse reactions, the following table displays unwanted effects that have been reported when using flunarizin from clinical trials and after circulation. Frequency occurs are classified as follows:

Very common (≥ 1/10); Common (≥ 1/100 to 1/10); rarely (≥1/1000 to

Classification of agency system

Unwanted effects

(≥ 1/10)

Common (≥ 1/100 to 1/10)

Uncommon (≥ 1/1000 to

Unknown frequency

Rhinitis

Increase appetite

Mental disorders

depression, insomnia

Symptoms of depression, sleep disorders, indifference, anxiety

Abnormalities in coordination, disorientation, indifference, abnormalities, restlessness, drowsiness, tinnitus, neck and neck

restlessness, slow movement, stiffness of gear muscles, movement disorders, foreign towering disorders, Parkinson , sedation, run

heart disorders

Hypotension

Constipation , discomfort in the stomach, nausea

intestinal obstruction, dry mouth, digestive disorders

Increase liver transaminase

Increase sweating

Redders

Muscle pain

Muscle spasm, muscle seizures

Mechanical hard

Breast disorders and genitalia

Abnormal menstrual periods, breast pain

Menstrual period, menstrual disorders, less menstrual, breast enlargement; Reduce sexual ability

Milk secretion

tired

Testing results

weight gain

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Do not use Frego 5mg medicine for the following cases:

Hypersensitivity to flunarizin or any excipients of the drug.

Symptoms of Parkinson's disease before treatment.

History of foreign symptoms.

depression or a history of recurrent depression syndrome.

Precautions when using

Do not use the recommended overdose. It is necessary to monitor patients regularly, periodically, especially during the maintenance treatment period to early detect expressions of foreign tapes, depression and stop treatment promptly.

Some fatigue cases with increasing severity have been recorded when using flunarizin. If this condition occurs, it is necessary to stop treating with flunarizin.

Frego can cause dizziness and drowsiness, especially when starting treatment, do not use Frego for patients doing jobs such as driving operation or machinery control.

Do not use frego for pregnant women due to the safety of the drug for this group of patients has not been proven. Flunarizin is secreted into breast milk, so do not use frego for breastfeeding mothers.

Flunarizin treatment may cause severe symptoms of extra -tapers, symptoms of depression, revealing Parkinson's disease, especially in patients at high risk such as older patients. Therefore, it is necessary to be cautious when using Frego for these patients. Patients should be used for special interruptions during maintenance treatment so that they can detect signs of extracurricular and depression symptoms soon and should stop treatment. It should also be noted when using frego for patients with low blood pressure.

Should be cautious when using drugs for older people and for patients with renal function.

Should check the liver function and kidney function when treated with prolonged frego.

Lactose-containing drugs, not for patients with Galactose intolerant, Lapp Lactose deficiency, glucose-Galactose absorption disorders.

The ability to drive and operate machinery

Frego can cause sleepiness, especially when starting treatment, need to be cautious when performing jobs such as driving or operating machinery.

Pregnancy

There is no data on the use of this drug for pregnant women. Animal studies do not show direct or indirect harm to pregnancy, the development of embryos/fetal embryos, childbirth or postpartum development. To prevent and avoid using flunarizin during pregnancy.

Breastfeeding period

It is unknown whether flunarizin will be excreted in breast milk. Animal studies show that flunarizin is secreted into mother milk. The decision to stop breastfeeding to continue treating or stopping treatment with flunarizin should be considered based on the benefits of breastfeeding for breastfeeding and the benefits of the mother's treatment.

Medicinal interaction

alcohol, some epilepsy, sleeping pills, antidepressants or sedatives can affect the effects of flunarizin or increase the likelihood of unwanted effects.

Simultaneous use of flunarizin with oral contraceptives can cause multi -dairy.

Storage

Store at temperatures below 30 ° C, avoiding light. To be out of reach of children.

24 -month expiry date from the date of manufacture.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.