Hot PLR Articles Directory Lesotho: March 2012

Saturday, 31 March 2012

Fentanyl Soluble Film

Pronunciation: FEN-ta-nil
Generic Name: Fentanyl
Brand Name: Onsolis

Fentanyl Soluble Film can be harmful or fatal if taken by children, patients for whom it has not been prescribed, or patients who are not tolerant to narcotic (opioid) pain medicine. Keep Fentanyl Soluble Film out of the reach of children.

Fentanyl Soluble Film is only for breakthrough pain caused by cancer in patients 18 years old and older who are already using and are tolerant to around-the-clock narcotic pain medicine. Severe and sometimes fatal breathing problems can occur in patients using Fentanyl Soluble Film, especially in patients not already using other narcotic medicines or patients taking certain other medicines. Ask your health care provider if Fentanyl Soluble Film may interact with other medicines that you take. Do not use Fentanyl Soluble Film for short-term pain (including headache, migraine, or dental pain) or for pain that occurs after surgery or injuries.

Do NOT take more than the recommended dose or use more often than prescribed. You must wait at least 2 hours after your last dose of Fentanyl Soluble Film before treating a NEW episode of breakthrough pain with Fentanyl Soluble Film.

Do not switch brands of Fentanyl Soluble Film without first talking with your doctor. Different brands may release different amounts of Fentanyl Soluble Film into your body. This may cause severe and possibly fatal overdose. Talk with your doctor or pharmacist for more information.

Fentanyl Soluble Film is used for:

Managing breakthrough pain in cancer patients 18 years old and older who are already using and are tolerant to around-the-clock narcotic pain medicines.

Fentanyl Soluble Film is a narcotic (opioid) analgesic. It works in the brain to decrease pain.

Do NOT use Fentanyl Soluble Film if:

you are allergic to any ingredient in Fentanyl Soluble Film or to any similar medicine (eg, sufentanil)

you have not been taking other narcotic pain medicines (eg, morphine, codeine) on a regular schedule

you have mild or short-term pain, including dental pain or pain from injuries, surgery, headache, or migraine

you are taking sibutramine or sodium oxybate (GHB)

you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fentanyl Soluble Film:

Some medical conditions may interact with Fentanyl Soluble Film. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of mental or mood problems (eg, depression), hallucinations, or suicidal thoughts or actions

if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or a recent head injury

if you or a family member has a history of alcohol, narcotic, or other substance abuse or dependence

if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, heart problems (eg, slow or irregular heartbeat, ventricle problems), low blood pressure, liver or kidney problems, inflammation in the mouth, an enlarged prostate or benign prostatic hypertrophy (BPH), stomach or bowel problems (eg, constipation, inflammatory bowel disease, pseudomembranous colitis, stomach pain), an underactive thyroid, or seizures

if you have been very ill, have a fever, have poor health or nutrition, or have had a recent surgery (eg, stomach or bowel surgery)

if you stop taking your around-the-clock narcotic pain medicine

Some MEDICINES MAY INTERACT with Fentanyl Soluble Film. Tell your health care provider if you are taking any other medicines, especially any of the following:

Serotonin reuptake blockers (eg, fluoxetine) or sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma may occur

Amiodarone, antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam, midazolam), calcium channel blockers (eg, diltiazem, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolides (eg, erythromycin, clarithromycin), MAOIs (eg, phenelzine), nefazodone, other opioid medicines (eg, oxycodone), phenothiazines (eg, chlorpromazine), skeletal muscle relaxants (eg, cyclobenzaprine), sleep medicines (eg, zolpidem), sodium oxybate (GHB), telithromycin, or troleandomycin because they may increase the risk of Fentanyl Soluble Film's side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness

Mixed agonist/antagonist analgesics (eg, buprenorphine, pentazocine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease Fentanyl Soluble Film's effectiveness and withdrawal symptoms may occur

Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), efavirenz, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifamycins (eg, rifampin), St. John's wort, or troglitazone because they may decrease Fentanyl Soluble Film's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fentanyl Soluble Film may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine

How to use Fentanyl Soluble Film:

Use Fentanyl Soluble Film as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Fentanyl Soluble Film comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fentanyl Soluble Film refilled.

Do not use Fentanyl Soluble Film if the foil pack is damaged in any way.

Do not chew or swallow the film whole. Do not try to cut or tear the film in half.

Do not remove the film from the foil package until you are ready to take Fentanyl Soluble Film. Make sure that your hands are dry when you open the foil package.

Using scissors, cut along the arrows of the foil package. Separate the layers of the foil package and remove the film. Take the film right away after opening the foil package. Do not store the removed film for future use.

Moisten the inside of your cheek. Place the film inside your mouth with the pink side against the inside of your moistened cheek. With your finger, press and hold the film against your cheek for 5 seconds. Leave the film in place and allow it to dissolve.

Fentanyl Soluble Film usually takes 15 to 30 minutes to dissolve. Do not touch or move the film while it dissolves. You may drink liquids after 5 minutes. Do not eat any food until after the film dissolves.

If your doctor tells you to use more than one film at the same time, place a film on either side of the mouth. Do not place the films on top of each other.

If you notice that your medicine is a different color or shape, check with your pharmacist to make sure that you have the right medicine strength.

If your breakthrough pain does NOT get better within 30 minutes after your dose, you may use other pain medicine as directed by your doctor. Do NOT use more than 1 dose of Fentanyl Soluble Film per episode of breakthrough pain.

Wait at least 2 hours after your last dose of Fentanyl Soluble Film before treating a NEW episode of breakthrough pain. If you have more than 4 episodes of breakthrough pain per day, tell your doctor.

Check with your doctor before including grapefruit or grapefruit juice in your diet while you use Fentanyl Soluble Film.

If Fentanyl Soluble Film is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Fentanyl Soluble Film properly.

Fentanyl Soluble Film is usually used as needed. If you forget to use a dose of Fentanyl Soluble Film and you still have pain, use it when you remember, as directed by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fentanyl Soluble Film.

Important safety information:

Fentanyl Soluble Film may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fentanyl Soluble Film with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol while you are using Fentanyl Soluble Film.

Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fentanyl Soluble Film; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Fentanyl Soluble Film may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Constipation is a common side effect of Fentanyl Soluble Film. Talk with your doctor about using laxatives or stool softeners while you take Fentanyl Soluble Film to prevent or treat constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation.

Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop taking Fentanyl Soluble Film without checking with your doctor.

Tell your doctor or dentist that you take Fentanyl Soluble Film before you receive any medical or dental care, emergency care, or surgery.

Contact your doctor if your pain is not relieved or if it worsens after you use Fentanyl Soluble Film. Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider how your pain is responding to Fentanyl Soluble Film so that your dose can be adjusted if needed.

Do not switch brands of Fentanyl Soluble Film without first talking to your doctor. Different brands may release different amounts of Fentanyl Soluble Film into your body. This may cause severe and possibly fatal overdose. Discuss any questions or concerns with your doctor or pharmacist.

Use Fentanyl Soluble Film with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, stomach pain, constipation, and vomiting.

Fentanyl Soluble Film can be harmful, even fatal, if used in CHILDREN. Keep Fentanyl Soluble Film out of the reach of children.

Use Fentanyl Soluble Film with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Fentanyl Soluble Film may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fentanyl Soluble Film while you are pregnant. Fentanyl Soluble Film is found in breast milk. Do not breast-feed while taking Fentanyl Soluble Film.

When used for long periods of time or at high doses, Fentanyl Soluble Film may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Fentanyl Soluble Film stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Fentanyl Soluble Film. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Fentanyl Soluble Film, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Fentanyl Soluble Film:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; nausea; numbness, tingling, pain, or irritation at the site where the film is used; vomiting; weakness or tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); blurred vision or other vision problems; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; mood or mental changes (eg, depression); mouth sores, ulcers, bleeding, or inflammation; seizures; severe drowsiness; severe dry eyes, mouth, or skin; severe or persistent dizziness or headache; severe or persistent stomach pain; shortness of breath; slowed or shallow breathing; trouble urinating; unusual or severe weakness or tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fentanyl side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; pinpoint pupils; severe drowsiness or dizziness; slow or shallow breathing; very slow or weak heartbeat.

Proper storage of Fentanyl Soluble Film:

Store Fentanyl Soluble Film between 59 and 86 degrees F (15 and 30 degrees C). Store in the original package, away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Do not use if the foil pouch has been opened. Keep Fentanyl Soluble Film out of the reach of children and away from pets.

General information:

If you have any questions about Fentanyl Soluble Film, please talk with your doctor, pharmacist, or other health care provider.

Fentanyl Soluble Film is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fentanyl Soluble Film. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Fentanyl resources

Fentanyl Side Effects (in more detail)
Fentanyl Use in Pregnancy & Breastfeeding
Fentanyl Drug Interactions
Fentanyl Support Group
149 Reviews for Fentanyl - Add your own review/rating

Compare Fentanyl with other medications

Anesthesia
Anesthetic Adjunct
Breakthrough Pain
Pain
Postoperative Pain
Sedation

Friday, 30 March 2012

Vesicare

Generic Name: Solifenacin Succinate
Class: Genitourinary Smooth Muscle Relaxants
Chemical Name: (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl-3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylate cmpd. with butanedioic acid (1:1)
Molecular Formula: C₂₃H₂₆N₂O₂•C₄H₆O₄
CAS Number: 242478-38-2

Introduction

Genitourinary antispasmodic agent; an antimuscarinic agent.¹

Uses for Vesicare

Overactive Bladder

Relief of symptoms associated with voiding (e.g., urge urinary incontinence, urgency, frequency).¹

Vesicare Dosage and Administration

Administration

Oral Administration

Administer orally once daily with liquids without regard to meals.¹ ⁸

Swallow tablets whole.¹ ⁸

Dosage

Available as solifenacin succinate; dosage expressed in terms of the salt.¹

Adults

Overactive Bladder

Oral

Initially, 5 mg once daily.¹ If well tolerated, may increase to 10 mg once daily.¹

Prescribing Limits

Adults

Overactive Bladder

Oral

Maximum 10 mg daily.¹

Special Populations

Hepatic Impairment

Maximum 5 mg daily in patients with moderate hepatic impairment (Child-Pugh class B).¹ (See Elimination: Special Populations, under Pharmacokinetics.)

Use not recommended in patients with severe hepatic impairment (Child-Pugh class C).¹

Renal Impairment

Maximum 5 mg daily in patients with severe renal impairment (Cl_cr <30 mL/minute).¹ (See Elimination: Special Populations, under Pharmacokinetics.)

Cautions for Vesicare

Contraindications

Urinary retention, gastric retention, or uncontrolled angle-closure glaucoma.¹

Known hypersensitivity to solifenacin succinate or any ingredient in the formulation.¹

Warnings/Precautions

Sensitivity Reactions

Angioedema

Angioedema reported in at least 1 patient.¹ ⁹

General Precautions

Urinary Retention

Risk of urinary retention; use with caution in patients with clinically important bladder outflow obstruction.¹

Decreased GI Motility

Use with caution in patients with decreased GI motility¹ (e.g., patients with severe constipation, ulcerative colitis, or myasthenia gravis) or obstructive GI disorders.⁹

Fecal impaction, colonic obstruction, and intestinal obstruction reported rarely with 10-mg daily dosage.¹

Prolongation of QT Interval

30-mg daily dosage associated with more pronounced prolongation of QT interval than 10-mg daily dosage.¹ (See Prescribing Limits under Dosage and Administration.) Consider this observation when deciding to use solifenacin in patients with history of QT interval prolongation or receiving drugs that prolong QT interval.¹

Controlled Angle-closure Glaucoma

Use with caution in patients being treated for angle-closure glaucoma.¹ (See Contraindications under Cautions.)

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in mice; not known whether distributed into human milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.⁹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹ (See Elimination: Special Populations, under Pharmacokinetics.)

Hepatic Impairment

Use with caution.¹ (See Hepatic Impairment under Dosage and Administration and see Elimination: Special Populations, under Pharmacokinetics.)

Use not recommended in patients with severe hepatic impairment (Child-Pugh class C).¹

Renal Impairment

Use with caution.¹ (See Renal Impairment under Dosage and Administration and see Elimination: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

Dry mouth, constipation.¹

Interactions for Vesicare

Metabolized principally by CYP3A4.¹ Does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4.¹

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma solifenacin concentrations).¹ Do not exceed 5 mg daily when used concomitantly with potent inhibitors of CYP3A4.¹ (See Specific Drugs under Interactions.)

Inducers of CYP3A4: Potential pharmacokinetic interaction (altered solifenacin pharmacokinetics).¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP1A1/2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4: Pharmacokinetic interaction unlikely

Drugs Affected by GI Motility

Potential pharmacokinetic interaction (altered absorption because of decreased GI motility).¹⁰ (See Decreased GI Motility under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Anticholinergic agents	Possible additive anticholinergic effects⁹
Digoxin	No substantial effect on digoxin pharmacokinetics¹
Hormonal contraceptives	No substantial changes in plasma concentrations of ethinyl estradiol or levonorgestrel¹
Ketoconazole	Increased plasma solifenacin concentrations¹	Do not exceed a solifenacin succinate dosage of 5 mg daily¹
Warfarin	No substantial effect on warfarin pharmacokinetics¹

Vesicare Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability is approximately 90%.¹ ⁶

Peak plasma concentrations achieved within 3–8 hours after administration.¹

Food

Food does not affect pharmacokinetics of solifenacin.¹ ⁷

Special Populations

Increased plasma concentrations reported in geriatric patients, patients with moderate hepatic impairment (Child-Pugh class B), and patients with severe renal impairment (Cl_cr <30 mL/minute).¹ (See Special Populations under Dosage and Administration and see Elimination: Special Populations, under Pharmacokinetics.)

Distribution

Extent

Highly distributed to tissues outside the CNS.¹

Distributed into milk in mice; not known whether distributed into human milk.¹

Plasma Protein Binding

Approximately 98% (mainly to α₁-acid glycoprotein).¹

Elimination

Metabolism

Extensively metabolized in the liver, mainly via CYP3A4.¹

Elimination Route

Excreted in urine (approximately 69%) and in feces (approximately 23%); unchanged drug accounts for <15% of recovered radioactivity.¹

Half-life

45–68 hours following long-term administration.¹

Special Populations

Prolonged half-life in geriatric patients, patients with moderate hepatic impairment (Child-Pugh class B), and patients with severe renal impairment (Cl_cr <30 mL/minute).¹ (See Special Populations under Dosage and Administration.)

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

Potent and selective antimuscarinic agent.¹ ²

Inhibits contraction of the detrusor muscle of the bladder, resulting in decreased bladder activity.²

Demonstrates binding specificity for muscarinic M₃ receptors in vitro and functional selectivity for urinary bladder over secretory (e.g., salivary) glands.²

Advice to Patients

Risk of blurred vision, constipation, dry mouth, and heat prostration (when used in a hot environment).¹ Use caution when driving or performing dangerous activities until effects on vision are known.⁸ Consult a clinician if severe abdominal pain occurs or if constipation persists for ≥3 days.¹

Importance of taking solifenacin succinate with liquids and swallowing the tablet whole.¹ ⁸ If a dose is skipped, resume therapy the next day; do not take 2 doses in the same day.⁸

Importance of reading manufacturer’s patient information leaflet before initiating therapy.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.¹

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Solifenacin Succinate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	5 mg	Vesicare	Yamanouchi (also promoted by GlaxoSmithKline)
		10 mg	Vesicare	Yamanouchi (also promoted by GlaxoSmithKline)

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

VESIcare 10MG Tablets (ASTELLAS): 30/$161.99 or 90/$458.96

VESIcare 5MG Tablets (ASTELLAS): 30/$165.98 or 90/$475.95

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Yamanouchi. VESIcare (solifenacin succinate) tablets prescribing information. Paramus, NJ; 2004 Nov.

2. Chilman-Blair K. Solifenacin: Treatment of overactive bladder. Drugs Today. 2004; 40:343-53. [PubMed 15190387]

3. Chapple CR, Rechberger T, Al-Shukri S et al. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int. 2004; 93:303-10. [IDIS 532014] [PubMed 14764127]

4. Cardozo L, Lisec M, Millard R et al. Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder. J Urol. 2004; 172:1919-24. [IDIS 522716] [PubMed 15540755]

5. Kelleher CJ, Cardozo L, Chapple CR et al. Improved quality of life in patients with overactive bladder symptoms treated with solifenacin. BJU Int. 2005; 95:81-5. [IDIS 532015] [PubMed 15638900]

6. Kuipers ME, Krauwinkel WJJ, Mulder H et al. Solifenacin demonstrates high absolute bioavailability in healthy men. Drugs R D. 2004; 5:73-81. [PubMed 15293866]

7. Uchida T, Krauwinkel WJ, Mulder H et al. Food does not affect the pharmacokinetics of solifenacin, a new muscarinic receptor antagonist: results of a randomized crossover trial. Br J Clin Pharmacol. 2004; 58:4-7. [IDIS 519282] [PubMed 15206986]

8. Yamanouchi. VESIcare (solifenacin succinate) patient information. Paramus, NJ; 2004 Nov.

9. Astellas Pharma, Durham, NC: Personal communication.

10. Novartis. Enablex (darifenacin hydrobromide) extended-release tablets prescribing information. East Hanover, NJ; 2004 Dec.

More Vesicare resources

Vesicare Side Effects (in more detail)
Vesicare Use in Pregnancy & Breastfeeding
Drug Images
Vesicare Drug Interactions
Vesicare Support Group
31 Reviews for Vesicare - Add your own review/rating

Vesicare Advanced Consumer (Micromedex) - Includes Dosage Information

Vesicare Consumer Overview

VESIcare Prescribing Information (FDA)

VESIcare MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Vesicare with other medications

Overactive Bladder
Urinary Incontinence

Sunday, 25 March 2012

Clobetasol

Dosage Form: ointment
Clobetasol Propionate

Ointment USP, 0.05%

Rx Only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE

Clobetasol Description

Clobetasol propionate ointment contains the active compound Clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:

C25H32ClFO5 Molecular Weight: 467

Each gram of the 0.05% ointment contains Clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.

Clobetasol - Clinical Pharmacology

Like other topical corticosteroids, Clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the Clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration studies. Studies performed with Clobetasol propionate gel, cream and ointment indicate that they are in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Clobetasol

Clobetasol propionate ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Contraindications

Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, Clobetasol propionate should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Clobetasol propionate should be discontinued until the infection has been adequately controlled.

Clobetasol propionate ointment should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or axillae.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1.: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2.: This medication should not be used for any disorder other than that for which it was prescribed.
3.: The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
4.: Patients should report any signs of local adverse reactions to the physician.
5.: Patients should inform their physicians that they are using Clobetasol propionate if surgery is contemplated.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test, A.M. plasma cortisol test, Urinary free cortisol test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Clobetasol propionate. Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was non-mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 0.33 and 0.01 times, respectively, the human topical dose of Clobetasol propionate ointment. Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, Clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.001 and 0.003 times, respectively, the human topical dose of Clobetasol propionate ointment. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of Clobetasol propionate in pregnant women. Clobetasol propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol propionate ointment is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Clobetasol propionate ointment in pediatric patients have not been established. Use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS).

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of Clobetasol propionate drug products in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

In controlled clinical trials, the most frequent adverse events reported for Clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

Overdosage

Topically applied Clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Clobetasol Dosage and Administration

Apply a thin layer of Clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)

Clobetasol propionate ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate ointment should not be used with occlusive dressings.

How is Clobetasol Supplied

Clobetasol Propionate Ointment USP, 0.05% is supplied in 15 g (NDC 60429-901-15), 30 g (NDC 60429-901-30), 45 g (NDC 60429-901-45), and 60 g (NDC 60429-901-60) tubes.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Marketed by: Golden State Medical Supply, Inc., Camarillo, CA 93012

Issued: April, 2010

PRINCIPAL DISPLAY PANEL - 15 g Tube Label

NDC 60429-901-15

GSMS™

incorporated

Clobetasol Propionate

Ointment USP, 0.05%

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

15 g

Rx only

Each gram contains: 0.5 mg Clobetasol propionate in an ointment base of propylene glycol,

sorbitan sesquioleate, and white petrolatum.

Usual dosage: A thin layer of Clobetasol propionate ointment should be applied with gentle

rubbing to the affected skin areas twice daily, once in the morning and once at night.

See package insert for full prescribing information.

Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. Do not refrigerate.

To Open: Use pointed end on cap to puncture seal.

For lot number and expiry date see crimp of tube.

Mfd. by:

Taro Pharmaceuticals Inc.

Brampton, Ontario, Canada L6T 1C1

Marketed by:

Golden State Medical Supply, Inc.

Camarillo, CA 93012

PK-6480-0 0410-0

Clobetasol PROPIONATE
Clobetasol propionate ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	60429-901
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clobetasol Propionate (Clobetasol)	Clobetasol Propionate	0.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
propylene glycol
sorbitan sesquioleate
petrolatum

Product Characteristics
Color	WHITE (White to cream-colored)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	60429-901-15	1 TUBE In 1 CARTON	contains a TUBE
1		15 g In 1 TUBE	This package is contained within the CARTON (60429-901-15)
2	60429-901-30	1 TUBE In 1 CARTON	contains a TUBE
2		30 g In 1 TUBE	This package is contained within the CARTON (60429-901-30)
3	60429-901-45	1 TUBE In 1 CARTON	contains a TUBE
3		45 g In 1 TUBE	This package is contained within the CARTON (60429-901-45)
4	60429-901-60	1 TUBE In 1 CARTON	contains a TUBE
4		60 g In 1 TUBE	This package is contained within the CARTON (60429-901-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074248	07/12/1996

Labeler - Golden State Medical Supply, Inc. (603184490)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (173762329)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE

Revised: 11/2010Golden State Medical Supply, Inc.

More Clobetasol resources

Clobetasol Side Effects (in more detail)
Clobetasol Use in Pregnancy & Breastfeeding
Clobetasol Drug Interactions
Clobetasol Support Group
48 Reviews for Clobetasol - Add your own review/rating

Compare Clobetasol with other medications

Anal Itching
Atopic Dermatitis
Cutaneous T-cell Lymphoma
Dermatitis
Lichen Planus
Lichen Sclerosus
Necrobiosis Lipoidica Diabeticorum
Psoriasis
Seborrheic Dermatitis

Anucort-HC cream, ointment, suppository

Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)

Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. 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.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

congestive heart failure;

a history of tuberculosis;

stomach ulcer or diverticulitis;

a colostomy or ileostomy;

fever or any type of infection;

kidney disease;

high blood pressure; or

myasthenia gravis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use hydrocortisone rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal 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. Call your doctor at once if you have a serious side effect such as:

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

muscle weakness;

rapid weight gain, especially in your face and midsection;

severe rectal pain or burning;

bleeding from your rectum;

severe stomach pain;

sudden and severe headache or pain behind your eyes; or

seizure (convulsions).

Less serious side effects may include:

mild rectal pain or burning;

acne;

changes in your menstrual periods;

increased sweating; or

increased facial or body hair growth.

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.

What other drugs will affect hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

More Anucort-HC resources

Anucort-HC Side Effects (in more detail)
Anucort-HC Use in Pregnancy & Breastfeeding
Anucort-HC Drug Interactions
Anucort-HC Support Group
1 Review for Anucort-HC - Add your own review/rating

Compare Anucort-HC with other medications

Anal Itching
Aphthous Stomatitis, Recurrent
Atopic Dermatitis
Dermatitis
Eczema
Gingivitis
Hemorrhoids
Proctitis
Pruritus
Psoriasis
Seborrheic Dermatitis

Where can I get more information?

Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Anucort-HC side effects (in more detail)

tolazamide

Generic Name: tolazamide (tole AZ a mide)

Brand Names: Tolinase

What is tolazamide?

Tolazamide is an oral diabetes medicine that helps control blood sugar levels. This medication helps your body respond better to insulin produced by your pancreas.

Tolazamide is used together with diet and exercise to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with tolazamide if needed.

Tolazamide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about tolazamide?

Do not use this medication if you are allergic to tolazamide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

Before taking tolazamide, tell your doctor if you have kidney or liver disease, or a history of heart disease.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your tolazamide dose.

Tolazamide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my doctor before taking tolazamide?

You should not use this medication if you are allergic to tolazamide, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure you can safely take tolazamide, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease; or

a history of heart disease.

FDA pregnancy category C. It is not known whether tolazamide will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether tolazamide passes into breast milk or if it could be harmful to a nursing baby. Do not take tolazamide without telling your doctor if you are breast-feeding a baby.

How should I take tolazamide?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Tolazamide is usually taken once a day, with breakfast or the first main meal of the day. Follow your doctor's instructions.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking tolazamide for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your tolazamide dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Use tolazamide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

See also: Tolazamide dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tolazamide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking tolazamide?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Tolazamide 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.

Hypoglycemia, or low blood sugar, is the most common side effect of tolazamide. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Call your doctor at once if you have a serious side effect such as:

chest pain, shortness of breath, feeling like you might pass out;

easy bruising or bleeding, unusual weakness; or

extreme thirst with headache, nausea, vomiting, and weakness.

Less serious side effects may include:

dizziness or weakness;

headache, tired feeling;

mild nausea, heartburn, full feeling;

skin rash, redness, or itching; or

increased skin sensitivity to sunlight.

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.

Tolazamide Dosing Information

Usual Adult Dose for Diabetes Mellitus Type II:

Initial dose: 100 mg to 250 mg orally daily with breakfast
Maintenance dose: 100 mg to 1000 mg orally daily with a meal in 1 or 2 divided doses. Dosage adjustments should be made in increments of 100 mg to 250 mg at weekly intervals based on the patient's blood glucose response.

Usual Geriatric Dose for Diabetes Mellitus Type II:

Initial dose: 100 mg orally daily with breakfast

What other drugs will affect tolazamide?

You may be more likely to have hyperglycemia (high blood sugar) if you take tolazamide with other drugs that can raise blood sugar, such as:

isoniazid;

diuretics (water pills);

steroids (prednisone and others);

heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, and others);

niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

phenothiazines (Compazine and others);

thyroid medicine (Synthroid and others);

birth control pills and other hormones;

seizure medicines (Dilantin and others);

diet pills or medicines to treat asthma, colds or allergies; and

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

You may be more likely to have hypoglycemia (low blood sugar) if you take tolazamide with other drugs that can lower blood sugar, such as:

exenatide (Byetta);

probenecid (Benemid);

some nonsteroidal anti-inflammatory drugs (NSAIDs);

aspirin or other salicylates (including Pepto-Bismol);

a blood thinner (warfarin, Coumadin and others);

heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);

sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);

a monoamine oxidase inhibitor (MAOI); or

other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

These lists are not complete and there are many other medicines that can increase or decrease the effects of tolazamide on lowering your blood sugar. 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.

More tolazamide resources

Tolazamide Side Effects (in more detail)
Tolazamide Dosage
Tolazamide Use in Pregnancy & Breastfeeding
Drug Images
Tolazamide Drug Interactions
Tolazamide Support Group
0 Reviews for Tolazamide - Add your own review/rating

tolazamide Advanced Consumer (Micromedex) - Includes Dosage Information

Tolazamide Prescribing Information (FDA)

Tolazamide Professional Patient Advice (Wolters Kluwer)

Tolazamide Monograph (AHFS DI)

Tolazamide MedFacts Consumer Leaflet (Wolters Kluwer)

Tolinase Prescribing Information (FDA)

Compare tolazamide with other medications

Diabetes, Type 2

Where can I get more information?

Your pharmacist can provide more information about tolazamide.

See also: tolazamide side effects (in more detail)

Sunday, 18 March 2012

Estinyl

Generic Name: conjugated estrogens and medroxyprogesterone (Oral route)

Commonly used brand name(s)

In the U.S.

Activella

Alesse

Angeliq

Estinyl

Hemocyte

Loestrin 1/20

Mircette

Ortho-Novum

Prefest

Premphase

Available Dosage Forms:

Tablet

Tablet, Chewable

Uses For Estinyl

Conjugated estrogens and medroxyprogesterone are estrogen and progestin hormones. Along with other effects, estrogens help females develop sexually at puberty and regulate the menstrual cycle. Progestin lowers the effect of estrogen on the uterus and keeps estrogen-related problems from developing.

Around the time of menopause, the ovaries produce less estrogen. Estrogens are given to:

Relieve the signs of menopause (vasomotor symptoms of menopause), such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Treat inflammation of the vagina (atrophic vaginitis) and of the genital area (atrophy of the vulva) by keeping these areas from becoming too dry, itchy, or painful.

Prevent the loss of bone that begins at the time of menopause. Keeping bones strong decreases the chance of developing weak bones that easily break (osteoporosis). Estrogen use is most effective when it is taken for more than 7 years while you are getting regular exercise and extra calcium. Protection from bone loss can then last for many years after you stop taking the medicine.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are related to the menopausal symptoms, such as hot flashes.

Progestins are not needed if the uterus has been removed by a surgical method called hysterectomy. In that case, it may be better to receive estrogens alone without the progestin.

Conjugated estrogens and medroxyprogesterone are available only with your doctor's prescription.

Before Using Estinyl

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Conjugated estrogens and medroxyprogesterone may increase your chance of having a stroke, memory problems, or breast cancer that spreads to other parts of your body.

Pregnancy

Conjugated estrogens and medroxyprogesterone are not recommended for use during pregnancy. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause. Tell your doctor right away if you suspect you are pregnant.

Breast Feeding

Conjugated estrogens and medroxyprogesterone pass into the breast milk. This medicine is not recommended for use during breast-feeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Boceprevir

Felbamate

Isotretinoin

Paclitaxel

Paclitaxel Protein-Bound

Theophylline

Tizanidine

Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of conjugated estrogens and medroxyprogesterone

This section provides information on the proper use of a number of products that contain conjugated estrogens and medroxyprogesterone. It may not be specific to Estinyl. Please read with care.

Conjugated estrogens and medroxyprogesterone usually come with patient directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer period of time than your doctor ordered. The length of time you take the medicine will depend on the medical problem for which you are taking conjugated estrogens and medroxyprogesterone. Discuss with your doctor how long you will need to take these medicines.

If you are taking the estrogen or progestin hormones in a certain order (i.e., conjugated estrogens tablets followed by conjugated estrogens and medroxyprogesterone tablets), be sure you know in which order you need to take the medicines. If you have questions about this, ask your health care professional.

Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For conjugated estrogens, and conjugated estrogens and medroxyprogesterone

For oral dosage form (tablets):
- To prevent loss of bone (osteoporosis) or for treating itching or dryness of the genital area (atrophy of the vulva), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—One tablet (containing 0.625 mg conjugated estrogens) once a day on Days 1 through 14; then, one tablet (containing 0.625 mg conjugated estrogens and 5 mg medroxyprogesterone) once a day on Days 15 through 28. Repeat cycle.

For conjugated estrogens and medroxyprogesterone

For oral dosage form (tablets):
- To prevent loss of bone (osteoporosis) or for treating itching or dryness of the genital area (atrophy of the vulva), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—One tablet (containing 0.3 mg conjugated estrogens and 1.5 mg medroxyprogesterone) once a day for twenty-eight days. Repeat cycle. If vaginal bleeding or spotting continues and it is undesired, your doctor may increase your dose to the next highest strength tablet (0.45 mg conjugated estrogens and 1.5 mg medroxyprogesterone). It should be taken once a day for twenty-eight days. Repeat cycle.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Estinyl

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. Plan on going to see your doctor every year, but some doctors require visits more often.

Although the risk for developing breast problems or breast cancer is low, it is still important that you regularly check your breasts for any unusual lumps or discharge, and report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) and breast examination done by your doctor whenever your doctor recommends it.

If your menstrual periods have stopped, they may start again once you begin taking this medicine. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are taking this medicine before having any laboratory test, because some test results may be affected.

You may need to stop taking this medicine before having some kinds of surgery or while your doctor has ordered a long period of bedrest. Talk with your doctor about this.

Estinyl Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Healthy women rarely have severe side effects from taking conjugated estrogens or medroxyprogesterone to replace estrogen.

Check with your doctor immediately if any of the following side effects occur:

More common

Itching of the vagina or genital area

menstrual periods beginning again, including changing menstrual bleeding pattern for up to 6 months (spotting, breakthrough bleeding, prolonged or heavier vaginal bleeding, or vaginal bleeding completely stopping by 10 months)

pain during sexual intercourse

thick, white vaginal discharge

Less common

Blurred vision

breast lumps

chest pain

discharge from breast

dizziness

feeling faint, dizzy, or light-headed

feeling of warmth or heat

flushing or redness of skin, especially on face and neck

headache

heavy nonmenstrual vaginal bleeding

pounding in the ears

severe cramping of the uterus

slow or fast heartbeat

sweating

Rare

Change in vaginal discharge

pain or feeling of pressure in pelvis

pain or tenderness in stomach, side, or abdomen

yellow eyes or skin

Incidence not known

Abdominal bloating

acid or sour stomach

belching

backache

full or bloated feeling or pressure in the stomach

heartburn

indigestion

loss of appetite

pelvic pain

stomach discomfort, upset or pain

stomach pain

swelling of abdominal or stomach are

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal cramps

back pain

body aches or pain

breast pain or tenderness

congestion

chills

cough

crying

depersonalization

diarrhea

dryness or soreness of throat

dysphoria

enlarged breasts

euphoria

feeling faint, dizzy, or light-headedness

feeling of warmth or heat

fever

flushing or redness of skin, especially on face and neck

general feeling of discomfort or illness

headache, severe and throbbing

hoarseness

increase in amount of clear vaginal discharge

itching

joint pain

lack or loss of strength

mental depression

muscle aches and pains

nausea

pain

pain or tenderness around eyes and cheekbones

painful menstrual periods

painful or difficult urination

paranoia

passing of gas

quick to react or overreact emotionally

rapidly changing moods

runny nose

shivering

shortness of breath or troubled breathing

sneezing

sore throat

stuffy nose

stomach discomfort following meals

tender, swollen glands in neck

tightness of chest or wheezing

trouble sleeping

trouble in swallowing

unusual tiredness

voice changes

vomiting

Less common

Acne

bloating or swelling of face, ankles, or feet

cervix disorder

crying

depersonalization

dysphoria

euphoria

increase in sexual desire

leg cramps

mental depression

paranoia

quick to react or overreact emotionally

rapidly changing moods

sleeplessness

tense muscles

trouble sleeping

unable to sleep

unusual weight gain or loss

Incidence not known

Abdominal cramping

bloody or cloudy urine

bloody vaginal discharge

difficult, burning, or painful urination

frequent urge to urinate

light vaginal bleeding between periods and after intercourse

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Estinyl side effects (in more detail)

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More Estinyl resources

Estinyl Side Effects (in more detail)
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Estinyl Drug Interactions
Estinyl Support Group
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