Combipatch

30/06/10

Generic Name: estradiol and norethindrone (topical patches) (ess tra DYE all and nor ETH in drone)
Brand Names: Combipatch

What are estradiol and norethindrone?

Estradiol is a form of estrogen. Estrogen is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Together, estradiol and norethindrone are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating (“hot flashes” or “hot flushes”); to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause; and to replace estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure that result in a lack of estrogen.

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


What is the most important information I should know about estradiol and norethindrone?

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and norethindrone.

Do not use this medication if you are pregnant. Do not place the transdermal patch on your breasts or at your waistline where tight-fitting clothing may interfere with its functioning.

What should I discuss with my healthcare provider before using estradiol and norethindrone?

Do not use estradiol and norethindrone without first talking to your doctor if you have

  • a circulation, bleeding, or blood-clotting disorder;

  • undiagnosed, abnormal vaginal bleeding; or

  • any type of breast, uterine, or hormone-dependent cancer. or

Using estradiol and norethindrone may be dangerous in some cases if you have any of the conditions listed above.

Before using estradiol and norethindrone, tell your doctor if you have

  • high blood pressure, angina, or heart disease;

  • high levels of cholesterol or triglycerides in your blood;

  • kidney disease;
  • liver disease;
  • asthma;

  • epilepsy;

  • migraines;

  • depression;

  • diabetes;

  • gallbladder disease;

  • uterine fibroids; or

  • had a hysterectomy (uterus removed).

You may not be able to use estradiol and norethindrone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Estradiol and norethindrone is in the FDA pregnancy category X. This means that estradiol and norethindrone will cause birth defects in an unborn baby. Do not use estradiol and norethindrone if you are pregnant or could become pregnant during treatment. Estradiol and norethindrone may decrease milk flow and have other effects on milk composition. Do not use estradiol and norethindrone without first talking to your doctor if you are breast-feeding a baby.


How should I use estradiol and norethindrone?

Use estradiol and norethindrone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use estradiol and norethindrone patches:

  • Apply each patch to a smooth (fold free), clean, dry area on your lower abdomen. The area should not be oily, damaged, or irritated.

  • Do not use the patch on your breasts or at your waistline, where clothing may interfere with its use.
  • After opening a pouch, remove one side of the protective liner, taking care not to touch the adhesive part with your fingers. Immediately apply the patch. Remove the second side of the protective liner and press the patch firmly in place with your hand for at least 10 seconds, making sure there is good contact, especially around the edges.

  • Replace the patch on the same two days each week (every 3 to 4 days) as directed by your doctor. Only one patch should be worn at any time.

  • Allow at least 1 week to pass between applications of the patch to a given area.

  • Do not cut the patches.
  • After a patch is in place, it should not be exposed the sun for prolonged periods of time.
  • Take care so the patch does not come off during bathing or other activities. If a patch falls off for any reason, reapply it to another site on your lower abdomen. If it will not stick, apply a new patch to a new site. Continue changing the patch on your regular schedule.

  • Removal of the patch should be done carefully and slowly to avoid irritation of the skin. If any adhesive remains on the skin, allow it to dry for 15 minutes. Then gently rub the area with an oil-based cream or lotion.

  • Your doctor may prescribe two different patches for you. In this treatment regimen, use the estrogen-only patch for the first 14 days of a 28-day cycle, according to the product directions. Then, use the estradiol and norethindrone patches for the remaining 14 days, according to the product directions. Follow your doctor’s instructions or ask your pharmacist for help if you do not remember. Monthly withdrawal bleeding often occurs with this regimen.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while using estradiol and norethindrone.

Store the patches in their sealed foil pouches at room temperature away from moisture, heat, and direct light for up to 6 months from the date you receive them from the pharmacy or the expiration date, whichever comes first.

What happens if I miss a dose?

Apply the next patch as soon as you remember. Continue to follow your regular schedule for changing the patch. Do not use two patches simultaneously unless your doctor directs otherwise.

If a patch falls off for any reason, reapply it to another site on your lower abdomen. If it will not stick, apply a new patch to a new site. Continue changing the patch on your regular schedule.


What happens if I overdose?

An overdose of estradiol and norethindrone is unlikely to occur and is not likely to threaten life. If you do suspect an overdose, or if a patch has been ingested, call an emergency room or poison control center for advice.

Symptoms of a estradiol and norethindrone overdose may include nausea, vomiting, and withdrawal bleeding may occur in females.

What should I avoid while using estradiol and norethindrone?

After a patch is in place, it should not be exposed the sun for prolonged periods of time.

There are no restrictions on food, beverages, or activity while using estradiol and norethindrone unless your doctor directs otherwise.


Estradiol and norethindrone side effects

Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side effects, stop using estradiol and norethindrone and seek emergency medical attention or notify your doctor immediately:

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

  • sharp chest pain, coughing of blood or shortness of breath (possible blood clot in the lung );

  • pain in the calf (possible blood clot in the leg);

  • crushing chest pain or heaviness in the chest (possible heart attack);

  • sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (possible stroke);

  • partial or complete loss of vision (possible clot in the eye);

  • stomach pain or tenderness, yellowing of the skin or eyes, fever, fatigue, loss of appetite, dark-colored urine, or light-colored stools (possible liver problems); or

  • new or changing breast lumps.

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

  • nausea and vomiting;

  • tenderness or enlargement of the breasts;

  • weakness;

  • swelling of the hands or feet;

  • spotty darkening of the skin, particularly on the face;

  • difficulty in wearing contact lenses;

  • vaginal irritation or discomfort;

  • a rash or reaction at the patch application site; or

  • changes in menstrual cycle, painful menstruation, or breakthrough bleeding.

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

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

What other drugs will affect estradiol and norethindrone?

Before using estradiol and norethindrone, tell your doctor if you are taking an anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to use estradiol and norethindrone, or you may require a dosage adjustment or special monitoring during treatment if you are taking warfarin (Coumadin).

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

Where can I get more information?

  • Your pharmacist has additional information about estradiol and norethindrone written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:43:32 PM.

 

Generic Name: Estradiol/Norethindrone (ES-tra-DYE-ol/nor-ETH-in-drone)
Brand Name: CombiPatch

Estrogens have been reported to increase the chance of womb (endometrial) cancer. Estrogen-containing products should not be used to prevent heart disease or dementia. Estrogen given alone or in combination with another hormone (progestin) for replacement therapy may increase your risk for heart disease (eg, heart attacks), stroke, serious blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), dementia, or breast cancer. These risks appear to depend on the length of time CombiPatch Patch (Bi-weekly) is used and the amount of estrogen per dose. Therefore, CombiPatch Patch (Bi-weekly) should be used for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.

CombiPatch Patch (Bi-weekly) is used for:

Treating certain symptoms (eg, hot flashes; vaginal itching, burning, or dryness) caused by menopause. It is also used to replace estrogen when your body does not produce enough.

CombiPatch Patch (Bi-weekly) is a combination of progestin and estrogen hormones. It works by replacing natural progestin and estrogen in women who do not produce enough of these hormones.

Do NOT use CombiPatch Patch (Bi-weekly) if:

  • you are allergic to any ingredient in CombiPatch Patch (Bi-weekly)
  • you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus
  • you have a history of serious blood clots (eg, in the legs, lungs, eyes), liver problems, or breast cancer; you may have breast cancer; or you have cancers that are estrogen-dependent
  • you have had a recent heart attack or stroke

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

Before using CombiPatch Patch (Bi-weekly):

Some medical conditions may interact with CombiPatch Patch (Bi-weekly). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a family history of breast cancer, or you have breast lumps or disease or an abnormal mammogram
  • if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
  • if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
  • if you have abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, gallbladder disease, heart disease or other heart problems, circulation problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, the blood disease porphyria, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
  • if you smoke, are very overweight, or will be having surgery
  • if you have had your uterus removed (hysterectomy)

Some MEDICINES MAY INTERACT with CombiPatch Patch (Bi-weekly). Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, clarithromycin) because they may increase the risk of CombiPatch Patch (Bi-weekly)’s side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), nevirapine, rifampin, or St. John’s wort because they may decrease CombiPatch Patch (Bi-weekly)’s effectiveness
  • Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because the risk of their side effects may be increased by CombiPatch Patch (Bi-weekly)
  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased by CombiPatch Patch (Bi-weekly)

This may not be a complete list of all interactions that may occur. Ask your health care provider if CombiPatch Patch (Bi-weekly) 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 CombiPatch Patch (Bi-weekly):

Use CombiPatch Patch (Bi-weekly) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with CombiPatch Patch (Bi-weekly). Talk to your pharmacist if you have questions about this information.
  • The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your doctor. Follow the dosing schedule carefully.
  • Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts, press down to reapply. Wear only 1 system at any one time.
  • Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.
  • After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
  • Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor right away.
  • Grapefruit and grapefruit juice may increase the risk of side effects from CombiPatch Patch (Bi-weekly). Talk with your doctor before including grapefruit or grapefruit juice in your diet while taking CombiPatch Patch (Bi-weekly).
  • If you forget to change the patch as scheduled, change it as soon as possible and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use CombiPatch Patch (Bi-weekly).

Important safety information:

  • CombiPatch Patch (Bi-weekly) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use CombiPatch Patch (Bi-weekly) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Limit alcoholic beverages.
  • CombiPatch Patch (Bi-weekly) may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to CombiPatch Patch (Bi-weekly). Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • CombiPatch Patch (Bi-weekly) may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years old).
  • Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
  • Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while using CombiPatch Patch (Bi-weekly).
  • Follow your doctor’s instructions for examining your breasts, and report any lumps immediately.
  • If you wear contact lenses and you develop problems with them, contact your doctor.
  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using CombiPatch Patch (Bi-weekly).
  • Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
  • CombiPatch Patch (Bi-weekly) may increase the risk of breast and endometrial cancer.
  • Diabetes patients – CombiPatch Patch (Bi-weekly) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • CombiPatch Patch (Bi-weekly) may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using CombiPatch Patch (Bi-weekly).
  • Lab tests, including physical exams and blood pressure, may be performed while you use CombiPatch Patch (Bi-weekly). You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • CombiPatch Patch (Bi-weekly) should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use CombiPatch Patch (Bi-weekly) if you are pregnant. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if CombiPatch Patch (Bi-weekly) is found in breast milk after topical use. If you are or will be breast-feeding while you use CombiPatch Patch (Bi-weekly), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of CombiPatch Patch (Bi-weekly):

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:

Back pain; diarrhea; headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; runny or stuffy nose; stomach pain, cramps, or bloating; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf pain or tenderness; changes in vision or speech (eg, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent breast pain; severe or unusual vaginal bleeding; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of CombiPatch Patch (Bi-weekly):

Store CombiPatch Patch (Bi-weekly) at room temperature, below 77 degrees F (25 degrees C), in the original sealed pouch. Store away from heat, moisture, and light. Do not store in the bathroom. Keep CombiPatch Patch (Bi-weekly) out of the reach of children and away from pets.

General information:

  • If you have any questions about CombiPatch Patch (Bi-weekly), please talk with your doctor, pharmacist, or other health care provider.
  • CombiPatch Patch (Bi-weekly) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about CombiPatch Patch (Bi-weekly). 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Collyrium Fresh

30/06/10

Generic Name: boric acid (ophthalmic) (BOR ik AS id off THAL mik)
Brand Names: Collyrium Fresh

What is Collyrium Fresh (boric acid (ophthalmic))?

Boric acid has mild antibiotic properties against fungal or bacterial infection.

Boric acid ophthalmic (for the eyes) is used as an eye wash to cleanse or irrigate the eyes. Boric acid provides soothing relief from eye irritation, and helps remove pollutants from the eye such as smog, chlorine, or other chemicals.

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


What is the most important information I should know about Collyrium Fresh (boric acid (ophthalmic))?

You should not use this medication if you are allergic to boric acid.

Avoid using this medication if you have any open wound or other skin injury around your eyes.

Boric acid ophthalmic is for use only in the eyes. Do not allow the medicine to get in your mouth, nose, or ears. Avoid getting this medication on any skin wound or abrasion. Do not use boric acid ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using boric acid ophthalmic before putting your contact lenses in. Call your doctor at once if you have a serious side effect such as severe burning or stinging of your eyes, severe eye pain, vision changes that last for several hours after use, or if your eye condition does not improve or if it gets worse after using boric acid.

Boric acid is a weak antibiotic and should not be used to treat any type of infection without the advice of a doctor. There are many other, more effective antibiotics available.


What should I discuss with my health care provider before taking Collyrium Fresh (boric acid (ophthalmic))?

You should not use this medication if you are allergic to boric acid.

Avoid using this medication if you have any open wound or other skin injury around your eyes.

Boric acid is a weak antibiotic and should not be used to treat any type of infection without the advice of a doctor. There are many other, more effective antibiotics available. Before using this medication, tell your doctor if you are pregnant or breast-feeding.


How should I take Collyrium Fresh (boric acid (ophthalmic))?

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

Boric acid is usually given using an eye cup.

Use only a clean or sterile eye cup. Avoid touching the rim of the eye cup with your fingers while you are using it.

It may be best to use this medicine while standing over a sink or eye wash fountain.

Fill the eye cup about half way with boric acid ophthalmic solution. Bend your head forward and bring the cup to your eye. Press it tightly to your face around the eye. Then tilt your head back and open your eye wide.

Move the eye around in all directions to allow the boric acid to cleanse the eyeball thoroughly.

While still pressing the cup to your eye, bend forward over a sink. Remove the eye cup from your face and empty it into the sink. Allow any remaining boric acid solution to drain from your eye into the sink.

Repeat this procedure with your other eye if needed.

After using this medication, pat the skin dry around your eye using a clean tissue or towel. Do not rub your eyelids with the tissue or towel, or apply it directly to your eye.

Store boric acid ophthalmic at room temperature away from moisture and heat.

Keep boric acid ophthalmic solution in its sealed container until you are ready to use it.

What happens if I miss a dose?

Since boric acid ophthalmic is used only when needed, you are not likely to be on a dosing schedule. If your condition does not improve after using boric acid ophthalmic, ask your doctor before using a second dose of this medication.


What happens if I overdose?

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

An overdose of boric acid ophthalmic is not likely to cause life-threatening symptoms.

What should I avoid while taking Collyrium Fresh (boric acid (ophthalmic))?

Do not use boric acid ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using boric acid ophthalmic before putting your contact lenses in. Boric acid ophthalmic is for use only in the eyes. Do not allow the medicine to get in your mouth, nose, or ears. Avoid getting this medication on any skin wound or abrasion.

Collyrium Fresh (boric acid (ophthalmic)) side effects

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

  • severe burning or stinging of your eyes;

  • severe eye pain;

  • vision changes that last for several hours after use; or

  • if your eye condition does not improve or if it gets worse after using boric acid.

Less serious side effects may include:

  • mild stinging or eye irritation;

  • blurred vision;

  • watery eyes; or

  • eye redness.

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 Collyrium Fresh (boric acid (ophthalmic))?

Avoid using boric acid together with a contact lens wetting solution, or any other ophthalmic solution that contains polyvinyl alcohol.

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

Where can I get more information?

  • Your pharmacist can provide more information about boric acid ophthalmic.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:42:15 PM.

 

Colobar-100

30/06/10

Generic Name: barium sulfate (Oral route, Rectal route)

BAR-ee-um SUL-fate

Commonly used brand name(s):

In the U.S.

  • Bar-Test
  • E-Z-Disk
  • Readi-Cat

In Canada

  • Acb
  • Baro-Cat
  • Barosperse Enema
  • Colobar-100
  • Epi-C
  • Epi-Stat
  • Esobar
  • Esopho-Cat Esophageal Cream
  • E-Z-Cat
  • E-Z-Hd
  • E-Z-Jug
  • E-Z-Paque

Available Dosage Forms:

  • Kit
  • Suspension
  • Powder for Suspension
  • Enema
  • Paste
  • Tablet
  • Liquid

Therapeutic Class: Diagnostic Agent, Radiological Contrast Media

Uses For Colobar-100

Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.

Barium sulfate is taken by mouth or given rectally by enema. If taken by mouth, it makes the esophagus, the stomach, and/or the small intestine opaque to the x-rays so that they can be “photographed”. If it is given by enema, the colon and/or the small intestine can be seen and photographed by x-rays.

The dose of barium sulfate will be different for different patients and depends on the type of test. The strength of the suspension and tablet is determined by how much barium they contain. Different tests will require a different strength and amount of suspension (some may require the tablet form), depending on the age of the patient, the contrast needed, and the x-ray equipment used.

Barium sulfate is to be used only by or under the direct supervision of a doctor.


Before Using Colobar-100

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, test results may be affected by other things. For barium sulfate, 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

Although there is no specific information comparing use of barium sulfate in children with use in other age groups, this agent is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

This contrast agent has been used in older people and has not been shown to cause different side effects or problems in them than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Asthma, hay fever, or other allergies (history of)—If you have a history of these conditions, the risk of having a reaction, such as an allergic reaction to the additives in the barium sulfate preparation, is greater
  • Cystic fibrosis—The risk of blockage in the small bowel is greater
  • Dehydration—Barium sulfate may cause severe constipation
  • Intestinal blockage or perforation—Barium sulfate may make this condition worse




Proper Use of barium sulfate

This section provides information on the proper use of a number of products that contain barium sulfate. It may not be specific to Colobar-100. Please read with care.

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.


Precautions While Using Colobar-100

Make sure to drink plenty of liquids after the test. Otherwise, barium sulfate may cause severe constipation.

Colobar-100 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:

Rare

  • Bloating
  • constipation (severe, continuing)
  • cramping (severe)
  • nausea or vomiting
  • stomach or lower abdominal pain
  • tightness in chest or troubled breathing
  • wheezing

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:

More common

  • Constipation or diarrhea
  • cramping

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

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

 

Colocort

30/06/10

Generic Name: hydrocortisone rectal (foam, enema) (hye dro KORT i zone REK tal)
Brand Names: Colocort, Cortenema, Cortifoam

What is hydrocortisone rectal foam or enema?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal foam or enema.

Hydrocortisone rectal is used to treat hemorrhoids and itching or swelling of the rectal area caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal foam or enema may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about hydrocortisone rectal foam or enema?

The information in this medication guide is specific to hydrocortisone rectal foam or enema.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. 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.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.


What should I discuss with my health care provider before using hydrocortisone rectal foam or enema?

Before using this medication, tell your doctor if you have:

  • congestive heart failure;

  • a history of tuberculosis;

  • stomach ulcer or diverticulitis;

  • a colostomy or ileostomy;

  • fever or any type of infection;

  • kidney disease;

  • high blood pressure; or

  • myasthenia gravis.

If you have any of these conditions, you may not be able to use hydrocortisone rectal foam or enema, or you may need a dose adjustment or special tests during treatment.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

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


How should I use hydrocortisone rectal foam or enema?

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

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using the hydrocortisone rectal foam or enema.

Use only the applicator provided with the medication to insert it into your rectum.

For best results from the enema, lie down on your left side for at least 30 minutes after using the foam or enema to allow the liquid to distribute throughout your intestines. Try to hold in the enema all night if possible. Avoid using the bathroom during this time.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

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

What happens if I miss a dose?

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


What happens if I overdose?

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

An overdose of hydrocortisone rectal foam or enema is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal foam or enema?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.


Hydrocortisone rectal foam or enema 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:

  • feeling short of breath, even with mild exertion;

  • swelling of your ankles or feet;

  • muscle weakness;

  • rapid weight gain, especially in your face and midsection;

  • severe rectal pain or burning;

  • bleeding from your rectum;

  • severe stomach pain;

  • sudden and severe headache or pain behind your eyes; or

  • seizure (convulsions).

Less serious side effects may include:

  • mild rectal pain or burning;

  • acne;

  • changes in your menstrual periods;

  • increased sweating; or

  • increased facial or body hair growth.

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 hydrocortisone rectal foam or enema?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or other diabetes medications you take by mouth.

There may be other drugs that can interact with hydrocortisone rectal. 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.

Where can I get more information?

  • Your pharmacist can provide more information about hydrocortisone rectal foam or enema.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 08/19/2009 10:06:59 AM.

 

Colocort Enema

30/06/10

Generic Name: Hydrocortisone (HYE-droe-KOR-ti-sone)
Brand Name: Examples include Colocort and Cortenema

Colocort Enema is used for:

Treating inflammatory conditions of the colon such as ulcerative colitis and ulcerative proctitis. It may also be used for other conditions as determined by your doctor.

Colocort Enema is a topical corticosteroid. It works by decreasing inflammation.

Do NOT use Colocort Enema if:

  • you are allergic to any ingredient in Colocort Enema
  • you are taking interleukin-2 or mifepristone, or you will be receiving a smallpox vaccine
  • you have a rectal obstruction, abscess, or perforation; recent colostomy surgery; or a systemic fungal infection

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

Before using Colocort Enema:

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

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a weakened immune system; a parasitic, bacterial, fungal, or viral infection; heart failure; diabetes; diarrhea; swelling of the esophagus; stomach problems; blockage of the bowel or other bowel problems; abnormal blood electrolyte (eg, potassium, sodium) levels; measles; tuberculosis (TB); chickenpox; shingles; or herpes infection of the eye; or if you have received a recent vaccination
  • if you have a history of glaucoma, cataracts, or other eye problems; high blood pressure; weak bones; heart attack; ulcers; kidney problems; liver problems (eg, cirrhosis); underactive thyroid; nerve problems (eg, myasthenia gravis); or a positive TB skin test

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

  • Aprepitant, clarithromycin, or hormonal contraceptives (eg, birth control pills) because they may increase the risk of Colocort Enema’s side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Colocort Enema’s effectiveness
  • Anticoagulants (eg, warfarin), ritodrine, or smallpox vaccine because the risk of their side effects may be increased by Colocort Enema
  • Interleukin-2 or mifepristone because their effectiveness may be decreased by Colocort Enema

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

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

  • An extra patient leaflet is available with Colocort Enema. Talk to your pharmacist if you have questions about this information.
  • Shake well before each use.
  • Wash your hands immediately after using Colocort Enema.
  • Use Colocort Enema on a regular schedule to get the most benefit from it. Using it at the same time each day (usually at bedtime or as directed by your doctor) will help you remember to use it.
  • Do not suddenly stop using Colocort Enema if your course of treatment lasts longer than 21 days. Your doctor will gradually lower your dose.
  • If you miss a dose of Colocort Enema and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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

Important safety information:

  • Do not use Colocort Enema for other rectal conditions at a later time.
  • Tell your doctor or dentist that you take Colocort Enema before you receive any medical or dental care, emergency care, or surgery.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Colocort Enema. Talk with your doctor before you receive any vaccine.
  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. If you are exposed to someone who has one of these conditions, contact your doctor right away.
  • If your symptoms do not get better within 2 to 3 weeks or if they get worse, check with your doctor.
  • Colocort Enema should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Colocort Enema.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Colocort Enema while you are pregnant. It is not known if Colocort Enema is found in breast milk. If you are or will be breast-feeding while you use Colocort Enema, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Colocort Enema:

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:

Mild irritation or dryness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or persistent sore throat; mental or mood changes; new or worsening rectal pain, burning, itching, bleeding, or irritation; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Colocort Enema may be harmful if swallowed.

Proper storage of Colocort Enema:

Store Colocort Enema at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Colocort Enema out of the reach of children and away from pets.

General information:

  • If you have any questions about Colocort Enema, please talk with your doctor, pharmacist, or other health care provider.
  • Colocort Enema is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Colocort Enema. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Colrex Compound

30/06/10

Generic Name: Acetaminophen/Chlorpheniramine/Codeine/Phenylephrine (a-seet-a-MIN-oh-fen/klor-fen-EER-a-meen/KOE-deen/fen-ill-EF-rin)
Brand Name: Colrex Compound

Colrex Compound is used for:

Treating symptoms of the common cold, flu, or hay fever, and other upper respiratory allergies such as cough, congestion, runny nose, pain, fever, sneezing, itching of the nose and throat, and itchy, watery eyes. Colrex Compound may also be used for other conditions as determined by your doctor.

Colrex Compound is a narcotic antitussive (cough suppressant), analgesic, antihistamine, and decongestant combination. The antitussive works by suppressing the cough center in the brain. The analgesic works in the brain to reduce pain and fever. The antihistamine works by blocking the action of histamine, which reduces the symptoms of an allergic reaction such as itch, watery eyes and runny nose. The decongestant shrinks swollen nasal passages, which relieves nasal congestion.

Do NOT use Colrex Compound if:

  • you are allergic to any ingredient in Colrex Compound or any other codeine-related medicine (eg, dihydrocodeine)
  • you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)
  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
  • you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Colrex Compound:

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

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of alcohol or drug abuse, dependence on narcotics, or suicidal thoughts or behaviors
  • if you have increased pressure in the head, an unusual growth in the brain (eg, tumor), a recent head injury, Parkinson disease, Reye syndrome, the blood disease porphyria, or a blockage of your stomach, bowel, or bladder
  • if you have a history of epilepsy or seizures, asthma or other breathing problems (eg, sleep apnea), stomach or intestinal problems, chronic constipation, liver problems (eg, hepatitis), severe kidney problems, glaucoma, an enlarged prostate gland or other prostate problems, difficulty urinating, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, overactive thyroid, seizures, or stroke
  • if you have recently had abdominal surgery

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

  • Barbiturate anesthetics (eg, thiopental), beta-blockers (eg, propranolol), cimetidine, catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, ketorolac, MAO inhibitors (eg, phenelzine), naltrexone, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Colrex Compound may be increased, including dangerous sleepiness and a decrease in the ability to breathe
  • Anticoagulants (eg, warfarin) or isoniazid because the risk of bleeding or liver problems may be increased
  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
  • Rifampin or risperidone because the effectiveness of Colrex Compound may be decreased
  • Bromocriptine or hydantoins (eg, phenytoin) because the actions and side effects may be increased by Colrex Compound
  • Guanadrel, guanethidine, mecamylamine, methyldopa, mexiletine, or reserpine because the effectiveness may be decreased by Colrex Compound
  • Naltrexone because the effectiveness of Colrex Compound will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids. You must not take naltrexone until you have stopped taking Colrex Compound for 7 to 10 days and after a naloxone challenge test is negative.

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

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

  • Colrex Compound may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you miss a dose of Colrex Compound and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

  • Colrex Compound may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Colrex Compound. Using Colrex Compound alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Do not drink alcohol while you are using Colrex Compound. Avoid taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Colrex Compound. Colrex Compound will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
  • If your symptoms do not improve within 7 days or if you develop a high fever or persistent headache, check with your doctor.
  • Use Colrex Compound with caution in the ELDERLY because they may be more sensitive to its effects, especially possible breathing problems and drowsiness.
  • Use Colrex Compound with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is unknown if Colrex Compound can cause harm to the fetus. If you become pregnant while taking Colrex Compound, discuss with your doctor the benefits and risks of using Colrex Compound during pregnancy. Colrex Compound is excreted in breast milk. If you are or will be breast-feeding while you are using Colrex Compound, check with your doctor or pharmacist to discuss the risks to your baby.

Use of Colrex Compound can lead to TOLERANCE. When using for an extended period, Colrex Compound may not work as well and may require different dosing. Talk with your doctor if Colrex Compound stops working well.

Long-term use of Colrex Compound can lead to physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness, when pain relief is more important. If using Colrex Compound for an extended period of time, do not suddenly stop taking Colrex Compound without your doctor’s approval. WITHDRAWAL symptoms have occurred when Colrex Compound is suddenly stopped and may include anxiety; diarrhea; fever; runny nose or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping use of Colrex Compound.

Possible side effects of Colrex Compound:

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

Constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; flushing or redness of face; stomach pain; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slowed breathing; slow heartbeat.

Proper storage of Colrex Compound:

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

General information:

  • If you have any questions about Colrex Compound, please talk with your doctor, pharmacist, or other health care provider.
  • Colrex Compound is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Colrex Compound. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Colsalide

30/06/10

Generic Name: colchicine (Oral route)

KOL-chi-seen

Commonly used brand name(s):

In the U.S.

  • Colcrys
  • Colsalide

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antigout

Uses For Colsalide

Colchicine is used to prevent or treat attacks of gout (also called gouty arthritis). This condition is caused by too much uric acid in the blood. An attack of gout occurs when uric acid causes inflammation (pain, redness, swelling, and heat) in a joint. Colchicine does not cure gout, but it will help prevent gout attacks. Colchicine is not an ordinary pain reliever and will not relieve most kinds of pain.

Colchicine is also used to treat a rare condition called familial Mediterranean fever (FMF) in adults and children above 4 years of age.

Colchicine may also be used for other conditions as determined by your doctor.

Colchicine may be used in 2 ways. Most people take small amounts of it regularly for a long time (months or even years) to prevent severe attacks or other problems caused by inflammation. Other people take large amounts of colchicine during a short period of time (several hours) only when the medicine is needed to relieve an attack that is occurring. The chance of serious side effects is much lower with the first (preventive) kind of treatment.

Because some of colchicine’s side effects can be very serious, you should discuss with your doctor about the good that this medicine can do as well as the risks of using it.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, colchicine is used in certain patients with the following medical conditions:

  • Amyloidosis.
  • Behçet’s syndrome.
  • Calcium pyrophosphate deposition disease (pseudogout).
  • Cirrhosis of the liver.
  • Pericarditis.
  • Sarcoid arthritis.

If you are taking colchicine for any of these conditions, the following information may apply:

  • For all of these conditions, colchicine is usually given regularly in small amounts to reduce inflammation (preventive treatment). This usually decreases the occurrence of severe attacks or other problems caused by inflammation.
  • Colchicine is not a cure for these conditions. It will help prevent problems caused by inflammation only as long as you continue to take it.
  • Some patients with calcium pyrophosphate deposition disease (pseudogout) or familial Mediterranean fever may take larger amounts of colchicine only when an attack occurs, to relieve the attack.


Before Using Colsalide

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

Appropriate studies have not been performed on the relationship of age to the effects of colchicine in children with gout. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of colchicine in children with FMF. However, safety and efficacy of colchicine have not been established in children with FMF younger than 4 years of age.

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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.

  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Clarithromycin
  • Cyclosporine
  • Diltiazem
  • Erythromycin
  • Fluconazole
  • Fosamprenavir
  • Gemfibrozil
  • Indinavir
  • Interferon Alfa-2a
  • Itraconazole
  • Ketoconazole
  • Lovastatin
  • Nefazodone
  • Nelfinavir
  • Pravastatin
  • Quinidine
  • Ranolazine
  • Reserpine
  • Ritonavir
  • Saquinavir
  • Tacrolimus
  • Telithromycin
  • Verapamil

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.

  • Atorvastatin
  • Bezafibrate
  • Ciprofibrate
  • Clofibrate
  • Digoxin
  • Fenofibrate
  • Fluvastatin
  • Simvastatin

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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

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:

  • Alcohol abuse or
  • Bowel disease or
  • Stomach ulcer or other stomach problems—The chance of stomach upset may be increased. Also, colchicine can make some kinds of stomach or intestinal problems worse.
  • Blood disorders (e.g., aplastic anemia, granulocytopenia, leukopenia, pancytopenia) or
  • Muscle or nerve problems—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Should not be used in patients with these conditions.




Proper Use of colchicine

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take more of it, and do not take it for a longer time than your doctor ordered. Do not change your dose or stop using this medicine without checking first with your doctor.

For patients taking small amounts of colchicine regularly (preventive treatment):

  • Take this medicine regularly as directed by your doctor, even if you feel well. If you are taking colchicine to prevent gout attacks, and you are also taking another medicine to reduce the amount of uric acid in your body, you probably will be able to stop taking colchicine after a while. However, if you stop taking it too soon, your attacks may return or get worse. If you are taking colchicine for certain other medical conditions, you may need to keep taking it for the rest of your life.
  • If you are taking colchicine to prevent gout attacks, ask your doctor to recommend other medicine to be taken if an attack occurs. Most people receiving preventive amounts of colchicine should not take extra colchicine to relieve an attack. However, some people cannot take the other medicines that are used for gout attacks and will have to take extra colchicine. If you are one of these people, ask your doctor to tell you the largest amount of colchicine you should take for an attack and how long you should wait before starting to take the smaller preventive amounts again. Be sure to follow these directions carefully.

For patients taking large amounts of colchicine only when needed to relieve an attack:

  • Start taking this medicine at the first sign of the attack for best results.
  • Stop taking this medicine as soon as the pain is relieved or at the first sign of nausea, vomiting, stomach pain, or diarrhea . Also, stop taking colchicine when you have taken the largest amount that your doctor ordered for each attack, even if the pain is not relieved or none of these side effects occurs.
  • The first few times you take colchicine, keep a record of each dose as you take it. Then, whenever stomach upset (nausea, vomiting, stomach pain, or diarrhea) occurs, count the number of doses you have taken. The next time you need colchicine, stop taking it before that number of doses is reached. For example, if diarrhea occurs after your fifth dose of medicine, take no more than four doses the next time. If taking fewer doses does not prevent stomach upset from occurring after a few treatments, check with your doctor.
  • After taking colchicine tablets to treat an attack, do not take any more colchicine for at least 3 days. Also, after receiving the medicine by injection for an attack, do not take any more colchicine (tablets or injection) for at least 7 days. Elderly patients may have to wait even longer between treatments and should check with their doctor for directions.
  • If you are taking colchicine for an attack of gout, and you are also taking other medicine to reduce the amount of uric acid in your body, do not stop taking the other medicine. Continue taking the other medicine as directed by your doctor.

You may take this medicine with or without food.

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 (tablets):
    • For familial mediterranean fever (FMF):
      • Adults and teenagers—1.2 to 2.4 milligrams (mg) given in one or two divided doses a day. Your doctor may adjust your dose as needed.
      • Children 6 to 12 years of age—0.9 to 1.8 milligrams (mg) given in one or two divided doses a day.
      • Children 4 to 6 years of age—0.3 to 1.8 milligrams (mg) given in one or two divided doses a day.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    • For gout attacks:
      • Adults—1.2 milligrams (mg) at the first sign of a gout attack, followed by 0.6 mg after one hour. The dose is usually 1.8 mg over a 1 hour period.
      • Children—Use is not recommended.

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 Colsalide

If you must take colchicine for a long time (preventive treatment), your doctor may want to check your progress at regular visits. Blood tests may be needed to check for unwanted effects.

Stomach problems may be more likely to occur if you drink large amounts of alcoholic beverages while taking colchicine. Also, drinking too much alcohol may increase the amount of uric acid in your blood. This may lessen the effects of colchicine when it is used to prevent gout attacks. Therefore, people who take colchicine should be careful to limit the amount of alcohol they drink.

For patients taking small amounts of colchicine regularly (preventive treatment):

  • Attacks of gout or other problems caused by inflammation may continue to occur during treatment. However, the attacks or other problems should occur less often, and they should not be as severe as they were before you started taking colchicine. Even if you think the colchicine is not working, do not stop taking it and do not increase the dose. Check with your doctor instead.

Colchicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

If your doctor tells you to increase the amount of medicine you are taking or if you are just starting this medicine, make sure you tell the doctor right away if you get muscle pain, tenderness, or weakness.

Grapefruits and grapefruit juice may increase the effects of colchicine by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking 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.

Colsalide 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:

More common

  • Diarrhea
  • nausea or vomiting
  • stomach pain

Rare

  • Black, tarry stools
  • blood in the urine or stools
  • burning, “crawling”, or tingling feeling in the skin
  • difficulty in breathing when exercising
  • fever with or without chills
  • headache
  • large, hive-like swellings on the face, eyelids, mouth, lips, or tongue
  • muscle weakness
  • numbness in the fingers or toes (usually mild)
  • pain
  • peeling of the skin
  • pinpoint red spots on the skin
  • redness
  • skin rash or hives
  • sores, ulcers, or white spots on the lips or in the mouth
  • sore throat
  • swelling
  • tenderness
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Bleeding
  • burning feeling in the stomach, throat, or skin
  • convulsions (seizures)
  • diarrhea (severe or bloody)
  • fast, shallow breathing
  • muscle weakness (very severe)
  • nausea, stomach pain, or vomiting (severe)

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

  • Hair loss
  • loss of appetite

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

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

 

Coly Mycin M

30/06/10

Generic Name: colistimethate (koe LIS ti METH ate)
Brand Names: Coly Mycin M

What is Coly Mycin M (colistimethate)?

Colistimethate is an antibiotic that fights bacteria in the body.

Colistimethate is used to treat infections caused by bacteria.

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


What is the most important information I should know about Coly Mycin M (colistimethate)?

You should not use this medication if you are allergic to colistimethate.

Before using colistimethate, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests during treatment.

Colistimethate is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Keep using colistimethate for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Colistimethate will not treat a viral infection such as the common cold or flu.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using colistimethate. You may need to stop using the medicine for a short time.

What should I discuss with my health care provider before taking Coly Mycin M (colistimethate)?

You should not use this medication if you are allergic to colistimethate.

Before using colistimethate, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need dose adjustments or special tests during treatment.

Your doctor will tell you if any of your medication doses need to be changed.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether colistimethate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.


How should I take Coly Mycin M (colistimethate)?

Colistimethate is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

The colistimethate injection is sometimes given every 12 hours. The medication can also be mixed with a liquid in an IV bag and given as a slow infusion over a 24-hour period.

Use each disposable needle and syringe only one time. Throw away used needles and syringes in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

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

Keep using colistimethate for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Colistimethate will not treat a viral infection such as the common cold or flu.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using colistimethate. You may need to stop using the medicine for a short time. If you store colistimethate at home, keep the medication at cool room temperature away from moisture and heat. After colistimethate is mixed in an IV bag, it must be kept in a refrigerator and used within 7 days of mixing.

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 take 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.

Overdose symptoms may include confusion, dizziness, loss of balance or coordination, blurred vision, slurred speech, severe numbness or tingling, or trouble breathing.

What should I avoid while taking Coly Mycin M (colistimethate)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.


Coly Mycin M (colistimethate) 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:

  • diarrhea that is watery or bloody;

  • fever;

  • urinating less than usual or not at all;

  • muscle weakness; or

  • trouble breathing.

Less serious side effects may include:

  • mild numbness or tingling in your hands or feet;

  • dizziness, spinning feeling;

  • itching, mild skin rash; or

  • upset stomach.

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 Coly Mycin M (colistimethate)?

The following antibiotics can interact with colistimethate. Tell your doctor if you are using any of these:

  • amikacin (Amikin);

  • gentamicin (Garamycin);

  • kanamycin (Kantrex);

  • neomycin (Mycifradin, Neo-Fradin, Neo-Tab);

  • netilmicin (Netromycin);

  • polymyxin;

  • streptomycin; or

  • tobramycin (Nebcin, Tobi).

This list is not complete and there may be other drugs that can interact with colistimethate. 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.

Where can I get more information?

  • Your pharmacist can provide more information about colistimethate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 4/12/2009 4:39:06 PM.

 

Coly Mycin S

30/06/10

Generic Name: colistin, hydrocortisone, neomycin, and thonzonium (otic) (koe LIS tin, HYE droe KOR ti sone, NEE oh MYE sin, thon ZOE nee um)
Brand Names: Coly Mycin S, Coly-Mycin S, Cortisporin-TC

What is colistin, hydrocortisone, neomycin, and thonzonium?

Colistin and neomycin are antibiotics that fight bacteria.

Hydrocortisone is in a class of drugs called steroids. Hydrocortisone prevents the release of substances in the body that cause inflammation.

Thonzonium is a wetting agent.

The combination of colistin, hydrocortisone, neomycin, and thonzonium otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Colistin, hydrocortisone, neomycin, and thonzonium otic may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum..

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing. Stop using this medication and call your doctor at once if you have a skin rash, redness, swelling, itching, dryness, or scaling.

What should I discuss with my health care provider before using colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum.. FDA pregnancy category C. It is not known whether colistin, hydrocortisone, neomycin, and thonzonium ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.


How should I use colistin, hydrocortisone, neomycin, and thonzonium?

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.

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before you measure a dose.

The usual dose of this medication is 5 drops into the affected ear every 6 to 8 hours. If you are using this medicine on a child, use only 4 drops per affected ear.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

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 or with your head tilted for at least 5 minutes.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 hours. Replace the cotton at least every 24 hours. Follow your doctor’s instructions about the use of cotton with this medication.

Wipe the ear 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. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

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

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.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using colistin, hydrocortisone, neomycin, and thonzonium?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using this medication.


Colistin, hydrocortisone, neomycin, and thonzonium side effects

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

  • skin rash, redness, swelling, itching, dryness, or scaling;

  • hearing loss; or

  • urinating less than usual or not at all.

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 colistin, hydrocortisone, neomycin, and thonzonium?

There may be other drugs that can interact with colistin, hydrocortisone, neomycin, and thonzonium. 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.

Where can I get more information?

  • Your pharmacist can provide more information about colistin, hydrocortisone, neomycin, and thonzonium otic.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 4/12/2009 4:42:53 PM.