Generic Tofranil ( Imipramine )

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Tofranil is a tricyclic antidepressant used to treat depression, including endogenous, organic, and psychogenic forms, as well as depression associated with personality disorders or chronic alcoholism. It is also used to treat childhood enuresis (bedwetting) and, in some cases, panic disorder and chronic pain. The medication works by increasing the levels of serotonin and norepinephrine in the brain, which helps improve mood and reduce anxiety.
A note on availability: Tofranil was originally marketed in Canada by Novartis Pharmaceuticals Canada Inc. The brand-name product has been discontinued, and several DINs are now cancelled after market. Generic imipramine hydrochloride tablets remain available in Canada from AA Pharma Inc. and Jamp Pharma Corporation. The dosing and safety information below reflects the product monograph and clinical data that apply to imipramine hydrochloride.
The usual starting dose for adult outpatients with depression is 25 mg one to three times daily. The daily dosage is raised gradually to 150-200 mg, reaching this level by the end of the first week and maintained until clear improvement is seen. The maintenance dose is usually 50-100 mg daily. Hospitalized patients may start at 25 mg three times daily, with the dose raised by 25 mg daily up to 200 mg, and in severe cases up to 300 mg daily.
The administration form is coated tablets containing 10 mg, 25 mg, and 50 mg of imipramine hydrochloride. A 75 mg strength has also been available in Canada. The 10 mg tablet is reddish-brown and triangular; the 25 mg tablet is reddish-brown and round.
Tofranil does not work overnight. The antidepressant effect may not be evident for one to three weeks in some patients. Do not stop taking it just because you do not feel better in the first few days.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that imipramine can cause, and it can increase the CNS depressant effects of the medication.
The most common side effects are dry mouth, constipation, blurred vision, urinary retention, drowsiness, dizziness, and weight gain. Orthostatic hypotension is the most common serious cardiovascular side effect.
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Common Use Tofranil

Imipramine is a tricyclic antidepressant of the dibenzazepine group. It works by blocking the reuptake of serotonin and norepinephrine at nerve endings, which increases their availability in the synaptic cleft. This helps restore chemical balance in the brain and is thought to underlie its antidepressant effect. Imipramine also has significant anticholinergic and antihistamine properties, which contribute to its sedative and side effect profile. Health Canada has approved imipramine for the treatment of all forms of depression, including endogenous, organic, and psychogenic forms, as well as depression associated with personality disorders or chronic alcoholism. It is also indicated for the treatment of childhood enuresis (bedwetting) in children over 6 years of age as part of a comprehensive treatment program. Imipramine is not recommended for use in children and adolescents (0-17 years) for the treatment of depression due to insufficient evidence of safety and efficacy.

Basic Tofranil Information

• INN (International Nonproprietary Name): Imipramine hydrochloride
• Brand names available in Canada: Tofranil® (original brand, previously marketed by Novartis Pharmaceuticals Canada Inc.; brand name product discontinued). Generics include Imipramine (AA Pharma Inc., DIN 00312797 for 25 mg, DIN 00326852 for 50 mg, DIN 00644579 for 10 mg) and Jamp Imipramine (Jamp Pharma Corporation, DIN 02546345 for 25 mg, DIN 02546353 for 50 mg, DIN 02546361 for 75 mg).
• ATC Code: N06AA02
• Forms and dosages: Coated tablets – 10 mg, 25 mg, 50 mg, and 75 mg. Tofranil 10 mg tablets are convex, reddish brown, sugar coated, triangular. Tofranil 25 mg tablets are biconvex, reddish brown, sugar coated, round.
• Manufacturers in Canada: AA Pharma Inc. (Imipramine, 10 mg, 25 mg, 50 mg), Jamp Pharma Corporation (Jamp Imipramine, 25 mg, 50 mg, 75 mg). The original Tofranil brand was marketed by Novartis Pharmaceuticals Canada Inc.; all Tofranil DINs are now cancelled post market. DINs include 00010464 (Tofranil 10 mg), 00010472 (Tofranil 25 mg), 00306487 (Tofranil 75 mg).
• Registration status in Canada: Imipramine hydrochloride is approved by Health Canada under multiple generic DINs, including 00312797 (Imipramine 25 mg, AA Pharma), 00326852 (Imipramine 50 mg, AA Pharma), 00644579 (Imipramine 10 mg, AA Pharma), 02546345 (Jamp Imipramine 25 mg), 02546353 (Jamp Imipramine 50 mg), and 02546361 (Jamp Imipramine 75 mg). The brand-name Tofranil is not currently marketed in Canada.
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Tofranil exactly as your doctor prescribes. The dose depends on what is being treated and your age. For depression in adult outpatients, start with 25 mg one to three times daily. Raise the daily dosage gradually to 150-200 mg. This dosage should be reached by the end of the first week and maintained until a clear improvement is seen. The maintenance dose, which must be individually determined by cautiously reducing the dosage, is usually 50-100 mg daily. For hospitalized patients, start treatment with 25 mg three times daily. Raise the dosage by 25 mg daily until a dose of 200 mg has been reached, and keep to this dose until the patient's condition has improved. In severe cases the dose may be increased to 100 mg three times daily. Once a clear improvement has set in, the maintenance dose should be determined according to the patient's individual requirements (generally 100 mg daily). For elderly patients, start treatment with 1 tablet of 10 mg daily. Gradually raise the dosage to 30-50 mg daily (optimum level), which should be reached after about 10 days and then maintained until the end of treatment. For adolescents and geriatric patients, initiate therapy at a total daily dosage of 25 to 50 mg. Dosage may be increased according to response and tolerance, but it is generally unnecessary to exceed 100 mg/day in these patients. The total daily dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule. Take the tablet with or without food. If it upsets your stomach, take it with a meal. Swallow the tablet whole with water. Do not crush or chew it. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Tofranil suddenly without talking to your doctor. Stopping abruptly can cause withdrawal symptoms such as nausea, headache, and malaise. Your doctor will taper the dose gradually.

Precautions

Imipramine carries a boxed warning about an increased risk of suicidal thoughts and behaviours in pediatric and young adult patients taking antidepressants. Close monitoring is required, especially during the first few weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Imipramine can cause serotonin syndrome, a potentially life-threatening condition caused by too much serotonin in the body. The risk is higher when imipramine is taken with other serotonergic drugs, including MAO inhibitors, SSRIs, SNRIs, triptans, tramadol, and St. John's wort. Symptoms include agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Stop the medication and seek emergency care if these occur. Imipramine can cause orthostatic hypotension, a drop in blood pressure when standing up. Almost 20% of patients in one clinical series had symptoms severe enough to interfere with treatment, and over 4% sustained physical injuries. This is the most common serious cardiovascular side effect of imipramine. The increased orthostatic hypotension occurred early in treatment and at low doses. Caution is advised in the use of imipramine for the elderly. Move slowly when getting up from a sitting or lying position. Imipramine can prolong the QT interval on an electrocardiogram, a change in heart rhythm that can lead to serious arrhythmias. Use with caution if you have heart disease or take other drugs that affect heart rhythm. The medication can cause anticholinergic effects, including dry mouth, blurred vision, constipation, urinary retention, and increased intraocular pressure. It should be used with caution in patients with narrow-angle glaucoma or a history of urinary retention. Imipramine can lower the seizure threshold. If you have epilepsy or a condition that increases seizure risk, tell your doctor. The medication can cause weight gain, but this is not as problematic with imipramine as with some other tricyclics. If weight gain cannot be controlled with diet and exercise, switching to another antidepressant may be considered. Imipramine is not recommended during pregnancy unless the benefit clearly outweighs the risk to the fetus. It passes into breast milk in small amounts. While side effects have not been reported in nursing infants, breastfeeding is to be avoided during treatment as a precaution. Women who could become pregnant should discuss the risks and benefits with their doctor. Imipramine is not recommended for use in children and adolescents (0-17 years) for the treatment of depression. Older adults may be more sensitive to the side effects of imipramine, especially orthostatic hypotension, and may need lower doses. Tell your doctor if you have liver or kidney problems, as dose adjustments may be needed.

Contraindications

Do not take Tofranil if you have had an allergic reaction to imipramine, any of the excipients, or cross-sensitivity to other tricyclic antidepressants of the dibenzazepine group. Tofranil is contraindicated during the acute recovery phase following myocardial infarction. It should not be used in patients with recent myocardial infarction, heart failure, conduction disorders, or a history of conduction disorders. Imipramine is contraindicated in patients with narrow-angle glaucoma, prostatic hyperplasia, pyloric stenosis, and other stenoses of the gastrointestinal and genitourinary systems. It should not be used in patients with severe liver disease. Tofranil should not be given in combination, or within 14 days before or after treatment, with a MAO inhibitor, because of the risk of severe symptoms such as hypertensive crisis, hyperpyrexia, myoclonus, agitation, seizures, delirium, and coma. Concomitant treatment with selective, reversible MAO-A inhibitors, such as moclobemide, is also contraindicated. Imipramine should not be used during pregnancy or breastfeeding unless specifically directed by a doctor. Do not take imipramine if you have mania or a history of mania. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

More than 1 in 10 people experience anticholinergic effects, including dry mouth, constipation, blurred vision, mydriasis (pupil dilation), and urinary retention. Drowsiness, dizziness, headache, tremor, and dysarthria (speech disturbance) are also common. Weight gain is common with tricyclic antidepressants, but this is not as problematic with imipramine. Other common side effects include sedation, sweating, increased appetite, and orthostatic hypotension. These effects are often most noticeable when starting treatment or increasing the dose. Serious side effects require immediate medical attention. Orthostatic hypotension can cause fainting and falls. QT prolongation can cause palpitations, fainting, or sudden collapse. Serotonin syndrome presents with agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Severe allergic reactions, including rash, hives, swelling of the face or throat, and difficulty breathing, need emergency care. Blood disorders, including agranulocytosis and thrombocytopenia, have been reported. Liver problems, including jaundice and altered liver function, can occur. If you develop any of these serious effects, stop the medication and seek medical help right away. Antidepressants, including Tofranil, may increase suicidal thoughts or behaviour, especially in young people. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately. Discontinuation syndrome can occur if the medication is stopped suddenly, causing nausea, headache, and malaise.

Drug Interaction

Imipramine interacts with a long list of medications. MAO inhibitors are strictly contraindicated and must not be used with imipramine. Do not give Tofranil for at least 2 weeks after discontinuation of treatment with MAO inhibitors, and the same applies when giving a MAO inhibitor after previous treatment with Tofranil. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, paroxetine, sertraline, and citalopram are potent CYP2D6 inhibitors. Fluvoxamine is a potent CYP1A2 inhibitor and a mid-level CYP2D6 inhibitor. The use of SSRIs together with imipramine may cause increased plasma concentration of imipramine, with corresponding adverse effects, and a dose adjustment may be necessary. Other serotonergic agents, including SNRIs, lithium, tramadol, pethidine, dextromethorphan, and buprenorphine, may cause additive effects and increase the risk of serotonin syndrome. Tricyclic antidepressants may potentiate the effects of alcohol and other central depressant substances, including barbiturates, benzodiazepines, and general anaesthetics. Neuroleptics may result in increased plasma levels of tricyclic antidepressants, a lowered convulsion threshold, and seizures. Combination with thioridazine may produce severe cardiac arrhythmias. Terbinafine is a potent CYP2D6 inhibitor and may cause an increase in imipramine and desipramine exposure and accumulation. Tofranil may diminish or abolish the antihypertensive effects of guanethidine, betanidine, reserpine, clonidine, and alpha-methyldopa. Tricyclic antidepressants may potentiate the anticoagulant effect of coumarin drugs by inhibiting hepatic metabolism of these anticoagulants. Careful monitoring of prothrombin time is recommended. Imipramine can increase the plasma concentration of phenytoin. Drugs that can prolong the QTc interval, such as some antipsychotics and antibiotics, increase the risk of QTc prolongation and/or ventricular arrhythmias (e.g., Torsades de pointes) when used with imipramine. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Tofranil, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can cause your symptoms to return, so try to take the medication at the same times each day.

Overdose

Overdose with imipramine is a medical emergency. Symptoms include irregular heartbeat, severe drowsiness, confusion, agitation, hallucinations, seizures, coma, and breathing problems. The risk is higher in children than in adults. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of heart rhythm. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Tofranil tablets at room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Brief exposure to temperatures between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit) is acceptable. Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines. Do not flush imipramine down the toilet or pour it down the sink.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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