Dolofarmalan gel

Dolofarmalan

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

The active ingredient of Dolofarmalan 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

Dolofarmalan 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 Dolofarmalan include: tightness in the chest; hearing loss; constipation; loss of consciousness; depression.

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  • Gastrointestinal risk
    • NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
    • GI adverse events may occur at any time during use and without warning symptoms
    • Elderly patients are at greater risk for serious GI events

This medication contains Dolofarmalan. Do not take Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, or Zorvolex if you are allergic to Dolofarmalan or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

2. Key facts

  • Take Dolofarmalan tablets or capsules with a meal or snack, or just after eating.
  • It's best to take the lowest dose of Dolofarmalan for the shortest time to control your symptoms.
  • The most common side effects are headaches, dizziness, stomach pain, feeling or being sick, diarrhoea and rashes.
  • Dolofarmalan tablets come as either Dolofarmalan potassium or Dolofarmalan sodium. They work as well as each other.
  • Dolofarmalan is also called by the brand names Voltarol, Dicloflex, Econac and Fenactol.

Allergy warning

If you have an allergy to aspirin or other similar NSAIDs, such as ibuprofen or naproxen, you could have an allergic reaction to Dolofarmalan. Call your doctor right away if you have any signs of:

  • wheezing
  • trouble breathing
  • hives
  • itchy rash

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t use this drug again if you’ve ever had an allergic reaction to it. Using it again could be fatal (cause death).

Before taking this medicine

Dolofarmalan can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Dolofarmalan may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use Dolofarmalan if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not use Cambia to treat a cluster headache. Do not use Zipsor if you are allergic to beef or beef protein.

To make sure Dolofarmalan is safe for you, tell your doctor if you have:

heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

a history of heart attack, stroke, or blood clot;

a history of stomach ulcers or bleeding;

liver or kidney disease;

Taking Dolofarmalan during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Dolofarmalan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Dolofarmalan is not approved for use by anyone younger than 18 years old.

How should I take Dolofarmalan?

Different brands of Dolofarmalan contain different amounts of this medicine, and may have different uses. If you switch brands, your dose needs may change. Follow your doctor's instructions about how much medicine to take. Ask your pharmacist if you have any questions about the brand you receive at the pharmacy.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Take Zorvolex on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not crush, chew, or break an extended-release tablet or delayed-release tablet. Swallow it whole.

Dissolve Cambia powder in to 2 ounces of water. Do not use any other type of liquid. Stir this mixture and drink all of it right away. Cambia works best if you take it on an empty stomach.

Call your doctor if your headache does not completely go away after taking Cambia. Do not take a second dose of Dolofarmalan powder without your doctor's advice. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

If you use Dolofarmalan long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Dolofarmalan Dosage

Dolofarmalan comes in several brands with different formulations, so depending on the brand and the condition you are treating, the recommended dose may range from 50 milligrams (mg) to 100 mg in eight- to 12-hour intervals.

You should take no more than 225 mg in a day of the regular-release form. Doses of the extended-release form should not exceed 200 mg in a day.

Always take Dolofarmalan with at least 8 ounces of water. Dolofarmalan can be very hard on the stomach, so for best results, try taking it with food or milk.

It may also help to take a drug that reduces your stomach acid, but some antacids interact with Dolofarmalan, so you should talk to your doctor about what to take and how to time it with your Dolofarmalan doses.

Another option is to ask your doctor to write a prescription for Arthrotec, a combination drug that contains Dolofarmalan and a stomach-protecting drug called misoprostol. If the prescription for Arthrotec is too expensive, ask your doctor to consider writing two separate prescriptions for Dolofarmalan and misoprostol.

Rated Dolofarmalan for Moderate Pain Report

Car accident 2 yrs ago caused lineal tears between my L3-L4; buldging disc & lots of pain. Recent carpal tunnel surgery also. Back Dr percribed Dicloefenac 100mg ER. I took it for weeks, one tablet daily. I experienced nausea & pretty severe stomach aches, some diarrhea then I stopped the Dolofarmalan. I had a follow up appt with my orthopedist & he said “be careful taking that stuff.” I decided to stop taking it because I hated th nausea & severe abdominal pain, burning sensation like having an ulcer. I decided to stop taking the Dolofarmalan. On day 3, I woke up & could hardly move. My back was killing me & I honestly haven’t felt this type of back pain since I can remember. All I could do was lay on the heating pad & take a narcotic pain med. I have realized maybe I would rather deal with the stomach pain and take nausea meds and Prilosec to coat the tummy than deal with this pain again. I see the spine dr again in a week. Will discuss further but I can say this medication is amazing restoring your quality of life without pain, IF you can tolerate side effects. Best wishes to you

What Other Drugs Interact with Dolofarmalan?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of Dolofarmalan include:

Serious Interactions of Dolofarmalan include:

Dolofarmalan has moderate interactions with at least 247 different drugs.

Dolofarmalan has mild interactions with at least 109 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

HOW SUPPLIED

VOLTAREN ® (Dolofarmalan sodium enteric-coated tablets)

75 mg - light pink, biconvex, triangular-shaped, enteric-coated tablets (imprinted VOLTAREN 75 on one side in black ink)

Bottles of 100 - NDC 0028-0264-01

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .

Protect from moisture.

Dispense in tight container (USP).

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936. Revised: May 2016

Rated Dolofarmalan for Osteoarthritis Report

I had my hip replaced 2 years ago. My hip was dead before so I have nothing bad to say about having my hip replaced other than the fact that I had a mild pain all the time and then is severe pain every once in awhile. The effects of the pain made me make choices of things I would do and wouldn't do. This drug it's a lifesaver it is made my life normal again like it was before I had my hip replaced with physical therapy in this drug I believe I will get back to normal again I did not believe that before.

What should I do if I forget a dose?

The powder for solution is usually taken as needed for migraine headaches. If you are taking any other Dolofarmalan product and you forget to take a dose, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Rated Dolofarmalan for Myalgia Report

The Oral Dolofarmalan was horrendous on my stomach from the first pill. Didn't help with all over connective tissue pain. Stopped taking it after 2 pills. That Said: the Topical Dolofarmalan gel works miracles on almost All types of pain including arthritis to muscle and even headaches. I rub this gel (light cream) into all parts of body and the pain is either reduced or completely gone. Don't be concerned about the amount of topical gel you rub into the body as only a tiny (less than 4 percent) of the active ingredient makes it into the body causing issues. No issues at all with the topical and many doctors and patients view this gel as a real pain reducer. I have literally rubbed this gel onto arms, legs, back, neck and forehead and horrendous pain reduced hugely. With the war on opioids being waged against chronic pain patients this is one fantastic pain reducing weapon. Slather this on, rub it in, but do Not take the oral version of Dolofarmalan.

Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects (see WARNINGS; Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation, Hepatotoxicity, Renal Toxicity and Hyperkalemia, PRECAUTIONS; Laboratory Monitoring ).

Dolofarmalan is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (See CLINICAL PHARMACOLOGY, ADVERSE REACTIONS).

Can you take Dolofarmalan and Ibuprofen together?

No, these drugs should not be used together, as they are from the same class, thus their effects will become additive increasing the risk of side effects such as bleeding and gastrointestinal ulcers to happen.

If you need additional medicine for your pain relieving treatment, and you already use Dolofarmalan or ibuprofen consult your doctor. Your doctor may prescribe you acetaminophen of 500 mg as additional treatment, because it is much safer to be combined with ibuprofen or Dolofarmalan.

What are the uses for Dolofarmalan?

Dolofarmalan is used to relieve the signs and symptoms of:

Other NSAIDs

Dolofarmalan 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:

Blood pressure drugs

Dolofarmalan may decrease the blood pressure-lowering effects of some drugs used to control blood pressure. Using Dolofarmalan with certain blood pressure medications may also increase your risk of kidney damage.

Examples of these blood pressure drugs include:

  • angiotensin-converting enzyme (ACE) inhibitors, such as benazepril, captopril, enalapril, and lisinopril
  • angiotensin II receptor blockers, such as candesartan, irbesartan, losartan, and olmesartan
  • beta blockers, such as acebutolol, atenolol, metoprolol, and propranolol
  • diuretics (water pills) such as furosemide or hydrochlorothiazide

Histopathology

Dolofarmalan 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.

Contraindications

  • Absolute: Hypersensitivity to Dolofarmalan, history of aspirin triad, treatment of perioperative pain associated with CABG; active gastrointestinal bleeding
  • IV: Moderate-to severe renal insufficiency in the perioperative period and patients who are at risk for volume depletion
  • Zipsor capsules are contraindicated in patients with history of hypersensitivity to bovineprotein

Effects of Drug Abuse

  • Agent is potent diuretic that, if given in excessive amounts, may lead to profound diuresis with water and electrolyte depletion

  • Increase in transaminase levels reported within 2 months of therapy; may occur at any time; monitor transaminase levels periodically beginning 4-8 weeks after initiation of therapy
  • See "What Are Side Effects Associated with Using Dolofarmalan?"

  • Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liverdysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
  • See "What Are Side Effects Associated with Using Dolofarmalan?"

  • Use caution in patients with bronchospasm, cardiac disease, CHF, hepaticporphyria, hypertension, fluid retention, severe renal impairment, smoking, systemic lupus erythematosus
  • Platelet aggregation and adhesion may be decreased; may prolong bleeding time
  • Use caution in blood dyscrasias or bone marrowdepression; also with thrombocytopenia, agranulocytosis, and aplastic anemia
  • Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
  • Therapy may increase risk of hyperkalemia, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely
  • May cause dizziness blurred vision and neurologic effects that may impair physical and mental abilities
  • Risk of serious skin reactions, including Stevens Johnson syndrome and necrotizing enterocolitis
  • Persistent urinary symptoms, including bladder pain and dysuria, hematuria or cystitis may occur after initiating therapy; discontinue therapy with symptomonset and evaluate cause
  • Increase in transaminase levels reported within 2 months of therapy; may occur at any time; monitor transaminase levels periodically beginning 4-8 weeks after initiation of therapy
  • May increase risk of asepticmeningitis (rare), especially in patients with systemiclupus erythematous, and mixed connective tissue disorders
  • Use caution if patient dehydrated before initiating therapy; rehydrate patient before initiating therapy and monitor renal function closely
  • Injectable dosage form not recommended for long-term use
  • Different formulations not bioequivalent even if milligram strength the same; do not interchange products
  • Withhold for at least 4-6 half-lives prior to surgical or dental procedures
  • NSAIDs have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascularresistance, and blunted response to diuretics
  • NSAIDs should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016;134

Is Dolofarmalan safe to take if I'm pregnant or breastfeeding?

It is not known whether Dolofarmalan is excreted in breast milk.


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