Generic Name: Nimotop
What is Nimotop?
As a result, we believe that the benefits of having nimodipine capsules on the market to treat these extremely sick patients, who could die or have serious permanent injury without treatment, outweigh the risks of medication errors. FDA will not begin procedures to withdraw approval of the approved ANDAs that refer to NIMOTOP Nimodipine Capsules, 30 mg.
Additional ANDAs that refer to NIMOTOP Nimodipine Capsules, 30 mg, may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. FDA became aware of these reports through a search of the FDA Adverse Event Reporting System FAERSthe Pennsylvania Patient Safety Reporting System PA-PSRSthe Institute for Safe Medication Practices' ISMP Quantros MEDMARX database, the Council for International Organizations of Medical Sciences CIOMS II database, or through their publication in the medical literature.
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Nimotop Nimodipine is used to prevent brain damage caused by reduced blood flow to the brain resulting from aneurysm. Generic Nimotop is a cost-saving medication prescribed by medical physicians worldwide.
Farmaci che notoriamente inibiscono il sistema del citocromo P450 3A4, e che quindi possono causare un aumento della concentrazione plasmatica di nimodipina, sono, per esempio: antibiotici macrolidi es.
Therefore, when administered together with oral nimodipine, a substantial increase in systemic bioavailability of nimodipine due to a decreased first-pass metabolism cannot be excluded. No formal studies have been performed to investigate the potential interaction between nimodipine and nefazodone. This antidepressant drug has been reported to be a potent inhibitor of the cytochrome P450 3A4.
The simultaneous administration of the anticonvulsant valproic acid can lead to an increase in the plasma nimodipine concentration. The steady-state concomitant administration of nimodipine and nortryptyline led to a slight decrease in nimodipine exposure with unaffected nortryptyline plasma concentrations.
Nimodipine may increase the blood pressure lowering effect of concomitantly administered anti-hypertensives, such as:However, if a combination of this type proves unavoidable particularly careful monitoring of the patient is necessary.
Since no specific antidote is known, subsequent treatment for other side effects should be governed by the most prominent symptoms. If Nimotop is inadvertently administered intravenously, clinically significant hypotension may require cardiovascular support with pressor agents. Nimotop is given orally in the form of ivory colored, soft gelatin 30 mg capsules for subarachnoid hemorrhage.
Unless otherwise prescribed, the oral dose is 60 mg two 30 mg capsules every 4 hours for 21 consecutive days.
How should I take Nimotop?
Other medications can affect the removal of nimodipine from your body, which may affect how nimodipine works. Examples include cimetidine, azole antifungals such as itraconazolemacrolide antibiotics such as erythromycinrifamycins such as rifabutinSt. Because cimetidine may interact with nimodipine, ask your pharmacist about other products to treat stomach acid. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.
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What should I avoid while taking Nimotop?
Tell your doctor if your condition worsens. What conditions does Nimotop Capsule treat. In the US -Call your doctor for medical advice about side effects. List Nimotop Capsule side effects by likelihood and severity. What should I know regarding pregnancy, nursing and administering Nimotop Capsule to children or the elderly. Interactions See also How To Use section.
Nimotop side effects
Consequently, the main and side effects, in particular its hypotensive effect may be intensified. In such cases, the drug dose must be reduced depending on the degree of decrease in blood pressure, and should be discontinued if necessary reception nimodipine.
Nimodipine may lower blood pressure in a joint appointment with diuretics, beta-blockers, ACE inhibitors, antagonists of A1 adenosine receptors, other calcium channel blockers, alpha-blockers, alpha-methyldopa, phosphodiesterase inhibitors. Prolonged use of nimodipine with the antidepressant nortriptyline resulted in a slight decrease in nimodipine plasma concentrations nortriptyline concentration remains unchanged.
Since nimodipine is metabolized with participation of cytochrome P450 3A4, drugs inhibiting this enzyme system may increase the concentration of nimodipine plasma. These are drugs likeThe joint appointment of such drugs should be provided for the reduction of the dose of nimodipine and monitoring blood pressure.
Grapefruit juice inhibits the oxidative metabolism of dihydropyridine.
Common Nimotop ide effects may include:
Each ivory colored, soft gelatin Nimotop capsule is imprinted with the word Nimotop and contains 30 mg of nimodipine.
If you frequently feel dizzy when taking nimodipine in combination with other medicines that can lower blood pressure you should let your doctor know, as your doses may need adjusting.
It does this by blocking 'calcium channels' in these muscle cells.
Twenty-five years later, this high-impact jour- nal is guided by an Editor-in-Chief, six Associate Editors and an Think-piece Board of 64 scientists.
Rachel Turow, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 Pub. NIMOTOP Nimodipine Capsules, 30 mg, the subject of NDA 18-869, held by Bayer HealthCare Pharmaceuticals Inc. The most recent labeling for NIMOTOP states that the product is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage ruptured blood vessels in the brain from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition i.
In a letter dated July 30, 2010, Bayer HealthCare Pharmaceuticals Inc.
Where can I get more information?
Hoe ziet Nimotop eruit en wat is de inhoud van de verpakking Nimotop 30 mg filmomhulde tabletten zijn rond en geel met aan de ene kant een BAYER-kruis en aan de andere kant SK.
Since Nimotop is highly protein-bound, dialysis is not likely to be of benefit.