Diclox tablets

Diclox

  • Active Ingredient: Diclofenac
  • 100 mg
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What is Diclox?

The active ingredient of Diclox brand is diclofenac. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. The inactive ingredients in Diclofenac sodium delayed-release tablets include: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Used for

Diclox is used to treat diseases such as: Ankylosing Spondylitis, Aseptic Necrosis, Back Pain, Frozen Shoulder, Migraine, Muscle Pain, Osteoarthritis, Pain, Period Pain, Rheumatoid Arthritis, Sciatica, Spondyloarthritis.

Side Effect

Possible side effects of Diclox include: puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; belching; constipation; change in consciousness; dizziness; troubled breathing with exertion.

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Alcohol interaction warning

Avoid drinking alcohol when using this drug. Alcohol can increase your risk of stomach ulcers from using Diclox.

DiureticsClinical Impact:Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.Intervention:During concomitant use of VOLTAREN with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects (see WARNINGS; Renal Toxicity And Hyperkalemia).DigoxinClinical Impact:The concomitant use of Diclox with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.Intervention:During concomitant use of VOLTAREN and digoxin, monitor serum digoxin levels.LithiumClinical Impact:NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.Intervention:During concomitant use of VOLTAREN and lithium, monitor patients for signs of lithium toxicity.MethotrexateClinical Impact:Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).Intervention:During concomitant use of VOLTAREN and methotrexate, monitor patients for methotrexate toxicity.CyclosporineClinical Impact:Concomitant use of VOLTAREN and cyclosporine may increase cyclosporine’s nephrotoxicity.Intervention:During concomitant use of VOLTAREN and cyclosporine, monitor patients for signs of worsening renal function.NSAIDs and SalicylatesClinical Impact:Concomitant use of Diclox with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).Intervention:The concomitant use of Diclox with other NSAIDs or salicylates is not recommended.PemetrexedClinical Impact:Concomitant use of VOLTAREN and pemetrexed may increase the risk of pemetrexedassociated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).Intervention:

During concomitant use of VOLTAREN and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.

NSAIDs with short elimination half-lives (e.g., Diclox, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.

In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.

CYP2C9 Inhibitors or Inducers: Clinical Impact: Diclox is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of Diclox with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of Diclox whereas coadministration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of Diclox. Intervention: A dosage adjustment may be warranted when Diclox is administered with CYP2C9 inhibitors or inducers (see CLINICAL PHARMACOLOGY; Pharmacokinetics).

3. Who can take and can't take Diclox

Most adults can take Diclox.

Children may be prescribed Diclox to treat joint problems. Diclox tablets, capsules and suppositories are suitable for children aged 1 year and above.

Diclox isn't suitable for certain people.

Tell your doctor or pharmacist if you have:

  • had an allergic reaction to Diclox or any other medicines in the past
  • an allergy to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen or naproxen
  • ever had signs of asthma (wheezing), a runny nose, swelling of the skin (angioedema) or a rash after taking NSAIDs
  • ever had stomach ulcers, bleeding in the stomach or intestines, or a hole in your stomach
  • high blood pressure (hypertension)
  • heart failure, or severe liver disease or kidney disease
  • Crohn's disease or ulcerative colitis
  • lupus
  • a blood clotting disorder

Tell your doctor or pharmacist if you're pregnant, planning to become pregnant, or breastfeeding.

Diclox Warnings

Diclox has two black-box warnings:

  • Diclox can increase the risk of heart trouble and has been linked to heart attacks, strokes, and blood clots — all of which can be deadly. Get emergency medical help right away if you experience signs of stroke or heart problems, such as chest pain, shortness of breath, changes in speech, or other unusual symptoms.
  • Diclox can damage the lining of your stomach, putting you at risk for stomach ulcers and heartburn. Tell your doctor if you have stomach pain, nausea, or black or tarry stools.

If you are about to have heart surgery, especially a procedure called coronary artery bypass graft (CABG), you should not take Diclox.

If you suffer from a condition known as the “aspirin triad,” where you have allergic reactions to aspirin or other NSAIDs and develop polyps or growths in the nose, you should not take Diclox.

You should also be careful taking Diclox and first speak to your doctor if you:

  • Have ever had asthma or a strong allergic reaction, such as hives, to aspirin or other NSAIDs
  • Congestive heart failure (CHF), recent heart attack, or high blood pressure
  • Have a tendency to retain fluid
  • Have a bleeding ulcer
  • Smoke or are a heavy drinker
  • Kidney or liver problems
  • Any condition that includes abnormal activity of the bone marrow
  • Any bleeding disorders, including poor clotting or blood cell abnormalities

Do not take Diclox if you are allergic to it or any of its inactive ingredients.

What Are Side Effects Associated with Using Diclox?

Side effects associated with use of Diclox, include the following:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Diclox is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1). Food has no significant effect on the extent of Diclox absorption. However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of PK Parameter Normal Healthy Adults (20-48 years) Mean Coefficient of Mean Variation (%) Absolute Bioavailability (%) 55 40 Tmax (hr) 2.3 69 Oral Clearance (CL/F; mL/min) 582 23 Renal Clearance (% unchanged drug in urine)

How to use Diclox 1 % Topical Gel

Read the Medication Guide and Patient Instructions for Use provided by your pharmacist before you start using Diclox and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use on the skin only. To measure the right dose, use the dosing card(s) provided with the medication. Place a dosing card on a flat surface so that you can read the print on the card. Squeeze an even line of the medication from the tube onto the dosing card, using the marks on the card to measure the prescribed dose. Gently rub the medication into the entire affected joint, usually 4 times daily or as directed by your doctor. You may use the dosing card to apply the medication. Do not apply the medication on skin that has cuts, infections, or rashes.

If the package instructions direct you to reuse the dosing card, then after each use, hold the card with your fingertips, rinse, and dry. When you are ready to discard the dosing card, fold the card in half with the medication side inside and throw away out of the reach of children and pets. Wash your hands after using the medication unless you are using it to treat the hands. Do not shower, bathe, or wash any treated areas for at least an hour after applying the medication. Wait at least 10 minutes before covering the treated area with gloves or clothing. Do not wrap, bandage, or apply heat (such as a heating pad) to the treated area.

The dosage is based on your medical condition and response to treatment. Do not apply more than 16 grams of Diclox per day to any single joint of the lower body (such as knee, ankle, foot). Do not apply more than 8 grams of Diclox per day to any single joint of the upper body (such as hand, wrist, elbow). No matter how many joints you are treating, do not use more than a total of 32 grams of Diclox per day.

Discuss the risks and benefits of using this drug with your doctor or pharmacist. To reduce the risk of side effects, use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, use it more often than prescribed, or apply the medication to any area not prescribed by your doctor.

Do not get the medication in the eyes, nose, or mouth. If you do get the medication in those areas, flush with plenty of water. Contact your doctor right away if irritation persists.

For certain conditions (such as arthritis), it may take up to 2 weeks of using this drug regularly until you get the full benefit.

If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Tell your doctor if your pain persists or worsens.

Rated Diclox for Osteoarthritis Report

I started taking 75mg in late January for horrible knee pain. This drug works great for pain. Within days I no longer hurt and really didn’t think I had a knee problem anymore. I was bone on bone knees and told I needed surgery. I took this drug twice a day and no problems at all until first if March. Started having eye problems and cornea abrasions appeared on both eyes and there had been no injuries of any kind. After weeks of eye treatments the eyes were not healing, I was referred to a cornea specialist. He told me to stop the drug that day, I did and two days later was healing finally. We have determined that if someone already has eye issues like dry severe dry eyes, etc. this drug could cause the abrasions. For me it did and now I’m afraid to take any NSAID of any kind. I know several friends who have taken this drug and have had no problems. I was one in a million but this problem does need to be documented. My doctor said it’s rare but he had several people with the same problem as I.

Serious Side Effects

Stop taking Diclox and get immediate medical attention if you experience any of the following:

  • Nosebleeds
  • Liver damage or inflammation of the liver (watch for yellowing or graying of the skin or eyes, swelling of the abdomen or lower extremities)
  • Low blood pressure (one sign of low blood pressure is dizziness when getting up to stand)
  • Blood disorders, such as low platelet count, decreased hemoglobin, and decreased bone marrow activity
  • Congestive heart failure (watch for swelling in your lower limbs, shortness of breath, trouble walking normal distances’, extra tiredness)
  • Bruising
  • Severe and potentially life-threatening skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (tell your doctor about any skin abnormalities; get emergency medical help right away if you have any dramatic or severe skin reactions)

DESCRIPTION

VOLTAREN ® (Diclox sodium enteric-coated tablets) is a benzene-acetic acid derivative. VOLTAREN is available as delayed-release (enteric-coated) tablets of 75 mg (light pink) for oral administration. Diclox sodium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2- benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula

The inactive ingredients in VOLTAREN include: hydroxypropyl methylcellulose, iron oxide, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium hydroxide, sodium starch glycolate, talc, titanium dioxide.

Other NSAIDs

Diclox is a nonsteroidal anti-inflammatory drug (NSAID). Don’t combine it with other NSAIDs unless directed by your doctor, as this may increase your risk of stomach and bleeding issues. Examples of other NSAIDs include:

Histopathology

Diclox hepatotoxicity is typically associated with an acute hepatitis-like histology with necrosis that may be most prominent in zone 3 (centrally). There is usually focal necrosis and inflammation, but with severe cases the injury can be confluent or submassive. Chronic hepatitis-like injury with prominence of portal inflammation, interface hepatitis and fibrosis can be found, particularly in cases with longer latency and more prolonged course. A minority of cases showed mixed hepatocellular cholestatic injury (cholestatic hepatitis) with varying degrees of inflammation. Three photomicrographs are shown.

Labor Or Delivery

There are no studies on the effects of VOLTAREN during labor or delivery. In animal studies, NSAIDS, including Diclox, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.


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