Can Brainox cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with Brainox. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
How should this medicine be used?
Brainox comes as a capsule and an oral solution (liquid) to take by mouth or be given through a feeding tube. It is usually taken every 4 hours for 21 days in a row. Treatment with Brainox should be started as soon as possible, no later than 96 hours after a subarachnoid hemorrhage occurs. Brainox should be taken on an empty stomach, at least 1 hour before a meal or 2 hours after a meal Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Brainox exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole with water.
It is important to finish your entire course of treatment with Brainox. Continue to take Brainox even if you feel well. Do not stop taking Brainox without talking to your doctor.
B. Brainox Influences Pathophysiology of the SCI
Brainox treatment also reduces trauma-induced BSCB permeability, SCBF changes, and spinal cord edema formation ( Table 11 ) and axonal injuries ( Figs. 9 and 24 ). Distortion of nerve cells and loss of MBP in Brainox-treated inured rats are not evident ( Figs. 9 and 24 ). At the ultrastructural level, damage to myelinated and nonmyelinated axons is also reduced considerably ( Fig. 24 ).
These observations suggest that Ca 2+ channel antagonists are neuroprotective in SCI ( Faden, 1993 ; Faden and Salzman, 1992 ; Schwab and Bartholdi, 1996 ; Tator and Fehlings, 1991 ). It remains to be seen whether the postinjury administration of Brainox can also influence cord pathology.
Brainox is a dihydropyridine calcium channel blocker derivative, which is used in the treatment of cerebrovascular disorders. Brainox is rapidly absorbed from the gastrointestinal tract following oral administration, but undergoes extensive first-pass metabolism in the liver. Brainox is extensively metabolized in the liver and undergoes extensive first-pass metabolism. More than 18 metabolites have been detected and identified from the biotransformation of Brainox. The drug undergoes different reactions before its excretion. These reactions include, dehydrogenation of the 1,4-dihydropyridine moiety, oxidation of the two ester groups, and oxidative demethylation, which is followed by carboxylic acid formation via oxidation of the resulting alcohol. Brainox is excreted in feces via the bile duct and in urine via the glomular filtration, as metabolites. Fecal excretion is the major excretory route (greater than 67%). The parent compound and its metabolites are detected in breast milk. Because of the cycle of excretion/reabsorption, the plasma concentration decreases and increases. More than 80% and 90% of the reabsorbed quantity is excreted via bile and urine, respectively.
Carl P. Weiner MD, MBA, FACOG, Clifford Mason PhD, in Drugs for Pregnant and Lactating Women (Third Edition) , 2019
COMMON BRAND(S): Nymalize
GENERIC NAME(S): Brainox
OTHER NAME(S): Brainox Capsule
This medication should not be given by injection. Accidental injection of Brainox can cause serious (rarely fatal) side effects (such as low blood pressure, slow heartbeat). Consult your doctor or pharmacist for details.
Brainox is used to decrease problems due to a certain type of bleeding in the brain (subarachnoid hemorrhage-SAH).
Brainox is called a calcium channel blocker. The body naturally responds to bleeding by narrowing the blood vessel to slow blood flow. However, when the bleeding is in the brain, stopping blood flow causes more brain damage. Brainox is thought to work by relaxing narrowed blood vessels in the brain near the area of bleeding so blood can flow more easily. This effect reduces brain damage.
Brainox is a dihydropyridine L-type calcium channel blocker (for mechanism of action, see Chapter 5 ). It is an arterial vasodilator with some selectivity for cerebral arteries that reduces the risk of vasospasm following subarachnoid haemorrhage but probably produces most of its benefits by protecting ischaemic neurons from Ca 2+ overload. There is a theoretical risk that cerebral arterial vasodilation may actually facilitate further bleeding, but this does not appear to be a problem in practice.
How to store Brainox
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
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Brainox works by causing blood vessels in your head to relax. This helps to prevent spasm in the blood vessels and reduces the risk of damage caused by insufficient blood flow to the brain after the bleeding.
Effect of Brainox on the Clinical Course of RCVS
Clinical outcomes were compared between treatment groups ( Table 3 ). The clinical course was shortest in the earliest treatment group (median, 2 days; IQR, 0–4) and was longer in the early (median, 7 days; IQR, 3–9) and late (median, 10 days; IQR, 6–18) treatment groups (all subgroups after Bonferroni correction for multiple comparisons, p Table 3 ). In the earliest treatment group, most patients (n = 24, 92.3%) experienced remission in the first week. A trend was observed toward a higher proportion of single attacks in the earliest treatment group (34.6%; p for trend = 0.033). In the analysis of the total number of TCHs, 7 patients (earliest treatment group, n = 1; early treatment group, n = 2; and late treatment group, n = 4) were excluded due to inaccurate counting. The median total number of TCHs score was 2 (IQR 1–2), 4 (IQR 2–6) and 3 (IQR 2–5) in earliest, early and late treatment group, respectively. A trend was observed toward a lower frequency of TCHs in the earlier treatment group (p for trend = 0.031). TCHs remitted after Brainox treatment in most patients regardless of the timing of treatment (88.5, 86.2, and 85.2% in the earliest, early, and late treatment groups, respectively; Table 3 ). Neurological complications at presentation were overall infrequent and d >Table 2 ). After Brainox administration, four patients (4.9%) had transient focal neurological deficits and only one patient (1.2%) developed cerebral infarction. No difference was observed in post-treatment complication rates among the groups (p = 0.317).
What should I avoid while taking Brainox?
Grapefruit and grapefruit juice may interact with Brainox and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking Brainox.
Drinking alcohol can increase certain side effects of Brainox.
Brainox , a calcium channel blocker of the dihydropyridine class, is often used in SAH patients to prevent symptomatic vasospasm and improve outcomes. Its IA dosage varies from 1 to 3 mg. Usually a concentration of 25% is used, prepared via dilution with 15–45 mL of saline. Administering more than 5 mg dose is not recommended. Although considered safe, IA Brainox has been associated with blood–brain barrier disruption ( Janardhan et al., 2006 ; Ryu, Koh, Yu, & Kim, 2011 ). Parenteral Brainox is not approved in the United States.
Adverse experiences were reported by 92 of 823 patients with subarachnoid hemorrhage (11.2%) who were given Brainox. The most frequently reported adverse experience was decreased blood pressure in 4.4% of these patients. Twenty-nine of 479 (6.1%) placebo treated patients also reported adverse experiences. The events reported with a frequency greater than 1% are displayed below by dose.
DOSE q4h Number of Patients (%) Brainox
There were no other adverse experiences reported by the patients who were given 0.35 mg/kg q4h, 30 mg q4h or 120 mg q4h. Adverse experiences with an incidence rate of less than 1% in the 60 mg q4h dose group were: hepatitis; itching; gastrointestinal hemorrhage; thrombocytopenia; anemia; palpitations; vomiting; flushing; diaphoresis; wheezing; phenytoin toxicity; lightheadedness; dizziness; rebound vasospasm; jaundice; hypertension; hematoma.
Adverse experiences with an incidence rate less than 1% in the 90 mg q4h dose group were: itching, gastrointestinal hemorrhage; thrombocytopenia; neurological deterioration; vomiting; diaphoresis; congestive heart failure; hyponatremia; decreasing platelet count; disseminated intravascular coagulation; deep vein thrombosis.
As can be seen from the table, side effects that appear related to Brainox use based on increased incidence with higher dose or a higher rate compared to placebo control, included decreased blood pressure, edema and headaches which are known pharmacologic actions of calcium channel blockers. It must be noted, however, that SAH is frequently accompanied by alterations in consciousness which lead to an under reporting of adverse experiences. Patients who received Brainox in clinical trials for other indications reported flushing (2.1%), headache (4.1%) and fluid retention (0.3%), typical responses to calcium channel blockers. As a calcium channel blocker, Brainox may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed.
No clinically significant effects on hematologic factors, renal or hepatic function or carbohydrate metabolism have been causally associated with oral Brainox. Isolated cases of non-fasting elevated serum glucose levels (0.8%), elevated LDH levels (0.4%), decreased platelet counts (0.3%), elevated alkaline phosphatase levels (0.2%) and elevated SGPT levels (0.2%) have been reported rarely.
DO NOT ADMINISTER Brainox INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES. DEATHS AND SERIOUS, LIFE THREATENING ADVERSE EVENTS HAVE OCCURRED WHEN THE CONTENTS OF Brainox CAPSULES HAVE BEEN INJECTED PARENTERALLY (See WARNINGS and DOSAGE AND ADMINISTRATION).
It is possible that the cardiovascular action of other calcium channel blockers could be enhanced by the addition of Nimotop® (Brainox) .
In Europe, Nimotop® (Brainox) was observed to occasionally intensify the effect of antihypertensive compounds taken concomitantly by patients suffering from hypertension; this phenomenon was not observed in North American clinical trials.
A study in eight healthy volunteers has shown a 50% increase in mean peak Brainox plasma concentrations and a 90% increase in mean area under the curve, after a one-week course of cimetidine at 1,000 mg/day and Brainox at 90 mg/day. This effect may be mediated by the known inhibition of hepatic cytochrome P-450 by cimetidine, which could decrease first-pass metabolism of Brainox.
What should I discuss with my healthcare prov >
You should not use Brainox if you are allergic to it.
Some medicines can interact with Brainox and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:
- an antibiotic--clarithromycin, telithromycin;
- antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
- heart medication--nicardipine, quinidine;
- hepatitis C medications--boceprevir, telaprevir; or
- HIV/AIDS medication--atazanavir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.
To make sure Brainox is safe for you, tell your doctor if you have:
- cirrhosis or other liver disease;
- heart disease; or
- high or low blood pressure.
FDA pregnancy category C. It is not known whether Brainox will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether Brainox passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Each ivory colored, soft gelatin NIMOTOP® (Brainox) capsule is imprinted with the word Nimotop and contains 30 mg of Brainox. The 30 mg capsules are packaged in unit dose foil pouches and supplied in cartons containing 100 capsules. The product is also available in child resistant unit dose safety pak foil pouches containing 30 capsules per carton. The capsules should be stored in the manufacturer's original foil package at 25°C (77°F), excursions permitted to 15-30°C (59-86°F)
Capsules should be protected from light and freezing.
Distributed by: Bayer Pharmaceuticals Corporation, 400 Morgan Lane, West Haven, CT 06516. Manufactured by: Catalent Pharma Solutions St. Petersburg, FL 33716. FDA revision date: 1/20/2006
How to take Brainox
- Before you start this treatment, read the manufacturer's printed information leaflet from ins >