Arthrotec

Name: Arthrotec

Is diclofenac and misoprostol available as a generic drug?

GENERIC AVAILABLE: No

How to use

Read the Patient Information Leaflet and the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug.Swallow this medication whole. Do not crush, chew, or dissolve the tablets. Doing so may increase side effects.Take this medication with food to prevent stomach upset and to reduce the chances of diarrhea. Avoid taking antacids that contain magnesium while using this medication because they may worsen diarrhea. If you need an antacid, consult your doctor or pharmacist to help you choose a product.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To minimize side effect risks (e.g., stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For ongoing conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.Take this medication regularly in order to get the most benefit from it. Remember to take it at the same times each day. It may take up to 2 weeks of regular use before the full benefits of this medication take effect.Inform your doctor if your condition worsens.

US Brand Name

  1. Arthrotec

Precautions While Using Arthrotec

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.

Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using this medicine and after treatment ends. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. Also, you must have a negative pregnancy test within 2 weeks before you will be allowed to take this medicine. If you think you have become pregnant while using this medicine, stop taking this medicine and tell your doctor right away.

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, are over 60 years of age, are in poor health, or are using certain medicines (such as a steroid medicine or a blood thinner).

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

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 the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Call your doctor right away if you have confusion, drowsiness, fever, general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of aseptic meningitis.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

This medicine may cause diarrhea in some people. The diarrhea will usually disappear within a few days as your body adjusts to the medicine. However, check with your doctor if the diarrhea is severe or does not stop after a week.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor.

Taking nonsteroidal anti-inflammatory drugs (eg, acetaminophen, aspirin or other salicylates, or ketorolac, ToradolĀ®) together with this medicine on a regular basis may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take everyday, and on how long you take the medicine together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (eg, ToradolĀ®) while you are taking this medicine, unless your doctor has directed you to do so and is following your progress.

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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Very bad belly pain.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Feeling very tired or weak.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Arthrotec, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Arthrotec. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Arthrotec.

Review Date: October 4, 2017

Arthrotec Dosage and Administration

Carefully consider the potential benefits and risks of Arthrotec and other treatment options before deciding to use Arthrotec. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

After observing the response to initial therapy with Arthrotec, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of rheumatoid arthritis and osteoarthritis, the dosage is given below.

Arthrotec is administered as Arthrotec 50 (50 mg diclofenac sodium/200 mcg misoprostol) or as Arthrotec 75 (75 mg diclofenac sodium/200 mcg misoprostol).

Note: See Special Dosing Considerations section below.

For osteoarthritis, the dosage for maximal GI mucosal protection is Arthrotec 50 three times a day. For patients who experience intolerance, Arthrotec 75 two times a day or Arthrotec 50 two times a day can be used, but are less effective in preventing ulcers. This fixed combination product, Arthrotec, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

OA regimen Diclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
Arthrotec 50 three times a day 150 600
two times a day 100 400
Arthrotec 75 two times a day 150 400

For rheumatoid arthritis, the dosage is Arthrotec 50 three or four times a day. For patients who experience intolerance, Arthrotec 75 two times a day or Arthrotec 50 two times a day can be used, but are less effective in preventing ulcers. This fixed combination product, Arthrotec, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

RA regimen Diclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
Arthrotec 50 four times a day 200 800
three times a day 150 600
two times a day 100 400
Arthrotec 75 two times a day 150 400

Special Dosing Considerations:

Arthrotec contains misoprostol, which provides protection against gastric and duodenal ulcers [see Clinical Studies (14)]. For gastric ulcer prevention, the 200 mcg four and three times a day regimens are therapeutically equivalent, but more protective than the two times a day regimen. For duodenal ulcer prevention, the four times a day regimen is more protective than the three or two times a day regimens. However, the four times a day regimen is less well tolerated than the three times a day regimen because of usually self-limited diarrhea related to the misoprostol dose [see Adverse Reactions (6.1)], and the two times a day regimen may be better tolerated than three times a day in some patients.

Dosages may be individualized using the separate products (misoprostol and diclofenac), after which the patient may be changed to the appropriate dose of Arthrotec. If clinically indicated, misoprostol co-therapy with Arthrotec, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

When concomitant use of CYP2C9 inhibitors is necessary, the total daily dose of diclofenac should not exceed the lowest recommended dose of Arthrotec 50 two times a day.

For additional information, it may be helpful to refer to the package inserts for misoprostol and diclofenac.

How Supplied/Storage and Handling

Arthrotec (diclofenac sodium/misoprostol) is supplied as a film-coated tablet in dosage strengths of either 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol. The 50 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with four "A's" encircling a "50" in the middle on one side and "SEARLE" and "1411" on the other. The 75 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with four "A's" encircling a "75" in the middle on one side and "SEARLE" and "1421" on the other.

The dosage strengths are supplied in:

Strength NDC Number Size
50/200 0025-1411-60 bottle of 60
0025-1411-90 bottle of 90
0025-1411-34 carton of 100 unit dose
75/200 0025-1421-60 bottle of 60
0025-1421-34 carton of 100 unit dose

Store at or below 25°C (77°F), in a dry area.

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.

  • Ankle Pain
  • Rheumatoid Arthritis (RA)

What should I avoid while taking Arthrotec?

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

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb Arthrotec.

Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.

Avoid taking aspirin or other NSAIDs.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Diclofenac / misoprostol Breastfeeding Warnings

Two small studies including a total of 22 lactating women found very low levels of misoprostol acid, a biologically active metabolite, in breast milk. The maximum concentration in the breast milk occurred 1 hour after the dose. The data on excretion of diclofenac into breast milk is limited. It does appear to pass in small amounts. Some experts consider this drug to be acceptable during breast feeding, however other agents have more published information and may be preferred, especially when nursing a newborn or preterm infant.

Use is not recommended. Excreted into human milk: Yes (diclofenac, misoprostol) Comments: The effects in the nursing infant are unknown; however diarrhea is a recognized side effect of misoprostol and could occur in the infant.

(web3)