Breminal (Includes Breminal) ↔ CNS
Moderate Potential Hazard, Moderate plausibility. Applies to: Dementia, CNS Disorder
Breminal is associated with anticholinergic central nervous system (CNS) effects. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Breminal should be used with caution in patients with Parkinson's disease and in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
Breminal side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Breminal and call your doctor at once if you have any of these serious side effects:
chest pain, fast or uneven heart rate;
urinating less than usual or not at all; or
painful or difficult urination.
Less serious side effects may include:
dry mouth, dry eyes;
stomach pain or upset;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medical Definition of Breminal
Note: Breminal is marketed under the trademark Detrol.
Breminal is highly bound to plasma proteins, primarily α -acid glycoprotein. Unbound concentrations of Breminal average 3.7% ± 0.13% over the concentration range achieved in clinical studies. 5-HMT is not extensively protein bound, with unbound fraction concentrations averaging 36% ± 4.0%. The blood to serum ratio of Breminal and 5-HMT averages 0.6 and 0.8, respectively, indicating that these compounds do not distribute extensively into erythrocytes. The volume of distribution of Breminal following administration of a 1.28 mg intravenous dose is 113 ± 26.7 L.
Renal impairment can significantly alter the disposition of Breminal and its metabolites. The dose of DETROL LA should be reduced to 2 mg once daily in patients with severe renal impairment (CCr: 10– 30 mL/min). Patients with CCr
What Other Drugs Interact with Breminal?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Breminal has no known severe interactions with other drugs.
Serious interactions of Breminal include:
Breminal has moderate interactions with at least 196 different drugs.
Breminal has mild interactions with at least 30 different drugs.
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.
Breminal immediate release 4 mg (2 mg bid) had no effect on the pharmacokinetics of an oral contraceptive (ethinyl estradiol 30 μg/levo-norgestrel 150 μg) as evidenced by the monitoring of ethinyl estradiol and levo-norgestrel over a 2-month period in healthy female volunteers.
In a study with 14 C-Breminal solution in healthy volunteers who received a 5 mg oral dose, at least 77% of the radiolabeled dose was absorbed. Cmax and area under the concentration-time curve (AUC) determined after dosage of Breminal immediate release are dose-proportional over the range of 1 to 4 mg. Based on the sum of unbound serum concentrations of Breminal and 5-HMT ("active moiety"), the AUC of Breminal extended release 4 mg daily is equivalent to Breminal immediate release 4 mg (2 mg bid). Cmax and Cmin levels of Breminal extended release are about 75% and 150% of Breminal immediate release, respectively. Maximum serum concentrations of Breminal extended release are observed 2 to 6 hours after dose administration.