Ortho-Novum 1/50

Generic Name: mestranol and norethindrone (MESS tra nol and nor eth IN drone)

Brand Names: Necon 1/50, Norinyl 1+50, Ortho-Novum 1/50

What is Ortho-Novum 1/50 (mestranol and norethindrone)?

Mestranol and norethindrone 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.

Mestranol and norethindrone is used as contraception to prevent pregnancy.

Mestranol and norethindrone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ortho-Novum 1/50 (mestranol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

What should I discuss with my healthcare provider before taking Ortho-Novum 1/50 (mestranol and norethindrone)?

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). Do not use this medication if you have:

• 
  

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

  
  


• 
  

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

  
  


• 
  

  abnormal vaginal bleeding;

  
  


• 
  

  liver disease or liver cancer; or

  
  


• 
  

  a history of jaundice caused by birth control pills.

  
  

Before using this medication, tell your doctor if you have any of the following conditions:

• 
  

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

  
  


• 
  

  high cholesterol or if you are overweight;

  
  


• 
  

  kidney disease;

  
  


• 
  

  a history of depression;

  
  


• 
  

  diabetes;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  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 birth control pills 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 Ortho-Novum 1/50 (mestranol and norethindrone)?

Take this medication exactly as it was prescribed for you. You will 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. Get your prescription refilled before you run out of pills completely.

If you need to have any type of medical tests or surgery, 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.

Store this medication 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 following the missed pills.

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 three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on 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 if you think you have used too much of this medicine. Symptoms of an overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Ortho-Novum 1/50 (mestranol and norethindrone)?

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.

Ortho-Novum 1/50 (mestranol and norethindrone) side effects

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

• 
  

  sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  swelling in your hands, ankles, or feet; o

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  darkening of facial skin, increased hair growth, loss of scalp hair;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  headache, nervousness, dizziness, tired feeling.

  
  

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

What other drugs will affect Ortho-Novum 1/50 (mestranol and norethindrone)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:

• 
  

  phenylbutazone (Azolid, Butazolidin);

  
  


• 
  

  an antibiotic such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), penicillin, rifampin (Rifadin), tetracycline, and others;

  
  


• 
  

  seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), phenobarbital (Solfoton), y otros; or

  
  


• 
  

  HIV medicines.

  
  

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

More Ortho-Novum 1/50 resources

• Ortho-Novum 1/50 Side Effects (in more detail)
• Ortho-Novum 1/50 Use in Pregnancy & Breastfeeding
• Drug Images
• Ortho-Novum 1/50 Drug Interactions
• Ortho-Novum 1/50 Support Group
• 1 Review for Ortho-Novum/50 - Add your own review/rating

• Ortho-Novum 1/50 MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ortho-Novum 1/50 with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Endometriosis
• Gonadotropin Inhibition

Where can I get more information?

• Your pharmacist can provide more information about mestranol and norethindrone.

See also: Ortho-Novum/50 side effects (in more detail)

Orudis

Generic Name: ketoprofen (Oral route)

kee-toe-PROE-fen

Oral route(Tablet;Capsule;Capsule, Extended Release)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ketoprofen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Orudis


• Orudis KT


• Oruvail

Available Dosage Forms:

• Tablet, Extended Release


• Tablet


• Capsule, Extended Release


• Capsule


• Tablet, Enteric Coated

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Orudis

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ketoprofen can be used to treat menstrual cramps and other conditions as determined by your doctor .

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

Before Using Orudis

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoprofen in children below 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ketoprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ketoprofen .

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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.

• Ketorolac


• Pentoxifylline

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.

• Abciximab


• Ardeparin


• Argatroban


• Aspirin


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Warfarin


• Zimeldine

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.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Anemia or


• Asthma or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• High blood pressure or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding or


• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use of ketoprofen

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

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

To lessen stomach upset, you may take this medicine with food, milk, or antacid unless your doctor tells you otherwise .

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 (capsules):
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults—At first, 75 milligrams (mg) three times a day or 50 mg four times a day. Your doctor may increase your dose, if necessary, up to a total of 300 mg a day.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For mild to moderate pain or menstrual cramps:
    
    • Adults—25 to 50 mg every six to eight hours as needed. Some people may need to take as much as 75 mg every six to eight hours. Doses larger than 75 mg are not likely to give better relief.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  


• For oral dosage form (extended-release capsules):
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults—200 mg once a day, in the morning or evening. Take the medicine at the same time every 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Orudis

It is very important that your doctor 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. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Orudis 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:

More common

• Abdominal pain


• bloody urine


• decreased frequency or amount of urine


• headache


• increased blood pressure


• increased thirst


• loss of appetite


• lower back or side pain


• nausea


• swelling of face, fingers, feet, or lower legs


• troubled breathing


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Bladder pain


• cloudy urine


• difficult, burning, or painful urination


• frequent urge to urinate


• rash


• swelling or inflammation of the mouth

Rare

• Back pain


• bleeding from rectum


• bleeding gums


• blistering, peeling, loosening of skin


• blood in vomit


• bloody nose


• bloody, black, or tarry stools


• blurred vision


• body aches or pain


• burning feeling in chest or stomach


• burning, dry or itching eyes


• change in color of eye


• chest pain


• chills


• clay-colored stools


• cold hands and feet


• coma


• confusion


• congestion


• constipation


• convulsions


• cough or hoarseness


• coughing or spitting up blood


• cracks in the skin


• dark urine


• decreased urination


• decreased vision or other changes in vision


• diarrhea


• difficult or labored breathing


• difficulty swallowing


• dilated neck veins


• discharge, excessive tearing


• dryness or soreness of throat


• extreme fatigue


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling faint, dizzy, or lightheadedness


• feeling of warmth or heat


• fever with or without chills


• flushing or redness of skin, especially on face and neck


• general tiredness and weakness


• heartburn


• hives or welts


• increased sensitivity of skin to sunlight


• indigestion


• itching


• joint or muscle pain


• light-colored stools


• loss of heat from the body


• muscle pain or cramps


• nervousness


• noisy breathing


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red or purple spots on skin


• pounding in the ears


• problems with bleeding or clotting


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


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness or other discoloration of skin


• redness or soreness around fingernails or loosening of the fingernails


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


• runny nose


• scaly skin


• severe abdominal cramping


• severe or continuing stomach pain


• severe sunburn


• shortness of breath


• skin rash, encrusted, scaly and oozing


• slow heartbeat


• slow or irregular breathing


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


• stomach pain or upset


• sweating


• swelling of face, ankles, or hands


• tender, swollen glands in neck


• tenderness in stomach area


• tightness in chest


• trouble in swallowing


• troubled breathing with exertion


• unpleasant breath odor


• unusual bleeding or bruising


• upper right abdominal pain


• voice changes


• vomiting of blood


• vomiting of material that looks like coffee grounds, severe and continuing


• wheezing


• yellow eyes or skin

Symptoms of overdose

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


• fast or shallow breathing


• pain or discomfort in chest, upper stomach, or throat


• unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

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


• bloated


• discouragement


• dreams


• excess air or gas in stomach or intestines


• excitation


• feeling sad or empty


• full feeling


• general feeling of discomfort or illness


• irritability


• lack of appetite


• loss of interest or pleasure


• passing gas


• sleepiness


• sleeplessness


• trouble concentrating


• trouble sleeping


• unable to sleep

Less common

• Continuing ringing or buzzing or other unexplained noise in ears


• disturbed color perception


• double vision


• halos around lights


• hearing loss


• loss of vision


• night blindness


• overbright appearance of lights


• tunnel vision


• weight loss

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: Orudis side effects (in more detail)

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More Orudis resources

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

• Orudis MedFacts Consumer Leaflet (Wolters Kluwer)


• Orudis Prescribing Information (FDA)


• Ketoprofen Professional Patient Advice (Wolters Kluwer)


• Ketoprofen Monograph (AHFS DI)


• Ketoprofen Prescribing Information (FDA)


• Actron Concise Consumer Information (Cerner Multum)


• Oruvail Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Orudis with other medications

• Back Pain
• Fever
• Frozen Shoulder
• Gout, Acute
• Osteoarthritis
• Pain
• Period Pain
• Rheumatoid Arthritis
• Sciatica

Orthovisc

Pronunciation: hye-a-loo-ROE-nan
Generic Name: Hyaluronan
Brand Name: Orthovisc

Orthovisc is used for:

Treating knee pain in patients with osteoarthritis who have not received relief from other treatments.

Orthovisc is a hyaluronic acid derivative. It works by increasing the effectiveness of the fluid within the knee joint to act as a lubricant and shock absorber.

Do NOT use Orthovisc if:

• you are allergic to any ingredient in Orthovisc or to birds or bird products (eg, eggs, feathers, poultry)


• you have an infection or skin disease near the joint or injection site

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

Before using Orthovisc:

Some medical conditions may interact with Orthovisc. 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 Orthovisc. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Quaternary ammonium salts because side effects may occur

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

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

• Orthovisc comes with an additional patient leaflet. Read it carefully and reread it each time you get Orthovisc refilled.


• Orthovisc is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Orthovisc at home, carefully follow the injection procedures taught to you by your health care provider.


• If Orthovisc contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Orthovisc, contact your doctor to establish a new dosing schedule.

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

Important safety information:

• Orthovisc is usually given as a series of injections 1 week apart for a total of 3 or 4 injections. You may not experience pain relief until after the third injection.


• You may experience a temporary inflammation in your knee after using Orthovisc. If the inflammation is severe or continues, contact your doctor.


• Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting) for at least 48 hours after you are injected with Orthovisc.


• Use Orthovisc with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


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

Possible side effects of Orthovisc:

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:

Mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

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

Severe allergic reactions (rash; hives; 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: Orthovisc 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 Orthovisc:

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

General information:

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


• Orthovisc 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 Orthovisc. 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 Orthovisc resources

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

• Orthovisc Advanced Consumer (Micromedex) - Includes Dosage Information


• Orthovisc Consumer Overview

Compare Orthovisc with other medications

• Osteoarthritis

Oruvail

Generic Name: ketoprofen (Oral route)

kee-toe-PROE-fen

Oral route(Tablet;Capsule;Capsule, Extended Release)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ketoprofen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Orudis


• Orudis KT


• Oruvail

Available Dosage Forms:

• Tablet, Extended Release


• Tablet


• Capsule, Extended Release


• Capsule


• Tablet, Enteric Coated

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Oruvail

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ketoprofen can be used to treat menstrual cramps and other conditions as determined by your doctor .

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

Before Using Oruvail

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoprofen in children below 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ketoprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ketoprofen .

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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.

• Ketorolac


• Pentoxifylline

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.

• Abciximab


• Ardeparin


• Argatroban


• Aspirin


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Warfarin


• Zimeldine

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.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Anemia or


• Asthma or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• High blood pressure or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding or


• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use of ketoprofen

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

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

To lessen stomach upset, you may take this medicine with food, milk, or antacid unless your doctor tells you otherwise .

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 (capsules):
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults—At first, 75 milligrams (mg) three times a day or 50 mg four times a day. Your doctor may increase your dose, if necessary, up to a total of 300 mg a day.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For mild to moderate pain or menstrual cramps:
    
    • Adults—25 to 50 mg every six to eight hours as needed. Some people may need to take as much as 75 mg every six to eight hours. Doses larger than 75 mg are not likely to give better relief.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  


• For oral dosage form (extended-release capsules):
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults—200 mg once a day, in the morning or evening. Take the medicine at the same time every 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Oruvail

It is very important that your doctor 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. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Oruvail 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:

More common

• Abdominal pain


• bloody urine


• decreased frequency or amount of urine


• headache


• increased blood pressure


• increased thirst


• loss of appetite


• lower back or side pain


• nausea


• swelling of face, fingers, feet, or lower legs


• troubled breathing


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Bladder pain


• cloudy urine


• difficult, burning, or painful urination


• frequent urge to urinate


• rash


• swelling or inflammation of the mouth

Rare

• Back pain


• bleeding from rectum


• bleeding gums


• blistering, peeling, loosening of skin


• blood in vomit


• bloody nose


• bloody, black, or tarry stools


• blurred vision


• body aches or pain


• burning feeling in chest or stomach


• burning, dry or itching eyes


• change in color of eye


• chest pain


• chills


• clay-colored stools


• cold hands and feet


• coma


• confusion


• congestion


• constipation


• convulsions


• cough or hoarseness


• coughing or spitting up blood


• cracks in the skin


• dark urine


• decreased urination


• decreased vision or other changes in vision


• diarrhea


• difficult or labored breathing


• difficulty swallowing


• dilated neck veins


• discharge, excessive tearing


• dryness or soreness of throat


• extreme fatigue


• fast, irregular, pounding, or racing heartbeat or pulse


• feeling faint, dizzy, or lightheadedness


• feeling of warmth or heat


• fever with or without chills


• flushing or redness of skin, especially on face and neck


• general tiredness and weakness


• heartburn


• hives or welts


• increased sensitivity of skin to sunlight


• indigestion


• itching


• joint or muscle pain


• light-colored stools


• loss of heat from the body


• muscle pain or cramps


• nervousness


• noisy breathing


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red or purple spots on skin


• pounding in the ears


• problems with bleeding or clotting


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


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness or other discoloration of skin


• redness or soreness around fingernails or loosening of the fingernails


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


• runny nose


• scaly skin


• severe abdominal cramping


• severe or continuing stomach pain


• severe sunburn


• shortness of breath


• skin rash, encrusted, scaly and oozing


• slow heartbeat


• slow or irregular breathing


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


• stomach pain or upset


• sweating


• swelling of face, ankles, or hands


• tender, swollen glands in neck


• tenderness in stomach area


• tightness in chest


• trouble in swallowing


• troubled breathing with exertion


• unpleasant breath odor


• unusual bleeding or bruising


• upper right abdominal pain


• voice changes


• vomiting of blood


• vomiting of material that looks like coffee grounds, severe and continuing


• wheezing


• yellow eyes or skin

Symptoms of overdose

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


• fast or shallow breathing


• pain or discomfort in chest, upper stomach, or throat


• unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

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


• bloated


• discouragement


• dreams


• excess air or gas in stomach or intestines


• excitation


• feeling sad or empty


• full feeling


• general feeling of discomfort or illness


• irritability


• lack of appetite


• loss of interest or pleasure


• passing gas


• sleepiness


• sleeplessness


• trouble concentrating


• trouble sleeping


• unable to sleep

Less common

• Continuing ringing or buzzing or other unexplained noise in ears


• disturbed color perception


• double vision


• halos around lights


• hearing loss


• loss of vision


• night blindness


• overbright appearance of lights


• tunnel vision


• weight loss

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: Oruvail side effects (in more detail)

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

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

More Oruvail resources

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

• Oruvail Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Oruvail Monograph (AHFS DI)


• Ketoprofen Professional Patient Advice (Wolters Kluwer)


• Ketoprofen MedFacts Consumer Leaflet (Wolters Kluwer)


• Ketoprofen Prescribing Information (FDA)


• Actron Concise Consumer Information (Cerner Multum)


• Orudis Prescribing Information (FDA)

Compare Oruvail with other medications

• Back Pain
• Fever
• Frozen Shoulder
• Gout, Acute
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• Pain
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• Rheumatoid Arthritis
• Sciatica

Ortho Guard

Dosage Form: gel, dentifrice

ACTIVE INGREDIENT

ACTIVE INGREDIENT (IN EACH 10 ml) 

SODIUM FLUORIDE 4.4 mg  PURPOSE - ANTICAVITY

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS: DEMINERALIZED WATER, MONOSODIUM PHOSPHATE, SODIUM BENZOATE, SODIUM SACCHARIN, ARTIFICIAL COLORING, ARTIFICIAL FLAVORING

USE

AIDS IN THE PREVENTION OF DENTAL DECAY

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

ADULTS AND CHILDREN 6 YEARS AND OLDER

USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE.  VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING.  INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING.

CHILDREN UNDER 6

CONSULT A DENTIST OR PHYSICIAN

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

QUESTIONS ? COMMENTS ?

QUESTIONS? COMMENTS?  CALL 1-479-787-5168 M-F 9 am TO 5pm CST

Warnings

WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.

IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR RINSING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

PACKAGE LABEL

ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE 0.044% SODIUM FLUORIDE IN AN ACIDULATED PHOSPHATE TOPICAL SOLUTION.  MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE AR (479) 787-5168.  WWW.MASSCODENTAL.NET

Ortho Guard  sodium fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-400 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE   SODIUM BENZOATE   SACCHARIN SODIUM

Product Characteristics Color      Score      Shape Size Flavor MINT (ICY COOL MINT) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-400-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Ortho Guard  sodium fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-401 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE   SODIUM BENZOATE   SACCHARIN SODIUM

Product Characteristics Color      Score      Shape Size Flavor GRAPE (GRAPE) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-401-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Ortho Guard  sodium fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-402 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE   SODIUM BENZOATE   SACCHARIN SODIUM

Product Characteristics Color      Score      Shape Size Flavor ORANGE (ORANGE) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-402-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1998

Ortho Guard  sodium fluoride  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-403 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE .044 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE   SODIUM BENZOATE   SACCHARIN SODIUM

Product Characteristics Color      Score      Shape Size Flavor STRAWBERRY (STRAWBERRY) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63783-403-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/1989

Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Establishment
Name	Address	ID/FEI	Operations
Massco Dental A Division of Dunacin Pharmaceuticals		008081858	manufacture

Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals

Ortho-Cept

Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)

Brand Names: Apri, Cesia, Cyclessa, Desogen, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet

What is Ortho-Cept (ethinyl estradiol and desogestrel)?

Ethinyl estradiol and desogestrel 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 desogestrel are used as contraception to prevent pregnancy.

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

What is the most important information I should know about Ortho-Cept (ethinyl estradiol and desogestrel)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by 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 Ortho-Cept (ethinyl estradiol and desogestrel)?

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). Do not use this medication if you have:

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  a history of a stroke or blood clot;

  
  


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  circulation problems (especially if caused by diabetes);

  
  


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

  
  


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  abnormal vaginal bleeding;

  
  


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  liver disease or liver cancer;

  
  


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  severe high blood pressure;

  
  


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  severe migraine headaches;

  
  


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  a heart valve disorder; or

  
  


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  a history of jaundice caused by birth control pills.

  
  

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dosage adjustment or special tests to safely take birth control pills.

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

  
  


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  high cholesterol or if you are overweight;

  
  


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  a history of depression;

  
  


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  gallbladder disease;

  
  


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  diabetes;

  
  


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  seizures or epilepsy;

  
  


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  a history of irregular menstrual cycles; or

  
  


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

  
  

The hormones in birth control pills 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 Ortho-Cept (ethinyl estradiol and desogestrel)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will 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 to have any type of medical tests or surgery, 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 see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.

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 following the missed pills.

If you miss two "active" pills in a row in week 3, 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 three "active" tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on 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 if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Ortho-Cept (ethinyl estradiol and desogestrel)?

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

This medication 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.

Ortho-Cept (ethinyl estradiol and desogestrel) side effects

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

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

  
  


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

  
  


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

  
  


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  a change in the pattern or severity of migraine headaches;

  
  


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  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


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  swelling in your hands, ankles, or feet;

  
  


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  a breast lump; or

  
  


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

  
  

Less serious side effects may include:

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  mild nausea, vomiting, bloating, stomach cramps;

  
  


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  breast pain, tenderness, or swelling;

  
  


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  freckles or darkening of facial skin;

  
  


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  increased hair growth, loss of scalp hair;

  
  


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  changes in weight or appetite;

  
  


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  problems with contact lenses;

  
  


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  vaginal itching or discharge;

  
  


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  changes in your menstrual periods, decreased sex drive; or

  
  


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  headache, nervousness, dizziness, tired feeling.

  
  

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

What other drugs will affect Ortho-Cept (ethinyl estradiol and desogestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:

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  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


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  an antibiotic;

  
  


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  phenylbutazone (Azolid, Butazolidin);

  
  


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  St. John's wort;

  
  


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  seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;

  
  


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  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


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  HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

  
  

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

More Ortho-Cept resources

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

• Ortho-Cept Prescribing Information (FDA)


• Ortho-Cept MedFacts Consumer Leaflet (Wolters Kluwer)


• Apri Prescribing Information (FDA)


• Caziant Prescribing Information (FDA)


• Cesia Prescribing Information (FDA)


• Cyclessa Prescribing Information (FDA)


• Cyclessa Advanced Consumer (Micromedex) - Includes Dosage Information


• Desogen Prescribing Information (FDA)


• Desogen Consumer Overview


• Emoquette Prescribing Information (FDA)


• Kariva Prescribing Information (FDA)


• Mircette Consumer Overview


• Mircette Prescribing Information (FDA)


• Reclipsen Prescribing Information (FDA)


• Solia Prescribing Information (FDA)


• Velivet Prescribing Information (FDA)

Compare Ortho-Cept with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Polycystic Ovary Syndrome

Where can I get more information?

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

See also: Ortho-Cept side effects (in more detail)