Remeron Soltab

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to mirtazapine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Dosage Forms & Strengths

tablet

• 7.5mg
• 15mg
• 30mg
• 45mg

disintegrating tablet

• 15mg
• 30mg
• 45mg

Depression

15 mg PO qHS; may increase no more frequently than q1-2Weeks; not to exceed 45 mg qHS

Post-traumatic Stress Disorder (Off-label)

15 mg PO qHS; may increase no more frequently than q1-2Weeks; not to exceed 60 mg qHS

Hot Flashes (Off-label)

7.5-60 mg PO qDay

Insomnia (Off-label)

15-45 mg PO qHS

Dosing Modifications

Renal impairment (CrCl <39 mL/min): Clearance is reduced; monitor closely

Hepatic impairment: Clearance is reduced; monitor closely

Safety and efficacy not established

Depression

7.5 mg/day PO qHS; increase by 7.5-15 mg/day no more frequently than q1-2Weeks; not to exceed 45 mg/day

Alzheimer Dementia-related Depression

7.5 mg/day PO qHS; increase by 7.5-15 mg/day no more frequently than q1-2Weeks; not to exceed 60 mg/day

Dosing Considerations

The elderly have reduced clearance of mirtazapine and, as a result, may have increased plasma levels of the drug

Use with caution

Mechanism of Action

Tetracyclic structure different from SSRIs, TCAs and MAOIs; through its central presynaptic alpha2-adrenergic antagonist effects, stimulates norepinephrine and serotonin release; potent antagonist of 5-HT2 and 5-HT3 serotonin and histamine receptors; is a moderate alpha1 adrenergic and muscarinic antagonist

Absorption

Bioavailability: 50%

Peak serum time: 2 hr

Distribution

Protein bound: 85%

Vd: 4.5 L/kg

Metabolism

Hepatic CYP450 enzymes CYP1A2, CYP2D6, CYP3A4

Metabolites: Inactive

Elimination

Half-life: 20-40 hr

Excretion: Urine (75%); feces (15%)

Drinking alcohol can increase certain side effects of mirtazapine.

Mirtazapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Your pharmacist can provide more information about mirtazapine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Remeron SolTab is part of the drug class:

• Other antidepressants

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Some Remeron SolTab may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Remeron SolTab.

Remeron SolTab Orally Disintegrating Tablet

• Take Remeron SolTab at the same time each day, preferably in the evening at bedtime.
• Open the tablet blister pack with dry hands and place the tablet whole on the tongue, immediately after removal from the blister pack.
• The tablet will disintegrate rapidly on the tongue and can be swallowed with saliva. No water is needed for taking it.
• Do not attempt to split the orally disintegrating tablet.

• Do not stop taking or change the dose of Remeron SolTab without first talking to your doctor, even if you feel better.
• Remeron SolTab may be taken with or without food.
• If you miss a dose of Remeron SolTab, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Remeron SolTab at the same time.
• If you take too much Remeron SolTab, call your healthcare provider or poison control center right away, or get emergency treatment.
• Remeron SolTab can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Remeron SolTab affects you.
• Avoid drinking alcohol or taking diazepam (a medicine used for anxiety, insomnia and seizures, for example) or similar medicines while taking Remeron SolTab. If you are uncertain about whether certain medication can be taken with Remeron SolTab, please discuss with your doctor.

It is very important that your doctor check your progress at regular visits, to allow changes in your dose and help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take mirtazapine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking mirtazapine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping mirtazapine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Mirtazapine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use mirtazapine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with mirtazapine.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts of hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Using this medicine may cause a serious condition called serotonin syndrome. Check with your doctor right away if you are having agitation, convulsions, difficulty in breathing, a fast heartbeat, hallucinations, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness while you are taking this medicine.

This medicine may add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

This medicine can temporarily lower the number of white blood cells in your blood, increasing your chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have a fever or chills, sore throat, sores in the mouth, lower back or side pain, or painful or difficult urination.

Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.

Mirtazapine may cause drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, and able to think well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dry mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth feels dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungal infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.