Lofepramine (Gamalin, Emdalin)

Lofepramine is a tricyclic antidepressant used in Europe. It is not approved for use in the USA.

The Bottom Line: What You Really Need to Know

Uses

Lofepramine is used to treat depression, especially depression with anxiety.

Dosage and instructions

The initial dose of lofepramine is 70 mg at bedtime. If this dose is tolerated well, after two or three weeks it is increased to 140 mg at bedtime. After another 2-3 weeks it can be increased to 210 mg/day if necessary.

The maximum dose of lofepramine that should be taken at one time is 140 mg. If the higher dose is necessary, it should be taken as 70 mg three times a day or 70 mg in the morning and 140 mg at bedtime.

How lofepramine works

Lofepramine is chemically similar to imipramine and has similar actions. It is metabolized to desipramine, so it has the same actions.

Lofepramine probably works by inhibiting reuptake of norepinephrine and by inhibiting serotonin transmission. It is absorbed rapidly and excreted rapidly, but the active metabolite extends its useful half-life.

Side Effects

Lofepramine has the same side effects as most tricyclic antidepressants. It may have less cardiac toxicity and could be safer for that reason.

The side effects most frequently experienced with lofepramine are dry mouth, drowsiness, palpitations and sweating. Other side effects that can occur are blood pressure problems, constipation, blurred vision, difficulty urinating, confusion in elderly people, behavior problems in young people, weight gain, blood sugar abnormalities and muscle aches.

Interactions

Many different medications interact with lofepramine. It is important to make sure your physician and pharmacist know about all the medications and health preparations you take.

Monamine oxidase inhibiting (MAOI) antidepressants should not be taken with lofepramine because of a serious and potentially fatal interaction.

If lofepramine is taken at the same time as other antidepressants, a toxicity syndrome (serotonin syndrome) can occur. This can be mild-tremors, felling ill, anxiety, sweating and palpitations-or it can be severe and lead to death.

Lofepramine can also interact with the following kinds of medications:

Withdrawal

When you stop taking lofepramine, the dose should be tapered gradually. If it is stopped suddenly, you could experience withdrawal symptoms, such as sweating, tremors, nausea, anxiety and feeling ill.

Warnings, precautions and contraindications

Lofepramine should not be taken if you have recently had a heart attack or stroke.

There is an increased risk of suicide with all antidepressants, especially in the first few weeks of therapy. You will need to see your physician or therapist weekly for several weeks so they can monitor you for signs of suicidality. Family and friends should check with you daily to see how you are doing. The physician should be notified immediately if anyone notices deepening depression, mood swings, unusual thoughts or behaviors, agitation, anxiety or thoughts of harming yourself or others.

Lofepramine can trigger manic episodes in people with bipolar disorder. It can also trigger psychosis in people with schizophrenia.

Lofepramine should not be given to people who are acutely intoxicated or delirious.

You should not drive, operate machinery or engage in risky activities until you know how your body reacts to lofepramine.

You should not take lofepramine if you are pregnant or plan to get pregnant.

Lofepramine should be used with caution in people who have seizures, glaucoma, heart disease or enlarged prostate.

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