probenecid

proe-BEN-e-sid

Commonly used brand name(s)

In the U.S.

• Benemid


• Probalan

Available Dosage Forms:

• Tablet

Therapeutic Class: Antigout

Uses For probenecid

Probenecid is used in the treatment of chronic gout or gouty arthritis. These conditions are caused by too much uric acid in the blood. The medicine works by removing the extra uric acid from the body. Probenecid does not cure gout, but after you have been taking it for a few months it will help prevent gout attacks. probenecid will help prevent gout attacks only as long as you continue to take it.

Probenecid is also used to prevent or treat other medical problems that may occur if too much uric acid is present in the body.

Probenecid is sometimes used with certain kinds of antibiotics to make them more effective in the treatment of infections.

Probenecid is available only with your doctor's prescription.

Before Using probenecid

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 probenecid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to probenecid 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

Probenecid has been tested in children 2 to 14 years of age for use together with antibiotics. It has not been shown to cause different side effects or problems than it does in adults. Studies on the effects of probenecid in patients with gout have been done only in adults. Gout is very rare in children.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking probenecid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Ketorolac

Using probenecid 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.

• Citalopram


• Doripenem


• Methotrexate


• Zalcitabine

Using probenecid 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.

• Amoxicillin


• Aspirin


• Bismuth Subsalicylate


• Cefditoren Pivoxil


• Cefotaxime


• Cefpodoxime Proxetil


• Cefprozil


• Choline Magnesium Trisalicylate


• Ciprofloxacin


• Enprofylline


• Ertapenem


• Gatifloxacin


• Lorazepam


• Magnesium Salicylate


• Meropenem


• Norfloxacin


• Phenprocoumon


• Piretanide


• Pralatrexate


• Sodium Salicylate


• Sodium Thiosalicylate


• Zidovudine


• Zomepirac

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 probenecid. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disease or


• Cancer being treated by antineoplastics (cancer medicine) or radiation (x-rays) or


• Kidney disease or stones (or history of) or


• Stomach ulcer (history of)—The chance of side effects may be increased

Proper Use of probenecid

If probenecid upsets your stomach, it may be taken with food. If this does not work, an antacid may be taken. If stomach upset (nausea, vomiting, or loss of appetite) continues, check with your doctor.

For patients taking probenecid for gout:

• After you begin to take probenecid, gout attacks may continue to occur for a while. However, if you take probenecid regularly as directed by your doctor, the attacks will gradually become less frequent and less painful than before. After you have been taking probenecid for several months, they may stop completely.


• probenecid will help prevent gout attacks but it will not relieve an attack that has already started. Even if you take another medicine for gout attacks, continue to take probenecid also. If you have any questions about this, check with your doctor.

For patients taking probenecid for gout or to help remove uric acid from the body:

• When you first begin taking probenecid, the amount of uric acid in the kidneys is greatly increased. This may cause kidney stones or other kidney problems in some people. To help prevent this, your doctor may want you to drink at least 10 to 12 full glasses (8 ounces each) of fluids each day, or to take another medicine to make your urine less acid. It is important that you follow your doctor's instructions very carefully.

Dosing

The dose of probenecid 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 probenecid. 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 treating gout or removing uric acid from the body:
  
  • Adults: 250 mg (one-half of a 500-mg tablet) two times a day for about one week, then 500 mg (one tablet) two times a day for a few weeks. After this, the dose will depend on the amount of uric acid in your blood or urine. Most people need 2, 3, or 4 tablets a day, but some people may need higher doses.
  
  
  • Children: It is not likely that probenecid will be needed to treat gout or to remove uric acid from the body in children. If a child needs probenecid, however, the dose would have to be determined by the doctor.
  
  


• For helping antibiotics work better:
  
  • Adults: The amount of probenecid will depend on the condition being treated. Sometimes, only one dose of 2 tablets is needed. Other times, the dose will be 1 tablet four times a day.
  
  
  • Children: The dose will have to be determined by the doctor. It depends on the child's weight, as well as on the condition being treated. Older children and teenagers may need the same amount as adults.
  
  

Missed Dose

If you miss a dose of probenecid, 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.

Precautions While Using probenecid

If you will be taking probenecid for more than a few weeks, your doctor should check your progress at regular visits.

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

For diabetic patients:

• Probenecid may cause false test results with copper sulfate urine sugar tests (Clinitest®), but not with glucose enzymatic urine sugar tests (Clinistix®). If you have any questions about this, check with your health care professional.

For patients taking probenecid for gout or to help remove uric acid from the body:

• Taking aspirin or other salicylates may lessen the effects of probenecid. This will depend on the dose of aspirin or other salicylate that you take, and on how often you take it. Also, drinking too much alcohol may increase the amount of uric acid in the blood and lessen the effects of probenecid. Therefore, do not take aspirin or other salicylates or drink alcoholic beverages while taking probenecid, unless you have first checked with your doctor.

probenecid 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

• Fast or irregular breathing


• puffiness or swellings of the eyelids or around the eyes


• shortness of breath, troubled breathing, tightness in chest, or wheezing


• changes in the skin color of the face occurring together with any of the other side effects listed here


• or skin rash, hives, or itching occurring together with any of the other side effects listed here

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Bloody urine


• difficult or painful urination


• lower back or side pain (especially if severe or sharp)


• skin rash, hives, or itching (occurring without other signs of an allergic reaction)

Rare

• Cloudy urine


• cough or hoarseness


• fast or irregular breathing


• fever


• pain in back and/or ribs


• sores, ulcers, or white spots on lips or in mouth


• sore throat and fever with or without chills


• sudden decrease in the amount of urine


• swelling of face, fingers, feet, and/or lower legs


• swollen and/or painful glands


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin


• weight gain

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

• Headache


• joint pain, redness, or swelling


• loss of appetite


• nausea or vomiting (mild)

Less common

• Dizziness


• flushing or redness of face (occurring without any signs of an allergic reaction)


• frequent urge to urinate


• sore gums

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: probenecid side effects (in more detail)

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

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More probenecid resources

• Probenecid Side Effects (in more detail)
• Probenecid Dosage
• Probenecid Use in Pregnancy & Breastfeeding
• Drug Images
• Probenecid Drug Interactions
• Probenecid Support Group
• 1 Review for Probenecid - Add your own review/rating

• probenecid Concise Consumer Information (Cerner Multum)


• Probenecid Prescribing Information (FDA)


• Probenecid Professional Patient Advice (Wolters Kluwer)


• Probenecid MedFacts Consumer Leaflet (Wolters Kluwer)


• Probenecid Monograph (AHFS DI)

Compare probenecid with other medications

• Adjunct to Antibiotic Therapy
• Gout

Schistosoma mansoni Medications

Definition of Schistosoma mansoni: A species of trematode worm that parasitises humans and that

Drugs associated with Schistosoma mansoni

The following drugs and medications are in some way related to, or used in the treatment of Schistosoma mansoni. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Biltricide

Vansil

Targinact 5 mg / 2.5 mg, 10 mg / 5 mg, 20 mg / 10 mg and 40 mg / 20 mg prolonged-release tablets

Targinact


5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged-release tablets

Oxycodone hydrochloride and Naloxone hydrochloride

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

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


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


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


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

In this leaflet:

• 1. What Targinact tablets are and what they are used for


• 2. Before you take Targinact tablets


• 3. How to take Targinact tablets


• 4. Possible side effects


• 5. How to store Targinact tablets


• 6. Further information

What Targinact tables are and what they are used for

These tablets contain the active ingredients oxycodone hydrochloride and naloxone hydrochloride. Oxycodone is for the pain-killing effect of the tablets. It is a strong analgesic ('painkiller') that belongs to a group of medicines called opioids. Naloxone is intended to bring relief from constipation. Constipation is a typical side effect of treatment with strong painkillers.

You have been prescribed these tablets for the treatment of severe pain, which requires the use of a strong painkiller (opioid analgesic).

These are prolonged-release tablets. This means that the active ingredients are slowly released from the tablets over a period of 12 hours.

Before you take Targinact tablets

Do not take Targinact tablets

• if you are allergic (hypersensitive) to oxycodone or naloxone, or any of the other ingredients of the tablets;


• if you have breathing problems, such as breathing more slowly or weakly than expected (respiratory depression);


• if you suffer from a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD);


• if you suffer from a condition known as cor pulmonale. In this condition, the right side of the heart becomes enlarged, due to increased pressure inside blood vessels in the lung etc. (e.g. as a result of COPD - see above);


• if you suffer from severe bronchial asthma;


• if you have a type of bowel obstruction (paralytic ileus) not caused by opioids;


• if you have moderate to severe liver problems.

Take special care with Targinact tablets

• in the case of elderly or debilitated (weak) patients;


• if you have a type of bowel obstruction (paralytic ileus) caused by opioids;


• if you have kidney problems;


• if you have mild liver problems;


• if you have severe lung problems (i.e. reduced breathing capacity);


• if you have myxoedema (a thyroid disorder, with dryness, coldness and swelling ['puffiness'] of the skin, affecting the face and limbs);


• if your thyroid gland is not producing enough hormones (underactive thyroid or hypothyroidism);


• if your adrenal glands are not producing enough hormones (adrenal insufficiency or Addison's disease);


• if you have a mental disorder as a result of an intoxication (toxic psychosis);


• if you suffer from gallstone problems;


• if your prostate gland is abnormally enlarged (prostate hypertrophy);


• if you are or ever have been addicted to alcohol or drugs, or have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping alcohol or drugs;


• if your pancreas is inflamed (pancreatitis);


• if you have low blood pressure (hypotension);


• if you have high blood pressure (hypertension);


• if you have heart problems;


• if you have a head injury (due to the risk of increased brain pressure);


• if you suffer from epilepsy or are prone to fits;


• if you are also taking a type of medicine known as a MAO inhibitor (used to treat depression or Parkinson's disease) e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid.

If any of these warnings apply to you, talk to your doctor before starting to take these tablets.

These tablets are not recommended for use in patients with advanced digestive or pelvic cancers where bowel obstruction may be a problem.

How to use Targinact tablets correctly

If you experience severe diarrhoea at the start of treatment (within the first 3-5 days) this may be due to the effect of naloxone. It may be a sign that your bowel movements are returning to normal. If diarrhoea persists after 3-5 days, or it gives you cause for concern, please contact your doctor.

If you have been using high doses of another opioid, withdrawal symptoms (such as restlessness, bouts of sweating or muscle pain) may occur when you initially switch to taking these tablets. If you experience withdrawal symptoms, you may need to be specially monitored by your doctor.

If you need to undergo surgery, please tell your doctor that you are taking these tablets.

If you have been taking these tablets for a long time, you may become tolerant. This means you may need a higher dose to achieve the desired pain relief. Long-term use of these tablets may also lead to addiction. Withdrawal symptoms may occur if treatment is stopped too suddenly. If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.

As with other strong opioid painkillers, there is a risk that you may develop a psychological dependence to oxycodone.

You may notice remains of the tablet in your stools. Do not be alarmed, as the active ingredients will have already been released in the stomach and gut, and absorbed into your body.

Incorrect use of Targinact tablets

You must swallow these tablets whole so as not to affect the slow release of oxyecodone. Do not break, chew or crush these tablets. Taking broken, chewed or crushed tablets may result in your body absorbing a potentially fatal dose of oxycodone (see under 'If you take more Targinact tablets than you should').

These tablets are not suitable for withdrawal treatment.

These tablets should never be abused, particularly if you have a drug addiction. If you are addicted to drugs such as heroin, morphine or methadone, severe withdrawal symptoms are likely if you abuse these tablets because they contain the ingredient naloxone. Pre-existing withdrawal symptoms may be made worse.

You should never misuse the tablets by dissolving and injecting them (e.g. into a blood vessel). They contain talc, which can cause destruction of local tissue (necrosis) and changes in lung tissue (lung granuloma). Misuse can also have other serious consequences which may be fatal.

The use of these tablets may produce positive results in drugs tests.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The risk of side effects is increased if you take these tablets at the same time as medicines which affect the way the brain works. For example, you may feel very sleepy, or breathing problems may get worse.

Examples of medicines that affect the way the brain works include:

• other strong painkillers (opioids);


• sleep medication and tranquillisers (sedatives, hypnotics);


• antidepressants;


• medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics);


• other medicines which act on the nervous system (phenothiazines, neuroleptics).

If you are taking these tablets at the same time as medicines that decrease the blood's clotting ability (coumarin derivatives), this clotting time may be speeded up or slowed down.

Taking Targinact tablets with food and drink

These tablets should not be taken with alcohol. Alcohol use could increase the risk of experiencing serious side effects, such as sleepiness, drowsiness and slow and shallow breathing.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Use of these tablets during pregnancy should be avoided unless your doctor thinks treatment with this medicine is essential. If used over prolonged periods during pregnancy, oxycodone may lead to withdrawal symptoms in the newborn baby. If oxycodone is given during childbirth, the baby may have breathing problems (respiratory depression).

Breastfeeding should be stopped during treatment with these tablets as oxycodone (one of the active ingredients of your medicine) passes into breast milk.

Driving and using machines

These tablets may affect your ability to drive or operate machines. This is most likely at the start of your treatment, after a dose increase or after switching from a different medication. These side effects should disappear once you are on a stable dose.

Ask your doctor whether you may drive or operate machines.

Important information about some of the ingredients of Targinact tablets

These tablets contain lactose (milk sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking these tablets.

How to take Targinact tablets

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

Adults

The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride every 12 hours.

Your doctor will decide how much you should take every day and how to divide your total daily dose into morning and evening doses. They will also decide on any necessary dose adjustments during treatment depending on your level of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you have already been treated with opioids, your treatment with these tablets may be started at a higher dose.

The maximum daily dose is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone without naloxone. However, the maximum daily dose of oxycodone should not exceed 400 mg. The beneficial effect of naloxone on bowel movements may be affected if additional oxycodone is given without additional naloxone.

If you experience pain between doses, you may need to take an additional fast-acting painkiller. These tablets are not suitable for this. Please talk to your doctor.

If you feel that these tablets are too strong or too weak, please talk to your doctor or pharmacist.

Liver or kidney problems

If you have kidney or mild liver problem your doctor may prescribe a lower dose. You must not take these tablets if you have moderate or severe liver problems, (see also section 2 'Do not take Targinact tablets' and 'Take special care with Targinact tablets').

Children and adolescents below 18 years of age

No studies have been carried out to show that these tablets work properly in children and adolescents, or are safe for them to take. They are therefore not recommended for use in patients under 18 years of age.

Elderly patients

In general, no dose adjustment is necessary for elderly patients with normal kidney and/or liver function.

Method of administration

Swallow your tablets whole with a glass of water. You can take these tablets with or without food. Take them every 12 hours. For instance, if you take a tablet at 8 o' clock in the morning, you should take your next tablet at 8 o'clock in the evening. Do not break, chew or crush the tablets.

Duration of use

You should not take these tables for any longer than you need to. If you have been taking them for a long time your doctor should regularly check that you still need them.

If you take more Targinact tablets than you should

If you have taken more than the prescribed dose, you must inform your doctor immediately.

An overdose may result in:

• a reduction in size of pupils in the eye


• breathing more slowly or weakly than expected (respiratory depression)


• drowsiness or loss of consciousness


• low muscle tone (hypotonia)


• reduced pulse rate


• a fall in blood pressure.

In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse may occur, which may be fatal.

You should avoid situations which require you to be alert, e.g. driving.

If you forget to take Targinact tablets,

or if you take a lower dose than the one prescribed, you may not feel any pain-killing effect.

• If you forget to take your tablets and your next usual dose is due in 8 hours time or more: Take the forgotten tablet immediately and continue with your normal dosing routine.


• If your next usual dose is due in less than 8 hours time: Take the forgotten tablet, then, wait another 8 hours before taking your next tablet. Try to get back in your normal dosing routine (e.g. 8 o'clock in the morning and 8 o'clock in the evening).

Do not take more than one dose within any 8 hour period.

Do not take a double dose to make up for a forgoten tablet.

If you stop taking Targinact tablets

Do not stop taking these tablets without first speaking with your doctor. If you do not require any further treatment, your doctor will advise you how to reduce the daily dose gradually. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating and muscle pain.

If you have any futher questions on the use of these tablets, ask your doctor or pharmacist.

Possible side effects

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

The following terms are used to explain how frequently patients experience side effects:

Very common: affecting more than 1 in 10 people taking these tablets

Common: affecting between 1 and 10 in 100 people taking these tablets

Uncommon: affecting between 1 and 10 in 1,000 people taking these tablets

Rare: affecting between 1 and 10 in 10,000 people taking these tablets

Very rare: affecting fewer than 1 in 10,000 people taking these tablets

Not known:frequency not known

Important side effects or signs to look out for, and what to do if you are affected:

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). It mostly occurs in elderly and weak patients. Opioids can also cause a severe drop in blood pressure in susceptible patient. If you are affected by these important side effects, consult a doctor immediately.

Other important side effects are:

Common

• abdominal pain


• constipation


• diarrhoea


• withdrawal symptoms such as agitation, anxiety, shaking or sweating


• feeling hot and cold


• chills


• dry mouth


• indigestion


• wind


• feeling or being sick


• restlessness


• loss of appetite


• general weakness


• fall in blood pressure


• headache


• itchy skin


• skin reactions/rash


• sweating


• a feeling of dizziness or 'spinning'


• changes in the results of blood tests that show how well your liver is working.

Uncommon

• abdominal bloating


• belching


• difficulty in concentrating


• tingling or numbness in the hands or feet


• difficulties with speech


• rise in blood pressure


• chest pain


• difficulty in sleeping


• generally feeling unwell


• swelling of the hands, ankles or feet


• abnormal thoughts


• anxiety


• confusion


• depression


• a feeling of extreme happiness


• hallucinations


• nervousness


• drowsiness


• abdominal pain or discomfort


• pain


• weight loss


• shaking


• shortness of breath


• impotence


• palpitations


• vision disturbances


• hypersensitivity/allergic reactions


• an increased risk of accidental injuries


• chest tightness (especially if you already have heart problems)


• runny nose


• cough


• a sudden urge to pass urine


• muscle pain, cramps or twitches

Rare

• epileptic fits (especially in people with epilepsy or a predisposition to fits)


• feeling more sleepy than normal


• fainting


• nightmares


• increase in pulse rate


• dental changes


• difficulty in passing urine


• yawning


• weight gain

Very rare

• breathing more slowly or weakly than expected

The active ingredient oxycodone hydrochloride, if not combine with naloxone hydrochloride, is known to have the following differing side-effects:

Breathing problems, such as breathing more slowly or weakly than expected (respiratory depression), reduction in size of the pupils in the eye, muscle cramps and decreased cough reflex.

Common

• altered mood and personality changes (e.g. depression, a feeling of extreme happiness)


• decreased or increased activity


• agitation


• difficulty in passing urine


• hiccups

Uncommon

• voice alteration


• difficulty in hearing


• mouth ulcers


• sore gums


• flushing of the skin


• migraines


• changes in taste


• increased muscle tension


• involutary muscle contractions


• reduce sensitivity to pain or touch


• problems with coordination


• water retention


• perception disturbances (e.g. hallucinations, feeling detached)


• decreased sexual drive

Rare

• absence of menstrual periods


• thirst


• dehydration


• increased appetite


• infections such as cold sores or herpes (which may cause blisters around the mouth or genitals)


• dark coloured, tarry stools


• bleeding gums


• difficulty in swallowing


• dry skin

Very rare

• serious allergic reactions


• itchy rash


• a condition where the small bowel (part of your gut) does not work properly (ileus)

Unknown

• drug dependence


• a need to take increasingly higher doses to obtain the same level of pain relief (tolerance)

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

How to store Targinact tablets

Keep out of the reach and sight of children.

Do not use any tablets after the expiry date which is stated on the carton and blister, after 'EXP...' The expiry date refers to the last day of the month.

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

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

Further information

What Targinact tablets contain

The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Each 5 mg/2.5 mg tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg oxycodone), and 2.73 mg naloxone hydrochloride dihydrate (equivalent to 2.5 mg naloxone hydrochloride and 2.25 mg naloxone).

Each 10 mg/5 mg tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg oxycodone), and 5.45 mg naloxone hydrochloride dihydrate (equivalent to 5 mg naloxone hydrochloride and 4.5 mg naloxone).

Each 20 mg/10 mg tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg oxycodone) and 10.9 mg naloxone hydrochloride dihydrate (equivalent to 10 mg naloxone hydrochloride and 9 mg naloxone).

Each 40 mg/20 mg tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36 mg oxycodone and 21.8 mg naloxone hydrochloride dihydrate (equivalent to 20 mg of naloxone hydrochloride and 18 mg naloxone).

The other ingredients are:

Tablet core:

hydropropylcellulose (5 mg/2.5 mg strength tablet only), povidone K30 (10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg strength tablets only), ethyl cellulose, strearyl alcohol, lactose monohydrate, talc, magnesium stearate

Tablet coat:

polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc

The 5 mg/2.5 mg tablets also contain brilliant blue (E133), the 20 mg/10 mg tablets also contain iron (III) oxide red (E172) and the 40 mg/20 mg tablets contain iron oxide yellow (E172).

What Targinact tablets look like and the contents of the pack

Targinact
5 mg/2.5 mg tablets are blue, oblong, film coated tablets, marked 'OXN' on one side and '5' on the other.

Targinact
10 mg/5 mg tablets are white, oblong, film coated tablets, marked "OXN" on one side and "10" on the other.

Targinact
20 mg/10 mg tablets are pink, oblong, film coated tablets, marked "OXN" on one side and "20" on the other.

Targinact
40 mg/20 mg tablets are yellow, oblong, film coated tablets, marked 'OXN' on one side and '40' on the other.

In each box there are 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder:

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

UK

Manufacturers:

Mundipharma GmbH

Mundipharma Straβe 2

65549 Limburg/Lahn

Germany

Bard Pharmaceuticals Limited

Cambridge Science

Milton Road

Cambridge

CB4 0GW

UK

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Targinact

Reference number: 16950/0161

This leaflet was last revised in 03/2010

Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks.

© 2010 Napp Pharmaceuticals Limited

7625-3

Nystatin/Triamcinolone

Pronunciation: nye-STAT-in/trye-am-SIN-oh-lone
Generic Name: Nystatin/Triamcinolone
Brand Name: Examples include Mycolog II and Mycogen II

Nystatin/Triamcinolone is used for:

Treating or preventing fungal infections of the skin.

Nystatin/Triamcinolone is an antifungal and steroid combination. It works by stopping fungus growth and reducing inflammation.

Do NOT use Nystatin/Triamcinolone if:

• you are allergic to any ingredient in Nystatin/Triamcinolone


• you are taking mifepristone

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

Before using Nystatin/Triamcinolone:

Some medical conditions may interact with Nystatin/Triamcinolone. 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 measles, had a positive skin tuberculin skin test, tuberculosis (TB), chickenpox, shingles, or wasting of the skin (skin atrophy)


• if you have had a vaccination with an inactivated or live vaccine

Some MEDICINES MAY INTERACT with Nystatin/Triamcinolone. Because little, if any, of Nystatin/Triamcinolone is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Nystatin/Triamcinolone 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 Nystatin/Triamcinolone:

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

• To prevent reinfection, wash your hands thoroughly before and after using Nystatin/Triamcinolone.


• Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed. Do not bandage, cover, or wrap the treated skin unless directed to do so by your doctor.


• Nystatin/Triamcinolone works best if used at the same time each day.


• To clear up your infection completely, use Nystatin/Triamcinolone for the full course of treatment. Keep using it even if you feel better in a few days.


• Nystatin/Triamcinolone is for external use only. Do not get it your eyes.


• If you miss a dose of Nystatin/Triamcinolone, 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. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nystatin/Triamcinolone.

Important safety information:

• If Nystatin/Triamcinolone is to be applied to the groin area, apply sparingly and wear loose-fitting clothing. If Nystatin/Triamcinolone is to be applied to skin covered by a diaper, do not use tight-fitting diapers or plastic pants.


• Nystatin/Triamcinolone should not be used if irritation occurs or if symptoms worsen or have not improved within 25 days of use.


• Nystatin/Triamcinolone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin/Triamcinolone while you are pregnant. It is unknown if Nystatin/Triamcinolone is found in breast milk. If you are or will be breast-feeding while you use Nystatin/Triamcinolone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Nystatin/Triamcinolone:

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:

Acne; burning; cracking and stinging of the skin; dryness; excessive hair growth; inflamed skin around the mouth; inflammation of hair follicles; irritation; itching; loss of skin color; secondary infection; skin wasting; streaking of skin.

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).

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

See also: Nystatin/Triamcinolone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Nystatin/Triamcinolone may be harmful if swallowed.

Proper storage of Nystatin/Triamcinolone:

Store Nystatin/Triamcinolone at controlled room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not freeze. Keep Nystatin/Triamcinolone out of the reach of children and away from pets.

General information:

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


• Nystatin/Triamcinolone is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nystatin/Triamcinolone resources

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

Compare Nystatin/Triamcinolone with other medications

• Cutaneous Candidiasis

Cepacol Extra Strength Honey Lemon

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Cepacol Extra Strength Honey Lemon (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

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

What is the most important information I should know about Cepacol Extra Strength Honey Lemon (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Cepacol Extra Strength Honey Lemon (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  asthma, bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical 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. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Cepacol Extra Strength Honey Lemon (benzocaine topical)?

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

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Cepacol Extra Strength Honey Lemon (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Cepacol Extra Strength Honey Lemon (benzocaine topical) side effects

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• 
  

  headache, tired feeling, confusion;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  feeling light-headed or short of breath; and

  
  


• 
  

  pale, blue, or gray appearance of your skin, lips, or fingernails.

  
  

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 benzocaine topical and call your doctor at once if you have any of these other serious side effects:

• 
  

  headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

  
  


• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness; or

  
  


• 
  

  oozing, blistering, or any signs of infection.

  
  

Less serious side effects may include:

• 
  

  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

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 Cepacol Extra Strength Honey Lemon (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cepacol Extra Strength Honey Lemon resources

• Cepacol Extra Strength Honey Lemon Side Effects (in more detail)
• Cepacol Extra Strength Honey Lemon Use in Pregnancy & Breastfeeding
• 0 Reviews for Cepacol Extra Strength Honey Lemon - Add your own review/rating

• Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information


• Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information


• Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Cepacol Extra Strength Honey Lemon with other medications

• Oral and Dental Conditions
• Tonsillitis/Pharyngitis

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

See also: Cepacol Extra Strength Honey Lemon side effects (in more detail)

Medihaler-Iso

isoproterenol sulfate

Dosage Form: Inhalation Aerosol

PHARMACIST:

Tear off “Patient Instructions for Use” and dispense with product.

Medihaler-Iso Description

Medihaler-Iso (isoproterenol sulfate) is a short-acting sympathomimetic administered by oral inhalation for the treatment of bronchoconstriction. Each metered dose of the aerosol delivers through the oral adapter 0.08 mg isoproterenol sulfate of appropriate particle size (the majority less than 5μ). This drug product also contains dichlorodifluoromethane, dichlorotetrafluoroethane, sorbitan trioleate, and trichloromonofluoromethane. Chemically, isoproterenol sulfate is 4-[1-hyroxy-2-[(1-methylethyl)amino]ethyl]-1,2-benzenediol sulfate.

Structural formula:

Medihaler-Iso - Clinical Pharmacology

Isoproterenol acts directly on beta-adrenergic receptors of tissues supplied by sympathetic nerves. The beta-adrenergic effects stem from the release of cyclic AMP following the activation of the enzyme adenyl cyclase. Therapeutic doses of isoproterenol result in relaxation of the smooth muscle of the bronchial tree and decrease in peripheral vascular resistance; increased cardiac output and stroke volume may occur due to its positive inotropic and chronotropic action. The coronary arteries may be dilated, increasing the blood flow. Isoproterenol also inhibits uterine motility and causes decreased tone and motility of intestinal musculature even when epinephrine causes contraction.

In patients with bronchial constriction, isoproterenol relieves bronchospasm, increases pulmonary function, decreases residual air, and facilitates lung clearance by increasing ciliary motility and mucous transport. Bronchodilatation occurs quickly after oral inhalation and lasts up to one hour. It is one of the most potent bronchodilators known and can be used in patients who do not respond to the bronchodilating action of epinephrine. The drug will prevent or overcome histamine-induced asthma in both experimental animals and man, and is effective when used prophylactically.

Isoproterenol has a cardio-accelerating effect, but its vasoconstricting action is less pronounced than that of epinephrine. Therapeutic doses may produce a slight increase in systolic blood pressure but a slight decrease in diastolic. Larger doses may cause peripheral vasodilation in the renal, mesenteric, and femoral beds; some patients respond with a decrease in diastolic but no change in systolic pressure. Such effects are usually of very short duration.

Pharmacokinetics:

The average plasma half-life for isoproterenol given intravenously in seven healthy volunteers was four minutes while the average half-life of the drug administered by aerosol to five patients was five minutes. In children, the decline in plasma concentration was biphasic, with a half-life during the first phase of two to five minutes and of three to seven hours during the second phase. A plasma concentration of 0.03 ng/ml was found within minutes, following an aerosol inhalation dose of 500 mcg.

Excretion following inhalation administration is primarily renal and the major metabolite is the sulfate conjugate of isoproterenol. When the drug is administered directly into the bronchial tree, it is inactivated by the enzyme catechol-o-methyl transferase, and the predominant metabolite is 3-o-methylisoproterenol sulfate. The explanation for this difference is supported by the observation that most (90%) of an aerosol dose is deposited in the mouth and pharynx and is swallowed. The swallowed isoproterenol is converted to its sulfate conjugate in the gut wall, and to a lesser extent in the liver. The remaining isoproterenol is excreted as follows: 1% to 2% unchanged, 1% to 2% free methylated metabolite, and small amounts of metabolites in the bile.

Recent studies in laboratory animals (minipigs, rodents, and dogs) recorded the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta agonists and methylxanthines were concomitantly administered. The significance of these findings when applied to human usage is currently unknown.

Indications and Usage for Medihaler-Iso

Medihaler-Iso is indicated for the treatment of reversible obstructive airways disease.

Contraindications

The use of isoproterenol in patients with pre-existing cardiac arrhythmias associated with tachycardia is contraindicated because the cardiac stimulant effects of the drug may aggravate such disorders. Medihaler-Iso must not be used by patients with known hypersensitivity to sympathomimetic amines.

Warnings

Excessive use of an adrenergic aerosol should be discouraged, as it may lose effectiveness. Occasional patients have been reported to develop severe paradoxical airway resistance with repeated, excessive use of isoproterenol inhalation preparations (see ADVERSE REACTIONS). The cause of this is unknown. It is advisable that in such instances the use of this preparation be discontinued immediately and alternative therapy instituted, since in the reported cases the patients did not respond to other forms of therapy until the drug was withdrawn. Deaths have been reported following excessive use of isoproterenol inhalation preparations, and the exact cause is unknown. Cardiac arrest was noted in several instances (see ADVERSE REACTIONS).

Precautions

General Precautions: Isoproterenol and epinephrine may be used interchangeably if the patient becomes unresponsive to one or the other, but should not be used concurrently. If desired, these drugs may be alternated, provided an interval of at least four hours has elapsed. As with all sympathomimetic drugs, isoproterenol should be used with great caution in the presence of coronary insufficiency, hypertension, hyperthyroidism, and diabetes.

Information for Patients: Patients who are being treated with Medihaler-Iso should be informed adequately of the dangers of overusage, tolerance, and rebound bronchospasm (see WARNINGS; ADVERSE REACTIONS). They should be instructed to take no more than two inhalations at any one time, nor more than six in any one hour during a 24-hour period, unless advised by the physician (see DOSAGE AND ADMINISTRATION; Patient Instructions for Use).

Isoproterenol may cause the patient's saliva to turn pinkish to red in color. Proper use of Medihaler-Iso oral inhaler should be demonstrated and discussed. Patient Instructions for Use are available with the package insert and should be provided when the medication is dispensed.

As with any drug, patients should be advised against the ingestion of alcohol during treatment.

Drug Interactions: Corticosteroids may be used to restore responsiveness to isoproterenol if necessary. This may come about by increasing the sensitivity of the beta-adrenergic receptors to isoproterenol. No adverse cardiovascular effects were observed in normal volunteers given isoproterenol by inhalation along with a monoamine oxidase inhibitor or a tricyclic anti-depressant.

Concomitant administration of ergot alkaloids and isoproterenol may result in additive peripheral vasoconstriction.

Arrhythmias may result from the administration of isoproterenol to patients who are receiving digitalis, epinephrine, cyclopropane, or halogenated hydrocarbon anesthetics. Beta-adrenergic blocking drugs such as propranolol antagonize the cardiac, bronchodilating, and vasodilating effects of isoproterenol.

Drug/Laboratory Test Interactions:

Isoproterenol causes false elevations of bilirubin as measured in vitro by a sequential multiple analyzer. An effect on serum bilirubin determinations in patients receiving the drug has not been determined. Isoproterenol inhalation may result in enough absorption of the drug to produce elevated values for urinary epinephrine. This effect is probably small with standard inhalation doses, but is likely to increase with larger doses.

Carcinogencity, Mutagensis, and Impairment of Fertility:

Isoproterenol sulfate has not been evaluated for carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy: Teratogenic Effects – Pregnancy Category B:

Reproduction studies have been performed in rats and rabbits at aerosol doses (30 minutes per day for 12 days) up to 15 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to isoproterenol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery:

Medihaler-Iso has no recognized, use during labor and delivery, and its effect during these processes is unknown.

Nursing Mothers:

It is not known whether isoproterenol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Medihaler-Iso is administered to a nursing woman.

Pediatric Use:

Safe and effective use of Medihaler-Iso in children below the age of 12 has not been established.

Geriatric Use:

Lower doses in elderly patients may be required due to increased sympathomimetic sensitivity (see DOSAGE AND ADMINISTRATION).

Adverse Reactions

The following adverse effects, listed by organ system in decreasing frequency have been associated with the use of Medihaler-Iso and are similar to those produced by other sympathomimetic agents:

Cardiovascular: Palpitation, tachycardia, coronary insufficiency, flushing of the skin, blood pressure changes, cardiac arrhythmias, anginal pain, cardiac arrest.

Pulmonary: Paradoxical airway resistance (see WARNINGS), rebound bronchospasm.

Central Nervous System: Headache, tremor, vertigo, central excitation, insomnia.

Gastrointestinal: Nausea.

Drug Abuse and Dependence

Drug abuse and dependence have not been reported with Medihaler-Iso.

Overdosage

The oral LD50 values for isoproterenol are as follows: mouse, 1260 mg/kg: rabbit, 3070 mg/kg; male rat, 2230 mg/kg; female rat, 2840 mg/kg; and dog, 600 mg/kg. The intravenous LD50 values are as follows: mouse, 126 mg/kg; rabbit, 27 mg/kg; male rat, 96 mg/kg; female rat, 112 mg/kg; and dog, 50 mg/kg.

Overdosage effects may occur at doses equal to the therapeutic dose.

Symptoms: Manifestations of acute overdosage include chest pain, dizziness, headache, irregular heartbeat, fast or pounding heartbeat, nausea or vomiting, restlessness, weakness, flushing, or decreased diastolic pressure.

Treatment: Discontinued dosing allows rapid reversal of adverse effects. Blood pressure and ECG may be monitored and the following treatment used, as appropriate: tachycardia in asthmatic patients may be treated with cardio-selective beta-blockers (metoprolol or atenolol, but used cautiously since cardio-selectivity may not be absolute) and in nonasthmatics with propranolol; blood pressure may be regulated with rapid-acting vasodilators (nitrites, sodium nitroprusside) or alpha-blocking agents (quinidine, phentolamine).

It is not known if isoproterenol is dialyzable; however, its rapid elimination should preclude the need for dialysis.

Medihaler-Iso Dosage and Administration

Adults: The usual dose for the relief of dyspnea in the acute episode is one or two inhalations. Start with a single inhalation. If no relief is evident after two to five minutes, a second inhalation may be taken. For daily maintenance, use one or two inhalations four to six times daily or as directed by the physician. The physician should be careful to instruct the patient in the proper technique of administration so that the number of inhalations per treatment and the frequency of retreatment may be titrated to the patient's response.

No more than two inhalations should be taken at any one time, nor more than six inhalations in any one hour during a 24-hour period, unless advised by the physician. Lower doses in elderly patients may be required due to increased sympathomimetic sensitivity.

Each depression of the valve delivers through the oral adapter 0.08 mg isoproterenol sulfate.

Children: Safety and effectiveness for children under 12 years have not been established (see Pediatric Use).

DIRECTIONS FOR USE

Before each use, remove dust cap and inspect mouthpiece for foreign objects. Shake Medihaler-Iso.

1. Breathe out fully and place mouthpiece well into the mouth aimed at the back of the throat.


2. As you begin to breathe in deeply, press the vial firmly down into the adapter with the index finger. This releases one dose.


3. Release pressure on vial and remove unit from mouth. Hold your breath as long as possible, then breathe out slowly.

Replace dust cap after each use.

How is Medihaler-Iso Supplied

Medihaler-Iso is an aerosol device which delivers 0.08 mg isoproterenol sulfate through the oral adapter with each depression of the valve.

15-ml vial and oral adapter, containing 21.0 gm, a minimum of 300 actuations (NDC 0089-0785-21).

15-ml refill vial only, containing 21.0 gm, a minimum of 300 actuations (NDC 0089-0785-11).

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's).

 

WARNING: Contains trichloromonofluoromethane, dichlorodifluoromethane, and dichlorotetrafluoroethane, substances which harm public health and environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the “Patient Instructions for Use” of this product pursuant to EPA regulations.

CAUTION

Federal law prohibits dispensing without prescription. CONTENTS UNDER PRESSURE. Do not puncture or incinerate container. Store at controlled room temperature between 15°C and 30°C (59°F and 86°F). KEEP OUT OF THE REACH OF CHILDREN.

3M Pharmaceuticals

Northridge, CA 91324

605600

December 1995

Patient Instructions for Use

Medihaler-Iso™

(isoproterenol sulfate)

FOR ORAL INHALATION THERAPY ONLY

For speed of relief and convenience, the Medihaler-Iso oral inhaler comes ready to use. It consists of a metal vial, containing the medication, with a single dose valve which fits into an oral adapter (plastic mouthpiece), and a dust cap. The vial can be used only with the Medihaler-Iso oral adapter.

Before each use, remove dust cap and inspect mouthpiece for foreign objects. Shake Medihaler-Iso well.

To get the medication deep into the lungs, follow these three simple steps which can be completed within five seconds:

1. Breathe out fully and place mouthpiece well into the mouth aimed at the back of the throat.


2. As you begin to breathe in deeply, press the vial firmly down into the adapter with the index finger. This releases one dose.


3. Release pressure on vial and remove unit from mouth. Hold your breath as long as possible, then breathe out slowly.

Replace dust cap after each use.

Start with a single inhalation. If no relief is evident after two to five minutes, a second inhalation may be taken. No more than two inhalations should be taken at any one time, nor more than six inhalations in any one hour during a 24-hour period, unless advised by the physician. IF DIFFICULTY IN BREATHING PERSISTS, CONTACT YOUR PHYSICIAN IMMEDIATELY.

Proper cleaning of the oral adapter (plastic mouthpiece) is critical to the accurate delivery of each dose. At the end of each day's use, simply remove metal vial and wash oral adapter with soap and hot water and rinse thoroughly. Dry adapter thoroughly and replace the vial.

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's).

 

This product contains trichloromonofluoromethane, dichlorodifluoromethane, and dichlorotetrafluoroethane, substances which harm the environment by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.

CAUTION: CONTENTS UNDER PRESSURE. Do not puncture or incinerate container. Store at controlled room temperature between 15°C and 30°C (59°F and 86°F). KEEP OUT OF THE REACH OF CHILDREN.

3M Pharmaceuticals

3M

Northridge, CA 91324

December 1995

Medihaler-Iso  isoproterenol sulfate  aerosol, metered

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0089-0785 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength isoproterenol sulfate (isoproterenol) Active 0.08 MILLIGRAM  In 1 INHALATION dichlorodifluoromethane Inactive   dichlorotetrafluoroethane Inactive   sorbitan trioleate Inactive   trichloromonofluoromethane Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0089-0785-21 300 INHALATION In 1 INHALER None 2 0089-0785-11 300 INHALATION In 1 INHALER, REFILL None

Revised: 01/20063M Pharmaceuticals

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Cedax Suspension

Pronunciation: sef-TYE-byoo-ten
Generic Name: Ceftibuten
Brand Name: Cedax

Cedax Suspension is used for:

Treating mild to moderate infections caused by certain bacteria.

Cedax Suspension is a cephalosporin antibiotic. It works by killing sensitive bacteria.

Do NOT use Cedax Suspension if:

• you are allergic to any ingredient in Cedax Suspension or any other cephalosporin antibiotic (eg, cephalexin)

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

Before using Cedax Suspension:

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

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin (eg, amoxicillin) or other beta-lactam antibiotic (eg, imipenem)


• if you have a blood clotting disorder, diabetes, kidney problems, or stomach or bowel problems (eg, inflammation)

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

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

How to use Cedax Suspension:

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

• Take Cedax Suspension on an empty stomach at least 2 hours before or 1 hour after eating.


• Shake well before taking a dose of Cedax Suspension.


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


• To clear up your infection completely, continue using Cedax Suspension for the full course of treatment even if you feel better in a few days.


• If you miss a dose of Cedax Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Cedax Suspension is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold)


• It is important to use Cedax Suspension for the full course of treatment. Failure to do so may decrease the effectiveness of Cedax Suspension and may increase the risk that the bacteria will no longer be sensitive to Cedax Suspension and will not be able to be treated by this or certain other antibiotics in the future.


• Long-term or repeated use of Cedax Suspension may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.


• If severe diarrhea, stomach pain or cramps, or bloody stools occur, contact your doctor immediately. This could be a symptom of a serious side effect requiring immediate medical attention. Do not treat diarrhea without consulting your doctor.


• Diabetes patients - Cedax Suspension may cause incorrect test results with some urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.


• Diabetes patients - Each teaspoonful of Cedax Suspension contains 1 gram of sucrose.


• Cedax Suspension may interfere with certain lab test results. Make sure your doctor and lab personnel know you are using Cedax Suspension.


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


• Use Cedax Suspension with extreme caution in CHILDREN younger than 6 months of age. Safety and effectiveness in this age group have not been confirmed.


• Use Cedax Suspension with extreme caution in CHILDREN younger than 10 years of age who have diarrhea or a stomach or bowel infection.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cedax Suspension, discuss with your doctor the benefits and risks of using Cedax Suspension during pregnancy. It is unknown if Cedax Suspension is excreted in breast milk. If you are or will be breast-feeding while you are using Cedax Suspension, check with your doctor of pharmacist to discuss the risk to your baby.

Possible side effects of Cedax Suspension:

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

Diarrhea; headache; indigestion; loose stools; nausea; vomiting.

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); bloody stools; dark urine; decreased urination; fever, chills, or sore throat; joint pain; mental or mood changes; red, swollen, or blistered skin; seizures; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; yellowing of the eyes or skin.

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

See also: Cedax side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Cedax Suspension:

Store Cedax Suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away any unused medicine after 14 days. Keep Cedax Suspension out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cedax resources

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

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