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Remeron mirtazapine (mir TAH zah peen)
Remeron, Remeron SolTab |
What is the most important information I should know about Remeron?
It may be several weeks before you start to feel better. Even when you start to feel better, do not stop taking Remeron without first talking to your doctor.
Contact your doctor if you experience fever, chills, a sore throat, flu-like symptoms, or sores in the mouth or nose.
Use caution when driving, operating machinery, or performing other hazardous activities. Remeron may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities.
Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
Avoid the use of alcohol while taking Remeron. Alcohol may increase drowsiness and dizziness.
Remeron is available in a regular tablet formulation (Remeron) that should be swallowed with water. Remeron is also available in a rapidly-disintegrating formulation (Remeron SolTab) that will disintegrate rapidly when placed on the tongue and can be swallowed with or without water.
What is Remeron?
Remeron is in a class of drugs called antidepressants. Remeron affects chemicals in your brain that may become unbalanced and cause depression.
Remeron is used to relieve symptoms of depression such as feelings of sadness, worthlessness, or guilt; loss of interest in daily activities; changes in appetite; tiredness; sleeping too much; insomnia; and thoughts of death or suicide.
Remeron may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking Remeron?
Do not take Remeron if you are currently taking, or have taken within the last 14 days, a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).
Before taking Remeron, tell your doctor if you
- have liver disease;
- have kidney disease;
- have a manic-depressive disorder;
- have blood problems;
- have high or low blood pressure or heart disease;
- have had a heart attack in the last 6 weeks; or
- have epilepsy or seizures.
You may not be able to take Remeron, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
The rapidly-disintegrating formulation of Remeron tablets (Remeron SolTab) contains phenylalanine. People with the disease phenylketonuria (PKU) need to monitor their intake of this additive.
Remeron is in the FDA pregnancy category C. This means that it is not known whether Remeron will harm an unborn baby. Do not take Remeron without first talking to your doctor if you are pregnant.
It is not known whether Remeron passes into breast milk. Do not take Remeron without first talking to your doctor if you are breast-feeding a baby.
If you are over 60 years of age, you may be more likely to experience side effects such as drowsiness, dizziness, unsteadiness, feeling uncoordinated, and low blood pressure. You may require a lower dose of this medication.
How should I take Remeron?
Take Remeron exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Remeron is available in a regular tablet formulation (Remeron) that should be swallowed with water. Remeron is also available in a rapidly-disintegrating formulation (Remeron SolTab) that will disintegrate rapidly when placed on the tongue and can be swallowed with or without water.
If you are taking the Remeron rapidly-disintegrating tablets (Remeron SolTab), open the blister pack with dry hands and use the tablet immediately after removal from the blister pack. Do not attempt to split the rapidly-disintegrating tablets.
Remeron is usually taken once a day, preferably at bedtime. Follow your doctor's instructions.
It may be several weeks before you start to feel better. Even when you start to feel better, do not stop taking Remeron without first talking to your doctor.
Store Remeron at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.
What happens if I overdose?
Seek emergency medical attention.
Symptoms of a Remeron overdose include confusion, drowsiness, poor memory, and a fast heartbeat.
What should I avoid while taking Remeron?
Use caution when driving, operating machinery, or performing other hazardous activities. Remeron may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities.
Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
Avoid the use of alcohol while taking Remeron. Alcohol may increase drowsiness and dizziness.
What are the possible side effects of Remeron?
If you experience any of the following serious side effects, stop taking Remeron and call your doctor immediately or seek emergency medical treatment:
- an allergic reaction (swelling of the lips, face, or tongue; difficulty breathing);
- seizures;
- a fast or irregular heartbeat; or
- fever, chills, a sore throat, flu-like symptoms, or sores in your mouth or nose.
Other, less serious side effects may be more likely to occur. Continue to take Remeron and talk to your doctor if you experience
- drowsiness;
- nausea;
- increase in weight or appetite;
- dizziness;
- dry mouth;
- constipation; or
- mild tremor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Depression is the most documented and common of all psychiatric disorders, dating back to ancient times, when clinical definitions were non-existent and depression was referred to as "melancholia." Clinical depression occurs in persons of all ages, ethnic groups and socio-economic groups, but because of the stigma often associated with depression, it is one of the least diagnosed diseases in the world. In individuals with clinical depression, data has shown low levels of serotonin vs. other receptors, to be the primary factor leading to low self-esteem, fatigue and suicidal tendencies as well as other psychologically debilitating consequences.
"Today the FDA has cleared a significant addition to the current arsenal of anti-depressants. Remeron takes the critical ability of serotonin receptor specificity to a new level which is so important in mitigating side-effects that current anti-depressants cause, said Dr. Paul Lammers, Medical Director at Organon, Inc.
WEST ORANGE, N.J., June 19, 1996 -- Organon, Inc. today announced that the U.S. Food and Drug Administration (FDA) cleared for marketing Remeron(TM) (Mirtazapine) Tablets for the treatment of depression. Remeron is the first agent in a new class of anti-depressants. Remeron stimulates norepinephrine and serotonin release while also blocking two specific serotonin receptors, (5-HT2 and 5-HT3). Remeron's ability to target specific serotonin receptors marks the next significant advance in the evolution of bio-chemical selectivity in the brain to treat depression.
"Remeron represents the biggest advance in receptor selectivity since Selective Serotonin Reuptake Inhibitors (SSRI's) were introduced in the early 1980's. Remeron's ability to specifically target serotonin receptors is critical, since it minimizes common side-effects patients typically find undesirable with most other agents, such as decreased sexual drive, nervousness and insomnia," said Dr. Paul Lammers, Medical Director at Organon, Inc.
What other drugs will affect Remeron?
Do not take Remeron if you are currently taking, or have taken within the last 14 days, a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).
Remeron may increase the effects of other drugs that cause drowsiness, including other antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.
Drugs other than those listed here may also interact with Remeron. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Where can I get more information?
Your pharmacist has additional information about Remeron written for health professionals that you may read.
REMERON? (mirtazapine) Tablets are an antidepressant for oral administration. Mirtazapine has a tetracyclic chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics or monoamine oxidase inhibitors (MAOI). Mirtazapine belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino[2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.36.
Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. REMERON? is supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose and other inactive ingredients.
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