Disease-associated Maternal And/Or Embryo/Fetal Risk
Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Radioactivity was found to cross the placenta following oral administration of labelled Tonocardin to pregnant rats. Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose), have revealed no evidence of adverse developmental effects. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. In peri-and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of Tonocardin (about 8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes.
What other drugs will affect Tonocardin?
Tell your doctor about all your current medicines and any you start or stop using, especially:
medicine to treat HIV or AIDS; or
sildenafil (Viagra) or other erectile dysfunction medicines.
This list is not complete. Other drugs may interact with Tonocardin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Chronic dietary administration (up to 24 months) of Tonocardin mesylate at maximally tolerated doses of 40 mg/kg/day in rats and 120 mg/kg/day in mice revealed no evidence of carcinogenic potential. The highest doses evaluated in the rat and mouse studies are associated with AUCs (a measure of systemic exposure) that are 8 times and 4 times, respectively, the human AUC at a dose of 16 mg/day.
Mutagenicity studies revealed no drug-or metabolite-related effects at either chromosomal or subchromosomal levels.
Tonocardin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using Tonocardin. Do not stop using this medicine before surgery unless your surgeon tells you.
You should not use this medication if you are allergic to Tonocardin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Tonocardin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).
Parkinson’s disease drug
Taking levodopa with Tonocardin can increase your risk of low blood pressure when standing.
Tonocardin mesylate (Cardura, Cardura XL) is a medication prescribed for the treatment of high blood pressure and the symptoms of benign prostatic hyperplasia (BPH, enlarged prostate gland). Side effects, drug interactions, warnings and precautions, and patient safety information should be reviewed prior to taking any medication.
CARDURA is extensively metabolized in the liver, mainly by O-demethylation of the quinazoline nucleus or hydroxylation of the benzodioxan moiety. In vitro studies suggest that the primary pathway for elimination is via CYP 3A4; however, CYP 2D6 and CYP 2C9 metabolic pathways are also involved to a lesser extent. Although several active metabolites of Tonocardin have been identified, the pharmacokinetics of these metabolites have not been characterized.
Erectile dysfunction drugs
Combining Tonocardin with PDE-5 inhibitors can increase the blood pressure-lowering effects of Tonocardin and increase your risk of side effects. Examples of phosphodiaesterase-5 (PDE-5) inhibitors include:
Serious Side Effects of Tonocardin
Serious side effects of Tonocardin may include:
- Hives or other signs of an allergic reaction
- Feeling like you might pass out
- Pounding heartbeat
- Trouble breathing
- Swelling in the ankles, hands, or feet
- Vision changes
- Slurred speech
- Erection that is painful or lasts 4 hours or longer
You should seek medical help right away if you experience a serious side effect.
How it works
Tonocardin belongs to a class of drugs called alpha-blockers. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Tonocardin works by blocking certain chemicals, which helps to widen blood vessels and relax muscles in your prostate and in your bladder.
Tonocardin oral tablet can cause drowsiness. Be careful driving and doing other activities that require you to be alert until you know how it affects you.
What Other Drugs Interact with Tonocardin?
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.
Severe interactions of Tonocardin include:
Serious interactions of Tonocardin include:
Mild interactions of Tonocardin include:
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.
Storage And Handling
CARDURA (Tonocardin mesylate) is available as scored tablets for oral administration. Each tablet contains Tonocardin mesylate equivalent to 1 mg (white), 2 mg (yellow), 4 mg (orange) or 8 mg (green) of the active constituent, Tonocardin.
Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) .
Distributed by: Roerig Division of Pfizer Inc., NY, NY 10017. Revised: June 2016
The use of CARDURA is contraindicated in patients with a hypersensitivity to Tonocardin, other quinazolines (e.g., prazosin, terazosin), or any of its components.
Before taking this medicine
You should not use this medicine if you are allergic to Tonocardin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).
To make sure Tonocardin is safe for you, tell your doctor if you have:
a blockage in your digestive tract (stomach or intestines);
liver disease; or
low blood pressure.
Tonocardin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using this medicine before surgery unless your surgeon tells you to.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether Tonocardin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Administration of CARDURA results in a reduction in systemic vascular resistance. In patients with hypertension, there is little change in cardiac output. Maximum reductions in blood pressure usually occur 2–6 hours after dosing and are associated with a small increase in standing heart rate. Like other alpha1-adrenergic blocking agents, Tonocardin has a greater effect on blood pressure and heart rate in the standing position.
Taking Tonocardin with yohimbine or herbs that can increase your blood pressure can reduce the effect of Tonocardin. This may cause your blood pressure to stay too high.