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Rx Item-Tolterodine 1Mg Tab 60 By Teva Pharma

NDC 00093-2056-06 UPC/GTIN No.3-00932-05606-3 Mfg.Part No.205606BRAND: TOLTERODINE NDC: 00093-2056-06,93205606 UPC: 3-00932-05606-3,300932056063 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Tolterodine 1Mg Tab 60 By Teva Pharma

$198.55$77.69

Item No.: RX499202/a NDC No.93205606 UPC No.:300932056063 NDC No. 00093-0010-06 UPC/GTIN No. 3-00932-05606-3 MPN 1006 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx499202 Tolterodine 1mg Tab 60 by Teva Pharma Item No. 499202 NDC No. 00093001006 UPC No. 300932056063 Other Name Detrol,Tolterodin

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OLTERODINE TARTRATE- tolterodine tartrate tablet, film coated
Greenstone LLC
DETROL LA- tolterodine tartrate capsule, extended release

DESCRIPTION

Tolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26 H37 NO7 , and its molecular weight is 475.6. The structural formula of tolterodine
Tolterodine tartrate is a white, crystalline powder. 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.

Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are colloidal anhydrous silica, calcium hydrogen phosphate dihydrate, cellulose microcrystalline, hypromellose, magnesium stearate, sodium starch glycolate (pH 3.0 to 5.0), stearic acid, and titanium dioxide.
The recommended dose of DETROL LA Capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for DETROL LA 2 mg


CLINICAL PHARMACOLOGY

Tolterodine is a competitive muscarinic receptor antagonist. Both urinary bladder contraction and salivation are mediated via cholinergic muscarinic receptors.

After oral administration, tolterodine is metabolized in the liver, resulting in the formation of the 5-hydroxymethyl derivative, a major pharmacologically active metabolite. The 5-hydroxymethyl metabolite, which exhibits an antimuscarinic activity similar to that of tolterodine, contributes significantly to the therapeutic effect. Both tolterodine and the 5-hydroxymethyl metabolite exhibit a high specificity for muscarinic receptors, since both show negligible activity or affinity for other neurotransmitter receptors and other potential cellular targets, such as calcium channels.

Tolterodine has a pronounced effect on bladder function. Effects on urodynamic parameters before and 1 and 5 hours after a single 6.4 mg dose of tolterodine immediate-release were determined in healthy volunteers. The main effects of tolterodine at 1 and 5 hours were an increase in residual urine, reflecting an incomplete emptying of the bladder, and a decrease in detrusor pressure. These findings are consistent with an antimuscarinic action on the lower urinary tract
INDICATIONS AND USAGE

Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

CONTRAINDICATIONS

Tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.

WARNINGS

Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate should be discontinued and appropriate therapy promptly provided.
Information for Patients
Patients should be informed that antimuscarinic agents such as tolterodine tartrate may produce the following effects: blurred vision, dizziness, or drowsiness. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug�s effects have been determined.

Drug Interactions
CYP3A4 Inhibitors
Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of tolterodine when coadministered to subjects who were poor metabolizers (see CLINICAL PHARMACOLOGY, Variability in Metabolism and Drug-Drug Interactions). For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals (e.g., itraconazole, miconazole) or macrolide antibiotics (e.g., erythromycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose of tolterodine tartrate is 1 mg twice daily (see DOSAGE AND ADMINISTRATION).

Drug-Laboratory-Test Interactions
Interactions between tolterodine and laboratory tests have not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with tolterodine were conducted in mice and rats. At the maximum tolerated dose in mice (30 mg/kg/day), female rats (20 mg/kg/day), and male rats (30 mg/kg/day), AUC values obtained for tolterodine were 355, 291, and 462 �g?h/L, respectively. In comparison, the human AUC value for a 2 mg dose administered twice daily is estimated at 34 �g?h/L. Thus, tolterodine exposure in the carcinogenicity studies was 9- to 14-fold higher than expected in humans. No increase in tumors was found in either mice or rats.
Pregnancy
Pregnancy Category C
OVERDOSAGE

A 27-month-old child who ingested 5 to 7 tolterodine tartrate tablets 2 mg was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered.

Management of Overdosage
Overdosage with tolterodine tartrate can potentially result in severe central anticholinergic effects and should be treated accordingly.

ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the recommended human dose. In clinical trials of normal volunteers and patients, QT interval prolongation was observed with tolterodine immediate-release at doses up to 8 mg (4 mg bid) and higher doses were not evaluated (see PRECAUTIONS, Patients with Congenital or Acquired QT Prolongation).

DOSAGE AND ADMINISTRATION

The initial recommended dose of tolterodine tartrate tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability. For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose of tolterodine tartrate is 1 mg twice daily
PATIENT INFORMATION tolterodine tartrate tablets

Read the Patient Information that comes with tolterodine tartrate tablets before you start using 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 condition or your treatment. Only your doctor can determine if treatment with tolterodine tartrate tablets is right for you.
What is tolterodine tartrate tablets?



Tolterodine tartrate tablets is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
Urgency: a strong need to urinate right away
Frequency: urinating often
Tolterodine tartrate extended release capsules did not help the symptoms of overactive bladder when studied in children.

What is overactive bladder?

Overactive bladder happens when you cannot control your bladder muscle. When the muscle contracts too often or cannot be controlled, you get symptoms of overactive bladder, which are leakage of urine (urge urinary incontinence), needing to urinate right away (urgency), and needing to urinate often (frequency).

Who should not take tolterodine tartrate tablets?

Do not take tolterodine tartrate tablets if you:

Are not able to empty your bladder (urinary retention)
Have delayed or slow emptying of your stomach (gastric retention)
Have an eye problem called �uncontrolled narrow-angle glaucoma"
Are allergic to tolterodine tartrate tablets or to any of its ingredients. See the end of this leaflet for a complete list of ingredients
Are allergic to TOVIAZ which contains fesoterodine.
What should I tell my doctor before starting tolterodine tartrate tablets?

Before starting tolterodine tartrate tablets, tell your doctor about all of your medical and other conditions that may affect the use of tolterodine tartrate tablets, including:

Stomach or intestinal problems or problems with constipation
Problems emptying your bladder or if you have a weak urine stream
Treatment for an eye problem called narrow-angle glaucoma
Liver problems
Kidney problems
A condition called myasthenia gravis
If you or any family members have a rare heart condition called QT prolongation (long QT syndrome)
If you are pregnant or trying to become pregnant. It is not known if tolterodine tartrate tablets could harm your unborn baby.
If you are breastfeeding. It is not known if tolterodine tartrate tablets passes into your breast milk or if it can harm your baby. Talk to your doctor about the best way to feed your baby if you take tolterodine tartrate tablets.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Other medicines can affect how your body handles tolterodine tartrate tablets. Your doctor may use a lower dose of tolterodine tartrate tablets if you are taking:

Certain medicines for fungus or yeast infections
Certain medicines for bacterial infections
Sandimmune� (cyclosporine) or Velban� (vinblastine)
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them with you to show your doctor or pharmacist each time you get a new medicine.

How should I take tolterodine tartrate tablets?

Take tolterodine tartrate tablets exactly as your doctor tells you to take it.
Your doctor will tell you how many tolterodine tartrate tablets to take and when to take them.
Do not change your dose unless told to do so by your doctor.
You can take tolterodine tartrate tablets with or without food.
Take tolterodine tartrate tablets at the same times each day.
If you miss a dose of tolterodine tartrate tablets, just take your next regular dose at your next regular time. Do not try to make up for your missed dose.
If you take too much tolterodine tartrate tablets, call your doctor, or go to the hospital emergency room right away.
What should I avoid while taking tolterodine tartrate tablets?

Medicines like tolterodine tartrate tablets can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how tolterodine tartrate tablets affects you.

What are possible side effects of tolterodine tartrate tablets?

Tolterodine tartrate tablets 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 tolterodine tartrate tablets and get emergency medical help right away.

The most common side effects with tolterodine tartrate tablets are:

Dry mouth
Dizziness
Headache
Stomach pain
Constipation
Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all the side effects with tolterodine tartrate tablets. For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How do I store tolterodine tartrate tablets?

Store tolterodine tartrate tablets at room temperature (59 to 86� F).
Keep it in a dry place.
Keep tolterodine tartrate tablets and all medicines out of the reach of children.

General Information about tolterodine tartrate tablets

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Only use tolterodine tartrate tablets the way your doctor tells you. Do not give tolterodine tartrate tablets to other people even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about tolterodine tartrate tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about tolterodine tartrate tablets that is written for health professionals. You can also visit www.greenstonellc.com on the Internet, or call 1-800-438-1985.

What are the ingredients in tolterodine tartrate tablets?
Active ingredients: tolterodine tartrate

NDC 00093-2056-06 UPC/GTIN No.3-00932-05606-3 Mfg.Part No.205606
RX ITEM-Tolterodine 1Mg Tab 60 By Teva P
NDC 00093-2056-06 UPC/GTIN No.3-00932-05606-3 Mfg.Part No.205606

BRAND: TOLTERODINE NDC: 00093-2056-06,93205606 UPC: 3-00932-05606-3,300932056063
Tolterodine 1Mg Tab 60 By Teva Pharma
BRAND: TOLTERODINE NDC: 00093-2056-06,93205606 UPC: 3-00932-05606-3,300932056063

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.