Dicloplast tablets

Dicloplast

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

The active ingredient of Dicloplast 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

Dicloplast 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 Dicloplast include: pain in the chest below the breastbone; loss of appetite; change in consciousness; confusion; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; increased bleeding time; Agitation.

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CONTRAINDICATIONS

VOLTAREN ® is contraindicated in the following patients:

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to Dicloplast or any components of the drug product (see WARNINGS; Anaphylactic Reactions, Serious Skin Reactions).
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNINGS; Anaphylactic Reaction, Exacerbation Of Asthma Related To Aspirin Sensitivity).
  • In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS; Cardiovascular Thrombotic Events).

Primary dysmenorrhea (painful menstrual period)

The immediate release forms of Dicloplast are usually dosed 3 to 4 times a day and start at a dose of 25 mg.

The extended-release form is usually dosed once a day. The dose often starts at 75 mg per day.

Dosage for people younger than 18 years has not been established.

Seniors: If you are aged 65 years and older, your body may process this drug more slowly. Your doctor may start you on a lowered dose so that too much of this drug does not build up in your body. Too much of the drug in your body can be toxic.

Immediate action required: Call 999 or go to A&E if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you're wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of Dicloplast. For a full list, see the leaflet inside your medicine packet.

You can report any suspected side effect to the UK safety scheme.

3. Who can take and can't take Dicloplast

Most adults can take Dicloplast.

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

Dicloplast isn't suitable for certain people.

Tell your doctor or pharmacist if you have:

  • had an allergic reaction to Dicloplast 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.

Rated Dicloplast 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 Dicloplast. 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 Dicloplast. 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

  • Extended release: 100 mg orally once daily; may be increased to 100 mg orally every 12 hours

  • Dicloplast potassium: 50 mg orally every 8-12 hours
  • Dicloplast sodium: 50 mg orally every 8 hours or 75 mg orally every 12 hours
  • Extended release: 100 mg orally once daily; may be increased to 100 mg orally every 12 hours
  • Zorvolex: 35 mg orally three times/day

  • Safety and efficacy not established; drug has been used safely in limited number of children aged 3-16 years with juvenile rheumatoid arthritis
  • Children younger than 3 years: Safety and efficacy not established
  • Children 3 years and older: 2-3 mg/kg/day for up to 4 weeks

  • Dicloplast sodium: 25 mg orally 4 or 5 times daily
  • Dicloplast potassium: 50 mg orally every 12 hours

  • Immediate-release (Cataflam): 100 mg orally once, then 50 mg orally every 8 hours as needed

  • Immediate-release tab (Cataflam): 100 mg orally once, then 50 mg orally every 8 hours as needed
  • Zipsor: 25 mg orally four times/day as needed
  • Zorvolex: 18 mg or 35 mg orally three times/day

Pain (IV Administration)

  • Indicated for management of mild-to-moderate pain and moderate-to-severe pain alone or in combination with opioid analgesics
  • Use for the shortest duration consistent with individual patient treatment goals
  • 37.5 mg intravenous (IV) bolus injection infused over 15 seconds every 6 hours as needed, not to exceed 150 mg/day
  • To reduce the risk of renal adverse reactions, patients must be well hydrated prior to IV administration

  • Oral solution: 50 mg (1 packet) in 30-60 mL of water, mixed well and drunk immediately
  • Not for prophylaxis

  • Dicloplast potassium: Cambia, Cataflam, Zipsor
  • Dicloplast sodium: Voltaren XR

  • Take with food or 8-12 oz of water to avoid GI adverse effects
  • Zorvolex: Take on empty stomach; food decreases AUC by 11% and peak concentration by 60%
  • Oral solution: Do not use liquids other than water to reconstitute; foods decrease effectiveness
  • May be combined with misoprostol

Contraindications

  • Absolute: Hypersensitivity to Dicloplast, 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 Dicloplast?"

  • 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 Dicloplast?"

  • 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

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of VOLTAREN ® (Dicloplast sodium enteric-coated tablets) and other treatment options before deciding to use VOLTAREN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).

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

For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day).

For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg three times a day. or four times a day, or 75 mg twice a day.).

For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg four times a day, with an extra 25-mg dose at bedtime if necessary.

Different formulations of Dicloplast are not necessarily bioequivalent even if the milligram strength is the same.

4. How and when to use them

You'll usually take Dicloplast tablets, capsules or suppositories 2 to 3 times a day.

The standard dose is 75mg to 150mg a day, depending on what your doctor prescribes for you. Follow your doctor's advice on how many tablets to take, and how many times a day.

If your doctor prescribes Dicloplast for your child, they'll use your child's weight to work out the right dose for them.

If you have pain all the time, your doctor may recommend slow-release Dicloplast tablets or capsules. It's usual to take these either once a day in the evening, or twice a day.

If you're taking slow-release Dicloplast twice a day, leave a gap of 10 to 12 hours between your doses.

Rated Dicloplast 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.

Common Side Effects of Dicloplast:

Although these side effects of Dicloplast are more common, they may be very serious. Stop taking Dicloplast and tell your doctor right away if you have any of the following symptoms:

  • Stomach problems, including gas, bloating, pain, cramping, constipation, and diarrhea
  • Upset stomach and/or bleeding in your stomach, esophagus, or intestines
  • Headache and ringing in the ears
  • Rash

What Other Drugs Interact with Dicloplast?

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 Dicloplast include:

Serious Interactions of Dicloplast include:

Dicloplast has moderate interactions with at least 247 different drugs.

Dicloplast 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.

What is the dosage for Dicloplast?

Dicloplast should be taken with food to reduce stomach upset. The recommended dose for most conditions is 100-200 mg daily. Dosing intervals are 2 to 4 times daily depending on the Dicloplast formulation used and the condition being treated.

Before taking Dicloplast,

  • tell your doctor and pharmacist if you are allergic to Dicloplast (also available as Solaraze and Pennsaid, in Arthrotec), aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the Dicloplast product you plan to take. Ask your pharmacist or check the medication guide for a list of the inactive ingredients. If you will be taking Dicloplast capsules (Zipsor), tell your doctor if you are allergic to bovine (cow) proteins such as those found in milk, beef, or gelatin.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: acetaminophen (Tylenol, in other products), angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); diuretics ('water pills'); insulin and oral medication for diabetes; lithium (Lithobid); medications for seizures; methotrexate (Otrexup, Rasuvo, Trexall), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and voriconazole (Vfend). Many other medications may also interact with Dicloplast, so be sure to tell your doctor about all the medications you are taking even if they do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); porphyria (an abnormal increase in the amount of certain natural substances made by the liver); heart failure ; swelling of the hands, feet, ankles, or lower legs; or liver or kidney disease.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking Dicloplast, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Dicloplast.
  • if you have phenylketonuria (PKU; an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the powder for solution contains aspartame, a source of phenylalanine.

Mechanism Of Action

Dicloplast has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of VOLTAREN, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Dicloplast is a potent inhibitor of prostaglandin synthesis in vitro. Dicloplast concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because Dicloplast is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.


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