AK-Pred

Generic Name: prednisolone ophthalmic (pred NIS oh lone)

Brand Names: Econopred Plus, Omnipred, Pred Forte, Pred Mild, Prednisol

What is AK-Pred (prednisolone ophthalmic)?

Prednisolone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Prednisolone ophthalmic (for the eyes) is used to treat eye swelling caused by allergy, infection, injury, surgery, or other conditions.

Prednisolone ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about AK-Pred (prednisolone ophthalmic)?

You should not use this medication if you are allergic to prednisolone or other steroids, or if you have certain types of infection (viral, fungal, or bacterial) that can affect your eyes.

Before using prednisolone ophthalmic, tell your doctor if you have glaucoma, herpes, or if you have recently had cataract surgery.

Do not use prednisolone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using prednisolone before putting your contact lenses in. Shake the eye drops gently before each use.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

If you still have pain or swelling after 2 days of treatment, stop using this medication and call your doctor. Do not stop using prednisolone ophthalmic suddenly after long-term use without first talking to your doctor. You may need to use less and less before you stop the medication completely.

What should I discuss with my healthcare provider before using AK-Pred (prednisolone ophthalmic)?

You should not use this medication if you are allergic to prednisolone or other steroids, or if you have certain types of infection (viral, fungal, or bacterial) that can affect your eyes.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use prednisolone ophthalmic:

• 
  

  glaucoma;

  
  


• 
  

  recent cataract surgery; or

  
  


• 
  

  herpes simplex.

  
  

FDA pregnancy category C. It is not known whether prednisolone ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether prednisolone ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use AK-Pred (prednisolone ophthalmic)?

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

Wash your hands before using prednisolone ophthalmic.

To apply the eye drops:

• Shake the bottle gently before each use to be sure the medicine is well mixed.


• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

If you still have pain or swelling after 2 days of treatment, stop using this medication and call your doctor. Do not stop using prednisolone ophthalmic suddenly after long-term use without first talking to your doctor. You may need to use less and less before you stop the medication completely.

If you use prednisolone ophthalmic for longer than 10 days, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

Store this medication at room temperature away from moisture and heat. Keep the bottle or tube tightly capped. Do not allow this medicine to freeze.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use 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.

An overdose of prednisolone ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while using AK-Pred (prednisolone ophthalmic)?

Do not wear any contact lens that has not been approved by your doctor.

Do not use prednisolone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using prednisolone ophthalmic before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Prednisolone ophthalmic can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

AK-Pred (prednisolone ophthalmic) 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:

• 
  

  pain behind your eyes, sudden vision changes, severe headache;

  
  


• 
  

  sudden eye irritation;

  
  


• 
  

  blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

  
  


• 
  

  signs of new eye infection, such as swelling, draining, or crusting of your eyes.

  
  

Less serious side effects may include:

• 
  

  temporary cloudy vision;

  
  


• 
  

  increased sensitivity to light; or

  
  


• 
  

  mild stinging, burning, itching, or irritation in your eyes.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect AK-Pred (prednisolone ophthalmic)?

It is not likely that other drugs you take orally or inject will have an effect on prednisolone used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More AK-Pred resources

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

• AK-Pred Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Econopred Prescribing Information (FDA)


• Econopred Plus Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Econopred Plus Prescribing Information (FDA)


• Omnipred Prescribing Information (FDA)


• Pred Forte Prescribing Information (FDA)


• Prednisolone Monograph (AHFS DI)


• Prednisolone Acetate eent Monograph (AHFS DI)

Compare AK-Pred with other medications

• Postoperative Ocular Inflammation

Where can I get more information?

• Your pharmacist can provide more information about prednisolone ophthalmic.

See also: AK-Pred side effects (in more detail)

Air Compressed

AIR, COMPRESSED

      

Linde

AIR, COMPRESSED

UN1002

MEDICAL AIR USP

MEDICAL GAS

NON-FLAMMABLE GAS 2

WARNING: For Breathing Support when used by properly trained personnel. For Medical Applications Rx only.

Administration of Medical Air may be hazardous or contraindicated. For use only by or under supervision of a licensed practitioner who is experienced in the use and administration of Medical Air and is familiar with the indications, effect, dosages, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.

CAUTION: HIGH PRESSURE COMPRESSED GAS MAY ACCELERATE COMBUSTION. Open valve slowly and close after each use. Keep away from heat, flame or sparks. Keep oil, grease and other combustibles away. Do not strike arc or laser beam on cylinder. Use equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52°C (125°F). Always secure cylinder in upright position. Return cylinder with 25 PSIG pressure. Return cylinder with cylinder cap secured, if applicable. Use this product in accordance with it's specific Material Safety Data Sheet, available at Web Site: www.lindeus.com.

CONTENTS:

Cylinder Type	Liters
K	6056	[_]
M	3000	[_]
E	679	[_]
D	396	[_]
_______	_______	_______

DO NOT REMOVE THIS PRODUCT LABEL.

Distributed by:

Linde

Linde Gas North America LLC

575 Mountain Ave.

Murray Hill, NJ 07974

CAS 132259-10-0

L&SP 4009 MG008D

Linde

AIR, COMPRESSED

UN1002

MEDICAL AIR USP

DO NOT REMOVE THIS PRODUCT LABEL

MEDICAL GAS

NON-FLAMMABLE GAS 2

WARNING: For breathing support when used by properly trained personnel. For Medical Applications Rx only. Administration of Medical Air may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Medical Air and is familiar with the indications, effect, dosages,  methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.

CAUTION: HIGH PRESSURE COMPRESSED GAS MAY ACCELERATE COMBUSTION. Open valve  slowly and close after each use. Keep away from heat, flame or sparks. Keep oil, grease and other combustibles away. Do not strike arc or laser beam on cylinder. Use equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52˚C (125˚F ). Always secure cylinder in upright position. Return cylinder with cylinder cap secured, if applicable. Use this product in accordance  with it's specific Material Safety Data Sheet, available at Web Site:  www.lindeus.com.

CONTENTS:

Cylinder Type	Liters
T	8066	[_]
K	6056	[_]
M	3000	[_]
_______	_______	_______

Distributed by:

Linde

Linde Gas North America LLC

575 Mountain Ave.

Murray Hill, NJ 07974

CAS 132259-10-0

L&SP 4010 MG009D

AIR, COMPRESSED   nitrogen, oxygen  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25373-006 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (Oxygen) Oxygen 21 L  in 100 L

Inactive Ingredients Ingredient Name Strength Nitrogen 79 L  in 100 L

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 25373-006-01 396 L In 1 CYLINDER None 2 25373-006-02 679 L In 1 CYLINDER None 3 25373-006-03 3000 L In 1 CYLINDER None 4 25373-006-04 6056 L In 1 CYLINDER None 5 25373-006-06 8050 L In 1 CYLINDER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		11/08/1989

Labeler - Linde Gas North America LLC (805568339)

Establishment
Name	Address	ID/FEI	Operations
Linde Gas North America LLC		010263301	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Linde Gas North America LLC		016271697	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Linde Gas North America LLC		833132561	MANUFACTURE

Revised: 12/2011Linde Gas North America LLC

Akineton HCl

Generic Name: biperiden (bye PEAR i den)

Brand Names: Akineton HCl

What is Akineton HCl (biperiden)?

Biperiden reduces the effects of certain naturally occurring chemicals in your body that may become unbalanced as a result of disease (such as Parkinson's disease), drug therapy, or other causes.

Biperiden is used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. It is also used to treat and prevent these same muscular conditions when they are caused by drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), and others.

Biperiden may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Akineton HCl (biperiden)?

Use caution when driving, operating machinery, or performing other hazardous activities. Biperiden may cause dizziness or blurred vision. If you experience dizziness or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking biperiden.

Avoid becoming overheated. Biperiden may cause decreased sweating. This could lead to heat stroke in hot weather or with vigorous exercise.

Who should not take Akineton HCl (biperiden)?

You cannot take biperiden if you

• 
  

  have ever had an allergic reaction to it,

  
  


• 
  

  have narrow-angle glaucoma,

  
  


• 
  

  have an obstruction in your bowel or a complication of bowel disease known as megacolon; or

  
  


• 
  

  have myasthenia gravis.

  
  

Before taking this medication, tell your doctor if you have

• 
  

  an enlarged prostate or difficulty urinating,

  
  


• 
  

  epilepsy or another seizure disorder,

  
  


• 
  

  heart disease or an irregular heartbeat,

  
  


• 
  

  depression or any other psychiatric illness, or

  
  


• kidney or liver disease.

You may need a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Biperiden is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Do not take biperiden without first talking to your doctor if you are pregnant. It is also not known whether biperiden passes into breast milk. Do not take biperiden without first talking to your doctor if you are breast-feeding a baby.

How should I take Akineton HCl (biperiden)?

Take biperiden exactly as directed by your doctor. 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. Take biperiden after a meal if it upsets your stomach.

Biperiden may be taken once or several times a day. The maximum amount of biperiden that should be taken in any one day is eight tablets (16 mg). Follow your doctor's instructions.

Store biperiden at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a biperiden overdose include large pupils; warm, dry skin; flushed face; fever; dry mouth; fast or irregular heartbeat; anxiety; hallucinations; confusion; agitation; hyperactivity; loss of consciousness; and seizures.

What should I avoid while taking Akineton HCl (biperiden)?

Use caution when driving, operating machinery, or performing other hazardous activities. Biperiden may cause dizziness or blurred vision. If you experience dizziness or blurred vision, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking biperiden.

Avoid becoming overheated. Biperiden may cause decreased sweating. This could lead to heat stroke in hot weather or with vigorous exercise. Try to keep as cool as possible and watch for signs of heat stroke such as decreased sweating, nausea, and dizziness.

Akineton HCl (biperiden) side effects

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

• 
  

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

  
  


• 
  

  unusual fever;

  
  


• 
  

  fast or irregular heartbeat;

  
  


• 
  

  anxiety, hallucinations, confusion, agitation, hyperactivity, or loss of consciousness;

  
  


• 
  

  seizures;

  
  


• 
  

  a rash; or

  
  


• 
  

  eye pain.

  
  

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

• 
  

  a dry mouth;

  
  


• 
  

  large pupils or blurred vision;

  
  


• 
  

  drowsiness;

  
  


• 
  

  difficulty urinating or constipation;

  
  


• 
  

  nervousness or anxiety;

  
  


• 
  

  upset stomach; or

  
  


• 
  

  decreased sweating.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Akineton HCl (biperiden)?

Before taking this medication, tell your doctor if you are taking:

• a tricyclic antidepressant (TCA) (used to treat depression, pain, or obsessive-compulsive disorder) such as amitriptyline (Elavil, Endep), doxepin (Sinequan), or clomipramine (Anafranil);


• other commonly used tricyclic antidepressants, including amoxapine (Asendin), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), and protriptyline (Vivactil);


• 
  

  a phenothiazine (used to treat mania, schizophrenia, other psychiatric conditions, and nausea and vomiting) such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), thioridazine (Mellaril), promazine (Sparine), trifluoperazine (Stelazine), and others;

  
  


• 
  

  an antihistamine such as diphenhydramine (Benadryl, others), chlorpheniramine (Chlor-Trimeton, others), triprolidine (Actifed, others), brompheniramine (Dimetapp, others), clemastine (Tavist) and others (antihistamines are often found in prescription and over-the-counter cold, allergy, and sleep medicines);

  
  


• 
  

  quinidine (Quinora, Quinaglute, Quinidex, Cardioquin);

  
  


• 
  

  amantadine (Symmetrel);

  
  


• 
  

  digoxin (Lanoxin, Lanoxicaps); or

  
  


• 
  

  haloperidol (Haldol).

  
  

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

More Akineton HCl resources

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

• Biperiden Professional Patient Advice (Wolters Kluwer)


• biperiden Advanced Consumer (Micromedex) - Includes Dosage Information


• Biperiden MedFacts Consumer Leaflet (Wolters Kluwer)


• Biperiden Hydrochloride Monograph (AHFS DI)

Compare Akineton HCl with other medications

• Extrapyramidal Reaction
• Parkinson's Disease

Where can I get more information?

• Your pharmacist has more information about biperiden written for health professionals that you may read.

See also: Akineton HCl side effects (in more detail)

AK-FLUOR

Dosage Form: injection
FULL PRESCRIBING INFORMATION

Indications and Usage for AK-FLUOR

AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

AK-FLUOR Dosage and Administration

Dosing

Adult Dose

The recommended dosage of AK-FLUOR® 10% (100 mg/mL) and of 25% (250 mg/mL) is 500 mg via intravenous administration.

Pediatric Dose

For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 10 lbs. (4.54 kg) of body weight.

Preparation for Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs.

Administration

Inject the dose (over 5-10 seconds is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with AK-FLUOR®, may be attached to transparent tubing and a 23 gauge butterfly needle for injection. Insert the needle and draw the patient's blood to the hub of the syringe so that a small air bubble separates the patient's blood in the tubing from the fluorescein. With the room lights on, slowly inject the blood back into the vein while watching the skin over the needle tip. If the needle has extravasated, the patient's blood will be seen to bulge the skin and the injection should be stopped before any fluorescein is injected. When assured that extravasation has not occurred, the room light may be turned off and the fluorescein injection completed. Luminescence usually appears in the retina and choroidal vessels in 7 to 14 seconds and can be observed by standard viewing equipment.

Reduction in dose from 500 mg to 200 mg of AK-FLUOR® 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.

Dosage Forms and Strengths

AK-FLUOR® (fluorescein injection, USP) 10%, 100 mg/mL in a 5 mL single use vial.

AK-FLUOR® (fluorescein injection, USP) 25%, 250 mg/mL in a 2 mL single use vial.

Contraindications

Hypersensitivity

AK-FLUOR® is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)].

Warnings and Precautions

Respiratory Reactions

Caution should be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should always be available.

If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.

Severe local tissue damage

Extravasation during injection can result in severe local tissue damage due to high pH of fluorescein solution. The following complications resulting from extravasation of fluorescein have been noted to occur: Sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median nerve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. [see Administration (2.3) and Adverse Reactions (6.6)].

Adverse Reactions

Skin and urine discoloration

The most common reaction is discoloration of the skin and urine. Skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours.

Gastrointestinal Reaction

The next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. A strong taste may develop after injection.

Hypersensitivity Reactions

Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. [see Contraindications (4.1) and Warnings and Precautions (5.1)]

Cardiopulmonary Reactions

Syncope and hypotension may occur. Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely. [see Warnings and Precautions (5.1)]

Neurologic Reactions

Headache may occur. Convulsions may rarely occur following injection.

Thrombophlebitis

Thrombophlebitis at the injection site has been reported. Extravasation of the solution at the injection site causes intense pain at the site and a dull aching pain in the injected arm. [see Administration (2.3) and Warnings and Precautions (5.2)].

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

Pediatric Use

Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients.

Geriatric Use

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

AK-FLUOR Description

AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 - 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure:

MW = 376.27

AK-FLUOR® 10% contains:

Active: fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL)

Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

AK-FLUOR® 25% contains:

Active: fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL)

Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

AK-FLUOR - Clinical Pharmacology

Mechanism of Action

Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465 to 490 nm and fluoresces, i.e., emits light at wavelengths of 520 to 530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the yellowish green fluorescence of the dye is captured by the camera. In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.

Pharmacokinetics

Distribution.

Within 7 to 14 seconds after IV administration into the antecubital vein, fluorescein usually appears in the central retinal artery of the eye. Within a few minutes of IV administration of fluorescein sodium, a yellowish discoloration of the skin occurs, which begins to fade 6 to 12 hours after dosing. Various estimates of volume of distribution indicate that fluorescein distributes into interstitial space (0.5 L/kg).

Metabolism.

Fluorescein is metabolized to fluorescein monoglucuronide. After IV administration of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was converted to glucuronide conjugate after a period of 1 hour post dose.

Excretion.

Fluorescein and its metabolite are mainly eliminated via renal excretion. After IV administration, the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 mL/min/kg and a hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated. The systemic clearance of fluorescein was essentially complete by 48 to 72 hours after administration of 500 mg fluorescein.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

How Supplied/Storage and Handling

AK-FLUOR® (fluorescein injection, USP) 10% is supplied in a single-use 5 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium.

(NDC 17478-253-10) 5 mL, single dose vials in a package of 12.

AK-FLUOR® (fluorescein injection, USP) 25% is supplied in a single-use 2 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium.

(NDC 17478-250-20) 2 mL, single dose vials in a package of 12.

AK-FLUOR® should be stored at 20° to 25°C (68° to 77°F). Do not freeze.

Patient Counseling Information

After administration of fluorescein sodium, skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours. [see Warnings and Precautions (6.1)].

Rx only

Manufactured by:

Akorn Inc.

Lake Forest, IL 60045

FL00N

Rev. 07/08

AK-FLUOR  fluorescein sodium  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17478-253 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Fluorescein Sodium (Fluorescein) Active 100 MILLIGRAM  In 1 MILLILITER Sodium Hydroxide Inactive   Hydrochloric Acid Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17478-253-10 12 VIAL In 1 PACKAGE contains a VIAL, SINGLE-DOSE 1 5 mL (MILLILITER) In 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (17478-253-10)

AK-FLUOR  fluorescein sodium  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17478-250 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Fluorescein Sodium (Fluorescein) Active 250 MILLIGRAM  In 1 MILLILITER Sodium Hydroxide Inactive   Hydrochloric Acid Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17478-250-20 12 VIAL In 1 PACKAGE contains a VIAL, SINGLE-DOSE 1 2 mL (MILLILITER) In 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (17478-250-20)

Revised: 08/2008Akorn Inc.

More AK-FLUOR resources

• AK-FLUOR Side Effects (in more detail)
• AK-FLUOR Dosage
• AK-FLUOR Drug Interactions
• AK-FLUOR Support Group
• 0 Reviews · Be the first to review/rate this drug

Ala-Quin

Generic Name: clioquinol and hydrocortisone topical (KLYE oh KWIN ol and HYE droe KOR ti sone TOP ik al)

Brand Names: Ala-Quin

What is clioquinol and hydrocortisone?

Clioquinol topical fights bacteria and prevents fungus from growing on your skin.

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of clioquinol and hydrocortisone is used to treat skin redness and itching caused by skin infections, eczema, or other skin conditions.

Clioquinol and hydrocortisone may also be used for other purposes not listed in this medication guide.

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

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

Do not cover the wound with a bandage dressing, unless your doctor has told you to. If you are treating diaper rash on an infant, do not use tight-fitting diapers or plastic pants. Covering the skin where this medicine has been applied can cause your body to absorb the steroid contained in the medication. Absorption of a steroid can cause unwanted side effects, especially in children. Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Call your doctor if your symptoms do not improve or if they get worse during the first 7 days of treatment with clioquinol and hydrocortisone.

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

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether clioquinol and hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. If you use clioquinol and hydrocortisone on a child, do not use the medication for longer than the child's doctor has prescribed.

How should I use clioquinol and hydrocortisone?

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

Before you apply clioquinol and hydrocortisone, use soap and water to wash the skin area you plan to treat.

Apply a thin layer of medication to the skin and rub it in gently.

Do not cover the wound with a bandage dressing, unless your doctor has told you to. If you are treating diaper rash on an infant, do not use tight-fitting diapers or plastic pants. Covering the skin where this medicine has been applied can cause your body to absorb the steroid contained in the medication. Absorption of a steroid can cause unwanted side effects, especially in children. Wash your hands thoroughly with soap and water after you apply this medication.

If you need to remove the medicine, wash it off with water and mild soap.

Call your doctor if your symptoms do not improve or if they get worse during the first 7 days of treatment with clioquinol and hydrocortisone.

Store this medication at room temperature away from moisture and heat. Do not allow the medicine to freeze.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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, or if anyone has accidentally swallowed it.

An overdose of clioquinol and hydrocortisone applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using clioquinol and hydrocortisone?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not give the medicine to another person, even if you think they have the same skin condition you have. Do not use this medication for any skin condition that has not been checked by your doctor.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Clioquinol and hydrocortisone may stain skin, clothing, and other fabrics it comes in contact with. Take care not to get this medicine on your clothes, carpet, or bed linens.

Clioquinol and hydrocortisone 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.

Other less serious side effects are more likely to occur, such as:

• 
  

  mild stinging or burning where the medicine is applied.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect clioquinol and hydrocortisone?

It is not likely that other drugs you take orally or inject will have an effect on topically applied clioquinol and hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Ala-Quin resources

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

• Ala-Quin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ala-Quin with other medications

• Dermatitis
• Eczema
• Pruritus

Where can I get more information?

• Your pharmacist can provide more information about clioquinol and hydrocortisone.

See also: Ala-Quin side effects (in more detail)

AK-Spore HC

Generic Name: neomycin, polymyxin B, and hydrocortisone ophthalmic (NEE oh MYE sin, POL ee MIX in, HYE droe KOR ti sone off THAL mik)

Brand Names:

What is neomycin, polymyxin B and hydrocortisone ophthalmic?

Neomycin and polymyxin B are antibiotics. They are used to treat bacterial infections.

Hydrocortisone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Neomycin, polymyxin B and hydrocortisone ophthalmic is used to treat bacterial infections of the eyes.

Neomycin, polymyxin B and hydrocortisone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about neomycin, polymyxin B and hydrocortisone ophthalmic?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Who should not use neomycin, polymyxin B and hydrocortisone ophthalmic?

Do not use neomycin, polymyxin B and hydrocortisone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether neomycin, polymyxin B and hydrocortisone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether neomycin, polymyxin B and hydrocortisone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use neomycin, polymyxin B and hydrocortisone ophthalmic?

Use neomycin, polymyxin B and hydrocortisone eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using your eyedrops.

To apply the eyedrops:

• 
  

  Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

  
  

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store neomycin, polymyxin B and hydrocortisone ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using neomycin, polymyxin B and hydrocortisone ophthalmic?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Neomycin, polymyxin B and hydrocortisone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Neomycin, polymyxin B and hydrocortisone ophthalmic side effects

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

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 neomycin, polymyxin B and hydrocortisone ophthalmic?

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with neomycin, polymyxin B and hydrocortisone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More AK-Spore HC resources

• AK-Spore HC Use in Pregnancy & Breastfeeding
• AK-Spore HC Drug Interactions
• AK-Spore HC Support Group
• 0 Reviews for AK-Spore HC - Add your own review/rating

Compare AK-Spore HC with other medications

• Blepharitis
• Conjunctivitis, Bacterial
• Keratitis
• Keratoconjunctivitis
• Uveitis

Where can I get more information?

• Your pharmacist has additional information about neomycin, polymyxin B and hydrocortisone written for health professionals that you may read.

AK-Con

Generic Name: naphazoline ophthalmic (na FAZ oh leen)

Brand Names: AK-Con, Albalon, Allerest Eye Drops, Clear Eyes, Degest 2, Estivin II, Nafazair, Naphcon, Naphcon Forte, VasoClear, Vasocon

What is AK-Con (naphazoline ophthalmic)?

Naphazoline ophthalmic causes constriction of blood vessels in the eyes. It also decreases itching and irritation of the eyes.

Naphazoline ophthalmic is used to relieve redness, burning, irritation, and dryness of the eye caused by wind, sun, and other minor irritants.

Naphazoline ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about AK-Con (naphazoline ophthalmic)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use naphazoline ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

What should I discuss with my healthcare provider before using AK-Con (naphazoline ophthalmic)?

Do not use naphazoline ophthalmic if you have glaucoma, except under the supervision of your doctor.

Before using this medication, tell your doctor if you

• 
  

  have any type of heart condition, including high blood pressure;

  
  


• 
  

  take any medicines to treat a heart condition;

  
  


• 
  

  have asthma;

  
  


• 
  

  have diabetes; or

  
  


• 
  

  have thyroid problems.

  
  

You may not be able to use naphazoline ophthalmic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Naphazoline ophthalmic is in the FDA pregnancy category C. This means that it is not known whether naphazoline ophthalmic will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether naphazoline passes into breast milk. Do not use naphazoline ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use AK-Con (naphazoline ophthalmic)?

Use naphazoline eye drops exactly as directed by your doctor, or follow the directions that accompany the package. If you do not understand these instructions, ask your doctor, pharmacist, or nurse to explain them to you.

Wash your hands before and after using the eye drops.

To apply the eye drops:

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

• 
  

  Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper. Squeeze out a drop and close the eye. Apply gentle pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down your tear duct. Repeat the process in the other eye if needed..

  
  

Do not use naphazoline ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen. Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye. Do not use any eye drop that is discolored or has particles in it. Store naphazoline ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to be harmful. If you do suspect an overdose, or if the drops have been ingested (taken by mouth), contact an emergency room or poison control center for advice.

What should I avoid while using AK-Con (naphazoline ophthalmic)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use naphazoline ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

AK-Con (naphazoline ophthalmic) side effects

If you experience any of the following serious side effects, stop using naphazoline ophthalmic and seek emergency medical attention or contact your doctor immediately:

• 
  

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

  
  


• 
  

  an irregular or fast heart rate; or

  
  


• 
  

  high blood pressure (severe headache, blurred vision, or flushed skin).

  
  

Other, less serious side effects may be more likely to occur. Continue to use naphazoline ophthalmic and talk to your doctor if you experience

• 
  

  burning, stinging, pain, or increased redness of the eye;

  
  


• 
  

  tearing or blurred vision;

  
  


• 
  

  headache;

  
  


• 
  

  tremor;

  
  


• 
  

  nausea;

  
  


• 
  

  sweating;

  
  


• 
  

  nervousness;

  
  


• 
  

  dizziness; or

  
  


• 
  

  drowsiness.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect AK-Con (naphazoline ophthalmic)?

Do not use other eye medications during treatment with naphazoline ophthalmic except under the direction of your doctor.

Although drug interactions between naphazoline ophthalmic and drugs taken by mouth are not expected, they can occur. Before using this medication, tell your doctor if you are taking any of the following medicines:

• 
  

  a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil); or

  
  


• 
  

  a beta-blocker such as propranolol (Inderal), metoprolol (Lopressor, Toprol XL), or labetalol (Normodyne, Trandate).

  
  

You may not be able to use naphazoline ophthalmic, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with naphazoline ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More AK-Con resources

• AK-Con Use in Pregnancy & Breastfeeding
• AK-Con Drug Interactions
• AK-Con Support Group
• 0 Reviews for AK-Con - Add your own review/rating

• AK-Con Advanced Consumer (Micromedex) - Includes Dosage Information


• Albalon Prescribing Information (FDA)


• Clear Eyes Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Naphcon Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Naphcon Prescribing Information (FDA)


• Naphcon Forte Prescribing Information (FDA)


• Vasocon Prescribing Information (FDA)

Compare AK-Con with other medications

• Eye Dryness/Redness
• Eye Redness/Itching

Where can I get more information?

• Your pharmacist has additional information about naphazoline ophthalmic written for health professionals that you may read.