Remeron (Mirtazapine)

$ 124.52$ 441.48

Category: Anti-Depressants
Commercial name: Remeron
Active ingredient: Mirtazapine
Production form: Pills
Available dosage: 15mg, 30mg

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Description

Remeron (Mirtazapine). Dosage, Side Effects, Interactions

Remeron (Mirtazapine) belongs to the active substance group of tetracyclic antidepressants, but is sometimes also assigned to the specific noradrenergic serotonergic antidepressants (NaSSA). Mirtazapine is indicated for the treatment of depressive episodes and is also often used off-label for the treatment of sleep disorders.

Remeron (Mirtazapine) has the following indications:

  • Treatment of depressive disorders ( major depressive episodes )

Within an off-label use , mirtazapine is also used in:

  • anxiety disorder
  • panic disorder
  • sleep disturbance
  • Post-traumatic stress disorder
  • Adjuvant pain therapy

How Remeron (Mirtazapine) works

Mirtazapine acts centrally as an alpha-2 antagonist and enhances noradrenergic and serotonergic neurotransmission. The enhancement of serotonergic neurotransmission is specifically mediated by 5-HT1 receptors, since 5-HT2 and 5-HT3 receptors are blocked by mirtazapine.

Both enantiomers of mirtazapine probably contribute to the  antidepressant  effect:

  • the S(+) enantiomer by blockade of alpha-2 and 5-HT2 receptors and

  • the R(-) enantiomer by blocking the 5-HT3 receptors.

The histamine H1 antagonistic effect of mirtazapine is related to its sedative properties. It has practically no anticholinergic effect and in therapeutic doses has almost no effect on the cardiovascular system.

 

Pharmacokinetics

  • After oral administration, mirtazapine is rapidly and well absorbed with a bioavailability of 50 percent.
  • Maximum plasma levels are reached after about 2 hours.
  • Mirtazapine is approximately 85 percent plasma protein bound.
  • The mean elimination half-life is 20 to 40 hours, with occasionally longer half-lives of up to 65 hours being measured.
  • Within the recommended dose range, mirtazapine shows linear kinetics.
  • Concomitant intake with food does not affect the pharmacokinetics of mirtazapine.
  • Mirtazapine is extensively metabolised and eliminated in the urine and faeces within a few days.
  • Biotransformation mainly occurs via demethylation and oxidation, followed by conjugation.
  • In vitro data using human liver microsomes indicate that the cytochrome P450 enzymes  CYP2D6  and  CYP1A2 are  involved in the formation of the 8-hydroxy metabolite of mirtazapine and  CYP3A4  in the formation of the  N -desmethyl and  N -oxide metabolites is.
  • The demethyl metabolite is pharmacologically active and appears to have the same pharmacokinetic profile as mirtazapine itself.
  • In hepatic or renal insufficiency the clearance of mirtazapine may be reduced.

Dosage of Remeron (Mirtazapine)

Mirtazapine is taken orally. At the start of therapy, the dosage should be tapered off. When stopping therapy, abrupt discontinuation should be avoided. The therapy should be tapered off. The daily dose is 15-45 mg, initially 15 or 30 mg once a day. The active ingredient is suitable for daily intake, which should preferably be done before going to bed. If the daily dose is divided into two daily doses (morning and evening), the higher dose should be taken in the evening.

 

Side effects of Remeron (Mirtazapine)

Depressed patients show a number of illness-related symptoms. It is therefore sometimes difficult to classify which symptoms are caused by the disease and which result from the treatment.

The most commonly reported side effects, occurring in more than 5 percent of patients in clinical trials, are:

  • sleepiness
  • sedation
  • dry mouth
  • weight gain
  • increased appetite
  • dizziness
  • exhaustion

Interactions

Interactions with the following drugs are known for the drug mirtazapine:

  • MAO inhibitors → contraindicated
  • Serotonergic agents ( L-tryptophan , triptans, tramadol , linezolid , SSRIs, venlafaxine , lithium and preparations containing St. John’s wort – Hypericum perforatum )
  • Benzodiazepines or other sedatives (especially most neuroleptics , histamine H1 receptor blockers, opioids ) → increase the effect
  • Alcohol → Mirtazapine can increase the central depressant effect of alcohol
  • Warfarin → small but statistically significant increase in the international normalized ratio (INR)
  • CYP3A4 inducers such as carbamazepine and phenytoin → the clearance of mirtazapine may be increased → reduction in the mean plasma concentration of mirtazapine
  • Inducers of hepatic metabolism (such as rifampicin ) → the mirtazapine dose may need to be increased
  • Strong CYP3A4 inhibitors such as ketoconazole → increase in the maximum plasma levels and the AUC of mirtazapine
  • Cimetidine (a weak inhibitor of CYP1A2 , CYP2D6 and CYP3A4 ) → mean plasma concentration of mirtazapine can increase by more than 50 percent
  • Strong CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals , erythromycin , cimetidine or nefazodone → dose may have to be reduced

Contraindication

Mirtazapine must not be used in:

  • Hypersensitivity to the active substance
  • therapy with monoamine oxidase (MAO) inhibitors

Pregnancy/breastfeeding

pregnancy

  • Animal studies have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see prescribing information). If used during pregnancy, caution is recomended.

lactation

  • Animal studies and limited human data have shown that mirtazapine is excreted in human milk in very small amounts. A decision should be made taking into account the benefit of breast-feeding to the child and the benefit of mirtazapine therapy to the mother.

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Additional information

Dosage

7.5 mg, 15 mg, 30 mg

Quantity

30, 60, 90, 120, 180

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