Iohist DM

Generic Name: brompheniramine/dextromethorphan/phenylpropanolamine (brome fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)

Brand Names: Delhistine DM, Dimetapp Cold and Cough Liquigel, Dimetapp DM, DM Cold and Cough, Histinex DM, Iohist DM, Liquihistine DM, Poly DM, Poly Histine DM, Prohistine DM, Trihist DM

What is Iohist DM (brompheniramine/dextromethorphan/phenylpropanolamine)?

Brompheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body. Brompheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow, allowing nasal passages to open up.

Brompheniramine/dextromethorphan/phenylpropanolamine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), and coughs associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Brompheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Iohist DM (brompheniramine/dextromethorphan/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Brompheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking brompheniramine/dextromethorphan/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Iohist DM (brompheniramine/dextromethorphan/phenylpropanolamine)?

Do not take brompheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or have an enlarged prostate.

  
  

You may not be able to take brompheniramine/dextromethorphan/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether brompheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Brompheniramine/dextromethorphan/phenylpropanolamine passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from brompheniramine/dextromethorphan/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Iohist DM (brompheniramine/dextromethorphan/phenylpropanolamine)?

Take brompheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

To ensure that you get a correct dose, measure the liquid forms of brompheniramine/dextromethorphan/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take brompheniramine/dextromethorphan/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store brompheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a brompheniramine/dextromethorphan/phenylpropanolamine overdose include dry mouth, large pupils, flushing, nausea, vomiting, hyperactivity, or hallucinations.

What should I avoid while taking Iohist DM (brompheniramine/dextromethorphan/phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Brompheniramine/dextromethorphan/phenylpropanolamine may cause dizziness. If you experience dizziness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking brompheniramine/dextromethorphan/phenylpropanolamine.

Brompheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Iohist DM (brompheniramine/dextromethorphan/phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking brompheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take brompheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Iohist DM (brompheniramine/dextromethorphan/phenylpropanolamine)?

Do not take brompheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking brompheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain brompheniramine, dextromethorphan, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Brompheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with brompheniramine/dextromethorphan/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Iohist DM resources

• Iohist DM Drug Interactions
• Iohist DM Support Group
• 0 Reviews for Iohist DM - Add your own review/rating

Compare Iohist DM with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist has additional information about brompheniramine/ dextromethorphan/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Brompheniramine/dextromethorphan/phenylpropanolamine is available over the counter and with a prescription in many different formulations. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Acid Controller Original Strength

famotidine

Dosage Form: tablet
Walgreen Co. Acid Controller Drug Facts

Active ingredient (in each tablet)

Famotidine 10 mg

Purpose

Acid reducer

Uses

• relieves heartburn associated with acid indigestion and sour stomach


• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.


• with other acid reducers

Ask a doctor before use if you have

• had heartburn over 3 months. This may be a sign of a more serious condition.


• heartburn with lightheadedness, sweating, or dizziness


• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness


• frequent chest pain


• frequent wheezing, particularly with heartburn


• unexplained weight loss


• nausea or vomiting


• stomach pain

Stop use and ask a doctor if

• your heartburn continues or worsens


• you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years and over:


• to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.


• to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn


• do not use more than 2 tablets in 24 hours


• children under 12 years: ask a doctor

Other information

• read the directions and warnings before use


• keep the carton. It contains important information.


• store at 20°-25°C (68°-77°F)


• protect from moisture and light

Inactive ingredients

carnauba wax, hypromellose, iron oxides, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Original Strength Pepcid® AC active ingredient

Original Strength

Acid Controller

Famotidine Tablets, 10 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Actual Size

Tablets

Acid Controller Carton

ACID CONTROLLER  ORIGINAL STRENGTH famotidine  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0363-0141 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code L141 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0363-0141-65 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0363-0141-65) 2 0363-0141-75 1 BOTTLE In 1 CARTON contains a BOTTLE 2 90 TABLET In 1 BOTTLE This package is contained within the CARTON (0363-0141-75)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075400	08/28/2009

Labeler - Walgreen Company (008965063)

Revised: 06/2009Walgreen Company

More Acid Controller Original Strength resources

• Acid Controller Original Strength Side Effects (in more detail)
• Acid Controller Original Strength Dosage
• Acid Controller Original Strength Use in Pregnancy & Breastfeeding
• Acid Controller Original Strength Drug Interactions
• 0 Reviews for Acid Controller Original Strength - Add your own review/rating

Compare Acid Controller Original Strength with other medications

• Allergic Urticaria
• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• GERD
• Indigestion
• Pathological Hypersecretory Conditions
• Peptic Ulcer
• Stomach Ulcer
• Upper GI Hemorrhage
• Urticaria
• Zollinger-Ellison Syndrome

Imuvac 2009 / 2010

imuvac

Imuvac 2009/2010, suspension for injection in prefilled syringe

Influenza vaccine (surface antigen, inactivated)

Read all of this leaflet carefully before you or your child is vaccinated.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This vaccine has been prescribed for you or your child. Do not pass it on to others.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1 WHAT IMUVAC IS AND WHAT IT IS USED FOR


• 2 BEFORE YOU OR YOUR CHILD USE IMUVAC


• 3 HOW TO USE IMUVAC


• 4 POSSIBLE SIDE EFFECTS


• 5 HOW TO STORE IMUVAC


• 6 FURTHER INFORMATION

What Imuvac Is And What It Is Used For

Imuvac is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in subjects who run a high risk of associated complications. The use of Imuvac should be based on official recommendations.

When a person is given the vaccine Imuvac, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.

Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why you might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child was not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or your child runs the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.

Imuvac will protect you or your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection.

The incubation period for flu is a few days, so if you are exposed to flu immediately before or after your vaccination, you could still develop the illness.

The vaccine will not protect you against the common cold, even though some of the symptoms are similar to flu.

Before You Or Your Child Use Imuvac

To make sure that Imuvac is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.

Do not use Imuvac

• If you or your child is allergic (hypersensitive) to the active substances, to any of the ingredients of Imuvac, to eggs, to chicken proteins, to gentamicin (an antibiotic that is used to treat bacterial infections), to formaldehyde, to cetryltrimethylammoniumbromide or to polysorbate 80 (For other ingredients of Imuvac, see section 6 “Further information”).


• If you or your child has an illness with a high temperature or acute infection, the vaccination shall be postponed until after you or your child has recovered.

Take special care with Imuvac

You should tell your doctor before vaccination if you or your child has a poor immune response (immunodeficiency or taking medicines affecting the immune system).

Your doctor will decide if you or your child should receive the vaccine.

If, for any reason, you or your child has a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.

As with all vaccines, Imuvac may not fully protect all persons who are vaccinated.

Using other medicines

• Please tell your doctor or pharmacist if you or your child is taking or has recently taken other vaccines or any other medicines, including medicines obtained without a prescription.


• Imuvac can be given at the same time as other vaccines by using separate limbs. It should be noted that the side effects may be stronger.


• The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.

Pregnancy and breast-feeding

Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.

Limited data from flu vaccinations in pregnant women do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

Imuvac may be used during breast-feeding.

Your doctor/pharmacist will be able to decide if you should receive Imuvac.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The vaccine is unlikely to affect your ability to drive or use machines.

How To Use Imuvac

Dosage

Adults and children aged from 36 months receive one 0.5 ml dose.

Children from 6 months to 35 months may receive one 0.25 ml dose or one 0.5 ml dose.

If your child has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.

Method and/or route(s) of administration

Your doctor will administer the recommended dose of the vaccine as an injection into the muscle or deep under the skin.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Imuvac 2009/2010 Side Effects

Like all medicines, Imuvac can cause side effects, although not everybody gets them.

During clinical trials, the following side effects have been observed. Their frequencies have been estimated as Common: affects 1 to 10 users in 100.

• headache


• sweating


• muscular pain (myalgia), joint pain (arthralgia)


• fever, generally feeling unwell (malaise), shivering, fatigue


• local reactions: redness, swelling, pain, bruising (ecchymosis), hardness (induration) around the area where the vaccine is injected.

These reactions usually disappear within 1-2 days without treatment.

Next to the above common side effects, the following side effects occurred after the vaccine came on the market:

• allergic reactions:
  
  
  • leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock) in rare cases
  • swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases


• skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash


• blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in temporary kidney problems


• pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions) associated with fever, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrom)


• temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Imuvac

Keep out of the reach and sight of children.

Do not use Imuvac after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store Imuvac in a refrigerator (+ 2 °C to + 8 °C). Do not freeze.

Store the product in the original package in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

The active substances are haemagglutinin and neuraminidase antigens of three different Influenza viruses

A/Brisbane/59/2007 (H1N1)-like strain (A/Brisbane/59/2007 IVR-148 reass.) 15 micrograms HA**

A/Brisbane/10/2007 (H3N2)-like strain (A/Uruguay/716/2007 NYMC X-175C reass.) 15 micrograms HA**

B/Brisbane/60/2008-like strain (B/Brisbane/60/2008) 15 micrograms HA**

Per 0.5 ml dose

* propagated in fertilised hens’eggs from healthy chicken flocks

** haemagglutinin

This vaccine complies with the WHO (World Health Organisation) recommendations (Northern hemisphere) and EU decision for the 2009/2010 season.

The other ingredients are potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride, magnesium chloride hexahydrate and water for injections.

What Imuvac looks like and contents of the pack

Imuvac is a suspension for injection presented in prefilled glass syringe (with / without needle) containing 0.5 ml of a colourless clear injection fluid. Each syringe can only be used once.

Pack size of 1 or 10.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Solvay Healthcare Limited

Southampton

SO18 3JD

UK

Manufacturer:

Solvay Biologicals B.V.

Veerweg 12

NL - 8121 AA Olst

Registration number: PL 00512/0188

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Fluvaccinol Subunit Impfstoff Injektionssuspension

Bulgaria, Netherlands: Vacciflu 2009/2010

Germany: Grippe-Impfstoff STADAN 2009/2010

Belgium, Spain: Serinflu

United Kingdom: Imuvac 2009/2010

This leaflet was last amended in: September 2009

For information in large print, tape, CD or Braille, phone 02380 467000.

Liquid Paraffin BP

1. Name Of The Medicinal Product

Liquid Paraffin BP.

2. Qualitative And Quantitative Composition

Liquid Paraffin BP 100% v/v.

3. Pharmaceutical Form

Liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of constipation.

4.2 Posology And Method Of Administration

Oral

Recommended doses and dosage schedules:

Adults including the elderly:	10-30ml when required.
Children over 3 years:	5-20ml when required.
Children under 3 years:	not recommended.

4.3 Contraindications

Use is contraindicated in children under 3 years of age.

4.4 Special Warnings And Precautions For Use

Avoid prolonged use.

Consult your doctor if laxatives are needed every day, if you have persistent abdominal pain or have a condition which makes swallowing difficult.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There may be interference with the absorption of fat soluble vitamins.

4.6 Pregnancy And Lactation

As with all medicines avoid during early pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Anal seepage of paraffin with consequent anal irritation after prolonged use.

Granulomatous reaction caused by absorption of small quantities of liquid paraffin.

Lipoid pneumonia (by accidental inhalation) may occur, therefore caution is required in patients with swallowing difficulty.

4.9 Overdose

If large doses are ingested withdraw medication. Supportive treatment may be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Liquid paraffin acts as a lubricant and penetrates and softens the stools.

5.2 Pharmacokinetic Properties

Liquid paraffin is indigestible and is absorbed only to a limited extent following ingestion.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

None.

6.3 Shelf Life

100ml: 36 months unopened.

150ml: 36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C. Protect from light.

6.5 Nature And Contents Of Container

100ml: Amber glass bottle with plastic cap.

150ml: Amber glass bottle with plastic cap.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L. C. M. Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing Authorisation Number(S)

PL 12965/0022

9. Date Of First Authorisation/Renewal Of The Authorisation

20.08.93 / 22.10.98

10. Date Of Revision Of The Text

May 1998

11 DOSIMETRY

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable

Toviaz

Generic Name: Fesoterodine Fumarate
Class: Genitourinary Smooth Muscle Relaxants
ATC Class: G04BD11
VA Class: AU350
Chemical Name: isobutyric acid 2-((R)-3diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate
Molecular Formula: C₂₆H₃₇NO₃
CAS Number: 286930-03-8

Introduction

Genitourinary antispasmodic; an antimuscarinic agent.^{1 2 3 4 6}

Uses for Toviaz

Overactive Bladder

Relief of symptoms associated with voiding (e.g., urge urinary incontinence, urgency, frequency).^{1 2 3 4 6 11}

Toviaz Dosage and Administration

Administration

Oral Administration

Administer orally once daily with liquids without regard to meals.^{1 5}

Swallow extended-release tablets whole; do not chew, divide, or crush.^{1 5}

Dosage

Available as fesoterodine fumarate; dosage expressed in terms of the salt.¹

Adults

Overactive Bladder

Oral

Initially, 4 mg once daily.¹ Depending on individual response and tolerability, may increase to 8 mg once daily.¹

Prescribing Limits

Adults

Overactive Bladder

Oral

Maximum 8 mg daily.¹

Special Populations

Hepatic Impairment

Manufacturer does not recommend dosage adjustments for patient with mild or moderate hepatic impairment.¹ Some clinicians recommend caution when increasing dosage from 4 mg to 8 mg daily in patients with mild hepatic impairment (Child-Pugh class A) and a maximum dosage of 4 mg daily in patients with moderate hepatic impairment (Child-Pugh class B).^{2 10} (See Absorption: Special Populations, under Pharmacokinetics.)

Use not recommended in patients with severe hepatic impairment (Child-Pugh class C).^{1 10}

Renal Impairment

Manufacturer does not recommend dosage adjustments for patient with mild or moderate renal impairment (Cl_cr 30–80 mL/minute); some clinicians recommend caution when increasing dosage from 4 mg to 8 mg daily in such patients.^{1 2 10} (See Absorption: Special Populations, under Pharmacokinetics.)

In patients with severe renal impairment (Cl_cr <30 mL/minute), maximum dosage 4 mg daily.^{1 10}

Geriatric Patients

No dosage adjustment required.¹

Cautions for Toviaz

Contraindications

• 
  

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

  
  


• 
  

  Known hypersensitivity to fesoterodine fumarate or any ingredient in the formulation.¹

  
  

Warnings/Precautions

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 motility (e.g., patients with severe constipation).¹

Controlled Angle-closure Glaucoma

Use with caution in patients being treated for angle-closure glaucoma and only when potential benefits outweigh risks.¹ (See Cautions: Contraindications.)

Myasthenia Gravis

Use with caution in patients with myasthenia gravis.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether fesoterodine is distributed into milk in humans; do not use unless benefit to woman outweighs potential risk to the infant.¹

Pediatric Use

Safety and efficacy not established in pediatric patients.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Incidence of adverse antimuscarinic events (e.g., dry mouth, constipation, dyspepsia, increase in residual urine, dizziness [only at a dosage of 8 mg daily]) and urinary tract infection was higher in patients ≥75 years of age compared with younger patients.¹

Hepatic Impairment

Not studied in patients with severe hepatic impairment (Child-Pugh class C); use not recommended in these patients.¹ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Dosage adjustment recommended in patients with severe renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Dry mouth, constipation.^{1 9}

Interactions for Toviaz

Rapidly metabolized to active metabolite, 5-hydroxymethyl tolterodine (5-HMT), by nonspecific esterases; active metabolite is further metabolized, principally via CYP2D6 and CYP3A4.^{1 2 10} 5-HMT does not inhibit CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4 and does not induce CYP isoenzymes 1A2, 2B6, 2C9, 2C19, or 3A4.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potent inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma 5-HMT concentrations).¹ Do not exceed 4 mg daily when used concomitantly with potent CYP3A4 inhibitors.¹

Weak or moderate inhibitors of CYP3A4: Effects on 5-HMT pharmacokinetics not studied; pharmacokinetic interaction is expected, albeit less than that observed with potent CYP3A4 inhibitors.¹ Carefully assess tolerability at 4-mg daily dosage of fesoterodine fumarate prior to increasing dosage to 8 mg daily in patients concomitantly receiving weak or moderate CYP3A4 inhibitors.¹

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma 5-HMT concentrations); no dosage adjustments are recommended.¹

Inhibitors of CYP2D6: Effects on 5-HMT pharmacokinetics not tested clinically.¹ However, increased plasma 5-HMT concentrations observed in subjects with poor metabolizer phenotype for CYP2D6; no dosage adjustments recommended when CYP2D6 inhibitors are used concomitantly.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP1isoenzymeA2 s, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4: Pharmacokinetic interactions unlikely.¹

Orally Administered Drugs

Potential pharmacokinetic interaction (altered absorption because of anticholinergic effects on GI motility).¹ (See Decreased GI Motility under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Antimuscarinic agents	Potential increased frequency and/or severity of adverse anticholinergic effects (e.g., dry mouth, constipation, urinary retention) 1
Azole antifungals (itraconazole, ketoconazole)	Possible increased plasma 5-HMT concentrations1 Ketoconazole: Increased plasma 5-HMT concentrations1	Do not exceed a fesoterodine fumarate dosage of 4 mg daily when used concomitantly1
Clarithromycin	Possible increased plasma 5-HMT concentrations1	Do not exceed a fesoterodine fumarate dosage of 4 mg daily when used concomitantly1
Hormonal contraceptives, oral (ethinyl estradiol-levonorgestrel)	Pharmacokinetic interaction unlikely1
Erythromycin	Effects on 5-HMT pharmacokinetics not studied; pharmacokinetic interaction is expected1	Carefully assess tolerability at fesoterodine fumarate 4-mg daily dosage prior to increasing dosage to 8 mg daily1
Rifampin	Decreased plasma 5-HMT concentrations and AUC1	No fesoterodine fumarate dosage adjustments recommended1

Toviaz Pharmacokinetics

Absorption

Bioavailability

Following oral administration of fesoterodine, peak plasma concentrations of active metabolite, 5-hydroxymethyl tolterodine (5-HMT), are achieved in approximately 5 hours; because of rapid metabolism, fesoterodine itself is not detected in plasma.¹

Bioavailability of 5-HMT is 52%.¹

Onset

Symptomatic improvement (i.e., reduction in number of urge incontinence episodes) observed as early as 2 weeks after starting fesoterodine therapy.¹

Food

Food has no clinically important effect on fesoterodine pharmacokinetics.¹

Special Populations

In individuals with poor metabolizer phenotypes of CYP2D6 (approximately 7% of Caucasians and 2% of African Americans), peak plasma concentrations of 5-HMT increased by 1.7-fold and AUC increased twofold as compared with extensive metabolizers.¹

In patients with mild or moderate renal insufficiency (Cl_cr 30–80 mL/minute), peak plasma concentrations and AUC of 5-HMT were increased up to 1.5- and 1.8-fold, respectively, as compared with those in healthy subjects.¹ In patients with severe renal impairment (Cl_cr <30 mL/minute), peak plasma concentrations and AUC of 5-HMT were increased twofold and 2.3-fold, respectively.¹ (See Renal Impairment under Dosage and Administration.)

In patients with moderate (Child-Pugh class B) hepatic impairment, peak plasma concentrations and AUC of 5-HMT were increased 1.4 and 2.1-fold, respectively, as compared with those in healthy subjects.¹ Subjects with severe hepatic impairment (Child-Pugh class C) have not been studied.¹ (See Hepatic Impairment under Dosage and Administration.)

Distribution

Extent

Not known whether distributed into human milk.¹

Plasma Protein Binding

5-HMT: Approximately 50%, principally to albumin and α₁-acid glycoprotein.¹

Elimination

Metabolism

Fesoterodine is a prodrug: rapidly and extensively hydrolyzed by nonspecific esterases to 5-HMT, which is responsible for the antimuscarinic effects of fesoterodine.^{1 2 6 10} Tolterodine, another antimuscarinic agent used in the treatment of overactive bladder, also is metabolized to 5-HMT; however, tolterodine metabolism to 5-HMT is via CYP2D6.^{1 2 10}

5-HMT is further metabolized to various metabolites in the liver, principally via CYP2D6 and CYP3A4.^{1 2 6 10} None of these metabolites contribute substantially to the antimuscarinic activity of fesoterodine.^{1 10}

Elimination Route

Recovered in urine (70%) and feces (7%) as various active and inactive metabolites.^{1 6}

Half-life

Terminal half-life of 5-HMT following oral administration of fesoterodine fumarate is approximately 7 hours.^{1 2 10}

Special Populations

Pharmacokinetics not substantially affected by gender or age; pharmacokinetics not studied in pediatric patients.¹

Available data indicate no differences in pharmacokinetics between Caucasian and black subjects.¹

Stability

Storage

Oral

Tablets

20–25°C (may be exposed to 15–30°C).¹ Protect from moisture.¹

ActionsActions

• 
  

  Fesoterodine is a competitive antimuscarinic agent.¹

  
  


• 
  

  Fesoterodine is a prodrug: rapidly and extensively hydrolyzed to 5-hydroxymethyl tolterodine (5-HMT), which is responsible for the antimuscarinic effects of fesoterodine.^{1 2 6 10}

  
  


• 
  

  Fesoterodine and 5-HMT inhibit contraction of the urinary bladder smooth muscle.^{1 6}

  
  


• 
  

  In urodynamic study, fesoterodine administration increased volume at first detrusor contraction and bladder capacity in dose-dependent manner.¹

  
  

Advice to Patients

• 
  

  Importance of reading manufacturer's patient information before beginning fesoterodine therapy.^{1 5}

  
  


• 
  

  Risk of dry mouth, constipation, dry eyes, urinary retention, decreased sweating and heat prostration (when used in a hot environment).^{1 5}

  
  


• 
  

  May cause blurred vision and drowsiness.^{1 5} Use caution when driving or performing dangerous activities until effects are known.⁵ Alcohol may enhance the drowsiness caused by fesoterodine.^{1 5}

  
  


• 
  

  Importance of taking fesoterodine with liquids and swallowing the extended-release tablet whole; do not chew, divide, or crush.^{1 5}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 5}

  
  


• 
  

  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 5}

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Fesoterodine Fumarate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, extended-release	4 mg	Toviaz	Pfizer
		8 mg	Toviaz	Pfizer

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 February 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Pfizer. Toviaz (fesoterodine fumarate) extended-release tablets prescribing information. NY, NY; 2008 Nov.

2. Michel MC. Fesoterodine: a novel muscarinic receptor antagonist for the treatment of overactive bladder syndrome. Expert Opin Pharmacother. 2008; 9:1787-96. [PubMed 18570610]

3. Nitti VW, Dmochowski R, Sand PK et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol. 2007; 178:2488-94. [PubMed 17937959]

4. Chapple C, Van Kerrebroeck P, Tubaro A et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007; 52:1204-12. [PubMed 17651893]

5. Pfizer. Toviaz (fesoterodine fumarate) extended-release tablets patient information. NY, NY; 2008 Nov.

6. McKeage K, Keating GM. Fesoterodine. Drugs. 2009; 69:731-8. [PubMed 19405552]

7. Kelleher CJ, Tubaro A, Wang JT et al. Impact of fesoterodine on quality of life: pooled data from two randomized trials. BJU Int. 2008; 102:56-61. [PubMed 18564231]

8. Chapple C, Van Kerrebroeck P, Tubaro A et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007; 52:1204-12. [PubMed 17651893]

9. Khullar V, Rovner ES, Dmochowski R et al. Fesoterodine dose response in subjects with overactive bladder syndrome. Urology. 2008; 71:839-43. [PubMed 18342923]

10. Witte LP, Mulder WM, de la Rosette JJ et al. Muscarinic receptor antagonists for overactive bladder treatment: does one fit all?. Curr Opin Urol. 2009; 19:13-9. [PubMed 19057211]

11. Chapple CR, Khullar V, Gabriel Z et al. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol. 2008; 54:543-62. [PubMed 18599186]

More Toviaz resources

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

• Toviaz Prescribing Information (FDA)


• Toviaz Advanced Consumer (Micromedex) - Includes Dosage Information


• Toviaz MedFacts Consumer Leaflet (Wolters Kluwer)


• Toviaz Consumer Overview

Compare Toviaz with other medications

• Overactive Bladder
• Urinary Incontinence

Nutritional products

Nutritional products include products, which either supplement the nutrition or provide part or all of the daily nutritional requirements. They include intravenous or oral nutrition that can provide all the nutrition. Nutritional products also include supplements for example, iron and other vitamins, minerals and electrolytes.

See also

• intravenous nutritional products
• iron products
• minerals and electrolytes
• oral nutritional supplements
• vitamin and mineral combinations
• vitamins

Drug List:

Prempro

Pronunciation: KON-joo-GAY-ted ES-troe-jenz/me-DROX-ee-proe-JES-ter-one
Generic Name: Conjugated Estrogens/Medroxyprogesterone
Brand Name: Examples include Premphase and Prempro

Do not use Prempro to prevent heart disease, heart attacks, strokes, or dementia. Prempro may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots in the lung or leg, or breast cancer. Talk with your doctor regularly about whether you still need treatment with Prempro.

Prempro is used for:

Treating menopausal symptoms (eg, hot flashes, vaginal dryness). If you are only being treated for vaginal menopause symptoms, products applied locally, such as vaginal creams, tablets, or rings, should be considered before products taken by mouth or absorbed through the skin. Prempro is also used to prevent bone loss (osteoporosis) in women at high risk.

Prempro is a combination of estrogen and progestin hormones. It works by replacing these hormones in the body when the body does not make enough on its own.

Do NOT use Prempro if:

• you are allergic to any ingredient in Prempro


• you are pregnant or think you may be pregnant


• you have abnormal vaginal bleeding, an estrogen-dependent tumor, a history of blood clots, circulation problems, active/recent stroke or heart attack, or liver disease


• you have or have had breast, uterine, ovarian, or vaginal cancer; or have had a hysterectomy (removal of the uterus)

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

Before using Prempro:

Some medical conditions may interact with Prempro. 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 family history of breast cancer or have had an abnormal breast mammogram or x-ray, a noncancerous lump on the breast, or bone cancer


• if you have asthma, diabetes, seizures, dementia, migraine headaches, heart disease (eg, high blood pressure, heart attacks, heart failure), kidney disease, an underactive thyroid, lupus, pancreatitis, or abnormal calcium levels in the blood


• if you have depression, uterus problems (eg, uterine fibroids, endometriosis), cholesterol or lipid problems, gallbladder disease, excessive weight gain, or a blood disorder (eg, porphyria), or if you are significantly overweight


• if you have had high blood pressure during pregnancy or yellowing of the skin or eyes during pregnancy or with past estrogen use


• if you are scheduled for surgery or will be on bed rest


• if you smoke cigarettes or use tobacco

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

• Aminogluthethimide, hydantoins (eg, phenytoin), or rifampin because they may decrease Prempro's effectiveness


• Anticoagulants (eg, warfarin) because their effectiveness may be decreased or their risk of side effects may be increased by Prempro


• Corticosteroids (eg, prednisone) or succinylcholine because the risk of their side effects may be increased by Prempro

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prempro 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 Prempro:

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

• An extra patient leaflet is available with Prempro. Talk to your pharmacist if you have questions about this information.


• Take Prempro by mouth with food or right after a meal to prevent stomach upset.


• Prempro works best if it is taken at the same time each day.


• Continue to take Prempro even if you feel well. Do not miss any doses.


• If you miss a dose of Prempro, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prempro.

Important safety information:

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


• Prempro may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker. If patches develop, consult your doctor about the use of sunscreen or protective clothing when your skin is exposed to the sun, sunlamps, or tanning booths.


• Prempro may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years of age).


• You should talk to your doctor about instructions for examining your own breasts, and report any lumps to your doctor immediately.


• Before you have surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), talk to your doctor about your use of Prempro.


• Tell your doctor or dentist that you take Prempro before you receive any medical or dental care, emergency care, or surgery.


• Prempro may interfere with certain lab tests. Be sure your doctors and lab personnel know that you are using Prempro.


• Diabetes patients - Prempro may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including blood pressure monitoring and Pap smears, may be performed while you use Prempro. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Prempro with caution in the ELDERLY; they may be more sensitive to its effects.


• Prempro should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Prempro if you are pregnant. If you think you may be pregnant, contact your doctor right away. Prempro is found in breast milk. Do not breast-feed while using Prempro.

Possible side effects of Prempro:

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:

Abnormal hair growth; bloating; breast tenderness or pain; changes in sleep patterns; darkening of the skin; dizziness; fatigue; hair loss; headache; irritability; increased or decreased sex drive; lightheadedness; nausea; stomach cramps; stomach upset; weight changes.

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, or tongue); breast lumps; calf pain or swelling; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); chest pain; faintness; leg pain; mental or mood changes (eg, severe depression, memory loss); one-sided weakness; shortness of breath; slurred speech; sudden severe headache; swelling of hands or feet; unusual vaginal discharge, itching, or odor; vision changes; vomiting; yellowing of the skin or eyes.

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: Prempro 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 excessive vaginal bleeding; severe nausea and vomiting.

Proper storage of Prempro:

Store Prempro at room temperature, between 68 and 77 degrees F (20 and 20 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prempro out of the reach of children and away from pets.

General information:

• If you have any questions about Prempro, please talk with your doctor, pharmacist, or other health care provider.


• Prempro 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 Prempro. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Prempro resources

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

• Prempro Advanced Consumer (Micromedex) - Includes Dosage Information


• Prempro Consumer Overview

Compare Prempro with other medications

• Atrophic Urethritis
• Atrophic Vaginitis
• Oophorectomy
• Osteoporosis
• Postmenopausal Symptoms
• Primary Ovarian Failure

Catapres-TTS-2 transdermal

Generic Name: clonidine (transdermal) (KLOE ni deen)

Brand Names: Catapres-TTS-1, Catapres-TTS-2, Catapres-TTS-3

What is Catapres-TTS-2 (clonidine (transdermal))?

Clonidine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels to relax and your heart to beat more slowly and easily.

Clonidine transdermal is used to treat hypertension (high blood pressure). It is sometimes used together with other blood pressure medications.

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

What is the most important information I should know about Catapres-TTS-2 (clonidine (transdermal))?

Before using clonidine transdermal, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, a history of heart attack or stroke, or kidney disease. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.

Clonidine skin patches come with optional "cover" patches. The cover patch is placed over the clonidine patch to help it stick to your skin. The cover patch does not contain any active medicine. It should be worn only over a clonidine patch.

Clonidine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms.

The clonidine transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the clonidine patch before undergoing such a test.

Tell any doctor or other healthcare provider who treats you that you are using clonidine transdermal. If you need emergency heart resuscitation, your family or caregivers should tell emergency medical personnel if you are wearing a clonidine skin patch. The patch should be removed before any electrical equipment (such as a defribrillator) is used on you.

Do not stop using clonidine transdermal suddenly, or you could have unpleasant or life-threatening withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using clonidine transdermal.

What should I discuss with my healthcare provider before using Catapres-TTS-2 (clonidine (transdermal))?

You should not use this medication if you are allergic to clonidine.

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

• 
  

  heart disease or severe coronary artery disease;

  
  


• 
  

  a heart rhythm disorder;

  
  


• 
  

  a history of heart attack or stroke;

  
  


• kidney disease; or


• 
  

  if you have ever had an allergic reaction to clonidine transdermal.

  
  

FDA pregnancy category C. It is not known whether clonidine transdermal is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Clonidine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Catapres-TTS-2 (clonidine (transdermal))?

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.

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.

Before applying a skin patch, wash your hands with soap and water and dry them thoroughly. Also wash and dry the skin area where you plan to apply the patch. Rinse and wipe dry with a clean tissue.

Apply the skin patch to a flat, hairless area of the chest, back, side, or outer side of your upper arm. To remove any hair from these areas, clip the hair short but do not shave it. Press the patch firmly with the palm making sure it sticks firmly, especially around the edges.

You will wear the patch for 7 days and then remove it and put on a new one. Apply the new patch to a different skin area on your arm or torso. Do not apply patches to the same skin area 2 weeks in a row. Do not wear more than 1 patch at a time unless your doctor has told you to.

Clonidine skin patches come with optional "cover" patches. The cover patch is placed over the clonidine patch to help it stick to your skin. The clonidine patch is square and the cover patch is round. The cover patch does not contain any active medicine. It should be worn only over a clonidine patch.

You may use a cover patch if the clonidine patch becomes loose or falls off before you have worn it for 7 days. Apply the cover patch over the clonidine patch. Keep both patches on for the rest of your 7-day wearing time.

After removing a skin patch fold it in half, sticky side in, and throw it away where children and pets cannot get to it.

The clonidine transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the clonidine patch before undergoing such a test.

Tell any doctor or other healthcare provider who treats you that you are using clonidine transdermal. If you need emergency heart resuscitation, your family or caregivers should tell emergency medical personnel if you are wearing a clonidine skin patch. The patch should be removed before any electrical equipment (such as a defribrillator) is used on you.

Do not stop using clonidine transdermal suddenly, or you could have unpleasant or life-threatening withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using clonidine transdermal.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat. Keep each skin patch in the foil pouch until you are ready to use it.

What happens if I miss a dose?

Apply a skin patch as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra patches 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.

Overdose symptoms may include high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath) followed by low blood pressure (feeling light-headed, fainting), drowsiness, cold feeling, slow heart rate, shallow breathing, weakness, fainting, or pinpoint pupils.

What should I avoid while using Catapres-TTS-2 (clonidine (transdermal))?

Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.

Drinking alcohol can increase certain side effects of clonidine transdermal. Clonidine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Catapres-TTS-2 (clonidine (transdermal)) 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:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  a very slow heart rate (fewer than 60 beats per minute);

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  fever, pale skin;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  numbness or cold feeling in your hands or feet;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  severe skin irritation, redness, swelling, burning, or blistering where the patch is worn.

  
  

Less serious side effects may include:

• 
  

  feeling dizzy, drowsy, tired, or nervous;

  
  


• 
  

  dry mouth;

  
  


• 
  

  dry or burning eyes, blurred vision;

  
  


• 
  

  headache, muscle or joint pain;

  
  


• 
  

  nausea, vomiting, constipation, loss of appetite;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  urinating more at night;

  
  


• 
  

  mild skin rash or itching;

  
  


• 
  

  decreased sex drive, impotence; or

  
  


• 
  

  skin rash, discoloration, or mild irritation where the patch is worn.

  
  

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 Catapres-TTS-2 (clonidine (transdermal))?

Before using clonidine transdermal, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by clonidine.

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

• 
  

  oral clonidine (tablets);

  
  


• 
  

  digitalis (digoxin, Lanoxin, Lanoxicaps);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

  
  


• 
  

  any other drugs to treat high blood pressure or heart problems.

  
  

This list is not complete and other drugs may interact with clonidine transdermal. 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 Catapres-TTS-2 resources

• Catapres-TTS-2 Side Effects (in more detail)
• Catapres-TTS-2 Use in Pregnancy & Breastfeeding
• Drug Images
• Catapres-TTS-2 Drug Interactions
• Catapres-TTS-2 Support Group
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Where can I get more information?

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See also: Catapres-TTS-2 side effects (in more detail)

Zymaxid

Generic Name: gatifloxacin (Ophthalmic route)

gat-i-FLOX-a-sin

Commonly used brand name(s)

In the U.S.

• Zymar


• Zymaxid

Available Dosage Forms:

• Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Uses For Zymaxid

Gatifloxacin ophthalmic (eye) preparation is used to treat infections of the eye, such as bacterial conjunctivitis. Gatifloxacin belongs to a group of medicines called fluoroquinolone antibiotics. It works by killing bacteria that cause conjunctivitis.

This medicine is available only with your doctor's prescription.

Before Using Zymaxid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zymaxid™ in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Zymaxid™ in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 gatifloxacin

This section provides information on the proper use of a number of products that contain gatifloxacin. It may not be specific to Zymaxid. Please read with care.

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

• First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.


• If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine 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 this medicine. 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 ophthalmic dosage form (eye drops):
  
  • For bacterial conjunctivitis:
    
    • Adults and children 1 year of age and older—
      
      • Day 1: Put one drop in the affected eye every two hours while awake, up to 8 times.
      
      
      • Days 2 through 7: Put one drop in the affected eye two to four times a day while awake.
      
      
    
    
    • Infants younger than 1 year of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zymaxid

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Stop using this medicine and check with your doctor right away if you have a rash, itching, or red or swollen skin around the eye or eyelid. These may be symptoms of an allergic reaction.

Do not wear contact lenses while you are using this medicine to avoid further eye irritation.

Zymaxid 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.

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

More common

• Eye irritation


• eye pain


• eye redness

Less common

• Bloody eye


• decrease in vision


• swelling of the membrane covering the white part of the eye

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

• Blurred vision


• discharge from the eyes


• itching eyes


• stringy mucus secretions


• swelling of the eye, eyelid, or inner lining of the eyelid


• watering eyes

Less common

• Bad, unusual, or unpleasant (after) taste


• change in taste


• dry eye


• headache

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: Zymaxid side effects (in more detail)

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More Zymaxid resources

• Zymaxid Side Effects (in more detail)
• Zymaxid Use in Pregnancy & Breastfeeding
• Zymaxid Support Group
• 0 Reviews for Zymaxid - Add your own review/rating

• Zymaxid Consumer Overview


• Zymaxid Prescribing Information (FDA)


• Zymar Prescribing Information (FDA)


• Zymar eent Monograph (AHFS DI)


• Zymar Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Zymaxid with other medications

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