Primox Tablets (Generic Nortriptyline Hydrochloride Tablets)

1. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) © The Swiss Pharmacy

2. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Primox tablets (Generic Nortriptyline Hydrochloride tablets) are used for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. It may help improve mood and feelings of well-being, relieve anxiety and tension, and increase your energy level. This medication belongs to a class of medications called tricyclic antidepressants. It is also a useful treatment for chronic neuropathic pain and for the treatment of nicotine dependence as an aid to smoking cessation. © The Swiss Pharmacy

3. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Primox tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strength of 25 mg. © The Swiss Pharmacy

4. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

5. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) The active ingredient contained in Primox tablets is Nortriptyline Hydrochloride. Each film-coated Primox tablet contains Nortriptyline Hydrochloride equivalent to 25 mg of Nortriptyline. © The Swiss Pharmacy

6. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Uses of Primox 25 mg Tablets: Nortriptyline is used to treat depression. It is thought to work by increasing the activity of serotonin in the brain. Nortriptyline is a tricyclic antidepressant. It can also be used off-label for conditions such as chronic pain, diabetic neuropathy, myofascial pain, orofacial pain, and postherpetic neuralgia. Nortriptyline has also shown to be useful in patients trying to quit smoking. Nortriptyline is not FDA approved for use in children. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

7. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Recommended Adult Dosage The adult dose of Primox tablets Primox tablets (Generic Nortriptyline Hydrochloride tablets) for the relief of symptoms of depression is 25 mg three or four times daily. Dosage must begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of Nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

8. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Recommended Adult Dosage The adult dose of Primox (Nortriptyline Hydrochloride) as an aid in smoking cessation is administered orally. Start dosing prior to quit date at 25 mg/day and then increase to 75 mg to 100 mg when feasible over 10 days to 5 weeks. The recommended starting time is 10 to 28 days prior to the quit date and gradually increase to achieve a maintenance dose of 75 to 100 mg/day when possible for a total of up to 12 weeks. The physician should maintain therapeutic monitoring for vulnerable subjects, inadequate response and compliance concerns. In case discontinuation is required Nortriptyline tablets should be tapered as withdrawal symptoms can occur with abrupt cessation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

9. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Contraindications ➔Primox is contraindicated in patients with a known hypersensitivity to Nortriptyline Hydrochloride, Tricyclic Antidepressants or any component of the tablet. ➔The use of MAOIs intended to treat psychiatric disorders with Nortriptyline Hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of Nortriptyline Hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

10. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Contraindications ➔Cross-sensitivity between Nortriptyline Hydrochloride (Primox tablets) and other dibenzazepines is a possibility. ➔Nortriptyline Hydrochloride is contraindicated during the acute recovery period after myocardial infarction. ➔Nortriptyline is contraindicated for the treatment of depression in patients 12 years of age and under. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

11. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Storage Instructions Primox Tablets (Generic Nortriptyline 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=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

12. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Warnings Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Nortriptyline Hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

13. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Warnings A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed that treating such an episode with any antidepressant alone may increase the likelihood of a mixed/manic episode in patients at risk for bipolar disorder. Before starting treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder. It should be noted that Nortriptyline tablets are not approved for use in treating bipolar depression. Patients and their caregivers should be alerted to the need to monitor for the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of depression, and suicidal ideation, especially early during antidepressant treatment. Such symptoms should be reported to the patient’s doctor, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

14. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Warnings In patients developing throat pain, fever and flu symptoms during the first 10 weeks of treatment, it is recommended that a full blood count is conducted to exclude agranulocytosis. Hyperpyrexia has been reported during treatment with tricyclic antidepressants together with anticholinergic or with neuroleptics, especially during hot weather. Nortriptyline (Primox tablets) should be used with caution in patients with cardiovascular disease, including heart failure, conduction disorders (e.g. AV block grades I to III), or arrhythmias. Cardiovascular and ECG monitoring should be undertaken in such patients. An ECG should be performed prior to starting treatment, at steady state, after an increase in dose or after starting any potentially interacting medicine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

15. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Warnings If the medicine is given to overactive or agitated patients, increased anxiety and agitation may occur. Troublesome patient hostility may be aroused by the use of Nortriptyline Hydrochloride. Discontinue Primox tablets for several days, if possible, prior to elective surgery. Both elevation and lowering of blood sugar levels have been reported. A case of significant hypoglycaemia has been reported after the addition of Nortriptyline (125 mg/day) in a type II diabetic patient maintained on Chlorpropamide (250 mg/day). Adjustment of anti- diabetic therapy may, therefore, be necessary. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

16. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Possible Side Effects The possible side effects of Primox (Generic Nortriptyline Hydrochloride Tablets) are: Cardiovascular – Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric – Confusional states with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis. Neurologic – Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

17. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Possible Side Effects Anticholinergic – Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic – Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs. Hematologic – Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia. Gastrointestinal – Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, black tongue. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

18. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Possible Side Effects Endocrine – Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion. Other – Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

19. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Withdrawal Symptoms Though these are not indicative of Primox addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, Lack of appetite, Lower abdominal cramping and pain, Diarrhea, Weight loss, Fever, Lower Back pain and malaise. Taper dosage off slowly under medical supervision. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

20. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Primox Tablets Overdosage Symptoms of Nortriptyline Hydrochloride (Primox tablets) overdose include: cardiac dysrhythmias, severe hypotension, shock, congestive heart failure, pulmonary edema, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include: confusion, restlessness, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the acute symptoms listed under side effects. There have been reports of patients recovering from Nortriptyline overdoses of up to 525 mg. © The Swiss Pharmacy

21. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Overdosage In case of Nortriptyline Hydrochloride (Primox tablets) overdose, Obtain an ECG and immediately start cardiac monitoring. Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. EMESIS IS CONTRAINDICATED. EMESIS IS CONTRAINDICATED. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

22. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Primox Tablets During Pregnancy Nortriptyline Hydrochloride (Primox tablets) has been classified by the US FDA as Pregnancy Category C. Nortriptyline Hydrochloride (Primox tablets) should only be used in pregnancy if considered necessary, taking into account the risks of untreated depression, and under the close supervision of a physician. Epidemiological studies have suggested an increased risk of congenital abnormalities associated with use of tricyclic antidepressants in pregnancy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

23. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Primox Tablets During Pregnancy There is evidence of interference with central monoamine neurotransmission in rats. Neonates should be observed if maternal use of Nortriptyline (Primox tablets) has continued into the later stages of pregnancy, particularly into the third trimester. Neonates exposed to tricyclic antidepressants, late in the third trimester have shown drug withdrawal symptoms such as dyspnoea, lethargy, colic irritability, hypotension or hypertension and tremor or spasms. Epidemiological data suggests that the use of tricyclic antidepressants in pregnancy may be associated with an increase in pre-term delivery. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy

24. Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) Primox Tablets Primox Tablets (Generic Nortriptyline Hydrochloride Tablets) are manufactured by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html © The Swiss Pharmacy