Nodict (Naltrexone Hydrochloride Tablets) is used as part of a complete treatment program in adults to treat alcoholism and narcotic (opioid) addiction. It is used as part of a complete treatment program for drug abuse (e.g., compliance monitoring, counseling, behavioral contract, lifestyle changes).

1. Naltrexone Hydrochloride Tablets
© Clearsky Pharmacy
Nodict (Naltrexone Hydrochloride Tablets) is used
as part of a complete treatment program in adults to
treat alcoholism and narcotic (opioid) addiction. It is
used as part of a complete treatment program for
drug abuse (e.g., compliance monitoring, counseling,
behavioral contract, lifestyle changes).

2. Nodict Tablets
© Clearsky Pharmacy
Nodict Tablets (Naltrexone
Hydrochloride) are manufactured by
Sun Pharmaceutical Industries Ltd. ,
India
(Website: www.sunpharma.com)

3. Naltrexone Hydrochloride Tablets – Brand Names
© Clearsky Pharmacy
Naltrexone Hydrochloride tablets are
available as Revia , Nodict, Nalcon,
Naltima, Naltrex Vivitrol, and Depade.

4. Active Ingredient
© Clearsky Pharmacy
The active ingredient contained in Nodict
tablets is Naltrexone Hydrochloride. Each
film-coated tablet of contains 50 mg of
Naltrexone Hydrochloride.

5. Chemical Structure
© Clearsky Pharmacy
The structure of Naltrexone Hydrochloride
is given below:

6. Uses of Nodict Tablets
© Clearsky Pharmacy
Naltrexone Hydrochloride (Nodict
Tablets) belongs to a class of drugs
known as opiate antagonists and is
used to treat alcoholism and narcotic
(opioid) addiction. It works in the brain
to prevent opiate and alcohol effects
(e.g., feelings of well-being, pain relief)
and also decreases the desire to take
them.

7. Naltrexone Tablets Dosage
© Clearsky Pharmacy
➢Treatment of Alcoholism: A dose of 50 mg
once daily is recommended for most patients.
During controlled studies that proved the
efficacy of Naltrexone as an adjunctive
treatment of alcoholism used a dose regimen
of Naltrexone 50 mg once daily for up to 12
weeks.
➢Treatment of Opioid Dependence: Treatment
should be started with an initial dose of 25 mg
of Naltrexone. If no withdrawal signs occur, the
patient may be started on 50 mg a day
thereafter.
The dosage of Nodict tablets (Naltrexone
Hydrochloride) is given below:

8. Storage Instructions
© Clearsky Pharmacy
Nodict (Naltrexone Hydrochloride
Tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) .
Keep this as well as all other medicines
away from children and pets.

9. Warnings
© Clearsky Pharmacy
Vulnerability to Opioid Overdose:
Patients who have been treated with
Nodict may respond to lower doses of
opioids than previously used, just as they
would shortly after completing
detoxification.
This could result in potentially life-
threatening opioid intoxication
(respiratory compromise or arrest,
circulatory collapse, etc.) if the patient
uses previously tolerated doses of
opioids.

10. Warnings
© Clearsky Pharmacy
Precipitated Opioid Withdrawal: The
symptoms of spontaneous opioid withdrawal
are uncomfortable, but they are not generally
seen to be severe or necessitate
hospitalization.
However, when withdrawal is precipitated
suddenly by the administration of an opioid
antagonist to an opioid-dependent patient, the
resulting withdrawal syndrome can be severe
enough to require hospitalization.

11. Warnings
© Clearsky Pharmacy
Hepatotoxicity: Cases of hepatitis and clinically
significant liver dysfunction were noticed in
association with Naltrexone Hydrochloride (Nodict
Tablets) exposure during the clinical development
program and in the postmarketing period. Transient,
asymptomatic hepatic transaminase elevations were
also seen in the clinical trials and postmarketing
period.
Depression and Suicidality: Depression, suicide,
attempted suicide and suicidal ideation have been
reported in the postmarketing experience with
Naltrexone Hydrochloride tablets used in the
treatment of opioid dependence.

12. Nodict Tablets
© Clearsky Pharmacy
Contraindications
Nodict is contraindicated in patients with a
hypersensitivity to Naltrexone Hydrochloride or
any other component of this medication.
This medicine is also contraindicated in patients
receiving opioid analgesics and patients currently
dependent on opioids.
and patients in acute opioid withdrawal .
Any individual who has failed the naloxone
challenge test or who has a positive urine screen
for opioids should not be administered Nodict
(Naltrexone Hydrochloride Tablets).

13. Nodict Side Effects
© Clearsky Pharmacy
➢Alcoholism: During a study involving individuals with
alcoholism being administered Naltrexone Hydrochloride
tablets, the following side effects were observed in 2% or
more of the patients: nausea (10%), headache (7%),
dizziness (4%), nervousness (4%), fatigue (4%), insomnia
(3%), vomiting (3%), anxiety (2%) and somnolence (2%). This
is not a list of complete Nodict side effects.
➢Opioid Addiction: The following side effects have been
reported both at baseline and during the Naltrexone
Hydrochloride tablets clinical trials in opioid addiction at an
incidence rate of more than 10%: Difficulty sleeping, anxiety,
nervousness, abdominal pain/cramps, nausea and/or
vomiting, low energy, joint and muscle pain, and headache.
➢The incidence of the following side effects was less than
10% for: Loss of appetite, diarrhea, constipation, increased
thirst, increased energy, feeling down, irritability, dizziness,
skin rash, delayed ejaculation, decreased potency, and chills.
➢This is not a list of complete Nodict side effects.

14. Nodict Overdose
© Clearsky Pharmacy
There is limited clinical experience with
Naltrexone HCl overdosage in humans. In
one study, subjects who were administered
800 mg daily of Naltrexone Hydrochloride
tablets for up to one week showed no
evidence of toxicity.
High doses of Nodict (Naltrexone
Hydrochloride Tablets), usually 1,000
mg/kg or higher, produced salivation,
depression/reduced activity, tremors, and
convulsions.

15. Nodict Overdose
© Clearsky Pharmacy
Treatment of Overdosage: In view of the
lack of actual experience in the treatment
of Nodict (Naltrexone Hydrochloride
Tablets) overdose, patients must be
treated symptomatically in a closely
supervised environment.

16. Naltrexone During Pregnancy
© Clearsky Pharmacy
Naltrexone Hydrochloride (Nodict Tablets)
has been classified by the US FDA as
Pregnancy Category C.
There are no adequate and well-controlled
studies in pregnant women. Naltrexone
(Nodict Tablets) should be used during
pregnancy only if the potential benefit
justifies the potential risk to the fetus.

17. Nodict Tablets
For more details on
Nodict Tablets click here
© Clearsky Pharmacy
Nodict (Naltrexone Hydrochloride
Tablets) by Limited,India.