Toltex tablets

Toltex

  • Active Ingredient: Tolterodine
  • 4 mg, 2 mg, 1 mg
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What is Toltex?

The active ingredient of Toltex brand is tolterodine. Tolterodine reduces spasms of the bladder muscles.

Used for

Toltex is used to treat diseases such as: Overactive Bladder, Urinary Incontinence.

Side Effect

Possible side effects of Toltex include: difficult, burning, or painful urination; Abnormal vision, including difficulty with adjusting to distances; tingling of the hands or feet; Abdominal or stomach pain; headache; difficulty with swallowing.

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Rated Toltex for Urinary Frequency Report

My 8 year old son was prescribed Toltex following a diagnosis of bladder instability. He has been taking it for 3 weeks now and it has helped a little. Before he was pretty much in and out of the toilet constantly but now he can at least leave the house. Only problem is it seems to have made him constipated! Bit frustrating :/

Rated Toltex for Urinary Frequency Report

I've taken several medications for urinary frequency and this one is the best. I love it because it works fast. Maybe because the pill doesn't have a hard outer shell which probably enables it to desolve quicker. For example, if you've had a few beverage in the morning (tea, juice, water) then pop a pill, Within 30mins - 1hr, you'll notice less trips to the bathroom. The only downside, is that it only last about 5-6 hrs. Other medications, take the usual 1hr - 2hrs to work. So it's good if you take it first thing in the morning, but if you forget, you're SCREWED. Age: 36 Bladder issues began: age 8 Side Effects: Absolutely Zero: I take it right along with my lortadine! GoodLuck

Interactions

Drug-drug. Clarithromycin, erythromycin, itraconazole, ketoconazole, miconazole: inhibited metabolism and increased effects of Toltex

Drug-food. Any food: increased drug bioavailability

Is Toltex safe to take if I'm pregnant or breastfeeding?

At doses much greater than those used in humans, Toltex causes fetal abnormalities in animals, but there are no studies with Toltex in pregnant women. Therefore, Toltex should only be given to pregnant women if the benefits are felt to outweigh the potential risks.

Toltex is secreted into breast milk in animals; however, it is not known if Toltex is secreted into the breast milk of women. Therefore, nursing mothers should either not breast feed or discontinue Toltex.

BRAND NAME(S): Detrol

USES: This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, Toltex improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

What is Toltex, and how does it work (mechanism of action)?

Toltex belongs to a class of drugs called cholinergic (acetylcholine) receptor blockers. It is used to treat disorders of the urinary bladder that affect urination. The urinary bladder is a muscular "bag." Urine coming from the kidneys fills the bladder and causes it to stretch like a balloon. As it stretches, pressure in the bladder increases and, when the bladder reaches a certain level of stretch, a desire to urinate is felt. Nerves in the muscular wall of the bladder release acetylcholine, a chemical that attaches to receptors on the muscle cells and causes the cells to contract (tighten). This contributes further to the increase in pressure within the bladder and the desire to urinate. At the appropriate time (for example, when a toilet is available), there is conscious relaxation of the muscle at the outlet of the bladder, and the high bladder pressure forces urine out of the bladder. Normally, urination is under conscious control; however, in some individuals normal control as well as normal sensation are lost. The desire to urinate may be felt when there is little urine in the bladder, and urination may occur without warning or control. By blocking the effect of acetylcholine on the muscle cells, Toltex slows the build-up of pressure in the bladder, reduces the sensation to urinate, and prevents uncontrolled urination. The FDA approved Toltex in 1998. An extended release form of Toltex, (Detrol LA) was approved by the FDA in 2001.

What other drugs will affect Toltex?

Tell your doctor about all other medicines you use, especially:

chloroquine (Arelan) or halofantrine (Halfan);

cyclosporine (Gengraf, Neoral, Sandimmune);

narcotic medication such as levomethadyl (Orlaam) or methadone (Dolophine, Methadose);

Precautions

Before taking Toltex, tell your doctor or pharmacist if you are allergic to it; or to fesoterodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems emptying your bladder (urinary retention, bladder outflow obstruction), severe blockage of stomach/intestines (gastric retention), glaucoma, stomach/intestinal disease (such as ulcerative colitis, slowed movement of stomach/intestines), severe constipation, kidney disease, liver disease, a certain muscle disease (myasthenia gravis).

Toltex may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Toltex, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Toltex safely.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Rated Toltex for Urinary Incontinence Report

I have a lot of conditions that cause problems so I took it for a month before realizing these symptoms were constant. One reason for that is because I could not think clearly and got very depressed. I was exhausted all the time. My vision became very blurry. I was dizzy or lightheaded often, had a racing heart that I thought was an anxiety attack.dry mouth , headaches and swelling. I have Lymphadema, but it was pretty well controled until I started this and it caused a month long episode of swelling. That caused me pain and also my joints hurt more than usual. The symptoms started off slow but the control of frequent urination and incontinence was immediate. I took 2 mg -er once a day.

Toltex is extensively metabolized by the liver following oral dosing. The primary metabolic route involves the oxidation of the 5-methyl group and is mediated by the cytochrome P450 2D6 (CYP2D6) and leads to the formation of a pharmacologically active metabolite, 5-HMT. Further metabolism leads to formation of the 5-carboxylic acid and N-dealkylated 5-carboxylic acid metabolites, which account for 51% ± 14% and 29% ± 6.3% of the metabolites recovered in the urine, respectively.

Variability in Metabolism

A subset of individuals (approximately 7% of Caucasians and approximately 2% of African Americans) are poor metabolizers for CYP2D6, the enzyme responsible for the formation of 5-HMT from Toltex. The identified pathway of metabolism for these individuals ("poor metabolizers") is dealkylation via cytochrome P450 3A4 (CYP3A4) to N-dealkylated Toltex. The remainder of the population is referred to as "extensive metabolizers." Pharmacokinetic studies revealed that Toltex is metabolized at a slower rate in poor metabolizers than in extensive metabolizers; this results in significantly higher serum concentrations of Toltex and in negligible concentrations of 5-HMT.

What other drugs will affect Toltex?

Tell your doctor about all other medicines you use, especially:

  • arsenic trioxide (Trisenox);
  • chloroquine (Arelan) or halofantrine (Halfan);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • droperidol (Inapsine);
  • narcotic medication such as levomethadyl (Orlaam) or methadone (Dolophine, Methadose);
  • pentamidine (NebuPent, Pentam);
  • vinblastine (Velban);
  • antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), pentamidine (NebuPent, Pentam), or telithromycin (Ketek);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil) pimozide (Orap), or thioridazine (Mellaril); or
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan, Pronestyl), quinidine (Quin-G), or sotalol (Betapace).

This list is not complete and there are many other drugs that can interact with Toltex. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

How to store Toltex

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Toltex 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.

DESCRIPTION

DETROL LA Capsules contain Toltex tartrate. The active moiety, Toltex, is a muscarinic receptor antagonist. The chemical name of Toltex tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5- methylphenyl)-3-phenylpropanamine L-hydrogen tartrate. The empirical formula of Toltex tartrate is C26H37NO7. Its structure is:

Toltex tartrate is a white, crystalline powder with a molecular weight of 475.6. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3.

DETROL LA 4 mg capsule for oral administration contains 4 mg of Toltex tartrate. Inactive ingredients are sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2.

DETROL LA 2 mg capsule for oral administration contains 2 mg of Toltex tartrate, and the following inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron oxide, and FD&C Blue #2.

Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.

References

  1. "Product Information. Detrol (Toltex)." Pharmacia and Upjohn, Kalamazoo, MI.

How is this medicine (Toltex Tablets) best taken?

Use this medicine (Toltex tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Take this medicine (Toltex tablets) at the same time of day.
  • Keep taking this medicine (Toltex tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Drug-Laboratory-Test Interactions

Interactions between Toltex and laboratory tests have not been studied.


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