Teolop may be available in the countries listed below.
Diflorasone 17α,21-diacetate (a derivative of Diflorasone) is reported as an ingredient of Teolop in the following countries:
International Drug Name Search
Acido Borico Medicinal may be available in the countries listed below.
Boric Acid is reported as an ingredient of Acido Borico Medicinal in the following countries:
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Repidose Farmintic may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Oxfendazole is reported as an ingredient of Repidose Farmintic in the following countries:
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Cisplatine may be available in the countries listed below.
Cisplatine (DCF) is known as Cisplatin in the US.
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Glossary
| DCF | Dénomination Commune Française |
Bart may be available in the countries listed below.
Tenoxicam is reported as an ingredient of Bart in the following countries:
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Mycoheal may be available in the countries listed below.
Hydrocortisone is reported as an ingredient of Mycoheal in the following countries:
Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Mycoheal in the following countries:
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Antrain may be available in the countries listed below.
Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Antrain in the following countries:
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Solvente Indoloro Northia may be available in the countries listed below.
Lidocaine is reported as an ingredient of Solvente Indoloro Northia in the following countries:
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Cepezet may be available in the countries listed below.
Chlorpromazine hydrochloride (a derivative of Chlorpromazine) is reported as an ingredient of Cepezet in the following countries:
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Bicusan may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bicusan in the following countries:
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Mesol may be available in the countries listed below.
Methylprednisolone is reported as an ingredient of Mesol in the following countries:
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Prednisolone-Darnitsa may be available in the countries listed below.
Prednisolone is reported as an ingredient of Prednisolone-Darnitsa in the following countries:
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Milnacipran Hydrochloride may be available in the countries listed below.
Milnacipran Hydrochloride (BANM, USAN) is known as Milnacipran in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| USAN | United States Adopted Name |
Zomiren may be available in the countries listed below.
Alprazolam is reported as an ingredient of Zomiren in the following countries:
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Rec.INN
N03AD03
0000077-41-8
C12-H13-N-O2
203
Antiepileptic agent
2,5-Pyrrolidinedione, 1,3-dimethyl-3-phenyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Generic Name: dimethyl sulfoxide (Intravesical route)
dye-METH-il sul-FOX-ide
In the U.S.
Available Dosage Forms:
Therapeutic Class: Renal-Urologic Agent
Dimethyl sulfoxide is a purified preparation used in the bladder to relieve the symptoms of the bladder condition called interstitial cystitis. A catheter (tube) or syringe is used to put the solution into the bladder where it is allowed to remain for about 15 minutes. Then, the solution is expelled by urinating.
Interstitial cystitis is the only human use for dimethyl sulfoxide that is approved by the U.S. Food and Drug Administration (FDA).
Claims that dimethyl sulfoxide is effective for treating various types of arthritis, ulcers in scleroderma, muscle sprains and strains, bruises, infections of the skin, burns, wounds, and mental conditions have not been proven.
Although other preparations of dimethyl sulfoxide are available for industrial and veterinary (animal) use, they must not be used by humans, because of their unknown purity. Impurities in these preparations may cause serious unwanted effects in humans. Even if dimethyl sulfoxide is applied to the skin, it is absorbed into the body through the skin and mucous membranes.
This medicine is available only with your doctor's prescription.
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:
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.
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal 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. |
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
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.
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:
Some patients may have some discomfort during the time this medicine is being put into the bladder. However, the discomfort usually becomes less each time the medicine is used.
Dimethyl sulfoxide may cause you to have a garlic-like taste within a few minutes after the medicine is put into the bladder. This effect may last for several hours. It may also cause your breath and skin to have a garlic-like odor, which may last up to 72 hours.
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.
See also: Rimso-50 side effects (in more detail)
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In the US, Versed (midazolam systemic) is a member of the drug class benzodiazepines and is used to treat ICU Agitation, Light Anesthesia and Light Sedation.
US matches:
Midazolam is reported as an ingredient of Versed in the following countries:
International Drug Name Search
The following drugs and medications are in some way related to, or used in the treatment of Cholera Prophylaxis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Medical Encyclopedia:
Prazinex may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Praziquantel is reported as an ingredient of Prazinex in the following countries:
International Drug Name Search
Claritromicina Winthrop may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Claritromicina Winthrop in the following countries:
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Medocycline may be available in the countries listed below.
Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Medocycline in the following countries:
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Neo Tylan may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Tylosin phosphate (a derivative of Tylosin) is reported as an ingredient of Neo Tylan in the following countries:
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Metacycline Hydrochloride may be available in the countries listed below.
Metacycline hydrochloride (a derivative of Metacycline) is reported as an ingredient of Metacycline Hydrochloride in the following countries:
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Klato Col may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Colistin sulfate (a derivative of Colistin) is reported as an ingredient of Klato Col in the following countries:
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Efedrin Gürsoy may be available in the countries listed below.
Ephedrine hydrochloride (a derivative of Ephedrine) is reported as an ingredient of Efedrin Gürsoy in the following countries:
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Calcio Cloruro Galenica may be available in the countries listed below.
Calcium Chloride dihydrate (a derivative of Calcium Chloride) is reported as an ingredient of Calcio Cloruro Galenica in the following countries:
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Orgafen may be available in the countries listed below.
Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Orgafen in the following countries:
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Musapam may be available in the countries listed below.
Tetrazepam is reported as an ingredient of Musapam in the following countries:
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USAN
C04AC02,C10AD05
0000100-55-0
C6-H7-N-O
109
Vasodilator, peripheric
Antilipemic agent, nicotinic acid derivative
3-Pyridinemethanol
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| USAN | United States Adopted Name |
Fortine may be available in the countries listed below.
Flurbiprofen is reported as an ingredient of Fortine in the following countries:
International Drug Name Search
Spiramycine Métronidazole EG may be available in the countries listed below.
Metronidazole is reported as an ingredient of Spiramycine Métronidazole EG in the following countries:
Spiramycin is reported as an ingredient of Spiramycine Métronidazole EG in the following countries:
International Drug Name Search
Perenal may be available in the countries listed below.
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Perenal in the following countries:
International Drug Name Search
Citalopram Asol may be available in the countries listed below.
Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram Asol in the following countries:
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Mirtazapin dura may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazapin dura in the following countries:
International Drug Name Search
Ketoconazol Korhispana may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Ketoconazol Korhispana in the following countries:
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Terfenadina may be available in the countries listed below.
Terfenadina (DCIT) is known as Terfenadine in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
T3 may be available in the countries listed below.
Liothyronine sodium salt (a derivative of Liothyronine) is reported as an ingredient of T3 in the following countries:
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Fortinol may be available in the countries listed below.
Carteolol hydrochloride (a derivative of Carteolol) is reported as an ingredient of Fortinol in the following countries:
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Methionin-CT may be available in the countries listed below.
Methionine is reported as an ingredient of Methionin-CT in the following countries:
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Aflorix may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Aflorix in the following countries:
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Randa may be available in the countries listed below.
Cisplatin is reported as an ingredient of Randa in the following countries:
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Difrin may be available in the countries listed below.
Diphenylpyraline hydrochloride (a derivative of Diphenylpyraline) is reported as an ingredient of Difrin in the following countries:
Dipivefrine hydrochloride (a derivative of Dipivefrine) is reported as an ingredient of Difrin in the following countries:
International Drug Name Search
Esital may be available in the countries listed below.
Escitalopram is reported as an ingredient of Esital in the following countries:
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Myambutol Orifarm may be available in the countries listed below.
Ethambutol dihydrochloride (a derivative of Ethambutol) is reported as an ingredient of Myambutol Orifarm in the following countries:
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Ethylpapaverine may be available in the countries listed below.
Ethaverine hydrochloride (a derivative of Ethaverine) is reported as an ingredient of Ethylpapaverine in the following countries:
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Pentoxyvérine may be available in the countries listed below.
Pentoxyvérine (DCF) is also known as Pentoxyverine (Rec.INN)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Mesulphen may be available in the countries listed below.
Mesulphen (BAN) is also known as Mesulfen (Prop.INN)
International Drug Name Search
Glossary
| BAN | British Approved Name |
| Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
Glaumol may be available in the countries listed below.
Timolol is reported as an ingredient of Glaumol in the following countries:
International Drug Name Search
Clotrizol may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Clotrizol in the following countries:
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Diazidan may be available in the countries listed below.
Gliclazide is reported as an ingredient of Diazidan in the following countries:
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Amazina may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Amazina in the following countries:
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Kilnits may be available in the countries listed below.
Permethrin is reported as an ingredient of Kilnits in the following countries:
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Bucain Actavis may be available in the countries listed below.
Bupivacaine hydrochloride (a derivative of Bupivacaine) is reported as an ingredient of Bucain Actavis in the following countries:
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Rec.INN
R06AX15
0000524-81-2
C19-H20-N2
276
Antiallergic agent
Histamine, H₁-receptor antagonist
1H-Pyrido[4,3-b]indole, 2,3,4,5-tetrahydro-2-methyl-5-(phenylmethyl)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Noameba-DS may be available in the countries listed below.
Secnidazole is reported as an ingredient of Noameba-DS in the following countries:
International Drug Name Search
Lactulosestroop CF may be available in the countries listed below.
Lactulose is reported as an ingredient of Lactulosestroop CF in the following countries:
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In the US, Exelon (rivastigmine systemic) is a member of the drug class cholinesterase inhibitors and is used to treat Alzheimer's Disease and Parkinson's Disease.
US matches:
UK matches:
Rivastigmine is reported as an ingredient of Exelon in the following countries:
Rivastigmine tartrate (a derivative of Rivastigmine) is reported as an ingredient of Exelon in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
Brexic may be available in the countries listed below.
Piroxicam is reported as an ingredient of Brexic in the following countries:
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Pyrimon may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Pyrimon in the following countries:
Dexamethasone is reported as an ingredient of Pyrimon in the following countries:
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Medsatrexate may be available in the countries listed below.
Methotrexate sodium salt (a derivative of Methotrexate) is reported as an ingredient of Medsatrexate in the following countries:
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Orixal may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Orixal in the following countries:
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Dentopain may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Dentopain in the following countries:
Paracetamol is reported as an ingredient of Dentopain in the following countries:
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Lactulose Biomedica may be available in the countries listed below.
Lactulose is reported as an ingredient of Lactulose Biomedica in the following countries:
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Forcet may be available in the countries listed below.
Sumatriptan succinate (a derivative of Sumatriptan) is reported as an ingredient of Forcet in the following countries:
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Pubergen may be available in the countries listed below.
Chorionic Gonadotrophin is reported as an ingredient of Pubergen in the following countries:
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Vitrax may be available in the countries listed below.
Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Vitrax in the following countries:
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Regroe may be available in the countries listed below.
Minoxidil is reported as an ingredient of Regroe in the following countries:
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Doxycycline Kombivet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Doxycycline is reported as an ingredient of Doxycycline Kombivet in the following countries:
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Adco-Cefotaxime may be available in the countries listed below.
Cefotaxime is reported as an ingredient of Adco-Cefotaxime in the following countries:
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0087139-86-4
Immunomodulator
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
Dozozin may be available in the countries listed below.
Doxazosin mesilate (a derivative of Doxazosin) is reported as an ingredient of Dozozin in the following countries:
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Escapelle may be available in the countries listed below.
Levonorgestrel is reported as an ingredient of Escapelle in the following countries:
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Amoxicillin Streuli may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicillin Streuli in the following countries:
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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 RemeronSolTab® (mirtazapine) Orally Disintegrating 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. RemeronSolTab is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)
RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and 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. The structural formula is the following and it is the racemic mixture:
Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. RemeronSolTab is available for oral administration as an orally disintegrating tablet containing 15, 30, or 45 mg of mirtazapine. It disintegrates in the mouth within seconds after placement on the tongue, allowing its contents to be subsequently swallowed with or without water. RemeronSolTab also contains the following inactive ingredients: aspartame, citric acid, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial orange flavor, polymethacrylate, povidone, sodium bicarbonate, starch, and sucrose.
The mechanism of action of RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets, as with other drugs effective in the treatment of major depressive disorder, is unknown.
Evidence gathered in preclinical studies suggests that mirtazapine enhances central noradrenergic and serotonergic activity. These studies have shown that mirtazapine acts as an antagonist at central presynaptic α2 adrenergic inhibitory autoreceptors and heteroreceptors, an action that is postulated to result in an increase in central noradrenergic and serotonergic activity.
Mirtazapine is a potent antagonist of 5-HT2 and 5-HT3 receptors. Mirtazapine has no significant affinity for the 5-HT1A and 5-HT1B receptors.
Mirtazapine is a potent antagonist of histamine (H1) receptors, a property that may explain its prominent sedative effects.
Mirtazapine is a moderate peripheral α1 adrenergic antagonist, a property that may explain the occasional orthostatic hypotension reported in association with its use.
Mirtazapine is a moderate antagonist at muscarinic receptors, a property that may explain the relatively low incidence of anticholinergic side effects associated with its use.
RemeronSolTab (mirtazapine) Orally Disintegrating Tablets are rapidly and completely absorbed following oral administration and have a half-life of about 20 to 40 hours. Peak plasma concentrations are reached within about 2 hours following an oral dose. The presence of food in the stomach has a minimal effect on both the rate and extent of absorption and does not require a dosage adjustment. RemeronSolTab Orally Disintegrating Tablets are bioequivalent to Remeron® (mirtazapine) Tablets.
Mirtazapine is extensively metabolized after oral administration. Major pathways of bio-transformation are demethylation and hydroxylation followed by glucuronide conjugation. In vitro data from human liver microsomes indicate that cytochrome 2D6 and 1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas cytochrome 3A is considered to be responsible for the formation of the N-desmethyl and N-oxide metabolite. Mirtazapine has an absolute bioavailability of about 50%. It is eliminated predominantly via urine (75%) with 15% in feces. Several unconjugated metabolites possess pharmacological activity but are present in the plasma at very low levels. The (–) enantiomer has an elimination half-life that is approximately twice as long as the (+) enantiomer and therefore achieves plasma levels that are about 3 times as high as that of the (+) enantiomer.
Plasma levels are linearly related to dose over a dose range of 15 to 80 mg. The mean elimination half-life of mirtazapine after oral administration ranges from approximately 20 to 40 hours across age and gender subgroups, with females of all ages exhibiting significantly longer elimination half-lives than males (mean half-life of 37 hours for females vs 26 hours for males). Steady state plasma levels of mirtazapine are attained within 5 days, with about 50% accumulation (accumulation ratio = 1.5).
Mirtazapine is approximately 85% bound to plasma proteins over a concentration range of 0.01 to 10 mcg/mL.
Following oral administration of Remeron (mirtazapine) Tablets 20 mg/day for 7 days to subjects of varying ages (range, 25–74), oral clearance of mirtazapine was reduced in the elderly compared to the younger subjects. The differences were most striking in males, with a 40% lower clearance in elderly males compared to younger males, while the clearance in elderly females was only 10% lower compared to younger females. Caution is indicated in administering RemeronSolTab (mirtazapine) Orally Disintegrating Tablets to elderly patients (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
Safety and effectiveness of mirtazapine in the pediatric population have not been established (see PRECAUTIONS).
The mean elimination half-life of mirtazapine after oral administration ranges from approximately 20 to 40 hours across age and gender subgroups, with females of all ages exhibiting significantly longer elimination half-lives than males (mean half-life of 37 hours for females vs. 26 hours for males) (see Pharmacokinetics).
There have been no clinical studies to evaluate the effect of race on the pharmacokinetics of RemeronSolTab.
The disposition of mirtazapine was studied in patients with varying degrees of renal function. Elimination of mirtazapine is correlated with creatinine clearance. Total body clearance of mirtazapine was reduced approximately 30% in patients with moderate (Clcr = 11–39 mL/min/1.73 m2) and approximately 50% in patients with severe (Clcr = <10 mL/min/1.73 m2) renal impairment when compared to normal subjects. Caution is indicated in administering RemeronSolTab to patients with compromised renal function (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
Following a single 15-mg oral dose of Remeron, the oral clearance of mirtazapine was decreased by approximately 30% in hepatically impaired patients compared to subjects with normal hepatic function. Caution is indicated in administering RemeronSolTab to patients with compromised hepatic function (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
The efficacy of Remeron (mirtazapine) Tablets as a treatment for major depressive disorder was established in 4 placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder. Patients were titrated with mirtazapine from a dose range of 5 mg up to 35 mg/day. Overall, these studies demonstrated mirtazapine to be superior to placebo on at least 3 of the following 4 measures: 21-Item Hamilton Depression Rating Scale (HDRS) total score; HDRS Depressed Mood Item; CGI Severity score; and Montgomery and Asberg Depression Rating Scale (MADRS). Superiority of mirtazapine over placebo was also found for certain factors of the HDRS, including anxiety/somatization factor and sleep disturbance factor. The mean mirtazapine dose for patients who completed these 4 studies ranged from 21 to 32 mg/day. A fifth study of similar design utilized a higher dose (up to 50 mg) per day and also showed effectiveness.
Examination of age and gender subsets of the population did not reveal any differential responsiveness on the basis of these subgroupings.
In a longer-term study, patients meeting (DSM-IV) criteria for major depressive disorder who had responded during an initial 8 to 12 weeks of acute treatment on Remeron were randomized to continuation of Remeron or placebo for up to 40 weeks of observation for relapse. Response during the open phase was defined as having achieved a HAM-D 17 total score of ≤8 and a CGI-Improvement score of 1 or 2 at 2 consecutive visits beginning with week 6 of the 8 to 12 weeks in the open-label phase of the study. Relapse during the double-blind phase was determined by the individual investigators. Patients receiving continued Remeron treatment experienced significantly lower relapse rates over the subsequent 40 weeks compared to those receiving placebo. This pattern was demonstrated in both male and female patients.
RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets are indicated for the treatment of major depressive disorder.
The efficacy of Remeron® (mirtazapine) Tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The effectiveness of RemeronSolTab in hospitalized depressed patients has not been adequately studied.
The efficacy of Remeron in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Remeron for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).
RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets are contraindicated in patients with a known hypersensitivity to mirtazapine or to any of the excipients.
The concomitant use of RemeronSolTab Orally Disintegrating Tablets and a monoamine oxidase (MAO) inhibitor is contraindicated. Remeron® should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor (MAOI) (see WARNINGS, PRECAUTIONS: Drug Interactions, and DOSAGE AND ADMINISTRATION).
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18–24) 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; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
|---|---|
| Increases Compared to Placebo | |
| <18 | 14 additional cases |
| 18–24 | 5 additional cases |
| Decreases Compared to Placebo | |
| 25–64 | 1 fewer case |
| ≥65 | 6 fewer cases |
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that RemeronSolTab (mirtazapine) Orally Disintegrating Tablets are not approved for use in treating bipolar depression.
In premarketing clinical trials, 2 (1 with Sjögren's Syndrome) out of 2796 patients treated with Remeron® (mirtazapine) Tablets developed agranulocytosis [absolute neutrophil count (ANC) <500/mm3 with associated signs and symptoms, e.g., fever, infection, etc.] and a third patient developed severe neutropenia (ANC <500/mm3 without any associated symptoms). For these 3 patients, onset of severe neutropenia was detected on days 61, 9, and 14 of treatment, respectively. All 3 patients recovered after Remeron was stopped. These 3 cases yield a crude incidence of severe neutropenia (with or without associated infection) of approximately 1.1 per thousand patients exposed, with a very wide 95% confidence interval, i.e., 2.2 cases per 10,000 to 3.1 cases per 1000. If a patient develops a sore throat, fever, stomatitis, or other signs of infection, along with a low WBC count, treatment with RemeronSolTab (mirtazapine) Orally Disintegrating Tablets should be discontinued and the patient should be closely monitored.
In patients receiving other drugs for major depressive disorder in combination with a monoamine oxidase inhibitor (MAOI) and in patients who have recently discontinued a drug for major depressive disorder and then are started on an MAOI, there have been reports of serious and sometimes fatal reactions, including nausea, vomiting, flushing, dizziness, tremor, myoclonus, rigidity, diaphoresis, hyperthermia, autonomic instability with rapid fluctuations of vital signs, seizures, and mental status changes ranging from agitation to coma. Although there are no human data pertinent to such an interaction with RemeronSolTab (mirtazapine) Orally Disintegrating Tablets, it is recommended that RemeronSolTab not be used in combination with an MAOI, or within 14 days of initiating or discontinuing therapy with an MAOI.
On rare occasions, serotonin syndrome has occurred in association with treatment of RemeronSolTab Orally Disintegrating Tablets, particularly when given in combination with other serotonergic drugs. As serotonin syndrome may result in potentially life-threatening conditions, treatment with Remeron should be discontinued if patients develop a combination of symptoms possibly including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma, and supportive symptomatic treatment should be initiated. Due to the risk of serotonin syndrome, Remeron should not be used in combination with MAO inhibitors or serotonin-precursors (such as L-tryptophan and oxitriptan) and should be used with caution in patients receiving other serotonergic drugs (e.g., triptans, lithium, tramadol, St. John's wort, and most tricyclic antidepressants) (see CONTRAINDICATIONS and PRECAUTIONS: Drug Interactions).
There have been reports of adverse reactions upon the discontinuation of Remeron®/ RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets (particularly when abrupt), including but not limited to the following: dizziness, abnormal dreams, sensory disturbances (including paresthesia and electric shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting, and sweating, or other symptoms which may be of clinical significance. The majority of the reported cases are mild and self-limiting. Even though these have been reported as adverse reactions, it should be realized that these symptoms may be related to underlying disease.
Patients currently taking Remeron should NOT discontinue treatment abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue treatment with Remeron, a gradual reduction in the dose, rather than an abrupt cessation, is recommended.
The use of antidepressants has been associated with the development of akathisia, characterized by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Hyponatremia has been reported very rarely with the use of mirtazapine. Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatremia.
In US controlled studies, somnolence was reported in 54% of patients treated with Remeron® (mirtazapine) Tablets, compared to 18% for placebo and 60% for amitriptyline. In these studies, somnolence resulted in discontinuation for 10.4% of Remeron-treated patients, compared to 2.2% for placebo. It is unclear whether or not tolerance develops to the somnolent effects of Remeron. Because of the potentially significant effects of Remeron on impairment of performance, patients should be cautioned about engaging in activities requiring alertness until they have been able to assess the drug's effect on their own psychomotor performance (see Information for Patients).
In US controlled studies, dizziness was reported in 7% of patients treated with Remeron, compared to 3% for placebo and 14% for amitriptyline. It is unclear whether or not tolerance develops to the dizziness observed in association with the use of Remeron.
In US controlled studies, appetite increase was reported in 17% of patients treated with Remeron, compared to 2% for placebo and 6% for amitriptyline. In these same trials, weight gain of ≥ 7% of body weight was reported in 7.5% of patients treated with mirtazapine, compared to 0% for placebo and 5.9% for amitriptyline. In a pool of premarketing US studies, including many patients for long-term, open-label treatment, 8% of patients receiving Remeron discontinued for weight gain. In an 8-week-long pediatric clinical trial of doses between 15 to 45 mg/day, 49% of Remeron-treated patients had a weight gain of at least 7%, compared to 5.7% of placebo-treated patients (see PRECAUTIONS: Pediatric Use).
In US controlled studies, nonfasting cholesterol increases to ≥20% above the upper limits of normal were observed in 15% of patients treated with Remeron, compared to 7% for placebo and 8% for amitriptyline. In these same studies, nonfasting triglyceride increases to ≥500 mg/dL were observed in 6% of patients treated with mirtazapine, compared to 3% for placebo and 3% for amitriptyline.
Clinically significant ALT (SGPT) elevations (≥3 times the upper limit of the normal range) were observed in 2.0% (8/424) of patients exposed to Remeron in a pool of short-term US controlled trials, compared to 0.3% (1/328) of placebo patients and 2.0% (3/181) of amitriptyline patients. Most of these patients with ALT increases did not develop signs or symptoms associated with compromised liver function. While some patients were discontinued for the ALT increases, in other cases, the enzyme levels returned to normal despite continued Remeron treatment. RemeronSolTab® (mirtazapine) Orally Disintegrating Tablets should be used with caution in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Mania/hypomania occurred in approximately 0.2% (3/1299 patients) of Remeron-treated patients in US studies. Although the incidence of mania/hypomania was very low during treatment with mirtazapine, it should be used carefully in patients with a history of mania/hypomania.
In premarketing clinical trials, only 1 seizure was reported among the 2796 US and non-US patients treated with Remeron. However, no controlled studies have been carried out in patients with a history of seizures. Therefore, care should be exercised when mirtazapine is used in these patients.
Clinical experience with RemeronSolTab in patients with concomitant systemic illness is limited. Accordingly, care is advisable in prescribing mirtazapine for patients with diseases or conditions that affect metabolism or hemodynamic responses.
RemeronSolTab has not been systematically evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or other significant heart disease. Remeron was associated with significant orthostatic hypotension in early clinical pharmacology trials with normal volunteers. Orthostatic hypotension was infrequently observed in clinical trials with depressed patients. RemeronSolTab should be used with caution in patients with known cardiovascular or cerebrovascular disease that could be exacerbated by hypotension (history of myocardial infarction, angina, or ischemic stroke) and conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medication).
Mirtazapine clearance is decreased in patients with moderate [glomerular filtration rate (GFR) = 11–39 mL/min/1.73 m2] and severe [GFR <10 mL/min/1.73 m2] renal impairment, and also in patients with hepatic impairment. Caution is indicated in administering RemeronSolTab to such patients (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with RemeronSolTab (mirtazapine) Orally Disintegrating Tablets and should counsel them in its appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for RemeronSolTab. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking RemeronSolTab.
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Patients who are to receive RemeronSolTab should be warned about the risk of developing agranulocytosis. Patients should be advised to contact their physician if they experience any indication of infection such as fever, chills, sore throat, mucous membrane ulceration, or other possible signs of infection. Particular attention should be paid to any flu-like complaints or other symptoms that might suggest infection.
RemeronSolTab may impair judgment, thinking, and particularly, motor skills, because of its prominent sedative effect. The drowsiness associated with mirtazapine use may impair a patient's ability to drive, use machines, or perform tasks that require alertness. Thus, patients should be cautioned about engaging in hazardous activities until they are reasonably certain that RemeronSolTab therapy does not adversely affect their ability to engage in such activities.
While patients may notice improvement with RemeronSolTab therapy in 1 to 4 weeks, they should be advised to continue therapy as directed.
Patients should be advised to inform their physician if they are taking, or intend to take, any prescription or over-the-counter drugs, since there is a potential for RemeronSolTab to interact with other drugs.
The impairment of cognitive and motor skills produced by Remeron has been shown to be additive with those produced by alcohol. Accordingly, patients should be advised to avoid alcohol while taking any dosage form of mirtazapine.
Phenylketonuric patients should be informed that RemeronSolTab contains phenylalanine 2.6 mg per 15-mg tablet, 5.2 mg per 30-mg tablet, and 7.8 mg per 45-mg tablet.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during RemeronSolTab therapy.
Patients should be advised to notify their physician if they are breast-feeding an infant.
There are no routine laboratory tests recommended.
As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see CLINICAL PHARMACOLOGY).
(See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)
Based on the mechanism of action of mirtazapine and the potential for serotonin syndrome, caution is advised when RemeronSolTab Orally Disintegrating Tablets are coadministered with other drugs or agents that may affect the serotonergic neurotransmitter systems, such as tryptophan, triptans, linezolid, serotonin reuptake inhibitors, venlafaxine, lithium, tramadol, or St. John's wort (see CONTRAINDICATIONS and WARNINGS).
The metabolism and pharmacokinetics of RemeronSolTab (mirtazapine) Orally Disintegrating Tablets may be affected by the induction or inhibition of drug-metabolizing enzymes.
In healthy male patients (n=18), phenytoin (200 mg daily) increased mirtazapine (30 mg daily) clearance about 2-fold, resulting in a decrease in average plasma mirtazapine concentrations of 45%. Mirtazapine did not significantly affect the pharmacokinetics of phenytoin.
In healthy male patients (n=24), carbamazepine (400 mg b.i.d.) increased mirtazapine (15 mg b.i.d.) clearance about 2-fold, resulting in a decrease in average plasma mirtazapine concentrations of 60%.
When phenytoin, carbamazepine, or another inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased. If treatment with such a medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.
In healthy male patients (n=12), when cimetidine, a weak inhibitor of CYP1A2, CYP2D6, and CYP3A4, given at 800 mg b.i.d. at steady state was coadministered with mirtazapine (30 mg daily) at steady state, the Area Under the Curve (AUC) of mirtazapine increased more than 50%. Mirtazapine did not cause relevant changes in the pharmacokinetics of cimetidine. The mirtazapine dose may have to be decreased when concomitant treatment with cimetidine is started, or increased when cimetidine treatment is discontinued.
In healthy, male, Caucasian patients (n=24), coadministration of the potent CYP3A4 inhibitor ketoconazole (200 mg b.i.d. for 6.5 days) increased the peak plasma levels and the AUC of a single 30-mg dose of mirtazapine by approximately 40% and 50%, respectively.
Caution should be exercised when coadministering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, or nefazodone.
In an in vivo interaction study in healthy, CYP2D6 extensive metabolizer patients (n=24), mirtazapine (30 mg/day), at steady state, did not cause relevant changes in the pharmacokinetics of steady state paroxetine (40 mg/day), a CYP2D6 inhibitor.
In healthy, CYP2D6 extensive metabolizer patients (n=32), amitriptyline (75 mg daily), at steady state, did not cause relevant changes to the pharmacokinetics of steady state mirtazapine (30 mg daily); mirtazapine also did not cause relevant changes to the pharmacokinetics of amitriptyline.
In healthy male subjects (n=16), mirtazapine (30 mg daily), at steady state, caused a small (0.2) but statistically significant increase in the International Normalized Ratio (INR) in subjects treated with warfarin. As at a higher dose of mirtazapine, a more pronounced effect can not be excluded. It is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.
No relevant clinical effects or significant changes in pharmacokinetics have been observed in healthy male subjects on concurrent treatment with subtherapeutic levels of lithium (600 mg/day for 10 days) at steady state and a single 30 mg dose of mirtazapine. The effects of higher doses of lithium on the pharmacokinetics of mirtazapine are unknown.
In an in vivo, nonrandomized, interaction study, subjects (n=6) in need of treatment with an antipsychotic and antidepressant drug, showed that mirtazapine (30 mg daily) at steady state did not influence the pharmacokinetics of risperidone (up to 3 mg b.i.d.).
Concomitant administration of alcohol (equivalent to 60 g) had a minimal effect on plasma levels of mirtazapine (15 mg) in 6 healthy male subjects. However, the impairment of cognitive and motor skills produced by Remeron were shown to be additive with those produced by alcohol. Accordingly, patients should be advised to avoid alcohol while taking RemeronSolTab.
Concomitant administration of diazepam (15 mg) had a minimal effect on plasma levels of mirtazapine (15 mg) in 12 healthy subjects. However, the impairment of motor skills produced by Remeron has been shown to be additive with those caused by diazepam. Accordingly, patients should be advised to avoid diazepam and other similar drugs while taking RemeronSolTab.
Carcinogenicity studies were conducted with mirtazapine given in the diet at doses of 2, 20, and 200 mg/kg/day to mice and 2, 20, and 60 mg/kg/day to rats. The highest doses used are approximately 20 and 12 times the maximum recommended human dose (MRHD) of 45 mg/day on an mg/m2 basis in mice and rats, respectively. There was an increased incidence of hepatocellular adenoma and carcinoma in male mice at the high dose. In rats, there was an increase in hepatocellular adenoma in females at the mid and high doses and in hepatocellular tumors and thyroid follicular adenoma/cystadenoma and carcinoma in males at the high dose. The data suggest that the above effects could possibly be mediated by non-genotoxic mechanisms, the relevance of which to humans is not known.
The doses used in the mouse study may not have been high enough to fully characterize the carcinogenic potential of Remeron(mirtazapine) Tablets.
Mirtazapine was not mutagenic or clastogenic and did not induce general DNA damage as determined in several genotoxicity tests: Ames test, in vitro gene mutation assay in Chinese hamster V 79 cells, in vitro sister chromatid exchange assay in cultured rabbit lymphocytes, in vivo bone marrow micronucleus test in rats, and unscheduled DNA synthesis assay in HeLa cells.
In a fertility study in rats, mirtazapine was given at doses up to 100 mg/kg [20 times the maximum recommended human dose (MRHD) on an mg/m2 basis]. Mating and conception were not affected by the drug, but estrous cycling was disrupted at doses that were 3 or more times the MRHD, and pre-implantation losses occurred at 20 times the MRHD.
Reproduction studies in pregnant rats and rabbits at doses up to 100 mg/kg and 40 mg/kg, respectively [20 and 17 times the maximum recommended human dose (MRHD) on an mg/m2 basis, respectively], have revealed no evidence of teratogenic effects. However, in rats, there was an increase in postimplantation losses in dams treated with mirtazapine. There was an increase in pup deaths during the first 3 days of lactation and a decrease in pup birth weights. The cause of these deaths is not known. The effects occurred at doses that were 20 times the MRHD, but not at 3 times the MRHD, on an mg/m2 basis. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether mirtazapine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RemeronSolTab (mirtazapine) Orally Disintegrating Tablets are administered to nursing women.
Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron (mirtazapine) Tablets, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of RemeronSolTab (mirtazapine) Orally Disintegrating Tablets in a child or adolescent must balance the potential risks with the clinical need.
In an 8-week-long pediatric clinical trial of doses between 15 to 45 mg/day, 49% of Remeron-treated patients had a weight gain of at least 7%, compared to 5.7% of placebo-treated patients. The mean increase in weight was 4 kg (2 kg SD) for Remeron-treated patients versus 1 kg (2 kg SD) for placebo-treated patients (see PRECAUTIONS: Increased Appetite/Weight Gain).
Approximately 190 elderly individuals (≥65 years of age) participated in clinical studies with Remeron (mirtazapine) Tablets. This drug is known to be substantially excreted by the kidney (75%), and the risk of decreased clearance of this drug is greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Sedating drugs may cause confusion and over-sedation in the elderly. No unusual adverse age-related phenomena were identified in this group. Pharmacokinetic studies revealed a decreased clearance in the elderly. Caution is indicated in administering RemeronSolTab (mirtazapine) Orally Disintegrating Tablets to elderly patients (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Approximately 16% of the 453 patients who received Remeron® (mirtazapine) Tablets in US 6-week controlled clinical trials discontinued treatment due to an adverse experience, compared to 7% of the 361 placebo-treated patients in those studies. The most common events (≥1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate at least twice that of placebo) included:
| Adverse Event | Percentage of Patients Discontinuing with Adverse Event | |
|---|---|---|
| Remeron (n=453) | Placebo (n=361) | |
| Somnolence | 10.4% | 2.2% |
| Nausea | 1.5% | 0% |
The most commonly observed adverse events associated with the use of Remeron (mirtazapine) Tablets (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (Remeron incidence at least twice that for placebo) were:
| Adverse Event | Percentage of Patients Reporting Adverse Event | |
|---|---|---|
| Remeron (n=453) | Placebo (n=361) | |
| Somnolence | 54% | 18% |
| Increased Appetite | 17% | 2% |
| Weight Gain | 12% | 2% |
| Dizziness | 7% | 3% |
The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among Remeron (mirtazapine) Tablets-treated pati
