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Drugs reference index «Remeron Soltab»

Remeron Soltab

Generic Name: mirtazapine (Oral route)

mir-TAZ-a-peen

Oral routeTabletTablet, Disintegrating
  • Suicidality and Antidepressant Drugs
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of mirtazapine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Mirtazapine is not approved for use in pediatric patients .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s):

In the U.S.

  • Remeron
  • Remeron Soltab

In Canada

  • Remeron RD

Available Dosage Forms:

  • Tablet, Disintegrating
  • Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tetracyclic

Uses For Remeron Soltab

Mirtazapine is used to treat mental depression.

This medicine is available only with your doctor's prescription.

Before Using Remeron Soltab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated any benefit to using mirtazapine in children with depression. Studies have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking the medicine. Because of this toxicity, use in children is not recommended .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of mirtazapine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving mirtazapine .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Isocarboxazid
  • Linezolid
  • Metoclopramide
  • Rasagiline
  • Selegiline
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clonidine
  • Fluoxetine
  • Fluvoxamine
  • Olanzapine
  • Procarbazine
  • Tramadol
  • Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Diazepam

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bipolar disorder (mental disease with cycles of elation and depression), history of, or
  • Bleeding problems or
  • Hypercholesterolemia (high cholesterol in the blood) or
  • Seizures (convulsions), history of—May make these conditions worse .
  • Dehydration or
  • Heart disease or
  • Stroke, history of—Mirtazapine may make the condition worse by causing low blood pressure (hypotension).
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
  • Mania or hypomania (a type of mental illness), or history of—Use of mirtazapine may activate these conditions .
  • Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.

Proper Use of mirtazapine

This section provides information on the proper use of a number of products that contain mirtazapine. It may not be specific to Remeron Soltab. Please read with care.

Take this medicine only as directed by your doctor in order to improve your condition as much as possible. Do not take more of it and do not take it more often than your doctor ordered.

Mirtazapine may be taken with or without food, on a full or empty stomach. If your doctor tells you to take it a certain way, follow your doctor's instructions.

For patients using the oral disintegrating tablet form of this medicine:

  • Make sure your hands are dry.
  • Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
  • Immediately place the tablet on top of the tongue. Do not break or split the tablet.
  • The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets and oral disintegrating tablets):
    • For mental depression:
      • Adults—At first, 15 milligrams (mg) once a day, preferably in the evening just before you go to sleep. Your doctor may increase the dose if necessary. However, the dose usually is not more than 45 mg a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Remeron Soltab

It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.

Do not take mirtazapine with monoamine oxidase (MAO) inhibitors (e.g., furazolidone, phenelzine, procarbazine, selegiline, or tranylcypromine) or sooner than 14 days after stopping an MAO inhibitor. Do not take an MAO inhibitor sooner than 14 days after stopping mirtazapine. To do so may increase the chance of serious side effects.

Mirtazapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away .

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 hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

Check with your doctor immediately if you develop fever, chills, sore throat, or sores in the mouth. These may be signs of a very serious blood problem that has occurred rarely in patients taking mirtazapine.

Mirtazapine may cause drowsiness or trouble in thinking. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert and clearheaded.

Dizziness, light-headedness, or fainting may occur, especially when you get up 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 dryness of the 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 fungus infections.

Remeron Soltab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Decreased or increased movement
  • mood or mental changes, including abnormal thinking, agitation, anxiety, confusion, and feelings of not caring
  • shortness of breath
  • skin rash
  • swelling
Rare
  • Convulsions (seizures)
  • decreased sexual ability
  • menstrual pain
  • missing periods
  • mood or mental changes, including anger, feelings of being outside the body, hallucinations (seeing, hearing, or feeling things that are not there), mood swings, and unusual excitement
  • mouth sores
  • sore throat, chills, or fever

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • dizziness
  • drowsiness
  • dryness of mouth
  • increased appetite
  • weight gain
Less common
  • Abdominal pain
  • abnormal dreams
  • back pain
  • dizziness or fainting when getting up suddenly from a lying or sitting position
  • increased need to urinate
  • increased sensitivity to touch
  • increased thirst
  • low blood pressure
  • muscle pain
  • nausea
  • sense of constant movement of self or surroundings
  • trembling or shaking
  • vomiting
  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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  • Mirtazapine Professional Patient Advice (Wolters Kluwer)
  • Mirtazapine MedFacts Consumer Leaflet (Wolters Kluwer)
  • Remeron Prescribing Information (FDA)
  • Remeron Consumer Overview
  • Remeron SolTab Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
  • Remeron SolTab Detailed Consumer Information (PDR)

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