Ambifed CD

Pronunciation: KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Codeine/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Ambifed CD and Maxifed-G CDX

Ambifed CD is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ambifed CD is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use Ambifed CD if:

• you are allergic to any ingredient in Ambifed CD or any other codeine- or morphine-related medicine (eg, oxycodone)


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you are having an asthma attack


• you are taking 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 Ambifed CD:

Some medical conditions may interact with Ambifed CD. 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 morphine, codeine, or any other opiate (eg, dihydrocodeine, hydrocodone, oxycodone)


• if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems


• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery


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


• if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions


• if you are taking medicine for high blood pressure or depression

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

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


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine ), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Ambifed CD's side effects


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Ambifed CD's effectiveness


• Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Ambifed CD


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Ambifed CD

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

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

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


• Drink plenty of water while taking Ambifed CD.


• If you miss a dose of Ambifed CD, 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 Ambifed CD.

Important safety information:

• Ambifed CD may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ambifed CD 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 Ambifed CD; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Ambifed CD 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.


• Do not take diet or appetite control medicines while you are taking Ambifed CD without checking with your doctor.


• Ambifed CD 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 days, if they get worse, or if they go away and then come back, check with your doctor.


• If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.


• Do not use Ambifed CD for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


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


• Ambifed CD may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ambifed CD.


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


• Use Ambifed CD with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Ambifed CD in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Ambifed CD should not be used in CHILDREN younger than 6 years 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 Ambifed CD while you are pregnant. Ambifed CD is found in breast milk. Do not breast-feed while taking Ambifed CD.

Possible side effects of Ambifed CD:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; 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); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

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: Ambifed CD 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Ambifed CD:

Store Ambifed CD 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 Ambifed CD out of the reach of children and away from pets.

General information:

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


• Ambifed CD 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 Ambifed CD. 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 Ambifed CD resources

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

• Ambifed CD Concise Consumer Information (Cerner Multum)


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Sitagliptin/Simvastatin

Pronunciation: SYE-ta-GLIP-tin /SIM-va-STAT-in
Generic Name: Sitagliptin/Simvastatin
Brand Name: Juvisync

Sitagliptin/Simvastatin is used for:

Treating type 2 diabetes and lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with diet and exercise. It is used in certain patients to reduce the risk of heart attack, stroke, and death due to coronary heart disease. It is also used to reduce the need for medical procedures to open blocked blood vessels. It may also be used for other conditions as determined by your doctor.

Sitagliptin/Simvastatin is a dipeptidyl peptidase-4 (DPP-4) inhibitor and HMG-CoA reductase inhibitor (statin) combination. The DPP-4 inhibitor works by increasing the amount of insulin released by your body and decreasing the amount of sugar made by your body. The statin works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Sitagliptin/Simvastatin if:

• you are pregnant, may become pregnant, or are breast-feeding


• you are allergic to any ingredient in Sitagliptin/Simvastatin


• you have type 1 diabetes


• you have high blood or urine ketone levels (diabetic ketoacidosis)


• you have moderate or severe kidney problems


• you have liver problems or unexplained abnormal liver function tests


• you take cyclosporine, danazol, gemfibrozil, a hepatitis C virus (HCV) protease inhibitor (eg, boceprevir, telaprevir), an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, certain macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, posaconazole, or telithromycin


• you take or have taken conivaptan within the past 7 days

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

Before using Sitagliptin/Simvastatin:

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

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


• if you are able to become pregnant


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


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


• if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, saxagliptin)


• if you have low blood pressure, kidney problems, low thyroid function, muscle problems or a family history of muscle problems, or serious metabolism, hormonal, or electrolyte problems


• if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse


• if you have a history of inflammation of the pancreas (pancreatitis) or stones in your gallbladder (gallstones)


• if you are scheduled for major surgery, have recently had major surgery or a serious injury, or if you have a serious infection


• if you have had an organ transplant and are taking medicine to suppress a rejection reaction

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

• Amiodarone, amlodipine, azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), colchicine, conivaptan, cyclosporine, danazol, daptomycin, delavirdine, diltiazem, dronedarone, fibrates (eg, gemfibrozil, clofibrate, fenofibrate), fusidic acid, HCV protease inhibitors (eg, boceprevir, telaprevir), HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, niacin, ranolazine, risperidone, streptogramins (eg, dalfopristin, quinupristin), telithromycin, or verapamil because they may increase the risk of muscle or kidney problems


• Rosiglitazone because the risk of swelling of the hands, legs, or feet may be increased


• Insulin or sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased


• Bosentan, carbamazepine, efavirenz, rifamycins (eg, rifampin), or St. John's wort because they may decrease Sitagliptin/Simvastatin's effectiveness


• Anticoagulants (eg, warfarin), digoxin, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Sitagliptin/Simvastatin

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

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

• Sitagliptin/Simvastatin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sitagliptin/Simvastatin refilled.


• Take Sitagliptin/Simvastatin by mouth with or without food in the evening, unless directed otherwise by your doctor.


• Swallow Sitagliptin/Simvastatin whole. Do not break, crush, or chew before swallowing.


• Eating grapefruit or drinking grapefruit juice may increase the amount of Sitagliptin/Simvastatin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Sitagliptin/Simvastatin.


• Take Sitagliptin/Simvastatin on a regular schedule to get the most benefit from it.


• Continue to take Sitagliptin/Simvastatin even if you feel well. Do not miss any doses.


• If you miss a dose of Sitagliptin/Simvastatin, 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 Sitagliptin/Simvastatin.

Important safety information:

• Sitagliptin/Simvastatin may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking Sitagliptin/Simvastatin. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Sitagliptin/Simvastatin, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Sitagliptin/Simvastatin. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).


• Carry an ID card at all times that says you have diabetes.


• Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Sitagliptin/Simvastatin.


• Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Sitagliptin/Simvastatin exactly as prescribed, tell your doctor.


• It may be harder to control your blood sugar during times of stress, such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.


• Tell your doctor or dentist that you take Sitagliptin/Simvastatin before you receive any medical or dental care, emergency care, or surgery. Sitagliptin/Simvastatin may need to be stopped for a few days before certain types of surgery.


• Do NOT take more than the recommended dose without checking with your doctor.


• Muscle problems (myopathy) may occur with Sitagliptin/Simvastatin. The risk of muscle problems may be greater in people who take higher doses of Sitagliptin/Simvastatin, in people older than 64 years old, in women, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort.


• Sitagliptin/Simvastatin usually does not cause low blood sugar. However, low blood sugar may occur when it is used along with certain other medicines for diabetes (eg, insulin, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Severe and sometimes fatal inflammation of the pancreas has been reported in patients taking Sitagliptin/Simvastatin. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe stomach or back pain with or without nausea or vomiting.


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


• Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.


• Lab tests, including blood cholesterol levels, blood glucose, hemoglobin A_1c, liver and kidney function, and creatine phosphokinase (CPK) blood levels, may be performed while you use Sitagliptin/Simvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sitagliptin/Simvastatin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.


• Sitagliptin/Simvastatin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.


• Women who are able to become pregnant should use effective birth control while taking Sitagliptin/Simvastatin. Check with your doctor if you have questions about using birth control.


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

Possible side effects of Sitagliptin/Simvastatin:

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; headache; mild stomach pain; nausea; runny or stuffy nose; sore throat; upper respiratory tract infection.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; dark or red-colored urine; decreased sexual ability; depression; dizziness; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; joint pain; memory problems; muscle pain, tenderness, or weakness (with or without fever and fatigue); red, swollen, blistered, or peeling skin; shortness of breath; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vomiting.

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.

Proper storage of Sitagliptin/Simvastatin:

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

General information:

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


• Sitagliptin/Simvastatin 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 Sitagliptin/Simvastatin. 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 Sitagliptin/Simvastatin resources

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

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Zyclara

Generic Name: imiquimod topical (i MI kwi mod TOP ik al)

Brand Names: Aldara, Zyclara

What is imiquimod topical?

Imiquimod is an immune response modifier. Imiquimod topical is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Imiquimod topical (for the skin) is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Imiquimod topical also treats genital warts that appear on the outside of the body, but this medicine is not a cure for genital warts. Imiquimod may be used in adults and children who are at least 12 years.

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

What is the most important information I should know about imiquimod topical?

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions. Follow your doctor's instructions.

Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical.

Before using this medication, tell your doctor if you have a weak immune system, an autoimmune disorder, graft-versus-host disease, or if you have recently received a bone marrow transplant or cord blood transplant.

When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination. Avoid exposure to sunlight or tanning beds. Imiquimod topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Imiquimod topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with imiquimod topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

Imiquimod will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

If you are treating the genital or rectal area with imiquimod topical, avoid sexual activity while the medicine is on your skin. Imiquimod topical can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm for birth control, these items could break if the rubber weakens and an unplanned pregnancy could result.

What should I discuss with my healthcare provider before using imiquimod topical?

To make sure you can safely take imiquimod topical, tell your doctor if you have any of these other conditions:

• 
  

  sunburn or other skin problems;

  
  


• 
  

  a weak immune system or autoimmune disorder;

  
  


• 
  

  graft-versus-host disease;

  
  


• 
  

  if you have recently been treated for actinic keratosis or genital warts with surgery or other medications; or

  
  


• 
  

  if you have recently received a bone marrow transplant or cord blood transplant.

  
  

FDA pregnancy category C. It is not known whether imiquimod topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. If you are treating the genital or rectal area with imiquimod topical, avoid sexual activity while the medicine is on your skin. Imiquimod topical can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm, these items could break if the rubber weakens, and an unplanned pregnancy could result. It is not known whether imiquimod topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 12 years old. Imiquimod topical is for use in treating genital warts in patients who are at least 12 years old. All other uses of this medication are for adults over 18 only.

How should I apply imiquimod topical?

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

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.

Before applying imiquimod topical, wash your hands and wash the skin area to be treated. Allow the skin to dry for at least 10 minutes before applying the medicine. Always wash your hands after applying the medicine also. Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical.

Imiquimod topical is normally used 2 to 5 times per week for up to 16 weeks. How you use this medication will depend on the condition you are treating. Follow your doctor's instructions.

Actinic keratosis:

Aldara is usually applied 2 times per week (such as Monday and Thursday, or Tuesday and Friday) for a full 16 weeks. Zyclara is applied once daily for 2 weeks followed by 2 weeks without treatment. Apply the cream to the treatment area in a thin layer, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Superficial basal cell carcinoma:

Usually applied 5 times per week (such as Monday through Friday) for a full 6 weeks. Apply the cream from one imiquimod topical packet to the treatment area and the border of skin around it, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Genital warts:

Usually applied 3 times per week (such as Monday, Wednesday, and Friday) for no longer than 16 weeks. Apply the cream from one imiquimod topical packet to the treatment area, and rub in the cream until it disappears. Do not cover the treated skin areas with any type of plastic bandaging, and avoid nylon underwear. You may wear cotton gauze or underwear over the treated area. Use the medicine before going to bed and leave it on for 6 to 10 hours. Then wash off the medicine with water and a mild soap.

When treating genital warts under the foreskin of an uncircumcised penis, pull back the foreskin and wash it with mild soap and water before applying imiquimod topical. Clean this area daily during treatment. When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination.

Imiquimod topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with imiquimod topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

All conditions:

Your doctor will need to check your skin on a regular basis, especially if you have a more severe skin reaction to the medication. Do not miss any scheduled appointments.

Call your doctor if your skin condition does not improve or if it gets worse during treatment.

Do not use imiquimod topical to treat any skin condition that has not been checked by a doctor. Do not share this medication with anyone else, even if they have the same symptoms you have.

Each packet of imiquimod topical is for a single application only. Throw away the packet after one use, even if there is medicine left in it. If you treat more than one skin area at a time, ask your doctor how many packets to use.

Store at room temperature away from moisture and heat. Do not freeze. Keep each packet unopened until you are ready to use it.

What happens if I miss a dose?

Skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.

What should I avoid while using imiquimod topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. Do not place the cream in your rectum, vagina, or urethra. If it does get into any of these areas, rinse with water. Do not use imiquimod topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with imiquimod topical unless you doctor tells you to.

Avoid exposure to sunlight or tanning beds. Imiquimod topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid having unprotected sex. Imiquimod is not a cure for genital warts, and it will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safe ways to prevent transmission during sex.

Imiquimod 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. Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied. Stop using imiquimod topical and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands. When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using imiquimod topical and call your doctor right away.

Less serious side effects may include:

• 
  

  mild skin irritation, itching, dryness, flaking, scabbing, crusting, redness, or hardening of the skin where the medicine was applied;

  
  


• 
  

  changes in the color of treated skin;

  
  


• 
  

  headache, dizziness, chest pain, back pain;

  
  


• 
  

  cold sores, fever blisters;

  
  


• 
  

  cold symptoms such as stuffy nose, sneezing, sore throat;

  
  


• 
  

  nausea, diarrhea, loss of appetite; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 imiquimod topical?

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

More Zyclara resources

• Zyclara Side Effects (in more detail)
• Zyclara Use in Pregnancy & Breastfeeding
• Zyclara Support Group
• 10 Reviews for Zyclara - Add your own review/rating

• Zyclara Prescribing Information (FDA)


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


• Zyclara Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Zyclara Consumer Overview


• Aldara Prescribing Information (FDA)


• Aldara Monograph (AHFS DI)


• Aldara MedFacts Consumer Leaflet (Wolters Kluwer)


• Aldara Consumer Overview

Compare Zyclara with other medications

• Actinic Keratosis
• Condylomata Acuminata

Where can I get more information?

• Your pharmacist can provide more information about imiquimod topical.

See also: Zyclara side effects (in more detail)

Phenergan Tablets

Pronunciation: proe-METH-a-zeen
Generic Name: Promethazine
Brand Name: Phenergan

Phenergan should not be used in children younger than 2 years old. Potentially fatal side effects (eg, difficult or slowed breathing, drowsiness leading to coma) may occur in this age group when taking Phenergan.

Caution should be used when using Phenergan in children 2 years old and older. The lowest possible dose should be used in this age group, and it should not be used with other medicines that cause slowed breathing.

Phenergan is used for:

Relieving allergy symptoms, including hives or runny nose. It is used to prevent and control nausea and vomiting during and after surgery. It is also used to help produce light sleep; prevent and treat motion sickness; or treat pain after surgery, in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Phenergan is a phenothiazine antihistamine. It works by blocking the sites where histamine acts.

Do NOT use Phenergan if:

• you are allergic to any ingredient in Phenergan


• you have severe central nervous system depression or are in a coma


• you are also taking astemizole, cisapride, terfenadine, or tramadol

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

Before using Phenergan:

Some medical conditions may interact with Phenergan. 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 nervous system problems, bone marrow depression, heart problems, a blood disease, glaucoma, increased eye pressure, low blood pressure, liver problems, prostate problems, Parkinson disease, seizures, or Reye syndrome


• if you regularly consume large amounts of alcohol

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

• Charcoal or lithium because they may decrease Phenergan's effectiveness


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), astemizole, cisapride, general anesthetics (eg, thiopental), methyldopa, terfenadine, or tramadol because side effects, such as low blood pressure and seizures, may occur


• ACE inhibitors (eg, enalapril), haloperidol, lithium, meperidine, metrizamide, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), naltrexone, polypeptide antibiotics (eg, actinomycin), or trazodone because the risk of their side effects may be increased by Phenergan


• Bromocriptine, epinephrine, levodopa, or pergolide because their effectiveness may be decreased by Phenergan

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

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

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


• If you are using Phenergan for motion sickness, take a dose at least 30 to 60 minutes before you begin traveling.


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

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

Important safety information:

• Phenergan may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Phenergan 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 Phenergan; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Phenergan. 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.


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


• Use Phenergan with extreme caution in the ELDERLY; they may be more sensitive to its effects.


• Phenergan should not be used in CHILDREN younger than 2 years old. Serious, and sometimes fatal, side effects (difficult or slowed breathing, drowsiness leading to coma) have occurred when Phenergan has been used in children in this age group.


• Phenergan should be used with extreme caution in CHILDREN 2 years old or older. The lowest effective dose should be used in children 2 years old or older.


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

Possible side effects of Phenergan:

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:

Blurred vision; dizziness; drowsiness; dry mouth; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; excessive sweating; fainting; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, delirium, exaggerated sense of well-being, excitability, hysteria, nervousness); seizures; severe of persistent dizziness; shortness of breath or trouble breathing; slow or fast heartbeat; tremor; trouble sleeping; uncontrolled muscle movements; unusual brusing or bleeding; yellowing of 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: Phenergan 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 convulsions; dry mouth; flushing; hallucinations; loss of consciousness; nightmares; seizures; shortness of breath; trouble breathing; unusual drowsiness or restlessness.

Proper storage of Phenergan:

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

General information:

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


• Phenergan 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 Phenergan. 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 Phenergan resources

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

Compare Phenergan with other medications

• Allergic Reactions
• Anaphylaxis
• Hay Fever
• Light Sedation
• Motion Sickness
• Nausea/Vomiting
• Opiate Adjunct
• Sedation
• Urticaria
• Vertigo

Aquadrate 10% w / w Cream

1. Name Of The Medicinal Product

Aquadrate 10% w/w Cream

2. Qualitative And Quantitative Composition

Aquadrate contains urea Ph Eur 10% w/w.

3. Pharmaceutical Form

A smooth, unperfumed, non greasy, off white cream for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of ichthyosis and hyperkeratotic skin conditions associated with atopic eczema, xeroderma, iasteatosis and other chronic dry skin conditions.

4.2 Posology And Method Of Administration

Aquadrate is applied topically. Wash affected areas well, rinse off all traces of soap, dry, and apply sparingly twice daily. Occlusive dressings may be used but are usually unnecessary because of the self-occlusive nature of the cream.

4.3 Contraindications

Known hypersensitivity to the product.

4.4 Special Warnings And Precautions For Use

Avoid application to moist or broken skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Aquadrate may increase the penetration through the skin barrier of other topically applied medicaments.

4.6 Pregnancy And Lactation

Animal reproduction studies have not been conducted with Aquadrate. Aquadrate should only be used if the anticipated benefits outweigh the risks.

4.7 Effects On Ability To Drive And Use Machines

Aquadrate does not interfere with the ability to drive or use machines.

4.8 Undesirable Effects

May produce local irritations (including erythema, burning or pruritus) and oedema when applied to sensitive, moist or fissured skin.

4.9 Overdose

Topical applications of excessive amounts of Aquadrate might cause skin irritation but no other effects would be expected. Ingestion of a large amount of Aquadrate would be expected to result in gastrointestinal irritation (nausea and vomiting). Symptomatic and supportive care should be given. Liberal oral administration of milk or water may be helpful.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Urea has a therapeutic effect in chronic dry skin conditions through its hydrating, keratolytic and anti-pruritic properties.

5.2 Pharmacokinetic Properties

There is no information available on the pharmacokinetics of urea.

6. Pharmaceutical Particulars

6.1 List Of Excipients

The cream also contains white soft paraffin, maize starch, isopropyl myristate, syncrowax HR-C, palmitic acid, sorbitan laurate and arlatone G.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Store below 30°C.

6.5 Nature And Contents Of Container

Aquadrate is available in tubes of 30g and 100g.

6.6 Special Precautions For Disposal And Other Handling

A patient leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL 16853/0061

9. Date Of First Authorisation/Renewal Of The Authorisation

10 September 1991

10. Date Of Revision Of The Text

5^th December 2008

Scholl Athlete's Foot Spray Liquid

1. Name Of The Medicinal Product

Scholl Athlete's Foot Spray Liquid.

2. Qualitative And Quantitative Composition

Tolnaftate 0.068% w/w (to deliver 1% to the skin).

3. Pharmaceutical Form

Topical spray.

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention and treatment of Athlete's Foot.

4.2 Posology And Method Of Administration

Adults and children: For best results, the feet should be washed and dried before use. Shake can before use. Point nozzle towards the affected area, holding it 10-15cm away. Spray liberally over the affected area. Recommended dose: Twice daily; in the morning and at night. Treatment should continue for up to two weeks after the symptoms disappear. No distinction is made between the different categories of patient.

4.3 Contraindications

Not recommended for nail or scalp infections.

4.4 Special Warnings And Precautions For Use

For external use only. Keep out of eyes. If symptoms do not improve within 10 days, discontinue use and consult your doctor. Keep out of the reach of children. Flammable, pressurised container. Protect from direct sunlight and do not expose to temperatures exceeding 50^oC. Do not spray on naked flame or incandescent material. Do not pierce or burn even after use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

No known restrictions.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Antifungal.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Butylated Hydroxytoluene BP; Polyethylene – propylene glycol monobutyl ether; Ethanol BP; Butane.

6.2 Incompatibilities

Not relevant.

6.3 Shelf Life

Four years (48 months).

6.4 Special Precautions For Storage

Keep out of reach of children. Flammable, pressurised container. Protect from direct sunlight and do not expose to temperatures exceeding 50^oC.

6.5 Nature And Contents Of Container

Tin plate aerosol can, epoxy coated internally with valve assembly and overcap. 150ml.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Scholl Consumer Products Limited, Venus, 1 Old Park Lane, Trafford Park, Manchester

M41 7HA

8. Marketing Authorisation Number(S)

PL 0587/0008.

9. Date Of First Authorisation/Renewal Of The Authorisation

24^th April 1985/30^th June 2004

10. Date Of Revision Of The Text

June 2006

AccuHist PDX Drops

Pronunciation: KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan/FEN-il-EF-rin
Generic Name: Chlorpheniramine/Dextromethorphan/Phenylephrine
Brand Name: Examples include AccuHist PDX Drops, Bronkids, and Sonahist DM Pediatric Drops

AccuHist PDX Drops is used for:

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

AccuHist PDX Drops is a decongestant, antihistamine, and cough suppressant combination. The decongestant 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. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use AccuHist PDX Drops if:

• you are allergic to any ingredient in AccuHist PDX Drops


• 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 are taking droxidopa, sodium oxybate (GHB), or 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 AccuHist PDX Drops:

Some medical conditions may interact with AccuHist PDX Drops. 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 adrenal gland problems (eg, an adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems


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


• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; an enlarged prostate or other prostate problems; or trouble urinating

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

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


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of AccuHist PDX Drops's side effects


• Barbiturates (eg, phenobarbital), bromocriptine, or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by AccuHist PDX Drops


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by AccuHist PDX Drops

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

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

• Take AccuHist PDX Drops by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use the dropper that comes with AccuHist PDX Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


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

Ask your health care provider any questions you may have about how to use AccuHist PDX Drops.

Important safety information:

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


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


• Do not take diet or appetite control medicines while you are taking AccuHist PDX Drops without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use AccuHist PDX Drops for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT exceed the recommended dose or take AccuHist PDX Drops for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days, if they get worse, if they are accompanied by fever, or if your cough is accompanied by rash or persistent headache, check with your doctor.


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


• AccuHist PDX Drops may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking AccuHist PDX Drops for a few days before the tests.


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


• Use AccuHist PDX Drops with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, nervousness, sleeplessness, and trouble urinating.


• Caution is advised when using AccuHist PDX Drops in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Different brands of AccuHist PDX Drops may have different dosing instructions for CHILDREN. They may also be indicated for different age ranges of children. Follow the dosing instructions that your doctor has given you. If you are unsure of the dose to give to your child or if you are unsure if AccuHist PDX Drops is appropriate for your child, check with your doctor or pharmacist.


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

Possible side effects of AccuHist PDX Drops:

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:

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; excitability; headache; heartburn; loss of appetite; nausea; nervousness; 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; increased urination; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

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: AccuHist PDX 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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include blurred vision; confusion; decreased coordination; excitability; fever; flushing; hallucinations; mental or mood changes; muscle spasms; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of AccuHist PDX Drops:

Store AccuHist PDX Drops between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep AccuHist PDX Drops out of the reach of children and away from pets.

General information:

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


• AccuHist PDX Drops 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 AccuHist PDX Drops. 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 AccuHist PDX resources

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

Compare AccuHist PDX with other medications

• Cough and Nasal Congestion

Sulfadimethoxine

Generic Name: Sulfadimethoxine powder

Dosage Form: FOR ANIMAL USE ONLY
Durvet Sulfadimethoxine Soluble Powder (Sulfadimethoxine) ANADA 200-376, Approved by FDA

Species:                                                   Concentration:                                          Use Directions:

Chickens                                                   0.05%                                                     Contents of packet to 50 gallons of water.

Turkeys                                                     0.025%                                                   Contents of packet to 100 gallons of water.

If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis.  Prepare a fresh stock solution daily.  Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water.  Administer as sole source of drinking water and sulfonamide medication.

Automatic Proportioners:  To make stock solution, add contents of 5 packets to 2 gallons of water for chickens and to 4 gallons of water for turkeys.  Set proportioner to feed at a rate of 1 fl oz of stock solution per gallon of water.

TREATMENT PERIOD - 6 CONSECUTIVE DAYS

Dairy Calves, Dairy Heifers and Beef Cattle

Dosage:  25 mg/lb first day followed by 12.5 mg/lb/day for 4 days.

Sulfadimethoxine in Water

                                                                                                                                              Water Consumption

                                    Amount of Stock Solution for Cattle*                                                     Summer:  1 gallon/**100lb body weight                        Winter:  1gallon/**150lb body weight

First Day Add:               1 quart                                                                                                10 gallons                                                                  7 gallons

                                    2 quarts                                                                                              20 gallons                                                                 14 gallons

                                    1 gallon                                                                                               40 gallons                                                                 28 gallons

Next 4 Days Add:          1 quart                                                                                                20 gallons                                                                  14 gallons

                                    2 quarts                                                                                              40 gallons                                                                  28 gallons

                                    1 gallon                                                                                               80 gallons                                                                  56 gallons

NOTE:  Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gallon of water.

**This dosage recommendation is based on a water consumption rate of 1 gallon per 100lb of body weight per day, the expected water consumption rate for summer.  Water consumption during cold months (winter) may drop markedly (30-40%).  Accordingly, adjustments must be made in the dilution rates to compensate for this and unsure proper drug intake.

For treatment of individual cattle, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench.

Twenty fl.oz. of cattle stock solution will medicate one-600lb animal initially or two-600lb animals on a maintenance dose.  Contents of packet will medicate six-600lb animals initially or twelve-600lb animals on a maintenance dose.

During treatment period, make certain that animals maintain adequate water intake.

If animals show no improvement within 2 or 3 days, re-evaluate diagnosis.  Treatment should not be continued beyond 5 days.

RESIDUE WARNINGS:  CHICKENS AND TURKEYS - Withddraw 5 days before slaughter.  Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age.

CATTLE - Withdraw 7 days before slaughter.  For dairy calves, dairy heifers and beef cattle only.  A withdrawal period has not been established for this product in pre-ruminating calves.  Do Not Use in Calves to be Processed for Veal.

Store at controlled room temperature 20 degrees - 25 degrees C (68 degrees - 77 degrees F), with excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F).

NDC # 30798-839-93

Durvet

Sulfadimethoxine Soluble Powder

Antibacterial

For Oral Use in Chickens, Turkeys and Cattle

Each packet contains 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.

Restricted Drug (California)-Use Only as Directed.

For Animal Use Only

Keep Out of Reach of Children

CAUTION:  Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Indications:

For Broiler and Replacement Chickens Only - Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

For Meat-producing Turkeys Only - Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

For Dairy Calves, Dairy Heifers, and Beef Cattle - Use for the treatment of shipping fever complex, bacterial pneumonia, calf diptheria and foot rot.

Sulfadimethoxine  Sulfadimethoxine  powder

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 30798-839 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfadimethoxine Sodium (Sulfadimethoxine) Sulfadimethoxine 94.6 g  in 107 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 30798-839-93 107 g In 1 POUCH None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200376	09/01/2009

Labeler - Durvet (056387798)

Revised: 12/2010Durvet

Quinoderm Cream ()

1. Name Of The Medicinal Product

QUINODERM CREAM

2. Qualitative And Quantitative Composition

Benzoyl Peroxide BP 10.0%

Potassium Hydroxyquinoline Sulphate BP 0.5%

3. Pharmaceutical Form

Quinoderm Cream is a creamy white astringent vanishing cream.

It is intended for topical use only.

4. Clinical Particulars

4.1 Therapeutic Indications

Acne vulgaris, acneform eruptions, folliculitis.

4.2 Posology And Method Of Administration

Route of administration

For topical use only

Adults, children and the elderly:

By gentle massage over all the affected area two or three times daily.

4.3 Contraindications

Acne rosacea. Patients with known sensitivity to either of the active ingredients should not use Quinoderm Cream.

4.4 Special Warnings And Precautions For Use

Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely dye fastness.

In a few isolated cases, overreaction to Quinoderm Cream may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Benzoyl Peroxide is an oxidising agent. Hence, Quinoderm Cream should not be used at the same time as other topical agents which would react with an oxidising agent.

4.6 Pregnancy And Lactation

Quinoderm Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Not applicable

4.9 Overdose

Not applicable.

5. Pharmacological Properties

The combination of the mild keratolytic properties of benzoyl peroxide and the antibacterial and antifungal properties of potassium hydroxyquinoline sulphate in a specially formulated bland water-miscible base make this preparation valuable in the treatment of acne vulgaris, acneform eruptions and folliculitus.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactic Acid BP, White Soft Paraffin B P, Edetic Acid BP., Sodium Acid Phosphate BP, Maize Starch BP, Cetyl Stearyl Alcohol, Sodium Cetyl Stearyl Sulphate, P.E.G. 40 Castor Oil, Purified Water BP.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three Years.

6.4 Special Precautions For Storage

Quinoderm Cream should be stored in a cool, dry place avoiding extremes

of temperature i.e. not less than 5°C and not more than 30°C.

6.5 Nature And Contents Of Container

Quinoderm Cream is available in heat sealed low density polyethylene tubes with flush fitting cap containing 25g and 50g of product. Each tube is cartoned and contains a patient information leaflet.

6.6 Special Precautions For Disposal And Other Handling

For topical use only.

7. Marketing Authorisation Holder

Quinoderm Limited

Manchester Road

Hollingwood

OLDHAM, UK

OL8 4PB

8. Marketing Authorisation Number(S)

0291/5000R

9. Date Of First Authorisation/Renewal Of The Authorisation

28/9/90

10. Date Of Revision Of The Text

September 1998

tripelennamine

Generic Name: tripelennamine (tri pel EH na meen)

Brand Names: PBZ, PBZ-SR

What is tripelennamine?

Tripelennamine is an antihistamine. Tripelennamine blocks the effects of the naturally occurring chemical histamine in the body.

Tripelennamine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

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

What is the most important information I should know about tripelennamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Tripelennamine 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 tripelennamine. Do not crush, chew, or break the sustained-release forms of tripelennamine. Swallow them whole. They are specially formulated to release slowly in the body.

What should I discuss with my healthcare provider before taking tripelennamine?

Do not take tripelennamine 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

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems, or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  high blood pressure or any type of heart problem; or

  
  


• 
  

  asthma.

  
  

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

It is not known whether tripelennamine will be harmful to an unborn baby. Do not take tripelennamine without first talking to your doctor if you are pregnant. Tripelennamine may be harmful to a nursing baby. Do not take tripelennamine without first talking to your doctor if you are breast-feeding. If you are over 60 years of age, you may be more likely to experience side effects from tripelennamine. You may require a lower dose of this medication.

How should I take tripelennamine?

Take tripelennamine exactly as directed by your doctor. 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. Tripelennamine can be taken with food to lessen stomach upset. Do not crush, chew, or break the sustained-release forms of tripelennamine. Swallow them whole. They are specially formulated to release slowly in the body.

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

Never take more of this medication than is prescribed for you. The regular-release tablets can be taken up to six times per day (every 4 hours) to a maximum of 600 mg for adults. The sustained-release tablets can be taken two or three times per day (every 8 to 12 hours) to a maximum of 300 mg for adults.

Store tripelennamine at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a tripelennamine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking tripelennamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Tripelennamine 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 tripelennamine.

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

Tripelennamine side effects

Stop taking tripelennamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

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

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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 tripelennamine?

Do not take tripelennamine 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.

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

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

More tripelennamine resources

• Tripelennamine Drug Interactions
• Tripelennamine Support Group
• 0 Reviews for Tripelennamine - Add your own review/rating

Compare tripelennamine with other medications

• Conjunctivitis, Allergic
• Eye Dryness/Redness
• Eye Redness/Itching
• Hay Fever
• Rhinorrhea
• Upper Respiratory Tract Infection
• Urticaria

Where can I get more information?

• Your pharmacist has more information about tripelennamine written for health professionals that you may read.