PITTSBURGH, Feb. 9 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that the U. S. Food and Drug Administration (FDA) has approved Mylan's Abbreviated New Drug Application (ANDA) for baclofen in the pediatric population.
Mylan Inc.is a pharmaceutical company that is committed to providing healthcare professionals with access to effective medication management solutions. As the leading provider of medications in the U. S., we take pride in our strong, innovative pipeline and committed products in the world of pharmaceuticals. Our specialty in pediatric health is based on the discovery, development and commercialization of medicines that have the potential to revolutionize the way children's health care is conducted.
In 2010, Mylan launched its first product,, which has been approved by the FDA for pediatric use. With its innovative formulation, Mylan provides the highest quality, affordable, and convenient treatment options for children with spasticity, spasticity associated with multiple sclerosis, and spinal cord injuries.
Currently, Mylan has approximately 13 ANDAs pending approval as a specialty pharmaceutical company. These pending ANDAs are:
Currently, we have over 1,000 ANDAs pending FDA approval representing approximately 1.5 million patients worldwide.
Mylan, based in Pittsburgh, is a global pharmaceutical company committed to providing healthcare professionals with effective medication management solutions. As a member of the PBMH (Professional and Scientific Companies), we have a broad portfolio of specialized products that include:
Our goal is to provide access to effective medication management solutions for the health of our communities, including those at the center of this critical journey.
How does the drug interact with Baclofen?Coadministration of Baclofen with cyclooxygenase-2 (COX-2) inhibitors can increase the risk of developing side effects such as tendon rupture or swelling. This medicine should not be used with other steroid medications being taken unless it is directed by your doctor. Ask your doctor or pharmacist for a list of the other steroid medications being taken.How should I take Baclofen?Your doctor or pharmacist will prescribe you the drug as directed by your doctor. Do not stop taking the drug unless your doctor advises you to do so. Do not stop taking the drug abruptly without consulting your doctor. Follow your doctor's instructions carefully.How is Baclofen different from other antipsychotics?Coadministration of antipsychotics with Baclofen may increase the risk of developing side effects such as extrapyramidal symptoms (extrapyramidal side effects) and extrapyramidal symptoms (paroxysmal side effects). These can be managed with medication control.What are the common side effects of antipsychotics?Side effects that may occur with all antipsychotics include extrapyramidal symptoms (EPS), hyperactivity, and akathisia. In most cases, these side effects go away within a few days. In some cases, they may become more bothersome or bother you, and you may need to stop taking antipsychotics. In these cases, contact your doctor immediately.What happens if I miss a dose of Baclofen?If you miss a dose of Baclofen, take it as soon as you can. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a missed dose.What happens if I take too much of Baclofen?Taking too much of Baclofen can lead to serious side effects. Some people may experience dry mouth, dry mouth, or dizziness. If you experience these or any other side effects while taking Baclofen, contact your doctor immediately.What happens if I take too much of a high blood pressure medication?High blood pressure medication can exacerbate symptoms of the diabetes called high blood pressure and increase the risk of stroke or heart attack in people with these conditions. Check your blood pressure regularly and tell your doctor if you experience any of the following symptoms while taking High Blood Pressure: dry mouth, dry mouth, drowsiness, dizziness, or tingling feet or lower legs. Your doctor will probably lower the dose of high blood pressure medication accordingly.What happens if I take too much phenytoin?Phenytoin may increase the risk of heart attack or stroke in some people. Check your blood pressure regularly and tell your doctor if you experience any of the following symptoms while taking Phenytoin: dry mouth, drowsiness, dizziness, or tingling feet or lower legs. Your doctor will probably lower the dose of phenytoin accordingly.What happens if I take too much phenytoin and my provider decides to lower the dose of Baclofen?Check your blood pressure regularly and tell your doctor if you experience: tingling feet, lower legs, numbness or weakness, lightheadedness, drowsiness, drowsiness, dry mouth, or dizziness.What happens if I take other antipsychotics that are taken together?Taking other antipsychotics that are taken together may increase the risk of developing side effects such as extrapyramidal symptoms or hyperactivity.What happens if I take other substances with Baclofen?Taking other substances that are taken with Baclofen may increase the risk of developing side effects such as extrapyramidal symptoms or hyperactivity. These can be managed by changing the substances or changing the dose of the other substances.What happens if I take other substances that are taken with Baclofen and my provider decides to lower the dose of Baclofen?Some substances that are taken with Baclofen may increase the risk of developing side effects such as extrapyramidal symptoms or hyperactivity.
[Generic Equivalent of Baclofen]
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Baclofen is a medication primarily used to treat muscle spasms caused by multiple sclerosis (MS). It works by relaxing the muscles and enhancing the natural balance of chemicals that cause spasticity and muscle spasms. Baclofen has a duration of action of several hours. It is usually taken orally once a day, as prescribed, for a period of 7 to 12 days.
For maximum effectiveness, Baclofen should be taken only when required. It should not be taken more frequently than directed. Alcohol is not recommended. It is not intended for continuous use. Baclofen can cause side effects like dizziness, headache, and nervousness. If you experience any severe or persistent side effects, such as dizziness, lightheadedness, fainting, or drowsiness, stop taking the medication and call your doctor right away.
The recommended dosage of Baclofen varies based on the condition being treated, individual response, and the severity of your muscle spasticity. Always follow your doctor’s instructions.
It is important to follow the instructions provided by your doctor or the instructions provided by your pharmacist. It is recommended that Baclofen be taken with or without food, as directed by the doctor.
Always take this medication as directed by your doctor or as the healthcare provider prescribes. Report any unusual or unexpected symptoms to the appropriate physician immediately.
Read more aboutBaclofen Overviewon.Baclofen belongs to a class of medications called skeletal muscle relaxants, which are used to treat muscle spasms caused by multiple sclerosis (MS). The main active ingredient in Baclofen is baclofen. Baclofen works by increasing the amount of brain chemicals that cause spasms, thereby helping to relax and improve your spinal cord’s muscles.
Baclofen is also known as spasmolytic muscle relaxant, skeletal muscle relaxant, muscle relaxant, tranquilizer, and an antispastic agent that works on the spinal cord. Baclofen is used to treat the symptoms of multiple sclerosis. It is used to treat muscle spasticity, as well as other spasticity symptoms.
The most common side effects of Baclofen include; nausea, vomiting, diarrhea, constipation, headache, dizziness, drowsiness, and restlessness. Baclofen is usually welltolerated. However, it may cause side effects such as headaches, weakness, nausea, dizziness, or constipation. Some people may also experience dizziness or difficulty falling asleep or staying asleep. If you experience any unusual or severe side effects while taking Baclofen, stop using the medication and contact your doctor right away.
The dosage of Baclofen varies depending on the condition being treated, individual response to the medication, and the severity of your muscle spasticity. It is usually taken once daily with or without food, as directed by your doctor or the healthcare provider. The usual starting dose is 10 mg/kg (0.75-20 mg/lb) taken once daily. The dosage should be adjusted depending on the severity of your muscle spasticity. Baclofen is usually taken once daily at the same time every day.
The dosage may be adjusted to the prescribed amount by your doctor or the healthcare provider. The dosage of Baclofen depends on the individual's response to the medication, the severity of muscle spasticity, and other medical conditions. The dosage of Baclofen can also be adjusted based on your age, the severity of muscle spasticity, your weight, and other medications you may be taking.
Your doctor may start you on a low dose of Baclofen (0.125-0.25 mg/lb) and gradually increase the dosage until your response is controlled. Baclofen is available as tablets. The tablets should be swallowed whole with a glass of water. Some people, particularly those with spinal cord injuries or other spinal cord conditions, should avoid this medication. However, this medication should not be used in patients with other conditions as it can cause drowsiness or dizziness.
The dosage may be adjusted based on your response to the medication, the severity of muscle spasticity, and other medical conditions you may have.
If you are taking the orally disintegrating tablet form, swallow it with or without food. The dose of Baclofen depends on your response.
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