SANCTURA- trospium chloride tablet
1 INDICATIONS AND USAGE
SANCTURA® is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
2 DOSAGE AND ADMINISTRATION
The recommended dose is 20 mg twice daily. SANCTURA® should be dosed at least one hour before meals or given on an empty stomach.
Dosage modification is recommended in the following patient populations:
For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [see Use in Specific Populations (8.5) ].
3 DOSAGE FORMS AND STRENGTHS
SANCTURA® is supplied as 20 mg tablets (brownish yellow, biconvex, glossy coated tablets printed with S in black ink).
SANCTURA® is contraindicated in patients with:
uncontrolled narrow-angle glaucoma.
known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported.
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Urinary Retention
SANCTURA® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention
SANCTURA® (trospium chloride) is a quaternary ammonium compound with the chemical name of Spiro[8-azoniabicyclo[3.2.1]octane-8,1?-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1?, 3?, 5?). The empirical formula of trospium chloride is C25 H30 ClNO3 and its molecular weight is 427.97
Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g per 2 mL.
Each SANCTURA® tablet contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate, titanium dioxide, stearic acid, croscarmellose sodium, povidone, polyethylene glycol 8000, colloidal silicon dioxide, ferric oxide, carboxymethylcellulose sodium, white wax, magnesium stearate, and carnauba wax.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
SANCTURA® is a muscarinic antagonist.
Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.
Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.
SANCTURA ® [ SANK-TOUR-AH]
(trospium chloride) tablets
Read the Patient Information that comes with SANCTURA® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is SANCTURA ® ?
SANCTURA® is a prescription medicine used to treat adults with overactive bladder who have the following symptoms:
a strong need to urinate right away;
leaking or wetting accidents due to a strong need to urinate right away;
a need to urinate often.
Who should not take SANCTURA ® ?
Do not take SANCTURA® if you:
have trouble emptying your bladder;
have delayed or slow emptying of your stomach;
have an eye problem called “uncontrolled narrow-angle glaucoma”;
are allergic to SANCTURA® or any of its ingredients. See the end of this leaflet for a complete list of ingredients.
SANCTURA® has not been studied in children under the age of 18 years.
What should I tell my doctor before starting SANCTURA ® ?
Tell your doctor about all of your medical conditions including if you:
have any stomach or intestinal problems or problems with constipation;
have trouble emptying your bladder or have a weak urine stream;
have an eye problem called narrow-angle glaucoma;
have kidney problems;
have liver problems;
are pregnant or planning to become pregnant. It is not known if SANCTURA® can harm your unborn baby.
are breastfeeding. It is not known if SANCTURA® passes into breast milk and if it can harm your baby. You should talk to your doctor about the best way to feed your baby if you are taking SANCTURA®.
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. SANCTURA® and certain other medicines can interact and make some side effects worse. SANCTURA® can affect how other medicines are handled by the body.
Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.
How should I take SANCTURA ® ?
Take SANCTURA® exactly as prescribed.
Take one SANCTURA® tablet twice daily with water.
Take SANCTURA® on an empty stomach or at least 1 hour before a meal.
If you take too much SANCTURA® , call your local Poison Control Center or go to an emergency room right away.
What are the possible side effects of SANCTURA ® ?
SANCTURA® may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue. If you experience these symptoms, you should stop taking SANCTURA® and get emergency medical help right away.
The most common side effects with SANCTURA® are:
SANCTURA® may cause other less common side effects, including:
trouble emptying the bladder;
blurred vision; and drowsiness. Do not drive or operate heavy machinery until you know how SANCTURA® affects you. Alcohol can worsen the drowsiness caused by drugs such as SANCTURA®.
heat prostration. Due to decreased sweating, heat prostration can occur when drugs such as SANCTURA® are used in a hot environment.
Tell your doctor if you have any side effects that bother you or that do not go away.
These are not all possible side effects of SANCTURA®. For more information, ask your doctor, healthcare professional or pharmacist.
How should I store SANCTURA ® ?
Keep SANCTURA® and all other medicines out of the reach of children.
Store SANCTURA® at room temperature, 68° to 77°F (20° to 25°C).
Safely dispose of SANCTURA® tablets that are out of date or that you no longer need.
General information about SANCTURA ®
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use SANCTURA® for a condition for which it was not prescribed. Do not give SANCTURA® to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about SANCTURA®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about SANCTURA® that is written for health professionals. You can also call Allergan’s product information department at 1-800-433-8871.
What are the ingredients in SANCTURA ® ?
Active Ingredient: trospium chloride.
Inactive Ingredients: sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate, titanium dioxide, stearic acid, croscarmellose sodium, povidone, polyethylene glycol 8000, colloidal silicon dioxide, ferric oxide, carboxymethylcellulose sodium, white wax, magnesium stearate, and carnauba wax.