Remeron Soltab

The active ingredient in Remeron Soltab is mirtazapine. Mirtazapine works by increasing the levels of norepinephrine and serotonin in the brain, two neurotransmitters that affect mood, sleep, and emotions. Its mechanism of action is unique compared to many other antidepressants like SSRIs or SNRIs. Instead of directly blocking serotonin reuptake, it enhances the release of these neurotransmitters by blocking specific receptors (alpha-2 adrenergic receptors).

This dual effect helps improve mood, reduce anxiety, and promote better sleep. Because of its sedative properties, it is often taken at bedtime. Mirtazapine also blocks certain histamine receptors, which can lead to drowsiness and increased appetite, two common side effects seen during clinical trials.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Remeron Soltab. However, the following is a synopsis of the general guidelines for the use of Remeron Soltab:

• Take Remeron Soltab exactly as prescribed by your healthcare provider.
• The orally disintegrating tablet should be kept in its blister pack until you are ready to take it.
• With dry hands, peel back the foil, remove the tablet, and place it on your tongue. The tablet will dissolve quickly and can be swallowed with saliva. No water is needed.
• It is usually taken once daily at bedtime, since it may cause sleepiness or sedation.
• Do not chew or crush the tablet.
• Continue taking the medication even if you feel better, unless instructed otherwise by your doctor.
• If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not double up.
• Do not stop taking Remeron Soltab suddenly; your healthcare provider will give you a plan to taper off gradually to avoid withdrawal symptoms such as dizziness, nausea, agitation, or trouble sleeping.
• Your prescriber may need to adjust your dose depending on your response and medical condition. Never change your dosage or stop treatment without medical advice.

Some mild or common side effects of Remeron Soltab seen in clinical trials as compared to placebo include:

• Drowsiness or sleepiness.
• Increased appetite and possible weight gain.
• Dry mouth.
• Constipation.
• Dizziness or lightheadedness.
• Abnormal dreams.
• Back pain.
• Sore throat.

Some individuals may experience serious side effects while using Remeron Soltab. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Suicidal thoughts or worsening depression, especially in children, adolescents, or young adults.
• Risk of serotonin syndrome.
• Severe allergic reactions or hives.
• Swelling of the face, tongue, or throat.
• Severe skin reactions, blisters, or peeling.
• Irregular heart rhythm (QT prolongation or torsades de pointes).
• Signs of low white blood cell count (agranulocytosis), such as fever, sore throat, or infection.
• Confusion, headache, or weakness due to hyponatremia (low sodium).
• Eye pain or vision changes related to narrow-angle glaucoma.
• Signs of a manic episode or hypomania in patients with bipolar disorder.

These are not all of the possible side effects of Remeron Soltab. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Remeron Soltab, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• A history of suicidal thoughts or behavior.
• Bipolar disorder or manic episodes.
• Low blood pressure (hypotension).
• Heart problems or irregular heartbeat.
• Glaucoma or increased eye pressure.
• Liver or kidney disease.
• Seizure disorders.
• Low sodium levels or hyponatremia.
• High cholesterol or triglyceride levels.
• A history of agranulocytosis or low white blood cell count.
• Phenylketonuria (PKU), the orally disintegrating tablet may contain phenylalanine.
• Avoid drinking alcohol while taking Remeron Soltab, as it can increase sedation and impair judgment. Be cautious when driving or operating machinery until you know how the medication affects you.
• If you experience worsening depression, anxiety, or thoughts of suicide, contact your healthcare provider immediately. Regular follow-ups are important, especially during the first few months of treatment or when changing doses.

Boxed Warning

Suicidal thoughts and behaviors

Antidepressants, including Remeron Soltab (mirtazapine), increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric conditions. Close monitoring is necessary for worsening symptoms, behavioral changes, or suicidal thoughts.

Remeron Soltab is not approved for use in pediatric patients.

Do not use Remeron Soltab if you:

• Are allergic to mirtazapine or any ingredients in the formulation.
• Are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI) such as phenelzine, selegiline, or tranylcypromine, or have stopped one within the past 14 days.
• Are you using certain drugs that can increase serotonin levels, such as linezolid or intravenous methylene blue.

Many people begin to notice some improvement in sleep or appetite within the first week of starting treatment. However, full antidepressant effects may take 2 to 4 weeks or longer. Continue taking the medication as prescribed, even if you don’t feel better immediately. If there is no improvement after several weeks, your healthcare provider may adjust your dose.

When Remeron Soltab is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• MAOIs or drugs that raise serotonin levels (SSRIs, SNRIs, tramadol, fentanyl, St. John’s wort, tryptophan, linezolid, methylene blue).
• Carbamazepine, phenytoin, or nefazodone.
• Warfarin.
• Cimetidine, ketoconazole, or diazepam.
• Alcohol or other sedatives.

Remeron Soltab (mirtazapine orally disintegrating tablets) is available in several strengths, typically 15 mg, 30 mg, and 45 mg.

The starting dose for most adults with major depressive disorder is 15 mg once daily at bedtime. Your healthcare provider may increase the dose gradually based on your response and tolerance. Do not adjust your dose without consulting your prescriber.

Store at room temperature (around 25°C or 77°F) and keep in the original blister pack until use to protect from moisture and light.

Remeron Soltab is manufactured by Organon LLC (previously by Merck & Co., Inc.), under license from the original developer.

Yes. Generic mirtazapine orally disintegrating tablets are available and contain the same active ingredient as Remeron Soltab. Generic versions are approved by regulatory agencies such as the FDA and Health Canada for safety, effectiveness, and quality.

Do not stop taking Remeron Soltab suddenly. Your doctor will create a tapering plan to reduce your dose slowly. Stopping abruptly may cause withdrawal symptoms like nausea, dizziness, agitation, anxiety, or trouble sleeping. Always follow your healthcare provider’s instructions when discontinuing antidepressants.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Limited data suggest that using mirtazapine during pregnancy may carry some risk, particularly if taken during the third trimester, when it may cause temporary withdrawal symptoms in newborns. The benefits and potential risks should be carefully weighed by your healthcare provider.

Mirtazapine passes into breast milk in small amounts. It may cause drowsiness or feeding problems in nursing infants. Your healthcare provider will help determine whether you should continue breastfeeding or use an alternative treatment.