Thursday, 8 March 2012

Vibra-Tabs


Generic Name: doxycycline (Oral route)

dox-i-SYE-kleen

Commonly used brand name(s)

In the U.S.


  • Adoxa

  • Adoxa CK

  • Adoxa Pak

  • Adoxa TT

  • Alodox

  • Doryx

  • Monodox

  • Oracea

  • Periostat

  • Vibramycin Calcium

  • Vibramycin Hyclate

  • Vibramycin Monohydrate

  • Vibra-Tabs

Available Dosage Forms:


  • Tablet

  • Powder for Suspension

  • Capsule

  • Capsule, Extended Release

  • Tablet, Delayed Release

  • Capsule, Delayed Release

  • Syrup

Therapeutic Class: Antibiotic


Chemical Class: Tetracycline (class)


Uses For Vibra-Tabs


Doxycycline is used to treat bacterial infections in many different parts of the body. It is also used to treat pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne.


Doxycycline delayed-release tablets are also used to prevent malaria and treat anthrax infection after possible exposure and other problems as determined by your doctor.


Doxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.


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


Before Using Vibra-Tabs


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


Allergies


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


Pediatric


Doxycycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger (except for treatment of exposure to inhalational anthrax), unless directed by the child's doctor.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doxycycline in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving doxycycline.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


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


  • Acitretin

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


  • Digoxin

  • Isotretinoin

  • Methotrexate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Aluminum Carbonate, Basic

  • Aluminum Hydroxide

  • Aluminum Phosphate

  • Bismuth Subsalicylate

  • Calcium

  • Desogestrel

  • Dienogest

  • Dihydroxyaluminum Aminoacetate

  • Dihydroxyaluminum Sodium Carbonate

  • Drospirenone

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Fosphenytoin

  • Iron

  • Levonorgestrel

  • Magaldrate

  • Magnesium Carbonate

  • Magnesium Hydroxide

  • Magnesium Oxide

  • Magnesium Trisilicate

  • Medroxyprogesterone Acetate

  • Mestranol

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Penicillin G

  • Penicillin G Procaine

  • Penicillin V

  • Rifampin

  • Rifapentine

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:


  • Diarrhea or

  • Vaginal candidiasis (yeast) infections—Use with caution. May make these conditions worse.

  • Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of doxycycline

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


Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.


To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.


If you are using Doryx® delayed-release tablets:


  • It may be taken with food or milk, if it upsets your stomach.

  • You may take this medicine by breaking the tablets. Hold the tablet between your thumb and index fingers close to the appropriate score (separation) line. Then, apply enough pressure to snap the tablet segments apart. Do not use the tablet if it does not break on the scored lines.

  • You may also take this medicine by sprinkling the equally broken tablets onto cold, soft food such as an applesauce. This mixture must be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. Do not store the mixture for later use.

  • Drink plenty of fluids to avoid throat irritation and ulceration.

If you are using this medicine to prevent malaria while traveling, start taking the medicine 1 or 2 days before you travel. Take the medicine every day during your trip and continue taking it for 4 weeks after you return. However, do not use the medicine for longer than 4 months.


If you are using For Oracea™ delayed-release capsules:


  • You should take this medicine on an empty stomach, preferably at least 1 hour before or 2 hours after meals.

  • You should take this medicine with a full glass of water while sitting or standing.

  • To prevent throat irritation, do not lay down right after taking this medicine.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.


Dosing


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


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


  • For oral dosage form (delayed-release tablets):
    • For infections:
      • Adults—100 milligrams (mg) every 12 hours on the first day, then 100 mg once a day or 50 to 100 mg every 12 hours.

      • Children older than 8 years of age who weigh 45 kg or less—Dose is based on body weight and must be determined by your doctor. The dose is usually 4.4 milligrams (mg) per kilogram (kg) of body weight per day and divided into two doses on the first day of treatment. This is followed by 2.2 mg per kg of body weight per day, taken as a single dose or divided into two doses on the following days.

      • Children up to 8 years of age—Use is not recommended.


    • For the prevention of malaria:
      • Adults—100 milligrams (mg) once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.

      • Children older than 8 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 milligrams (mg) per kilogram (kg) of body weight per day, taken as a single dose. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.

      • Children up to 8 years of age—Use is not recommended.



  • For oral dosage form (delayed-release capsules):
    • For the treatment of pimples from rosacea:
      • Adults—40 milligrams (mg) or one capsule once a day, in the morning.

      • Children—Use and dose must be determined by your doctor.



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.


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


Precautions While Using Vibra-Tabs


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


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.


This medicine may darken the color of your skin, nails, eyes, teeth, gums, or scars. Talk with your doctor if you have any concerns.


Doxycycline may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.


Birth control pills (containing estrogen) may not work properly while you are using doxycycline. To keep from getting pregnant, use other forms of birth control. These include condoms, diaphragms, or contraceptive foams or jellies.


Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:


  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

  • Wear protective clothing, including a hat. Also, wear sunglasses.

  • Apply a sunblock product that has a skin protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

  • Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.

  • Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.


Contact your doctor immediately if fever, rash, joint pain, or tiredness occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.


You should not take antacids that contain aluminum, calcium or magnesium, or any product that contains iron such as vitamin or mineral supplements.


If you are using this medicine to prevent malaria, take extra care not to get bitten by mosquitoes. Use protective clothing, mosquito netting or screens, and an insect repellent.


Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Vibra-Tabs Side Effects


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


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


Incidence not known
  • Abdominal or stomach tenderness

  • bloating

  • clay-colored stools

  • cough

  • dark urine

  • decreased appetite

  • diarrhea

  • diarrhea, watery and severe, which may also be bloody

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • feeling of discomfort

  • fever

  • headache

  • hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • hives or welts

  • increased thirst

  • inflammation of the joints

  • itching

  • joint or muscle pain

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • loss of appetite

  • nausea and vomiting

  • numbness or tingling of the face, hands, or feet

  • pain

  • rash

  • redness and soreness of the eyes

  • redness of the skin

  • shortness of breath

  • sore throat

  • sores in the mouth

  • stomach cramps

  • stomach pain or tenderness

  • swelling of the feet or lower legs

  • swollen lymph glands

  • tightness in the chest

  • unusual tiredness or weakness

  • unusual weight loss

  • wheezing

  • yellow eyes or skin

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:


Incidence not known
  • Back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • blurred vision

  • bulging soft spot on the head of an infant

  • change in the ability to see colors, especially blue or yellow

  • chest pain, discomfort, or burning

  • chills

  • cracks in the skin

  • decrease in vision

  • difficulty breathing

  • discoloration of the thyroid glands

  • double vision

  • general body swelling

  • heartburn

  • increased sensitivity of the skin to sunlight

  • loss of heat from the body

  • lower back or side pain

  • nosebleeds

  • pain or burning in the throat

  • pain with swallowing

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

  • rash with flat lesions or small raised lesions on the skin

  • red, swollen skin

  • redness or other discoloration of the skin

  • redness, swelling, or soreness of the tongue

  • scaly skin

  • severe nausea

  • severe stomach pain

  • severe sunburn

  • sores, ulcers, or white spots on the lips or tongue or inside the mouth

  • unusual bleeding or bruising

  • vomiting blood

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: Vibra-Tabs 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.


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More Vibra-Tabs resources


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


  • Vibra-Tabs MedFacts Consumer Leaflet (Wolters Kluwer)

  • Doxycycline Monograph (AHFS DI)

  • Doxycycline Professional Patient Advice (Wolters Kluwer)

  • Doxycycline Prescribing Information (FDA)

  • Doxycycline MedFacts Consumer Leaflet (Wolters Kluwer)

  • Adoxa MedFacts Consumer Leaflet (Wolters Kluwer)

  • Alodox Prescribing Information (FDA)

  • Doryx Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Doryx Prescribing Information (FDA)

  • Doxycycline Calcium Monograph (AHFS DI)

  • Monodox Prescribing Information (FDA)

  • Ocudox Convenience Kit MedFacts Consumer Leaflet (Wolters Kluwer)

  • Oracea Prescribing Information (FDA)

  • Oracea Consumer Overview

  • Periostat MedFacts Consumer Leaflet (Wolters Kluwer)

  • Periostat Prescribing Information (FDA)

  • Vibramycin Prescribing Information (FDA)



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Monday, 5 March 2012

Acular eent


Generic Name: Ketorolac Tromethamine eent
Class: Nonsteroidal Anti-inflammatory Agents
ATC Class: S01BC05
VA Class: OP300
CAS Number: 74103-07-4

Introduction

Prototypical NSAIA; a pyrrolizine carboxylic acid derivative.1 2 3 4 14 21 22 25 26 27 28


Uses for Acular


Conjunctivitis


Temporary relief of ocular itching due to seasonal allergic (hay fever, pollinosis) conjunctivitis.1 141 142 143


Postoperative Ocular Inflammation


Management of postoperative inflammation associated with cataract extraction.1 11 17 18 19 61 85 110 147


Postoperative Ocular Pain


Reduction of ocular pain and burning/stinging following corneal refractive surgery and photorefractive keratectomy (PRK).155 156


Ketorolac tromethamine 0.5% preservative-free ophthalmic solution is used for the reduction of ocular pain and photophobia following incisional refractive surgery.154


Cystoid Macular Edema


Treatment, with or without concomitant topical corticosteroid therapy, to prevent or relieve postoperative cystoid macular edema associated with cataract extraction.61


Has been used for the active treatment of chronic aphakic or pseudophakic cystoid macular edema.14 20 23


Inhibition of Intraoperative Miosis


Has been used prophylactically before ocular surgery to prevent or reduce intraoperative miosis.53 81 106 107 108 110 137 139


Acular Dosage and Administration


Administration


Ophthalmic Administration


Apply topically to the eye as an ophthalmic solution.1 154 155


Avoid contamination of the solution container.154


Do not administer while wearing contact lenses.1 154 155


Preservative-free solution is for single use only in one or both eyes; use immediately after opening and discard any unused portion immediately after administration.154


Has been safely administered with other ophthalmic medications (e.g., antibiotics, β-blockers, carbonic anhydrase inhibitors, cycloplegics, mydriatics).1


Dosage


Available as ketorolac tromethamine; dosage expressed in terms of the salt.154 155


Pediatric Patients


Conjunctivitis

Ophthalmic

Children ≥3 years of age: 1 drop (250 mg) of a 0.5% solution in the affected eye(s) 4 times daily.1 141 142


Postoperative Ocular Inflammation

Ophthalmic

Children ≥3 years of age: 1 drop (250 mcg) of a 0.5% solution in the eye(s) undergoing surgery 4 times daily beginning 24 hours after surgery and typically continuing for 2 weeks after surgery.1


Postoperative Ocular Pain

Ophthalmic

Children ≥3 years of age undergoing ocular incisional refractive surgery: 1 drop (250 mcg) of a 0.5% preservative-free solution 4 times daily in the eye(s) that underwent surgery as needed for up to 3 days after surgery.154


Children ≥3 years of age undergoing corneal refractive surgery: 1 drop (200 mcg) of a 0.4% solution 4 times daily in the eye(s) that underwent surgery as needed for up to 4 days after surgery.155


Adults


Conjunctivitis

Ophthalmic

1 drop (250 mg) of a 0.5% solution in the affected eye(s) 4 times daily.1 141 142


Postoperative Ocular Inflammation

Ophthalmic

1 drop (250 mcg) of a 0.5% solution in the eye(s) undergoing surgery 4 times daily beginning 24 hours after surgery and typically continuing for 2 weeks after surgery.1


Postoperative Ocular Pain

Ophthalmic

Patients undergoing ocular incisional refractive surgery: 1 drop (250 mcg) of a 0.5% preservative-free solution 4 times daily in the eye(s) that underwent surgery as needed for up to 3 days after surgery.154


Patients undergoing corneal refractive surgery: 1 drop (200 mcg) of a 0.4% solution 4 times daily in the eye(s) that underwent surgery as needed for up to 4 days after surgery.155


Cystoid Macular Edema

Postoperative Cystoid Macular Edema

Ophthalmic

1–2 drops (250–500 mcg) of a 0.5% solution in the eye(s) undergoing surgery every 6–8 hours beginning 24 hours prior to surgery and continuing for 3–4 weeks after surgery.11 17 18 19 61 85


Chronic Aphakic or Pseudophakic Cystoid Macular Edema

Ophthalmic

1–2 drops (250–500 mcg) of a 0.5% solution in the affected eye(s) 4 times daily for 2–3 months.20 23


Cautions for Acular


Contraindications


Known hypersensitivity to ketorolac tromethamine or any ingredient in the formulation.1 154 155


Warnings/Precautions


Warnings


Hematologic Effects

May inhibit platelet aggregation and prolong bleeding time.1 137 154 155


May increase bleeding (e.g., hyphemas) of ocular tissues in patients undergoing ocular surgery.1 24 53 106 154 155


Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.1 154 155


Sensitivity Reactions


Cross-sensitivity

Possible cross-sensitivity with aspirin, phenylacetic acid derivatives, and other NSAIAs.1 154 155 Use with caution in patients with history of hypersensitivity to these drugs.1 54 55 56 57 58 59 85 117 118 154 155


General Precautions


Wound Healing Complications

Possible slow or delayed wound healing; may be potentiated with concomitant adminsitration of topical NSAIAs or topical corticosteroids.1 154 155 (See Specific Drugs under Interactions.)


Ocular Effects

Use may result in keratitis.1 85 139 154 155 In susceptible patients, continued use may result in epithelial breakdown, corneal thinning, erosion, ulceration, or perforation, which may be sight-threatening.1 154 155


If manifestations of corneal epithelial breakdown occur, discontinue immediately and closely monitor corneal health.1 154 155


Increased risk of sight-threatening, adverse corneal effects in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time; use with caution in such patients.1 154 155


Use >24 hours prior to surgery or >14 days postoperatively may precipitate or exacerbate adverse corneal effects.1 154 155


Specific Populations


Pregnancy

Category C.1 154 155 Avoid use in the third trimester because of possible premature closure of the ductus arteriosus.1 154 155


Lactation

Distributed into milk after systemic administration.2 14 21 22 48 85 Caution if used in nursing women.1 154 155


Pediatric Use

Safety and efficacy not established in children <3 years of age.1 154 155


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 154 155


Common Adverse Effects


Ocular stinging and burning.1 154 155


Interactions for Acular


No formal drug interaction studies to date.1 154 155


Specific Drugs









Drug



Interaction



Comments



Corticosteroids, ophthalmic



Possible additive effects on delaying wound healing1 154 155


Additive ocular anti-inflammatory activity1 154 155



Concomitant use may increase the potential for wound healing complications1 154 155


Potential for additive effects used to therapeutic advantage11 18 81


Acular Pharmacokinetics


Absorption


Bioavailability


Extent of ocular and systemic absorption not fully elucidated;1 however, limited concentrations are achieved systemically following topical application to the eye relative to usual oral or parenteral doses.1 14 16 18


Following topical application to the eye, plasma ketorolac concentrations were detectable (range: 10.7–22.5 ng/mL) in about 20% of patients.1 154 155


Distribution


Extent


Distribution into human ocular tissues and fluids not fully characterized to date.1 14 78


Ketorolac crosses the placenta21 28 46 47 78 and is distributed into milk following systemic administration.2 14 21 22 48 78


Plasma Protein Binding


>99%.2 14 28 45 49 78


Stability


Storage


Ophthalmic


0.4% Solution

15–25°C.155


0.5% Solution

Light-resistant containers at 15–30°C.1 154


ActionsActions



  • Inhibits synthesis of certain ocular prostaglandins (e.g., PGE2) in iris, ciliary body, and conjunctiva by inhibiting cyclooxygenase-1 (COX-1) and -2 (COX-2).1 2 4 6 10 21 28 40 62 66 68 69 70 71 72 73 77 80 81 110 154 155




  • Substantially reduces aqueous humor concentrations of these prostaglandins.1 80 81 110 121 122 123 126 128




  • Does not appear to inhibit lipoxygenase;21 81 does not inhibit aspects of inflammation mediated by leukotrienes.81 119 137



Advice to Patients



  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1 154 155




  • Importance of removing contact lenses before administration.1 154 155




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 154 155




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1 154 155




  • Importance of informing patients of other important precautionary information.1 154 155 (See Cautions.)



Preparations


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























Ketorolac Tromethamine

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Ophthalmic



Solution



0.4%



Acular LS (with benzalkonium chloride)



Allergan



0.5%



Acular (with benzalkonium chloride)



Allergan



Acular PF (preservative-free)



Allergan


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.


Acular 0.5% Solution (ALLERGAN): 3/$59.34 or 9/$158.96


Acular 0.5% Solution (ALLERGAN): 5/$132.07 or 15/$370.21


Acular 0.5% Solution (ALLERGAN): 10/$236.03 or 30/$687.45


Acular LS 0.4% Solution (ALLERGAN): 5/$133.52 or 15/$400.6


Acuvail 0.45% Solution (ALLERGAN): 30/$133.11 or 90/$374.39


Ketorolac Tromethamine 0.4% Solution (FALCON PHARMACEUTICALS): 5/$75.99 or 15/$199.96



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 January 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



1. Allergan. Acular (ketorolac tromethamine) ophthalmic solution 0.5% sterile prescribing information. Irvine, CA; 2002 Feb.



2. Syntex Laboratories Inc. Toradol (ketorolac tromethamine) tablets and injection prescribing information. Physicians’ desk reference. 47th ed. Montvale, NJ: Medical Economics Company Inc; 1993:2411-5.



3. Muchowski JM, Unger SH, Ackrell J et al. Synthesis and antiinflammatory and analgesic activity of 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole -1-carboxylic acids and related compounds. J Med Chem. 1985; 28: 1037-49. [PubMed 4020827]



4. Rooks WH II, Maloney PJ, Shott LD et al. The analgesic and anti-inflammatory profile of ketorolac and its tromethamine salt. Drugs Exp Clin Res. 1985; 11:479-92. [PubMed 3879752]



5. Guzman A, Yuste F, Toscano RA et al. Absolute configuration of (-)-5-benzoyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole -1-carboxy lic acid, the active enantiomer of ketorolac. J Med Chem. 1986; 29:589-91. [PubMed 3959034]



6. Syntex Laboratories Inc, Palo Alto, CA: Personal communication on ketorolac 28:08.04.



7. Gu L, Strickley RG. Preformulation salt selection: physical property comparisons of the tris(hydroxymethyl)aminomethane (THAM) salts of four analgesic/antiinflammatory agents with the sodium salts and the free acids. Pharm Res. 1987; 4:255-7. [PubMed 3509292]



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10. Rooks WH II, Tomolonis AJ, Maloney PJ et al. The analgesic and anti-inflammatory profile of (±)-5-benzoyl-1,2-dihydro-3 H-pyrrolo[1,2a]pyrrole-1-carboxylic acid (rS -37619). Agents Actions. 1982; 12:684-90. [PubMed 6984594]



11. Flach AJ, Lavelle CJ, Olander KW et al. The effect of ketorolac tromethamine solution 0.5% in reducing postoperative inflammation after cataract extraction and intraocular lens implantation. Ophthalmology. 1988; 95:1279-84. [PubMed 3062540]



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53. Allergan Medical Optics. Ocufen Liquifilm (flurbiprofen sodium) 0.03% sterile ophthalmic solution prescribing information. Physicians’ desk reference for ophthalmology. Montvale, NJ: Medical Economics Company Inc; 1993:236-7.



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55. Pleskow WW, Stevenson DD, Mathison DA et al. Aspirin desensitization in aspirin-sensitive asthmatic patients: clinical manifestations and characterization of the refractory period. J Allergy Clin Immunol. 1982; 69(1 Part 1):11-9. [IDIS 144037] [PubMed 7054250]



56. VanArsdel PP Jr. Aspirin idiosyncrasy and tolerance. J Allergy Clin Immunol. 1984; 73:431-3. [IDIS 183975] [PubMed 6423718]



57. Stevenson DD. Diagnosis, prevention, and treatment of adverse reactions to nonsteroidal anti-inflammatory drugs. J Allergy Clin Immunol. 1984; 74(4 Part 2):617-22. [IDIS 193318] [PubMed 6436354]



58. Stevenson DD, Mathison DA. Aspirin sensitivity in asthmatics: when may this drug be safe? Postgrad Med. 1985; 78:111-3,116-9.



59. Settipane GA. Aspirin and allergic diseases: a review. Am J Med. 1983; 74(Suppl):102-9. [IDIS 171763] [PubMed 6344621]



60. Indocin (indomethacin) capsules, oral suspension, and suppositories prescribing information. In: Barnhart ER, ed. Physicians’ desk reference. 44th ed. Oradell, NJ: Medical Economics Company Inc; 1990:1395-8.



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75. Helleboid L, Khatami M, Wei ZG et al. Histamine and prostacyclin: primary and secondary release in allergic conjunctivitis. Invest Ophthalmol Vis Sci. 1991; 32:2281-9. [PubMed 1712764]



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77. Trocme SD. Medical therapy for ocular allergy. Mayo Clin Proc. 1992; 67:557-65. [IDIS 296611] [PubMed 1359206]



78. Brocks DR, Jamali F. Clinical pharmacokinetics of ketorolac tromethamine. Clin Pharmacokinet. 1992; 23:415-27. [PubMed 1458761]



79. Sabiston D, Tessler H, Sumers K et al. Reduction of inflammation following cataract surgery by the nonsteroidal anti-inflammatory drug, flurbiprofen. Ophthalmic Surg. 1987; 18:873-7. [PubMed 3502173]



80. Bhattacherjee P. The role of arachidonate metabolites in ocular inflammation. Prog Clin Biol Res. 1989; 312:211-27. [PubMed 2508125]



81. Flach AJ. Cyclo-oxygenase inhibitors in ophthalmology. Surv Ophthalmol. 1992; 36:259-84. [PubMed 1549810]



82. Buckley DC, Caldwell DR, Reaves TA Jr. Treatment of vernal conjunctivitis with suprofen, a topical nonsteroidal anti-inflammatory agent. Invest Ophthalmol Vis Sci. 1986; 27:29. [IDIS 213714] [PubMed 3941035]



83. Wood TS, Stewart RH, Bowman RW et al. Suprofen treatment of contact lens-associated giant papillary conjunctivitis. Ophthalmology. 1988; 95:822-6. [PubMed 3211485]



84. Gupta S, Khurana AK, Ahluwalia BK et al. Topical indomethacin for vernal keratoconjunctivitis. Acta Opthalmol (Copenh). 1991; 69:95-8.



85. Allergan. Acular (ketorolac tromethamine) prescribing information. In: Krogh CME, ed. Compendium of pharmaceuticals and specialties 1993. 28th ed. Ottawa, Ontario: Canadian Pharmaceutical Association; 1993:23.



86. CIBA Vision. Voltaren Ophthalmic (diclofenac sodium) prescribing information. In: Krogh CME, ed. Compendium of pharmaceuticals and specialties 1993. 28th ed. Ottawa, Ontario: Canadian Pharmaceutical Association; 1993:1333-4.



87. Merck Sharp and Dohme. Indocid (indomethacin) ophthalmic suspension prescribing information. In: Krogh CME, ed. Compendium of pharmaceuticals and specialties 1993. 28th ed. Ottawa, Ontario: Canadian Pharmaceutical Association; 1993:583.



88. Asbell PA, Torres MA. Therapeutic dilemmas in external ocular diseases. Drugs. 1991; 42:606-15. [PubMed 1723363]



89. Leibowitz HM, Ryan WJ, Kupferman A et al. Bioavailability of corneal anti-inflammatory effect of topical suprofen. Invest Ophthalmol Vis Sci. 1986; 27:628-31. [PubMed 3957583]



90. Leibowitz HM, Ryan WJ, Kupferman A et al. Effect of concurrent topical corticosteroid and NSAID therapy of experimental keratitis. Invest Ophthalmol Vis Sci. 1986; 27:1226-9. [PubMed 3733368]



91. Kraff MC, Sanders DR, McGuigan L et al. Inhibition of blood-aqueous humor barrier breakdown with diclofenac: a fluorophotometric study. Arch Ophthalmol. 1990; 108:380-3. [IDIS 296047] [PubMed 2178597]



92. Bito LZ. Surgical miosis: have we been misled by a bunch of rabbits? Ophthalmology. 1990; 97:1-2. Letter.



93. Kraff MC, Sanders DR, Jampol LM et al. Factors affecting pseudophakic cystoid macular edema: five randomized trials. J Am Intraocul Implant Soc. 1985; 11:380-5. [PubMed 4030486]



94. Gnad HD, Paroussis P, Skorpik C. Treatment of cystoid macular edema after intracapsular cataract extraction and implantation of the Binkhorst 4-loop lens. (German; with English abstract.) Wien Klin Wochenschr. 1985; 97:625-7.



95. Alpar JJ. Posterior capsulotomy in sulcus-fixated versus bag-fixated intraocular lenses in diabetic patients. J Am Intraocul Implant Soc. 1985; 11:577-80. [PubMed 4077672]



96. Jampol LL. Pharmacologic therapy of aphakic and pseudophakic cystoid macular edema. 1985 update. Ophthalmology. 1985; 92:807-10. [PubMed 3897936]



97. Lambrix K. Cystoid macular edema: a postoperative complication. J Ophthalmic Nurs Technol. 1990; 9:152-4. [PubMed 2374166]



98. Peterson M, Yoshizumi MO, Hepler R et al. Topical indomethacin in the treatment of chronic cystoid macular edema. Graefes Arch Clin Exp Ophthalmol. 1992; 230:401-5. [PubMed 1521802]



99. Sears ML. Aphakic cystoid macular edema. The pharmacology of ocular trauma. Surv Ophthalmol. 1984; 28(Suppl):525-34. [PubMed 6379950]



100. Yannuzzi LA. A perspective on the treatment of aphakic cystoid macular edema. Surv Ophthalmol. 1984; 28(Suppl):540-53. [PubMed 6379952]



101. Yannuzzi LA, Landau AN, Turtz AL. Incidence of aphakic cystoid macular edema with the use of topical indomethacin. Ophthalmolgy. 1981; 88:947-54.



102. Kraff MC, Sanders DR, Jampol LM et al. Prophylaxis of pseudophakic cystoid macular edema with topical indomethacin. Ophthalmology. 1982; 89:885-90. [PubMed 6752799]



103. Miyake K, Sakamura S, Miura H. Long-term follow-up study on the prevention of aphakic cystoid macular edema by topical indomethacin. Br J Ophthalmol. 1980; 64:324-8. [PubMed 7437393]



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105. Foster CS, Rice BA, Dutt JE. Immunopathology of atopic keratocomjunctivitis. Ophthalmology. 1991; 98:1190-6. [PubMed 1923355]



106. Alcon Laboratories. Profenal (suprofen) 1% sterile ophthalmic solution prescribing information. In: Physicians’ desk reference for ophthalmology. 21st ed. Montvale, NJ: Medical Economics Company; 1993;233-5.



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Saturday, 3 March 2012

Maxiphen CDX


Generic Name: codeine, guaifenesin, and phenylephrine (KOE deen, gwye FEN e sin, FEN il EFF rin)

Brand Names: Maxiphen CD, Maxiphen CDX


What is Maxiphen CDX (codeine, guaifenesin, and phenylephrine)?

Codeine is in a group of drugs called narcotics. It is a cough suppressant that affects the signals in the brain that trigger cough reflex.


Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.


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


The combination of codeine, guaifenesin, and phenylephrine is used to treat cough, nasal, and sinus congestion, and to reduce chest congestion caused by upper respiratory infections or the common cold.


Codeine, guaifenesin, and phenylephrine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Maxiphen CDX (codeine, guaifenesin, and phenylephrine)?


Do not take 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 cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains guaifenesin or phenylephrine. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. 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.

What should I discuss with my healthcare provider before taking Maxiphen CDX (codeine, guaifenesin, and phenylephrine)?


Do not take 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 cough or cold medicine before the MAO inhibitor has cleared from your body. You should not take codeine, guaifenesin, and phenylephrine if you have ever had an allergic reaction to it, or if you have:

  • severe or uncontrolled high blood pressure;




  • severe coronary artery disease;




  • enlarged prostate; or




  • if you are breast-feeding a baby.



If you have certain conditions, you may need a dose adjustment or special tests to safely take codeine, guaifenesin, and phenylephrine. Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:



  • heart disease or high blood pressure;




  • ischemic heart disease (reduced circulation of blood to the heart);




  • asthma, COPD, sleep apnea, or other breathing disorders;




  • diabetes;




  • a thyroid disorder;




  • glaucoma;




  • a history of head injury or brain tumor;




  • epilepsy or other seizure disorder;



  • liver or kidney disease;


  • a stomach or intestinal disorder;




  • Addison's disease or other adrenal gland disorders; or




  • if you have recently had stomach, bladder, or kidney surgery.




FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Older adults may be more likely to have side effects from this medication.

How should I take Maxiphen CDX (codeine, guaifenesin, and phenylephrine)?


Take this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.


Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take codeine, guaifenesin, and phenylephrine with food if it upsets your stomach. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you also have a fever, headache, or skin rash.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using codeine guaifenesin, and phenylephrine.


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


Keep track of how many pills have been used from each new bottle of this medicine. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?


Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. An overdose of codeine can be fatal.

Overdose symptoms may include extreme dizziness or drowsiness, nausea, vomiting, stomach, sweating, confusion, hallucinations, cold and clammy skin, blue-colored lips or fingernails, weak or limp muscles, pinpoint pupils, weak pulse, slow breathing, fainting, or seizures (convulsions).


What should I avoid while taking Maxiphen CDX (codeine, guaifenesin, and phenylephrine)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other over-the-counter cough, cold, pain, or allergy medication without first asking your doctor or pharmacist. Guaifenesin and phenylephrine are contained in many medicines available over the counter. 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 guaifenesin or phenylephrine.


Avoid drinking alcohol. It can increase some of the side effects of this medication.

Maxiphen CDX (codeine, guaifenesin, and phenylephrine) 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 taking this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness, anxiety, restless feeling, or nervousness, tremors;




  • confusion, hallucinations, unusual thoughts or behavior;




  • seizure (convulsions);




  • fast, pounding, or uneven heartbeat;




  • slow heart rate, weak pulse, fainting, weak or shallow breathing; or




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



Less serious side effects include:



  • dizziness, drowsiness, headache;




  • nausea, vomiting;




  • constipation;




  • feeling excited or restless;




  • sleep problems (insomnia);




  • warmth, tingling, or redness under your skin; or




  • skin rash or itching.



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 Maxiphen CDX (codeine, guaifenesin, and phenylephrine)?


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

Also tell your doctor if you are using any of the following drugs:



  • medicines to treat high blood pressure;




  • indomethacin (Indocin);




  • mecamylamine (Inversine);




  • methyldopa (Aldomet);




  • reserpine;




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol, and others; or




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



This list is not complete and there may be other drugs that can interact with codeine, guaifenesin, and phenylephrine. 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 Maxiphen CDX resources


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


  • Codeine/Guaifenesin/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Maxiphen CDX with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about codeine, guaifenesin, and phenylephrine.


Thursday, 1 March 2012

Provigil






PROVIGIL Tablets 100 mg/200 mg


(Modafinil)



Read all of this leaflet carefully before you start taking this medicine.


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

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

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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



In this leaflet:


  • 1. What PROVIGIL is and what it is used for.

  • 2. Before you take PROVIGIL.

  • 3. How to take PROVIGIL.

  • 4. Possible side effects.

  • 5. How to store PROVIGIL.

  • 6. Further information.




What Provigil Is And What It Is Used For


The name of your medicine is PROVIGIL 100 mg or 200 mg tablets. The active ingredient in them is modafinil.


PROVIGIL is a medicine that helps people with sleep problems stay awake, including the following medical conditions; narcolepsy, obstructive sleep apnoea or a moderate to severe sleep disorder (i.e. due to shift work patterns).




Before You Take Provigil



Do not take PROVIGIL if you:


  • Are allergic (hypersensitive) to modafinil, or any of the other ingredients of PROVIGIL.

  • Are pregnant, planning to become pregnant or breast-feeding.

  • Have an irregular heartbeat.

  • Have uncontrolled, moderate/severe high blood pressure (hypertension).

PROVIGIL is not recommended for children.




Take Special Care with PROVIGIL if you:


  • Have any heart problems.

  • Have an abnormal heart beat.

  • Have problems with excessive anxiety.

  • Have high blood pressure (hypertension).

  • Have kidney disease.

  • Have liver disease.

  • Are over 65 years of age.

  • Have ever had depression, low mood, psychosis (loss of contact with reality) or mania (over excitation).

If any of the above apply to you, you should speak to your doctor before taking this medicine.


Some people have reported suicidal or aggressive thoughts or behaviour while taking PROVIGIL. Be sure to tell your doctor if you notice that you are becoming depressed or have suicidal thoughts or changes in your behaviour. You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.


Although this medicine has a low potential for dependence, the chance of this happening with long-term use cannot be completely ruled out.




Taking with other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. It is especially important if you are taking:


  • Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches). Talk to your doctor about birth control methods that are right for you while using PROVIGIL, and for two months after stopping PROVIGIL.

  • Medicines for acid reflux (eg omeprazole).

  • Antiviral medicines (protease inhibitors).

  • Ciclosporin (eg used in organ transplants, arthritis and psoriasis).

  • Medicines for epilepsy (eg phenytoin).

  • Medicines for depression or anxiety.

  • Medicines for thinning the blood (eg warfarin).

  • Medicines for high blood pressure or heart problems (eg calcium channel blockers).

  • Medicines for lowering cholesterol (statins).

  • Betablockers (eg propanalol).



Pregnancy and breast-feeding


If you are pregnant, think you might be or are breast-feeding you should not take PROVIGIL. It is not known if PROVIGIL may harm your unborn baby.




Driving and operating machinery


PROVIGIL can sometimes cause blurred vision or dizziness in some people. If you are affected or you find that using this medication makes you feel excessively sleepy, do not attempt to drive or operate machinery.




Important information about one of the ingredients of PROVIGIL


These tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, you should contact them before taking this medicine.





How To Take Provigil


Always take PROVIGIL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



Narcolepsy and sleep apnoea


The usual dose is 200 to 400 mg a day. This can be taken once daily (in the morning) or twice daily (in the morning and at midday).



Moderate to severe chronic shift work sleep disorder


The recommended dose is 200 mg, once a day (approximately 1 hour before the start of a night shift).


Your doctor may sometimes prescribe a lower dose than this, depending on your individual circumstances.


Tablets should be swallowed whole with water.



If you take more PROVIGIL than you should


If you take too much PROVIGIL contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any remaining tablets with you.




If you forget to take PROVIGIL


If you forget to take PROVIGIL take the next dose at the usual time, do not take a double dose to make up for the forgotten one.



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




Provigil Side Effects


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



Stop taking this medicine and tell your doctor immediately if you have difficulty breathing or your mouth or throat begins to swell or if you start suffering from a severe rash, itching or other skin reactions, as these may be signs of an allergic reaction.



Other side effects include the following:



Very common side effects (affecting more than 1 in 10 people):


  • Headache.


Common side effects (affecting between 1 in 10 and 1 in 100 people):


  • An irregular or fast heartbeat.

  • Chest pain, stomach pain, indigestion.

  • Weakness, flushing, feeling sick, dizziness, dry mouth.

  • Diarrhoea, constipation, loss of appetite.

  • Nervousness, anxiety, depression, abnormal thinking, confusion.

  • Difficulty sleeping (insomnia), sleepiness, excessive tiredness.

  • Pins and needles, blurred vision, abnormal liver function tests.


Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 people):


  • Back pain, neck pain, muscle soreness, muscle weakness, leg cramps, joint pain, twitching.

  • Difficulty moving muscles smoothly, muscle tension, coordination problems, movement disorder.

  • Minor allergic reactions (such as hayfever), shortness of breath, itchy/runny nose, increased cough, asthma, sore throat.

  • Skin rash, acne, itchy skin, excessive sweating.

  • Increased blood pressure, abnormal heart tests, irregular or unusually slow heart beat, high/low blood pressure.

  • Excess wind, reflux (bringing back fluid from the stomach), increased appetite, thirst, taste alteration.

  • Being sick, migraine, speech disorder.

  • Difficulty swallowing, sore tongue, mouth ulcers.

  • Diabetes, blood disorders, increased blood cholesterol or blood sugar.

  • Swelling of hands and feet, weight changes.

  • Over-activity, agitation, tremor, vertigo, hostile behaviour, feeling detached, numbness, personality disorder.

  • Sleep disturbance, abnormal dreams, mood swings, aggression, forgetfulness, loss of sex drive.

  • Nose bleeds, inflamed nasal passages (sinuses).

  • Abnormal vision, dry eyes, abnormal urine, more frequent urination, abnormal periods.



In addition, if you experience any of the following you should tell your doctor immediately:


  • Psychological effects e.g. mood elation and over excitation, suicidal behaviour, agitation, and/or psychosis (a loss of contact with reality which may include delusions or hearing sounds that are not there).

  • Severe rash that may cause peeling of the skin.

  • Sudden wheeziness, difficulty breathing, swelling, rash or itching, especially if it affects your whole body.


If any of these side effects become serious or you experience any side effects not listed, please tell your doctor or pharmacist.




How To Store Provigil


Keep out of the reach and sight of children.


Do not take this medicine after the expiry date shown on the pack.


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




Further Information



What PROVIGIL contains


Each tablet contains modafinil (either 100 mg or 200 mg) as the active ingredient. In addition the tablets also contain lactose monohydrate, pregelatinised starch, microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate as inactive ingredients.




What PROVIGIL looks like and the contents of the pack


The tablets come in a capsule shaped, white to off-white colour.


They are supplied in packs of blister strips and each box contains 30 tablets.




Marketing Authorisation Holder



Cephalon UK Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

UK




Manufacturers



Laboratoires Macors

Rue des Caillottes

ZI Plaine des Isles

89000 Auxerre

France


And



Cephalon France

20 rue Charles Martigny

94700 Maisons-Alfort

France





This leaflet was last approved in September 2009


For more information please call free on 0800 783 4869 or e-mail: UKMedlnfo@cephalon.com


Additional information is available from various sources including the British Snoring & Sleep Apnoea Association (www.britishsnoring.co.uk, tel. 01737 245638).



08612-1596/1





Monday, 27 February 2012

Coldloc-LA


Generic Name: guaifenesin and phenylpropanolamine (gwye FEN e sin/fen ill proe pa NOLE a meen)

Brand Names: Ami-Tex LA, Banex-LA, Coldloc-LA, Dayquil Sinus Pressure and Congestion, Despec, Entex LA, Exgest LA, G-Vent, Guaifenex PPA 75, Guaivent, Guiatex LA, Naldecon-EX Pediatric, Nasahist LA, Phentex-LA, Phenylfenesin LA, Poly-Vent, Profen LA, Stamoist LA, Triaminic Expectorant, Vanex-LA


What is Coldloc-LA (guaifenesin and phenylpropanolamine)?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to make breathing easier. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose and throat), and increases the removal of mucous.


Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries), which reduces swelling of mucous membranes in areas such as the nose and sinuses.


Guaifenesin and phenylpropanolamine is used to treat the symptoms of the common cold and of infections of the sinuses, lungs, and throat.


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


Guaifenesin and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Coldloc-LA (guaifenesin and phenylpropanolamine)?


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


Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

Who should not take Coldloc-LA (guaifenesin and phenylpropanolamine)?


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

Before taking this medication, tell your doctor if you have



  • high blood pressure or any other type of heart disease,




  • diabetes,




  • a peripheral vascular disorder (poor circulation),




  • glaucoma or increased pressure in the eyes,




  • an overactive thyroid, or




  • difficulty urinating or an enlarged prostate.



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


Guaifenesin and phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin and phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin and phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin and phenylpropanolamine has not been approved for use by children younger than 6 years of age.

How should I take Coldloc-LA (guaifenesin and phenylpropanolamine)?


Take guaifenesin and phenylpropanolamine 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. Increasing fluid intake during the day may help relieve congestion. Take guaifenesin and phenylpropanolamine with food if it causes stomach upset. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed. Store guaifenesin and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


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


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a guaifenesin and phenylpropanolamine overdose include vomiting, high blood pressure (headache, redness of face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.


What should I avoid while taking Coldloc-LA (guaifenesin and phenylpropanolamine)?


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

Coldloc-LA (guaifenesin and phenylpropanolamine) side effects


No serious side effects from guaifenesin and phenylpropanolamine are expected. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

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



  • dizziness or headache;




  • nervousness, restlessness, or insomnia;




  • nausea or stomach upset; or




  • difficulty urinating.



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


What other drugs will affect Coldloc-LA (guaifenesin and phenylpropanolamine)?


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

Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin and phenylpropanolamine if you are taking any of these medications.


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


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



More Coldloc-LA resources


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


Compare Coldloc-LA with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist has additional information about guaifenesin and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Guaifenesin and phenylpropanolamine is available with a prescription under several brand names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



  • Entex LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--orange, scored tablets




  • Exgest LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--white, oval-shaped, scored, long-acting tablets with blue speckles




  • Dura-Vent, 600 mg of guaifenesin and 75 mg of phenylpropanolamine--white, scored tablets



See also: Coldloc-LA side effects (in more detail)