Corticosteroid Rectal

Class Name: corticosteroid (Rectal route)

Commonly used brand name(s)

In the U.S.

• Anucort-HC


• Anu-Med HC


• Anusol HC


• Anusol-HC


• Anuzone-HC


• Colocort


• Cortifoam


• Encort


• Hemril-30


• Hemril-HC Uniserts


• Proctocort


• Procto-Kit 1%


• Procto-Kit 2.5%


• Proctosert HC


• Proctosol-HC


• Proctozone-HC


• Rectasol-Hc

In Canada

• Cortiment-10


• Cortiment-40


• Rectocort

Available Dosage Forms:

• Kit


• Enema


• Cream


• Suppository


• Foam


• Solution

Uses For This Medicine

Rectal corticosteroids are used to treat mild or moderate ulcerative colitis. They also may be used along with systemic (oral or injection) corticosteroids or other medicines to treat severe disease or mild to moderate disease that has spread too far to be treated effectively by medicine inserted into the rectum alone. Rectal corticosteroids also are used to help relieve swelling, itching, and discomfort of some other rectal problems, including hemorrhoids and inflammation of the rectum caused by radiation therapy.

Rectal corticosteroids are available only with your doctor's prescription.

Before Using This Medicine

Allergies

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

Pediatric

Children and teenagers who must use this medicine should be checked often by their doctor. Rectal corticosteroids may be absorbed through the lining of the rectum and, rarely, may affect growth, especially if used in large amounts or for a long time. Before using this medicine in children, you should discuss its use with the child's doctor.

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. Although there is no specific information comparing use of rectal corticosteroids in the elderly with use in other age groups, these medicines are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Betamethasone may change the number and ability of movement of sperm in men. Budesonide crosses the placenta. It is not known whether other rectal corticosteroids cross the placenta. Studies in animals have shown that budesonide, hydrocortisone, and hydrocortisone acetate cause birth defects. Rectal corticosteroids should not be used in large amounts or for a long time by women who are pregnant or who are planning to become pregnant.

Breast Feeding

It is not known whether rectal corticosteroids pass into breast milk. However, systemic (oral and injection) corticosteroids pass into breast milk and may cause problems with growth in nursing babies. It may be necessary for you to take a different medicine or to stop breast-feeding during treatment. Be sure you have discussed with your doctor the risks and benefits of using the medicine.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Acute psychosis—This condition may be made worse.

• Chickenpox (including recent exposure) or


• Measles (including recent exposure)—Risk of severe disease affecting other parts of the body.

• Type 2 diabetes mellitus—Corticosteroids may cause a loss of control of diabetes by increasing blood glucose (sugar).

• Glaucoma—Corticosteroids may cause the pressure within the eye to increase.

• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease or


• Myasthenia gravis or


• Overactive thyroid or


• Swelling of blood vessels—Corticosteroids should be used with caution.

• Herpes simplex of the eye—Corticosteroids may cause additional problems in the eye.

• Ileocolostomy, postsurgical or


• Infection or


• Tuberculosis (active TB, nonactive TB, or past history of)—Corticosteroids may cause slower healing, worsen existing infections, or cause new infections.

• Liver disease or


• Underactive thyroid—With these conditions, the body may not eliminate the corticosteroid at the usual rate; therefore, the medicine's effect may be increased.

• Osteoporosis—Corticosteroids may worsen osteoporosis because they cause the body to lose more calcium.

• Other stomach or intestine problems or


• Severe ulcerative colitis—Corticosteroids may cover up symptoms of a worsening stomach or intestinal condition; a patient would not know if his or her condition was getting worse and would not get medical help when needed.

• Stomach ulcer—Corticosteroids may worsen this condition by causing an increase in the amount of acid in the stomach.

Proper Use of This Medicine

It is important that your doctor check your progress at regular visits.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read and follow them carefully before using this medicine.

For patients using the foam form of this medicine:

• This medicine is used with a special applicator. Do not insert any part of the aerosol container into the rectum.

For patients using the suppository form of this medicine:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the wrapper.


• To insert the suppository: First remove the wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

Do not use rectal corticosteroids in larger amounts, more often, or for a longer time than your doctor ordered. To do so may increase the chance of absorption through the lining of the rectum and the chance of side effects.

Dosing

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

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

• For betamethasone


• For enema dosage form:
  
  • For ulcerative colitis:
    
    • Adults—The usual dose is 5 milligrams (mg) (1 unit), used as directed, every night for two to four weeks.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For budesonide


• For enema dosage form:
  
  • For ulcerative colitis:
    
    • Adults—The usual dose is 2 milligrams (mg) (1 unit), used as directed, every night for four to eight weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For hydrocortisone


• For enema dosage form:
  
  • For ulcerative colitis:
    
    • Adults—The usual dose is 100 milligrams (mg) (1 unit), used as directed, every night for two or three weeks or until condition improves as determined by your doctor.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For hydrocortisone acetate


• For foam dosage form:
  
  • For ulcerative colitis:
    
    • Adults—At first, 1 applicatorful, used as directed, one or two times a day for two or three weeks. Then, the dose may be decreased to 1 applicatorful every other day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For suppository dosage form:
  
  • For ulcerative colitis:
    
    • Adults—The usual dose is 25 or 30 milligrams (mg) two times a day, in the morning and at night, for two weeks. In more severe cases, the dose may be 25 or 30 mg three times a day or 50 or 60 mg two times a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • For inflammation of the rectum caused by radiation therapy:
    
    • Adults—The usual dose is 25 or 30 mg two times a day, in the morning and at night, for six to eight weeks.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • For other rectal problems:
    
    • Adults—The usual dose is 20 to 30 mg a day for three days, or 40 to 80 mg a day as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For tixocortol


• For enema dosage form:
  
  • For ulcerative colitis:
    
    • Adults—The usual dose is 250 milligrams (mg) (1 unit), used as directed, at bedtime for twenty-one days in a row.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Do not puncture, break, or burn the rectal foam aerosol container, even when it is empty.

Precautions While Using This Medicine

Do not stop using this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before you completely stop using it.

Check with your doctor if your condition does not improve within 2 or 3 weeks or if it becomes worse.

Check with your doctor if you notice rectal bleeding, pain, burning, itching, blistering, or any other sign of irritation that you did not have before you started using this medicine.

Use of suppositories may cause staining of clothing or fabric.

Tell the doctor in charge that you are using this medicine:

• Before having skin tests


• Before having any kind of surgery (including dental surgery) or emergency treatment


• If you get a serious infection or injury

Avoid close contact with anyone who has chickenpox or measles. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.

While you are being treated with this medicine, and after you stop taking it, do not have any immunizations without your doctor's approval.

For patients with diabetes:

• This medicine may affect blood glucose (sugar) levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Side Effects of This Medicine

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 as soon as possible if any of the following side effects occur:

Less common or rare

• Burning and itching of skin


• chills


• depression


• diarrhea


• false sense of well-being


• fever


• infection


• mood swings


• painful, red or itchy, pus-containing blisters in hair follicles


• personality changes


• rectal bleeding, burning, dryness, itching, or pain not present before therapy


• sensation of pins and needles


• stabbing pain


• straining while passing stool (with tixocortol only)

Additional side effects may occur if you use this medicine for a long time. Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal or stomach pain


• acne


• backache


• coughing


• coughing up blood


• decreased resistance to infection


• dryness of mouth


• eye pain


• filling or rounding out of the face


• gradual blurring or loss of vision


• headache


• hunchback


• increased thirst


• irregular heartbeat


• loss of appetite


• menstrual irregularities


• mood or mental changes


• muscle cramps or pain


• muscle weakness


• nausea or vomiting


• nonelevated blue or purplish patch on the skin


• osteoporosis or bone fractures


• pain in joints


• pain or discomfort in the area of a vein


• rapid weight gain


• reddish purple lines on arms, face, legs, trunk, or groin


• redness of eye


• sensitivity of eye to light


• shortness of breath


• skin rash


• slow wound healing


• stunting of growth (in children)


• swelling of feet or lower legs


• trouble in sleeping


• unusual decrease in sexual desire or ability in men


• tearing of eyes


• unusual increase in hair growth (especially on the face)


• unusual tiredness or weakness


• unusual weight loss


• weak pulse

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

Less common or rare

• Dizziness


• dry, scaly skin


• increase in appetite


• increased sweating


• lightened skin color


• passing of gas (with budesonide only)


• sensation of spinning


• thin, fragile skin


• thinning hair on scalp


• unusual weight gain

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

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

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

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

Contac 12 Hour

Generic Name: chlorpheniramine and phenylpropanolamine (klor feh NEER a meen and feh nill proe pa NO la meen)

Brand Names: A.R.M. Allergy Relief, Allerest 12 Hour, Chlornade, Condrin, Contac 12 Hour, Decongex-3, Demazin, Dura-Vent/A, Equi-Nade, Genamin, Gencold, Histade, Or-Phen-Ade, Ordrine, Ornade Spansules, Resaid, Rescon Liquid, Rhinolar-EX, Teldrin, Triac, Triaminic, Vanex Forte-R

What is Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.

Chlorpheniramine and phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

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

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

What is the most important information I should know about Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

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

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

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

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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

Chlorpheniramine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine and phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Take chlorpheniramine and phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of your medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid forms of chlorpheniramine and phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine and phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.

Contac 12 Hour (chlorpheniramine and phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine and phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine and phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

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

What other drugs will affect Contac 12 Hour (chlorpheniramine and phenylpropanolamine)?

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

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

Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.

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

More Contac 12 Hour resources

• Contac 12 Hour Drug Interactions
• 1 Review for Contac2 Hour - Add your own review/rating

• Triaminic Consumer Overview

Compare Contac 12 Hour with other medications

• Cold Symptoms
• Cough and Nasal Congestion
• Hay Fever
• Sinusitis
• Upper Respiratory Tract Infection

Where can I get more information?

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

What does my medication look like?

Many formulations of chlorpheniramine and phenylpropanolamine are available both over-the-counter and with a prescription. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Catapres

clonidine hydrochloride

Dosage Form: tablet
Catapres®

(clonidine hydrochloride, USP)

Oral Antihypertensive

Tablets of 0.1, 0.2 and 0.3 mg

Prescribing Information

Catapres Description

Catapres® (clonidine hydrochloride, USP) is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base.

The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, FD&C Yellow No. 6, gelatin, glycerin, lactose, and magnesium stearate. The Catapres 0.1 mg tablet also contains FD&C Blue No.1 and FD&C Red No.3.

Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:

Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.

Catapres - Clinical Pharmacology

Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Catapres tablets act relatively rapidly. The patient’s blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise.

Tolerance to the antihypertensive effect may develop in some patients, necessitating a reevaluation of therapy.

Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.

Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use.

Pharmacokinetics

The plasma level of clonidine peaks in approximately 3 to 5 hours and the plasma half-life ranges from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Following oral administration about 40-60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine.

Indications and Usage for Catapres

Catapres® (clonidine hydrochloride, USP) tablets are indicated in the treatment of hypertension. Catapres tablets may be employed alone or concomitantly with other antihypertensive agents.

Contraindications

Catapres tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS).

Warnings

Withdrawal

Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with Catapres® (clonidine hydrochloride, USP) tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology.

An excessive rise in blood pressure following discontinuation of Catapres tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of Catapres tablets.

Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.

Precautions

General

In patients who have developed localized contact sensitization to Catapres-TTS® (clonidine), continuation of Catapres-TTS or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash.

In patients who develop an allergic reaction to Catapres-TTS, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema).

Catapres tablets should be used with caution in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease or chronic renal failure.

Perioperative Use

Administration of Catapres tablets should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.

Information for Patients

Patients should be cautioned against interruption of Catapres tablets therapy without their physician's advice.

Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. They should also be informed that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Patients who wear contact lenses should be cautioned that treatment with Catapres tablets may cause dryness of eyes.

Drug Interactions

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.

Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology).

Toxicology

In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid.

In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged.

In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity.

Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m2 basis.)

Pregnancy

Teratogenic Effects: Pregnancy Category C.

Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of Catapres® (clonidine hydrochloride, USP) tablets produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6-15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m2 basis) in mice and rats treated on gestation days 1-14 (lowest dose employed in the study was 500 mcg/kg).

No adequate, well-controlled studies have been conducted 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.

Nursing Mothers

As clonidine hydrochloride is excreted in human milk, caution should be exercised when Catapres® (clonidine hydrochloride, USP) tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal).

Adverse Reactions

Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100.

The following less frequent adverse experiences have also been reported in patients receiving Catapres tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.

Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting.

Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

Musculoskeletal: Leg cramps and muscle or joint pain.

Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.

Overdosage

Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children.

There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine.

The largest overdose reported to date involved a 28-year old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/ml after 1 hour, 190 ng/ml after 1.5 hours, 370 ng/ml after 2 hours, and 120 ng/ml after 5.5 and 6.5 hours. In mice and rats, the oral LD50 of clonidine is 206 and 465 mg/kg, respectively.

Catapres Dosage and Administration

Adults

The dose of Catapres® (clonidine hydrochloride, USP) tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration.

Initial Dose

0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.

Maintenance Dose

Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.

Renal Impairment

Dosage must be adjusted according to the degree of impairment, and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.

How is Catapres Supplied

Catapres® (clonidine hydrochloride, USP) tablets are supplied as follows:

Dose (mg)	Color	Marking	Bottle of 100
0.1	Tan	BI 6	NDC 0597-0006-01
0.2	Orange	BI 7	NDC 0597-0007-01
0.3	Peach	BI 11	NDC 0597-0011-01

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container.

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT 06877 USA

Manufactured by:

Boehringer Ingelheim Promeco S.A. de C.V.,

Mexico City, Mexico

Licensed from:

Boehringer Ingelheim

International GmbH

Address medical inquiries to: (800) 542-6257 or (800) 459-9906 TTY.

©Copyright Boehringer Ingelheim International GmbH 2010

ALL RIGHTS RESERVED

Printed in USA

Rev: April 2010

OT6000HD1310

090340066/US/7

Catapres 0.1 mg

100 tablets

NDC-0597-0006-01

Catapres  clonidine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0597-0006 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clonidine hydrochloride (clonidine) clonidine hydrochloride 0.100 mg

Inactive Ingredients Ingredient Name Strength silicon dioxide   starch, corn   dibasic calcium phosphate dihydrate   FD&C Blue No. 1   FD&C Red No. 3   FD&C Yellow No. 6   gelatin   glycerin   lactose   magnesium stearate

Product Characteristics Color BROWN (TAN) Score 2 pieces Shape OVAL (OVAL) Size 8mm Flavor Imprint Code BI;6 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0597-0006-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017407	05/01/1999

Catapres  clonidine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0597-0007 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clonidine hydrochloride (clonidine) clonidine hydrochloride 0.200 mg

Inactive Ingredients Ingredient Name Strength silicon dioxide   starch, corn   dibasic calcium phosphate dihydrate   FD&C Yellow No. 6   gelatin   glycerin   lactose   magnesium stearate

Product Characteristics Color ORANGE (ORANGE) Score 2 pieces Shape OVAL (OVAL) Size 8mm Flavor Imprint Code BI;7 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0597-0007-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017407	05/01/1999

Catapres  clonidine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0597-0011 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clonidine hydrochloride (clonidine) clonidine hydrochloride 0.300 mg

Inactive Ingredients Ingredient Name Strength silicon dioxide   starch, corn   dibasic calcium phosphate dihydrate   FD&C Yellow No. 6   gelatin   glycerin   lactose   magnesium stearate

Product Characteristics Color ORANGE (PEACH) Score 2 pieces Shape OVAL (OVAL) Size 9mm Flavor Imprint Code BI;11 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0597-0011-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017407	05/01/1999

Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)

Establishment
Name	Address	ID/FEI	Operations
Boehringer Ingelheim Promeco S.A. de C.V.		812579472	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Boehringer Ingelheim Pharma GmbH and Co. KG		551147440	API MANUFACTURE

Revised: 11/2006Boehringer Ingelheim Pharmaceuticals Inc.

More Catapres resources

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

• Catapres Consumer Overview


• Catapres Advanced Consumer (Micromedex) - Includes Dosage Information


• Catapres MedFacts Consumer Leaflet (Wolters Kluwer)


• Clonidine Monograph (AHFS DI)


• Clonidine MedFacts Consumer Leaflet (Wolters Kluwer)


• Kapvay Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Kapvay Consumer Overview


• Nexiclon XR MedFacts Consumer Leaflet (Wolters Kluwer)


• clonidine Epidural Advanced Consumer (Micromedex) - Includes Dosage Information

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• Pain
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Crizotinib

Pronunciation: kriz-OH-ti-nib
Generic Name: Crizotinib
Brand Name: Xalkori

Crizotinib is used for:

Treating certain types of lung cancer. It may also be used for other conditions as determined by your doctor.

Crizotinib is a tyrosine kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Crizotinib if:

• you are allergic to any ingredient in Crizotinib


• you have previously developed a certain lung problem (pneumonitis) from taking Crizotinib


• you have a history of certain types of irregular heartbeat (eg, QT prolongation, long QT syndrome)


• you are taking alfentanil, certain azole antifungals (eg, itraconazole, ketoconazole, voriconazole), carbamazepine, cyclosporine, ergot derivatives (eg, ergotamine), fentanyl, certain macrolide antibiotics (eg, clarithromycin, troleandomycin), nefazodone, phenobarbital, pimozide, certain protease inhibitors (eg, ritonavir), quinidine, rifamycins (eg, rifampin), sirolimus, St. John's wort, tacrolimus, or telithromycin

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

Before using Crizotinib:

Some medical conditions may interact with Crizotinib. 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 able to become pregnant


• 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 kidney or liver problems, eye or vision problems, heart problems (eg, congestive heart failure; fast, slow, or irregular heartbeat), or abnormal blood electrolyte levels (eg, calcium, potassium, magnesium)


• if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

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

• Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), macrolide antibiotics (eg, clarithromycin, erythromycin, troleandomycin), nefazodone, protease inhibitors (eg, ritonavir), or telithromycin because they may increase the risk of Crizotinib's side effects


• Carbamazepine, phenobarbital, phenytoin, rifamycins (eg, rifampin), or St. John's wort because they may decrease Crizotinib's effectiveness


• Alfentanil, cyclosporine, ergot derivatives (eg, ergotamine), fentanyl, pimozide, quinidine, sirolimus , or tacrolimus because the risk of their side effects may be increased by Crizotinib

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

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

• An extra patient leaflet is available with Crizotinib. Talk to your pharmacist if you have questions about this information.


• Take Crizotinib by mouth with or without food.


• Swallow Crizotinib whole. Do not break, crush, dissolve, open, or chew before swallowing.


• Do not eat grapefruit or drink grapefruit juice while you use Crizotinib.


• Take Crizotinib on a regular schedule to get the most benefit from it.


• Continue to take Crizotinib even if you feel well. Do not miss any doses.


• If you miss a dose of Crizotinib, take it as soon as possible. If it is within 6 hours of 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 Crizotinib.

Important safety information:

• Crizotinib may cause dizziness, drowsiness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Crizotinib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not change your dose or stop taking Crizotinib without first checking with your doctor.


• Crizotinib may cause vision changes such as blurred vision, flashes of light, floaters in your vision, or sensitivity to light. If this occurs, it usually begins within 2 weeks after starting Crizotinib. Tell your doctor right away if you develop any of these symptoms.


• Serious and sometimes fatal inflammation of the lungs (pneumonitis) has occurred in some patients taking Crizotinib. These cases occurred within 2 months after Crizotinib was started. Contact your doctor right away if you develop trouble breathing, shortness of breath, cough with or without mucus, or fever.


• If you experience nausea, vomiting, diarrhea, or constipation, talk with your doctor about ways to lessen these effects.


• Crizotinib may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Crizotinib may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Tell your doctor or dentist that you take Crizotinib before you receive any medical or dental care, emergency care, or surgery.


• Women who may become pregnant should use effective birth control while taking Crizotinib and for 90 days after stopping it. Check with your doctor if you have questions about effective birth control.


• Men who take Crizotinib should always use effective birth control when having sex with a woman who may become pregnant. Do this for as long as you take Crizotinib and for 90 days after you stop taking it. Check with your doctor if you have questions about effective birth control.


• Lab tests, including liver and heart function, blood electrolytes, eye exams, and complete blood cell counts, may be performed while you use Crizotinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Crizotinib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Crizotinib may cause harm to the fetus. Avoid becoming pregnant while you are taking it and for 90 days after you stop taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Crizotinib is found in breast milk. Do not breast-feed while taking Crizotinib.

Possible side effects of Crizotinib:

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; constipation; diarrhea; dizziness; headache; indigestion; joint pain; loss of appetite; mild sore throat; mild swelling; nausea; runny nose; stomach pain; taste changes; tiredness; trouble sleeping; upset stomach; vomiting.

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); burning, numbness, or tingling; changes in sense of touch; chest pain; coughing up blood; fainting; fast, slow, or irregular heartbeat; mouth sores or swelling; severe or persistent dizziness; severe or unusual swelling; shortness of breath; symptoms of infection (eg, fever, chills, persistent sore throat or cough); symptoms of liver problems (eg, dark urine; persistent loss of appetite; right-sided stomach pain; severe or persistent tiredness, nausea, or vomiting; yellowing of the skin or eyes); trouble swallowing; unusual bruising or bleeding.

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: Crizotinib 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.

Proper storage of Crizotinib:

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

General information:

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


• Crizotinib 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 Crizotinib. 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.

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

• Crizotinib Professional Patient Advice (Wolters Kluwer)


• crizotinib Advanced Consumer (Micromedex) - Includes Dosage Information


• Xalkori Consumer Overview

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Celluvisc

Generic Name: ocular lubricant (OK yoo lar LOO bri kant)

Brand Names: Artificial Tears, Celluvisc, Clear Eyes CLR, Comfort Tears, Dry Eye Relief, GenTeal, Isopto Tears, Lacri-Lube S.O.P., Lacrisert, Lubricant Eye Drops, Moisture Drops, Oasis Tears, Opti-Free Rewetting Drops, optive, Refresh, Soothe, Sterilube, Systane, Systane Balance, Tears Again, Tears Naturale, Tears Renew, TheraTears, Ultra Fresh, Visine Tears

What is Celluvisc (ocular lubricant)?

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

Ocular lubricant is a solution specially formulated to moisten the eyes.

Ocular lubricant is used to relieve burning, irritation, and discomfort caused by dry eyes.

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

What is the most important information I should know about Celluvisc (ocular lubricant)?

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.

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

Stop using ocular lubricant and call your doctor if you have severe burning, stinging, irritation, eye pain, or vision changes.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant.

What should I discuss with my healthcare provider before using Celluvisc (ocular lubricant)?

You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.

Ocular lubricant is not expected to harm an unborn baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant. It is not known whether ocular lubricant passes into breast milk or if it could harm a nursing baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant.

How should I use Celluvisc (ocular lubricant)?

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.

Do not use this medication while wearing contact lenses. Eye medication may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medication before putting your contact lenses in. Wash your hands before using ocular lubricant.

To apply the eye drops:

• 
  

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

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

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

  
  


• 
  

  Do not use the eye drops if the liquid has changed colors or has particles in it.

  
  

To apply the ointment:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

  
  


• 
  

  Squeeze out a ribbon of ointment 1/2-inch long into the lower eyelid pocket without touching the tip of the tube to your eye. Look down and close your eyes for a few minutes. Rolling your eyes around gently will help spread the ointment evenly.

  
  


• 
  

  After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

  
  

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

Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant. Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

What happens if I miss a dose?

Since ocular lubricant is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

An overdose of ocular lubricant is not expected to be dangerous.

What should I avoid while using Celluvisc (ocular lubricant)?

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid using other medications in your eyes during treatment with ocular lubricant unless your doctor tells you to.

Celluvisc (ocular lubricant) 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 ocular lubricant and call your doctor if you have a serious side effect such as:

• 
  

  severe burning, stinging, or eye irritation after using the medication;

  
  


• 
  

  eye pain; or

  
  


• 
  

  vision changes.

  
  

Less serious side effects may include:

• 
  

  mild eye burning or irritation;

  
  


• 
  

  itching or redness of your eyes;

  
  


• 
  

  watery eyes;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Celluvisc (ocular lubricant)?

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

More Celluvisc resources

• Celluvisc Use in Pregnancy & Breastfeeding
• Celluvisc Support Group
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• Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer)


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• Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Refresh liquigel

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Where can I get more information?

• Your pharmacist can provide more information about ocular lubricant.

Corticosteroid - low potency Topical application

Class Name: corticosteroid- low potency (Topical application route)

Commonly used brand name(s):

In the U.S.

• Aclovate


• Ala-Cort


• Cloderm


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• SAStid


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Alocort


• Barriere-Hc


• Cortacet


• Cortate


• Cortef


• Cort-Eze


• Corticreme 0.1%


• Corticreme 0.5%


• Corticreme 1%


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort

Available Dosage Forms:

• Gel/Jelly


• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Paste


• Liquid


• Kit


• Foam


• Stick

Uses For This Medicine

Topical corticosteroids are used to help relieve redness, swelling, itching, and discomfort of many skin problems. These medicines are like cortisone. They belong to the general family of medicines called steroids.

Most corticosteroids are available only with your doctor's prescription. Some strengths of hydrocortisone are available without a prescription. However, your doctor may have special instructions on the proper use for your medical condition.

Before Using This Medicine

Allergies

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

Pediatric

Children and teenagers who must use this medicine for a long time should be checked often by their doctor. Other, more potent corticosteroids are absorbed through the skin and can affect growth or cause other unwanted effects. Topical corticosteroids also can be absorbed if they are applied to large areas of skin. These effects are less likely to occur with the use of the lower potency corticosteroids. However, before using this medicine in children, you should discuss its use with your child's doctor.

Geriatric

This medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

When used properly, these medicines have not been shown to cause problems in humans. Studies on birth defects have not been done in humans. However, studies in animals have shown that topical corticosteroids, when applied to the skin in large amounts or used for a long time, could cause birth defects.

Breast Feeding

Topical corticosteroids have not been reported to cause problems in nursing babies when used properly. However, corticosteroids should not be applied to the breasts just before nursing.

Interactions with Medicines

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

• Varicella Virus Vaccine

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus—Too much use of corticosteroids may cause a loss of control of diabetes by increasing blood and urine glucose. However, this is not likely to happen when topical corticosteroids are used for a short time.

• Infection or sores at the place of treatment or


• Tuberculosis—Corticosteroids may make existing infections worse or cause new infections.

• Skin conditions that cause thinning of skin with easy bruising—Corticosteroids may make thinning of the skin worse.

Proper Use of This Medicine

Be very careful not to get this medicine in your eyes. Wash your hands after using your finger to apply the medicine. If you accidentally get this medicine in your eyes, flush them with water.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap or a special patch) to be applied over this medicine, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your doctor.

For patients using the topical aerosol form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• It is important to avoid breathing in the vapors from the spray or getting them in your eyes. If you accidentally get this medicine in your eyes, flush them with water.


• Do not use near heat, near an open flame, or while smoking.

Do not use this medicine more often or for a longer time than your doctor ordered or than recommended on the package label. To do so may increase the chance of absorption through the skin and the chance of side effects.

If this medicine has been prescribed for you, it is meant to treat a specific skin problem. Do not use it for other skin problems, and do not use nonprescription hydrocortisone for skin problems that are not listed on the package label, without first checking with your doctor. Topical corticosteroids should not be used on many kinds of bacterial, viral, or fungal skin infections.

The dose of topical corticosteroid will be different for different patients and products. Follow your doctor's orders or the directions on the label.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Do not puncture, break, or burn aerosol containers, even after they are empty.

Precautions While Using This Medicine

Check with your doctor if your symptoms do not improve within 1 week or if your condition gets worse.

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

Side Effects of This Medicine

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:

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

Less common or rare

• Blood-containing blisters on skin


• burning and itching of skin


• increased skin sensitivity


• lack of healing of skin condition


• numbness in fingers


• painful, red or itchy, pus-containing blisters in hair follicles


• raised, dark red, wart-like spots on skin, especially when used on the face


• skin infection


• thinning of skin with easy bruising

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

Less common or rare - usually mild and transient

• Burning, dryness, irritation, itching, or redness of skin


• increased redness or scaling of skin sores


• skin rash

When the gel, lotion, solution, or aerosol form of this medicine is applied, a mild, temporary stinging may be expected.

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

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

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

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