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Arthrotec (Generic Diclofenac and Misoprostol)

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WARNING

Female patients:

If you are pregnant or intend to become pregnant, avoid using diclofenac with misoprostol. When taking misoprostol and diclofenac together, if you become pregnant or suspect that you could be pregnant, stop taking the drug right away and contact your doctor. If taken during pregnancy, diclofenac and misoprostol have been linked to premature birth (baby is born too early), severe bleeding, and miscarriage (pregnancy loss).

Misoprostol and diclofenac should typically not be used by women who are or may become pregnant. However, you and your doctor might decide that a combination of misoprostol and diclofenac is necessary to address your condition. In that situation, you must:

  • Agree to take effective birth control both during and for at least one month (or one menstrual cycle) following treatment;
  • Have a negative pregnancy blood test within two weeks after beginning misoprostol and diclofenac;
  • Only start taking the drug on the second or third day of your subsequent regular menstruation.

 

Every patient:

Nonsteroidal anti-inflammatory drugs (NSAIDs) other than aspirin, such as the combination of diclofenac and misoprostol, may increase a person’s chance of suffering a heart attack or stroke compared to a person who does not take them. These occurrences could be fatal and could occur suddenly. For those who take NSAIDs for an extended period of time, this risk may be larger. If you’ve recently experienced a heart attack, avoid taking an NSAID like the diclofenac and misoprostol combo unless your doctor specifically instructs you to. Inform your doctor if you smoke, have high cholesterol, high blood pressure, or diabetes, or if you or anyone in your family has ever suffered from heart disease, a heart attack, or a stroke. If you suffer any of the following symptoms, seek emergency medical attention right away: chest pain, shortness of breath, weakness on one side or area of the body, or slurred speech.

You shouldn’t take diclofenac and misoprostol shortly before or right after having a coronary artery bypass graft (CABG; a form of cardiac surgery).

NSAIDs like diclofenac may result in stomach or intestine ulcers, bleeding, or holes. While misoprostol and diclofenac are used together to protect the stomach and intestine, some damage to these organs may still occur. Any moment throughout therapy, issues with the stomach and intestines have the potential to arise without any prior signs and to be fatal. People who use NSAIDs frequently, are older, are in poorer health, smoke, or consume substantial amounts of alcohol while taking diclofenac and misoprostol may be at higher risk. Any of the following medications should be disclosed to your doctor: Aspirin, other NSAIDs including ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and warfarin (Coumadin, Jantoven) are anticoagulants (sometimes known as “blood thinners”); oral steroids like dexamethasone, methylprednisolone (Medrol) and prednisone (Rayos); SSRIs including citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft);  or SNRIs (serotonin norepinephrine reuptake inhibitors), which include duloxetine (Cymbalta), desvenlafaxine (Khedezla), and venlafaxine (Effexor XR). Inform your doctor if you experience any stomach or intestinal bleeding or any of the following symptoms: bloody or coffee-ground-looking vomit, blood in the stool, or dark, tarry stools. prior to starting your misoprostol and diclofenac medication. Most likely, your doctor will advise against using misoprostol and diclofenac. Additionally, let your doctor know whether you now or ever had an ulcer or a bleeding issue. Call your doctor and stop taking misoprostol and diclofenac immediately if you suffer any of the following symptoms: stomach pain, heartburn, vomiting of a bloody or coffee-ground-like substance, blood in the stool, or dark, tarry stools.

Keep all of your appointments with your physician and the lab. Your doctor will keep a close eye on your symptoms and possibly recommend a few tests to see how your body is responding to the diclofenac and misoprostol. Inform your physician about your feelings so that they can prescribe the ideal dosage of medication to cure your problem with the least chance of negative side effects.

Give this medication only to those who need it, especially not to pregnant or potentially pregnant women.

When you start your therapy and each time you renew your prescription, your doctor or pharmacist will give you the patient information sheets from the manufacturer for diclofenac and misoprostol as well as the general Medication Guide for NSAIDs. If you have any questions, carefully read the material and contact your doctor or pharmacist. The patient information sheet and medication guide are also available on the Food and Drug Administration (FDA) website or the manufacturer’s website.

Why is this medication prescribed?

In patients who have a high risk of developing stomach ulcers, the drug combination of diclofenac and misoprostol is used to reduce pain, tenderness, swelling, and stiffness brought on by osteoarthritis (arthritis brought on by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis brought on by swelling of the lining of the joints). Diclofenac belongs to a group of drugs known as NSAIDs. It functions by preventing the body from producing a chemical that promotes inflammation and pain. Misoprostol belongs to the prostaglandins group of drugs. By defending the stomach lining and reducing production of stomach acid, it prevents ulcers brought on by diclofenac.

How should this medicine be used?

The oral tablet containing misoprostol and diclofenac is available for consumption. It is often taken two to four times a day with food. Take it at roughly the same times each day to help you remember to take the misoprostol and diclofenac. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take the misoprostol and diclofenac combination precisely as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole. Do not take broken or damaged tablets.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking diclofenac and misoprostol,

  • Inform your doctor and pharmacist if you have any allergies to aspirin, other NSAIDs such ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), misoprostol (Cytotec), diclofenac (Cambia, Flector, Pennsaid, Solaraze, Voltaren XR, Zipsor, Zorvolex), misoprostol or other prostaglandins (Caverject, Edex, Muse), any other drugs, including any of the inactive substances in diclofenac and misoprostol pills, including carboprost (Hemabate), dinoprostone (Cervidil, Prepidil, Prostin E2), and mifepristone (Korlym, Mifeprex). Request a list of the inactive components from your pharmacist.
  • Inform your doctor and pharmacist about any vitamins, nutritional supplements, herbal items, and prescription and over-the-counter medicines you are now taking or intend to take. Mention all of the prescription drugs listed in the IMPORTANT WARNING section as well as any of the following: ACE inhibitors include benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, and others. Angiotensin receptor blockers include losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (Atacand, in Atacand HCT). Lisinopril, moexipril, perindopril, antibiotics, beta blockers like atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran), cyclosporine (Geograf, Neoral, Sandimmune); phenobarbital, rifampin (Rifadin, Rimacatane, in Rifamate, in Rifater), tacrolimus (Astagraf, Envarsus XR, Prograf), and voriconazole (Vfend). Your doctor might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Diclofenac and misoprostol may interact with other drugs, so be sure to let your doctor know about all the ones you are taking, even if they are not on this list.
  • If you need to take an antacid throughout your treatment with diclofenac and misoprostol, consult your doctor. Magnesium-containing antacids shouldn’t be taken (Mylanta, others). Your physician could advise you to take an antacid that contains calcium or aluminium.
  • Inform your doctor if you have or have ever had any of the conditions listed in the “IMPORTANT WARNING” section, including: asthma, particularly if you also frequently have a stuffy or runny nose or nasal polyps (swelling of the lining of the nose); inflammatory bowel disease (swelling of the lining of the intestine that may cause painful or bloody diarrhoea and cramping); heart failure, liver or kidney disease, hepatic porphyria, lupus, which causes the body to attack numerous of its own tissues and organs, frequently including the skin, joints, blood, and kidneys; swelling of the hands, feet, ankles, or lower legs; and liver or kidney disease.
  • Inform your doctor if you are nursing a baby.
  • Inform the surgeon or dentist that you are taking diclofenac and misoprostol if you are having surgery, including dental surgery.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Misoprostol with diclofenac may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Bloating or gas
  • Constipation

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical assistance if you notice any of the following symptoms or those listed in the IMPORTANT WARNING section. Until you speak with your doctor, stop taking misoprostol and diclofenac.

  • Unaccounted-for weight gain
  • Respiratory issues or shortness of breath
  • Abdomen, ankles, foot, or legs swelling
  • Excessive fatigue
  • Not enough energy
  • Itching
  • Uneasy stomach
  • Reduced appetite
  • Upper right stomach region discomfort
  • Skin or eyes turning yellow
  • Flu-like signs
  • Light skin
  • Rapid heart rate
  • Headache
  • Rigid neck
  • Unwell throat
  • Muscle ache
  • Confusion
  • Light sensitivity
  • Fever
  • Blisters
  • Rash
  • Hives
  • Eye, face, lip, tongue, throat, arm, or hand swelling
  • Having trouble swallowing
  • Hoarseness
  • Extraordinary vaginal bleeding
  • Urine that is cloudy, discoloured, or bloody
  • Back ache
  • Uncomfortable or challenging urinating

 

Misoprostol with diclofenac may also have additional adverse effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

  • Abdominal pain
  • Vomiting
  • Diarrhea
  • Confusion
  • Drowsiness
  • Muscle wasting
  • Uncontrollable trembling of a body part
  • Seizures
  • Breathing difficulty
  • Fever
  • Heartbeats can be rapid, hammering, or sluggish.
  • Dizziness
  • Fainting

What other information should I know?

Inform the lab staff and your doctor that you are taking misoprostol and diclofenac prior to any laboratory test.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

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