Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section ). Preventing recurrence. Mirtazapine 15 mg tablets are yellow, biconvex, capsule shaped, film-coated tablets with a score line in between 0 and 8 debossed on one side and 'A' on the . Read the Medication Guide provided by your pharmacist before you start using mirtazapine and each time you get a refill because new information may be.
Per Pill 15mg
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases see section 4. Seizures where in most cases a history of seizures or risk factors for seizures were reported Thromboembolism including pulmonary embolism and deep vein thrombosis see section 4.
Respiratory, thoracic and mediastinal disorders. Mild, transient anticholinergic effects including constipation and dry mouth. Transient, asymptomatic elevations of hepatic aminotransferases ALT, AST , especially in early treatment see section 4. Hepatitis including hepatocellular, cholestatic or mixed liver injury Skin and subcutaneous tissue disorders.
Renal and urinary disorders. Pregnancy, puerperium and perinatal conditions. Drug withdrawal syndrome neonatal see section 4.
Erectile dysfunction in males. General disorders and administration site conditions. Elevated plasma prolactin levels 8. Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol. In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range.
In adult patients who completed months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months. In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo see section 4.
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls. Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly. In clinical trials in patients with drug-induced dopamine agonist psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4. Speech disorder was also reported commonly. Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years. Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients aged years than in adult patients or adverse reactions only identified during short-termclinical trials in adolescent patients. The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure at least 24 weeks than with short-term exposure.
With long-term exposure at least 24 weeks , Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Fatal outcomes have been reported for acute overdoses as low as mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine. There is no specific antidote for olanzapine. Induction of emesis is not recommended. Standard procedures for management of overdose may be indicated i. Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Do not use epinephrine, dopamine, or other sympathomimetic agents with betaagonist activity since beta stimulation may worsen hypotension. Cardiovascular monitoring is necessary to detect possible arrhythmias. Close medical supervision and monitoring should continue until the patient recovers. Psycholeptics, diazepines, oxazepines thiazepines, and oxepines. Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile. Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo models. Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic A10 dopaminergic neurons, while having little effect on the striatal A9 pathways involved in motor function.
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects. In addition, a Single Photon Emission Computed Tomography SPECT imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
In two of two placebo and two of three comparator controlled trials with over 2, schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms. In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1, patients with varying degrees of associated depressive symptoms baseline mean of In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium divalproex in reduction of manic symptoms over 3 weeks.
Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks. In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg co-therapy with lithium or valproate resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
In a month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence. Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
In a second month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence olanzapine In an month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser lithium or valproate , long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic diagnostic criteria.
Controlled efficacy data in adolescents ages 13 to 17 years are limited to short term studies in schizophrenia 6 weeks and mania associated with bipolar I disorder 3 weeks , involving less than adolescents. Olanzapine was used as a flexible dose starting with 2. During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin see sections 4. There are no controlled data on maintenance of effect and limited data on long term safety see sections 4.
Information on long term safety is primarily limited to open-label, uncontrolled data. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
The absorption is not affected by food. Absolute oral bioavailability relative to intravenous administration has not been determined. Olanzapine is metabolized in the liver by conjugative and oxidative pathways. The major circulating metabolite is the N-glucuronide, which does not pass the blood brain barrier. Cytochromes P CYP1A2 and PCYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
The predominant pharmacologic activity is from the parent olanzapine. After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
In healthy elderly 65 and over versus non-elderly subjects, the mean elimination half-life was prolonged The pharmacokinetic variability observed in the elderly is within the range for the non-elderly. In female versus male subjects the mean elimination half life was somewhat prolonged In smoking subjects with mild hepatic dysfunction, mean elimination half-life In non-smoking versus smoking subjects males and females the mean elimination half-life was prolonged The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals. In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Adolescents ages 13 to 17 years: The pharmacokinetics of olanzapine are similar between adolescents and adults. Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers. Such factors possibly contribute to the higher average exposure observed in adolescents. Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders. Tolerance developed to the CNS depression. Growth parameters were decreased at high doses. Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow. Olanzapine had no teratogenic effects. Sedation affected mating performance of male rats. Estrous cycles were affected at doses of 1. In the offspring of rats given olanzapine, delays in foetaldevelopment and transient decreases in offspring activity levels were seen.
Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests. Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Back to top Aurobindo Pharma - Milpharm Ltd. Last updated on eMC: Show table of contents Hide table of contents 1. Name of the medicinal product 2. Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text. This information is intended for use by health professionals.
Each tablet contains 15 mg olanzapine. Excipient with known effect: For the full list of excipients, see section 6. Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is indicated for the treatment of moderate to severe manic episode. Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors In the same clinical trials, cerebrovascular adverse events CVAE e. Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebocontrolled clinical trials see section 4. Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro , experience during the clinical trials revealed a low incidence of related events.
Hepatic function Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment. General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol. Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia. Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials. Sudden cardiac death In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in patients with olanzapine.
Paediatric population Olanzapine is not indicated for use in the treatment of children and adolescents. Lactose Olanzapine Milpharm tablets contain lactose. Interaction studies have only been performed in adults. Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Olanzapine showed no interaction when co-administered with lithium or biperiden. General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression. QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval see section 4.
Pregnancy There are no adequate and well-controlled studies in pregnant women. Breast-feeding In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk. Fertility Effects on fertility are unknown see section 5. Various studies suggest that obtaining an accurate dose from a split tablet is uncertain, even if the tablet is scored. S afe P ractice R ecommendations: Health care providers should make every effort to use commercially available oral tablets, when available, in both inpatient and outpatient settings.
National Center for Biotechnology Information , U. Journal List P T v. Author information Copyright and License information Disclaimer. Although using more than one tablet for a single dose is customary, tablet splitting has become more commonplace for several reasons: Different tablet strengths often cost about the same.
Patients who cannot afford their medications have received a higher-strength tablet with directions to take a half tablet or even a quarter tablet per dose. Some health insurers have denied payment of prescriptions for the lower strength of certain drugs, thus requiring patients to receive the higher-strength tablet and to split it in half for each dose. Some health care organizations have not purchased all commercially available strengths of oral medications.
Thus, some tablets might need to be split for specific doses in the inpatient setting. Patients might not be able to swallow whole tablets. Patients might assume that tablets have already been split when they have not, or they might split the tablets again when they have been split already, especially if the pharmacy inconsistently splits the tablets upon refill.
Before a half tablet is prescribed, dispensed, or administered, drug references should be checked to ensure that the agent is safe. If its safety cannot be confirmed, the manufacturer should be contacted. Patients should understand the risks associated with splitting tablets.
If a patient cannot be expected to split a tablet, a qualified family member should be entrusted to do this. In some states, it might not be legal for a pharmacist to split tablets if the dose is available commercially. Split tablets should be dispensed in the hospital. For the hospitalized patient, pharmacy staff members should dispense exact doses by either splitting tablets and repackaging them or by preparing an oral solution in a unit—dose oral syringe for each dose.
Nurses should not be expected to split tablets. Sanitary conditions must prevail. Patients and health care providers who split tablets should wash their hands first; the practitioner should also wear gloves. If a tablet-splitting device is used, it should be washed afterward to remove any powder or particles. Patient counseling is recommended. A system should be established so that patients are counseled when prescriptions for medications that require half tablets are picked up at community pharmacies, even if the pharmacist has split the tablets for the patient.
Mirtazapine 15mg Tablets
The higher strengths of this drug ( milligrams or more per tablet) should be used only if you have been regularly taking moderate to large amounts of opioid . Nonsteroidal anti-inflammatory drugs (including meloxicam) may rarely increase the risk of a heart attack or stroke. This effect can happen at any time while. In addition, the facility should attempt periodic tapering of the medication or Increase by 5 mg/day at intervals of 3 to 7 days as tolerated up to a maximum of