Naltrexone Hydrochloride 50 Mg 100 Caps.

For use as an additional therapy in a comprehensive treatment program, including psychological guidance for opioid-dependent (see Sections 4.2 and 4.4) and detoxified patients with alcohol dependence to support withdrawal.

Category:

Description

Naltrexone Hydrochloride 50 Mg 100 Caps.

1. Clinical information
1.1 Therapeutic indications
For use as an additional therapy in a comprehensive treatment program, including psychological guidance for opioid-dependent (see Sections 4.2 and 4.4) and detoxified patients with alcohol dependence to support withdrawal.

1.2 Posology and method of administration

Use in adults

Naltrexone treatment should be initiated and supervised by appropriate specialist physicians.
For opalite dependent patient, the initial dose of naltrexone hydrochloride should be 25 mg (half a tablet) followed by a normal dose of one tablet per day (= 50 mg naltrexone hydrochloride).
A missed dose can be managed by providing 1 tablet daily, until the next regular dosage application.
Naltrexone administered to opioid-dependent individuals can cause life-threatening withdrawal symptoms. Patients suspected of using opioids or suspected to be addicted should undergo naloxone provocation testing before starting treatment for 7-10 days (urine test) to confirm that they have not received any opioids.
Since naltrexone is an adjunct therapy and the full recovery process is individually variable in opioid-dependent patients, a standard treatment period cannot be specified; a three-month start period should be considered. However, long-term administration may be necessary.
The recommended dose for alcohol dependence to support withdrawal is 50 mg per day (1 tablet). A dose of over 150 mg is not recommended on any day, as this can lead to a higher incidence of side effects.
Since naltrexone hydrochloride is an adjunct therapy and the process of full recovery from alcohol dependence is individually variable, a standard treatment period cannot be specified; a three-month start period should be considered. However, long-term administration may be necessary
The dosage regimen can be changed to improve compliance with a dosing schedule three times a week as follows: Monday and Wednesday 2 tablets (= 100 mg naltrexone hydrochloride) and 3 tablets (= 150 mg naltrexone) hydrochloride) on Friday.

Pediatric population

Naltrexone should not be used in children and adolescents under 18 years of age because there are no clinical data in this age group. Safe use in children has not been established.
Older people
There is insufficient data on the safety and efficacy of naltrexone for this indication in elderly patients.

MILK SUPPLEMENT OVERSEAS DRUG PRICE LIST (ANNEX-4 / C)
Medicines marked with (**) in the column “DRUGS SUPPLIED BY THE INSTITUTION” are provided by the Ankara Social Security Provincial Directorate İbn-i Sina Health Social Security Center.
RG- 01/02 / 2019-30673 / 20 art. Force:
1) Drugs marked with an asterisk (*) in the “Price Change Date” or “Date of Entry” column,
2) Medicines with “Price change date”, “Date of entry list”, “Date of exclusion” are on the specified dates
3) Drugs without “Price change date” and “Date of entry list” on 01/02/2019
comes into force. ”

Additional information

ETKEN MADDE

Naltrexone Hydrochloride

EŞDEĞER GRUBU

I456A

KURUMCA TEDARİK EDİLEN İLAÇLAR

**

FİYAT DEĞİŞİKLİK TARİHİ

LİSTEYE GİRİŞ TARİHİ

13.02.2019

LİSTEDEN ÇIKARILDIĞI TARİH

ATC kodu

N07BB04

ATC Adı

Naltrexone

Reçete Türü

Normal

TİTCK Yazılı Onayı Olmadan  İthal Edilemeyecek İlaçlar

Sadece Toplu Teminine İzin Verilen İlaçlar

Acil Durumlarda Kullanımı İçin TİTCK Tarafından Hastanelere Toplu Temin İzni Verilen İlaçlar

ICD10 Kodu

F10;F10.2;F11;F11.2

ICD10 Adı

Zihin ve davranış bozuklukları, alkol kullanımına bağlı;Alkol kullanımına bağlı bağımlılık sendromu; Zihin ve davranış bozuklukları, opioid kullanımına bağlı; Opioid kullanımına bağlı bağımlılık sendromu

Kullanım Şartları 

1-ALKOL BAĞIMLILIĞI TEDAVİSİNDE KULLANILIR.
2-OPİOİD BAĞIMLILIĞI TEDAVİSİNDE KULLANILIR.

Açıklama

SGK bünyesindeki İbn-i Sina Sağlık Sosyal Güvenlik Merkezi tarafından barkod talebinde bulunulmuş olup, talep uygun bulunmuştur.

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