Nodict Tablets (Generic Naltrexone Hydrochloride Tablets)

Nodict Tablets (Generic Naltrexone Hydrochloride Tablets)
© The Swiss Pharmacy

Nodict (Generic Naltrexone Hydrochloride
tablets) an opioid antagonist, and is indicated for
the treatment of alcohol dependence in patients
who are able to abstain from alcohol in an
outpatient setting before starting treatment with
Nodict.
Nodict is also indicated for the prevention of
relapse to opioid dependence, following opioid
detoxification.

Nodict Tablets are manufactured by Sun
Pharmaceutical Industries Limited, India in the strength
of 50 mg.

Chemical Structure

The active ingredient contained in Nodict tablets is
Naltrexone Hydrochloride.
Each film-coated tablet of Nodict contains 50 mg of
Naltrexone Hydrochloride.

Uses of Nodict 50 mg Tablets:
Nodict is used for use within a comprehensive treatment
programme for alcohol dependence. It can help people drink less
alcohol or stop drinking altogether. It also reduces the desire to drink
alcohol when used along with a treatment program that includes
counseling, support, and lifestyle changes.
Nodict (Generic Naltrexone Hydrochloride tablets) is also used as
adjunctive therapy in the maintenance of formally opioid-
dependent patients who have stopped the use of opioids such as
diamorphine (heroin) and morphine. Naltrexone (Nodict tablets) is
used to help narcotic dependents who have stopped taking narcotics
to stay drug-free.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html

The medicine is not a cure for addiction. It is used as part of an
overall program that may include counseling, attending support
group meetings, and other treatment recommended by your doctor.
It is used as part of a complete treatment program for drug abuse
(e.g., compliance monitoring, counseling, behavioral contract, lifestyle
changes).
Naltrexone (Nodict tablets) is not a narcotic. It works by blocking the
effects of narcotics, especially the "high'' feeling that makes you want
to use them. It also may block the "high'' feeling that may make you
want to use alcohol. It will not produce any narcotic-like effects or
cause mental or physical dependence. It will not prevent you from
becoming impaired while drinking alcohol.

Nodict tablets will cause withdrawal symptoms in people who are
physically dependent on narcotics. Naltrexone treatment is started
after you are no longer dependent on narcotics.
The length of time this takes may depend on which narcotic you took,
the amount you took, and how long you took it.
Before you start taking this medicine, be sure to tell your doctor if you
think you are still having withdrawal symptoms.

Recommended Adult Dosage
For most patients, the starting dose of Nodict Tablets
(Generic Naltrexone Tablets) for treatment of alcoholism is
50 mg once daily for up to 12 weeks.
Naltrexone may be taken with food or antacids if stomach
upset occurs. A urine test should be done to check for recent
opiate drug use. Do not increase your dose, take it more
often, or stop taking it without your doctor's approval.

Recommended Adult Dosage
A patient is a candidate for treatment with Nodict (Generic
Naltrexone Tablets) if:
the patient is willing to take a medicine to help with alcohol
dependence
the patient is opioid free for 7 to 10 days
the patient does not have severe or active liver or kidney
problems
the patient is not allergic to Naltrexone, and no other
contraindications are present

Contraindications
➔
Nodict is contraindicated in patients with a known
hypersensitivity to Naltrexone Hydrochloride or any component
of the tablet.
➔
Is contraindicated in Patients receiving opioid analgesics.
➔
Patients currently dependent on opioids since an acute
withdrawal syndrome may ensue.
➔
Patients in acute opioid withdrawal.

Contraindications
➔
Nodict is contraindicated in any individual who has failed the
Naloxone challenge test or who has a positive urine screen for
opioids. Any individual with a history of sensitivity to Nodict or any
other components of this product. It is not known if there is any
cross-sensitivity with Naloxone or the Phenanthrene containing
opioids.
➔
Any individual with acute hepatitis or liver failure. Nodict
(Generic Naltrexone Tablets) should not be given to patients with
acute hepatitis or liver failure.

Storage Instructions
Nodict Tablets (Generic Naltrexone Hydrochloride
Tablets) have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
Hepatocellular Injury: Cases of hepatitis and clinically significant liver
dysfunction were observed in association with Naltrexone treatment
during the clinical development program and in the post marketing
period.
Naltrexone has the capacity to cause hepatocellular injury when given
in excessive doses. Naltrexone is contraindicated in acute hepatitis or
liver failure, and its use in patients with active liver disease must be
carefully considered in light of its hepatotoxic effects.

Warnings
Vulnerability to Opioid Overdose: Following Naltrexone treatment
opioid tolerance is reduced from pretreatment baseline, and patients
are vulnerable to potentially fatal overdose at the end of a dosing
interval, after missing a dose, or after discontinuing Nodict (Naltrexone
Hydrochloride tablets) treatment. Attempts to overcome blockade
may also lead to fatal overdose.
Precipitation of Opioid Withdrawal: Opioid-dependent and opioid-using
patients, including those being treated for alcohol dependence, should
be opioid-free before starting Nodict treatment, and should notify
healthcare providers of any recent opioid use. An opioid- free duration
of a minimum of 7 to 10 days is recommended for patients to avoid
precipitation of opioid withdrawal that may be severe enough to
require hospitalization.

Warnings
Depression and Suicidality: Monitor patients for the development of
depression or suicidal thinking.
When Reversal of Naltrexone Blockade Is Required for Pain
Management: In an emergency situation in patients receiving
Naltrexone, suggestions for pain management include regional
analgesia or use of non-opioid analgesics.

Possible Side Effects
Most common Naltrexone Hydrochloride (Nodict tablets) side
effects with an incidence rate of greater than or equal to 2% of the
patients during safety study with approximately 570 individuals with
alcoholism receiving Naltrexone : nausea (10%), headache (7%),
dizziness (4%), nervousness (4%), fatigue (4%), insomnia (3%), vomiting
(3%), anxiety (2%) and somnolence (2%).

Possible Side Effects
The following side effects have been reported both at baseline and during
the Naltrexone (Nodict 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 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.

Nodict Tablets Overdosage
There is limited clinical experience with naltrexone overdosage in
humans. In one study, subjects who received 800 mg daily Naltrexone
Hydrochloride (Nodict tablets) for up to one week showed no evidence
of toxicity. The most common effects were nausea, abdominal pain,
somnolence, and dizziness. There were no significant increases in
hepatic enzymes.
In the mouse, rat and guinea pig, high doses of naltrexone
hydrochloride (generally 1,000 mg/kg or more) produced salivation,
depression/reduced activity, tremors, and convulsions. Mortalities in
animals due to high-dose Naltrexone administration usually were due
to clonic-tonic convulsions and/or respiratory failure.

Treatment of Nodict Tablets Overdosage
In view of the lack of actual experience in the treatment of
Naltrexone Hydrochloride (Nodict tablets) overdose,
patients should be treated symptomatically in a closely
supervised environment.

Nodict Tablets During Pregnancy
Naltrexone Hydrochloride (Nodict tablets) has been classified by the
US FDA as Pregnancy Category C.
Naltrexone has been shown to increase the incidence of early fetal
loss when given to rats at doses 30 mg/kg/day or greater than (5
times the recommended therapeutic dose, based on body surface
area).
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.

Nodict Tablets (Generic Naltrexone Hydrochloride
Tablets) are manufactured by Sun Pharmaceutical
Industries Limited, India.

Nodict Tablets (Generic Naltrexone Hydrochloride Tablets)

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