Camptosar

Generic Name: irinotecan (Intravenous route)

ir-in-oh-TEE-kan

Intravenous route(Solution)

Irinotecan can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms, and both forms of diarrhea may be severe. Early diarrhea may be accompanied by cholinergic symptoms that may be prevented or ameliorated by atropine. Late diarrhea (generally occurring more than 24 hours after administration of irinotecan) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide and administration of irinotecan should be interrupted and subsequent doses reduced if severe diarrhea occurs. Severe myelosuppression may occur with irinotecan administration .

Commonly used brand name(s)

In the U.S.

• Camptosar


• Novaplus Irinotecan Hydrochloride

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Topoisomerase I Inhibitor

Uses For Camptosar

Irinotecan injection is given together with other medicines to treat patients with metastatic cancer (a cancer that has already spread) of the colon or rectum.

Irinotecan belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with irinotecan has been stopped. Be sure that you have discussed with your doctor the possible side effects of this medicine as well as the good it can do.

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

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

• Carcinoma, lung, non-small cell (treatment of non–small cell cancer of the lung).


• Extensive-stage small-cell lung cancer, first-line treatment, in combination with cisplatin (treatment of small-cell lung cancer; used together with cisplatin [Platinol®]).


• Ovarian cancer, platinum-refractory or platinum-resistant (treatment of ovarian cancer that does not respond to platinum-type medicines).


• Malignant glioma, recurrent or progressive (treatment of brain cancer that has returned or is advancing).

Before Using Camptosar

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of irinotecan injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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

Interactions with Medicines

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

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

• Atazanavir


• Ketoconazole


• Rotavirus Vaccine, Live


• St John's Wort

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

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Aprepitant


• Bacillus of Calmette and Guerin Vaccine, Live


• Carbamazepine


• Fosaprepitant


• Influenza Virus Vaccine, Live


• Lopinavir


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Phenobarbital


• Phenytoin


• Rifabutin


• Rifampin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

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

• Citalopram


• Sorafenib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Tobacco

Other Medical Problems

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

• Bleeding problems or


• Diabetes or


• Hereditary fructose intolerance, history of or


• Hyperglycemia (high blood sugar) or


• Kidney disease or


• Liver disease or


• Lung disease or


• Severe diarrhea—Use with caution. May make these conditions worse.

• Bone marrow disease, severe or


• Bowel blockage or


• Gilbert's syndrome (an inherited disorder) or


• Neutropenia (low white blood cells) or


• Reduced UGT1A1 activity (an enzyme problem)—May increase risk for more serious side effects.

• Infection—This medicine may decrease your body's ability to fight an infection.

Proper Use of irinotecan

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

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

Irinotecan often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. You may receive other medicines to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

Precautions While Using Camptosar

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant before you receive this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have chills; fever; hives; hoarseness; itching; rash; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

While you are being treated with irinotecan, and after you stop treatment, do not have any immunizations (vaccinations) without your doctor's approval. Irinotecan may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., nasal influenza or flu vaccine). Try to avoid persons who have taken live vaccines. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should wear a protective face mask that covers the nose and mouth.

Irinotecan may cause diarrhea, which can last long enough and be severe enough to cause serious medical problems. If diarrhea occurs while you are being treated with irinotecan:

• Check with your doctor immediately. Be sure to let your doctor know if the diarrhea started during an irinotecan injection or less than 24 hours afterwards. Also, be sure to tell your doctor if you had any other symptoms, such as stomach cramps or sweating, before the diarrhea started. This means that you are having a certain kind of diarrhea that may need to be treated by your doctor.


• If diarrhea first occurs more than 24 hours after a dose of irinotecan, start taking loperamide (Imodium A-D®) as soon as you notice that your bowel movements are occurring more often or are more loose than usual. Loperamide is available without a prescription. Buy some of it ahead of time, so that you will have it on hand in case it is needed. Unless otherwise directed by your doctor, take 4 milligrams (mg) of loperamide (2 capsules or tablets, or 4 teaspoonfuls of the oral solution dosage form) for the first dose, then 2 mg (1 capsule or tablet, or 2 teaspoonfuls of the oral solution dosage form) every two hours. To interrupt your sleep less often, you may take 4 mg of loperamide every four hours during the night. Continue taking loperamide, day and night, until you have not had any diarrhea for twelve hours. It is very important that you follow these (or your doctor's) directions, even though they are different from the directions on the nonprescription (over-the-counter [OTC]) loperamide package label. The largest amount of loperamide recommended on the package label for use in a twenty-four-hour period (8 mg) is not enough for treating diarrhea caused by irinotecan. Notify your doctor if the diarrhea is not controlled within 24 hours.


• Diarrhea causes loss of body fluid, which can lead to dehydration, a serious medical problem. To prevent this, it is very important that you replace the lost fluid. While you have diarrhea, and for a day or two after the diarrhea has stopped, drink plenty of clear liquids, such as ginger ale, caffeine-free cola, decaffeinated tea, and broth. Ask your doctor about the amount of liquid you should be drinking every day. Also, ask your doctor whether you should use a sports drink (e.g., Gatorade®), which contains other substances, such as sodium and potassium, that may be lost along with body fluid. Follow your doctor's directions very carefully.


• Because alcohol and caffeine can increase fluid loss, you should not drink beverages or take any medicines that contain them while you have diarrhea. Also, avoid eating foods that may make diarrhea worse, such as bran, raw fruits or vegetables, or fatty, fried, or spicy foods.


• Vomiting can also increase the amount of fluid lost by the body and increase the risk of dehydration. If vomiting occurs at the same time as diarrhea, check with your doctor right away.


• Signs of too much fluid loss (dehydration) include decreased urination, dizziness or light-headedness, dryness of the mouth, fainting, increased thirst, and wrinkled skin. If any of these occur, check with your doctor immediately.

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

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Also, check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Call your doctor right away if you have an unexplained fever, cough, shortness of breath, trouble with breathing, or wheezing after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may increase your risk of having blood clots. Tell your doctor right away if you start having a sudden and severe headache, trouble with breathing, or problems with vision, speech, or walking.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. This medicine may also cause blurred vision or other vision problems. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well. If these reactions are especially bothersome, check with your doctor.

Ketoconazole (Nizoral®) and St. John's wort should not be used while you are receiving irinotecan. If you are using St. John's Wort, it should be discontinued at least 2 weeks before the first cycle of irinotecan. If you are using ketoconazole, it should be discontinued at least 1 week before starting irinotecan treatment.

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

Camptosar 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 or nurse immediately if any of the following side effects occur:

More common

• Anxiety


• black, tarry stools


• blood in the urine or stools


• blurred vision


• changes in skin color


• chest pain or discomfort


• chest tightness or heaviness


• chills


• clay colored stools


• cold hands and feet


• confusion


• constricted pupils


• cough or hoarseness


• dark urine


• diarrhea with or without stomach cramps or sweating


• dizziness


• fainting


• fast, slow, or irregular heartbeat


• fever


• full or bloated feeling or pressure in the stomach


• headache


• increased production of saliva


• increased tear production


• itching


• lightheadedness when getting up suddenly from a lying or sitting position


• loss of appetite


• low blood pressure or pulse


• lower back or side pain


• nausea or vomiting


• numbness or tingling in the face, arms, or legs


• pain


• pain in the chest, groin, or legs, especially calves of the legs


• pain in the shoulders, arms, jaw, or neck


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• redness or swelling of the leg


• runny nose


• severe headache of sudden onset


• shortness of breath or troubled breathing


• skin rash


• slow breathing


• slurred speech


• sore throat


• stomach pain


• stopping of the heart


• sudden and severe weakness in the arm or leg on one side of the body


• sudden loss of coordination


• sudden vision changes


• sweating


• swelling


• swelling of the abdomen or stomach area


• temporary blindness


• tenderness, pain, or swelling of the arm, foot, or leg


• trouble with speaking or walking


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


• unconsciousness


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood


• warm, red feeling over the body


• yellow eyes or skin

Less common

• Bleeding gums


• coughing up blood


• decreased urination


• difficulty with swallowing


• dryness of the mouth


• increased menstrual flow or vaginal bleeding


• increased thirst


• nosebleeds


• paralysis


• prolonged bleeding from cuts


• sneezing


• wheezing


• wrinkled skin

Rare

• Decreased amount of urine


• decreased frequency of urination


• fast, irregular, or troubled breathing


• hives


• increased blood pressure


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


• rapid weight gain

Incidence not known

• Abdominal or stomach pain and tenderness


• agitation


• bloated or full feeling


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• coma


• constipation


• depression


• heartburn or indigestion


• hostility


• irritability


• lethargy


• muscle pain and cramps


• muscle twitching


• pain in the stomach, side, or abdomen, possibly radiating to the back


• pain or discomfort in the arms, jaw, back, or neck


• rectal bleeding


• severe abdominal or stomach cramping or burning


• severe and continuing nausea


• stupor


• swelling of the face, lower legs, ankles, fingers, or hands


• tightness in the chest


• unusual tiredness or weakness


• vomiting of material that looks like coffee grounds

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

• Acid or sour stomach


• belching


• blistering, peeling, redness, or swelling of the palms of hands or bottoms of the feet


• cracked lips


• excess air or gas in the stomach or intestines


• feeling of constant movement of self or surroundings


• numbness, pain, tingling, or unusual sensations in the palms of hands or bottoms of feet


• passing gas


• right upper abdominal or stomach pain and fullness


• sensation of spinning


• sleepiness or unusual drowsiness


• sleeplessness


• stomach discomfort, upset, or pain


• trouble sleeping


• unable to sleep


• weight loss

Incidence not known

• Hiccups

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: Camptosar 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.

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

More Camptosar resources

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

• Camptosar Prescribing Information (FDA)


• Camptosar Consumer Overview


• Camptosar Monograph (AHFS DI)


• Camptosar MedFacts Consumer Leaflet (Wolters Kluwer)


• Irinotecan Prescribing Information (FDA)


• Irinotecan Professional Patient Advice (Wolters Kluwer)

Compare Camptosar with other medications

• Colorectal Cancer

Maxidex

Generic Name: dexamethasone (ophthalmic) (DEX a METH a sone off THAL mik)

Brand Names: AK-Dex, Ocu-Dex

What is Maxidex (dexamethasone (ophthalmic))?

Dexamethasone ophthalmic is in a class of drugs called corticosteroids. It inhibits processes in the body that cause inflammation. Therefore, the swelling and pain of inflammatory conditions is decreased.

Dexamethasone ophthalmic is used to treat eye inflammation caused by infections, injury, surgery, or other conditions.

Dexamethasone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Maxidex (dexamethasone (ophthalmic))?

Do not stop using this medication suddenly if you have been using it for several weeks or more. Before stopping, you may need to reduce the dose over several days to prevent side effects.

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

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

Who should not use Maxidex (dexamethasone (ophthalmic))?

Do not use dexamethasone ophthalmic if you have a bacterial, viral, or fungal infection in your eye without also receiving proper anti-infective treatment. Dexamethasone ophthalmic is in the FDA pregnancy category C. This means that it is not known whether dexamethasone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether dexamethasone ophthalmic passes into breast milk. Do not use dexamethasone ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use Maxidex (dexamethasone (ophthalmic))?

Use dexamethasone ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eyedrops:

• 
  

  Shake the bottle gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out the prescribed number of drops and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using drops in both eyes, repeat the process in the other eye.

  
  

To apply the ointment:

• 
  

  Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

  
  

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store dexamethasone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, call an emergency room or poison control center near you. If the drops or ointment have been ingested, call an emergency center for advice.

What should I avoid while using Maxidex (dexamethasone (ophthalmic))?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Dexamethasone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with dexamethasone ophthalmic.

Maxidex (dexamethasone (ophthalmic)) side effects

Serious side effects are not expected with this medication. Rarely, an increase in the pressure inside of the eye, formation of cataracts, or a perforation of the cornea has been reported. Talk to your doctor about any possible side effects.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision, or sensitivity to light may occur.

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 Maxidex (dexamethasone (ophthalmic))?

Do not use other eyedrops or eye medications during treatment with dexamethasone ophthalmic without first talking to your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

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

More Maxidex resources

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

• Maxidex eent Monograph (AHFS DI)


• Maxidex Prescribing Information (FDA)


• Maxidex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Dexasol Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Ozurdex Prescribing Information (FDA)


• Ozurdex Advanced Consumer (Micromedex) - Includes Dosage Information


• Ozurdex Consumer Overview

Compare Maxidex with other medications

• Acute Otitis Externa
• Conjunctivitis
• Cyclitis
• Iritis
• Keratitis
• Macular Edema
• Uveitis

Where can I get more information?

• Your pharmacist has additional information about dexamethasone ophthalmic written for health professionals that you may read.

See also: Maxidex side effects (in more detail)

Clorpres

Pronunciation: klor-THAL-i-done/KLON-i-deen
Generic Name: Chlorthalidone/Clonidine
Brand Name: Clorpres

Clorpres is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Clorpres is a combination alpha agonist and diuretic. The alpha agonist works by relaxing blood vessels and decreasing heart rate. The diuretic works by increasing elimination of sodium and water.

Do NOT use Clorpres if:

• you are allergic to any ingredient in Clorpres, thiazides (eg, hydrochlorothiazide) or related diuretics, or to sulfonamide medicines (eg, sulfamethoxazole)


• you are unable to urinate

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

Before using Clorpres:

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

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


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


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


• if you have a blood vessel disease affecting the brain, heart or blood vessel problems, or you have had a stroke or recent heart attack


• if you have gout, liver disease, low blood levels of potassium or sodium, kidney problems, the blood disease porphyria, lupus, or if you are vomiting


• if you have a history of allergy or bronchial asthma


• if you will be in a hot environment for long periods of time


• if you are scheduled for surgery

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

• Beta-blockers (eg, propranolol) or calcium channel blockers (eg, verapamil) because a severe decrease in heart rate or an increase or decrease in blood pressure may occur


• Tricyclic antidepressants (eg, amitriptyline) because they may decrease Clorpres's effectiveness


• Barbiturates (eg, phenobarbital), corticosteroids (eg, cortisone), or narcotics (eg, codeine) because they may increase the risk of Clorpres's side effects


• Diazoxide, digitalis glycosides (eg, digoxin), ketanserin, lithium, tubocurarine, or other medicines for high blood pressure because their actions and the risk of their side effects may be increased by Clorpres


• Insulin, norepinephrine, or oral diabetes medicines (eg, glipizide) because their effectiveness may be decreased by Clorpres

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

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

• Take Clorpres by mouth with or without food.


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


• Continue to use Clorpres even if you feel well. Do not miss any doses.


• Clorpres may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you miss a dose of Clorpres, 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. If you miss 2 or more doses in a row, contact your doctor.

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

Important safety information:

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


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clorpres; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Clorpres may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• If you experience dry mouth, use sugarless candy or gum, or melt bits of ice in your mouth to help keep your mouth moist.


• Clorpres may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Clorpres may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Clorpres. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


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


• Diabetes patients - Clorpres may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including blood pressure and blood electrolyte levels, may be performed while you use Clorpres. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Clorpres with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness.


• Clorpres should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Also, CHILDREN who are sick and vomiting may be more sensitive to developing withdrawal symptoms.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clorpres while you are pregnant. Clorpres is found in breast milk. Do not breast-feed while using Clorpres.

If you stop taking Clorpres suddenly, you may have WITHDRAWAL symptoms. These may include nervousness, agitation, headache, tremor, and rapid increase in blood pressure.

Possible side effects of Clorpres:

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

Constipation; dizziness; drowsiness; dry mouth; tiredness.

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); agitation; confusion; dark urine; decreased urination; depression; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; inability to have sex; increased thirst; joint pain (gout); muscle pain or cramps; nausea; numbness or tingling of the skin; pounding in the chest; rapid breathing; red, swollen, blistered, or peeling skin; restlessness; severe or persistent drowsiness or dry mouth; sluggishness; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomiting; weakness; yellowing of the skin or eyes.

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

See also: Clorpres 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. Accidental overdose of Clorpres is an increasing cause of poisoning in children 3 years of age and younger. Symptoms may include difficult or slow breathing; drowsiness leading to unresponsiveness or coma; irritability; lightheadedness, especially upon standing; pinpoint pupils; seizures; severe or persistent dizziness; slow or irregular heartbeat; vomiting; weakness.

Proper storage of Clorpres:

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

General information:

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


• Clorpres 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 Clorpres. 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 Clorpres resources

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

• Clorpres Prescribing Information (FDA)


• Clorpres Concise Consumer Information (Cerner Multum)


• Clorpres Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Clorpres with other medications

• High Blood Pressure

Sulforcin

Generic Name: sulfur topical (SULL fur)

Brand Names: Acnotex, Fostril, Liquimat Light, Liquimat Medium, Rezamid, Sulfo-Lo, Sulfoam, Sulforcin, Sulmasque, Sulpho-Lac, Sulpho-Lac Soap

What is Sulforcin (sulfur topical)?

Topical sulfur causes drying and peeling of the skin. This allows excess oil and dirt to be easily washed away.

Sulfur topical is used to treat acne.

Sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sulforcin (sulfur topical)?

Do not use sulfur on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid abrasive, harsh, or drying soaps and cleansers while using sulfur topical.

Who should not use Sulforcin (sulfur topical)?

Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions much worse. Also avoid using sulfur topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use sulfur topical during treatment with other topical acne products unless otherwise directed with your doctor. The combination could lead to severe skin irritation.

It is not known whether sulfur topical will harm an unborn baby. Do not use sulfur topical without first talking to your doctor if you are pregnant. It is also not known whether sulfur passes into breast milk. Do not use sulfur topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Sulforcin (sulfur topical)?

Use sulfur topical exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Shake lotions well before using them. Clean and dry the area to which you will apply sulfur topical. Apply the medication to the affected area. When applying sulfur topical, avoid your eyes, the inside of your nose and mouth, your lips, and areas where the skin is broken to prevent excessive irritation. If you get medication in any of these areas, rinse it off with water.

Do not cover the affected area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Sulfur topical is usually applied one to three times daily.

It may take several weeks or more to see the effects of this drug. Do not stop using sulfur topical if you do not see results immediately.

Apply sulfur topical less often if you experience excessive burning, dryness, or irritation.

Store sulfur topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

What happens if I overdose?

An overdose of sulfur topical is unlikely to occur. If you do suspect an overdose, or if sulfur topical has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using Sulforcin (sulfur topical)?

Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid using other topical products on the same area unless otherwise directed to do so by your doctor. They may interfere with the effects or absorption of sulfur topical.

Do not cover the area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Avoid using harsh, abrasive or irritating cleansers, perfumes or cosmetics on the area you are treating.

Sulforcin (sulfur topical) side effects

Serious side effects are not likely to occur. Stop using sulfur topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some burning, stinging, tingling, itching, redness, dryness, peeling, or irritation while you are using sulfur topical. If these side effects are excessive, apply sulfur topical less often.

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

What other drugs will affect Sulforcin (sulfur topical)?

Do not use other topical preparations unless directed to do so by your doctor. They may interfere with your treatment or increase irritation to your skin.

Avoid using harsh, abrasive or irritating cleansers, perfumes, or cosmetics on the area you are treating.

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

More Sulforcin resources

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

• Sulfo-Lo Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Sulforcin with other medications

• Acne

Where can I get more information?

• Your pharmacist has additional information about sulfur topical written for health professionals that you may read.

See also: Sulforcin side effects (in more detail)

Loxitane

loxapine succinate

Dosage Form: capsule
Loxitane

Loxitane®

(Loxapine Succinate USP)

Capsules

Revised: September 2010

Rx only

WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxitane is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DESCRIPTION

Loxitane, loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4] oxazepine. It is present as the succinate salt.

Each capsule for oral administration, contains loxapine succinate USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25 or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: gelatin, silicon dioxide, NF, sodium lauryl sulfate, NF, anhydrous lactose, D & C Yellow 10, FD&C Blue 1, polacrilin potassium, magnesium stearate, talc, and titanium dioxide. Additionally, the 5 mg capsule contains D & C Red 33, the 10 mg capsule contains D & C Red 28 and D & C Red 33, and the 25 mg capsule contains FD & C Yellow 6.

CLINICAL PHARMACOLOGY

Pharmacodynamics:

Pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such manifestations of tranquilization as calming effects and suppression of aggressive behavior.

In normal human volunteers, signs of sedation were seen within 20 to 30 minutes after administration, were most pronounced within one and one-half to three hours, and lasted through 12 hours. Similar timing of primary pharmacologic effects was seen in animals.

Absorption, Distribution, Metabolism, and Excretion

Absorption of loxapine following oral or parenteral administration is virtually complete. The drug is removed rapidly from the plasma and distributed in tissues. Animal studies suggest an initial preferential distribution in lungs, brain, spleen, heart, and kidney. Loxapine is metabolized extensively and is excreted mainly in the first 24 hours. Metabolites are excreted in the urine in the form of conjugates and in the feces unconjugated.

INDICATIONS AND USAGE

Loxitane is indicated for the treatment of schizophrenia. The efficacy of Loxitane in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.

CONTRAINDICATIONS

Loxitane is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.).

Loxitane is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.

WARNINGS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Loxitane is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).

Tardive Dyskinesia

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome. (See ADVERSE REACTIONS and Information for Patients sections.)

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.

The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

Loxitane, like other antipsychotics, may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, ambulatory patients should be warned about activities requiring alertness (e.g., operating vehicles or machinery) and about concomitant use of alcohol and other CNS depressants.

Loxitane has not been evaluated for the management of behavioral complications in patients with mental retardation, and therefore, it cannot be recommended.

PRECAUTIONS

Leukopenia, Neutropenia and Agranulocytosis

In clinical trial and postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.

Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a preexisting low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Loxitane at the first sign of a decline in WBC in the absence of other causative factors.

Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue Loxitane and have their WBC followed until recovery.

General

Loxitane should be used with extreme caution in patients with a history of convulsive disorders since it lowers the convulsive threshold. Seizures have been reported in patients receiving Loxitane at antipsychotic dose levels, and may occur in epileptic patients even with maintenance of routine anticonvulsant drug therapy.

Loxitane has an antiemetic effect in animals. Since this effect may also occur in man, Loxitane may mask signs of overdosage of toxic drugs and may obscure conditions such as intestinal obstruction and brain tumor.

Loxitane should be used with caution in patients with cardiovascular disease.

Increased pulse rates have been reported in the majority of patients receiving antipsychotic doses; transient hypotension has been reported. In the presence of severe hypotension requiring vasopressor therapy, the preferred drugs may be norepinephrine or angiotensin. Usual doses of epinephrine may be ineffective because of inhibition of its vasopressor effect by Loxitane.

The possibility of ocular toxicity from loxapine cannot be excluded at this time. Therefore, careful observation should be made for pigmentary retinopathy and lenticular pigmentation since these have been observed in some patients receiving certain other antipsychotic drugs for prolonged periods.

Because of possible anticholinergic action, the drug should be used cautiously in patients with glaucoma or a tendency to urinary retention, particularly with concomitant administration of anticholinergic-type antiparkinson medication.

Experience to date indicates the possibility of a slightly higher incidence of extrapyramidal effects following intramuscular administration than normally anticipated with oral formulations. The increase may be attributable to higher plasma levels following intramuscular injection.

Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

Information for Patients

Given the likelihood that some patients exposed chronically to antipsychotics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.

Drug Interactions

There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of loxapine and lorazapam.

The risk of using loxapine in combination with CNS-active drugs has not been systematically evaluated. Therefore, caution is advised if the concomitant administration of loxapine and CNS-active drugs is required.

Pregnancy

Non-teratogenic Effects

Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Loxapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Safe use of Loxitane during pregnancy or lactation has not been established; therefore, its use in pregnancy, in nursing mothers, or in women of childbearing potential requires that the benefits of treatment be weighed against the possible risks to mother and child. No embryotoxicity or teratogenicity was observed in studies in rats, rabbits, or dogs although, with the exception of one rabbit study, the highest dosage was only two times the maximum recommended human dosage and in some studies it was below this dose. Perinatal studies have shown renal papillary abnormalities in offspring of rats treated from mid-pregnancy with doses of 0.6 and 1.8 mg/kg, doses which approximate the usual human dose but which are considerably below the maximum recommended human dose.

Nursing Mothers

The extent of the excretion of Loxitane or its metabolites in human milk is not known. However, Loxitane and its metabolites have been shown to be transported into the milk of lactating dogs. Loxitane administration to nursing women should be avoided if clinically possible.

Pediatric Use

Safety and effectiveness of Loxitane in pediatric patients have not been established.

ADVERSE REACTIONS

CNS Effects: Manifestations of adverse effects on the central nervous system, other than extrapyramidal effects, have been seen infrequently. Drowsiness, usually mild, may occur at the beginning of therapy or when dosage is increased. It usually subsides with continued Loxitane therapy. The incidence of sedation has been less than that of certain aliphatic phenothiazines and slightly more than the piperazine phenothiazines. Dizziness, faintness, staggering gait, shuffling gait, muscle twitching, weakness, insomnia, agitation, tension, seizures, akinesia, slurred speech, numbness, and confusional states have been reported. Neuroleptic malignant syndrome (NMS) has been reported (see WARNINGS).

Extrapyramidal Symptoms - Neuromuscular (extrapyramidal) reactions during the administration of Loxitane have been reported frequently, open during the first few days of treatment.  In most patients, these reactions involved parkinsonian-like symptoms such as tremor, rigidity, excessive salivation, and masked facies. Akathisia (motor restlessness) also has been reported relatively frequently. These symptoms are usually not severe and can be controlled by reduction of Loxitane dosage or by administration of antiparkinson drugs in usual dosage.

Dystonia - Class effect:

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Persistent Tardive Dyskinesia - As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movement of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities.

There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been suggested that fine vermicular movements of the tongue may be an early sign of the syndrome, and if the medication is stopped at that time the syndrome may not develop.

Cardiovascular Effects: Tachycardia, hypotension, hypertension, orthostatic hypotension, lightheadedness, and syncope have been reported.

A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known whether these were related to Loxitane administration.

Hematologic: Rarely, agranulocytosis, thrombocytopenia, leukopenia.

Skin: Dermatitis, edema (puffiness of face), pruritus, rash, alopecia, and seborrhea have been reported with loxapine.

Anticholinergic Effects: Dry mouth, nasal congestion, constipation, blurred vision, urinary retention, and paralytic ileus have occurred.

Gastrointestinal: Nausea and vomiting have been reported in some patients. Hepatocellular injury (i.e., SGOT/SGPT elevation) has been reported in association with loxapine administration and rarely, jaundice and/or hepatitis questionably related to Loxitane treatment.

Other Adverse Reactions: Weight gain, weight loss, dyspnea, ptosis, hyperpyrexia, flushed facies, headache, paresthesia, and polydipsia have been reported in some patients. Rarely, galactorrhea, amenorrhea, gynecomastia, and menstrual irregularity of uncertain etiology have been reported.

OVERDOSAGE

Signs and symptoms of overdosage will depend on the amount ingested and individual patient tolerance. As would be expected from the pharmacologic actions of the drug, the clinical findings may range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression, and unconsciousness. The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind. Renal failure following loxapine overdosage has also been reported.

The treatment of overdosage is essentially symptomatic and supportive. Early gastric lavage and extended dialysis might be expected to be beneficial. Centrally-acting emetics may have little effect because of the antiemetic action of loxapine. In addition, emesis should be avoided because of the possibility of aspiration of vomitus. Avoid analeptics, such as pentylenetetrazol, which may cause convulsions. Severe hypotension might be expected to respond to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED SINCE ITS USE IN A PATIENT WITH PARTIAL ADRENERGIC BLOCKADE MAY FURTHER LOWER THE BLOOD PRESSURE. Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson agents or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated. Additional measures include oxygen and intravenous fluids.

DOSAGE AND ADMINISTRATION

Loxitane is administered, usually in divided doses, two to four times a day. Daily dosage (in terms of base equivalents) should be adjusted to the individual patient’s needs as assessed by the severity of symptoms and previous history of response to antipsychotic drugs.

Oral Administration

Initial dosage of 10 mg twice daily is recommended, although in severely disturbed patients initial dosage up to a total of 50 mg daily may be desirable. Dosage should then be increased fairly rapidly over the first seven to ten days until there is effective control of symptoms of schizoprenia. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. However, as with other drugs used to treat schizoprenia, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.

Maintenance Therapy

For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosages in the range of 20 to 60 mg daily.

HOW SUPPLIED

Loxitane®, loxapine succinate capsules, are available in the following strengths:

Loxapine Succinate USP 6.8 mg equivalent to 5 mg loxapine, hard shell, opaque, dark green capsules printed with “

NDC 52544-494-01 - Bottle of 100s

NDC 52544-494-10 - Bottle of 1000s

Loxapine Succinate USP 13.6 mg equivalent to 10 mg loxapine, hard shell, opaque, with yellow body and a dark green cap, printed with “

NDC 52544-495-01 - Bottle of 100s

NDC 52544-495-10 - Bottle of 1000s

Loxapine Succinate USP 34.0 mg equivalent to 25 mg loxapine, hard shell, opaque, with a light-green body and a dark green cap, printed with “

NDC 52544-496-01 - Bottle of 100s

NDC 52544-496-10 - Bottle of 1000s

Loxapine Succinate USP 68.1 mg equivalent to 50 mg loxapine, hard shell, opaque, with a blue body and a dark green cap, printed with “

NDC 52544-497-01 - Bottle of 100s

NDC 52544-497-10 - Bottle of 1000s

Store at 20°-25°C (68°-77°F). [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.

Manufactured By:

Watson Pharma Private Limited

Verna, Salcette Goa 403 722 INDIA

Distributed by:

Watson Pharma, Inc.

Corona, CA 92880 USA

Revised: September 2010

174361-2

PRINCIPAL DISPLAY PANEL

NDC 52544-494-01

Loxitane®

Loxapine Succinate

Capsules

5 mg base

Watson® Rx only

100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 52544-495-01

Loxitane®

Loxapine Succinate

Capsules

10 mg base

Watson® Rx only

100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 52544-496-01

Loxitane®

Loxapine Succinate

Capsules

25 mg base

Watson® Rx only

100 Capsules

PRINCIPAL DISPLAY PANEL

NDC 52544-497-01

Loxitane®

Loxapine Succinate

Capsules

50 mg base

Watson® Rx only

100 Capsules

Loxitane  loxapine succinate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52544-494 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOXAPINE SUCCINATE (LOXAPINE) LOXAPINE SUCCINATE 5 mg

Inactive Ingredients Ingredient Name Strength GELATIN   SILICON DIOXIDE   SODIUM LAURYL SULFATE   ANHYDROUS LACTOSE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   POLACRILIN POTASSIUM   MAGNESIUM STEARATE   TALC   TITANIUM DIOXIDE   D&C RED NO. 33

Product Characteristics Color GREEN (opaque dark green) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code WATSON;Loxitane;5;mg Contains

Packaging # NDC Package Description Multilevel Packaging 1 52544-494-01 100 CAPSULE In 1 BOTTLE, PLASTIC None 2 52544-494-10 1000 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072204	06/15/1988

Loxitane  loxapine succinate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52544-495 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOXAPINE SUCCINATE (LOXAPINE) LOXAPINE SUCCINATE 10 mg

Inactive Ingredients Ingredient Name Strength GELATIN   SILICON DIOXIDE   SODIUM LAURYL SULFATE   ANHYDROUS LACTOSE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   POLACRILIN POTASSIUM   MAGNESIUM STEARATE   TALC   TITANIUM DIOXIDE   D&C RED NO. 28   D&C RED NO. 33

Product Characteristics Color YELLOW (body opaque yellow) , GREEN (cap opaque dark green) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code WATSON;Loxitane;10;mg Contains

Packaging # NDC Package Description Multilevel Packaging 1 52544-495-01 100 CAPSULE In 1 BOTTLE, PLASTIC None 2 52544-495-10 1000 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072205	06/15/1988

Loxitane  loxapine succinate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52544-496 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOXAPINE SUCCINATE (LOXAPINE) LOXAPINE SUCCINATE 25 mg

Inactive Ingredients Ingredient Name Strength GELATIN   SILICON DIOXIDE   SODIUM LAURYL SULFATE   ANHYDROUS LACTOSE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   POLACRILIN POTASSIUM   MAGNESIUM STEARATE   TALC   TITANIUM DIOXIDE   FD&C YELLOW NO. 6

Product Characteristics Color GREEN (body opaque light-green) , GREEN (cap opaque dark-green) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code WATSON;Loxitane;25;mg Contains

Packaging # NDC Package Description Multilevel Packaging 1 52544-496-01 100 CAPSULE In 1 BOTTLE, PLASTIC None 2 52544-496-10 1000 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072206	06/15/1988

Loxitane  loxapine succinate  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52544-497 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOXAPINE SUCCINATE (LOXAPINE) LOXAPINE SUCCINATE 50 mg

Inactive Ingredients Ingredient Name Strength GELATIN   SILICON DIOXIDE   SODIUM LAURYL SULFATE   ANHYDROUS LACTOSE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   POLACRILIN POTASSIUM   MAGNESIUM STEARATE   TALC   TITANIUM DIOXIDE

Product Characteristics Color BLUE (body opaque blue) , GREEN (cap opaque dark green) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code WATSON;Loxitane;50;mg Contains

Packaging # NDC Package Description Multilevel Packaging 1 52544-497-01 100 CAPSULE In 1 BOTTLE, PLASTIC None 2 52544-497-10 1000 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072062	06/15/1988

Labeler - Watson Pharma, Inc. (023932721)

Establishment
Name	Address	ID/FEI	Operations
Watson Laboratories, Inc.		840054118	ANALYSIS, LABEL, MANUFACTURE, PACK

Establishment
Name	Address	ID/FEI	Operations
Watson Pharma Private Limited		677605709	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 02/2011Watson Pharma, Inc.

More Loxitane resources

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

• Loxitane Concise Consumer Information (Cerner Multum)


• Loxitane MedFacts Consumer Leaflet (Wolters Kluwer)


• Loxitane Monograph (AHFS DI)


• Loxitane Advanced Consumer (Micromedex) - Includes Dosage Information


• Loxapine Professional Patient Advice (Wolters Kluwer)

Compare Loxitane with other medications

• Schizophrenia

ClindaMax

Generic Name: clindamycin topical (klin da MYE sin)

Brand Names: Cleocin T, Clindagel, ClindaMax, ClindaReach Pledget, Evoclin

What is ClindaMax (clindamycin topical)?

Clindamycin is an antibiotic. Clindamycin topical prevents bacteria from growing on the skin.

Clindamycin topical (for the skin) is used to treat severe acne.

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

What is the most important information I should know about ClindaMax (clindamycin topical)?

Use clindamycin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.

Avoid getting this medication in your eyes. If it does get into your eyes, rinse thoroughly with water.

It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve.

Although this medicine is applied to the skin, your body may absorb enough clindamycin to cause serious side effects. You may not be able to use this medication if you have inflammation of your intestines (also called enteritis), ulcerative colitis, or if you have ever had severe diarrhea caused by antibiotic medicine.

What should I discuss with my healthcare provider before using ClindaMax (clindamycin topical)?

You should not use this medication if you are allergic to clindamycin or if you have:

• 
  

  inflammation of your intestines (also called enteritis);

  
  


• 
  

  ulcerative colitis; or

  
  


• 
  

  if you have ever had severe diarrhea caused by antibiotic medicine.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether clindamycin 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 medication on a child younger than 12 years old without the advice of a doctor.

How should I use ClindaMax (clindamycin topical)?

Use clindamycin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.

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

Wash your hands before and after applying this medication.

Wash your face with a mild soap or cleanser and pat the skin dry with a clean towel.

Avoid getting this medication in your eyes. If it does get into your eyes, rinse thoroughly with water.

It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve.

Store this medication at room temperature away from moisture and heat. Keep the clindamycin topical foam canister away from an open flame or high heat. Do not puncture the canister or throw an empty canister into a fire.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms include bloody or watery diarrhea, which may result if you absorb this medicine through your skin by applying too much.

What should I avoid while taking ClindaMax (clindamycin topical)?

Do not smoke while using clindamycin topical foam, or immediately after applying it. The contents of the foam canister are flammable.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

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

ClindaMax (clindamycin topical) side effects

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

• 
  

  severe redness, itching, or dryness of treat skin areas; or

  
  


• 
  

  diarrhea that is watery or bloody.

  
  

Less serious side effects may include:

• 
  

  mild burning or itching;

  
  


• 
  

  mild dryness of treated skin; or

  
  


• 
  

  redness or other irritation.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ClindaMax (clindamycin topical)?

Before using clindamycin topical, tell your doctor if you are using any of the following drugs:

• 
  

  erythromycin topical (Akne-Mycin, Emcin Clear, Eryderm, Erygel, Erythra-Derm, Ery-Sol, and others); or

  
  


• 
  

  erythromycin taken by mouth (E.E.S., E-Mycin, Ery-Tab, E-Mycin, Robimycin, and others).

  
  

This list is not complete and there may be other drugs that can interact with clindamycin topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More ClindaMax resources

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

• ClindaMax Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• ClindaMax Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Clindamycin Topical Prescribing Information (FDA)


• Cleocin Vaginal Advanced Consumer (Micromedex) - Includes Dosage Information


• Clinda-Derm Prescribing Information (FDA)


• Clindacin P Prescribing Information (FDA)


• Clindagel Prescribing Information (FDA)


• Clindamax Prescribing Information (FDA)


• Clindamax Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Clindesse Prescribing Information (FDA)


• Clindesse Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Clindesse Consumer Overview


• Evoclin Prescribing Information (FDA)


• Evoclin Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Evoclin Consumer Overview

Compare ClindaMax with other medications

• Bacterial Vaginitis

Where can I get more information?

• Your pharmacist can provide more information about clindamycin topical.

See also: ClindaMax side effects (in more detail)