Aceclofenac

(ah-see-kloe-fen-ack)

PCI - Contraindicated in pregnancy

Molecule Info

| See TERMINOLOGY & ABBREVIATIONS |

Indication(s) & dosage

Aceclofenac is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.

Ankylosing spondylitis, Rheumatoid arthritis, Osteoarthritis

Adult: 100mg plain formulation bid or 200mg Controlled Release (CR) once daily orally.
Hepatic impairment: Reduce initial dose to 100mg daily .

Administration

Should be taken with food. Take with or immediately after meals.

Overdose

Mangagement: Gastric lavage and treatment with activated characoal. Treatment is supportive and symptomatic. Dialysis, haemoperfusion unlikely to be useful.

Contraindication(s)

Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like ASPIRIN, NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.

Precaution(s)

Patients with symptoms indicative of gastro-intestinal disorders, with a history of gastroulceration.  Patients with severe hepatic impairment or cardiac or renal impairment.  Patients under the medication of diuretics.  Patients in recovery after surgical treatment.

GENERAL PRECAUTIONS: Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery.

Adverse Drug Reaction(s)

The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness.

Drug Interactions

May increase plasma concentrations of lithium and digoxin. Increased nephrotoxicity when used with diuretics or CICLOSPORIN/ CYCLOSPORINE. Monitor serum potassium when used with potassium-sparing diuretics and ACE inhibitors. May enhance activity of anticoagulants. May increase risk of methotrexate toxicity when administered within 24 hr of methotrexate admin. Increased risk of GI bleed with other NSAIDs. Increased risk of convulsion with quinolones.
Potentially Fatal: May increase plasma concentrations of lithium and digoxin. Increased nephrotoxicity when used with diuretics or ciclosporin. Monitor serum potassium when used with potassium-sparing diuretics and ACE inhibitors. May enhance activity of anticoagulants. May increase risk of methotrexate toxicity when administered within 24 hr of methotrexate admin. Increased risk of GI bleed with other NSAIDs. Increased risk of convulsion with quinolones.

Use in Pregnancy and Specific Population

USE IN PREGNANCY AND NURSING MOTHERS: Since there is no information on the safe use of Aceclofenac during pregnancy and lactation, the use of Aceclofenac should therefore be avoided in pregnancy and lactation.
USE IN CHILDREN: The dosage and indication is not established yet for children with less than 6 years old.

Storage

Store below 30°C.

Pharmacology

Aceclofenac, a phenylacetic acid derivative, has antiinflammatory and analgesic properties. It is a potent inhibitor of cyclo-oxygenase which is involved in the production of prostaglandins.
Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 1-3 hr.
Distribution: Protein-binding: 99%.
Excretion: Urine (as hydroxymetabolites); 4 hr (elimination half-life).

ATC Classification

M02AA25 - aceclofenac; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains. 
M01AB16 - aceclofenac; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

Brand/Product Info


Total Products : 77                                                                             
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
AC PR Pacific Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
ACEBID Beacon Pharmaceuticals Limited Aceclofenac BP 100mg Film Coated Tablet 50's: 150.50 MRP
ACECLOBEN Benham Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
ACECLORA Marksman Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 95.00 MRP
ACECOL Ziska Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 100.00 MRP
ACEDOL Concord Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ACEFENAC General Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 150.50 MRP
ACEGIC Belsen Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ACELOCK Bristol Pharma Limited Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ACELON Central Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ACENAC Medicon Laboratories Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
ACEPRO The White Horse Pharma Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
ACF Decent Pharma Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ACFLAM Apollo Pharmaceutical Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ACLO Alco Pharma Ltd Aceclofenac BP 100mg Film Coated Tablet 100's: 250.00 MRP
ACLONAC Pharmasia Limited Aceclofenac BP 100mg Film Coated Tablet 50's: 151.00 IP
ACLOPAIN R A K Pharmaceuticals Pvt. Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ACLOVIX Aexim Pharmaceutical Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 250.00 MRP
ACN Modern Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
ALONA-100 Kemiko Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
ANALGEN Cosmo Pharma Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
APECLO Apex Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 150.00 MRP
APITAC The Acme Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
AROS Globe Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
AVENAC Radiant Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 250.00 MRP
CECLOFEN Renata Limited Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
CECONAC Hudson Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
CELOFEN ACI Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.50 MRP
CLOF Biopharma Laboratories Ltd Aceclofenac BP 100mg Film Coated Tablet 100's: 301.00 MRP
CLOFENTA Amico Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
DOLONAC Cosmic Chemical Industries Limited Aceclofenac BP 100mg Film Coated Tablet 100's: 250.00 MRP
ECENA Edruc Limited Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
ENA Asiatic Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
FIXONAC Euro Pharma Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
FLECO Ad-din pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 190.00 MRP
FLEXI Square Pharmaceuticals Ltd. Aceclofenac 100mg Tablet 10x10's: 402.00 MRP
FLEXI 200 Square Pharmaceuticals Ltd. Aceclofenac 200mg Tablet 3x10's: 210.60 MRP
JOFINE NIPRO JMI Pharma Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 151.00 MRP
LOFENS Zenith Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 150.00 MRP
LOFLAM-100 Millat Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
MACLO-100 Doctors Chemical Works Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 125.00 MRP
MERVAN Aristopharma Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
MOTIFEN Pharmadesh Laboratories Limited Aceclofenac BP 100mg Film Coated Tablet 50's: 125.50 MRP
MOVEX Opsonin Pharma Limited Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
MOVON Hallmark Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 125.50 MRP
NOAK Orion Pharma Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.50 MRP
NOFENAC Drug International Ltd Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
NOSTRIN Monico Pharma Limited Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
ORIFEN Silva Pharmaceuticals Limited Aceclofenac BP 100mg Film Coated Tablet 100's: 250.94 MRP
OSTOFLEX Somatec Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 301.00 MRP
PAINEX Chemist Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
PANKIL Everest Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 250.00 MRP
PENAC-AC APC Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
PRESERVIN IBN SINA Pharmaceutical Industry Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 175.00 IP
PROTILEZ Reliance Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 308.00 MRP
QRIP Sanofi Aceclofenac BP 100mg Film Coated Tablet 100's: 301.01 MRP
RAPIDOR Rephco Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 250.00 MRP
Reservix Incepta Pharmaceuticals Limited Aceclofenac BP 100 mg Film Coated Tablet 10x10's:MRP 400 Tk
REUSE Indo-Bangla Pharmaceuticals Works Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 250.00 MRP
RHEUMA 100 Mystic Pharmaceuticals Limited Aceclofenac BP 100mg Film Coated Tablet 6's: 120.48 MRP
RUCLON Novus Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
SAPCLO Shamsul Alamin Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
SENAC-A Seema Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
SERVEX Novo Healthcare and Pharma Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
SYCLOFEN Syntho Laboratories Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
TERNILLA Healthcare Pharmacuticals Ltd. Aceclofenac BP 100 mg Film Coated Tablet 50's MRP 200 Tk
TUFFOX Eskayef Bangladesh Ltd Aceclofenac BP 100mg Film Coated Tablet 100's MRP: 301.14
VAXTIN Sandoz/Novartis Aceclofenac BP 100mg Film Coated Tablet 60's: MRP 300.00
VOLFENAC S.N. Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 300.00 MRP
XE FAST Desh Pharmaceuticals (Pvt) Ltd Aceclofenac BP 100mg Film Coated Tablet 40's & 80's: 100.00 & 200.00 MRP
XERIFEN Peoples Pharma Ltd. Aceclofenac BP 100mg Film Coated Tablet 100's: 200.00 MRP
XERIFLAM Kumudini Pharma Ltd Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
XPAIN Gaco Pharmaceutical Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP
XYFEN Supreme Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 30's: 90.00 MRP
ZERODOL Navana Pharmaceuticals Limited Aceclofenac BP 100mg Film Coated Tablet 50's: 150.50 MRP
ZOLFIN Beximco Pharmaceuticals Ltd Aceclofenac BP 100mg Film Coated Tablet 150's: 600.00 MRP
ZOLONAC Sharif Pharmaceuticals Ltd. Aceclofenac BP 100mg Film Coated Tablet 50's: 150.00 MRP

General Medical Info

 

What Aceclofenac Tablets are and what they are used for
Aceclofenac Tablets belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs.
Aceclofenac Tablet is used to relieve pain and inflammation in patients suffering from:

  • arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.
  • autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis).
  • arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondylitis).

Before you take Aceclofenac Tablets-

Do not take Aceclofenac tablets,

  • If you are allergic to aceclofenac or any of the other ingredients of Aceclofenac Tablets
  • If you are pregnant (unless considered essential by your doctor).
  • If aspirin or other NSAIDs have caused asthma, rhinitis (running nose) or urticaria (skin rash) or other allergic reaction.
  • If you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
  • If you have severe kidney disease
  • If you have severe heart disease
  • If you have severe liver disease

Take special care with Aceclofenac Tablets
Tell your doctor before taking Aceclofenac tablets if:

  • You have ever experienced stomach discomfort or pain, vomiting of blood or heartburn after taking aspirin or other nonsteroidal anti-inflammatory drugs.
  • You suffer from any other form of kidney or liver disease.
  • You suffer from asthma or any other breathing problems.
  • You have suffered from any blood- clotting problem (if you bleed easily).
  • You have recently undergone major surgery.
  • You are breast-feeding.
  • You are suffering from Crohn's disease (chronic inflammatory bowel disease) or ulcerative colitis (inflammatory bowel disease).
  • You suffer from a blood disorder known as porphyria.
  • You have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor.

Medicines such as Aceclofenac Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. Aceclofenac Tablets may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Taking other medicines:
Please inform your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

  • Anticoagulants (drugs that alter the rate of blood clotting) like warfarin.
  • Diuretics (drugs used to increase the rate of urine excretion) such as furosemide, hydrochlorothiazide or triamterene.
  • Antidiabetic drugs (medicines used to lower blood sugar levels).
  • Methotrexate (used to treat cancer, arthritis)
  • Steroids.
  • Ciclosporin and Tacrolimus (drugs used to suppress the immune system)
  • Anti infectives (Such as quinoline antibiotics)
  • Zidovudine (drug used to treat HIV)
  • Other non-steroidal anti-inflammatory agents (NSAIDs) like aspirin, ibuprofen
  • SSRIs and lithium (used to treat depression or manic depression)
  • Medicines used to treat high blood pressure (antihypertensives)
  • Cardiac glycosides like digoxin (used to treat heart failure and irregular heart beats)

You should not take Aceclofenac Tablets for 8-12 days after taking mifepristone (drug used to terminate pregnancy).
Taking Aceclofenac Tablets with food and drink:
Aceclofenac Tablets should be taken preferably with or after food.
Pregnancy and breast-feeding:
Do not take Aceclofenac Tablets if you plan to become pregnant, are pregnant or breast-feeding. Ask your doctor for advice before taking any medicine.
Driving and using machines:
As a precaution, you should refrain from driving or operating machinery if you feel dizzy or sleepy when you take Aceclofenac Tablets. Do not perform any of these actions until the effects wear off.

How to take Aceclofenac Tablets
Always take Aceclofenac Tablets exactly as your doctor has told you. You will be prescribed the lowest effective dose over the shortest duration to reduce side effects. You should check with your doctor or pharmacist if you are not sure.
Adults: The recommended dose in adults is 200 mg a day. One 100 mg tablet should be taken in the morning and one in the evening (1 tablet every 12 hours).
Children: Aceclofenac Tablets is not recommended for use in children under the age of 18.
Elderly: If you are elderly, you are more likely to experience serious side effects (listed in section 4 ‘Possible Side Effects). If your doctor prescribes Aceclofenac Tablets for you, you will be given the lowest effective dose over the shortest duration.
Method and route of administration:
Swallow the tablet whole with a glass of water. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends.
If you take more Aceclofenac Tablets than you should:

  • If you take more Aceclofenac tablets than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.
  • If you forget to take Aceclofenac Tablets:
  • If you forget to take your medicine at any time, take it as soon as you remember; then continue to take it at the usual times. Do not take a double dose to make up for a forgotten dose.
  • If you stop taking Aceclofenac Tablets:
  • Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
  • If you have any further question on the use of the product, ask your doctor.

Possible side effects
Like all medicines, Aceclofenac tablets can cause side effects, although not everybody gets them.
If you experience any of the following side effects, tell your doctor IMMEDIATELY:

  • medicines such as Aceclofenac tablets may be associated with a small increased risk of heart attack, (”myocardial infarction”) or stroke
  • severe allergic reaction (anaphylactic shock). Symptoms may include difficulty breathing, wheezing, abnormal pain and vomiting
  • swelling of the face
  • kidney failure

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

  • Pass blood in your faeces (stools/motions)
  • Pass black tarry stools
  • Vomit any blood or dark particles that look like coffee grounds.

STOP TAKING the medicine and tell your doctor if you experience:

  • Indigestion or heartburn
  • Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

If any of the below side effects get serious, or if you notice any other side effects not listed in this section, please tell your doctor.

Common (occur in more than 1 in 100 patients but in less than 1 in 10 patients):

  • dizziness
  • nausea
  • diarrhoea
  • increased liver enzymes in the blood

Uncommon (occur in more than 1 in 1,000 patients but in less than 1 in 100 patients):

  • wind (flatulence)
  • inflammation or irritation of the lining of the stomach (gastritis)
  • constipation
  • vomiting
  • mouth ulcers
  • itching
  • rash
  • inflammation of the skin (dermatitis)
  • raised circular red itchy, stinging or burning patches on the skin (hives)
  • increase in blood urea levels
  • increase in blood creatinine levels

Rare (occur in more than 1 in 10,000 patients but in less than 1 in 1,000 patients):

  •  low levels of iron in the blood
  •  hypersensitivity (allergic reaction)
  •  visual disturbance
  •  shortness of breath

Very Rare (occur in less than 1 in 10,000 patients):

  • low white blood cells levels
  • low platelets levels in the blood
  • abnormal breakdown of red blood cells (anemia)
  • high potassium levels in the blood
  • depression
  • strange dreams
  • inability to sleep
  • tingling, pricking or numbness of skin
  • uncontrollable shaking (tremor)
  • drowsiness
  • headaches
  • abnormal taste in the mouth
  • sensation of spinning when standing still
  • heart pounding or racing (palpitations)
  • hot flushes
  • difficulty breathing
  • high pitched noise when breathing
  • inflammation of the mouth
  • stomach ulcer
  • inflammation of the pancreas (pancreatitis)
  • inflammation of the liver (hepatitis)
  • yellowing of the skin (jaundice)
  • spontaneous bleeding into the skin (appears as a rash)
  • blisters
  • water retention and swelling
  • tiredness
  • leg cramps
  • increased blood alkaline phosphatase levels
  • weight gain

If any of the below side effects get serious, please tell your doctor.
Other side effects that have been reported with this type of drug (NSAIDs) are:

  • bone marrow failure
  • hallucinations
  • confusion
  • blurred, partial or complete loss of vision
  • painful movement of the eye
  • ringing in the ears
  • aggravated asthma
  • ulcers
  • perforation of either the stomach, large intestine or bowel wall
  • blistering and peeling of the top layer of skin
  • mild, itchy pink/redness of the skin
  • reddening or scaling of skin
  • skin irritation (eczema)
  • skin reaction to sunlight
  • inflammation of the kidneys
  • generally feeling unwell
  • aseptic meningitis
  • exacerbation of colitis and Crohn's disease
  • hypertension (high blood pressure)
  • cardiac failure
  • bone marrow depression

How to store Aceclofenac Tablets

  • Keep out of the reach and sight of children.
  • Store below 25°C.
  • Do not use the medicine after the expiry date, which is stated on the carton after (EXP). The expiry date refers to the last day of that month.
  • Medicines should not be disposed of via waste water or household waste. Ask your Doctor how to dispose of medicines no longer required. These measures will help to protect the environment. 

Ref: U.S. Natl. Library of Medicine


 This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

 

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