Sample Article Directory Oklahoma: October 2012

Monday, 8 October 2012

P1E1

Generic Name: epinephrine and pilocarpine ophthalmic (ep ih NEF rin and pie low CAR peen)

Brand Names: E-Pilo-1, E-Pilo-2, E-Pilo-4, E-Pilo-6, P1E1, P2E1, P3E1, P4E1, P6E1

What is P1E1 (epinephrine and pilocarpine ophthalmic)?

Epinephrine ophthalmic reduces congestion in the eye by constricting blood vessels in the eye. It also enlarges the pupil, and it reduces the amount of fluid in the eye in two ways: It reduces the production of fluid inside the eye, and it increases the amount of fluid that drains from the eye.

Pilocarpine ophthalmic also reduces pressure in the eye by increasing the amount of fluid that drains from the eye. In addition, pilocarpine causes the pupil to become smaller and reduces its response to light or dark conditions.

Together, epinephrine and pilocarpine are used to lower increased pressure in the eye that may be caused by conditions such as open-angle glaucoma and ocular (eye) hypertension (high pressure).

Epinephrine and pilocarpine ophthalmic is not commercially available in the United States.

Epinephrine and pilocarpine 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 P1E1 (epinephrine and pilocarpine ophthalmic)?

Contact your doctor immediately if you notice any decrease in vision or an increase in "floaters" in your visual field. Rarely, pilocarpine ophthalmic may cause retinal detachment. Retinal detachment can lead to blind spots, floaters in your visual field, and even blindness. Your doctor will want to check your retina before you use this medication to determine if you have an increased risk of retinal detachment.

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.

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

What should I discuss with my healthcare provider before using P1E1 (epinephrine and pilocarpine ophthalmic)?

Epinephrine and pilocarpine ophthalmic should not be used to treat narrow- or shallow-angle glaucoma.

Rarely, pilocarpine ophthalmic may cause retinal detachment. Tell your doctor if you have any type of retinal disease, if you have had a retinal tear, if you are nearsighted, or if you have had cataract surgery. These conditions may increase the risk of retinal detachment.

Before using this medication, tell your doctor if you have

heart failure,

high or low blood pressure,

ever had a heart attack,

asthma,

a stomach ulcer or stomach spasms,

epilepsy,

hyperthyroidism (an overactive thyroid),

blockage of your urinary tract or difficulty urinating, or

Parkinson's disease.

You may not be able to use epinephrine and pilocarpine 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 epinephrine and pilocarpine ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication.

It is not known whether epinephrine and pilocarpine ophthalmic will be harmful to an unborn baby. Do not use epinephrine and pilocarpine ophthalmic without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether epinephrine and pilocarpine passes into breast milk. Do not use epinephrine and pilocarpine ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use P1E1 (epinephrine and pilocarpine ophthalmic)?

Use epinephrine and pilocarpine ophthalmic eye drops exactly as directed by your doctor. 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.

If you wear contact lenses, remove them before applying epinephrine and pilocarpine ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication.

To apply the eye drops:

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 the tear duct. If you are using more than 1 drop in the same eye, repeat the process with about 5 minutes between drops. Repeat the process in the other eye if needed.

Epinephrine and pilocarpine ophthalmic is usually used once or twice a day. Follow your doctor's instructions.

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 epinephrine and pilocarpine 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?

The symptoms of an epinephrine and pilocarpine ophthalmic overdose are unknown. Sweating, nausea, vomiting, diarrhea, watering mouth, and tearing eyes may occur. If you suspect an overdose, or if the drops have been ingested, call an emergency room or poison control center for advice.

What should I avoid while using P1E1 (epinephrine and pilocarpine ophthalmic)?

Use caution when driving, operating machinery, or performing other hazardous activities. Epinephrine and pilocarpine ophthalmic may cause blurred or decreased night vision. If you experience blurred or decreased vision, avoid these activities. 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.

If you wear contact lenses, remove them before applying epinephrine and pilocarpine ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication.

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

P1E1 (epinephrine and pilocarpine ophthalmic) side effects

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

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

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

an irregular or fast heartbeat.

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

burning, stinging, redness, or tearing of the eye;

blurred vision;

headache or brow ache;

dizziness;

decreased vision in poor light;

nausea, vomiting, or diarrhea;

watering mouth;

sweating; or

increased urination.

Colored deposits (spots) on the inner lining of the eyelid or on the surface of the eye may develop during chronic treatment with epinephrine and pilocarpine ophthalmic. These deposits are harmless.

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 P1E1 (epinephrine and pilocarpine ophthalmic)?

Before using this medication, tell your doctor if you are using another eye medication especially if it is a nonsteroidal anti-inflammatory drug (NSAID) such as flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren), or ketorolac (Acular).

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

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

More P1E1 resources

P1E1 Drug Interactions
P1E1 Support Group
0 Reviews for P1E1 - Add your own review/rating

Compare P1E1 with other medications

Glaucoma
Glaucoma, Open Angle
Glaucoma/Intraocular Hypertension

Where can I get more information?

Your pharmacist has additional information about epinephrine and pilocarpine ophthalmic written for health professionals that you may read.

What does my medication look like?

Epinephrine and pilocarpine ophthalmic is currently not available in the United States.

Sunday, 7 October 2012

Viva DHA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Viva DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

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

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Viva DHA resources

Viva DHA Use in Pregnancy & Breastfeeding
Viva DHA Drug Interactions
Viva DHA Support Group
0 Reviews for Viva DHA - Add your own review/rating

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare Viva DHA with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

Saturday, 6 October 2012

fluocinolone ophthalmic implant

Generic Name: fluocinolone ophthalmic implant (floo oh SIN oh lone off THAL mik IM plant)

Brand Names: Retisert

What is fluocinolone ophthalmic implant?

Fluocinolone is in a group of drugs called corticosteroids. It prevents the release of substances in the body that cause inflammation.

Fluocinolone ophthalmic (for the eye) implant is used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The implant slowly releases fluocinolone into the eye over a period of approximately 30 months. Fluocinolone will not treat an eye infection.

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

What is the most important information I should know about fluocinolone ophthalmic implant?

The fluocinolone ophthalmic implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Before receiving the implant, tell your doctor if you are allergic to any drugs, or if you have glaucoma, herpes simplex or other eye infection, or if you have recently had cataract surgery.

Do not use any eye medications that your doctor has not prescribed. Fluocinolone ophthalmic implant can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

The placement of the fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

What should I discuss with my healthcare provider before receiving a fluocinolone ophthalmic implant?

You should not receive this medication if you are allergic to fluocinolone, or if you have:

a viral, bacterial, or fungal infection of your eye; or

a history of allergy to a steroid medicine.

If you have certain conditions, you may need special tests or other medications after receiving a fluocinolone implant. Tell your doctor if you are allergic to any drugs, or if you have:

glaucoma;

herpes simplex or other eye infection; or

if you have recently had cataract surgery.

FDA pregnancy category C. It is not known whether the fluocinolone ophthalmic implant is harmful to an unborn baby if you receive the implant while you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during the 30 months after you receive the implant. It is not known whether fluocinolone from the ophthalmic implant passes into breast milk or if it could harm a nursing baby. Do not receive this implant without telling your doctor if you are breast-feeding a baby.

How is the fluocinolone ophthalmic implant put into place?

This implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Your doctor may prescribe other medications to help control the pressure inside your eyes. Increased pressure inside the eye (also called ocular hypertension) can damage the optic nerve and lead to permanent blindness.

You may need to use the medications to control pressure inside your eyes for several weeks after receiving the fluocinolone ophthalmic implant. Be sure to use this medication as directed by your doctor to avoid complications or needing further surgical procedures to control ocular hypertension.

To be sure the implant is helping your condition and is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Since the fluocinolone ophthalmic implant is surgically put into place, you will not be on a dosing schedule for this medication.

If you are taking medication to control pressure inside your eyes and you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of fluocinolone is unlikely to occur with the ophthalmic implant.

What should I avoid after receiving a fluocinolone ophthalmic implant?

Avoid wearing contact lenses after receiving the fluocinolone ophthalmic implant unless your doctor has told you to.

Fluocinolone ophthalmic implant side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

sudden vision loss, eye pain or redness;

bleeding, oozing, or crusting of your eyes;

cloudiness in the pupils or iris of your eyes;

seeing flashes of light, halos around lights, or "floaters" in your vision; or

tunnel vision, problems with peripheral (side) vision.

Less serious side effects may include:

swelling of the eyelids;

mild eye irritation;

dry or watery eyes;

itching, mild skin rash;

the feeling that something is in your eye;

headache, dizziness;

runny or stuffy nose, sore throat, fever, cough;

nausea, vomiting; or

back pain, joint or muscle pain.

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.

Fluocinolone ophthalmic implant Dosing Information

Usual Adult Dose for Uveitis:

Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.

Usual Pediatric Dose for Uveitis:

12 years to 18 years:
Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.

What other drugs will affect fluocinolone ophthalmic implant?

Before using this medication, tell your doctor if you are using any other steroid medications, including:

nasal or inhaled steroids such as budesonide (Pulmicort, Rhinocort, Symbicort), flunisolide (AeroBid, Nasarel), fluticasone (Advair, Flonase, Flovent), mometasone (Asmanex, Nasonex), or triamcinolone (Azmacort); or

steroid medication taken by mouth such as betamethasone (Celestone), budesonide (Entocort), dexamethasone (Decadron, Hexadrol), fludrocortisone (Florinef), hydrocortisone (Cortef, Hydrocortone), prednisone (Deltasone, Meticorten, Orasone, others), methylprednisolone (Medrol), triamcinolone (Aristocort).

There may be other drugs that can affect fluocinolone ophthalmic implant. 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 fluocinolone ophthalmic implant resources

Fluocinolone ophthalmic implant Use in Pregnancy & Breastfeeding
Fluocinolone ophthalmic implant Drug Interactions
Fluocinolone ophthalmic implant Support Group
3 Reviews for Fluocinolone - Add your own review/rating

Compare fluocinolone ophthalmic implant with other medications

Uveitis

Where can I get more information?

Your doctor can provide more information about fluocinolone ophthalmic implant written for health professionals that you may read.

Thursday, 4 October 2012

Methylsulfonylmethane

Pronunciation: Not applicable.
Generic Name: Methylsulfonylmethane
Brand Name: Generics only. No brands available.

Methylsulfonylmethane is used for:

Pain and swelling in muscles and joints. It may have other uses as well. Check with your pharmacist for more details regarding the particular brand you use.

This product is a naturally occurring chemical, which provides a dietary source of sulfur. It is thought to work by reducing pain and swelling in the joints.

Do NOT use Methylsulfonylmethane if:

you are allergic to any ingredient in Methylsulfonylmethane or to any other sulfa or sulfonamide (eg, sulfisoxazole, sulfamethoxazole)

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

Before using Methylsulfonylmethane:

Some medical conditions may interact with Methylsulfonylmethane. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Methylsulfonylmethane. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methylsulfonylmethane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Methylsulfonylmethane:

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

Dosing depends on the use and the source of the product.

Use as directed on the package, unless instructed otherwise by your doctor.

If you miss taking a dose of Methylsulfonylmethane for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information:

Keep all doctor and laboratory appointments while you are taking this product.

This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of dietary supplements is not known. Before using any alternative medicine, talk with your doctor or pharmacist.

PREGNANCY and BREAST-FEEDING: Do not use this product if you are pregnant. Do not breast-feed while using this product.

Possible side effects of Methylsulfonylmethane:

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

Diarrhea; headache; nausea.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Methylsulfonylmethane side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include lethargy; paralysis.

Proper storage of Methylsulfonylmethane:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most dietary supplements are not in childproof containers. Keep Methylsulfonylmethane out of the reach of children and away from pets.

General information:

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

Methylsulfonylmethane is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Methylsulfonylmethane. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Methylsulfonylmethane resources

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

Compare Methylsulfonylmethane with other medications

Dietary Supplementation
Muscle Pain

Thrombin-JMI

Generic Name: Thrombin
Class: Hemostatics
CAS Number: 9002-04-4

Use of topical thrombin (bovine) can stimulate antibody formation against bovine thrombin and/or bovine factor V, potentially resulting in severe hemorrhagic or thrombotic complications; rarely fatal.¹⁰⁰ ¹⁰³ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹¹² (See Antibody Formation under Cautions.)

Consult expert in coagulation disorders if patient exhibits abnormal coagulation test results, bleeding, or thrombosis.¹⁰⁰ Do not readminister drug to patients with evidence of anti-bovine thrombin antibodies.¹⁰⁰ ¹⁰³ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁹ ¹¹¹

Introduction

Hemostatic agent.¹⁰⁰ ^b

Uses for Thrombin-JMI

Hemorrhage

Aids hemostasis at accessible sites of oozing blood and minor bleeding from capillaries and small venules.¹⁰⁰ In various types of surgery, may be used in conjunction with an absorbable gelatin sponge.¹⁰⁰

Does not control arterial bleeding when used alone.^b

Thrombin-JMI Dosage and Administration

General

The concentration of thrombin solutions used depends on the severity of bleeding.¹⁰⁰ ¹⁰⁹ ^b

Administration

Topical Administration

Apply topically as a powder or solution; do not inject.¹⁰⁰ ¹⁰²

Prepare and administer solution according to manufacturer’s recommendations.¹⁰⁰ Use solution promptly upon removal from container.¹⁰⁰

Spray reconstituted solution directly onto bleeding surfaces (using a sterile syringe and spray tip, spray pump and actuator, or nasal delivery device) or apply with an absorbable gelatin sponge;¹⁰⁰ do not leave solution in syringe as an intermediate step when preparing the spray delivery device.¹⁰²

Alternatively, flood surfaces with thrombin solution using a sterile syringe and small gauge needle.¹⁰⁰ To avoid inadvertent intravascular administration, label syringes containing reconstituted thrombin (bovine) with a warning against IV injection and keep separate from parenteral preparations.¹⁰²

May apply as a dry powder; preferred method of application to oozing surfaces in some cases.¹⁰⁰ ¹⁰²

May use in conjunction with a bovine gelatin-based hemostatic matrix (e.g., FloSeal NT).¹⁰⁰

Before application, sponge (do not wipe) recipient surface free of blood; otherwise, blood may clot on surface layers while bleeding continues underneath clot.¹⁰⁰ After application, avoid sponging treated areas so clot is not disturbed.¹⁰⁰

When used with an absorbable gelatin sponge, immerse sponge strips of the desired size in the solution and knead vigorously with moistened, gloved fingers to remove trapped air and facilitate saturation.¹⁰⁰ Apply the saturated sponge to the bleeding area and hold in place with a cotton pledget or small gauze sponge until hemostasis occurs.¹⁰⁰ Consult manufacturer’s information for detailed instructions on use of absorbable gelatin sponge preparations.¹⁰⁰

Reconstitution

To prepare a solution containing 1000 units/mL of thrombin (bovine), transfer entire contents of the supplied diluent vial (5 or 20 mL) to a vial containing 5000 or 20,000 units, respectively, of lyophilized thrombin via a syringe or transfer needle.¹⁰⁰ Consult manufacturer’s instructions for appropriate use of the transfer device.¹⁰⁰

Use an appropriate volume of the 0.9% sodium chloride diluent to prepare other concentrations.¹⁰⁰

Dosage

Adults

Hemorrhage

Topical

Plastic surgery, dental extractions, skin grafting, other general uses: Solutions containing approximately 100 units/mL are frequently used.¹⁰⁰ ^b

Profuse bleeding (e.g., from cut surfaces of the liver or spleen): Solutions containing 1000 units/mL may be required.¹⁰⁰ ^b

Cautions for Thrombin-JMI

Contraindications

Known sensitivity to any ingredient in the formulation and/or to material of bovine origin.¹⁰⁰

Warnings/Precautions

Warnings

Effects on Hemostasis

Because of its hemostatic activity, thrombin should not be injected or otherwise allowed to enter large blood vessels; may result in extensive intravascular clotting and even death.¹⁰⁰ ¹⁰²

Abnormalities in hemostasis reported, ranging from asymptomatic alterations in coagulation test results (e.g., PT, PTT) to severe bleeding or thrombosis (rarely fatal); may be related to antibody formation.¹⁰⁰ ¹⁰³ ¹⁰⁵ ¹⁰⁶ ¹⁰⁸ ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹¹² (See Antibody Formation under Cautions.)

Consult an expert in coagulation disorders if patient exhibits abnormal coagulation test results, bleeding, or thrombosis.¹⁰⁰ Consider underlying immunologic mechanisms with any contemplated intervention.¹⁰⁰ ¹⁰⁶

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis with profound bradycardia and hypotension reported rarely.¹⁰¹ ^b

Potential allergic reactions in patients sensitive to bovine materials.¹⁰⁰

Antibody Formation

Can stimulate antibody formation against bovine thrombin and/or bovine factor V (a potential contaminant in some bovine thrombin preparations).¹⁰⁰ ¹⁰³ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹¹² Such antibodies may cross-react with human factor V, potentially resulting in a factor V deficiency and hemorrhagic complications; paradoxical thrombosis also has occurred.¹⁰⁰ ¹⁰³ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁹ ¹¹¹ ¹¹² (See Effects on Hemostasis under Cautions.) Antibodies may develop as early as 8 days after use and may persist for months to years following initial exposure.¹⁰³ ¹⁰⁵ ¹⁰⁶ ¹¹¹ Not known whether highly purified preparations (i.e., containing no detectable levels of factor Va) are associated with reduced risk of immunogenicity.¹⁰⁰ ¹⁰⁹

Patients with evidence of anti-bovine thrombin antibodies should not be reexposed to the drug; increased likelihood of antibody formation with repeated application.¹⁰⁰ ¹⁰³ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁹ ¹¹¹

General Precautions

Concomitant Absorbable Gelatin Sponge

Consult prescribing information for absorbable gelatin sponge preparations when used concomitantly.¹⁰⁰

Specific Populations

Pregnancy

Category C.¹⁰⁰

Pediatric Use

Safety and efficacy not established.¹⁰⁰

Stability

Storage

Topical

Powder

2–25°C.¹⁰⁰ May refrigerate reconstituted solution at 2–8°C for up to 24 hours or store at room temperature for up to 8 hours.¹⁰⁰

ActionsActions

Causes clotting of whole blood or plasma without the addition of other substances.¹⁰⁰ ^b Affects hemostasis principally by converting fibrinogen to fibrin; several other mechanisms (e.g., stimulation of platelet release reaction, aggregation of platelets) may be involved.¹⁰⁰ ¹⁰⁹ ^b

Rate of blood clotting depends on concentration of thrombin and fibrinogen.¹⁰⁰ ^b

Does not clot blood when clotting defect is the rare absence of fibrinogen.¹⁰⁰

Advice to Patients

Importance of informing clinician of allergy to bovine materials. (See Cautions.)¹⁰⁰

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰⁰

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹⁰⁰

Importance of informing patients of other important precautionary information.¹⁰⁰ (See Cautions.)

Preparations

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

Thrombin (Bovine)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Powder	5000 units	Thrombin-JMI (with 0.9% sodium chloride diluent)	King
			Thrombin-JMI (with 0.9% sodium chloride diluent; epistaxis kit also contains nasal delivery device and syringe)	King
		20,000 units	Thrombin-JMI (with 0.9% sodium chloride diluent)	King
			Thrombin-JMI (with 0.9% sodium chloride diluent; syringe spray kit also contains sterile syringe with transfer device and spray tip)	King
			Thrombin-JMI (with 0.9% sodium chloride diluent; pump spray kit also contains spray pump and actuator)	King

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 01, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. King Pharmaceuticals, Inc. Thrombin-JMI (thrombin, topical USP) bovine origin prescribing information. Bristol, TN; 2007 Nov.

101. Rothenberg DM, Moy JN. Anaphylactic reaction to topical bovine thrombin. Anesthesiology. 1993; 78:779-82. [IDIS 316352] [PubMed 8096685]

102. Cohen MR, Smetzer JL. ISMP medical error report analysis: Danger of giving topical thrombin intravascularly. Hosp Pharm. 2007; 42:284-5.

103. Winterbottom N, Kuo JM, Nguyen K et al. Antigenic responses to bovine thrombin exposure during surgery: a prospective study of 309 patients. J Applied Research. 2002; 2:1–11.

104. Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Ferraris SP et al. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg. 2007; 83:S27-86. [PubMed 17462454]

105. Ortel TL, Mercer MC, Thames EH et al. Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin. Ann Surg. 2001; 233:88-96. [PubMed 11141230]

106. Streiff MB, Ness PM. Acquired FV inhibitors: a needless iatrogenic complication of bovine thrombin exposure. Transfusion. 2002; 42:18-26. [PubMed 11896308]

107. Doria C, Fischer CP, Wood CG et al. Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin. 2008; 24:785-94. [PubMed 18241525]

108. Chapman WC, Singla N, Genyk Y et al. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007; 205:256-65. [PubMed 17660072]

109. Cheng CM, Meyer-Massetti C, Kayser SR. A review of three stand-alone topical thrombins for surgical hemostasis. Clin Ther. 2009; 31:32-41. [PubMed 19243705]

110. Clark J, Crean S, Reynolds MW. Topical bovine thrombin and adverse events: a review of the literature. Curr Med Res Opin. 2008; 24:2071-87. [PubMed 18549663]

111. Dorion RP, Hamati HF, Landis B et al. Risk and clinical significance of developing antibodies induced by topical thrombin preparations. Arch Pathol Lab Med. 1998; 122:887-94. [PubMed 9786349]

112. Lundblad RL, Bradshaw RA, Gabriel D et al. A review of the therapeutic uses of thrombin. Thromb Haemost. 2004; 91:851-60. [PubMed 15116244]

b. AHFS Drug Information 2004. McEvoy GK, ed. Heparin. Bethesda, MD: American Society of Health-System Pharmacists; 2004: 1454-5.

More Thrombin-JMI resources

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

Thrombin-JMI Prescribing Information (FDA)

Evithrom Consumer Overview

Recothrom Consumer Overview

Recothrom Prescribing Information (FDA)

Compare Thrombin-JMI with other medications

Hemostasis

Wednesday, 3 October 2012

Uni-Otic Ear Drops

Generic Name: chloroxylenol and pramoxine otic (KLOR oh ZYE le nol and pra MOX een OH tik)

Brand Names: Pramotic, Uni-Otic Ear Drops

What is Uni-Otic Ear Drops (chloroxylenol and pramoxine otic)?

Chloroxylenol is an antibiotic that fights bacteria in your body.

Pramoxine is an anesthetic. It is used to reduce itching and pain caused by ear infections.

The combination of chloroxylenol and pramoxine otic (for the ears) is used to treat ear infections.

Chloroxylenol and pramoxine otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about my Uni-Otic Ear Drops (chloroxylenol and pramoxine otic)?

You should not use this medication if you are allergic to it, or if you have a ruptured ear drum. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive or do anything that requires you to be awake and alert. Do not use other ear drops during treatment with chloroxylenol and pramoxine otic unless your doctor tells you to. Call your doctor if your infection does not improve, or if you have ear pain, burning or itching, hearing problems, or ear drainage or discharge.

What should I discuss with my healthcare provider before using Uni-Otic Ear Drops (chloroxylenol and pramoxine otic)?

You should not use this medication if you are allergic to it, or if you have a ruptured ear drum. Do not use chloroxylenol and pramoxine otic without telling your doctor if you are pregnant. Do not use chloroxylenol and pramoxine otic without telling your doctor if you are breast-feeding.

How should I use Uni-Otic Ear Drops (chloroxylenol and pramoxine otic)?

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

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down with your head tilted for at least 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out. Follow your doctor's instructions about the use of cotton.

Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Call your doctor if your infection does not improve.

Store chloroxylenol and pramoxine otic at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not 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 chloroxylenol and pramoxine otic is not likely to cause life-threatening symptoms.

What should I avoid while using this medication?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive or do anything that requires you to be awake and alert. Do not use other ear drops during treatment with chloroxylenol and pramoxine otic unless your doctor tells you to.

Uni-Otic Ear Drops (chloroxylenol and pramoxine otic) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

ear pain, burning, or itching;

hearing problems;

ear drainage or discharge; or

worsening pain, irritation, or rash.

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 my Uni-Otic Ear Drops (chloroxylenol and pramoxine otic)?

It is not likely that other drugs you take orally or inject will have an effect on chloroxylenol and pramoxine used in the ears. 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 Uni-Otic Ear Drops resources

Uni-Otic Ear Drops Side Effects (in more detail)
Uni-Otic Ear Drops Use in Pregnancy & Breastfeeding
Uni-Otic Ear Drops Support Group
0 Reviews for Uni-Otic Ear - Add your own review/rating

PramOtic MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Uni-Otic Ear Drops with other medications

Otitis Externa

Where can I get more information?

Your pharmacist can provide more information about chloroxylenol and pramoxine otic.

See also: Uni-Otic Ear side effects (in more detail)

sulfonamide Vaginal

Class Name: sulfonamide (Vaginal route)

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Cream

Suppository

Uses For This Medicine

Sulfonamides, or sulfa medicines, are used to treat bacterial infections. They work by killing bacteria or preventing their growth.

Vaginal sulfonamides are used to treat bacterial infections. These medicines may also be used for other problems as determined by your doctor.

Vaginal sulfonamides are available only with your doctor's prescription.

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Studies on this medicine have been done only in adult patients and there is no specific information comparing the use of vaginal sulfonamides in children with use in other age groups.

Geriatric

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

Pregnancy

Studies have not been done in humans. However, vaginal sulfonamides are absorbed through the vagina into the bloodstream and appear in the bloodstream of the fetus. Studies in rats and mice given high doses by mouth have shown that certain sulfonamides cause birth defects.

Breast Feeding

Vaginal sulfonamides are absorbed through the vagina into the bloodstream and pass into the breast milk. Use is not recommended in nursing mothers. Vaginal sulfonamides may cause liver problems in nursing babies. These medicines may also cause anemia in nursing babies with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Bepridil

Cisapride

Dofetilide

Levomethadyl

Mesoridazine

Pimozide

Terfenadine

Thioridazine

Using medicines in this class 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.

Acecainide

Acenocoumarol

Ajmaline

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Aprindine

Arsenic Trioxide

Astemizole

Azimilide

Bretylium

Chloral Hydrate

Chloroquine

Chlorpromazine

Clarithromycin

Desipramine

Dibenzepin

Digitalis

Disopyramide

Dolasetron

Doxepin

Droperidol

Enflurane

Erythromycin

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gemifloxacin

Halofantrine

Haloperidol

Halothane

Hydroquinidine

Ibutilide

Imipramine

Isoflurane

Isradipine

Ketorolac

Levomethadyl

Lidoflazine

Lorcainide

Mefloquine

Metformin

Methotrexate

Naproxen

Nortriptyline

Octreotide

Pentamidine

Pirmenol

Prajmaline

Probucol

Procainamide

Prochlorperazine

Propafenone

Proscillaridin

Pyrimethamine

Quetiapine

Quinidine

Riluzole

Risperidone

Sematilide

Sertindole

Sotalol

Spiramycin

Sultopride

Tedisamil

Telithromycin

Trifluoperazine

Trimipramine

Vasopressin

Warfarin

Zotepine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of This Medicine

Vaginal sulfonamides usually come with patient directions. Read them carefully before using this medicine.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, do not stop using this medicine if your menstrual period starts during the time of treatment.

Dosing

The dose medicines in this class 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 these medicines. 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 sulfanilamide

For vaginal dosage form (cream):
- For bacterial infections:
  - Adults and teenagers—One applicatorful (approximately 6 grams) inserted into the vagina one or two times a day for thirty days.
  - Children—Use and dose must be determined by your doctor.

For vaginal dosage form (suppositories):
- For bacterial infections:
  - Adults and teenagers—One suppository inserted into the vagina one or two times a day for thirty days.
  - Children—Use and dose must be determined by your doctor.

For triple sulfa

For vaginal dosage form (cream):
- For bacterial infections:
  - Adults and teenagers—At first, one applicatorful (approximately 4 to 5 grams) inserted into the vagina two times a day for four to six days. Then, your doctor may lower your dose to one-half to one-quarter applicatorful two times a day. Use when you wake up and just before you go to bed.
  - Children—Use and dose must be determined by your doctor.

For vaginal dosage form (tablets):
- For bacterial infections:
  - Adults and teenagers—One tablet inserted into the vagina two times a day for ten days.
  - 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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

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

Vaginal medicines usually will slowly work their way out of the vagina during treatment. To keep the medicine from soiling or staining your clothing, a sanitary napkin may be worn. Minipads, clean paper tissues, or paper diapers may also be used. However, the use of tampons is not recommended since they may soak up too much of the medicine. In addition, tampons may be more likely to slip out of the vagina if you use them during treatment with this medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) underclothes.

Wear only freshly washed underclothes.

If you have any questions about this, check with your health care professional.

Many vaginal infections are spread by sexual intercourse. The male sexual partner may carry the fungus or other organism in his reproductive tract. Therefore, it may be desirable that your partner wear a condom (prophylactic) during intercourse to keep the infection from returning. Also, it may be necessary for your partner to be treated at the same time you are being treated to avoid passing the infection back and forth. In addition, do not stop using this medicine if you have intercourse during treatment.

Some patients who use vaginal medicines may prefer to use a douche for cleansing purposes before inserting the next dose of medicine. Some doctors recommend a vinegar and water or other douche. However, others do not recommend douching at all. If you do use a douche, do not overfill the vagina with douche solution. To do so may force the solution up into the uterus (womb) and may cause inflammation or infection. Also, do not douche if you are pregnant since this may harm the fetus. If you have any questions about this or which douche products are best for you, check with your health care professional.

Side Effects of This Medicine

Studies in rats have shown that long-term use of sulfonamides may cause cancer of the thyroid gland. In addition, studies in rats have shown that sulfonamides may increase the chance of goiters (noncancerous tumors of the thyroid gland).

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:

Less common

Itching, burning, skin rash, redness, swelling, or other sign of irritation not present before use of this medicine

Rare

Burning at site of application

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

Rash or irritation of penis of sexual partner

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.

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

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

Monday, 1 October 2012

Kytril Paediatric Liquid

1. Name Of The Medicinal Product

Kytril Paediatric Liquid.

2. Qualitative And Quantitative Composition

Granisetron hydrochloride equivalent to 200μg granisetron (free base equivalent) per 1ml.

3. Pharmaceutical Form

An orange coloured and flavoured clear solution equivalent to 200μg of granisetron free base per 1ml.

4. Clinical Particulars

4.1 Therapeutic Indications

Kytril Paediatric Liquid is indicated for the prevention of nausea and vomiting induced by cytostatic therapy.

4.2 Posology And Method Of Administration

Children

A single dose of 20μg/kg bodyweight (up to 1mg)twice a day up to 5 days during cytostatic therapy. The first dose of Kytril should be administered within one hour before the start of cytostatic therapy.

Patients with renal or hepatic impairment

No special requirements apply.

4.3 Contraindications

Hypersensitivity to granisetron, or related substances, or any of the other constituents.

4.4 Special Warnings And Precautions For Use

As Kytril may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following administration of Kytril.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In studies in healthy subjects, no evidence of any interaction has been indicated between Kytril and cimetidine or lorazepam. No evidence of drug interactions has been observed in clinical studies.

4.6 Pregnancy And Lactation

Whilst animal studies have shown no teratogenic effects, there is no experience of Kytril in human pregnancy. Therefore Kytril should not be administered to women who are pregnant unless there are compelling clinical reasons. There are no data on the excretion of Kytril in breast milk. Breast feeding should therefore be discontinued during therapy.

4.7 Effects On Ability To Drive And Use Machines

There has been no evidence from human studies that Kytril has any adverse effect on alertness.

4.8 Undesirable Effects

Kytril has been generally well tolerated in human studies. As reported with other drugs of this class, headache and constipation have been the most frequently noted adverse events but the majority have been mild or moderate in nature. Rare cases of hypersensitivity reaction, occasionally severe (e.g. anaphylaxis) have been reported. Other allergic reactions including minor skin rashes have also been reported. In clinical trials transient increases in hepatic transaminases, generally within the normal range, have been seen.

4.9 Overdose

There is no specific antidote for Kytril. In the case of overdosage, symptomatic treatment should be given. One patient has received 30mg of Kytril intravenously. The patient reported a slight headache but no other sequelae were observed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Kytril is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5₃) receptors. Radioligand binding studies have demonstrated that Kytril has negligible affinity for other receptor types including 5₂ binding sites.

Kytril is effective orally prophylactically in prevention of the retching and vomiting evoked by cytostatic therapy.

5.2 Pharmacokinetic Properties

General characteristics

Absorption

Absorption of Kytril is rapid and complete, though oral bioavailability is reduced to about 60% as a result of first pass metabolism. Oral bioavailability is generally not influenced by food.

Distribution

Kytril is extensively distributed, with a mean volume of distribution of approximately 3 l/kg; plasma protein binding is approximately 65%.

Biotransformation

Biotransformation pathways involve N-demethylation and aromatic ring oxidation followed by conjugation.

Elimination

Clearance is predominantly by hepatic metabolism. Urinary excretion of unchanged Kytril averages 12% of dose whilst that of metabolites amounts to about 47% of dose. The remainder is excreted in faeces as metabolites. Mean plasma half-life in patients is approximately 9 hours, with a wide inter-subject variability.

Characteristics in patients

The plasma concentration of Kytril is not clearly correlated with anti-emetic efficacy. Clinical benefit may be conferred even when Kytril is not detectable in plasma.

In elderly subjects after single intravenous doses, pharmacokinetic parameters were within the range found for non-elderly subjects. In patients with severe renal failure, data indicate that pharmacokinetic parameters after a single intravenous dose are generally similar to those in normal subjects. In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance of an intravenous dose was approximately halved compared to patients without hepatic involvement. Despite these changes, no dosage adjustment is necessary.

In children, after single intravenous doses, pharmacokinetics are similar to those in adults when appropriate parameters (volume of distribution, total plasma clearance) are normalised for body-weight.

5.3 Preclinical Safety Data

Data from two-year carcinogenicity studies have shown an increase in hepatocellular carcinoma and/or adenoma in rats and mice of both sexes given 50mg/kg (rat dosage reduced to 25mg/kg/day at week 59). Increases in hepatocellular neoplasia were also detected at 5mg/kg in male rats. In both species, drug-induced effects (hepatocellular neoplasia) were not observed in the low-dose group (1mg/kg).

In several in vitro and in vivo assays, Kytril was shown to be non-genotoxic in mammalian cells.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol Ph Eur.

Sodium Benzoate (E211) Ph Eur.

Citric Acid Anhydrous Ph Eur.

Orange Flavour D3798 HSE.

Orange Flavour D2362 HSE.

F.D. & C Yellow No. 6 (E110) HSE.

Purified Water Ph Eur.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Unopened: 4 years.

After opening for the first time: one month.

6.4 Special Precautions For Storage

Kytril Paediatric Liquid should be stored at or below 30°C and capped after partial use.

6.5 Nature And Contents Of Container

Kytril Paediatric Liquid is supplied in a 30ml amber glass bottle with a child resistant high density polyethylene cap with a PVdC faced boxboard wad. The bottle contains 30ml of solution and is enclosed in an outer carton.

6.6 Special Precautions For Disposal And Other Handling

Administering the Oral Solution

Children: To administer the dose of 20μg/kg, 0.1ml of solution per one kilogram of body weight should be withdrawn from the bottle up to a maximum of 5ml per dose.

An oral dosing syringe should be used. When administering the measured dose, insert the syringe tip into the child's mouth and drip the medicine in slowly.

7. Marketing Authorisation Holder

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.

8. Marketing Authorisation Number(S)

PL 00031/0593

9. Date Of First Authorisation/Renewal Of The Authorisation

15 August 2001

10. Date Of Revision Of The Text

September 2005

LEGAL STATUS

POM

Kytril is a registered trade mark

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