Fluoxetine: useful modern medicine.

uses of Fluoxetine

Fluoxetine is a selective serotonin reuptake inhibitor ( SSRI ) used to treat depression, anxiety disorders ( panic attacks ) , obsessive-compulsive disorder ( OCD ) , a certain eating disorder ( bulimia ) , and a severe form of premenstrual syndrome ( premenstrual dysphoric disorder ) .

SSRIs work by helping to restore balance of certain natural substances in the brain ( neurotransmitters such as serotonin ) . Fluoxetine may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease anxiety/unreasonable fears, persistent/troubling thoughts ( obsessions ) , and unwanted urges that keep returning ( compulsions ) . It may decrease number and severity of panic attacks. Fluoxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression. It may decrease bingeing and purging behaviors in bulimia.

how to use of Fluoxetine

Read Medication Guide provided by your pharmacist before you start using Fluoxetine and each time we get a refill. If we have any questions, consult your doctor or pharmacist.

Take Fluoxetine by mouth with or without food, usually once daily or as directed by your doctor. Fluoxetine may make we either sleepy or wakeful. Therefore, depending on how Fluoxetine affects you, your doctor may direct we to take the entire dose once daily in either morning or evening. If we are taking Fluoxetine twice a day, your doctor may direct you to take it in morning and at noon.

If we are taking Fluoxetine for premenstrual problems, your doctor may direct we to take it every day of month or just for 2 weeks before your period through first full day of your period. To help we remember, mark your calendar.

If you're using liquid form of Fluoxetine, measure dose carefully using a special measuring device/spoon. Don't use a household spoon because you mayn't get correct dose.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may start we at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Don't take more or less medication or take it more frequently than prescribed. Your condition won't improve any faster, and your risk of side effects will increase. Use Fluoxetine regularly in order to get the most benefit from it. To help we remember, use it at same time ( s ) each day.

It is important to continue taking Fluoxetine as prescribed even if we feel well. Don't stop taking Fluoxetine without first consulting your doctor. Some conditions may become worse when drug is abruptly stopped. Your dose may need to be gradually decreased.

You should see some improvement in 1 to 2 weeks. It may take several weeks before we feel full benefit.

Tell your doctor if your condition does not improve or if it worsens.

other used of Fluoxetine

This section contains uses of Fluoxetine that aren't listed in the approved professional labeling for drug but that may be prescribed by your health care professional. Use Fluoxetine for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Fluoxetine is also used to treat certain other eating disorders ( anorexia nervosa ) , obesity, and certain nervous system/sleep disorders ( catalepsy, narcolepsy ) .

side effects of Fluoxetine

See also Warning section.

Nausea, drowsiness, dizziness, anxiety, trouble sleeping, loss of appetite, weakness, tiredness, sweating, or yawning may occur while use Fluoxetine. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed Fluoxetine because he or she has judged that benefit to we is greater than risk of side effects. Many people using Fluoxetine do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Tell your doctor immediately if any of these rare but very serious side effects occur:

Fluoxetine may rarely cause a very serious condition called serotonin syndrome. The risk increases when Fluoxetine is used with certain other drugs such as " triptans " used to treat migraine headaches ( e. g. , sumatriptan, eletriptan ) , certain antidepressants including other SSRIs ( e. g. , citalopram, paroxetine ) and SNRIs ( e. g. , duloxetine, venlafaxine ) , lithium, tramadol, tryptophan, or a certain drug to treat obesity ( sibutramine ) . See also Drug Interactions section. Before taking Fluoxetine, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of following symptoms:

For males, in very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using Fluoxetine and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to Fluoxetine is rare. However, seek immediate medical attention if we notice any symptoms of a serious allergic reaction, including:

This isn't a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

precautions of Fluoxetine

Before taking Fluoxetine, tell your doctor or pharmacist if you're allergic to it; or if we have any other allergies.

Before using Fluoxetine, tell your doctor or pharmacist your medical history, especially of:

Fluoxetine may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any other activity that requires alertness. Avoid alcoholic beverages.

If we have diabetes, Fluoxetine may affect your blood sugar levels. Monitor your blood sugar regularly and share results with your doctor. Your doctor may need to adjust your medication, diet, and exercise when you start or stop Fluoxetine. Liquid forms of Fluoxetine may contain sugar and/or alcohol. Caution is advised if we have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.

Caution is advised when using Fluoxetine in elderly because they may be more sensitive to its effects. The elderly are more likely to lose too much salt ( hyponatremia ) , especially if they're also taking " water pills " ( diuretics ) with Fluoxetine.

Fluoxetine isn't recommended for use during pregnancy. It may harm an unborn baby. Also, babies born to mothers who have used Fluoxetine during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If we notice any of these symptoms in your newborn, tell doctor promptly.

Since untreated depression can be a serious condition, do not stop taking Fluoxetine unless directed by your doctor. If we are planning pregnancy, become pregnant, or think we may be pregnant, immediately discuss benefits and risks of using Fluoxetine during pregnancy with your doctor.

Fluoxetine may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding isn't recommended while using Fluoxetine. Consult your doctor before breast-feeding.

interactions of Fluoxetine

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change dosage of any medicine before checking with your doctor or pharmacist first.

Fluoxetine can stay in your body for many weeks after your last dose and may interact with many other medications. Before using any medication, tell your doctor or pharmacist if we have taken Fluoxetine in the previous 5 weeks.

Certain medications taken with Fluoxetine could result in serious ( rarely fatal ) drug interactions. Avoid taking MAO inhibitors ( e. g. , furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine ) with Fluoxetine for 2 weeks before, during treatment, and at least 5 weeks after your last dose of Fluoxetine. Consult your doctor or pharmacist for additional information.

The following medications should not be used with Fluoxetine and for 5 weeks after your last dose of Fluoxetine because very serious ( possibly fatal ) interactions may occur while use Fluoxetine:

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting Fluoxetine.

Before using Fluoxetine, tell your doctor or pharmacist of all prescription and nonprescription/herbal products we may use, especially of:

Aspirin can increase risk of bleeding when used with Fluoxetine ( see above ) . If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention ( usually at dosages of 81-325 milligrams a day ) , you should continue taking it unless your doctor instructs we otherwise. Discuss the risks and benefits with your doctor.

Also tell your doctor if you take any other drugs that increase serotonin, such as bromocriptine, buspirone, dextromethorphan, lithium, meperidine, propoxyphene, phentermine, SSRIs, SNRIs, tryptophan, St. John's wort, drugs used to treat migraines such as " triptans " and dihydroergotamine, street drugs such as MDMA/ " ecstasy, " amphetamine. ( See also Side Effects section. )

Tell your doctor or pharmacist if we also take drugs that cause drowsiness, such as certain antihistamines ( e. g. , diphenhydramine ) , anti-seizure drugs ( e. g. , carbamazepine ) , medicine for sleep or anxiety ( e. g. , lorazepam, zolpidem ) , muscle relaxants, narcotic pain relievers ( e. g. , codeine ) , psychiatric medicines ( e. g. , chlorpromazine, quetiapine, nortriptyline, trazodone ) .

Check labels on all your medicines ( e. g. , cough-and-cold products ) because they may contain ingredients that cause drowsiness. Dextromethorphan is a commonly used cough medication and may interact with Fluoxetine. Ask your pharmacist about using those products safely.

Cimetidine is a nonprescription drug that's commonly used to treat extra stomach acid. Because it may cause undesirable interactions when used with Fluoxetine, ask your pharmacist about other products to treat stomach acid.

This document does not contain all possible interactions. Therefore, before using Fluoxetine, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

FDA approved Fluoxetine

RegeneRx Completes Enrollment And Dosing Of Phase IA Safety Trial For Potential Heart Drug - First Injectable Use Of RGN-352 Tested In Humans

Regenerx Biopharmaceuticals, Inc. announced today that it has completed enrollment and dosing of 40 healthy subjects for its Phase IA clinical trial testing RGN-352, an injectable formulation of Tβ4 for potential use in treating acute myocardial infarction patients ( AMI or heart attack ) . The trial includes four groups of ten subjects each to assess safety of escalating doses of RGN-352 injected into the blood stream. To date, there have been no significant drug-related adverse events. A final analysis and report will be completed after 28 days of follow-up of last subject.

RegeneRx expects to initiate second part of Phase I with a Phase IB trial in the 3rd quarter 2008 after submitting a IA report to FDA. The IB trial design is similar to IA; however, the 40 subjects will be dosed once daily for 14 days, rather than given only a single dose, and will undergo a 28-day and a 6-month follow-up.

" We've reached an important milestone with completion of enrollment and dosing of Phase IA trial. RGN-352 appears to be safe in single doses at low, medium, and high concentrations. This is an exciting and positive step as we prepare for IB phase of trial. This trial is intended to provide safety data for Phase II clinical trials that are being planned to evaluate RGN-352 for treatment of patients immediately after an AMI and also to support other potential uses of RGN-352 in medical indications where short-term systemic administration of the drug candidate may be warranted, " stated J. J. Finkelstein, RegeneRx's president and chief executive officer.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. These product candidates are based on Tβ4, a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides and is currently sponsoring three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase IA parenteral ( injectable ) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.

RegeneRx Technology Background

Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of Tβ4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions throughout the U. S. , have published numerous scientific articles indicating Tβ4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to Tβ4's cardio-protective effects have been published in Nature and Circulation. Abstracts of these and other scientific papers related to Tβ4's mechanisms of action may be viewed at RegeneRx's web page: http: //www. regenerx. com.

Forward-Looking Statements This presentation contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Examples of such forward-looking statements include statements concerning the safety and efficacy of RGN-352, target dates for completing company's ongoing preclinical studies and clinical trials for dermal, ophthalmic, cardiovascular, neurovascular and orphan indications, potential size of addressable markets, including market for topical gels, sterile eye drops and parenteral delivery products, company's ability to enter into any collaborations with respect to development or commercialization of its product candidates, and the therapeutic potential of Tβ4 for dermal, ophthalmic, cardiovascular and neurovascular wounds. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include risk that although Tβ4 has demonstrated potential therapeutic benefit for dermal, ophthalmic, cardiovascular and neurovascular wounds, the company's product candidates may not demonstrate safety and/or efficacy in clinical trials, risk that encouraging results from early research, preclinical studies, compassionate use or clinical trials may not be confirmed upon further analysis of detailed results of such research, preclinical study, compassionate use or clinical trial, risk that additional information relating to safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, risk that company's or its collaborators won't obtain approval to market the company's product candidates in U. S. or abroad, risks associated with reliance on outside financing to meet capital requirements, risks associated with reliance on collaborators for funding or conduct of further development and commercialization activities relating to the company's product candidates, risks associated with protecting company's intellectual property, including risk that company won't be able to obtain patent protection or that its issued patents will be infringed, and such other risks described in the company's annual report on Form 10-K, for the year ended December 31, 2007, as amended, its quarterly report on Form 10-Q for period ended March 31, 2008, and other filings company makes with SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of date made. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

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