Ongoing Review of Cholesterol Drug Vytorin. FDA issued an Early Communication on January 25, 2008, announcing that it will conduct a review of Merck/Schering Plough's recently completed study on Vytorin (ezetimibe/simvastatin) once the agency receives the final results Stronger Warnings Requested for Fluoroquinolones. FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Drug Approved for Irritable Bowel Syndrome with Constipation. FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over Adverse Reactions Linked to Botox. Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions Albuterol Inhalers: Time to Transition. Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. FDA's Strategic Plan: Charting Our Course for the Future. FDA's Strategic Action Plan sets forth the agency's long-term strategic goals and objectives.
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What we know about Buspirone. Buspirone: uses Buspirone is used to treat anxiety. It may help we think more clearly, relax, worry less, and take part in everyday life. It may also help we to feel less jittery and irritable, and may control symptoms such as trouble sleeping, sweating, and pounding heartbeat. Buspirone is a medication for anxiety ( anxiolytic ) that works by affecting certain natural substances in brain ( neurotransmitters ) . Buspirone: how to use Take Buspirone by mouth, usually 2 or 3 times a day or as directed by your doctor. You may take Buspirone with or without food, but it is important to choose one way and always take it the same way so that amount of drug absorbed will always be the same. Buspirone may come in a tablet that can be split to get the correct dose for you. Follow manufacturer's Patient Instruction Sheet or ask your pharmacist how to split tablet to get your dose. Limit amount of grapefruit we may eat or drink ( less than one quart a day ) while being treated with Buspirone unless your doctor directs we otherwise. Grapefruit may increase the amount of Buspirone in your bloodstream. Consult your pharmacist or doctor for more information. Dosage is based on your medical condition and response to therapy. Use Buspirone regularly in order to get most benefit from it. To help you remember, use it at same times each day. When this medication is started, symptoms of anxiety ( e. g. , restlessness ) may sometimes get worse before they improve. It may take up to a month or more to get the full effect of Buspirone. Inform your doctor if your symptoms persist or worsen. Buspirone: side effects Dizziness, drowsiness, headache, nausea, nervousness, lightheadedness, restlessness, blurred vision, tiredness, and trouble sleeping may occur while use Buspirone. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed Buspirone because he or she has judged that benefit to you is greater than risk of side effects. Many people using Buspirone don't have serious side effects. Rarely, patients taking Buspirone may develop movement disorders such as shakiness ( tremors ) , muscle stiffness, mask-like facial expression, jerky walking movements, or a condition known as tardive dyskinesia. In some cases, these conditions may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements ( especially of face, mouth, tongue, arms, or legs ) . Seek immediate medical attention if any of these rare but serious side effects occur: A very serious allergic reaction to Buspirone is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: This is not a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist . Buspirone: precautions Before taking Buspirone, tell your doctor or pharmacist if you are allergic to it; or if we have any other allergies. Buspirone should not be used if we have certain medical conditions. Before using Buspirone, consult your doctor if you have: Before using Buspirone, tell your doctor or pharmacist your medical history, especially of: Buspirone may make we dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. If you're taking other medications for anxiety, don't suddenly stop them unless directed by your doctor. Buspirone won't prevent withdrawal symptoms from other medications, and your dose may need to be lowered slowly when we switch to Buspirone. Discuss your treatment plan with your doctor. If we experience withdrawal symptoms, tell your doctor immediately. During pregnancy, Buspirone should only be used when clearly needed. Tell your doctor if you're pregnant before using this medication. Discuss risks and benefits with your doctor. Buspirone may pass into breast milk. While there have been no reports of harm to nursing infants, breast-feeding while using this medication isn't recommended. Consult your doctor before breast-feeding. Buspirone: interactions Your healthcare professionals ( e. g. , doctor or pharmacist ) may already be aware of any possible drug interactions and may be monitoring we for it. Do not start, stop or change dosage of any medicine before checking with them first. Buspirone shouldn't be used with MAO inhibitors ( e. g. , furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine ) . Don't take Buspirone within 2 weeks before, during and after treatment with MAO inhibitors. In some cases, a serious, possibly fatal, drug interaction may occur while use Buspirone. Before using Buspirone, tell your doctor or pharmacist of all prescription and nonprescription/herbal products we may use, especially of: Tell your doctor or pharmacist if we also take drugs that cause drowsiness such as: certain antihistamines ( e. g. , diphenhydramine ) , anti-seizure medications ( e. g. , valproic acid ) , medicine for sleep or anxiety ( e. g. , alprazolam, flurazepam, zolpidem ) , muscle relaxants, narcotic pain relievers ( e. g. , codeine ) , psychiatric medications ( e. g. , risperidone ) . This document doesn't contain all possible interactions. Therefore, before using Buspirone, tell your doctor or pharmacist of all the products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist. Buspirone: overdose If overdose of Buspirone is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Buspirone: notes Do not share Buspirone with others. Keep all regular medical and laboratory appointments. If we are also taking trazodone, liver function tests may be performed regularly to check for side effects. Consult your doctor for more details. Buspirone: missed dose If we miss a dose Buspirone, take it as soon as we remember. If it's near time of next dose, skip missed dose and resume your usual dosing schedule. Don't double dose of Buspirone to catch up. Buspirone: storage Store US product in a tightly closed container at room temperature below 86 degrees F ( 30 degrees C ) away from light and moisture. Store Canadian product in a tightly closed container at room temperature 59-86 degrees F ( 15-30 degrees C ) away from light and moisture. Do not store Buspirone in the bathroom. Keep all medicines away from children and pets. Properly discard Buspirone when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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