Nodict Tablets (Generic Naltrexone Hydrochloride Tablets)

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

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

3. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) Nodict Tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strength of 50 mg. © The Swiss Pharmacy

4. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

5. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) The active ingredient contained in Nodict tablets is Naltrexone Hydrochloride. Each film-coated tablet of Nodict contains 50 mg of Naltrexone Hydrochloride. © The Swiss Pharmacy

6. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

7. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) Uses of Nodict 50 mg Tablets: 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

8. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) Uses of Nodict 50 mg Tablets: 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

9. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. Nodict Tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

10. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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 URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

11. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

12. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

13. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

14. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

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

16. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

17. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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%). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

18. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

19. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

20. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

21. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy

22. Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) Nodict Tablets Nodict Tablets (Generic Naltrexone Hydrochloride Tablets) are manufactured by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9940_Naltrexone-Tablets.html © The Swiss Pharmacy