Triple X Pediculicide

Generic Name: piperonyl butoxide and pyrethrins topical (pi PER o nil bue TOX ide and pye RETH rins)

Brand Names: A-200 Lice Control, A-200 Lice Treatment, Good Sense Lice Killing Shampoo, Step 1, Lice Treatment Maximum Strength, Pronto Lice Kill System, Pronto Shampoo & Cream Rinse, Pronto Shampoo Kit, Pronto Spray, Pronto with Metal Comb, R & C Lice Treatment Kit, Rid Pediculicide, Tegrin-LT Lice Spray, Tegrin-LT Lice Treatment Kit, Tegrin-LT Shampoo, Triple X Pediculicide

What is Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

Piperonyl butoxide and pyrethrins are insecticide chemicals.

Piperonyl butoxide and pyrethrins topical (for the skin) is used to treat lice.

Piperonyl butoxide and pyrethrins topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins, or if you have an allergy to chrysanthemums or ragweed.

Check all household members for signs of lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

What should I discuss with my healthcare provider before using Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

You should not use this medication if you are allergic to piperonyl butoxide and pyrethrins topical, or if you have an allergy to chrysanthemums or ragweed. It is not known whether piperonyl butoxide and pyrethrins topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Piperonyl butoxide and pyrethrins 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 Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

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.

Check for signs of lice on all household members. They may also need to be treated for lice. Lice can be spread from person to person by sharing a hairbrush, a comb, hats, or headbands. It can also be spread through head-to-head contact.

Apply the shampoo form of this medication to dry hair. Wetting the hair first may make the medication less effective. Apply the shampoo to all areas of the scalp, including behind the ears and neck. Treat hair from the roots to the ends and leave the shampoo in the hair for 10 minutes. Add warm water to form a lather and shampoo. Then rinse thoroughly with warm water. Piperonyl butoxide and pyrethrins shampoo is usually used once every 7 to 10 days.

You may need to use a larger amount of the shampoo if you have long hair. Follow the directions on the product label.

Keep your eyes tightly closed while using the shampoo, foam, or spray, and while rinsing it out of your hair. You may use a washcloth or towel to protect your eyes while applying the medication to your head.

Do not apply this medication to your eyebrows or eyelashes. Call your doctor if these areas become infected with lice.

Avoid inhaling the vapors from this medication. Use in a well-ventilated area.

You will need to remove any eggs (nits) from the hair shafts with a special comb. Some piperonyl butoxide and pyrethrins products come provided with a nit comb. If you do not have such a comb, ask your pharmacist where you can get one. Nits may not be removed effectively with a regular fine-tooth comb.

Use this medication for the full prescribed length of time. Your symptoms may improve before the lice infestation is completely cleared. Call your doctor if your condition does not improve, or if your symptoms get worse while using this medication.

To prevent reinfection with lice, wash all clothing, hats, bed linens, stuffed toys, hair brushes, and combs in hot water with a strong cleanser to remove any mites or eggs. You may need to use a special lice control spray to treat furniture, mattresses, sports helmets, headphones, and other non-washable items. Ask your doctor of pharmacist about disinfecting your home.

Store this medication at room temperature away from moisture and heat. Keep the medicine canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or incinerate the can, the contents are under pressure.

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.

What should I avoid while using Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

Avoid using other medications or skin products on the areas you treat with piperonyl butoxide and pyrethrins topical, unless you doctor tells you to.

Avoid getting this medication in your eyes, nose, mouth, or vagina. If this does happen, rinse with water. Do not use piperonyl butoxide and pyrethrins topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid close contact with others until the infection has been cured. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, pillows, and other items of personal use. Lice infestations are highly contagious.

Triple X Pediculicide (piperonyl butoxide and pyrethrins topical) 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. Stop using piperonyl butoxide and pyrethrins and call your doctor at once if you have severe stinging, burning, itching, swelling, or irritation where the medication is applied.

Less serious side effects may include:

• 
  

  mild itching, burning, or stinging;

  
  


• 
  

  mild skin rash; or

  
  


• 
  

  numbness or tingly feeling.

  
  

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 Triple X Pediculicide (piperonyl butoxide and pyrethrins topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied piperonyl butoxide and pyrethrins. But many drugs can interact with each other. 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 Triple X Pediculicide resources

• Triple X Pediculicide Use in Pregnancy & Breastfeeding
• Triple X Pediculicide Support Group
• 0 Reviews for Triple X Pediculicide - Add your own review/rating

Compare Triple X Pediculicide with other medications

• Head Lice

Where can I get more information?

• Your pharmacist can provide more information about piperonyl butoxide and pyrethrins.

Teslac

Generic Name: testolactone (Oral route)

tes-toe-LAK-tone

Commonly used brand name(s)

In the U.S.

• Teslac

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Androgen

Uses For Teslac

Testolactone belongs to the general group of medicines called antineoplastics. It is used to treat some cases of breast cancer in females.

Testolactone is available only with your doctor's prescription.

Before Using Teslac

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.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of testolactone in the elderly with use in other age groups.

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or kidney disease

Proper Use of Teslac

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Testolactone sometimes causes nausea and vomiting. However, it may have to be taken for several weeks or months to be effective. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of testolactone, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

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.

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

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.

Precautions While Using Teslac

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Teslac 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 as soon as possible if any of the following side effects occur:

Less common

• Numbness or tingling of fingers, toes, or face

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:

Less common

• Diarrhea


• loss of appetite


• nausea or vomiting


• pain or swelling in feet or lower legs


• swelling or redness of tongue

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: Teslac side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Teslac resources

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

• Teslac Prescribing Information (FDA)


• Teslac Concise Consumer Information (Cerner Multum)


• Teslac MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Teslac with other medications

• Breast Cancer, Palliative

Sheerfluorx FluorideTreatment

Generic Name: sodium fluoride

Dosage Form: dental film
Product Information

Sheer FluorX™ PEDO fluoride treatment is the ideal way to make in-office fluoride treatments easy, safer, faster, more comfortable, and more practical. Kids will love Sheer FluorX – no more trays, foams or gels that cause gagging and mess. The sheer film molds to teeth delivering fluoride exactly where you want it, eliminating gel running down the throat and being swallowed. The 5% sodium fluoride acidulated formula provides an effective and rapid uptake of fluoride to the teeth. Each film contains 0.4 grams (400 mg) of total composition including 20mg sodium fluoride, active ingredient.

• Avoid eating or drinking while wearing the film.


• Flush with copious amounts of water if accidentally
  
  placed in eye.


• Keep out of reach of young children.


• Not for use by children under the age of 12 without adult supervision.


• Avoid contact with clothing.


• Do not use if you have a known allergy to fluoride.


• Do not wear for more than 60 minutes in a 24 hour period.


• Avoid swallowing.
  

• Attention - Refer to the instructions for use and complete information.


• Use only as directed. Keep out of reach of small children and animals.


• Storage Temperature - Store product at the indicated temperature (32°F/0°C to 100°F/38°C).
  

• Do not store above 100°F (38°C). Do not freeze. Do not use beyond indicated shelf life.


• Do not use if the packaging has been damaged, or if the seals are found to be broken or open.

Shelf Life: 2 years

1. Use enclosed EZ opener to cut wrapper open.
   


2. Remove shrink wrap from tray. Carefully remove film from tray. The sticky gel side faces up. You may use scissors to trim film to desired size.


3. You may use scissors to trim film to desired size.
   


4. Position the film so it is centered on the arch. Firmly apply the film to the teeth, with the edge of the film just extending onto the gums.


5. Starting at the front teeth, wrap the film onto the back side of the teeth. Use your fingers to firmly mold the film to your teeth. Repeat process for other arch.
   


6. Leave the film in place for 15-60 minutes. DO NOT wear for more than 60 minutes in a 24 hour period.


7. To remove, grasp corner of film and begin to loosen away from teeth. Rinsing with water may help.
   


8. Continue removing film from all surfaces. The film may come away in pieces; this is normal. Avoid swallowing gel, rinse to sink.
   


9. Brush teeth and gums to remove any remaining gel. Rinse to sink, avoid swallowing excess gel.
   

COMPLETE INSTRUCTIONS - Back Page

Patent Pending

Caution: Federal law restricts this device to sale by or on the order of a licensed professional.

Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

Manufactured by CAO (China) Medical Equipment Co,. Ltd. for CAO Group. Inc.

P 877.236.4408 F 801.256.9287

4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A.

www.caogroup.com

SAL-CAI200C.1/28MAR2011

FRONT PANEL

Sheer FluorX PEDO

Fluoride Treatment

Chairside Strength - Home Applied.

Patent Pending

Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

Shelf Life: 2 years

Manufactured by CAO (China) Medical Equipment Co,. Ltd. for CAO Group, Inc.

Phone 877.236.4408 Fax 801.256.9287

4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A.

www.caogroup.com

SAL-PTI200A.1/15MAR2011

Back panel of Patient Guide

IMMEDIATE PACKAGE DISPLAY PANEL

Sheer FluorX PEDO

Fluoride Treatment

Chairside Strength - Home Applied.

Wear Time 15-60m

LOT: [lot number]

EXP: [expiration date]

Sodium fluoride, 20mg per film

Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

Easier. Faster. Better.

TO REORDER:

Henry Schein

1.800.372.4346

Adult supervision of children is required.

Storage

[32°F/0°C to 100°F/38°C]

Patent Pending

See carton for complete instructions and information. Keep out of reach of children.

For one-time use only.

Introductory Kit  Part #006-00133

Refill Kit  Part #006-00134

PAK-LA0200B.1/23MAR2011

OUTER PACKAGE - Back panel

TO REORDER: Henry Schein 1.800.372.4346

PACKAGE CONTENTS: 6) PEDO Patient Treatment Kits (Ieach containing 4 treatment trays), each contains 2 PEDO treatment films, 1 EZ opening tool.

See package insert for dosage information. Product expiration shown on Date/Lot label (24 months from date of manufacture). Rx Only.

Dispose of properly after use. For complete safety information see product MSDS.

Do not use if the packaging has been damaged, or if the safety seals are broken.

REORDER # 006-00133

Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

4628 West Skyhawk Drive

West Jordan, UT 84084

U.S.A.

877-236-4408 (tel)

801-256-9287 (fax)

www.caogroup.com

Patent Pending

STORAGE: [32°F/0°C to 100°F/38°C]

Expiration Date: [lot and expiration label]

[Barcode: 872320001322]

MADE IN CHINA

Adult supervision of children is required.

OUTER PACKAGE - Side panel

Sheer FluorX PEDO

Ingredients: Water/eau, xylitol, glycerin, sodium fluoride, peppermint oil, sucralose, proprietary polymer.

NDC# 1406000503

Fluoride Treatment

Sheer FluorX PEDO

Fluoride Treatment

Patient Treatment Kit PEDO

Chairside Strength - Home Applied.

Net Qty: 8 - 0.4 grams per film

Active ingredient: Sodium fluoride, 20mg/film

SHEER FLUORX PEDO  FLUORIDE TREATMENT sodium fluoride  film

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 14060-006 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 20 mg

Inactive Ingredients Ingredient Name Strength Water   Glycerin   Xylitol   Sucralose

Product Characteristics Color      Score      Shape Size Flavor PEPPERMINT (Peppermint Oil) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 14060-006-03 4 TRAY In 1 PACKAGE contains a TRAY 1 2 FILM In 1 TRAY This package is contained within the PACKAGE (14060-006-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/15/2011

Labeler - CAO Group, Inc. (102422578)

Revised: 06/2011CAO Group, Inc.

Topcare Infants Ibuprofen

Generic Name: ibuprofen

Dosage Form: oral suspension
Topco Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

• reduces fever


• relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives


• facial swelling


• asthma (wheezing)


• shock


• skin reddening


• rash


• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if the child

• has had stomach ulcers or bleeding problems


• takes a blood thinning (anticoagulant) or steroid drug


• takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]


• takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

• if the child has ever had an allergic reaction to any other pain reliever/fever reducer


• right before or after heart surgery

Ask a doctor before use if

• the stomach bleeding warning applies to your child


• child has a history of stomach problems, such as heartburn


• child has not been drinking fluids


• child has lost a lot of fluid due to vomiting or diarrhea


• child has high blood pressure, heart disease, liver cirrhosis, or kidney disease


• child has asthma


• child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

• under a doctor’s care for any serious condition


• taking any other drug

When using this product

• give with food or milk if stomach upset occurs


• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

• child experiences any of the following signs of stomach bleeding:


• feels faint


• vomits blood


• has bloody or black stools


• has stomach pain that does not get better


• the child does not get any relief within first day (24 hours) of treatment


• fever or pain gets worse or lasts more than 3 days


• redness or swelling is present in the painful area


• any new symptoms appear

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• this product does not contain directions or complete warnings for adult use


• do not give more than directed


• do not give longer than 10 days, unless directed by a doctor (see Warnings)


• shake well before using


• find right dose on chart below. If possible, use weight to dose; otherwise use age.


• measure with the dosing device provided. Do not use with any other device.


• dispense liquid slowly into the child’s mouth, toward the inner cheek


• if needed, repeat dose every 6-8 hours


• do not use more than 4 times a day

Dosing Chart
Weight (lb)	Age (mos)	Dose (mL)
under 6 mos		ask a doctor
12-17 lbs	6-11 mos	1.25 mL
18-23 lbs	12-23 mos	1.875 mL

Other information

• do not use if printed neckband is broken or missing


• store at 20-25°C (68-77°F)


• see bottom of box for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warnings Information

For Ages 6 Mos. to 23 Mos.

Concentrated Drops

Infants’

Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Alcohol Free

Berry Flavor

Use Only with Enclosed Syringe

Compare to Motrin® Infants’ Drops active ingredient

Ibuprofen Oral Suspension Carton

Topcare Infants Ibuprofen  ibuprofen  suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-057 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 50 mg  in 1.25 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK (light) Score      Shape Size Flavor FRUIT (mixed) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-057-05 1 BOTTLE In 1 CARTON contains a BOTTLE 1 15 mL In 1 BOTTLE This package is contained within the CARTON (36800-057-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075217	01/22/2002

Labeler - Topco Associates LLC (006935977)

Revised: 05/2009Topco Associates LLC

More Topcare Infants Ibuprofen resources

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

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• Aseptic Necrosis
• Back Pain
• Costochondritis
• Cystic Fibrosis
• Diffuse Idiopathic Skeletal Hyperostosis
• Dysautonomia
• Fever
• Frozen Shoulder
• Gout, Acute
• Headache
• Muscle Pain
• Osteoarthritis
• Pain
• Patent Ductus Arteriosus
• Period Pain
• Rheumatoid Arthritis
• Sciatica
• Spondylolisthesis
• Temporomandibular Joint Disorder

Tiotropium Bromide

Class: Antimuscarinics/Antispasmodics
VA Class: RE105
Chemical Name: di-2-thienylglycolate-6β,7β-Epoxy-3β-hydroxy-8-methyl-1αH,5αH-tropanium bromide
Molecular Formula: C₁₉H₂₂BrNO₄S₂
CAS Number: 139404-48-1
Brands: Spiriva Handihaler

Introduction

Bronchodilator; a synthetic quaternary ammonium antimuscarinic agent.¹

Uses for Tiotropium Bromide

COPD

Long-term treatment of reversible bronchospasm associated with COPD, including chronic bronchitis and emphysema.^{1 12 13 14 15}

A long-acting bronchodilator (e.g., orally inhaled salmeterol, formoterol, tiotropium) or an inhaled corticosteroid recommended for maintenance monotherapy in patients with moderate to severe COPD (e.g., FEV₁ 30 to <80% of predicted¹⁵ or, alternatively, <60% of predicted)¹⁸ who have persistent symptoms not relieved by as-needed therapy with a selective, short-acting inhaled β₂-adrenergic agonist.^{15 18} Maintenance therapy with long-acting bronchodilators in such patients more effective and more convenient than regular therapy with short-acting bronchodilators.^{13 15 18} Insufficient data to favor one maintenance monotherapy over another in patients with moderate to severe COPD.^{15 18} In selected patients with inadequate response, may use a combination of several long-acting bronchodilators, such as tiotropium, and a long-acting β₂-adrenergic agonist.^{13 15}

In patients with severe to very severe COPD (e.g., FEV₁ <30 to <50% of predicted), some clinicians recommend addition of an inhaled corticosteroid to one or more long-acting bronchodilators, given separately or in fixed combination;^{12 14 15} however, benefits of combination therapy over monotherapy not consistently established.^{15 18} If inadequate response or limiting adverse effects occur, may consider the addition or substitution of extended-release oral theophylline.^{12 14 15}

Not indicated for the initial treatment of acute episodes of bronchospasm or acute exacerbations of COPD;^{1 5} a drug with a more rapid onset of action (e.g., a short-acting β-adrenergic agonist) preferred.^{2 3 7 8}

Tiotropium Bromide Dosage and Administration

Administration

Administer by oral inhalation only using a special oral inhalation device (HandiHaler) that delivers powdered drug from capsules.^{1 5}

Do not take capsules orally, as intended effects on the lungs will not be obtained.^{1 5 16}

Oral Inhalation

Open the dust cap by pressing the green piercing button.⁵ Pull the dust cap upward on the side opposite the hinge of the Handihaler device to expose the mouthpiece.⁵ Open the mouthpiece by pulling the mouthpiece ridge upward on the side opposite the hinge of the inhaler to expose the center chamber.⁵ Carefully open the blister card to expose only one capsule immediately before use.^{1 5} Place capsule into the center chamber of the inhaler,^{1 5} and close the inhaler mouthpiece firmly until it snaps (clicks) into position, leaving the dust cap open (up).⁵ (See Stability.) Push down on the mouthpiece ridge to make sure that the mouthpiece is seated in the gray base of the inhaler.⁵ Hold the inhaler with the seated mouthpiece upward, depress the green button on the side of the inhaler completely (until the button is flush with the gray base of the inhaler), then release the button.^{1 5} The green button pierces the capsule and disperses the powdered drug upon inspiration.^{1 5 11} Do not press the green piercing button more than once.^{5 11}

Exhale completely; do not exhale into the HandiHaler device.⁵ Hold the inhaler by the gray base; take care not to block the air intake vents near the mouthpiece ridge.⁵ With the head kept level, place the mouthpiece of the inhaler between the lips (inhaler is in a horizontal position) and inhale deeply and slowly through the inhaler with a rate sufficient to hear or feel the loaded capsule vibrate.^{5 11} Pressure from inhalation will disperse the drug from center chamber into air stream created by the patient’s inhalation.^{1 5} Continue breathing until the lungs are full.⁵ Remove the inhaler from the mouth and hold the breath for as long as comfortable, then resume normal breathing.⁵ Breathe out completely and inhale once again to ensure full delivery of the powder.⁵ Do not press the green piercing button again.⁵ Upon completion of the second inhalation, open the mouthpiece and tip the device to dispose of the used capsule; close the mouthpiece and dust cap of the inhaler device.⁵

Do not take extra doses despite not being able to hear or feel the capsule vibrate.⁵ Tap the inhaler device on a table, holding the gray base in an upright position.⁵ Then check to see that the mouthpiece is properly seated in the gray base and attempt to inhale through the device again.⁵ (See Advice to Patients.)

If no improvement in COPD symptoms, make sure patient is inhaling the drug using the oral inhaler rather than swallowing the dry-powder capsules.¹⁶ (See Accidental Oral Ingestion under Cautions.)

Clean the Handihaler device once a month.⁵ Open the dust cap and mouthpiece, then open the base by lifting the green piercing button; rinse with warm water (do not use cleaning agents or detergents) to remove any remaining powder.⁵ Dry the inhaler thoroughly; leave dust cap, mouthpiece, and gray base open to air dry for 24 hours.⁵ Do not use the inhaler when wet.⁵ If needed, clean the outside of the mouthpiece with a moist, but not wet, tissue.^{5 11}

Dosage

Available as tiotropium bromide monohydrate; dosage expressed in terms of anhydrous tiotropium.^{1 11}

Each capsule contains 18 mcg of tiotropium as an inhalation powder.¹ However, the precise amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.¹

Adults

COPD

Inhalation

18 mcg (contents of one capsule) once daily.^{1 11}

Special Populations

Hepatic Impairment

No dosage adjustments required.¹

Renal Impairment

No dosage adjustments required.¹

Geriatric Patients

No dosage adjustments required.¹

Cautions for Tiotropium Bromide

Contraindications

• 
  

  Known hypersensitivity to tiotropium bromide or any ingredient in the formulation.¹

  
  


• 
  

  Known hypersensitivity to atropine or its derivatives (e.g., ipratropium).¹

  
  

Warnings/Precautions

Warnings

Acute Bronchospasm

Delayed onset of action; not indicated for initial treatment.^{1 5} Do not use for the treatment of acute episodes of bronchospasm (i.e., as rescue therapy).^{1 5}

Possible Increased Risk of Stroke, Mortality, and/or Cardiovascular Events

Data are conflicting; possible increased risk of stroke identified from ongoing safety monitoring and pooled analysis of placebo-controlled trials.¹⁹ Data on approximately 13,500 patients with COPD suggest an absolute excess risk of 2 strokes per 1000 patient-years with exposure to tiotropium compared with that of placebo.¹⁹ Other observational data involving over 32,000 patients and pooled analyses of almost 15,000 patients suggest an increased risk of mortality and/or cardiovascular events with use of inhaled anticholinergic agents, including tiotropium bromide.^{20 21} However, increased risk of stroke with tiotropium not revealed in a preliminary analysis of a placebo-controlled trial (Understanding the Potential Long-term Impacts on Function with Tiotropium [UPLIFT]) in approximately 6000 patients with COPD.¹⁹ Results of these analyses pending confirmation by FDA; postmarketing adverse event reports and results of the UPLIFT trial currently under review.¹⁹

Sensitivity Reactions

Hypersensitivity Reactions

Immediate hypersensitivity reactions, including angioedema, reported.⁵ Possible acute paradoxical bronchospasm.^{1 11} If such reactions occur, discontinue immediately and consider alternative therapy.¹

General Precautions

Ocular Effects

Possible temporary blurred vision, worsening of acute angle-closure glaucoma (e.g., ocular pain or discomfort, blurred vision, visual halos, or colored images in association with conjunctival congestion and corneal edema), or pupillary dilation following inadvertent contact of tiotropium with the eyes.^{1 5 8 11} Miotic eye drops alone are not considered effective treatment for this condition.¹ (See Advice to Patients.)

GU Effects

Possible urinary retention, urinary difficulty,¹ or urinary tract infection.¹

May worsen symptoms and signs associated with prostatic hyperplasia or bladder neck obstruction.^{1 11} Use with caution in patients with these conditions.¹

Accidental Oral Ingestion

Acute intoxication unlikely following inadvertent oral ingestion of the dry-powder capsules for oral inhalation since the drug is not well absorbed systemically.¹ Adverse effect reports uncommon following ingestion of dry-powder capsules.¹⁶

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rodents; not known whether tiotropium is distributed into human milk.¹ Use caution.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 11}

Geriatric Use

Possible increased incidence of dry mouth, constipation, and urinary tract infection compared with younger adults.¹ However, no overall differences in efficacy relative to younger adults.¹

Hepatic Impairment

Pharmacokinetics not evaluated, but impact of hepatic impairment should be minimal.¹

Renal Impairment

Clearance may be decreased; closely monitor patients with moderate to severe renal impairment (CL_cr of ≤50 mL/minute) during therapy.¹

Common Adverse Effects

Upper respiratory tract infection,¹ dry mouth,¹ accidents,¹ sinusitis,¹ pharyngitis,¹ urinary tract infection,¹ chest pain (nonspecific),¹ rhinitis,¹ dyspepsia,¹ abdominal pain,¹ edema (dependent),¹ constipation,¹ vomiting,¹ infection,¹ moniliasis,¹ epistaxis,¹ myalgia,¹ rash.¹

Interactions for Tiotropium Bromide

Metabolized by CYP isoenzymes, principally CYP2D6 and CYP3A4.^{1 8}

Does not inhibit CYP1A1, 1A2, 2B6, C29, 2C19, 2D6, 2E1, or 3A4.¹

Specific Drugs

Drug	Interaction	Comments
β2-Adrenergic agonists	No adverse drug interactions reported1
Antimuscarinic agents	Interaction not studied1	Concomitant use not recommended by manufacturer1
Corticosteroids, oral and inhaled	No adverse drug interactions reported1
Histamine H2-receptor antagonists	Increased AUC and decreased renal clearance of IV tiotropium (not currently available in the US) with concomitant cimetidine but not ranitidine1	Pharmacokinetic interactions not considered clinically important1
Methylxanthines	No adverse drug interactions reported1

Tiotropium Bromide Pharmacokinetics

Absorption

Bioavailability

Following inhalation, absolute bioavailability is 19.5%.¹ Most of a dose is swallowed^{1 11} and minimally absorbed into systemic circulation;¹ the fraction reaching the lungs appears to be readily absorbed.^{1 7 11} Peak plasma concentrations following oral inhalation are attained within 5 minutes.¹

Onset

Following oral inhalation, bronchodilation evident within 30 minutes.⁴

Duration

Bronchodilation generally persists for >24 hours.¹

Food

Food does not appear to affect absorption from GI tract.¹

Special Populations

In patients with renal impairment, increased plasma drug concentrations and AUC.¹

Distribution

Extent

Widely distributed into tissues.¹ Does not penetrate the blood-brain barrier in animals.¹

Plasma Protein Binding

72%.¹

Elimination

Metabolism

Metabolized to a limited extent, principally by isoenzymes CYP2D6 and 3A4.^{1 8}

Elimination Route

Excreted principally in the feces (86%), mainly as unabsorbed drug, and in the urine (approximately 14%) as unchanged drug.^{1 7 8}

Half-life

Terminal elimination half-life is 5–6 days following oral inhalation.¹

Special Populations

In patients with renal impairment, reduced clearance.¹

Stability

Storage

Parenteral

Powder for Oral Inhalation

25°C (may be exposed to 15–30°C).¹ Do not expose to extreme temperatures and moisture.¹

Keep capsules in sealed blisters until immediately before use.^{1 5} Do not store used or unused capsules in the inhaler device.⁵ Remove only one capsule immediately before use or effectiveness of the drug may be reduced.^{1 5} Discard additional capsules if opened and exposed to air (i.e., not intended for immediate use).^{1 5 11}

ActionsActions

• 
  

  Competitively and reversibly inhibits the actions of acetylcholine and other cholinergic stimuli at M₃ receptors in the smooth muscle of the respiratory tract, leading to bronchodilation.^{1 7 11 15}

  
  

Advice to Patients

• 
  

  Importance of providing patient a copy of manufacturer’s patient information.⁵

  
  


• 
  

  Importance of informing a clinician of allergies to any medications prior to initiation of tiotropium bromide therapy.⁵

  
  


• 
  

  Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the inhalation delivery system (HandiHaler).^{1 5 16}

  
  


• 
  

  Importance of not using the HandiHaler device to administer other drugs.^{5 11}

  
  


• 
  

  Importance of consulting a clinician of faulty inhaler performance (i.e., if capsule vibration is not felt or heard upon inhalation) when certain procedures (i.e., confirming that the mouthpiece is firmly seated in the gray base, tapping the inhaler gently on a table) do not improve inhaler performance.⁵

  
  


• 
  

  Importance of avoiding inadvertent contact of the drug with the eyes, as contact may cause blurred vision and pupillary dilation.^{1 5}

  
  


• 
  

  Importance of not using tiotropium to relieve acute symptoms or exacerbations of COPD.^{1 5}

  
  


• 
  

  Importance of patients consulting clinician before discontinuing tiotropium therapy if they are concerned about potential adverse effects (e.g., stroke).¹⁹

  
  


• 
  

  Importance of informing a clinician if eye pain or discomfort, blurred vision, or visual halos or colored images in association with conjunctival congestion or corneal edema occur.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., eye drops) and herbal supplements, as well as any concomitant illnesses (e.g., urinary difficulty, enlarged prostate, angle-closure glaucoma).^{1 5 11}

  
  


• 
  

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

  
  


• 
  

  Importance of informing 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.

Tiotropium Bromide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Powder for Inhalation (contained in capsules)	18 mcg (of anhydrous tiotropium)	Spiriva HandiHaler	Boehringer Ingelheim (comarketed by Pfizer)

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.

Spiriva HandiHaler 18MCG Capsules (BOEHRINGER INGELHEIM): 30/$230 or 90/$670

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 August 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Boehringer Ingelheim. Spiriva HandiHaler (tiotropium bromide) inhalation powder prescribing information. Ridgefield, CT; 2007 Dec.

2. Veterans’ Health Administration Department of Veteran Affairs. The pharmacologic management of chronic obstructive pulmonary disease. Washington, DC: Veterans’ Health Administration; 1999 June. Pharmacy Benefits Management No. 99-0012. Available at . Accessed Sep. 30, 2002.

3. Veterans’ Health Administration, Department of Veterans’ Affairs. VHA/DOD clinical practice guideline for the management of chronic obstructive pulmonary disease: complete summary. Washington, DC: Veterans’ Health Administration; 1999 Aug.

4. Vincken W, van Noord JA, Greefhorst AP et al. Improved health outcomes in patients with COPD during 1 yr’s treatment with tiotropium. Eur Respir J. 2002; 19:209-16. [PubMed 11871363]

5. Boehringer Ingelheim. Spiriva HandiHaler (tiotropium bromide) inhalation powder patient instructions for use. Ridgefield, CT; 2007 Dec.

6. Casaburi R, Mahler DA, Jones PW et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002; 19:217-24. [IDIS 514612] [PubMed 11866001]

7. Hvizdos KM, Goa KL. Tiotropium bromide. Drugs. 2002; 62:1195-203. [PubMed 12010082]

8. Anon. Tiotropium (Spiriva) for COPD. Med Lett Drugs Ther. 2004: 46:41-2.

9. Brusasco V, Hodder R, Miravitlles M et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax. 2003: 58:399-404.

10. Donohue JF, van Noord JA, Bateman ED et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest. 2002: 122:47-55.

11. Boehringer Ingelheim, Ridgefield, CT: Personal communication.

12. ATS/ERS Standards for the diagnosis and management of patients with COPD. New York, NY: American Thoracic Society, European Respiratory Society; 2004. Available at . Accessed Dec. 8, 2004.

13. O’Donnell DE, Aaron S, Bourbeau J et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease-2003. Can Respir J. 2003; 10 (Suppl. A):11A-65A.

14. Celli BR, Macnee W. Standard for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004; 23:932-46. [PubMed 15219010]

15. National Heart, Lung, and Blood Institute/World Health Organization. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda, MD: National Heart, Lung, and Blood Institute, Global Initiative for Chronic Obstructive Lung Disease, World Health Organization; 2007 Dec. Available at: . Accessed 2008 May 19.

16. Food and Drug Administration. FDA public health advisory: Important information on correct use of Spiriva and Foradil capsules. Rockville, MD; 2008 Feb 29. Available at . Accessed 2008 Apr 23.

18. Qaseem A, Snow V, Shekelle P et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2007; 147:633-8. [PubMed 17975186]

19. Food and Drug Administration. Early communication about an ongoing safety review of tiotropium (marketed as Spiriva Handihaler). Rockville, MD; 2008 Oct 7. Available at . Accessed 2008 Oct 8.

20. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease. JAMA. 2008; 300:1439-50. [PubMed 18812535]

21. Lee TA, Pickard AS, Au DH et al. Risk of death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med. 2008; 149:380-90. [PubMed 18794557]

More Tiotropium Bromide resources

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

Compare Tiotropium Bromide with other medications

• COPD, Maintenance

Sudafed Sinus

Generic Name: acetaminophen and pseudoephedrine (a SEET a MIN oh fen and SOO doe ee FED rin)

Brand Names: Alka-Seltzer Cold and Sinus, Allerest No Drowsiness, Bayer Select Decongestant, Benadryl Allergy Sinus Headache, Dristan Cold Non-Drowsy, Ornex, Ornex Maximum Strength, Sinarest Sinus, Sine-Off Maximum Strength, Tavist Sinus, Triaminic Softchews Allergy Sinus, Tylenol Sinus Childrens

What is Sudafed Sinus (acetaminophen and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen and pseudoephedrine is used to treat stuffy nose, sinus congestion, and pain or fever caused by the common cold.

Acetaminophen and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sudafed Sinus (acetaminophen and pseudoephedrine)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen (sometimes abbreviated as "APAP") or pseudoephedrine. If you drink more than three alcoholic beverages per day, do not take this medication without your doctor's advice.

What should I discuss with my healthcare provider before taking Sudafed Sinus (acetaminophen and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen or pseudoephedrine. Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a decongestant before the MAO inhibitor has cleared from your body.

Before taking acetaminophen and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• cirrhosis or other liver disease;


• 
  

  a history of alcoholism;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  an enlarged prostate;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking acetaminophen and pseudoephedrine, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and pseudoephedrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Sudafed Sinus (acetaminophen and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine should be taken only for a short time until your symptoms clear up.

Drink extra fluids while you are taking acetaminophen and pseudoephedrine. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen and pseudoephedrine tablet may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of acetaminophen and pseudoephedrine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medication at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

What should I avoid while taking Sudafed Sinus (acetaminophen and pseudoephedrine)?

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") and pseudoephedrine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, or pseudoephedrine. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Sudafed Sinus (acetaminophen and pseudoephedrine) 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  mild loss of appetite;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  skin rash or itching;

  
  

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 Sudafed Sinus (acetaminophen and pseudoephedrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  isoniazid;

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  gout medications such as probenecid (Benemid) or sulfinpyrazone;

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

  
  


• 
  

  stimulants (caffeine, diet pills, ADHD medications such as Ritalin or Adderall);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others; or

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

  
  

This list is not complete and there may be other drugs that can interact with acetaminophen and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Sudafed Sinus resources

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

• Ornex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sudafed Sinus with other medications

• Fever
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and pseudoephedrine.

See also: Sudafed Sinus side effects (in more detail)

Salonpas Gel-Patch

Generic Name: capsaicin topical (kap SAY sin TOP i kal)

Brand Names: Axsain, Capsicum Oleoresin, Capsin, Capzasin Back and Body, Capzasin Quick Relief, Capzasin-HP, Capzasin-P, Castiva Warming, Dolorac, Icy Hot PM, Icy Hot with Capsaicin, Menthac Arthritis Cream with Capsaicin, Qutenza, Salonpas Gel-Patch, Salonpas Pain Patch with Capsaicin, Sloan's Liniment, Trixaicin, Trixaicin HP, Zostrix, Zostrix Diabetic Foot Pain, Zostrix Foot Pain, Zostrix Neuropathy, Zostrix Sports, Zostrix-HP

What is Salonpas Gel-Patch (capsaicin topical)?

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Capsaicin used on the body causes a sensation of heat that activates certain nerve cells. With regular use of capsaicin, this heating effect reduces the amount of substance P, a chemical that acts as a pain messenger in the body.

Capsaicin topical is used for temporary relief of muscle or joint pain caused by strains, sprains, arthritis, bruising, or backaches. Capsaicin topical is also used to treat nerve pain (neuralgia) in people who have had herpes zoster, or "shingles."

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

What is the most important information I should know about Salonpas Gel-Patch (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies or serious medical conditions. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Capsaicin can cause a burning sensation, which is usually mild and should lessen over time with continued use. If the burning sensation causes significant discomfort, wash the treated skin area with soap and cool water. Stop using the medication and call your doctor if you have severe burning or redness where the medicine was applied.

Avoid getting capsaicin topical in your mouth or eyes or near your nose.

Do not apply to open wounds or irritated skin, and avoid getting the medicine on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. Accidental swallowing of capsaicin can cause problems with swallowing or breathing.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

What should I discuss with my healthcare provider before using Salonpas Gel-Patch (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether capsaicin topical 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 capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply capsaicin topical to your breast area if you are breast-feeding a baby. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

How should I use Salonpas Gel-Patch (capsaicin topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

Do not apply capsaicin topical to open wounds, or to skin that is sunburned, windburned, dry, chapped, or otherwise irritated. Do not get this medication in your mouth or eyes, or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

To keep the medication from getting on your fingers when you apply it, you may use a rubber glove, finger cot, cotton ball, or clean tissue to apply the medicine.

Make sure your skin is clean and dry before you apply capsaicin topical.

When using capsaicin topical cream or lotion, apply a thin layer to the affected area and rub in gently until completely absorbed.

To use capsaicin topical liquid or stick, uncap the applicator and press it firmly on your skin to apply the medication. Massage gently onto the affected are until completely absorbed.

Capsaicin topical may be used up to 4 times daily or as directed on the medicine label.

To apply a capsaicin topical patch, remove the liner and apply the patch to your skin over the area of pain. Press the edges firmly into place. Remove the patch and apply a new patch 1 or 2 times daily if needed.

Wash your hands with soap and water immediately after applying capsaicin topical or handling the topical patch. If you have applied the medicine to your hands or fingers to treat pain in those areas, wait at least 30 minutes before washing your hands. Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin topical to your skin. Also avoid swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

If the burning sensation caused by capsaicin is painful or causes significant discomfort, wash the treated skin area with soap and cool water.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days. Store capsaicin topical at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Capsaicin topical liquid is flammable. Do not use or store near fire or open flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply capsaicin more than 4 times in one day, or use extra medicine to make up a missed dose .

A missed dose of capsaicin topical will not cause harm but may make the medication less effective reducing substance P and relieving your pain.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed it.

Accidental swallowing of capsaicin can cause severe burning in or around the mouth, watery eyes, runny nose, and trouble swallowing or breathing.

Applying too much capsaicin topical to the skin can cause severe burning or redness.

What should I avoid while using Salonpas Gel-Patch (capsaicin topical)?

Avoid inhaling the odor or dried residue of capsaicin topical. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off your hands. Also avoid handling food while the medication is still on your hands.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. Capsaicin can cause a burning sensation that may be made worse by heat.

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where you have applied capsaicin, unless your doctor has told you to.

Salonpas Gel-Patch (capsaicin topical) 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. Stop using capsaicin topical and call your doctor at once if you have a serious side effect such as:

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  severe burning or irritation where the medicine was applied;

  
  


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  skin redness where the medicine was applied; or

  
  


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  trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

  
  

Less serious side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of capsaicin topical.

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 Salonpas Gel-Patch (capsaicin topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied capsaicin. But many drugs can interact with each other. 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 Salonpas Gel-Patch resources

• Salonpas Gel-Patch Side Effects (in more detail)
• Salonpas Gel-Patch Use in Pregnancy & Breastfeeding
• Salonpas Gel-Patch Drug Interactions
• Salonpas Gel-Patch Support Group
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Compare Salonpas Gel-Patch with other medications

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Where can I get more information?

• Your pharmacist can provide more information about capsaicin topical.

See also: Salonpas-Patch side effects (in more detail)