Carbachol

Generic Name: carbachol ophthalmic (KAR ba kall)

Brand Names: Carbachol Ophthalmic, Carboptic, Isopto Carbachol, Miostat

What is Carbachol (carbachol ophthalmic)?

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

Carbachol ophthalmic is used to treat glaucoma by lowering the pressure inside the eye.

Carbachol 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 Carbachol (carbachol ophthalmic)?

Contact your doctor immediately if you notice any decrease in vision or an increase in "floaters" in your visual field. Rarely, carbachol ophthalmic may cause retinal detachment. Retinal detachment can lead to blind spots, floaters in your visual field, and even blindness. Your doctor will want to check your retina before you use this medicine to determine if you have an increased risk of retinal detachment. Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

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

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

What should I discuss with my healthcare provider before using Carbachol (carbachol ophthalmic)?

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

Before using this medication, tell your doctor if you have

• 
  

  heart failure,

  
  


• 
  

  high or low blood pressure,

  
  


• 
  

  ever had a heart attack,

  
  


• 
  

  asthma,

  
  


• 
  

  a stomach ulcer or stomach spasms,

  
  


• 
  

  epilepsy,

  
  


• 
  

  hyperthyroidism (an overactive thyroid),

  
  


• 
  

  blockage of your urinary tract or difficulty urinating, or

  
  


• 
  

  Parkinson's disease.

  
  

You may not be able to use carbachol ophthalmic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Carbachol ophthalmic is in the FDA pregnancy category C. This means that it is not known whether carbachol ophthalmic will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether carbachol passes into breast milk. Do not use carbachol ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use Carbachol (carbachol ophthalmic)?

Use carbachol ophthalmic eye drops exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, pharmacist, or nurse to explain them to you.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying carbachol ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Carbachol ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

To apply the eye drops:

• 
  

  Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper. Squeeze out a drop and close the eye. Apply gentle pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down the tear duct. If you are using more than 1 drop in the same eye, repeat the process with about 5 minutes between drops. Repeat the process in the other eye if needed.

  
  

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected or if the drops have been ingested.

Symptoms of a carbachol ophthalmic overdose may include sweating, nausea, vomiting, diarrhea, watering mouth, and tearing eyes.

What should I avoid while using Carbachol (carbachol ophthalmic)?

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

If you wear contact lenses, remove them before applying carbachol ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Carbachol ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

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

Carbachol (carbachol ophthalmic) side effects

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

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

• 
  

  burning, stinging, or tearing eyes;

  
  


• 
  

  decreased vision in poor light;

  
  


• 
  

  headache;

  
  


• 
  

  watering mouth;

  
  


• 
  

  sweating;

  
  


• 
  

  increased urination;

  
  


• 
  

  nausea, vomiting, or diarrhea; or

  
  


• 
  

  dizziness.

  
  

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 Carbachol (carbachol ophthalmic)?

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

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

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

More Carbachol resources

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

Compare Carbachol with other medications

• Glaucoma
• Intraocular Hypertension
• Production of Miosis

Where can I get more information?

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

See also: Carbachol side effects (in more detail)

Chlorpromazine Syrup

Pronunciation: klor-PROE-ma-zeen
Generic Name: Chlorpromazine
Brand Name: Generic only. No brands available.

Chlorpromazine Syrup is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Chlorpromazine Syrup is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.

Chlorpromazine Syrup is used for:

Treating certain mental or mood disorders (eg, schizophrenia), the manic phase of manic-depressive disorder, anxiety and restlessness before surgery, the blood disease porphyria, severe behavioral and conduct disorders in children, nausea and vomiting, and severe hiccups. It is also used with other medicines to treat symptoms associated with tetanus. It may also be used for other conditions as determined by your doctor.

Chlorpromazine Syrup is a phenothiazine. It is not known exactly how it works

Do NOT use Chlorpromazine Syrup if:

• you are allergic to any ingredient in Chlorpromazine Syrup or to other phenothiazines (eg, thioridazine)


• you have severe drowsiness


• you have recently taken large amounts of alcohol or medicines that may cause drowsiness, such as barbiturates (eg, phenobarbital) or narcotic pain medicines (eg, codeine)


• you are taking certain antiarrhythmic medicines (eg, amiodarone, dofetilide, dronedarone, quinidine, sotalol), cisapride, pergolide, pimozide, quetiapine, or ziprasidone

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

Before using Chlorpromazine Syrup:

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

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


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


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


• if you have a history of heart problems, low blood pressure, blood problems, bone marrow problems, low white blood cell count, diabetes, liver problems (eg, cirrhosis), kidney problems, neuroleptic malignant syndrome (NMS), enlarged prostate gland, seizures or epilepsy, or an adrenal gland tumor (pheochromocytoma)


• if you have asthma, lung infection, or other lung problems (eg, emphysema); increased pressure in the eyes; glaucoma; or if you are at risk for glaucoma


• if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome


• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer


• if you are regularly exposed to extreme heat or organophosphate insecticides


• if you have a history of alcohol abuse or if you consume more than 3 alcoholic drinks per day

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

• Lithium because the risk of a severe and sometimes permanent nervous system problem (encephalopathic syndrome) characterized by weakness, lethargy, fever, tremor, confusion, or uncontrolled muscle movements may be increased


• Certain antiarrhythmic medicines (eg, amiodarone, dofetilide, dronedarone, quinidine, sotalol), cisapride, pergolide, pimozide, quetiapine, or ziprasidone because the risk of side effects, such as racing heartbeat, dizziness, fainting, and life-threatening irregular heartbeat leading to unconsciousness, may be increased by Chlorpromazine Syrup


• Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Chlorpromazine Syrup, increasing the risk of side effects

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

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

• Take Chlorpromazine Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


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


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

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

Important safety information:

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


• Do not drink alcohol while you are using Chlorpromazine Syrup.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Chlorpromazine Syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Chlorpromazine Syrup may cause dizziness, light-headedness, 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.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


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


• Chlorpromazine Syrup 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.


• Some patients who take Chlorpromazine Syrup may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Chlorpromazine Syrup in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Chlorpromazine Syrup.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Chlorpromazine Syrup. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


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


• Chlorpromazine Syrup may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.


• Chlorpromazine Syrup may raise or lower 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. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you hungrier. If these symptoms occur, tell your doctor right away.


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


• Chlorpromazine Syrup may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.


• Chlorpromazine Syrup may interfere with certain lab tests, including phenylketonuria (PKU) tests. Be sure your doctor and lab personnel know you are taking Chlorpromazine Syrup.


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


• Use Chlorpromazine Syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, light-headedness (especially upon standing), rapid heartbeat, breathing problems, urinary retention, and constipation.


• Chlorpromazine Syrup should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Chlorpromazine Syrup while you are pregnant. Using Chlorpromazine Syrup during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Chlorpromazine Syrup is found in breast milk. Do not breast-feed while taking Chlorpromazine Syrup.

If you stop taking Chlorpromazine Syrup suddenly, you may have WITHDRAWAL symptoms. These may include nausea, vomiting, dizziness, and tremors.

Possible side effects of Chlorpromazine Syrup:

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:

Agitation; constipation; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose.

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); changes in menstrual period; changes in sexual ability; confusion; dark urine; difficulty swallowing; drooling; fainting; fast or irregular heartbeat; fever, chills, or sore throat; involuntary movements or spasms of the arms and legs, tongue, face, mouth, or jaw; mask-like face; muscle restlessness; prolonged or painful erection; restlessness; seizures; severe constipation; severe or persistent dizziness; shuffling walk; sleeplessness; stiff or rigid muscles; stomach pain; sweating; tremor; trouble urinating; unusual bruising or bleeding; unusual eye movements or inability to move your eyes; unusual mood or mental changes, including lack of response to your surroundings; unusual tiredness or weakness; unusually pale skin; vision changes; 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: Chlorpromazine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; fainting; involuntary movements or muscle spasms; irregular heartbeat; light-headedness; loss of consciousness; restlessness; seizures; severe drowsiness or dizziness; tremors; twitching.

Proper storage of Chlorpromazine Syrup:

Store Chlorpromazine Syrup at room temperature, below 77 degrees F (25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpromazine Syrup out of the reach of children and away from pets.

General information:

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


• Chlorpromazine Syrup 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.


• If using Chlorpromazine Syrup for an extended period of time, obtain refills before your supply runs out.


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

This information is a summary only. It does not contain all information about Chlorpromazine Syrup. 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 Chlorpromazine resources

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

Compare Chlorpromazine with other medications

• Hiccups
• Light Sedation
• Mania
• Nausea/Vomiting
• Opiate Withdrawal
• Porphyria
• Psychosis
• Schizophrenia
• Tetanus

Xgeva

Generic Name: denosumab (Subcutaneous route)

den-OSE-ue-mab

Commonly used brand name(s)

In the U.S.

• Prolia


• Xgeva

Available Dosage Forms:

• Solution

Pharmacologic Class: Monoclonal Antibody

Uses For Xgeva

Denosumab injection is used to treat osteoporosis (thinning of the bones) in women after menopause who have an increased risk for fractures. This medicine is used when women cannot use other medicines for osteoporosis or after other medicines did not work well.

Denosumab injection is also used to treat bone loss in men and women who are receiving treatments for prostate and breast cancers.

Denosumab injection is also used to prevent bone problems in patients with bone metastases (cancer that has spread) from certain types of tumors.

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

Before Using Xgeva

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

Use of denosumab injection is not recommended 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 denosumab injection in the elderly.

Pregnancy

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

Breast Feeding

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Anemia or


• Blood clotting problems or


• Cancer or


• Dental disease, history of or


• Dental implants, history of or


• Dentures that don't fit well or


• Gum disease or


• Hypoparathyroidism (underactive parathyroid gland), history of or


• Kidney problems, severe and may require dialysis or


• Malabsorption syndrome (trouble absorbing food), history of or


• Mouth surgery, history of or


• Parathyroid surgery, history of or


• Thyroid surgery, history of or


• Tooth extraction, history of—May cause side effects to become worse.

• Ear infection or


• Eczema or


• Endocarditis (heart infection) or


• Skin infections or


• Skin rashes or


• Stomach infection or


• Urinary tract infection—Use with caution. May make these conditions worse.

• Hypocalcemia (low calcium in the blood)—Prolia® should not be given in patients with this condition.

Proper Use of denosumab

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

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the upper arm, upper thigh, or stomach.

The needle cover of the prefilled Prolia® syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Prolia® is usually given once every 6 months, and Xgeva™ is usually given once every 4 weeks. Your doctor may also give you vitamin D and calcium supplements. Follow your doctor's instructions about how to take these medicines.

This medicine comes with a Medication Guide. Read the information carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using Xgeva

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

Prolia® contains denosumab which can also be found in Xgeva™. Patients using Prolia® should not receive Xgeva™.

This medicine may cause hypocalcemia (low calcium in the blood). A low blood calcium must be treated before you receive this medicine. Call your doctor right away if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.

Prolia® may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor right away if you have a fever or chills; red, swollen skin; severe abdominal or stomach pain; or burning or painful urination.

Skin problems may occur after receiving Prolia®. Check with your doctor right away if you have any of the following symptoms that do not go away or get worse: blistering, crusting, irritation, itching, or reddening of the skin; cracked, dry, or scaly skin; rash; or swollen skin.

It is important that you tell all of your doctors that you are using denosumab injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy surveillance program for patients receiving this medicine.

Xgeva 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

• Back pain


• blistering, crusting, irritation, itching, or reddening of the skin


• bloody or cloudy urine


• cracked, dry, or scaly skin


• difficult, burning, or painful urination


• frequent urge to urinate


• muscle or bone pain


• pain in the arms or legs


• rash


• skin rash, encrusted, scaly, and oozing


• swelling

Less common

• Abdominal or stomach cramps


• arm, back, or jaw pain


• bloating or swelling of the face, arms, hands, lower legs, or feet


• body aches or pain


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• congestion


• convulsions


• cough


• difficulty with breathing


• difficulty with moving


• dryness or soreness of the throat


• ear congestion


• fast or irregular heartbeat


• fever or chills


• headache


• hoarseness


• joint pain


• loss of voice


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle stiffness


• numbness and tingling around the mouth, fingertips, hands, or feet


• pain in the lower back, bottom, or hips


• pain in the upper leg


• painful blisters on the trunk of the body


• pale skin


• rapid weight gain


• runny or stuffy nose


• shortness of breath


• sneezing


• swollen joints


• tender, swollen glands in the neck


• tremor


• trouble with swallowing


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• voice changes


• wheezing

Rare

• Abdominal or stomach discomfort


• blood in the stool


• change in bowel habits


• clear or bloody discharge from the nipple


• constipation


• darkened urine


• difficulty with swallowing or eating


• dimpling of the breast skin


• indigestion


• inverted nipple


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• loss of appetite


• lower back or side pain


• lump in the breast or under the arm


• lump or swelling in the abdomen or stomach


• nausea


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


• persistent crusting or scaling of the nipple


• raised, firm, and bright red patches of the skin on the arm or leg


• redness or swelling of the breast


• sore on the skin of the breast that does not heal


• unexplained weight loss


• vomiting


• yellow eyes or skin

Incidence not known

• Heavy feeling in the jaw


• loose teeth


• pain, swelling, or numbness in the mouth or jaw

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

• Dizziness or lightheadedness


• excess air or gas in the stomach or intestines


• feeling of constant movement of self or surroundings


• full feeling


• heartburn


• lack or loss of strength


• passing gas


• redness, pain, itching, burning, swelling, or a lump under your skin where the shot was given


• sensation of spinning


• sleeplessness


• trouble sleeping


• unable to sleep


• upper abdominal or stomach pain

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: Xgeva side effects (in more detail)

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

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More Xgeva resources

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

• Xgeva Prescribing Information (FDA)


• Xgeva MedFacts Consumer Leaflet (Wolters Kluwer)


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• Denosumab MedFacts Consumer Leaflet (Wolters Kluwer)


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Coal Tar/Salicylic Acid/Sulfur Shampoo

Pronunciation: kole tar/SAL-i-SIL-ik AS-id/SUL-fur
Generic Name: Coal Tar/Salicylic Acid/Sulfur
Brand Name: Examples include Ala-Seb-T and Pazol XS

Coal Tar/Salicylic Acid/Sulfur Shampoo is used for:

Relieving itching, flaking, irritation, redness, and scaling caused by dandruff, seborrheic dermatitis, and psoriasis of the scalp. It may also be used for other conditions as determined by your doctor.

Coal Tar/Salicylic Acid/Sulfur Shampoo is a topical coal tar, salicylate, and sulfur combination. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.

Do NOT use Coal Tar/Salicylic Acid/Sulfur Shampoo if:

• you are allergic to any ingredient in Coal Tar/Salicylic Acid/Sulfur Shampoo


• you are using prescription medicine or other treatments for psoriasis (eg, ultraviolet radiation therapy), unless instructed by your doctor

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

Before using Coal Tar/Salicylic Acid/Sulfur Shampoo:

Some medical conditions may interact with Coal Tar/Salicylic Acid/Sulfur Shampoo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)


• if you have liver or kidney problems, a skin infection, skin irritation, eczema, diabetes, or poor blood circulation

Some MEDICINES MAY INTERACT with Coal Tar/Salicylic Acid/Sulfur Shampoo. Because little, if any, of Coal Tar/Salicylic Acid/Sulfur Shampoo is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Coal Tar/Salicylic Acid/Sulfur Shampoo 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 Coal Tar/Salicylic Acid/Sulfur Shampoo:

Use Coal Tar/Salicylic Acid/Sulfur Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.


• Wet hair, apply generously, and massage onto wet scalp. Leave lather on your scalp for a full 5 minutes. Rinse well and repeat. Be sure to wash your hands after each use.


• If you miss a dose of Coal Tar/Salicylic Acid/Sulfur Shampoo, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Coal Tar/Salicylic Acid/Sulfur Shampoo.

Important safety information:

• Coal Tar/Salicylic Acid/Sulfur Shampoo is for external use only. Avoid getting Coal Tar/Salicylic Acid/Sulfur Shampoo in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes. Do not inhale the vapors of Coal Tar/Salicylic Acid/Sulfur Shampoo.


• Coal Tar/Salicylic Acid/Sulfur Shampoo may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Overuse of topical products may worsen your condition. Do NOT use more than the recommended dose of Coal Tar/Salicylic Acid/Sulfur Shampoo. Do not use for longer than prescribed by your doctor or on the package label without checking with your doctor.


• If your condition does not get better after regular use of Coal Tar/Salicylic Acid/Sulfur Shampoo or if it gets worse, check with your doctor.


• Check with your doctor before use if you have a condition that covers a large area of the body.


• Be sure to apply Coal Tar/Salicylic Acid/Sulfur Shampoo only to the affected area and not to normal healthy skin.


• Do not use Coal Tar/Salicylic Acid/Sulfur Shampoo on skin that is irritated, infected, or reddened.


• Do not use Coal Tar/Salicylic Acid/Sulfur Shampoo on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair.


• Do not use any other medicines or drying products on your skin unless your doctor instructs you otherwise.


• Coal Tar/Salicylic Acid/Sulfur Shampoo may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Coal Tar/Salicylic Acid/Sulfur Shampoo. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Coal Tar/Salicylic Acid/Sulfur Shampoo contains a salicylate, which has been linked to Reye syndrome. Do not use Coal Tar/Salicylic Acid/Sulfur Shampoo on children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.


• Coal Tar/Salicylic Acid/Sulfur Shampoo should not be used in CHILDREN younger than 2 years old unless your doctor tells you otherwise.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Coal Tar/Salicylic Acid/Sulfur Shampoo during pregnancy. It is not known if Coal Tar/Salicylic Acid/Sulfur Shampoo is found in breast milk. Do not breast-feed while you are using Coal Tar/Salicylic Acid/Sulfur Shampoo.

Possible side effects of Coal Tar/Salicylic Acid/Sulfur Shampoo:

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:

Dry, peeling, red, or scaling skin.

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

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

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: Coal Tar/Salicylic Acid/Sulfur side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; diarrhea; dizziness; loss of appetite; loss of hearing; mental disturbances; nausea; rapid or difficult breathing; ringing in the ears; seizures; sluggishness; vomiting; yellowing of the skin or eyes.

Proper storage of Coal Tar/Salicylic Acid/Sulfur Shampoo:

Store Coal Tar/Salicylic Acid/Sulfur Shampoo at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Coal Tar/Salicylic Acid/Sulfur Shampoo out of the reach of children and away from pets.

General information:

• If you have any questions about Coal Tar/Salicylic Acid/Sulfur Shampoo, please talk with your doctor, pharmacist, or other health care provider.


• Coal Tar/Salicylic Acid/Sulfur Shampoo 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 Coal Tar/Salicylic Acid/Sulfur Shampoo. 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 Coal Tar/Salicylic Acid/Sulfur resources

• Coal Tar/Salicylic Acid/Sulfur Side Effects (in more detail)
• Coal Tar/Salicylic Acid/Sulfur Use in Pregnancy & Breastfeeding
• Coal Tar/Salicylic Acid/Sulfur Drug Interactions
• Coal Tar/Salicylic Acid/Sulfur Support Group
• 0 Reviews · Be the first to review/rate this drug

Cleocin Topical Solution

Generic Name: clindamycin phosphate

Dosage Form: topical solution
Cleocin T®

(clindamycin phosphate topical solution, USP)

(clindamycin phosphate topical gel)

(clindamycin phosphate topical lotion)

For External Use

Cleocin Topical Solution Description

CLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each CLEOCIN T Topical Solution pledget applicator contains approximately 1 mL of topical solution.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water.

The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water.

The structural formula is represented below:

The chemical name for clindamycin phosphate is Methyl 7 - chloro - 6,7,8 - trideoxy - 6 - (1 - methyl - trans - 4 - propyl - L - 2 - pyrrolidinecarboxamido) - 1 - thio - L - threo - α - D - galacto - octopyranoside 2-(dihydrogen phosphate).

Cleocin Topical Solution - Clinical Pharmacology

Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Cross resistance has been demonstrated between clindamycin and lincomycin.

Antagonism has been demonstrated between clindamycin and erythromycin.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of CLEOCIN T Topical Solution for 4 weeks was 597 mcg/g of comedonal material (range 0–1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

Indications and Usage for Cleocin Topical Solution

CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS.)

Contraindications

CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Warnings

Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Precautions

General

CLEOCIN T Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.

CLEOCIN T should be prescribed with caution in atopic individuals.

Drug Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.

Pregnancy

Teratogenic effects—Pregnancy Categoty B

Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether clindamycin is excreted in human milk following use of CLEOCIN T. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatric Use

Clinical studies for Cleocin T did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Adverse Reactions

In 18 clinical studies of various formulations of CLEOCIN T using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].

Number of Patients Reporting Events

Treatment     Emergent Adverse Event	Solution n=553(%)		Gel n=148(%)		Lotion n=160(%)
# not recorded
* of 126 subjects
Burning	62	(11)	15	(10)	17	(11)
Itching	36	( 7)	15	(10)	17	(11)
Burning/Itching	60	(11)	#	( – )	#	( – )
Dryness	105	(19)	34	(23)	29	(18)
Erythema	86	(16)	10	( 7)	22	(14)
Oiliness/Oily Skin	8	( 1)	26	(18)	12*	(10)
Peeling	61	(11)	#	( – )	11	( 7)

Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.

Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS).

Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.

Overdosage

Topically applied CLEOCIN T can be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

Cleocin Topical Solution Dosage and Administration

Apply a thin film of CLEOCIN T Topical Solution, CLEOCIN T Topical Lotion, CLEOCIN T Topical Gel, or use a CLEOCIN T Topical Solution pledget for the application of CLEOCIN T twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded.

Lotion: Shake well immediately before using.

Pledget: Remove pledget from foil just before use. Do not use if the seal is broken. Discard after single use.

Keep all liquid dosage forms in containers tightly closed.

How is Cleocin Topical Solution Supplied

CLEOCIN T Topical Solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:

30 mL applicator bottle — NDC 0009-3116-01

60 mL applicator bottle — NDC 0009-3116-02

Carton of 60 single-use pledget applicators — NDC 0009-3116-14

CLEOCIN T Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

60 gram tube — NDC 0009-3331-01

30 gram tube — NDC 0009-3331-02

CLEOCIN T Topical Lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size:

60 mL plastic squeeze bottle — NDC 0009-3329-01

Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Protect from freezing.

Rx Only

LAB-0042-3.0

November 2005

PRINCIPAL DISPLAY PANEL - 1% Pledget Label

NDC 0009-3116-14

1 Pledget

Rx only

Cleocin T®

clindamycin phosphate

topical solution, USP

Pledget for topical use only

1%*

Pfizer

Distributed by

Pharmacia & Upjohn Co

Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 0009-3329-01

60 mL

Rx only

Cleocin T®

clindamycin phosphate

topical lotion

For topical use only

1%*

Pfizer

Distributed by

Pharmacia & Upjohn Co

Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 60 gram Tube

NDC 0009-3331-01

60 gram

Rx only

Cleocin T®

clindamycin phosphate topical gel

For topical use only

1%*

Store at controlled room temperature 20° to 25°C (68° to 77°F)

[see USP]. Protect from freezing.

For external use only. Avoid contact with eyes.

See crimp of tube for Expiration Date and Lot Number.

DOSAGE AND USE: See accompanying prescribing information.

* Each gram contains clindamycin phosphate equivalent to 10 mg

(1%) of clindamycin. Also contains allantoin, carbomer 934P,

methylparaben, polyethylene glycol 400, propylene glycol, sodium

hydroxide, and purified water.

Pfizer

Distributed by

Pharmacia & Upjohn Co

Division of Pfizer Inc, NY, NY 10017

CLEOCIN T  clindamycin phosphate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-3116 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin phosphate (clindamycin) clindamycin phosphate 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength isopropyl alcohol   propylene glycol   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3116-01 30 mL In 1 BOTTLE None 2 0009-3116-02 60 mL In 1 BOTTLE None 3 0009-3116-14 60 mL In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050537	06/20/1980

CLEOCIN T  clindamycin phosphate  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-3329 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin phosphate (clindamycin) clindamycin phosphate 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength cetostearyl alcohol   glycerin   isostearyl alcohol   methylparaben   sodium lauroyl sarcosinate   stearic acid   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3329-01 60 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050600	05/31/1989

CLEOCIN T  clindamycin phosphate  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-3331 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin phosphate (clindamycin) clindamycin phosphate 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength allantoin   carbomer 934P   methylparaben   polyethylene glycol 400   propylene glycol   sodium hydroxide   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3331-01 60 g In 1 TUBE None 2 0009-3331-02 30 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050615	01/07/1987

Labeler - Pharmacia and Upjohn Company (829076566)

Establishment
Name	Address	ID/FEI	Operations
Chongqing Carelife Pharmaceutical Co., Ltd		531132009	API MANUFACTURE, MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Pfizer Pharmaceuticals LLC		829084545	MANUFACTURE

Revised: 03/2010Pharmacia and Upjohn Company

More Cleocin Topical Solution resources

• Cleocin Topical Solution Use in Pregnancy & Breastfeeding
• Cleocin Topical Solution Drug Interactions
• Cleocin Topical Solution Support Group
• 20 Reviews for Cleocin Topical - Add your own review/rating

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Carbodex DM Elixir

Pronunciation: brome-fen-IR-a-meen/dex-troe-meth-OR-fan/sue-do-eh-FED-rin
Generic Name: Brompheniramine/Dextromethorphan/Pseudoephedrine
Brand Name: Examples include Bromfed DM and Carbodex DM

Carbodex DM Elixir is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Carbodex DM Elixir is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Carbodex DM Elixir if:

• you are allergic to any ingredient in Carbodex DM Elixir


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Carbodex DM Elixir:

Some medical conditions may interact with Carbodex DM Elixir. 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 fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

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

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Carbodex DM Elixir's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Carbodex DM Elixir


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Carbodex DM Elixir

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

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

• Take Carbodex DM Elixir by mouth with or without food.


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


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

Ask your health care provider any questions you may have about how to use Carbodex DM Elixir.

Important safety information:

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


• Do not take diet or appetite control medicines while you are taking Carbodex DM Elixir without checking with you doctor.


• Carbodex DM Elixir has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


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


• If you are scheduled for allergy skin testing, do not take Carbodex DM Elixir for several days before the test because it may decrease your response to the skin tests.


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


• Use Carbodex DM Elixir with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Carbodex DM Elixir in CHILDREN; they may be more sensitive to its effects.


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

Possible side effects of Carbodex DM Elixir:

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; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Carbodex DM Elixir:

Store Carbodex DM Elixir 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 Carbodex DM Elixir out of the reach of children and away from pets.

General information:

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


• Carbodex DM Elixir 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 Carbodex DM Elixir. 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 Carbodex DM resources

• Carbodex DM Use in Pregnancy & Breastfeeding
• Carbodex DM Drug Interactions
• 0 Reviews for Carbodex DM - Add your own review/rating

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• Cough and Nasal Congestion

Clemastine and phenylpropanolamine

Generic Name: clemastine and phenylpropanolamine (KLEM as teen/fen ill proe pa NOLE a meen)

Brand Names: Allerhist-D, Dayhist-D, Tavist-D

What is clemastine and phenylpropanolamine?

Clemastine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Clemastine 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 and respiratory (breathing) passages to open up.

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

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.

Clemastine 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 clemastine 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. Clemastine 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 clemastine 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 clemastine and phenylpropanolamine?

Do not take clemastine 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, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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

Clemastine 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 clemastine 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. Clemastine and phenylpropanolamine is not approved for use by children younger than 12 years of age.

How should I take clemastine and phenylpropanolamine?

Take clemastine 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 tablets. Swallow them whole. They are specially formulated to release slowly over 12 hours. Do not take more than one tablet every 12 hours. If one tablet per day controls your symptoms, use that dosage. Never take more than two tablets in 1 day. Taking too much of this medication could cause severe dizziness, insomnia, and nervousness.

Do not take clemastine 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 clemastine and phenylpropanolamine at room temperature away from moisture and heat.

See also: Clemastine and phenylpropanolamine dosage (in more detail)

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 clemastine and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking clemastine and phenylpropanolamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine 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 clemastine and phenylpropanolamine.

Clemastine and phenylpropanolamine side effects

Serious side effects are unlikely to occur. Stop taking clemastine 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 clemastine 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.

Clemastine and phenylpropanolamine Dosing Information

Usual Adult Dose for Cold Symptoms:

1 tablet orally twice a day as needed.
This dosage should not be exceeded.

What other drugs will affect clemastine and phenylpropanolamine?

Do not take clemastine 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 clemastine and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain clemastine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Clemastine 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 clemastine and phenylpropanolamine is taken with any of these medications.

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

More clemastine and phenylpropanolamine resources

• Clemastine and phenylpropanolamine Dosage
• Clemastine and phenylpropanolamine Use in Pregnancy & Breastfeeding
• Clemastine and phenylpropanolamine Drug Interactions
• Clemastine and phenylpropanolamine Support Group
• 0 Reviews for Clemastine and phenylpropanolamine - Add your own review/rating

Compare clemastine and phenylpropanolamine with other medications

• Cold Symptoms

Where can I get more information?

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

What does my medication look like?

Clemastine and phenylpropanolamine is available with a prescription under the brand name Tavist-D. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Tavist-D 1 mg of clemastine and 75 mg of phenylpropanolamine-- round, white tablets