Dolokind aa инструкция по русски

Dolokind AA — Mankind Pharma Pvt. Ltd.

Price Updated on August 8, 2019

Dolokind Aa

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Aceclofenac is a NSAID that inhibits both isoforms of COX enzyme, a key enzyme involved in the inflammatory cascade. COX-1 enzyme is a constitutive enzyme involved in prostacyclin production and protective functions of gastric mucosa whereas COX-2 is an inducible enzyme involved in the production of inflammatory mediators in response to inflammatory stimuli. Aceclofenac displays more selectivity towards COX-2 (IC50 of 0.77uM) than COX-1 (IC50 of >100uM), which promotes its gastric tolerance compared to other NSAIDs. The primary metabolite, 4′-hydroxyaceclofenac, also minimally inhibits COX-2 with IC50 value of 36uM . Although the mode of action of aceclofenac is thought to mainly arise from the inhibition of synthesis of prostaglandins (PGE2), aceclofenac also inhibits the production of inflammatory cytokines, interleukins (IL-1β, IL-6), and tumor necrosis factors (TNF) . It is also reported that aceclofenac also affects the cell adhesion molecules from neutrophils [A19763]. Aceclofenac also targets the synthesis of glycosaminoglycan and mediates chrondroprotective effects .

Uses

Aceclofenac is used for the relief of pain and inflammation in both acute and chronic pain like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain etc.

Dolokind Aa is also used to associated treatment for these conditions:

Ankylosing Spondylitis (AS), Osteoarthritis (OA), Rheumatoid Arthritis

How Dolokind Aa works

Through COX-2 inhibition, aceclofenac downregulates the production of various inflammatory mediators including prostaglandin E2 (PGE2), IL-1β, and TNF from the arachidonic acid (AA) pathway. Inhibition of IL-6 is thought to be mediated by diclofenac converted from aceclofenac . Suppressed action of inflammatory cytokines decreases the production of reactive oxygen species. Aceclofenac is shown to decreased production of nitrous oxide in human articular chondrocytes . In addition, aceclofenac interferes with neutrophil adhesion to endothelium by decreasing the expression of L-selectin (CD62L), which is a cell adhesion molecule expressed on lymphocytes . Aceclofenac is proposed to stimulate the synthesis of glycosaminoglycan in human osteoarthritic cartilage which may be mediated through its inhibitory action on IL-1 production and activity . The chrondroprotective effects are generated by 4′-hydroxyaceclofenac which suppresses IL-1 mediated production of promatrix metalloproteinase-1 and metalloproteinase-3 and interferes with the release of proteoglycan from chrondrocytes .

Table Of contents

• Dolokind Aa
• Uses
• Dosage
• Side Effect
• Precautions
• Interactions
• Uses during Pregnancy
• Uses during Breastfeeding
• Accute Overdose
• Food Interaction
• Half Life
• Volume of Distribution
• Clearance
• Interaction With other Medicine
• Contradiction
• Storage

Dosage

Dolokind Aa dosage

Adults: The maximum recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Children: There is no clinical data on the use of aceclofenac in children.

Elderly: The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency.

Renal insufficiency: There is no evidence that the dosage of aceclofenac needs to be modified in patients with mild renal impairment.

Hepatic insufficiency: The dose of aceclofenac should be reduced in patients with hepatic impairment. An initial daily dose of 100 mg should be administered.

Aceclofenac SR tablet:

The recommended dose is 200 mg once daily.

Side Effects

Generally aceclofenac is well tolerated. The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.

Toxicity

Some common adverse effects include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness . Oral LD50 value in rats is 130 mg/kg .

Precaution

Aceclofenac should be administered with caution to patients with symptoms indicative of gastrointestinal disorders, with a history of peptic ulceration, ulcerative colitis, Crohn\’s disease, hepatic porphyria, and coagulation disorders. Patients suffering from severe hepatic impairment must be monitored.

Interaction

Lithium and Digoxin: Aceclofenac, like many NSAIDs may increase plasma concentrations of lithium and Digoxin.

Diuretics: Aceclofenac, like other NSAIDs, may interact the activity of diuretics.

Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulant. Close monitoring of patients on combined anticoagulants and Aceclofenac therapy should be undertaken.

Methotrexate: Caution should be exercised if NSAIDs and Methotrexate are administered within 24 hours of each other, since NSAIDs may increase Methotrexate plasma levels, resulting in increased toxicity.

Volume of Distribution

The volume of distribution is approximately 25 L .

Elimination Route

Aceclofenac is rapidly and completely absorbed from the gastrointestinal tract and circulates mainly as unchanged drug following oral administration. Peak plasma concentrations are reached around 1.25 to 3 hours post-ingestion, and the drug penetrates into the synovial fluid where the concentration may reach up to 60% of that in the plasma . There is no accumulation in regular dosing, with similar maximum plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax) after single and multiple doses .

Half Life

The mean plasma elimination half-life is approximately 4 hours .

Clearance

The mean clearance rate is approximately 5 L/h .

Elimination Route

The main route of elimination is via the urine where the elimination accounts for 70-80% of clearance of the drug . Approximately two thirds of the administered dose is excreted via the urine, mainly as glucuronidated and hydroxylated forms of aceclofenac . About 20% of the dose is excreted into feces .

Pregnancy & Breastfeeding use

Pregnancy: There is no information on the use of aceclofenac during pregnancy. Aceclofenac should not be administered during pregnancy, unless there are compelling reasons for doing so. The lowest effective dose should be administered.

Lactation: There is no information on the secretion of aceclofenac in breast milk. The use of aceclofenac should therefore be avoided during lactation unless the potential benefits to the mother outweigh the possible risks to the children.

Contraindication

Aceclofenac should not be administered to patients with active or suspected peptic ulcer or gastro-intestinal bleeding. It should not be given to patients with moderate to severe renal impairment. Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function. It should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. Aceclofenac should not be administered to patients previously sensitive to Aceclofenac or in whom aspirin or NSAIDs precipitate attacks of asthma, acute rhinitis or urticaria or who are hypersensitive to these drugs.

Acute Overdose

There is no human data available on the consequences of aceclofenac overdosage. After overdosage, following therapeutic measures to be taken: absorption should be prevented as soon as possible by means of gastric lavage and treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications.

Storage Condition

Keep at a cool and dry place, protected from light and moisture.

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Medical Description of Dolokind AA Tablet

Dolokind AA Tablet contains Aceclofenac 100mg, Serratiopeptidase 15mg and Paracetamol 325mg is a pain-relieving medicine used to treat pain and swelling in conditions like rheumatoid arthritis, ankylosing spondylitis, and Osteoarthritis. It is also used to treat muscle aches, back pain, joint pain, and postoperative pain. The combination of this medicine produces its action by inhibiting the release of chemical substances which cause pain and inflammation in your body.

Dolokind AA Tablet Uses

It is used in the treatment of the pain

Dolokind AA Tablet Benefits

The use of this Tablet helps to relieve moderate to severe pain in conditions like menstrual cramps, headaches, joints, muscles, rheumatoid arthritis, and osteoarthritis by inhibiting the chemical messengers in the brain.

Dolokind AA Tablet Indication

The Dolokind AA Tablet is prescribed in the following indications as a pain reliever.

Mechanism of action of Dolokind AA Tablet

Dolokind AA Tablet contains Aceclofenac 100mg, Serratiopeptidase 15mg, and Paracetamol 325mg. Aceclofenac is an analgesic and anti-inflammatory medication. It produces its action by inhibiting the cyclooxygenase (COX-1) and (COX-2). Thus it inhibits the synthesis of prostaglandins which is responsible for pain and inflammation. It also inhibits the aggregation and activation of neutrophil and chemotaxis, decreases the proinflammatory cytokine level, and alter the activity of lymphocyte.

Paracetamol is an analgesic and antipyretic. It produces its action by acting on the hypothalamus to produce antipyresis. It also works peripherally to block the pain impulse generation and it also inhibits the synthesis of prostaglandin synthesis in the central nervous system.

Serratiopeptidase is an enzyme that produces its action by breaking the abnormal proteins at the site of inflammation and it also promotes healing.

How Dolokind AA Tablet works

Dolokind AA Tablet contains Aceclofenac 100mg, Serratiopeptidase 15mg, and Paracetamol 325mg. Aceclofenac is an analgesic and anti-inflammatory medication. It produces its action by inhibiting the release of chemical messengers which is responsible for pain and inflammation

Paracetamol  is an analgesic and antipyretic. It produces its action by the release of chemical messengers which is responsible for pain and fever

Serratiopeptidase is an enzyme that produces its action by breaking the abnormal proteins at the site of inflammation and it also promotes healing.

Dolokind AA Tablet Contraindication

• Do not take this medicine if you are allergic to Aceclofenac, Serratiopeptidase, and Paracetamol
• It is contraindicated to use this medicine in patients with a history of asthma, urticaria, coronary artery bypass graft surgery.
• It is contraindicated to use this medicine in patients with severe active liver disease.

Dolokind AA Tablet Side Effects

• Edema
• Headache
• Dizziness
• Abdominal pain
• Constipation
• Diarrhea
• Flatulence
• Heartburn
• GI ulcers
• Abnormal renal function
• Elevated liver enzymes
• Hepatotoxicity
• Live failure
• Pneumonitis
• Nephrotoxicity

FAQs for Dolokind AA Tablet

• Can Dolokind AA Tablet damage your kidneys?

Long-term use of this medicine may cause renal damage such as protein or blood in urine and painful urination. Kindly monitor the patient’s kidney function.

• Is the Dolokind AA Tablet a good painkiller?

Yes, the use of this medicine is considered an effective treatment to relieve pain and inflammation.

• Does the Dolokind AA Tablet make you drowsy?

Yes, the use of this medicine makes you feel drowsy, fatigue and drowsiness but it is considered a common effect.

Precautions and general warning of Dolokind AA Tablet

Alcohol

It is considered unsafe to consume alcohol while taking this medication. Kindly consult with your doctor

Driving or operating machinery

It is considered unsafe to drive while you are receiving this medicine it may affect your ability to drive. Kindly consult with your doctor.

Pregnancy

It is considered unsafe during pregnancy it may produce harmful effects on the fetus. Kindly consult with your doctor.

Breast Feeding

Limited information is available regarding the use of this medicine in patients during breastfeeding. Kindly consult with your doctor.

Kidney Problem

This medicine should be used with caution in patients with renal impairment. The use of this medicine required dose modification. Kindly consult with your doctor.

Liver Disease

This medicine should be used with caution in patients with severe liver impairment. The use of this medicine required dose modification. Kindly consult with your doctor.

How to Take Dolokind AA Tablet

The Tablet is taken orally with food. You should not chew, cut or crush the Tablet. Dissolve it in a glass of water. Take this medicine as per the dose and duration advised by your doctor. Follow the direction mentioned within the label if you probably did not understand the appliance kindly ask your doctor or pharmacist to elucidate in detail. Do not withdraw the medicine when you feel better kindly complete the course of treatment to avoid reoccurrence.

Use of Dolokind AA Tablet in Adult

It is considered to be safe to use this medicine in an adult patient if the medicine is prescribed by a doctor. Kindly consult with your doctor.

Use of Dolokind AA Tablet in children

Dolokind AA Tablet is considered unsafe in children who are below 12 years old. Kindly consult with your doctor.

Use of Dolokind AA Tablet in Elderly Patients

Dolokind AA Tablet should be used with caution in patients with an elderly age group, which leads to developing further medical problems, leads to worsening the patient’s health conditions. Kindly consult with your doctor. Dose modification or replacement is required based on the medical conditions of the patient.

Other general warnings

• Nonsteroidal anti-inflammatory drugs may increase the risk of developing cardiovascular thrombotic events, myocardial infarction, and stroke
• The use of this medicine also increase the risk of developing serious GI adverse events including bleeding, ulceration, and gastric perforation
• Therapy should be administered with caution in patients with bronchospasm, cardiac diseases, hepatic porphyria, hypertension, fluid retention, severe renal impairment, smoking, and systemic lupus erythematosus
• The use of this medicine decrease platelet aggregation and may prolong the bleeding time
• Therapy should be administered with caution in patients with blood dyscrasias, and bone marrow depression
• The use of this medicine may increase the risk of hyperkalemia and aseptic meningitis
• Therapy should be administered with caution in patients with severe hepatic impairment, renal impairment, chronic malnutrition, and G6PD deficiency.
• The use of this medicine increase the risk of developing hepatotoxicity, and serious skin reactions

Talk to your doctor if

• You have a history of gastrointestinal disease
• You are not responding to the treatment
• You have experienced any allergic reaction like rashes and itching
• You are suffering from anemia
• You have watery diarrhea, stomach pain, and fever

General instructions

Aceclofenac 100mg, Serratiopeptidase 15mg, and Paracetamol 325mg is a pain-relieving medicine used to treat pain and swelling in conditions like rheumatoid arthritis, ankylosing spondylitis, and Osteoarthritis. It is also used to treat muscle aches, back pain, joint pain, and postoperative pain. The combination of this medicine produces its action by inhibiting the release of chemical substances which cause pain and inflammation in your body.

Drug Interaction of Dolokind AA Tablet

Drug-Drug Interaction

Apixaban

The use of this drug is contraindicated because the combination of this drug increases the effect of anticoagulation

Captopril

Use alternative drug because the use of the non-steroidal anti-inflammatory drug may decrease the effectiveness of the antihypertensive drug and the combination of these drugs also decrease the renal functions

Aliskiren

Therapy should be administered with caution because the use of aceclofenac will decrease the effect of aliskiren by other

Apalutamide

Therapy should be administered with caution because the use of apalutamide will decrease the effect of acetaminophen by increasing its elimination.

Eltrombopog

Therapy should be administered with caution because the use of eltrombopag increases the levels of acetaminophen by decreasing its metabolism.

Isoniazid

Isoniazid will increase the effect of acetaminophen by affecting its hepatic enzyme metabolism. Therapy should be administered with caution.

Colestipol

Colestipol decreases the effect of acetaminophen by inhibiting GI absorption. Use alternative drugs.

Drug-Food Interaction

The use of alcohol should be avoided in patients who are taking this medicine because it may increase the risk of bleeding in the stomach which includes tarry, bloody stools, or coughing up blood while vomiting.  Do not withdraw the medication without consulting with the doctor

Drug-Disease Interaction

Asthma

Therapy should be administered with caution in patients who are having asthma because the use of the non-steroidal anti-inflammatory drug (NSAIDs) to an asthma patient may cause nasal polyposis, pansinusitis, eosinophilia, and rhinitis. Before initiating the therapy ask the patients whether they are allergic to salicylate salts.

Heart failure

Therapy should be administered with caution in patients with heart failure because the use of NSAIDs may cause fluid retention and edema

Hepatotoxicity

Therapy should be administered with caution in a patient with liver diseases because the use of NSAIDs may increase the serum transaminases, LDH, and alkaline phosphatase. And in rare cases, it may cause hepatotoxicity including liver cirrhosis, jaundice, and hepatic failure

Hypertension:

Therapy should be administered with caution in patients with hypertension because the use of NSAIDs may increase blood pressure and cardiovascular events. During this course of treatment monitor the patient blood pressure

Renal toxicities

Therapy should be administered with caution in a patient with renal diseases because the use of NSAIDs may increase the serum creatinine, BUN, tubular necrosis, glomerulus, renal papillary necrosis, nephrotic syndrome, and cause renal failure.

Liver diseases

Therapy should be administered with caution in patients with hepatic insufficiency because severe liver injury including acute liver failure resulting in liver transplant and death has been reported in patients using acetaminophen. Patients with hepatic impairment may increase the risk of toxicity due to increased metabolic pathway activity. During acetaminophen-containing treatment, patients should avoid consuming alcohol.

Alcoholism

Therapy should be administered with caution in patients who are consuming alcohol because severe liver injury including acute liver failure resulting in liver transplant and death has been reported in patients using acetaminophen. During acetaminophen-containing treatment, patients should avoid consuming alcohol. The patient should immediately seek the hospital if they experience signs and symptoms of liver injury such as fever, rash, anorexia, nausea, vomiting, fatigue, dark urine, and jaundice.

Over Dose

Take the medicine as directed by the doctor don’t overdose on the medicine. If you have taken an overdose of this medicine immediately meet the doctor and rush to the nearby hospital.

Missed Dose

Take the medicine as directed by the doctor. Do not skip the medicine, if you forgot to take the medicine or missed the dose. It is almost time for your next dose, skip the missed dose and go back to your regular schedule. Don’t take the extra dose take the regular dose immediately. Don’t use the two-dose at one time (Double Dose).

Storage and Disposal

• Stored at 10-30°C room temperature.
• Protect from light and heat.
• Keep away from children and pets. Otherwise, it becomes toxic to them.
• Disposed of properly in a suitable bag.

Fast Tag

• Dolokind AA Tablet contains Aceclofenac 100mg, Serratiopeptidase 15mg and Paracetamol 325mg is a pain-relieving medicine used to treat pain
• It produces its action by inhibiting the release of chemical substances which cause pain and inflammation in your body.
• Kindly inform your doctor if you have a history of heart disease or stroke
• The Tablet is taken orally by mouth with food
• Monitor the patient’s kidney functions, liver function, and levels of blood components
• Avoid consuming alcohol because it may cause excessive drowsiness and stomach problems