Accredo Health, Inc.

Address Accredo Health, Inc., 1640 Century Center Parkway Memphis, TN 38134 Contact Details Phone: (866) 591-9075 Website: http://www.accredo.com Careers: http://www.accredo.com/Careers.html

Anaplex DMX Suspension

Generic Name: Brompheniramine/Dextromethorphan/Pseudoephedrine (BROME-fen-IR-a-meen/DEX-troe-meth-OR-fan/SOO-do-e-FED-rin)
Brand Name: Examples include Anaplex DMX and BromTann/DM Tann/PSE Tann

Anaplex DMX Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Anaplex DMX Suspension is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Anaplex DMX Suspension if:

• you are allergic to any ingredient in Anaplex DMX Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Anaplex DMX Suspension:

Some medical conditions may interact with Anaplex DMX Suspension. 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 fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Anaplex DMX Suspension's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Anaplex DMX Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Anaplex DMX Suspension

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

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

• Take Anaplex DMX Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Anaplex DMX Suspension, 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 Anaplex DMX Suspension.

Important safety information:

• Anaplex DMX Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Anaplex DMX Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you take Anaplex DMX Suspension without checking with your doctor.


• Anaplex DMX Suspension has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Anaplex DMX Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Anaplex DMX Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Anaplex DMX Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Anaplex DMX Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Anaplex DMX Suspension for a few days before the tests.


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


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


• Caution is advised when using Anaplex DMX Suspension in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anaplex DMX Suspension while you are pregnant. It is not known if Anaplex DMX Suspension is found in breast milk. Do not breast-feed while taking Anaplex DMX Suspension.

Possible side effects of Anaplex DMX Suspension:

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

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

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: Anaplex DMX 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Anaplex DMX Suspension:

Store Anaplex DMX Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anaplex DMX Suspension out of the reach of children and away from pets.

General information:

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


• Anaplex DMX Suspension 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.

This information is a summary only. It does not contain all information about Anaplex DMX Suspension. 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 Anaplex DMX resources

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

Compare Anaplex DMX with other medications

• Cough and Nasal Congestion

Tusnel

Pronunciation: brome-fen-EER-a-meen/dex-troe-meth-OR-fan/gwye-FEN-e-sin
Generic Name: Brompheniramine/Dextromethorphan/Guaifenesin
Brand Name: Tusnel

Tusnel is used for:

Relieving runny nose, sneezing, cough, and throat and airway irritation due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tusnel is an antihistamine, cough suppressant, and expectorant combination. The expectorant works by loosening mucus and lung secretions in the chest, and making coughs more productive. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tusnel if:

• you are allergic to any ingredient in Tusnel


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tusnel:

Some medical conditions may interact with Tusnel. 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 fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, a blockage of your bladder, stomach, or intestines, ulcers, trouble urinating, an enlarged prostate, seizures, or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

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

• Furazolidone, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tusnel may be increased


• Hydantoins (eg, phenytoin) because their side effects may be increased by Tusnel

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

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

• Tusnel may be taken with or without food.


• If you miss a dose of Tusnel, 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 Tusnel.

Important safety information:

• Tusnel may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tusnel. Using Tusnel alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Tusnel without checking with your doctor.


• Tusnel contains brompheniramine and dextromethorphan. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains brompheniramine or dextromethorphan. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Tusnel for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Tusnel may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tusnel. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• If you are scheduled for allergy skin testing, do not take Tusnel for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tusnel.


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


• Caution is advised when using Tusnel in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tusnel, discuss with your doctor the benefits and risks of using Tusnel during pregnancy. It is unknown if Tusnel is excreted in breast milk. Do not breast-feed while taking Tusnel.

Possible side effects of Tusnel:

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

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

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: Tusnel 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tusnel:

Store Tusnel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tusnel out of the reach of children and away from pets.

General information:

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


• Tusnel 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 Tusnel. 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 Tusnel resources

• Tusnel Side Effects (in more detail)
• Tusnel Support Group
• 0 Reviews · Be the first to review/rate this drug

DulcoEase 100mg Capsules

Dulcoease

docusate sodium 100mg capsules

STOOL SOFTENER

To soften hard stools for a comfortable way to go to the loo

30 SOFT GEL CAPSULES

Dulcoease stool softener provides relief when bowel movement is painful or difficult. It can be used when you have constipation, piles or anal fissure. It works by helping hard, dry stools soak up natural fluids. Also may be used before abdominal X-ray.

Do not take this medicine if you are:

• Pregnant, thinking of becoming pregnant, or breast-feeding


• Having stomach pains, feeling sick, or have been sick in the last 24 hours


• Allergic to any of the ingredients (see side of pack)


• Intolerant to some sugar (such as sorbitol, fructose)


• Taking a laxative called liquid paraffin

How to take:

• Swallow each capsule whole with water.


• Adults: Start with 1 capsule, 3 times a day


• Then take more (1 capsule, up to 5 times a day), or less, if you need to


• You should feel more comfortable within 1-2 days


• Do not give to children under 12 years


• For use prior to abdominal X-ray: 4 capsules, as instructed by hospital.

See a doctor or pharmacist if you need to use this medicine every day, or have a stomach ache which does not go away.

If you take more than you should: drink lots of water and see a doctor straight away.

Possible side effects

This medicine does not usually cause side-effects, but some people may feel sick, get diarrhoea, stomach cramps, or skin rash. If these continue for more than a few days or become troublesome, stop taking Dulcoease and see a pharmacist or doctor.

Revision date: June 2009

Active ingredient:

Each Dulcoease capsule contains docusate sodium 100mg.

Other ingredients:

macrogol 400, propylene glycol, gelatin, glycerol, sorbitol (E420), titanium dioxide (E171), water, sunset yellow (E110), quinoline yellow (E104). Contains sunset yellow (E110) which may cause allergic reactions.

Storage:

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package in order to protect from moisture.

Distributor:

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

PL 00039/0737 held by

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

Manufacturer:

Banner Pharmacaps Europe B.V.

De Posthoornstraat 7

5048 AS Tilburg

Netherlands

BANBICN003-7

Topcare Children's Ibuprofen

Generic Name: ibuprofen

Dosage Form: suspension
Topco Children's Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

• relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache


• reduces fever

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 your 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. If possible, use weight to dose; otherwise use age.


• use only enclosed measuring cup


• if needed, repeat dose every 6-8 hours


• do not use more than 4 times a day


• replace original bottle cap to maintain child resistance


• wash dosage cup after each use

Dosing Chart
Weight (lb)	Age(yrs)	Dose (teaspoonful or mL)
under 2 years		ask a doctor
24-35 lbs	2-3 years	1 tsp or 5 mL
36-47 lbs	4-5 years	1 ½ tsp or 7.5 mL
48-59 lbs	6-8 years	2 tsp or 10 mL
60-71 lbs	9-10 years	2 ½ tsp or 12.5 mL
72-95 lbs	11 years	3 tsp or 15 mL

Other information

• each teaspoon contains: sodium 2 mg


• do not use if printed neckband is broken or missing


• store at 20-25°C (68-77°F)


• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavors, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warnings Information

For Ages 2 to 11

Children’s

Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever/Fever Reducer (NSAID)

Lasts Up to 8 Hours

Alcohol Free

Bubble Gum Flavor

Compare to Children’s Motrin® Bubble Gum Flavor active ingredient

Children's Ibuprofen Oral Suspension Carton

TOPCARE CHILDRENS IBUPROFEN  ibuprofen  suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-166 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK (light) Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-166-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (36800-166-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074937	07/30/2002

Labeler - Topco Associates LLC (006935977)

Revised: 07/2009Topco Associates LLC

More Topcare Children's Ibuprofen resources

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

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Atropine Ophthalmic Solution

Generic Name: atropine sulfate

Dosage Form: ophthalmic solution
ATROPINE SULFATE OPHTHALMIC SOLUTION 1%

STERI-UNITS®

STERILE OPHTHALMIC SOLUTION

FOR ONE TIME USE

Packaged in Pre-Sterilized Ready-to-Use Units—Sterile Unless Opened or Damaged

1. STERI-UNITS® Ophthalmic Solutions may be stored under ordinary conditions and handled freely prior to opening blister pack or vial without danger of contaminating the sterile surface of the enclosed DROP-TAINER® dispenser.

2. Open package using standard aseptic technique. The DROP-TAINER® dispenser may then be allowed to fall upon a sterile surface.

3. The entire outer surface of the DROP-TAINER® dispenser, as well as its contents, is sterile and thus may be safely handled by the surgeon or scrub nurse. The cap of the DROP-TAINER® dispenser is quickly and easily unscrewed; and the specially designed tip needs no puncturing before use.

4. Gentle pressure on the sides of the DROP-TAINER® dispenser will empty its contents in uniform drops.

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using Atropine Sulfate in animals to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Atropine Sulfate. It is also not known whether these ingredients can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. STERI-UNITS® Solutions containing these ingredients should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atropine Sulfate or Pilocarpine Hydrochloride is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

STORAGE

Store Atropine Sulfate Ophthalmic Solution 1% at 46° - 80°F (8° -27°C). Protect from light.

Atropine Ophthalmic Solution Description

ATROPINE SULFATE OPHTHALMIC SOLUTION 1%

The active ingredient is represented by the chemical structure:

Established name: Atropine Sulfate

Chemical name: Benzeneacetic acid, α-(hydroxy-methyl)-, 8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester,endo-(±)-, sulfate (2:1) (salt), monohydrate.

Each mL Contains: Active: Atropine Sulfate 1%. Inactives: Boric Acid, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Water for Injection.

Atropine Ophthalmic Solution - Clinical Pharmacology

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).

INDICATIONS & USAGE

For mydriasis and/or cycloplegia. For cycloplegic refraction; for papillary dilation desired in inflammatory conditions of the iris and uveal tract.

Contraindications

Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g., narrow anterior chamber angle; and in those persons showing hypersensitivity to any component of these preparations.

Warnings

For topical eye use only, not for injection. Use with extreme caution in infants, small children and geriatrics. Excessive use in children or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.

PATIENT WARNINGS

Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation.

Precautions

To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.

Adverse Reactions

Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in young children. Increase in IOP may occur in patients with open angle glaucoma. Photophobia may occur with a fixed and dilated pupil. Decreased lacrimation may aggravate a dry eye condition.

Overdosage

Systemic atropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distention in infants, mental aberration (hallucinosis) and loss of neuromuscular coordination. Atropine poisoning, although distressing, is rarely fatal even with large doses of atropine, and is self-limited if the cause is recognized and the atropine medication discontinued. Treatment includes supportive measures including maintaining a patent airway and assisting respiration if needed. Treat hyperthermia, coma and seizures if they occur.1 In infants and children, the body surface must be kept moist. Excitement may be controlled by diazepam or a short acting barbiturate. For ingestion, activated charcoal can be used to prevent drug absorption. If necessary, ipecac or another cathartic may be useful for drug removal during initial treatment.1,2 Physostigmine is used as an antidote to the systemic effects of atropine and may be administered parenterally to provide more prompt relief of intoxication. Parenteral physostigmine may be particularly useful in cases of pronounced hallucinations, agitation in which a patient may be dangerous to himself or others, arrhythmias resulting in uncontrolled hemodynamic instability, and intractable seizures.

DOSAGE & ADMINISTRATION

One drop topically in the eye(s) as required, with care to avoid overdosage. Discard unused portion. May be used during ocular surgery.

How is Atropine Ophthalmic Solution Supplied

2 mL in DROP-TAINER® dispenser in carton of 12.

NDC 0065-0702-12

REFERENCES

1Kirk M, Kulig K, Rumack BH. Anticholinergics. In: Clinical management of Poisoning and Drug Overdose, Second Edition. Edited by Haddad LM, Winchester JF. Philadelphia, W.B. Saunders Company, 1990, p861-867.

2Tani SA. Anticholinergics. In: Poisoning and Drug Overdose, Second Edition. Olson KR. Norwalk, CT, Appleton & Lange, 1994, p75-76.

PRINCIPAL DISPLAY PANEL

STERi-UNiTS®

Single Dose DROP-TAINER® dispensers for topical use only.

Not for internal use. See package insert for directions.

Rx Only

©1999, 2006 Alcon, Inc.

12 x 2mL

STERILE

Alcon®Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

Printed in USA

ATROPINE SULFATE   atropine sulfate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0702 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Atropine Sulfate (Atropine) Atropine Sulfate 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Boric Acid   Sodium Hydroxide   Hydrochloric Acid   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0702-12 2 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/12/2000

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 09/2011Alcon Laboratories, Inc.

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• Atropine Ophthalmic Solution Dosage
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• Atropine Ophthalmic Solution Drug Interactions
• Atropine Ophthalmic Solution Support Group
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Testomar

Generic Name: yohimbine (yo HIM bean)

Brand Names: Erex, Testomar, Yocon, Yohimar, Yohimbe, Yohimex

What is Testomar (yohimbine)?

Yohimbine increases the amount of blood that is allowed to flow into the penis and prevents blood from flowing out of the penis. It can cause an erection.

Yohimbine is used to treat and diagnose some types of impotence.

Yohimbine may also be used for purposes other than those listed in this product guide.

What is the most important information I should know about Testomar (yohimbine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Yohimbine may cause dizziness. If you experience dizziness, avoid these activities.

Use caution when rising from a sitting or lying position. Yohimbine may be more likely to cause dizziness when changing positions.

What should I discuss with my healthcare provider before taking Testomar (yohimbine)?

Before taking this medication, tell your doctor if you

• have kidney disease;


• 
  

  have peptic ulcer disease (stomach ulcers);

  
  


• 
  

  are suffering from depression;

  
  


• 
  

  are being treated for a psychiatric condition; or

  
  


• 
  

  have any type of heart disease.

  
  

You may not be able to take yohimbine, or you may require a lower dose or special monitoring during therapy if you have any of the conditions listed above.

Yohimbine should not be used by women. Do not take this medication if you are pregnant or are breast-feeding. Yohimbine should not be used by children.

How should I take Testomar (yohimbine)?

Take yohimbine 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.

Yohimbine is usually taken three times a day. Follow your doctor's instructions.

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

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra yohimbine 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.

Symptoms of a yohimbine overdose include increased blood pressure (severe headache, blurred vision, flushing); a fast heart rate; numbness or tingling; runny nose; tremor; anxiety; poor coordination; and confusion or abnormal behavior.

What should I avoid while taking Testomar (yohimbine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Yohimbine may cause dizziness. If you experience dizziness, avoid these activities.

Use caution when rising from a sitting or lying position. Yohimbine may be more likely to cause dizziness when you change positions.

Testomar (yohimbine) side effects

If you experience any of the following serious side effects, stop taking yohimbine and seek emergency medical attention:

• 
  

  an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  
  


• 
  

  a very irregular or fast heartbeat; or

  
  


• 
  

  confusion or unusual behavior.

  
  

Other, less serious side effects are more likely to occur. Continue to take yohimbine and talk to your doctor if you experience

• 
  

  dizziness;

  
  


• 
  

  anxiety, irritability, or nervousness;

  
  


• 
  

  tremor (shaking);

  
  


• 
  

  headache; or

  
  


• 
  

  skin flushing.

  
  

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 Testomar (yohimbine)?

Before taking this medication, tell your doctor if you are taking a medicine for depression, mania, or another psychiatric condition. Generally, yohimbine should not be used with these medicines.

Drugs other than those listed here may also interact with yohimbine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Testomar resources

• Testomar Side Effects (in more detail)
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• Testomar Drug Interactions
• Testomar Support Group
• 0 Reviews for Testomar - Add your own review/rating

• yohimbine Advanced Consumer (Micromedex) - Includes Dosage Information


• Aphrodyne MedFacts Consumer Leaflet (Wolters Kluwer)


• Yohimbe Natural MedFacts for Professionals (Wolters Kluwer)


• Yohimbe Natural MedFacts for Consumers (Wolters Kluwer)

Compare Testomar with other medications

• Erectile Dysfunction
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Where can I get more information?

• Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

See also: Testomar side effects (in more detail)