Aquanil HC

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Aquanil HC (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

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

What is the most important information I should know about Aquanil HC (hydrocortisone topical)?

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

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

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Aquanil HC (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Aquanil HC (hydrocortisone topical)?

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

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Aquanil HC (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

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

Aquanil HC (hydrocortisone topical) side effects

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

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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 Aquanil HC (hydrocortisone topical)?

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

More Aquanil HC resources

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

• Aquanil HC Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Aquanil HC with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: Aquanil HC side effects (in more detail)

AmLactin AP Cream

Generic Name: Ammonium Lactate/Pramoxine (ah-MOE-nee-uhm LACK-tate/pra-MOX-een)
Brand Name: AmLactin AP

AmLactin AP Cream is used for:

Treating itching due to dry skin and other minor skin irritations.

AmLactin AP Cream is a combination moisturizer and local anesthetic. It works by moisturizing the skin and decreasing itching in the affected area.

Do NOT use AmLactin AP Cream if:

• you are allergic to any ingredient in AmLactin AP Cream

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

Before using AmLactin AP Cream:

Some medical conditions may interact with AmLactin AP Cream. 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 any kind of skin infection, open cuts, or scrapes


• if you have a parasitic, bacterial, fungal, or viral infection of the affected area

Some MEDICINES MAY INTERACT with AmLactin AP Cream. Because little, if any, of AmLactin AP Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if AmLactin AP Cream 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 AmLactin AP Cream:

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

• AmLactin AP Cream is for use on the skin only.


• If you miss a dose of AmLactin AP Cream and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use AmLactin AP Cream.

Important safety information:

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


• Avoid getting AmLactin AP Cream in your eyes, nose, or mouth. If you get AmLactin AP Cream in your eyes, immediately flush them with cool tap water.


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


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using AmLactin AP Cream while you are pregnant. It is not known if AmLactin AP Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use AmLactin AP Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of AmLactin AP Cream:

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 skin; itching.

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

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

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

See also: AmLactin AP 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face. AmLactin AP Cream may be harmful if swallowed.

Proper storage of AmLactin AP Cream:

Store AmLactin AP Cream 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 AmLactin AP Cream out of the reach of children and away from pets.

General information:

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


• AmLactin AP Cream 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.

This information is a summary only. It does not contain all information about AmLactin AP Cream. 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 AmLactin AP resources

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

Compare AmLactin AP with other medications

• Dry Skin

Insulin Aspart Protamine/Insulin Aspart Vials

Pronunciation: IN-su-lin AS-part PROE-ta-meen
Generic Name: Insulin Aspart Protamine/Insulin Aspart
Brand Name: NovoLog Mix 70/30

Insulin Aspart Protamine/Insulin Aspart Vials are used for:

Treating diabetes mellitus.

Insulin Aspart Protamine/Insulin Aspart Vials are a combination of an intermediate-acting and a fast-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Aspart Protamine/Insulin Aspart Vials if:

• you are allergic to any ingredient in Insulin Aspart Protamine/Insulin Aspart Vials


• you are having an episode of low blood sugar

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

Before using Insulin Aspart Protamine/Insulin Aspart Vials:

Some medical conditions may interact with Insulin Aspart Protamine/Insulin Aspart Vials. 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 drink alcoholic beverages or smoke


• if you have kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; or diabetic ketoacidosis


• if you use 3 or more insulin injections per day


• if you are fasting, are on a low-salt (sodium) diet, have blood electrolyte problems (eg, high blood sodium levels, low blood potassium levels), or you exercise


• if you have had or will be having heart surgery

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

• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicines for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, pramlintide, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased


• Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs


• Atypical antipsychotics (eg, risperidone), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Aspart Protamine/Insulin Aspart Vials's effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Insulin Aspart Protamine/Insulin Aspart Vials 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 Insulin Aspart Protamine/Insulin Aspart Vials:

Use Insulin Aspart Protamine/Insulin Aspart Vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Insulin Aspart Protamine/Insulin Aspart Vials. Talk to your pharmacist if you have questions about this information.


• Use Insulin Aspart Protamine/Insulin Aspart Vials within 15 minutes before meals, unless directed otherwise by your doctor.


• If you will be using Insulin Aspart Protamine/Insulin Aspart Vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Aspart Protamine/Insulin Aspart Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Carefully shake or rotate the vial as directed before each injection. This will ensure that the contents are evenly mixed. This combination insulin should look uniformly cloudy or milky.


• Do not use Insulin Aspart Protamine/Insulin Aspart Vials if it contains particles, is discolored, or if the vial is cracked or damaged.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.


• Injection sites within an injection area (abdomen, buttock, thigh, upper arm) must be rotated from one injection to the next. Do not inject into skin that is red, swollen, or itchy.


• Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe. Do not use Insulin Aspart Protamine/Insulin Aspart Vials in an insulin pump.


• Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.


• Insulin Aspart Protamine/Insulin Aspart Vials begins lowering blood sugar within 15 minutes after an injection. The peak effect occurs from 1 to 4 hours after a dose. The effects last up to 24 hours.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Insulin Aspart Protamine/Insulin Aspart Vials.

Important safety information:

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


• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing high or low blood sugar.


• Do NOT use more than the recommended dose, use Insulin Aspart Protamine/Insulin Aspart Vials more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.


• Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.


• Stress or illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.


• Tell your doctor or dentist that you take Insulin Aspart Protamine/Insulin Aspart Vials before you receive any medical or dental care, emergency care, or surgery.


• If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.


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


• An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. 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 more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or 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.


• Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell you doctor right away.


• Check with your doctor if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique.


• Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Aspart Protamine/Insulin Aspart Vials. Tell your doctor if you have had a recent change in diet or physical activity.


• Lab tests, including fasting blood glucose levels and hemoglobin A_1c, may be performed while you use Insulin Aspart Protamine/Insulin Aspart Vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Insulin Aspart Protamine/Insulin Aspart Vials with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.


• Insulin Aspart Protamine/Insulin Aspart Vials should be used with extreme caution in CHILDREN younger than 18 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 Insulin Aspart Protamine/Insulin Aspart Vials while you are pregnant. It is not known if Insulin Aspart Protamine/Insulin Aspart Vials are found in breast milk. If you are or will be breast-feeding while you use Insulin Aspart Protamine/Insulin Aspart Vials, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Aspart Protamine/Insulin Aspart Vials:

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

Back pain; diarrhea; indigestion; redness, swelling, itching, or mild pain at the injection site; runny nose; weight gain.

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; wheezing); burning, numbness, or tingling of the arms, hands, legs, or feet; changes in vision; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; flu-like symptoms (eg, fever, chills, sore throat); headache; loss of consciousness; mental or mood changes; muscle pain, weakness, or cramping; seizures; slurred speech; stomach pain; swelling; tremor; trouble concentrating; unusual hunger; unusual sweating; weakness.

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 chills; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Aspart Protamine/Insulin Aspart Vials:

Store new (unopened) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store used (open) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Insulin Aspart Protamine/Insulin Aspart Vials has been frozen or overheated, throw it away. Throw away unrefrigerated or opened vials after 28 days, even if they still contain medicine.

Do not leave Insulin Aspart Protamine/Insulin Aspart Vials in a car on a warm or sunny day. Do not use Insulin Aspart Protamine/Insulin Aspart Vials after the expiration date stamped on the label. Keep Insulin Aspart Protamine/Insulin Aspart Vials, as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Insulin Aspart Protamine/Insulin Aspart Vials, please talk with your doctor, pharmacist, or other health care provider.


• Insulin Aspart Protamine/Insulin Aspart Vials are 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 Insulin Aspart Protamine/Insulin Aspart Vials. 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 Insulin Aspart Protamine/Insulin Aspart resources

• Insulin Aspart Protamine/Insulin Aspart Use in Pregnancy & Breastfeeding
• Insulin Aspart Protamine/Insulin Aspart Drug Interactions
• Insulin Aspart Protamine/Insulin Aspart Support Group
• 2 Reviews for Insulin Aspart Protamine/Insulin Aspart - Add your own review/rating

Compare Insulin Aspart Protamine/Insulin Aspart with other medications

• Diabetes, Type 1
• Diabetes, Type 2

TriNessa

Generic Name: ethinyl estradiol and norgestimate (ETH in ill ess tra DYE ol and nor JESS ti mate)

Brand Names: Mononessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri-Lo-Sprintec, Tri-Previfem, Tri-Sprintec, TriNessa

What is TriNessa (ethinyl estradiol and norgestimate)?

Ethinyl estradiol and norgestimate contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norgestimate is used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norgestimate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about TriNessa (ethinyl estradiol and norgestimate)?

This medication can harm an unborn baby or cause birth defects. Do not use birth control pills if you are pregnant or if you have recently had a baby. You should not take birth control pills if you have coronary artery disease, severe heart valve disorder, uncontrolled high blood pressure, a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or a history of jaundice caused by pregnancy or birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking TriNessa (ethinyl estradiol and norgestimate)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

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

• 
  

  high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

  
  


• 
  

  high cholesterol or triglycerides, or if you are overweight;

  
  


• 
  

  a history of depression;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  a history of irregular menstrual cycles; or

  
  


• 
  

  a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

  
  

The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take TriNessa (ethinyl estradiol and norgestimate)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

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 nausea or vaginal bleeding.

What should I avoid while taking TriNessa (ethinyl estradiol and norgestimate)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

TriNessa (ethinyl estradiol and norgestimate) side effects

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

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; 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 TriNessa (ethinyl estradiol and norgestimate)?

Some drugs can make ethinyl estradiol and norgestimate less effective, which may result in pregnancy. Before using ethinyl estradiol and norgestimate, tell your doctor if you are using any of the following drugs:

• 
  

  bosentan (Tracleer);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. 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 TriNessa resources

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

• TriNessa Prescribing Information (FDA)


• MonoNessa Prescribing Information (FDA)


• Ortho Tri-Cyclen Consumer Overview


• Ortho Tri-Cyclen Prescribing Information (FDA)


• Ortho Tri-Cyclen MedFacts Consumer Leaflet (Wolters Kluwer)


• Ortho Tri-Cyclen Lo Prescribing Information (FDA)


• Previfem Prescribing Information (FDA)


• Sprintec Prescribing Information (FDA)


• Tri-Lo-Sprintec Prescribing Information (FDA)


• Tri-Previfem Prescribing Information (FDA)


• Tri-Sprintec Prescribing Information (FDA)

Compare TriNessa with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Ovarian Cysts

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norgestimate.

See also: TriNessa side effects (in more detail)

Ibuleve Speed Relief Gel

IBULEVE
SPEED RELIEF GEL ibuprofen 5% w/w

Read all of this leaflet carefully before using this product.

This medicine is available without prescription. However, you still need to use it carefully to get the best results from it. Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after a few weeks.

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

In this leaflet:

• 1. What Ibuleve Speed Relief Gel is and what it is used for


• 2. Before you use Ibuleve Speed Relief Gel


• 3. How to use Ibuleve Speed Relief Gel


• 4. Possible side effects


• 5. How to store Ibuleve Speed Relief Gel


• 6. Further information

What Ibuleve Speed Relief Gel Is And What It Is Used For

• Ibuleve Speed Relief Gel is an anti-inflammatory painkiller applied to, and absorbed through, the skin.


• It is for the treatment of the following conditions involving the musculoskeletal system:
  
  
  • muscular backache
  
  
  • muscular pain
  
  
  • rheumatic pain
  
  
  • aches
  
  
  • pains
  
  
  • swellings
  
  
  • sprains
  
  
  • strains
  
  
  • sports injuries.
  
  



• Ibuleve Speed Relief Gel is recommended for use by adults, the elderly and children over the age of 12 years. Children under the age of 12 may also use it if recommended by their doctor.


• The active ingredient in this product is ibuprofen. This is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).


• Ibuprofen works by:
  
  
  • relieving pain
  
  
  • reducing swelling and inflammation.
  
  

Before You Use Ibuleve Speed Relief Gel

Do not use Ibuleve Speed Relief Gel:

• if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuleve listed in section 6;


• if you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past;


• if you are pregnant or breast-feeding;


• on broken, damaged, infected or diseased skin.

Before applying this product for the first time, make sure it is suitable for you to use:

Because Ibuleve Speed Relief Gel is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth.

However, in rare cases you may be at risk:

• if you have a stomach ulcer (also called a peptic or gastric ulcer);


• if you have ever had kidney problems;


• if you have ever had asthma;


• if you have ever had a bad reaction to aspirin or ibuprofen taken by mouth.

If any of the above apply to you, only use this product on advice from your doctor or pharmacist.

Take special care when using this product:

• Use it only on the skin.


• Do not use it on children under 12 years old unless advised by a doctor.


• Do not apply it to broken or irritated skin.


• Do not use under protective waterproof dressings.


• Do not use more than the recommended dose (see Section 3).


• Keep the gel away from the eyes, nose and mouth.

Using other medicines

• Interaction between Ibuleve Speed Relief Gel and blood pressure lowering drugs and anticoagulants is possible, in theory, although very unlikely. If you would like more advice about this, speak to your doctor or pharmacist.


• If you are also taking aspirin or other NSAIDs by mouth, discuss this beforehand with your doctor or pharmacist because these may increase the risk of undesirable effects.


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

Pregnancy and breast-feeding

You should not use Ibuleve Speed Relief Gel if you are pregnant or breast-feeding.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

Important information about one of the ingredients of Ibuleve Speed Relief Gel

The product contains a small amount of propylene glycol. This ingredient may cause skin irritation in a small number of people who are intolerant to it. If your doctor has told you that you have an intolerance to propylene glycol, please talk to your doctor before using this product.

How To Use Ibuleve Speed Relief Gel

Before using this tube of gel for the first time, open it as follows:

• Unscrew the cap, turn it upside down and then use the sharp point of the cap to pierce the membrane in the neck of the tube.

To use the gel

(for adults, the elderly and children over 12 years old):

• Use the gel up to three times a day, leaving 4 hours between applications.


• Lightly apply the gel to intact skin over the painful area.


• Apply 4 to 10 cm gel to thinly cover the affected area, then massage gently until absorbed. Do not apply more than 30 cm of gel in any 24 hour period.


• Wash hands after use, unless treating them.


• Carry on using the gel in this way until your condition gets better (you may find you need to use it for a few weeks, and your doctor may want you to continue using it for longer than this).


• If your symptoms worsen or continue for more than a few weeks, discuss this with your doctor before continuing treatment.

If the gel comes into contact with broken skin or gets into the eyes, nose or mouth

• The product may cause irritation if it comes into contact with broken skin or gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist.

If the gel is accidentally swallowed

• Symptoms may include headache, vomiting, drowsiness and low blood pressure.


• If you experience any of these symptoms contact a doctor or hospital straight away.

If you forget to use this product

Do not worry if you occasionally forget to use this product, just carry on using it when you remember. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Ibuleve Speed Relief Gel can cause side effects, although not everybody gets them.

Occasionally, mild skin rashes, itching or irritation can sometimes occur at the site of application. If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.

Very rarely, the following side effects can happen with ibuprofen, although these are extremely uncommon with products such as Ibuleve Speed Relief Gel that are applied to the skin.

If you experience any of the following, stop using Ibuleve Speed Relief Gel immediately and tell your doctor:

• Allergic reactions (particularly in people who have a history of asthma or allergic problems), such as:
  
  
  • unexplained runny nose and watery eyes, or, in more serious cases asthma or aggravated asthma involving breathing difficulties, wheezing or chest tightness;
  
  
  • generalised allergic skin reactions involving itch, swelling, inflammation, redness and perhaps blistering and light sensitivity;
  
  
  • other more serious generalised allergic reactions possibly involving unexplained nausea and vomiting, swollen eyes, face or tongue, difficulty swallowing, dizziness or light-headedness. Unconsciousness could perhaps occur in the most serious cases.
  
  



• Kidney problems
  (particularly in people who have a history of kidney disease), such as:
  
  
  • decreased urine volume;
  
  
  • loss of appetite / weight loss;
  
  
  • swelling to abdomen.
  
  



• Problems with the digestive system
  (particularly in people who have a history of stomach ulcers etc), such as:
  
  
  • stomach pain;
  
  
  • heartburn / indigestion.
  
  

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

How To Store Ibuleve Speed Relief Gel

• Keep it out of the reach and sight of children.


• Always replace the cap tightly after use.


• Do not store the product above 25°C.


• Do not use after the expiry date shown on the fold of the tube and the carton. The expiry date refers to the last day of that month.


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

Further Information About Ibuleve Speed Relief Gel

What Ibuleve Speed Relief Gel contains:

The active ingredient is ibuprofen (5% w/w). The other ingredients are industrial methylated spirit, carbomers, propylene glycol, diethylamine and purified water.

What Ibuleve Speed Relief Gel looks like and contents of the pack

• The product is a clear, colourless gel that contains no fragrance.


• The gel is available in tubes containing 40 g.

The Marketing Authorisation holder is

Diomed Developments Limited

Tatmore Place

Gosmore

Hitchin

Herts

SG4 7QR

UK

The Manufacturer is

DDD Limited

94 Rickmansworth Road

Watford

Herts

WD18 7JJ

UK

The Distributor is

DDD Limited

94 Rickmansworth Road

Watford

Herts

WD18 7JJ

UK

This leaflet was last approved in February 2008.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Ibuleve Speed Relief Gel 00173/0060.

This is a service provided by the Royal National Institute of Blind People (RNIB).

KD53/08/1

Hytrin Tablets 1mg

1. Name Of The Medicinal Product

Hytrin Tablets 1mg

Terazosin Tablets 1 mg

2. Qualitative And Quantitative Composition

		mg/tablet
Active :	Terazosin	1.0
	as monohydrochloride dihydrate

3. Pharmaceutical Form

White, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Orally administered Hytrin is indicated in the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole therapy where other agents are inappropriate or ineffective. The hypotensive effect is most pronounced on the diastolic pressure. Although the exact mechanism of the hypotensive action of terazosin is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha-1- adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Orally administered Hytrin is also indicated as a therapy for the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). Terazosin is a selective post synaptic alpha-1 -adrenoreceptor antagonist. Antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve urinary tract flow and relieve the urinary obstruction caused by BPH.

4.2 Posology And Method Of Administration

Hypertension.

Adults

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Compliance with this initial dosage recommendation should be strictly observed to minimise potential for acute first-dose hypotensive episodes.

Subsequent doses

The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response.

The usual maintenance dose is 2mg to 10mg once daily. Doses over 20mg rarely improve efficacy and doses over 40mg have not been studied.

BPH

Adults Only:

The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration:

Initial dose

1 mg before bedtime is the starting dose for all patients and should not be exceeded. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes.

Subsequent dose

The dose may be increased by approximately doubling at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily. Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin.

At present there are insufficient data to suggest additional symptomatic relief with doses above 10mg once daily.

Treatment should be initiated using the BPH Starter Pack and response to treatment reviewed at four weeks. Transient side effects may occur at each titration step. If any side effects persist, consideration should be given to reducing the dose.

Use in renal insufficiency

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosages.

Use in Children

Safety and efficacy in children has not been established.

Use in the Elderly

Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is required.

Postural Hypotension

Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic treatment of urinary obstruction caused by BPH. In these cases, the incidence of postural hypotensive events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%)

Use with thiazide diuretics and other antihypertensive agents

When adding a thiazide diuretic or another antihypertensive agent to a patient's regimen the dose of Hytrin should be reduced and retitration carried out if necessary. Caution should be observed when Hytrin is administered with thiazides or other antihypertensive agents as hypotension may develop.

4.3 Contraindications

Known sensitivity to alpha-adrenoceptor antagonists.

4.4 Special Warnings And Precautions For Use

As with other alpha adrenoreceptor antagonists, terazosin is not recommended in patients with a history of micturition syncope.

In clinical trials, the incidence of postural hypotension was greater in BPH patients than those with hypertension. In these cases, the incidence of postural hypotension events was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).

If administration is discontinued for more than several days, therapy should be re-instituted using the initial dosing regimen.

¹Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and terazosinmay lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phosphodiesterase-5-inhibitors.

²The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

¹ PL 20072/0028-0006; 11/06/2009

² PL 20072/0028-0002; 16/07/2007

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In patients receiving terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical trials.

Caution should be observed when terazosin is administered with other antihypertensive agents, to avoid the possibility of significant hypotension. When adding terazosin to a diuretic or other antihypertensive agent, dosage reduction and retitration may be necessary.

Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac glycosides, hypoglycemics, antiarrhythmics, anxiolytics/sedatives, antibacterials, hormones/steroids and drugs used for gout.

Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).

4.6 Pregnancy And Lactation

Although no teratogenic effects were seen in animal testing, the safety of Hytrin use during pregnancy or during lactation has not yet been established. Hytrin should not be used therefore in pregnancy unless the potential benefit outweighs the risk.

4.7 Effects On Ability To Drive And Use Machines

Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent reinitiation of Hytrin therapy. Patients should be cautioned about these possible adverse effects and the circumstances in which they may occur and advised to avoid driving or hazardous tasks for approximately 12 hours after initial dose or when the dose is increased.

4.8 Undesirable Effects

Hytrin in common with other alpha-adrenoceptor antagonists may cause syncope. Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in association with rapid dosage increases or the introduction of another antihypertensive agent.

In clinical trials in hypertension, the incidence of syncopal episodes was approximately one percent. In most cases this was believed to be due to an excessive postural hypotensive effect although occasionally the syncopal episode has been preceded by a bout of tachycardia with heart rates of 120 to 160 beats per minute.

If syncope occurs the patient should be placed in a recumbent position and supportive treatment applied as necessary.

Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting position. Patients should be advised of this possibility and instructed to lie down if these symptoms appear and then sit for a few minutes before standing to prevent their recurrence.

These adverse effects are self limiting and in most cases do not recur after the initial period of therapy or during subsequent re-titration.

Adverse events reported with terazosin

The most common events were asthenia, palpitations, nausea, peripheral oedema, dizziness, somnolence, nasal congestion/rhinitis and blurred vision/amblyopia.

In addition, the following have been reported: back pain; headache; tachycardia; postural hypotension; syncope; oedema; weight gain; pain in extremities; decreased libido; depression; nervousness; paraesthesia; vertigo; dyspnoea; sinusitis and impotence.

Additional adverse reactions reported in clinical trials or reported during marketing experience but not clearly associated with the use of terazosin include the following:

chest pain; facial oedema; fever; abdominal pain; neck pain; shoulder pain; vasodilation; arrhythmia; constipation; diarrhoea; dry mouth; dyspepsia; flatulence; vomiting; gout; arthralgia; arthritis; joint disorders; myalgia; anxiety; insomnia; bronchitis; epistaxis; flu symptoms; pharyngitis; rhinitis; cold symptoms; pruritis; rash; increased cough; sweating; abnormal vision; conjunctivitis; tinnitus; urinary frequency; urinary tract infection and urinary incontinence primarily reported in post-menopausal women.

At least two cases of anaphylactoid reactions have been reported with the administration of terazosin.

Post marketing experience: Thrombocytopenia and priapism have been reported. Atrial fibrillation has been reported: however, a cause and effect relationship has not been established.

Laboratory tests: Small but statistically significant decreases in haematocrit, haemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggest the possibility of haemodilution. Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen (PSA) levels.

4.9 Overdose

Should administration of Hytrin lead to acute hypotension, cardiovascular support is of first importance. Restoration of blood pressure and normalisation of heart rate may be accomplished by keeping the patient in a supine position. If this measure is inadequate, shock should first be treated with volume expanders and if necessary, vasopressors could then be used. Renal function should be monitored and general supportive measures applied as required. Dialysis may not be of benefit since laboratory data indicate that terazosin is highly protein bound.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Although the exact mechanism of the hypotensive action is not established, the relaxation of peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic alpha-adrenoceptors. Hytrin usually produces an initial gradual decrease in blood pressure followed by a sustained antihypertensive action.

Clinical experience indicates that a 2-5% decrease in total cholesterol plasma concentration and a 3-7% decrease in the combined LDL_C + VLDL_C fraction plasma concentration from pretreatment values are associated with the administration of therapeutic doses of terazosin.

In clinical trials, plasma concentrates of total cholesterol and combined low density and very low density lipoproteins were found to be slightly reduced following Hytrin administration. Additionally, the increase in total cholesterol seen with other hypertensive agents did not occur when these were used in combination with Hytrin.

Studies suggest that alpha-1-adrenoreceptor antagonism is useful in improving the urodynamics in patients with chronic bladder obstruction such as in benign prostatic hyperplasia (BPH).

The symptoms of BPH are caused mainly by the presence of an enlarged prostate and by the increased smooth muscle tone of the bladder outlet and prostate, which is regulated by alpha-1 -adrenergic receptors.

In in-vitro experiments, terazosin has been shown to antagonise phenylephrine-induced contractions of human pro static tissue. In clinical trials terazosin has been shown to improve the urodynamics and symptomatology in patients with BPH.

5.2 Pharmacokinetic Properties

The plasma concentration of the parent drug is a maximum about 1 hour post administration and declines with a half-life of approximately 12 hours. Food has little or no effect on bioavailability. Approximately 40% of the administered dose is eliminated in the urine and 60% in the faeces. The drug is highly bound to plasma proteins.

5.3 Preclinical Safety Data

Carcinogenicity: Hytrin has been shown to produce tumours in male rats when administered at a high dose over a long period of time. No such occurrences were seen in female rats or in a similar study in mice. The relevance of these findings with respect to the clinical use of the drug in man is unknown.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Maize starch

Pregelatinised starch

Purified talc

Magnesium stearate

Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Tablets in a blister original pack.

Starter Pack for Hypertension:

Tablets in a blister original pack. The 1mg tablets form part of a starter pack of 28 tablets which also contains 21 x 2mg tablets. Blisters are packaged in a carton with a package insert.

Starter pack for BPH:

Tablets in a blister pack. The starter pack consists of 7 x 1mg, 14 x 2mg and 7 x 5mg tablets. The blisters, of PVC/PVdC, are heat sealed with 20 micron hard tempered aluminium foil and packaged in a carton with a pack insert.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Amdipharm plc

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

8. Marketing Authorisation Number(S)

PL 20072/0028

9. Date Of First Authorisation/Renewal Of The Authorisation

13/05/97

10. Date Of Revision Of The Text

June 2009

Sudal 12 Tannate Chewable

pseudoephedrine hydrochloride and chlorpheniramine maleate

Dosage Form: tablet, chewable
Sudal® 12 TANNATE CHEWABLE PSEUDOEPHEDRINE HCL - CHLORPHENIRAMINE MALEATE

DESCRIPTION:

Each Sudal®-12 Tannate Chewable tablet contains: 30 mg of pseudoephedrine hydrochloride and 4 mg of chlorpheniramine maleate. Sudal®-12 Tannate Chewable tablets are used for oral administration only. Sudal®-12 Tannate Chewable tablets contain the following inactive ingredients: Acesulfame K, Aluminum Lake Blue #2, Aspartame, Avicel, Bitter Mask, Calcium Phosphate Dibasic, Carmine Red, Citric Acid, Corn Starch, DI-PAC, Grape Flavor, Hypromelose, Magnasweet, Magnesium Aluminometasilicate, Magnesium Stearate, Mannitol, Purified Water, Sucralose, Talc, Tannic Acid, Vanilla Flavor and Xanthan Gum.

Pseudoephedrine hydrochloride: [S(R*,R*)]-α-[1-(methylamino)ethyl] benzenemethanol hydrochloride.

Chlorpheniramine maleate: 2-[p-chloro-α-[2-(dimethylamino) ethyl]-benzyl] pyridine.

CLINICAL PHARMACOLOGY:

Pseudoephedrine is an α-adrenergic receptor antagonist (sympathomimetic) which produces vasoconstriction by stimulating α-receptors within the mucosa of the respiratory tract. Clinically, pseudoephedrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency. The vasoconstriction action of pseudoephedrine is similar to that of ephedrine. In the usual dose it has minimal vasopressor effects. Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. It has a plasma half-life of 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. The drug is distributed to body tissues and fluids, including the fetal tissue, breast milk and the central nervous system (CNS). Chlorpheniramine is an alkylamine-type antihistamine. The antihistamine in Sudal®-12 Tannate Chewable tablets acts by competing with histamine for H1 histamine receptor sites, thereby preventing the action of histamine on the cell. Clinically, chlorpheniramine suppresses the histamine-mediated symptoms of allergic rhinitis, relieving sneezing, rhinorrhea, and itching of the eyes, nose, and throat.

INDICATIONS AND USAGE:

Sudal®-12 Tannate Chewable tablets are indicated for temporary relief of symptoms associated with seasonal and perennial allergic rhinitis, cold and sinusitis, including rhinorrhea, sneezing and nasal congestion.

CONTRAINDICATIONS:

Sudal®-12 Tannate Chewable tablets are contraindicated in patients with hypersensitivity to antihistamines or sympathomimetic amines, nursing mothers and patients receiving monoamine oxidase inhibitor (MAOI) therapy (see Drug Interactions section). Sympathomimetic amines are contraindicated in patients with severe hypertension or severe coronary artery disease and patients that are taking a prescription MAOI (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug.

WARNINGS:

Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism and prostatic hypertrophy. Sympathomimetics may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses. Alkylamine-type antihistamines should be used with extreme caution in patients with narrow angle glaucoma; stenosing peptic ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy, or bladder neck obstruction. Due to its mild atropine-like action, chlorpheniramine should be used cautiously in patients with bronchial asthma, emphysema, or chronic pulmonary disease. May cause excitability, especially in children. Do not exceed recommended dosage.

PRECAUTIONS:

General:

Caution should be exercised in patients with high blood pressure, heart disease, diabetes mellitus, or thyroid disease. The antihistamine in Sudal®-12 Tannate Chewable tablets may exhibit additive effects with CNS depressants, including alcohol. Phenylketonurics: contains Phenylalanine 25 mg per chewable tablet.

Information for Patients:

• Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.


• Patients should also be warned about possible additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers).

Drug Interactions:

• MAOIs and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines.


• Beta-adrenergic blockers and MAOIs.


• Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias.


• Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids.


• Concurrent use of tricyclic antidepressants may antagonize the effects of pseudoephedrine.


• Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect.

Laboratory Test Interactions:

The in vitro addition of pseudoephedrine to sera containing the cardiac isoenzyme MB of serum creatine phosphokinase progressively inhibits the activity of the enzyme. The inhibition becomes complete over six hours. Carcinogenesis, Mutagenesis, Impairment of Fertility: No data is available on the long-term potential of the components of Sudal®-12 Tannate Chewable tablets for carcinogenesis, mutagenesis or impairment of fertility in animals or humans.

Pregnancy: Category C:

Animal reproduction studies have not been conducted with components of Sudal®-12 Tannate Chewable tablets. It is also not known whether Sudal®-12 Tannate Chewable tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nursing Mothers: Pseudoephedrine is excreted in breast milk. Use of Sudal®-12 Tannate Chewable tablets by nursing mothers is contraindicated because of the higher-than-usual risk for infants from sympathomimetic amines.

Pediatric Use:

Safety and effectiveness of Sudal®-12 Tannate Chewable tablets in pediatric patients under age two have not been established. Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults. Demonstrate safe use of a short-acting sympathomimetic amine before use of a sustained-action formulation in pediatric patients.

Geriatric Use: (Ages 65 and older)

Geriatric patients taking sympathomimetics may be more likely to experience confusion, hallucinations, seizures, and CNS depression. Geriatric patients may also be more sensitive to the effects, especially to the vasopressor effects, of sympathomimetic amines. Demonstrate safe use of a short-acting sympathomimetic formulation before use of a sustained-action formulation in elderly patients.

ADVERSE REACTIONS:

Pseudoephedrine may cause mild CNS stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias and cardiovascular collapse with hypotension. Chlorpheniramine may cause slight to moderate drowsiness and is the most frequent side effect. Other possible side effects of antihistamines include:

General:

Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat;

Cardiovascular:

Hypotension, headache,palpitation, tachycardia, extra systoles;

Hematological:

Hemolytic anemia, thrombocytopenia, agranulocytosis;

CNS:

Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, hysteria, neuritis, convulsion;

Gastrointestinal:

Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation;

Genitourinary:

Urinary frequency, difficult urination, urinary retention, early menses;

Respiratory:

Thickening of bronchial secretions, tightness of chest, wheezing and nasal stuffiness.

DRUG ABUSE AND DEPENDENCE:

Pseudoephedrine, like other CNS stimulants, has been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable, and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose and toxic signs and symptoms appear. Depression may follow rapid withdrawal. Narcotic antitussives and stimulants, such as pseudoephedrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

OVERDOSE:

Overdosage with pseudoephedrine may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness and insomnia. Other effects may include tachycardia, hypertension, pallor, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with pseudoephedrine overdosage. Manifestations of antihistamine overdosage may vary from CNS depression (sedation, apnea, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors or convulsions).

Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia and gastrointestinal symptoms).

Treatment:

In the event of overdosage, emergency treatment should be started immediately. Since the action of long- acting products may continue for as long as 18 hours, treatment of overdosage should be directed toward reducing further absorption and supporting the patient for at least that length of time. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. Either isotonic or half-isotonic saline may be used for lavage. Administration of an activated charcoal slurry is beneficial after lavage and/or emesis if less than four hours have passed since ingestion. Saline cathartics, such as Milk of Magnesia, are useful for hastening the evacuation of unreleased medication. Adrenergic Receptor-blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the beta-blocker propanolol, which is indicated when there are signs of cardiac toxicity. In severe cases of overdosage, it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. Vasopressors may be used to treat hypotension. Excessive CNS stimulation may be counteracted with parenteral diazepam. Stimulants should not be used. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or a hyperthermic blanket. Apnea is treated with ventilatory support.

DOSAGE AND ADMINISTRATION:

Adults and children over age 12: 1 — 2 tablets every 12 hours.

Children ages 6 to 12: 1/2 — 1 tablet every 12 hours.

Children ages 2 to 6: 1/2 tablet every 12 hours.

Children under age 2: As directed by a physician.

HOW SUPPLIED:

Sudal®-12 Tannate Chewable tablets are supplied as a purple, grape-flavored tablet embossed "S / 12" on one side and "4 / 30" on the other. Available in sample bins of 20 pouches, containing one tablet each, NDC 59702-819-05, and in bottles of 100, NDC 59702-819-01.

STORAGE AND HANDLING:

Dispense in a well closed, light-resistant container.

Store at controlled room temperature, 20° — 25°C (68° — 77°F).

REPRESENTATIVE PACKAGING


See How Supplied section for a complete list of available packages of Sudal® 12 Tannate Chewable

NDC 59702-819-01

Sudal® 12

TANNATE CHEWABLE

PSEUDOEPHEDRINE HCL - CHLORPHENIRAMINE MALEATE

NEW FORMULATION

Decongestant - Antihistamine

Pseudoephedrine HCL..........30 mg

Chlorpheniramine Maleate......4 mg

Atley

Rx Only

100 Tablets

Store at controlled room temperature betwee 20° — 25°C (68° — 77°F) (see USP).

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


Rx Only


Manufactured for:

Atley Pharmaceuticals, Inc.

Ashland, VA 23005


Utilizing: TANNATE CONVERSION TECHNOLOGY(TM)


4004?? REV 11/06


USUAL DOSAGE:

Adults and children over age 12: 1 — 2 tablets every 12 hours.

Children ages 6 to 12: 1/2 — 1 tablet every 12 hours.

Children ages 2 to 6: 1/2 tablet every 12 hours.

Children under age 2: As directed by a physician.


For full prescribing information, see attached product literature.


Pharmacist: Dispense well closed, light-resistant container.

Sudal 12 Tannate Chewable  pseudoephedine hydrochloride chlorpheniramine maleate  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59702-819 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride 30 mg Chlorpheniramine maleate (Chlorpheniramine) Chlorpheniramine maleate 4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color purple (Purple) Score 2 pieces Shape OVAL (Oblong) Size 15mm Flavor GRAPE (Grape) Imprint Code S;12;4;30 Contains

Packaging # NDC Package Description Multilevel Packaging 1 59702-819-15 20 POUCH In 1 BOX contains a POUCH (59702-819-05) 1 59702-819-05 1 TABLET In 1 POUCH This package is contained within the BOX (59702-819-15) 2 59702-819-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2007	09/01/2010

Labeler - Atley Pharmaceuticals, Inc. (928666536)

Revised: 03/2010Atley Pharmaceuticals, Inc.

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