For use as an additional therapy within a comprehensive treatment program including psychological guidance for detoxified patients who have been opioid-dependent & alcohol dependence to support abstinence.
Use in adults
Naltrexone treatment should be initiated and supervised by suitable qualified physicians.
The initial dose of naltrexone hydrochloride should be 25 mg (half a tablet) for opioid-dependent patient followed by the usual dose of one tablet per day (= 50 mg naltrexone hydrochloride)
A missed dose can be managed by providing 1 tablet per day each day till the next regular dosage-administration.
Naltrexone administered to opioid-dependent persons can cause life-threatening withdrawal symptoms. Patients suspected of using or being addicted to opioids must undergo a naloxone provocation test , unless it can be verified that the patient has not taken any opioids for 7-10 days (urine test) prior to the initiation of treatment with naltrexone.
As Naltrexone is an adjunctive therapy and the full recovery process in opioid-dependent patients is individually variable, no standard duration of treatment can be stated; an initial period of three months should be considered. However, prolonged administration may be necessary.
The recommended dose for alcohol dependence to support abstinence is 50 mg per day (1 tablet). A dose of over 150 mg on any single day is not recommended, since this can lead to a higher incidence of side effects.
As naltrexone hydrochloride is an adjunctive therapy and the full recovery process from alcohol dependence is individually variable, no standard duration of treatment can be stated; an initial period of three months should be considered. However, prolonged administration may be necessary
The dosage-regimen can be modified in order to improve compliance to a three-times-a-week dosing schedule as follows: administration of 2 tablets (=100 mg naltrexone hydrochloride) on Monday and on Wednesday and 3 tablets (=150 mg naltrexone hydrochloride) on Friday.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Concomitant administration of naltrexone with an opioid-containing medication should be avoided.
There are no clinical data on naltrexone hydrochloride use in pregnancy. Data from animal studies have shown reproductive toxicity. The data are insufficient to establish clinical relevance. The potential risk for humans is unknown. Naltrexone should only be given to pregnant women when, in the judgement of the attending physician the potential benefits outweigh and the possible risk.
The use of naltrexone in pregnant alcoholic patients receiving long-term treatment with opiates or substitution treatment with opiates, or in pregnant patients who are opioid-dependent, creates a risk of acute withdrawal syndrome which could have serious consequences for the mother and the foetus. Naltrexone administration must be suspended if opiate analgesics are prescribed.
There are no clinical data on naltrexone HCl use in lactation. It is unknown whether naltrexone or 6-beta-naltrexol is excreted in human breast milk. During treatment breast feeding is not recommended.
Very common (At least 1 in every 10 people)
- Sleep disorders
- Abdominal pain
- Abdominal cramps
- Nausea or inclination to vomit
- Arthralgia- Joint stiffness.
- Myalgia-Muscle pain
- Asthenia-The body loses strength
Common(?1/100 to <1/10)
- Decreased appetite
- Affective disorders
- Despondency- A period of low spirit
- Mood swings
- Lycrimation increase
- Electrocardiogram change
- Chest pain
- Skin rash
- Urine retention
- Delayed ejaculation
- Lack of appetite
- Increased energy
- Uncommon (?1/1,000 to < 1/100)
- Oral herpes
- Tinea pedis- Athletes foot
- Confusion state
- Libido disorder
- Abnormal dreams
Rare (? 1/10,000 to < 1/1,000)
- Idiopathic thrombocytopenia
- Suicidal Ideation
- Attempted suicide
- Speech disorder
Very rare (< 1/10,000)
- Exanthema-Diffuse skin rash
- Rhabdomyolysis- The breakdown of muscle tissue that leads to the release of muscle fiber contents into the blood.