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Strattera (Atomoxetine)

Atomoxitin molecule

Pharmacological group: sympathomimetics; sympatomimetics of central action; selective inhibitors of norepinephrine reuptake
Pharmacological action: Sympathomimetic of central action. Atomoxetine is a highly selective potent inhibitor of presynaptic norepinephrine carriers. Atomoxetine has minimal affinity for other noradrenergic receptors or other carriers or receptors of neurotransmitters.
Effects on receptors: NMDA receptors (antagonist)
Norepinephrine (noradrenaline) reuptake
inhibitor The inhibitor of norepinephrine, serotonin and dopamine transporters
Strattera – a drug for the treatment of attention deficit hyperactivity disorder (ADHD). It is a selective inhibitor of norepinephrine reuptake, which should not be confused with serotonin and noradrenaline reuptake inhibitors or selective serotonin reuptake inhibitors, which are currently the most popular form of antidepressants. Produced and sold in the United States in the form of hydrochloride (Atomoxetine HCl) under the brand name Strattera from Eli Lilly and Company, which has the original US patent for it. The non-proprietary form of Atomoxetine sold in other countries is manufactured by Torrent Pharmaceuticals under the trade name Tomoxetin, as well as Ranbaxy Laboratories (through its Solus division), under the trade names Attentin, Sun Pharmaceuticals (through its division of Milmet Pharmaceuticals) and Intas Biopharmaceuticals. Currently, the generic form of the drug is not produced in the United States, since in this country the drug has a patent valid until 2017. On August 12, 2010, Lilly lost the lawsuit to obtain a patent for Strattera, which increased the likelihood of an earlier appearance of the drug in the US market. Since September 1, 2010, Sun Pharmaceuticals has announced its intention to begin production of the generic form of the drug in the United States. However, during the conference on July 29, 2011, the chairman of Sun Pharmaceutical stated that “Lilly won an appeal trial, so I think that the release of the generic form of Strattera will be postponed.” Currently, the generic form of the drug is not produced in the United States, since in this country the drug has a patent valid until 2017. On August 12, 2010, Lilly lost the lawsuit to obtain a patent for Strattera, which increased the likelihood of an earlier appearance of the drug in the US market. Since September 1, 2010, Sun Pharmaceuticals has announced its intention to begin production of the generic form of the drug in the United States. However, during the conference on July 29, 2011, the chairman of Sun Pharmaceutical stated that “Lilly won an appeal trial, so I think that the release of the generic form of Strattera will be postponed.” Currently, the generic form of the drug is not produced in the United States, since in this country the drug has a patent valid until 2017. On August 12, 2010, Lilly lost the lawsuit to obtain a patent for Strattera, which increased the likelihood of an earlier appearance of the drug in the US market. Since September 1, 2010, Sun Pharmaceuticals has announced its intention to begin production of the generic form of the drug in the United States. However, during the conference on July 29, 2011, the chairman of Sun Pharmaceutical stated that “Lilly won an appeal trial, so I think that the release of the generic form of Strattera will be postponed.” On August 12, 2010, Lilly lost the lawsuit to obtain a patent for Strattera, which increased the likelihood of an earlier appearance of the drug in the US market. Since September 1, 2010, Sun Pharmaceuticals has announced its intention to begin production of the generic form of the drug in the United States. However, during the conference on July 29, 2011, the chairman of Sun Pharmaceutical stated that “Lilly won an appeal trial, so I think that the release of the generic form of Strattera will be postponed.” On August 12, 2010, Lilly lost the lawsuit to obtain a patent for Strattera, which increased the likelihood of an earlier appearance of the drug in the US market. Since September 1, 2010, Sun Pharmaceuticals has announced its intention to begin production of the generic form of the drug in the United States. However, during the conference on July 29, 2011, the chairman of Sun Pharmaceutical stated that “Lilly won an appeal trial, so I think that the release of the generic form of Strattera will be postponed.”

Using

Classified as a norepinephrine (noradrenaline) reuptake inhibitor, Atomoxetine has been approved for use in children, adolescents, and adults. Nevertheless, the effect of the drug on children under the age of six years has not yet been studied. Strattera has an advantage over stimulants in the treatment of ADHD, which is less potential for abuse, and that the drug is not on the list of controlled substances, and in clinical trials demonstrated a 24-hour repayment of symptoms associated with ADHD in adults and children.
Therapeutic effect of Stratter begins to manifest, at least, a week after the application. To determine the effectiveness of the drug Stratter, it is necessary, at least, 6-8 weeks of taking the drug. Many people with ADHD syndrome who do not respond to stimulants can respond to Stratter. For patients with psychiatric disorders that do not tolerate the action of stimulants, and patients who have recurrent substance abuse in their history, Strutter may be preferable to amphetamine-based stimulants. ADHD patients suffering from nervous disorders (facial tics, cramps, etc.) are not recommended taking stimulant medications. In such cases, Stratter is the most optimal drug of choice. Treatment usually begins with a gradual increase in the dose, to minimize the risk of minor side effects. In addition, some people may be sensitive to lower doses. If a person is on treatment with stimulants, the doctor can prescribe a gradual reduction in the dose of stimulants in order to minimize side effects.
The Stratter drug was originally launched as a new antidepressant, but in clinical trials it was not proven that the drug has this effectiveness. Since noradrenaline is believed to play a role in the treatment of ADHD, Stratter’s drug has been tested – and subsequently approved – as an agent for the treatment of ADHD.

Nomenclature

Atomoxetine was originally known as Tomoxetine, but the US Food and Drug Administration (FDA) has requested a change in the name of the drug because, in their opinion, the similarity between the names “tomoxetine” and ” tamoxifen ” (medication for treatment breast cancer) can lead to vacation errors in pharmacies.

Pharmacology

Strattera inhibits the carriers of norepinephrine, serotonin and dopamine, with the corresponding Ki values ​​at 5, 77 and 1451 nm. In microdialysis studies, he increased 3 times the levels of norepinephrine and dopamine in the prefrontal cortex, but did not alter the levels of dopamine in the striatum or nucleus. In clinically significant doses, Stratter also acts as an NMDA receptor antagonist. This action of the drug has yet to be studied. Recently in the scientific literature there are data on glutaminergic dysfunction as central in the pathophysiology and etiology of ADHD. Strattera has a slight affinity for serotonergic, cholinergic and adrenergic receptors.

Chemistry and composition

Strattera has the chemical designation (-) – N-methyl-3-phenyl-3- (o-tolyloxy) -propylamine hydrochloride, and has a molecular weight of 291.82. The solubility in water is 27.8 mg / ml. Strattera is a white solid in the form of a capsule with a granular powder inside, including starch and dimethicone. Capsule shells contain gelatin, sodium lauryl sulfate, indigocarmine, synthetic yellow iron oxide, titanium dioxide, red iron oxide, edible black ink and a small amount of other inactive ingredients.

Therapeutic efficacy

Strattera has been shown to be effective in several placebo-controlled studies in the short-term treatment of ADHD in children and adolescents when applied once or twice a day. With a one-time admission in the morning the drug showed its effectiveness in the evening, while with the termination of the use of Stratter did not show any symptoms.

Side Effects of Stratter

Strutter’s side effects include: dry mouth, fatigue, irritability, nausea, decreased appetite, constipation, dizziness, sweating, urination disorder, sexual problems, decreased libido, urinary retention, obsessive behavior, weight changes, growth retardation in children, increased heart rate and increased blood pressure.
Eli Lilly and Company reports cases of serious liver damage. In 2004, the company received a warning from the Food and Drug Administration (FDA) about the dangers of the drug.
Other side effects include psychosis, mood swings, mood disorders, depression, abnormal or suicidal thoughts or self-harm patterns.

Termination of admission

When you stop taking Stratter, you do not need a gradual dose reduction. Side effects are usually manifested as a counter-reaction to effects from use, and include: increased appetite and its disturbance, as well as mood swings and apathy.

Psychiatric reactions

Since 2004, the UK Agency for the Control of Drugs and Medical Supplies (MHRA) has included Stratter in the list of drugs marked with a black triangle and admissible for admission only in conditions of intensive surveillance. “MHRA usually removes the mark” black triangle “two years after the product was released to the market. However, there is no standard time to save the product for this status. The symbol is not removed until the safety of the drug has been fully proven. “
“As the owner of the Strattera trademark (Eli Lilly) reported on September 15, 2005, Stratter’s analysis of a double-blind, randomized, placebo-controlled clinical trial showed a statistically significant increase in the risk of suicidal thoughts compared with placebo in children with a deficit syndrome attention and hyperactivity (ADHD). ” During the trial, there was one case of attempted suicide among 1,357 young patients taking Stratter, and five other volunteers reported suicidal thoughts, while in a placebo group of 851 people, no such case was reported.
The MHRA release on the risk-to-benefit ratio of Stratter (Atomoxetine), according to the Freedom of Information Act, December 9, 2005, states:
“The Stratter (Atomoxetine Hydrochloride) went through a mutual recognition procedure in the UK. During the discussion of the drug with Germany, the Netherlands and Norway, and then with the Labor Party on Pharmacovigilance it was decided that the new data justified the risk: Stratter in his licensing testimony showed himself positively, especially in the light of previous concerns about his safety, including the symptoms of serious liver damage and seizures. Meanwhile, during the Urgent Security Procedures (USR), it was suggested that a warning should be given about the risks of suicidal behavior when using Stratter. “
In March 2009, the MHRA stated that “there were reports of possible psychiatric side effects of the drug” and that “Strutter’s reception is associated with psychotic or manic symptoms resulting from treatment in children and adolescents who did not have such disorders in the medical history before taking the drug. “
On August 1, 2006, an article by Janne Larsson was published, referring to the MHRA document, promulgated by a court in Sweden. The document says that the company Eli Lilly received about 10,998 reports of adverse psychiatric reactions to the drug in three years.

Abuse

To date, the potential of Stratter’s abuse is still not widely explored. Two studies have concluded that the drug has a weak or moderate risk of abuse due to a sufficiently long titration period (that is, it may not have any effect on users if they do not take it regularly for several days ), and does not produce a strong stimulating effect, like most other agents for the treatment of ADHD. There was no evidence of potential abuse of Atomoxetine in monkeys for self-administration. In experiments on rats, pigeons and monkeys, it has been shown that atomoxetine produces effects that are indistinguishable from small doses of cocaine or methamphetamine, but the effect is not comparable to high doses of cocaine.

Improper use

Stratter, a drug that inhibits norepinephrine reuptake, was originally studied by Eli Lilly as a drug for depression, but did not show favorable results during the trials. The results of unsuccessful clinical trials have not been submitted to regulatory authorities and are considered a trade secret. Subsequently, Lilly decided to continue studying Stratter as a means to treat ADHD. Many patients showed a marked antidepressant effect when taking the drug in combination with other antidepressants. In order to understand the entire pharmacodynamics of the drug, more research is needed.

Experimental application

The Journal of Clinical Psychiatry reports that in 2007, a 10-week, double-blind clinical trial involving 40 people on Stratter’s effectiveness in treating bulimia was conducted. The average daily dose of the drug was 106 mg / day. At the end of the trial, it was reported that Strutter’s use was “associated with a significantly higher rate of weight loss, [and] body mass index.” The authors concluded that Stratter is effective for short-term treatment of bulimia.
A preliminary 12-week, randomized, double-blind, placebo-controlled study was conducted at the University of Duke Medical Center, which examined the effectiveness of Stratter in adult obese women. The study involved 30 obese women with an average body mass index of 36.1. Fifteen of them took Stratter, starting at 25 mg / day with a gradual increase to 100 mg / day for 1 week. The remaining fifteen women were given a placebo, in the same doses. By the end of the study, participants in the Stratter group lost an average of 3.6 kg (3.7% of body weight) versus 0.1 kg in the placebo group (0.2% increase). Three participants from the Strutter group lost more than 5% of the mass, which was not observed in the placebo group at all.

Overdose

Drowsiness is the most common symptom in acute or chronic overdose of Stratter. Other signs of overdose may include agitation, hyperactivity, behavioral disorders, and gastrointestinal symptoms. As a result of an overdose, sometimes there is mydriasis, causing blurred vision, tachycardia and dry mouth. Treatment of an overdose of Stratter can include cleaning the stomach and taking repeated doses of activated charcoal. However, in the emergency departments in case of an overdose, the washing procedure is no longer applied, since Strattera has strong connections with proteins.

Detection in biological fluids

In order to distinguish between slow or fast metabolism in patients receiving the drug therapeutically, it is possible to analyze the presence of Stratter in plasma, serum or blood flow to confirm the diagnosis from potential victims of poisoning or to assist in forensic examination in cases of fatal overdose.

Availability:

Strattera is a central sympatomimetic used for the treatment of attention deficit hyperactivity disorder. The drug is released by prescription.

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