Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets)

1. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) © The Swiss Pharmacy

2. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Tryptomer (Generic Amitriptyline Hydrochloride Tablets) is used for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. Tryptomer, because of its sedative action, is also of value in alleviating the anxiety component of depression. © The Swiss Pharmacy

3. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Tryptomer Tablets are manufactured by Wockhardt Limited, India in the strengths of 10 mg, 25 mg and 50 mg. © The Swiss Pharmacy

4. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

5. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) The active ingredient contained in Tryptomer tablets is Amitriptyline Hydrochloride. Each film-coated tablet contains 10 mg, 25 mg or 50 mg of Amitriptyline Hydrochloride. © The Swiss Pharmacy

6. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Uses of 10 mg, 25 mg or 50 mg Tryptomer Tablets: Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) are used for the treatment of major depressive disorder in adults, the treatment of neuropathic pain in adults, the prophylactic treatment of chronic tension type headache (CTTH) in adults and the prophylactic treatment of migraine in adults. The treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products. This medicine should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

7. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Recommended Adult Dosage The dose of Tryptomer Tablets Tryptomer Tablets (Generic Amitriptyline Tablets) should be started at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. For outpatients 75 mg of Tryptomer (Amitriptyline Hydrochloride Tablets) a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

8. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Recommended Adult Dosage Adolescent and Elderly Patients: In general, lower dosages are recommended for these patients. 10 mg three times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages. Maintenance: The usual maintenance dosage of Tryptomer (Generic Amitriptyline Hydrochloride Tablets) is 50 mg to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain a relief of symptoms. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

9. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Contraindications ➔Tryptomer is contraindicated in patients with a known hypersensitivity to Amitriptyline Hydrochloride or any other component of the tablet. ➔It should not be given concomitantly with Monoamine Oxidase Inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and Monoamine Oxidase Inhibiting medications simultaneously. ➔Amitriptyline Hydrochloride (Tryptomer Tablets) should not be given with Cisapride due to the potential for increased QT interval and increased risk for arrhythmia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

10. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Contraindications ➔When it is desired to replace a monoamine oxidase inhibitor with Amitriptyline Hydrochloride (Tryptomer Tablets), a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline Hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. ➔This medicine is not recommended for use during the acute recovery phase following myocardial infarction. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

11. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Storage Instructions Tryptomer Tablets (Generic Amitriptyline 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=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

12. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Warnings Amitriptyline should be used with caution in patients with a history of seizures, impaired liver function, a history of hepatic damage or blood dyscrasias and, because of its atropine-like action, in patients with a history of urinary retention, or with narrow-angle glaucoma or increased intraocular pressure. In patients with narrow-angle glaucoma, even average doses may precipitate an attack. There has been a report of fatal dysrhythmia occurring as late as 56 hours after Amitriptyline overdose. Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant drugs, including Amitriptyline, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of the conduction time. A few instances of unexpected deaths have been reported in patients with cardiovascular disorders. © The Swiss Pharmacy

13. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Warnings Myocardial infarction and stroke have also been reported with drugs of this class. Therefore, these drugs should be used with caution in patients with a history of cardiovascular disease, such as myocardial infarction and congestive heart failure. Concurrent administration of Amitriptyline Hydrochloride (Tryptomer tablets) and electroshock therapy may increase the hazards of therapy. Such treatment should be limited to patients for whom it is essential. Close supervision is required when Amitriptyline (Tryptomer tablets) is given to hyperthyroid patients or those receiving thyroid medication. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

14. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Warnings Amitriptyline Hydrochloride (Tryptomer tablets) may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. In view of the lack of experience with the use of Amitriptyline Hydrochloride (Tryptomer Tablets) in the treatment of depression in children, Amitriptyline tablets are not recommended for depressed patients under 12 years of age. The potency of Amitriptyline (Tryptomer tablets) is such that addition of other antidepressant drugs generally does not result in any additional therapeutic benefit. Untoward reactions have been reported after the combined use of antidepressant agents having varying modes of activity. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

15. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Possible Side Effects If you get any of the following symptoms of serious Amitriptyline Hydrochloride (Tryptomer Tablets) side effects you should see your doctor immediately: Common side effect: may affect up to 1 in 10 people: A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG). Rare side effect: may affect up to 1 in 1,000 people: Bad constipation, a swollen stomach, fever and vomiting. These symptoms may be due to parts of the intestine becoming paralysed. Any yellowing of the skin and the white in the eyes (jaundice). Your liver may be affected. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

16. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Possible Side Effects If you get any of the following symptoms of serious Amitriptyline Hydrochloride (Tryptomer Tablets) side effects you should see your doctor immediately: Bruising, bleeding, pallor or persistent sore throat and fever. These symptoms can be the first signs that your blood or bone marrow may be affected. Effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting). Suicidal thoughts or behaviour. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

17. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Possible Side Effects Side effects listed below have been reported in the following frequencies: Very common: may affect more than 1 in 10 people: sleepiness/drowsiness, shakiness of hands or other body parts, dizziness, headache, irregular, hard, or rapid heartbeat, dizziness when you stand up due to low blood pressure (orthostatic hypotension), dry mouth, constipation, nausea, excessive sweating, weight gain, slurred or slow speech, aggression, congested nose. Common: may affect up to 1 in 10 people: confusion, sexual disturbances (decreased sex- drive, problems with erection), disturbance in attention, changes in taste, numbness or tingling in the arms or legs, disturbed coordination, dilated pupils, heart block, fatigue, low sodium concentration in the blood, agitation, urination disorders, feeling thirsty. Uncommon: may affect up to 1 in 100 people: excitement, anxiety, difficulties sleeping, nightmares, convulsions, tinnitus, increased blood pressure, diarrhoea, vomiting, skin rash, nettle rash (urticarial), swelling of the face and tongue, difficulties passing urine, increased production of breast milk or breast milk outflow without breast feeding, increased pressure in the eye ball, collapse conditions, worsening of cardiac failure, liver function impairment (e.g. cholestatic liver disease). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

18. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Possible Side Effects Side effects listed below have been reported in the following frequencies: Rare: may affect up to 1 in 1,000 people: decreased appetite, delirium (especially in elderly patients), hallucinations, abnormality in the heart's rhythm, or heartbeat pattern, swelling of the salivary glands, hair loss, increased sensitivity to sunlight, breast enlargement in men, fever, weight loss, abnormal results of liver function tests. Very rare: may affect up to 1 in 10,000 people: heart muscle disease, feeling of inner restlessness and a compelling need to be in constant motion, disorder of the peripheral nerves, acute increase of pressure in the eye, particular forms of abnormal heart rhythm (so called torsades de pointes), allergic inflammation of the lung alveoli and of the lung tissue. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

19. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Possible Side Effects Side effects listed below have been reported in the following frequencies: Not known: frequency cannot be estimated from the available data: absent sensation of appetite, elevation or lowering of blood sugar levels, weakness, poor concentration, disorientation, delusion, restlessness, pain, poor co- ordination, blurred vision, dry eyes, paranoia, movement disorders (involuntary movements or decreased movements), hypersensitivity inflammation of heart muscle, heart attack, stroke, hepatitis, hot flush., stomach pain, sore mouth, black tongue, breast enlargement, changes in sex drive or function, ADH secretion changes. An increased risk of bone fractures has been observed in patients taking this type of medicines. Additional side effects in children are changes in behaviour. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

20. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Possible Side Effects Post-marketing Side Effects: A syndrome resembling neuroleptic malignant syndrome (NMS) has been very rarely reported after starting or increasing the dose of Amitriptyline Hydrochloride (Tryptomer Tablets), with and without concomitant medications known to cause NMS. Symptoms have included muscle rigidity, fever, mental status changes, diaphoresis, tachycardia, and tremor. Very rare cases of serotonin syndrome (SS) have been reported with Amitriptyline Hydrochloride in combination with other drugs that have a recognized association with SS. Very rare cases of cardiomyopathy have been reported with Amitriptyline Hydrochloride tablets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

21. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Tryptomer Tablets Overdosage Critical manifestations of Amitriptyline Hydrochloride overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. In addition, a rightward axis shift in the terminal QRS complex together with a prolonged QT interval and sinus tachycardia are specific and sensitive indicators of first generation tricyclic overdose. The absence of these findings is not exclusionary. Prolonged PR interval, ST-T wave changes, ventricular tachycardia and fibrillation may also occur. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

22. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Tryptomer Tablets Overdosage Other signs of overdose may include: impaired myocardial contractility, confusion, disturbed concentration, transient visual hallucinations, dilated pupils, disorders of ocular motility, agitation, hyperactive reflexes, polyradiculoneuropathy, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under side effects. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

23. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Treatment of Tryptomer Tablets Overdosage Obtain an ECG and immediately initiate 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 the period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient. © The Swiss Pharmacy

24. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Treatment of Tryptomer Tablets Overdosage Gastrointestinal Decontamination: 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

25. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Tryptomer Tablets During Pregnancy Amitriptyline Hydrochloride (Tryptomer Tablets) has been classified by the US FDA as Pregnancy Category C. Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration. The potential benefits must be weighed against the possible hazards to mother and child. If you have taken this medicine during the last part of the pregnancy, the newborn may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention, and constipation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy

26. Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) Tryptomer Tablets Tryptomer Tablets (Generic Amitriptyline Hydrochloride Tablets) are manufactured by Wockhardt Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9549_Amitriptyline-Hydrochloride-Tablets.html © The Swiss Pharmacy