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Page Created On : 24 Feb 2021 9:02 AM GMT , Page Last Updated On : 14 May 2022 12:11 PM GMT
Dolokind
Medicine composition: Aceclofenac 100mg + Paracetamol 325mg
Marketed/Manufactured by Mankind Pharma Ltd.
Medicine Type : PAIN ANALGESICS pain analgesics
Prescription Type : OTC
Pharmacological Class: Anti- inflammatory
Therapy Class: ANALGESICS
Chemical Class: Dichlorobenzenes Derivative
Approval Central Drugs Standard Control Organisation(CDSCO)
Schedule Schedule

About the molecule

Dolokind 100mg Tablet is a pain-relieving medicine. It alleviates pain and inflammation in conditions like rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
Dolokind 100mg Tablet should be taken in the dose and duration as advised by your doctor. It should be taken with food or milk to prevent stomach upset. Taking the medicine regularly at the right times increases its effectiveness. It is important to keep taking the medicine regularly until your doctor tells you it is safe to stop.

Mechanism of Action

Dolokind 100mg Tablet is a non-steroidal anti-inflammatory drugs (NSAID). It works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling).

Dosage Form

Oral : Tablets
One tablet in morning and one tablet in evening.


Strengths

Aceclofenac 100 mg Paracetamol 500 mg

Usage

Pain Reliever

Indications

Indicated for acute painful condition in adults.

Method of administration

Oral

Dietary Restrictions

Dietary Restrictions

Contraindications

  • Dolokind is contraindicated in the following situations
  • Patients sensitive to Aceclofenac, Paracetamol or to any of the excipients of the product
  • Patients in whom aspirin or other NSAIDs, precipitate attacks of bronchospasm, acute rhinitis or urticaria or patients hypersensitive to these drugs
  • Patients with active or suspected peptic ulcer or gastrointestinal bleeding or bleeding disorders
  • Patients with severe heart failure, hypertension, hepatic or renal insufficiency
  • Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, in women attempting to conceive and during lactation unless there are compelling reasons for doing so. The lowest effective dosage should be used.

Warnings

Alcohol Warning

It is unsafe to consume alcohol with Dolokind 100mg Tablet.


Breastfeeding Warning

Information regarding the use of Dolokind 100mg Tablet during breastfeeding is not available. Please consult your doctor.


Pregnancy Warning

Dolokind is a fixed combination of active ingredients including aceclofenac; it should not be used during pregnancy. Dolokind 100mg Tablet may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.


Adverse Reactions

Aceclofenac

GI: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angio-oedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Cardiovascular and Cerebrovascular: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Aceclofenac is both structurally related and metabolised to diclofenac for which a greater amount of clinical and epidemiological data consistently point towards an increased risk of general arterial thrombotic events (myocardial infarction or stroke, particularly at high doses and in long treatment). Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac. Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment.

Other adverse reactions reported less commonly include the following:

  • Renal: interstitial nephritis
  • Hepatic: abnormal liver function, hepatitis and jaundice.
  • Neurological and Special Senses: optic neuritis, reports of aseptic meningitis (especially in patients with existing auto immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation confusion, hallucinations, and drowsiness.
  • Haematological: agranulocytosis, aplastic anaemia.
  • Dermatological: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Photosensitivity

If serious adverse reactions occur, aceclofenac tablets should be withdrawn

Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common ((≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System organ class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare/isolated reports(<1/10,000)
Blood and lymphatic system disorders Anaemia Granulocytopaenia Thrombocytopaenia Neutropaenia Haemolytic anaemia
Immune system disorders Anaphylactic reaction (including shock) Hypersensitivity
Metabolism and nutrition disorders Hyperkalaemia
Psychiatric disorders Depression Abnormal dreams Insomnia
Tremor Somnolence Headache Dysgeusia (abnormal taste)
Eye disorders Visual disturbance
Ear and labyrinth disorders Vertigo Tinnitus
Cardiac disorders Cardiac failure Palpitations
Vascular disorders Hypertension Flushing Hot flush Vasculitis
Respiratory, thoracic and mediastinal disorders Dyspnoea Bronchospasm Stridor
GI disorders Dyspepsia Abdominal pain Nausea Diarrhoea Flatulence Gastritis Constipation Vomiting Mouth ulceration Melaena GI haemorrhage GI ulceration Stomatitis Intestinal perforation Exacerbation of Crohn's disease and Colitis Ulcerative haematemesis Pancreatitis
Hepatobiliary disorders Hepatic enzyme increased Hepatic injury (including hepatitis) Jaundice Blood alkaline phosphatase increased
Skin and subcutaneous tissue disorders Pruritus Rash Dermatitis Urticaria Angio-oedema Purpura Severe mucocutaneous skin reaction (including Stevens-Johnson syndrome and toxic epidermal necrolysis)
Renal and urinary disorders Blood urea increased Blood creatinine increased Renal failure Nephrotic syndrome
General disorders and administration site conditions Oedema Fatigue Cramps in legs
Investigations Weight increase

Paracetamol

The information below lists reported adverse reactions, ranked using the following frequency classification:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Immune System Disorders: Hypersensitivity, including skin rash may occur

NOT KNOWN: anaphylactic shock, angio-oedema.

Blood and Lymphatic System Disorders

NOT KNOWN: blood dyscrasias, including thrombocytopaenia and agranulocytosis.

Skin and Subcutaneous Disorders

Very rare cases of serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, and fixed drug eruption have been reported.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents with influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with aceclofenac, consideration should be given to adjustment of the dosage of hypoglycaemic agents.

Anti-Coagulants: NSAIDs and Paracetamol may enhance the effects of anticoagulants, such as warfarin. Close monitoring of patients on combined anticoagulants and therapy should be undertaken

Other NSAIDs: Concomitant therapy with aspirin or other NSAIDs may increase the frequency of adverse reactions, including the risk of GI bleeding.

Paracetamol

Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.

Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

Chloramphenicol: Increased plasma concentration of chloramphenicol

Drug Interactions

Aceclofenac

Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects.

Anti-Hypertensives

Reduced anti-hypertensive effect. The risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when Angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists are combined with NSAIDs. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated, and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Side Effects

Vomiting, stomach pain, nausea, and indigestion are some of the common side effects of taking this medicine.

Overdosage

The clinical presentation of overdose may include the signs and symptoms of aceclofenac toxicity, paracetamol toxicity or both

Aceclofenac

a) Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measure Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Specific therapies such as dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition. Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures

Paracetamol

The initial symptoms seen within the first 24 hours following an paracetamol overdose are: anorexia, nausea, vomiting, malaise, pallor and diaphoresis. In paracetamol over dosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects also may occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion.

In the treatment of paracetamol over dosage, gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if paracetamol ingestion is known or suspected to have occurred within a few hours of presentation. Serum paracetamol levels should be obtained immediately if the patient presents 4 or more hours after ingestion to assess potential risk of hepatotoxicity; paracetamol levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs early in the course of intoxication.

Clinical Pharmacology

Aceclofenac After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The volume of distribution is approximately 25 L. The mean plasma elimination half-life is around 4 hours. Aceclofenac is highly protein- bound (>99%). Aceclofenac circulates mainly as unchanged drug. 4'- Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two- thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites. No changes in the pharmacokinetics of aceclofenac have been detected in the elderly. Paracetamol Absorption and Fate Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. Paracetamol appears to be widely distributed throughout most body tissues except fat. Its apparent volume of distribution is about 0.9L/kg. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.

Clinical Studies

Non-clinical Toxicology

Non-clinical Toxicology

Faq

Q. Is Dolokind 100mg Tablet a good painkiller?
Dolokind 100mg Tablet is effective in relieving pain and inflammation. It is used to provide relief from various sorts of pain such as sprains, strains and other injuries. It is also helpful in various types of arthritis, gout, pain and inflammation following surgery.
Q. Is Dolokind 100mg Tablet safe?
Dolokind 100mg Tablet is safe if used in the dose and duration advised by your doctor. Take it exactly as directed and do not skip any dose. Follow your doctor's instructions carefully and let your doctor know if any of the side effects bother you.
Q. Does Dolokind 100mg Tablet get you high?
No, Dolokind 100mg Tablet does not get you high. It does not have an abuse potential (drug-seeking behavior) and does not cause physical or psychological dependence. However, if you do not feel well, consult your doctor.
Q. Can Dolokind 100mg Tablet hurt your kidneys?
Long-term use and high doses of Dolokind 100mg Tablet may cause renal problems, such as protein or blood in urine and pain during urination. Patients who had or have heart failure, impaired kidney function and hypertension are at risk of kidney problems. The risk of developing kidney problems is also high in patients who are on medicines which cause excess urination (diuretics), or medicines which have significant impact on kidney function. Along with that, Dolokind 100mg Tablet can affect kidneys of patients who are above 65 years of age or who remain dehydrated. Therefore, kidney function monitoring is recommended for such patients.

References

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Author Details

Dr O P Yadava M.B.B.S., M.S., DNB (General Surgery), DNB (Cardiothoracic Surgery), Mnams, FIACS, FICC. He is currently the CEO & Chief Consultant Cardiothoracic Surgeon at National Heart Institute, New Delhi. Dr Yadava is the Chief Editor of Cardiology Today and is a member of the Editorial Boards of various journals, including the Journal of American Medical Association (Indian Edition), the Indian Heart Journal, the Journal of Cardiovascular Diseases (Pakistan), and Hospital Today.

Author

Dr O P Yadava M.B.B.S., M.S., DNB (General Surgery), DNB (Cardiothoracic Surgery), Mnams, FIACS, FICC. He is currently the CEO & Chief Consultant Cardiothoracic Surgeon at National Heart Institute, New Delhi. Dr Yadava is the Chief Editor of Cardiology Today and is a member of the Editorial Boards of various journals, including the Journal of American Medical Association (Indian Edition), the Indian Heart Journal, the Journal of Cardiovascular Diseases (Pakistan), and Hospital Today.

Reviewer Details

Dr Prem Aggarwal M.B.B.S., M.S., DNB (General Surgery), DNB (Cardiothoracic Surgery), Mnams, FIACS, FICC. He is currently the CEO & Chief Consultant Cardiothoracic Surgeon at National Heart Institute, New Delhi. Dr Yadava is the Chief Editor of Cardiology Today and is a member of the Editorial Boards of various journals, including the Journal of American Medical Association (Indian Edition), the Indian Heart Journal, the Journal of Cardiovascular Diseases (Pakistan), and Hospital Today.
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