Online Article Directory New Zealand: September 2016

Wednesday 28 September 2016

Cialis

Generic Name: tadalafil (Oral route)

ta-DAL-a-fil

Commonly used brand name(s)

In the U.S.

Adcirca

Cialis

Available Dosage Forms:

Tablet

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

Uses For Cialis

Tadalafil is used to treat men who have erectile dysfunction (also called sexual impotence). Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, tadalafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, tadalafil will not work to cause an erection.

Tadalafil is also used to treat men who have signs and symptoms of benign prostatic hyperplasia (BPH). BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Tadalafil will make these symptoms less severe and reduce the chance that prostate surgery will be needed. This medicine is also used to treat erectile dysfunction and signs and symptoms of BPH.

Tadalafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Tadalafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

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

Before Using Cialis

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

Allergies

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

Pediatric

Use of Cialis® tablet is not indicated for use in the pediatric population. Safety and efficacy have not been established.

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

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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

Interactions with Medicines

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

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

Boceprevir

Erythrityl Tetranitrate

Isosorbide Dinitrate

Isosorbide Mononitrate

Nitroglycerin

Pentaerythritol Tetranitrate

Telaprevir

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

Alfuzosin

Atazanavir

Bunazosin

Clarithromycin

Erythromycin

Indinavir

Itraconazole

Ketoconazole

Moxisylyte

Nefazodone

Nelfinavir

Phenoxybenzamine

Phentolamine

Prazosin

Saquinavir

Simvastatin

Tamsulosin

Telithromycin

Terazosin

Trimazosin

Urapidil

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

Doxazosin

Rifampin

Ritonavir

Silodosin

Tipranavir

Interactions with Food/Tobacco/Alcohol

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

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

Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of tadalafil

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

Use tadalafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

Special patient instructions come with tadalafil. Read the directions carefully before you start using tadalafil and each time you get a refill of your medicine.

You may take this medicine with or without food.

Swallow the Cialis® tablet whole. Do not split, break, or crush it.

When using this medicine for erectile dysfunction, the ability to have sexual activity may be improved for up to 36 hours after taking the tablet.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

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

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

For oral dosage form (tablets):
- For treatment of benign prostatic hyperplasia (daily use):
  - Adults—5 milligrams (mg) as a single dose, no more than once a day, taken at the same time each day.
  - Children—Use is not recommended.
- For treatment of erectile dysfunction (as needed):
  - Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 30 minutes before you think sexual activity may occur. Your doctor may adjust your dose if needed.
  - Children—Use is not recommended.
- For treatment of erectile dysfunction (daily use):
  - Adults—2.5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity. Your doctor may adjust your dose if needed.
  - Children—Use is not recommended.
- For treatment of erectile dysfunction and benign prostatic hyperplasia (daily use):
  - Adults—5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity.
  - Children—Use is not recommended.
- For treatment of pulmonary arterial hypertension:
  - Adults—40 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Cialis

It is important that you tell all of your doctors that you take tadalafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took tadalafil.

If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If you take tadalafil for pulmonary arterial hypertension, do not take Cialis® or other PDE5 inhibitors, such as sildenafil (Revatio® or Viagra®) or vardenafil (Levitra®). Cialis® also contains tadalafil. If you take too much tadalafil or take it together with these medicines, the chance for side effects will be higher.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

Do not use this medicine if you are also using a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates.

Do not drink excessive amounts of alcohol (e.g., 5 glasses of wine or 5 shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increase your heart rate, or lower your blood pressure.

If you experience sudden loss of vision in one or both eyes, stop using tadalafil and contact your doctor immediately.

Stop using this medicine and check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

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

Cialis Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Arm, back, or jaw pain

blurred vision

chest pain or discomfort

chest tightness or heaviness

chills

cold sweats

confusion

dizziness

fainting

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

fast or irregular heartbeat

headache

hearing loss

nausea

nervousness

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

pounding in the ears

shortness of breath

slow or fast heartbeat

sweating

unusual tiredness or weakness

vomiting

Rare

Painful or prolonged erection of the penis

Incidence not known

Abdominal or stomach pain

blindness

blistering, peeling, or loosening of the skin

cough

cracks in the skin

decrease or change in vision

diarrhea

difficulty with speaking

double vision

fast, irregular, pounding, or racing heartbeat or pulse

headache, severe and throbbing

hives or welts

inability to move the arms, legs, or facial muscles

inability to speak

itching

joint or muscle pain

loss of heat from the body

numbness or tingling of the face, hands, or feet

red irritated eyes

red skin lesions, often with a purple center

red, swollen skin

redness of the skin

redness or soreness of the eyes

scaly skin

skin rash

slow speech

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

sudden cardiac death

swelling of the feet or lower legs

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

More common

Acid or sour stomach

belching

heartburn

indigestion

stomach discomfort, upset, or pain

Less common

Bloody nose

body aches or pain

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

burning, dry, or itching eyes

burning feeling in the chest or stomach

congestion

difficulty with moving

difficulty with swallowing

dry mouth

dryness or soreness of the throat

excessive eye discharge

eye pain

feeling of constant movement of self or surroundings

feeling of warmth, redness of the face, neck, arms and occasionally, upper chest

fever

hoarseness

increased erection

lack or loss of strength

loose stools

muscle aching or cramping

muscle stiffness

nasal congestion

neck pain

pain

pain in the arms or legs

pain or burning in the throat

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

reduced sensitivity to touch

runny nose

sensation of spinning

sleepiness or unusual drowsiness

sleeplessness

spontaneous penile erection

stomach upset

swelling of the eyelids

swelling or puffiness of the eyes or face

swollen joints

tearing

tender, swollen glands in the neck

tenderness in the stomach area

trouble with sleeping

unable to sleep

upper abdominal or stomach pain

voice changes

watering of the eyes

Rare

Changes in color vision

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

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

See also: Cialis side effects (in more detail)

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More Cialis resources

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

Cialis Prescribing Information (FDA)

Cialis Monograph (AHFS DI)

Cialis MedFacts Consumer Leaflet (Wolters Kluwer)

Cialis Consumer Overview

Tadalafil Professional Patient Advice (Wolters Kluwer)

Adcirca MedFacts Consumer Leaflet (Wolters Kluwer)

Adcirca Prescribing Information (FDA)

Adcirca Consumer Overview

Compare Cialis with other medications

Benign Prostatic Hyperplasia
Erectile Dysfunction

Carmex

Generic Name: topical emollients (TOP i kal ee MOL i ents)

Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care

What are Carmex (topical emollients)?

Emollients are substances that moisten and soften your skin.

Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.

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

Topical emollients may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Carmex (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.

What should I discuss with my healthcare provider before using Carmex (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

deep wounds or open sores;

swelling, warmth, redness, oozing, or bleeding;

large areas of skin irritation;

any type of allergy; or

if you are pregnant or breast-feeding.

How should I use Carmex (topical emollients)?

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

Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.

Shake the product container if recommended on the label.

Apply a small amount of topical emollient to the affected area and rub in gently.

If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.

Do not use this product over large area of skin. Do not apply a topical emollient to a deep puncture wound or severe burn without medical advice.

If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.

Some forms of topical emollient may be flammable and should not be used near high heat or open flame, or applied while you are smoking.

Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.

What happens if I miss a dose?

Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.

What happens if I overdose?

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

What should I avoid while taking Carmex (topical emollients)?

Avoid getting topical emollients in your eyes, nose, or mouth. If this does happen, rinse with water. Avoid exposure to sunlight or tanning beds. Some topical emollients can make your skin more sensitive to sunlight or UV rays.

Carmex (topical emollients) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the topical emollient and call your doctor if you have severe burning, stinging, redness, or irritation where the product was applied.

Less serious side effects are more likely, and you may have none at all.

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 Carmex (topical emollients)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied products. 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 Carmex resources

Carmex Use in Pregnancy & Breastfeeding
Carmex Support Group
0 Reviews for Carmex - Add your own review/rating

Biafine Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)

Campath Monograph (AHFS DI)

Campral Monograph (AHFS DI)

Camptosar Monograph (AHFS DI)

Diabinese Monograph (AHFS DI)

Kinerase Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Neosalus Foam MedFacts Consumer Leaflet (Wolters Kluwer)

Promiseb Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Carmex with other medications

Dry Skin

Where can I get more information?

Your pharmacist can provide more information about topical emollients.

Hydro-Tussin EXP Syrup

Pronunciation: dye-hye-droe-KOE-deen/gwye-FEN-e-sin /sue-doe-eh-FED-rin
Generic Name: Dihydrocodeine/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Hydro-Tussin EXP and Pancof EXP

Hydro-Tussin EXP Syrup is used for:

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

Hydro-Tussin EXP Syrup is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Hydro-Tussin EXP Syrup if:

you are allergic to any ingredient in Hydro-Tussin EXP Syrup or any other codeine or morphine related medicine (eg, oxycodone)

you have severe high blood pressure, a rapid heartbeat, other severe heart problems (eg, heart blood vessel disease), severe bowel problems (eg, paralytic ileus), severe asthma, or you are having an asthma attack

you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (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 Hydro-Tussin EXP Syrup:

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

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

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

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

if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, 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, adrenal gland problems (eg, Addison disease), or an overactive thyroid

if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), gallbladder problems (eg, gallstones), a blockage of your bladder or bowel, kidney or liver problems, or if you have had recent abdominal surgery

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

if you have recently had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures

if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

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

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Hydro-Tussin EXP Syrup may be increased

Digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased

Naltrexone and quinidine because the effectiveness of Hydro-Tussin EXP Syrup may be decreased.

Bromocriptine because the risk of side effects may be increased by Hydro-Tussin EXP Syrup

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Hydro-Tussin EXP Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydro-Tussin EXP Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hydro-Tussin EXP Syrup:

Use Hydro-Tussin EXP Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Hydro-Tussin EXP Syrup by mouth with or without food.

Drink plenty of water while taking Hydro-Tussin EXP Syrup.

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

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

Ask your health care provider any questions you may have about how to use Hydro-Tussin EXP Syrup.

Important safety information:

Hydro-Tussin EXP Syrup may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Hydro-Tussin EXP Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not take appetite suppressants while you are taking Hydro-Tussin EXP Syrup without checking with your doctor.

Hydro-Tussin EXP Syrup has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

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

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

Hydro-Tussin EXP Syrup may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Hydro-Tussin EXP Syrup.

Tell your doctor or dentist that you take Hydro-Tussin EXP Syrup before you receive any medical or dental care, emergency care, or surgery.

Use Hydro-Tussin EXP Syrup with caution in the ELDERLY; they may be more sensitive to its effects.

Hydro-Tussin EXP Syrup should not be used in CHILDREN younger than 2 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 Hydro-Tussin EXP Syrup while you are pregnant. It is not known if Hydro-Tussin EXP Syrup is found in breast milk. Do not breast-feed while taking Hydro-Tussin EXP Syrup.

Possible side effects of Hydro-Tussin EXP Syrup:

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

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; 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; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

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: Hydro-Tussin EXP 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; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Hydro-Tussin EXP Syrup:

Store Hydro-Tussin EXP Syrup 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 Hydro-Tussin EXP Syrup out of the reach of children and away from pets.

General information:

If you have any questions about Hydro-Tussin EXP Syrup, please talk with your doctor, pharmacist, or other health care provider.

Hydro-Tussin EXP Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

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

This information is a summary only. It does not contain all information about Hydro-Tussin EXP Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Hydro-Tussin EXP resources

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

Compare Hydro-Tussin EXP with other medications

Cough
Cough and Nasal Congestion
Expectoration
Hay Fever
Nasal Congestion
Sinusitis

Monday 26 September 2016

Caspofungin

Pronunciation: KAS-poe-FUN-jin
Generic Name: Caspofungin
Brand Name: Cancidas

Caspofungin is used for:

Treating certain fungal infections.

Caspofungin is an antifungal agent. It works by weakening fungal cell walls, which allows the cell contents to leak out, resulting in the death of the fungus.

Do NOT use Caspofungin if:

you are allergic to any ingredient in Caspofungin

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

Before using Caspofungin:

Some medical conditions may interact with Caspofungin. 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 liver problems or are using cyclosporine

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

Cyclosporine because the risk of liver problems may be increased

Carbamazepine, dexamethasone, efavirenz, nevirapine, phenytoin, or rifampin because they may decrease Caspofungin's effectiveness

Tacrolimus because its effectiveness may be decreased by Caspofungin

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

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

Caspofungin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Caspofungin at home, a health care provider will teach you how to use it. Be sure you understand how to use Caspofungin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Do not use Caspofungin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

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.

If you miss a dose of Caspofungin, contact your doctor right away.

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

Important safety information:

Be sure to use Caspofungin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Lab tests, including liver function tests, may be performed while you use Caspofungin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

Caspofungin should be used with extreme caution in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.

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

Possible side effects of Caspofungin:

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:

Cough; diarrhea; headache; mild fever; nausea; stomach pain; 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; unusual hoarseness); blood in the urine; decreased urine; fainting, fatigue, or dizziness; fast, slow or irregular heartbeat; fever, chills, or sore throat; mood or mental changes (eg, anxiety, confusion, depression, trouble sleeping); muscle pain, weakness, or cramps; pain, swelling, weakness, or redness at the infusion site or in the infused limb; rapid breathing, shortness of breath, or wheezing; red, swollen, blistered or peeling skin; seizure; severe headache, dizziness, or blurred vision; severe stomach or back pain with nausea and vomiting; swelling of the hands or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); unusual bleeding or bruising; unusual feeling of warmth; unusual tiredness or weakness.

See also: Caspofungin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Caspofungin:

Caspofungin is usually handled and stored by a health care provider. If you are using Caspofungin at home, store Caspofungin as directed by your pharmacist or health care provider. Keep Caspofungin out of the reach of children and away from pets.

General information:

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

Caspofungin 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 Caspofungin. 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

More Caspofungin resources

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

caspofungin Concise Consumer Information (Cerner Multum)

caspofungin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Cancidas Prescribing Information (FDA)

Cancidas Monograph (AHFS DI)

Compare Caspofungin with other medications

Aspergillosis, Invasive
Candida Infections, Systemic
Esophageal Candidiasis
Febrile Neutropenia

Friday 23 September 2016

Claritine

Claritine may be available in the countries listed below.

Ingredient matches for Claritine

Loratadine

Loratadine is reported as an ingredient of Claritine in the following countries:

Bahrain

Belgium

Bulgaria

Croatia (Hrvatska)

Czech Republic

Estonia

Ethiopia

Georgia

Guyana

Hungary

Latvia

Lithuania

Luxembourg

Netherlands

Oman

Poland

Portugal

Romania

Russian Federation

Serbia

Slovakia

Slovenia

Switzerland

Turkey

International Drug Name Search

Simethicone

Pronunciation: sih-METH-ih-cone
Generic Name: Simethicone
Brand Name: Examples include Gas-X Extra Strength and Mylanta Gas Relief Maximum Strength

Simethicone is used for:

Relieving pressure, bloating, and gas in the digestive tract. It may also be used for other conditions as determined by your doctor.

Simethicone is an antiflatulent. It works by breaking up gas bubbles, which makes gas easier to eliminate.

Do NOT use Simethicone if:

you are allergic to any ingredient in Simethicone

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

Before using Simethicone:

Some medical conditions may interact with Simethicone. 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

Some MEDICINES MAY INTERACT with Simethicone. However, no specific interactions with Simethicone are known at this time.

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

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

Take Simethicone as needed after meals and at bedtime, unless otherwise directed by your doctor.

If you miss a dose of Simethicone 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 Simethicone.

Important safety information:

Do not exceed the recommended dose without checking with your doctor.

If your condition persists, contact your health care provider.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Simethicone, discuss with your doctor the benefits and risks of using Simethicone during pregnancy. It is unknown if Simethicone is excreted in breast milk. If you are or will be breast-feeding while you are taking Simethicone, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Simethicone:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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).

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 Simethicone:

Store Simethicone 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. Avoid temperatures above 104 degrees F (40 degrees C). Keep Simethicone out of the reach of children and away from pets.

General information:

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

Simethicone 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 Simethicone. 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

More Simethicone resources

Simethicone Dosage
Simethicone Use in Pregnancy & Breastfeeding
Drug Images
Simethicone Support Group
2 Reviews for Simethicone - Add your own review/rating

Simethicone Professional Patient Advice (Wolters Kluwer)

Simethicone Monograph (AHFS DI)

simethicone Advanced Consumer (Micromedex) - Includes Dosage Information

simethicone Concise Consumer Information (Cerner Multum)

Compare Simethicone with other medications

Endoscopy or Radiology Premedication
Functional Gastric Disorder
Gas
Postoperative Gas Pains

Thursday 22 September 2016

Carmol Scalp

Generic Name: sulfacetamide sodium and urea topical (sul fa SEET a mide SOE dee um and ure EE a TOP i kal)

Brand Names: Carmol Scalp, Carmol Scalp Treatment Kit, Rosula NS

What is Carmol Scalp (sulfacetamide sodium and urea topical)?

Sulfacetamide sodium is a sulfa antibiotic that fights bacteria on the skin.

Urea helps moisturize the skin.

The combination of sulfacetamide sodium and urea topical (for the skin) is used to treat acne vulgaris and seborrheic dermatitis (red, flaking skin rash).

Sulfacetamide sodium and urea topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Carmol Scalp (sulfacetamide sodium and urea topical)?

You should not use this medication if you are allergic to sulfacetamide, urea, or sulfa drugs. Do not use sulfacetamide sodium and urea topical medicated pads if you have kidney disease.

To make sure you can safely use sulfacetamide sodium and urea topical, tell your doctor if you have a history of burns, open sores, or skin wounds in the skin area you plan to treat with this medication.

Do not use sulfacetamide sodium and urea topical to treat any skin condition that has not been checked by your doctor.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve, or if they get worse while using sulfacetamide sodium and urea topical.

Do not share this medication with another person, even if they have the same symptoms you have.

What should I discuss with my healthcare provider before using Carmol Scalp (sulfacetamide sodium and urea topical)?

You should not use this medication if you are allergic to sulfacetamide, urea, or sulfa drugs. Do not use sulfacetamide sodium and urea topical medicated pads if you have kidney disease.

Do not use sulfacetamide sodium and urea topical to treat any skin condition that has not been checked by your doctor. FDA pregnancy category C. It is not known whether sulfacetamide sodium and urea topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and urea 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.

How should I use Carmol Scalp (sulfacetamide sodium and urea 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.

This medication is usually applied 1 to 3 times per day. Follow your doctor's instructions.

Wash your hands after applying the lotion or using the medicated pad.

Do not cover the treated skin area unless your doctor has told you to.

Throw away the medicated pad after one use.

Use sulfacetamide sodium and urea topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not share this medication with another person, even if they have the same symptoms you have.

This medicine may appear to get darker in color over time. This is not harmful and will not affect safe use of sulfacetamide sodium and urea topical.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. 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.

What should I avoid while using Carmol Scalp (sulfacetamide sodium and urea topical)?

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not apply the medication to your lips or eyelids. Do not use sulfacetamide sodium and urea topical on irritated or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and urea topical unless you doctor tells you to.

Carmol Scalp (sulfacetamide sodium and urea topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using sulfacetamide sodium and urea topical and call your doctor at once if you have a serious side effect such as:

fever, sore throat, body aches, flu symptoms;

mouth sores;

easy bruising or bleeding, unusual weakness;

dark urine, jaundice (yellowing of the skin or eyes); or

warmth, swelling, oozing, or other signs of skin infection; or

severe burning, stinging, swelling, or redness of your skin after applying this medicine.

Less serious side effects may include mild skin irritation.

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 Carmol Scalp (sulfacetamide sodium and urea topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and urea 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 Carmol Scalp resources

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

Rosula NS Medicated Pads MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Carmol Scalp with other medications

Dandruff
Seborrheic Dermatitis
Secondary Cutaneous Bacterial Infections

Where can I get more information?

Your pharmacist can provide more information about sulfacetamide sodium and urea topical.

See also: Carmol Scalp side effects (in more detail)

Certolizumab Pegol

Class: Disease-modifying Antirheumatic Agents
Molecular Formula: C₂₁₁₅H₃₂₅₂N₅₅₆O₆₇₃S₁₆
CAS Number: 428863-50-7
Brands: Cimzia

Special Alerts:

[Posted 09/07/2011] ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNF blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNF blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

BACKGROUND: The class of TNF blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

RECOMMENDATION: The risks and the benefits of TNF blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for certolizumab pegol to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of certolizumab pegol and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Serious Infections

Serious, sometimes fatal infections including tuberculosis (frequently disseminated or extrapulmonary), bacterial and viral infections, invasive fungal infections (may be disseminated), and other opportunistic infections reported.¹ (See Infectious Complications under Cautions.)

Carefully consider risks and benefits prior to initiating certolizumab pegol therapy in patients with chronic or recurring infections.¹

Evaluate patients for latent tuberculosis infection prior to and periodically during certolizumab pegol therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating therapy.¹

Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.¹ Discontinue certolizumab pegol if serious infection occurs.¹ Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.¹

Malignancy

Lymphoma and other malignancies (some fatal) reported in children and adolescents receiving TNF blocking agents.¹ (See Malignancies and Lymphoproliferative Disorders under Cautions.)

Introduction

Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant humanized Fab′ fragment of a monoclonal antibody specific for tumor necrosis factor (TNF; TNF-α).¹ ² ³ ⁷ ⁸ ¹⁴ ¹⁵ ¹⁶

Uses for Certolizumab Pegol

Crohn's Disease

Used to reduce the signs and symptoms of moderately to severely active Crohn's disease and to maintain clinical response in adults who have had an inadequate response to conventional therapies.¹ ² ³

Rheumatoid Arthritis

Management of moderately to severely active rheumatoid arthritis in adults.¹ May be used alone or in combination with methotrexate or other nonbiologic DMARDs.¹

Certolizumab Pegol Dosage and Administration

General

Oral corticosteroids, NSAIAs, and/or analgesics may be continued in adults with rheumatoid arthritis.¹⁷ ¹⁸ ¹⁹

REMS Program

FDA has approved a REMS for certolizumab pegol.¹¹

The program consists of a medication guide that must be provided to patients (see Advice to Patients) and a communication plan that includes initial communications targeting selected groups of clinicians.¹¹

The goals are to inform patients about the serious risks associated with the drug and to inform clinicians about invasive fungal infections associated with use of TNF blocking agents (see Warnings/Precautions under Cautions).¹¹

Administration

Sub-Q Administration

Administer by sub-Q injection into the thighs or abdomen using a 23-gauge needle.¹ Rotate injection sites.¹ Do not inject into areas where the skin is tender, bruised, red, or hard.¹

Allow reconstituted solution and prefilled syringes sit at room temperature for 30 minutes prior to administration.¹

Following reconstitution, draw up each 400 mg dose into 2 syringes, each containing 200 mg, and administer by sub-Q injection into separate sites on the thighs or abdomen using 23-gauge needles.¹

Reconstituted solution intended for use under the guidance and supervision of a clinician.¹ Certolizumab pegol solution supplied in prefilled syringes may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training.¹

Reconstitution

Allow lyophilized powder kit (containing drug, diluent, syringes, needles) to reach room temperature prior to reconstitution.¹

Reconstitute vial containing 200 mg of certolizumab pegol lyophilized powder by adding 1 mL of sterile water for injection (provided by manufacturer) to provide a solution containing approximately 200 mg/mL.¹

Gently swirl vial to ensure all of the powder comes into contact with the diluent; do not shake.¹ Leave vial undisturbed to fully reconstitute (may take up to 30 minutes).¹

Dosage

Adults

Crohn's Disease

Sub-Q

400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks (induction regimen); patients who respond may receive additional 400-mg doses every 4 weeks (maintenance regimen).¹

Rheumatoid Arthritis

Sub-Q

400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks, followed by 200 mg every 2 weeks.¹ For maintenance therapy, 400 mg every 4 weeks may be considered.¹

Special Populations

Dosage adjustment based on weight not necessary.¹ (See Special Populations under Pharmacokinetics.)

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

No specific dosage recommendations at this time for patients with moderate or severe renal impairment.^a (See Special Populations under Pharmacokinetics.)

Geriatric Patients

No specific dosage recommendations at this time.¹

Cautions for Certolizumab Pegol

Contraindications

Manufacturer states none known.¹

Warnings/Precautions

Warnings

Infectious Complications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Serious, sometimes fatal infections (including bacterial, mycobacterial, invasive fungal, viral, or other opportunistic infections) reported with certolizumab pegol and other TNF blocking agents, particularly in patients receiving concomitant therapy with immunosuppressive agents (e.g., methotrexate, corticosteroids).¹ The most common opportunistic infections include , histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis.¹ Infections frequently are disseminated.¹

Do not initiate certolizumab pegol in patients with active infections, including clinically important localized infections.¹ Consider potential risks and benefits of the drug prior to initiating therapy in patients with a history of chronic or recurring infections; patients with underlying conditions that may predispose them to infections; and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.¹

Closely monitor patients during and after treatment for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock).¹ ⁶

If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient.¹ ⁶ Discontinue certolizumab pegol if serious infection or sepsis develops.¹ ⁶

Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy.¹ When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to certolizumab pegol therapy.¹ Consider antimycobacterial therapy prior to initiating certolizumab pegol in patients with a history of latent or active tuberculosis for whom adequate antimycobacterial treatment is unconfirmed, and in patients with a negative tuberculin skin test who have risk factors for tuberculosis.¹ Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.¹

Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.¹ Strongly consider tuberculosis in patients who develop new infections during therapy, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.¹

Invasive fungal infections often not recognized in patients receiving TNF blocking agents; this has led to delays in appropriate treatment.⁶

Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.¹ ⁶ Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.¹ ⁶

When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic.⁶ Whenever feasible, consult specialist in fungal infections.⁶

Increased incidence of serious infection and neutropenia observed with concomitant use of etanercept (another TNF blocking agent) and anakinra (a human interleukin-1 receptor antagonist).¹ ⁵ Increased incidence of infection and serious infection reported with concomitant use of a TNF blocking agent and abatacept.¹ ²³ (See Specific Drugs and Laboratory Tests under Interactions.)

Malignancies and Lymphoproliferative Disorders

Lymphoma and other malignancies (some fatal) reported during postmarketing surveillance in children and adolescents receiving TNF blocking agents, particularly in those receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly.¹ ⁹ Malignancies included lymphomas (about 50% of the cases) (e.g., Hodgkin's disease, non-Hodgkin's lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers), including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children and adolescents (e.g., leiomyosarcoma, hepatic malignancies, renal cell carcinoma).¹ ⁹ Median time to occurrence was 30 months (range: 1–84 months) after the initial TNF blocking agent dose.¹ FDA has concluded that there is an increased risk of malignancy with TNF blocking agents in children and adolescents; however, the strength of the association is not fully characterized.⁹

In controlled studies, lymphoma was reported more frequently in patients receiving certolizumab pegol or other TNF blocking agents than in control patients.¹ Patients with Crohn's disease, rheumatoid arthritis, and other chronic inflammatory diseases, especially those with highly active disease and/or chronic exposure to immunosuppressive therapies, may be at increased risk of lymphoma.¹ ⁹

In clinical studies of certolizumab pegol, rate of malignancies other than nonmelanoma skin cancer was 0.5 or 0.6 per 100 patient-years in patients receiving certolizumab pegol or placebo, respectively; however, the role of certolizumab pegol use in the development of malignancies not fully determined.¹ ⁹

Acute and chronic leukemias (some fatal) reported during postmarketing surveillance of TNF blocking agents in adults and pediatric patients, particularly in those receiving other immunosuppressive agents concomitantly.¹ ⁹ Leukemia (most commonly acute myeloid leukemia, chronic lymphocytic leukemia, and chronic myeloid leukemia) generally occurred during first 2 years of therapy.⁹ FDA has concluded that there is a possible association between TNF blocking agents and development of leukemia; interpretation of findings is complicated because patients with rheumatoid arthritis may be at increased risk for leukemia independent of any treatment with TNF blocking agents.¹ ⁹

Consider possibility of and monitor for occurrence of malignancies during and following treatment with TNF blocking agents.⁹

Other Warnings/Precautions

Cardiovascular Effects

Worsening CHF and new-onset CHF reported in patients receiving TNF blocking agents; certolizumab pegol not studied in patients with CHF.¹ If used in patients with CHF, caution and careful monitoring recommended.¹

Sensitivity Reactions

Angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria reported rarely.¹ If allergic reaction occur, discontinue certolizumab pegol and initiate appropriate treatment.¹

Hepatitis B Virus (HBV) Reactivation

Increased risk of reactivation of HBV infection in patients who are chronic carriers of this virus (i.e., hepatitis B surface antigen-positive [HBsAg-positive]).¹ ⁵ Fatalities reported.¹ Use of multiple immunosuppressive agents may contribute to HBV reactivation.¹

Screen at-risk patients prior to initiation of therapy.¹ Evaluate and monitor HBV carriers before, during, and for up to several months after therapy.¹ Safety and efficacy of antiviral therapy for prevention of HBV reactivation not established.¹ Discontinue certolizumab pegol and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs.¹ Not known whether certolizumab pegol can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.¹

Nervous System Effects

New onset or exacerbation of CNS demyelinating disorders (e.g., multiple sclerosis) and peripheral demyelinating disorders (e.g., Guillain-Barré syndrome) reported rarely.^a Use cautiously in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.^a

Seizure disorder, optic neuritis, and peripheral neuropathy reported rarely.¹

Hematologic Effects

Pancytopenia (including aplastic anemia),¹ leukopenia, and thrombocytopenia reported rarely; causal relationship unclear.¹ Use with caution in patients with a history of substantial hematologic abnormalities.^a Consider discontinuing therapy if substantial hematologic abnormalities occur.¹

Immunologic Reactions and Antibody Formation

Possible formation of autoimmune antibodies.¹ ² ³ Lupus-like syndrome reported rarely.¹ Discontinue therapy if manifestations suggestive of a lupus-like syndrome occur.¹

Antibodies to certolizumab pegol may develop.¹ Incidence of antibody formation was lower in patients receiving concomitant therapy with other immunosuppressive agents (e.g., methotrexate) than in those not receiving immunosuppressive agents at baseline.¹

Antibody formation associated with lower plasma drug concentrations and reduced efficacy in patients with rheumatoid arthritis.¹ In patients with Crohn's disease, no apparent association between antibody development and efficacy or adverse events.¹

Immunization

Avoid live vaccines.¹ (See Interactions.)

Immunosuppression

May affect host defenses against infections and malignancies.^a (See Infectious Complications and also Malignancies and Lymphoproliferative Disorders, under Cautions.) Safety and efficacy in immunosuppressed patients not evaluated.¹

Psoriasis

New-onset psoriasis, including pustular and palmoplantar psoriasis, and exacerbation of existing psoriasis reported with TNF blocking agents.¹ ⁹ Onset of new cases observed weeks to years following initiation of drug.⁹ Some patients required hospitalization.⁹ Most patients experienced improvement following discontinuance of the TNF blocking agent.⁹ FDA has concluded that there is a possible association between use of TNF blocking agents and development of psoriasis.⁹

Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.⁹ Consider discontinuance of certolizumab pegol if psoriasis occurs or worsens.^a

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established.¹

Malignancies, some fatal, reported in children and adolescents who received TNF-blocking agents.¹ ⁹ (See Malignancies and Lymphoproliferative Disorders under Cautions.)

Geriatric Use

No substantial differences in response relative to younger adults.¹

Possible increased incidence of infections in geriatric patients; use with caution.¹

Common Adverse Effects

Upper respiratory infection, urinary tract infection, arthralgia, rash.¹ ² ^a

No formal drug interaction studies with oral corticosteroids, NSAIAs, analgesics, or immunosuppressants to date.¹ ^a

Administered concomitantly with methotrexate, corticosteroids, NSAIAs, and/or other analgesics in patients with rheumatoid arthritis.¹ ¹⁷ ¹⁸ ¹⁹ ^a

Administered concomitantly with aminosalicylates, corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or anti-infective agents in patients with Crohn's disease.² ³

Vaccines

Avoid live vaccines.¹ No data available on secondary transmission of infection by live vaccines in certolizumab pegol-treated patients.¹

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Abatacept	Increased incidence of infection and serious infection, without additional clinical benefit, reported with abatacept and TNF blocking agents in patients with rheumatoid arthritis¹ ²³	Concomitant use not recommended¹ ²³
Anakinra	Possible increased risk of serious infection and neutropenia, with no clinical benefit, reported with anakinra and etanercept (another TNF blocking agent); similar toxicities expected with certolizumab pegol and anakinra¹ ⁵	Concomitant use not recommended¹
Corticosteroids, oral	Increased risk of serious infection¹	Used concomitantly in clinical studies¹
Methotrexate	Increased risk of serious infection¹ Possible decrease in rate of development of antibodies to certolizumab pegol in patients with rheumatoid arthritis; may result in sustained therapeutic plasma certolizumab pegol concentrations¹ Methotrexate pharmacokinetics not altered by certolizumab pegol in patients with rheumatoid arthritis; effect of methotrexate on certolizumab pharmacokinetics not determined¹	Used concomitantly in clinical studies¹
Natalizumab	Increased risk of progressive multifocal leukoencephalopathy (PML) or other serious infection¹ ¹²	Concomitant use not recommended¹ ¹²
Rituximab	Increased risk of serious infection¹ ¹³	Concomitant use not recommended¹ ¹³
Tests, coagulation	May erroneously elevate aPPT; thrombin time and PT unaffected; no evidence of effect on in vivo coagulation¹

Certolizumab Pegol Pharmacokinetics

Absorption

Bioavailability

Bioavailability is approximately 80% following sub-Q administration.¹ Peak serum concentrations achieved in 54–171 hours.¹

Elimination

Metabolism

Not studied.¹

Elimination Route

Not studied.^a Polyethylene glycol moiety excreted principally in urine.¹

Half-life

Approximately 14 days.^a

Special Populations

Pharmacokinetics of certolizumab pegol not formally studied in patients with renal impairment.^a However, pharmacokinetics of polyethylene glycol moiety dependent on renal function.^a

Among adults, age does not appear to influence pharmacokinetics.^a

Clearance of certolizumab pegol is higher with increasing body weight; however, no clinically important weight-related differences observed.^a

In patients with certolizumab pegol antibodies, clearance of certolizumab is higher.^a

No gender-related pharmacokinetic differences apparent. ^a

Stability

Storage

Sub-Q

Injection in Prefilled Syringes

2–8°C.^a Do not freeze.^a Protect from light; store in original carton until administration.^a

Powder for Injection Kit

2–8°C.^a Do not freeze.^a Protect from light; store in original carton until administration.^a

Store reconstituted solution for up to 2 hours at room temperature or up to 24 hours (in vials) at 2–8°C.^a Do not freeze.^a

Actions

Recombinant humanized Fab′ fragment of an anti-TNF monoclonal antibody conjugated to an approximately 40-kilodalton polyethylene glycol (PEG2MAL40K) in order to prolong the half-life.¹ ² ³ ⁷ ⁸

Binds with high affinity to TNF-α, a cytokine involved in the regulation of immune response.¹ ² ³ ⁷ ⁸

Does not contain a fragment crystallizable (Fc) region or induce complement activation, antibody-dependent cellular cytotoxicity, apoptosis, or neutrophil degranulation in vitro.¹ ² ³ ⁷ ⁸

Advice to Patients

A copy of the manufacturer's patient information (medication guide) for certolizumab pegol must be provided to all patients with each prescription of the drug. (See REMS Program under Dosage and Administration.)¹ ¹¹ ^a Importance of advising patients about potential benefits and risks of certolizumab pegol.^a ⁹ Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.¹

Importance of instructing patient and/or caregiver regarding proper dosage and administration of certolizumab pegol, including the use of aseptic technique, and proper disposal of needles and syringes if it is determined that the patient and/or caregiver is competent to safely administer the drug.^a

Risk of increased susceptibility to infection.¹ Importance of informing clinician promptly if any signs or symptoms of infection (e.g., persistent fever, sweating, cough, dyspnea, fatigue) occur.¹ ⁶

Risk of lymphoma, leukemia, and other malignancies.¹ ⁹ Importance of informing patients and families about the increased risk of cancer development in children and adolescents, taking into account the clinical utility of TNF blocking agents, the benefits and risks of other immunosuppressive drugs, and the risks associated with untreated disease.⁹ Importance of promptly informing clinicians if signs and symptoms of cancer occur (e.g., unexplained weight loss; fatigue; swollen lymph nodes in the neck, underarm, or groin; easy bruising or bleeding).⁹

Risk of new-onset psoriasis or worsening of existing psoriasis with TNF blocking agents.¹ ⁹ Importance of informing clinicians of any manifestations of new or worsening psoriasis (e.g., new rash).¹ ⁹

Importance of seeking immediate medical attention for symptoms of severe allergic reactions.¹

Importance of informing clinician of any new or worsening medical conditions (e.g., CHF, neurologic disease, autoimmune disorders, cytopenias).¹

Importance of promptly informing clinician if symptoms suggestive of blood dyscrasias (e.g., bruising, bleeding, pallor, persistent fever) develop.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or history of tuberculosis, hepatitis B virus infection, or recurrent infections.¹ ⁶

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing patients of other important precautionary information. (See Cautions.)¹

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Certolizumab Pegol
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for subcutaneous use	2 vials (200 mg each)	Cimzia (available as kit with sterile water for injection diluent, needles, syringes, and alcohol swabs)	UCB
		2 syringes (200 mg/mL each)	Cimzia (available as disposable prefilled syringes)	UCB

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. UCB, Inc. Cimzia (certolizumab pegol) for subcutaneous injection prescribing information. Smyrna, GA; 2009 Nov.

2. Sandborn WJ, Feagan BG, Stoinov S et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007; 357:228-38. [PubMed 17634458]

3. Schreiber S, Khaliq-Kareemi M, Lawrance IC et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007; 357:239-50. [PubMed 17634459]

4. Best WR, Becktel JM, Singleton JW et al. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976; 70:439-44. [PubMed 1248701]

5. Amgen/Wyeth Corporation. Enbrel (etanercept) for subcutaneous injection prescribing information. Thousand Oaks, CA: 2008 Jun.

6. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). Rockville MD: Food and Drug Administration; 2008 Sep 4. Available from FDA website. Accessed 2008 Sep 25.

7. Bourne T, Fossati G, Nesbitt A. A PEGylated Fab' fragment against tumor necrosis factor for the treatment of Crohn disease: exploring a new mechanism of action. BioDrug. 2008; 22:331-7.

8. Nesbitt A, Fossati G, Bergin M et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor α agents. In flamm Bowel Dis. 2007; 13:1323-32.

9. Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: Tumor necrosis factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). FDA alert, Rockville, MD; 2009 Aug 4. Available from FDA website. Accessed 2009 Nov 3.

10. UCB, Smyrna, GA: Personal communication.

11. Cimzia (certolizumab pegol) risk evaluation and mitigation strategy (REMS). From FDA website. Accessed 2010 Jul 28.

12. Biogen Idec Inc. Tysabri (natalizumab) injection prescribing information. Cambridge, MA; 2010 Jul.

13. Centocor Ortho Biotech Inc. Simponi (golimumab) injection prescribing information. Horsham, PA; 2009 Nov.

14. Sebba A. Tocilizumab: the first interleukin-6-receptor inhibitor. Am J Health Syst Pharm. 2008; 65:1413-8. [PubMed 18653811]

15. McCluggage LK, Scholtz JM. Golimumab: a tumor necrosis factor alpha inhibitor for the treatment of rheumatoid arthritis. Ann Pharmacother. 2010; 44:135-44. [PubMed 20118145]

16. . Drugs for rheumatoid arthritis. Treat Guidel Med Lett. 2009; 7:37-46; quiz 47-8. [PubMed 19390497]

17. Keystone E, Heijde D, Mason D et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008; 58:3319-29. [PubMed 18975346]

18. Smolen J, Landewé RB, Mease P et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009; 68:797-804. [PubMed 19015207]

19. Fleischmann R, Vencovsky J, van Vollenhoven RF et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009; 68:805-11. [PubMed 19015206]

20. Felson DT, Anderson JJ, Boers M et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-35. [PubMed 7779114]

21. Felson DT, Anderson JJ, Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993; 36:729-40. [PubMed 8507213]

22. Felson DT, Anderson JJ, Lange MLM et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent. Arthritis Rheum. 1998; 41:1564-70. [IDIS 411264] [PubMed 9751088]

23. Bristol-Myers Squibb. Orencia (abatacept) lyophilized powder for intravenous infusion prescribing information. Princeton, NJ; 2009 Aug.

a. UCB, Inc. Cimzia (certolizumab pegol) powder for sub-Q injection prescribing information. Smyrna, GA; 2010 Dec..

b. AHFS Drug Information. McEvoy GK, ed. Certolizumab Pegol. Bethesda, MD: American Society of Health-System Pharmacists; 2011.

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Psoriatic Arthritis
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