Dollars

Dolaren is a combination drug that contains two active ingredients: diclofenac sodium and paracetamol. These two substances work in synergy to provide analgesic, anti-inflammatory and antipyretic effects, making it an effective treatment for a variety of conditions associated with pain and inflammation.

Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) that inhibits the enzymes cyclooxygenase 1 and 2 (COX-1 and COX-2), involved in the synthesis of prostaglandins, substances that play a key role in inflammation, pain and fever. For this reason, diclofenac is effective in treating symptoms such as back pain, osteoarthritis, rheumatoid arthritis and other musculoskeletal disorders.

Paracetamol (or acetaminophen) acts mainly in the central nervous system, increasing the pain threshold and having an antipyretic effect. It is added to many combination drugs to enhance the analgesic effect and for a wider spectrum of action against heat and inflammation.

Dolaren is often used to reduce pain and inflammation from arthritis, toothache, headaches, menstrual cramps and other conditions. It can also be used to temporarily reduce body temperature during fever.

Indications Dolarena

1. Osteoarthritis: Dolaren may be used to relieve pain and inflammation associated with osteoarthritis, a chronic joint disease.
2. Rheumatoid arthritis: This drug may help reduce the inflammation and pain of rheumatoid arthritis, an inflammatory joint disease.
3. Muscle pain: Dolaren is often used to relieve pain and inflammation from muscle sprains, sprains, strains and other muscle injuries.
4. Pain after surgery: After surgery, such as orthopedic surgery or dental procedures, using Dolaren can help reduce pain and inflammation.
5. Aches and pains due to colds or flu: Paracetamol, one of the ingredients in Dolaren, can be used to reduce fever and relieve pain associated with headaches, muscle aches and other symptoms of colds or flu.
6. Other conditions: Dolaren can also be used to treat other conditions that involve pain and inflammation, such as ankylosing spondylitis, gout, etc.

Release form

1. Tablets: The most common form of release. The tablets are convenient for adults to take and are generally preferred for regular use. They may be coated to protect the stomach or be soluble.
2. Chewable tablets: This form may be more pleasant to take, especially for those who have difficulty swallowing regular tablets.
3. Dissoluble/Effervescent Tablets: These tablets dissolve in water to create a pleasant drink, making them easier and more acceptable to a wide range of patients, including those suffering from dysphagia (difficulty swallowing).
4. Suspensions and syrups: These forms are especially suitable for children and adults who have difficulty taking solid dosage forms. Syrups often have a pleasant taste, which makes taking the medicine easier.
5. Topical gels or creams: Although the focus here is on systemic forms, Dolaren may also contain diclofenac in the form of a gel or cream for topical use for joint pain, muscle pain or injury.

Pharmacodynamics

1. Diclofenac sodium:

   • Mechanism of action: Diclofenac belongs to the class of anti-inflammatory, analgesic and anti-rheumatic drugs - NSAIDs (non-steroidal anti-inflammatory drugs). It works by inhibiting the enzyme cyclooxygenase (COX), especially COX-1 and COX-2. These enzymes are involved in the process of converting arachidonic acid into prostaglandins, substances that play a key role in the inflammatory process. Inhibition of COX leads to a decrease in prostaglandin synthesis and therefore a decrease in inflammation, pain and fever.
   • Pharmacological effects: Diclofenac has anti-inflammatory, analgesic and antipyretic effects. It can reduce inflammation, pain and fever.

2. Paracetamol:

   • Mechanism of Action: The mechanism of action of paracetamol is not fully understood, but it is thought to bind to COX-3 in the central nervous system and block its activity. In addition, it has been suggested that paracetamol may modulate endogenous pain perception systems.
   • Pharmacological effects: Paracetamol has an analgesic (pain-relieving) and antipyretic (antipyretic) effect. It reduces pain and fever, but unlike NSAIDs it does not have an anti-inflammatory effect.

Pharmacokinetics

1. Diclofenac sodium:

   • Absorption: Diclofenac sodium is usually well absorbed from the gastrointestinal tract after oral administration. It can be absorbed both in the stomach and intestines.
   • Distribution: Diclofenac sodium has a high affinity for plasma proteins and is widely distributed in body tissues, including joints.
   • Metabolism: Diclofenac is metabolized in the liver, mainly through hydroxylation and conjugation with glucuronides.
   • Elimination: Diclofenac is mainly excreted through the kidneys in the form of metabolites. Its half-life from the body is about 2 hours.

2. Paracetamol:

   • Absorption: Paracetamol is quickly and completely absorbed from the gastrointestinal tract. Its absorption does not depend on food intake.
   • Distribution: Paracetamol is widely distributed in the body and penetrates the placental barrier. It is also present in breast milk.
   • Metabolism: Paracetamol is metabolized in the liver. Mainly, it undergoes glucuronidation and sulfation.
   • Elimination: Paracetamol is mainly excreted through the kidneys in the form of conjugated metabolites. Its half-life from the body is about 2-3 hours.

Dosing and administration

For adults:

• Tablets: It is usually recommended to take 1 tablet (the content of diclofenac and paracetamol may vary, but usually 50 mg of diclofenac and 500 mg of paracetamol) every 8 hours. Do not exceed the maximum dose of paracetamol 3000 mg per day and diclofenac 150 mg per day.
• Suspension or syrup: Dosage is calculated individually, based on the weight and age of the patient.

For children:

• Suspension or syrup: The dosage must be strictly calculated by the doctor. Usually it is about 15 mg of diclofenac and 150-200 mg of paracetamol per kilogram of body weight per day, divided into several doses.

Special instructions:

• The drug should be taken during or after meals to minimize stomach irritation.
• It is important to drink plenty of water while taking the drug.
• With prolonged use, it is necessary to monitor liver and kidney function, as well as blood patterns.

Use Dolarena during pregnancy

The use of the combination drug Dolaren, which contains diclofenac sodium and paracetamol, during pregnancy requires caution. Paracetamol is widely used during pregnancy as it is considered relatively safe for the treatment of pain and fever, however some studies indicate possible risks, such as an increased likelihood of hyperactivity and other behavioral problems in children if it is used for a long time or in high doses (Liew et al., 2014).

With respect to diclofenac, its use may be associated with risks to the fetus, including possible effects on the infant's cardiovascular system, such as premature closure of the ductus arteriosus and neonatal pulmonary hypertension. Diclofenac should be avoided in the third trimester of pregnancy and used with caution in the first two trimesters (Siu & Lee, 2004).

Before using Dolaren or any other medicine during pregnancy, it is important to consult your doctor to evaluate all potential risks and benefits.

Contraindications

1. Allergic reactions to diclofenac, paracetamol or any other component of the drug.
2. Severe liver dysfunction. Both diclofenac and paracetamol are metabolized in the liver, and their use may worsen existing liver diseases or provoke new ones.
3. Severe renal dysfunction. These substances are excreted through the kidneys, and their accumulation can be dangerous if kidney function is impaired.
4. Peptic ulcer or active bleeding in the gastrointestinal tract. Diclofenac may aggravate these conditions or provoke their occurrence.
5. Severe heart failure, hypertension, or other cardiovascular diseases. NSAIDs may worsen these conditions.
6. Last trimester of pregnancy. Diclofenac can adversely affect the fetus and complicate the course of pregnancy and childbirth.
7. Breastfeeding period. Diclofenac and paracetamol can pass into breast milk and affect the baby.

Side effects Dolarena

1. Gastrointestinal Disorders: The most common side effects include dyspepsia (digestive problems), nausea, vomiting, diarrhea, stomach pain and dyspeptic symptoms.
2. Peptic ulcers and gastrointestinal bleeding: Diclofenac, especially in high doses or with long-term use, may increase the risk of developing gastric or intestinal ulcers and may cause bleeding.
3. Increased blood pressure: In some patients, the use of diclofenac may lead to increased blood pressure.
4. Kidney Damage: Long-term use of Dolaren may cause kidney damage, especially in people with a predisposition to kidney failure.
5. Liver Damage: Dolaren may cause toxic liver damage, especially in patients with pre-existing liver disease or who drink alcohol.
6. Allergic reactions: May include skin rash, itching, redness of the skin, angioedema (swelling of the skin, mucous membranes, sometimes subcutaneous tissue) and anaphylactic shock (very rare).
7. Increased potassium levels in the blood: Diclofenac may cause an increase in potassium levels in the blood, which is especially dangerous in patients with heart or kidney disease.
8. Dysfunction of the hematopoietic organs: Changes in the blood, such as anemia, leukopenia, thrombocytopenia, may be observed.
9. Headaches and dizziness: These symptoms can also be a side effect when using Dolaren.

Overdose

1. For diclofenac:

   • Gastrointestinal complications: stomach ulcers, bleeding from the gastrointestinal tract, perforation (hole) of the gastrointestinal tract.
   • Liver toxicity: Liver damage can be serious and even fatal.
   • Kidney failure: People with pre-existing kidney disease are especially vulnerable to overdose.
   • Neurological symptoms: headache, dizziness, convulsions, drowsiness and other symptoms.

2. For paracetamol:

   • Liver failure: Paracetamol in high doses can cause liver toxicity, which can be fatal.
   • Analgesic non-reliance: unlike other NSAIDs, paracetamol does not cause inflammation and is a poor pain reliever in overdose.
   • Methemoglobinemia: a rare but serious complication that can be caused by high doses of paracetamol.

Interactions with other drugs

1. Drugs affecting the gastrointestinal tract: NSAIDs, including diclofenac sodium, may increase the risk of developing stomach and intestinal ulcers. Taking Dolaren together with other NSAIDs or glucocorticosteroids, as well as with anticoagulants or antiplatelet agents, may increase the risk of bleeding from the gastrointestinal tract.
2. Drugs affecting renal function: Diclofenac sodium may worsen renal function or lead to the development of acute renal failure, especially in patients predisposed to this condition. The combination of Dolaren with other drugs that affect kidney function, such as angiotensin-converting enzyme (ACE) inhibitors or diuretics, may increase this risk.
3. Drugs that affect liver function: Paracetamol is metabolized in the liver, so taking Dolaren with other drugs that can also cause hepatotoxicity (for example, alcohol or anti-tuberculosis drugs) may increase the risk of liver damage.
4. Drugs affecting the blood coagulation system: Diclofenac sodium may increase the effects of anticoagulants such as warfarin, which may result in prolonged bleeding time and increase the risk of bleeding.
5. Drugs that affect the central nervous system: Combining Dolaren with other drugs that may also have a sedative or stimulating effect on the central nervous system (for example, alcohol or sleeping pills) may enhance these effects.
6. Drugs that affect intestinal microflora: Taking antibiotics that change intestinal microflora in combination with Dolaren can increase the risk of developing diarrhea or superinfection.