Apo-Napro with naproxen for inflammation. How to use?

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Apo-Napro is a general-purpose preparation containing a non-steroidal anti-inflammatory drug – naproxen. The drug is prescribed by a doctor and is mainly used in family medicine, orthopedics and rheumatology. It is used to reduce inflammation and pain in joints and muscles. What is the composition and action of Apo-Napro? What are the indications and contraindications to its use and what side effects can it cause? How does it affect the course of pregnancy and can it be used during lactation? How to take Apo-Napro and with what drugs should not be combined?

Apo-Napro – characteristics

Apo-Napro belongs to a group of medicines called NSAIDs, i.e. non-steroidal anti-inflammatory drugs. It is known internationally as Naproxenum.

This drug is characterized by anti-inflammatory, analgesic and antipyretic effects.

Apo-Napro is prescribed by a prescription to a specific person and must not be passed on to other patients as it may harm another person, even though the symptoms of the disease are the same.

This preparation is in the form of tablets packed in 30 or 90 pieces, in doses of 250 or 500 mg.

Apo-Napro is partially reimbursed in some cases. It can be used by patients requiring treatment in connection with the treatment of rheumatoid arthritis, degenerative disease, ankylosing spondylitis, gout, musculoskeletal disorders, and juvenile rheumatoid arthritis. After reimbursement, the price of the drug ranges from PLN 6 to PLN 13, depending on the packaging and the selected pharmacy.

This preparation should be kept out of the sight and reach of children. Apo Napro should be sealed in its original packaging and stored below 25 ° C to protect from moisture.

The manufacturer of Apo-Napro is a company from the pharmaceutical industry Aurovitas Pharma Polska Sp. z o. o. It was established as the third Aurovitas company in Europe and together with sister companies from Spain and Portugal it belongs to the Aurobindo Pharma Group with European headquarters in London. The concern is one of the main companies operating in the area of ​​development, production and marketing of generic drugs and active substances for the pharmaceutical industry.

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Apo-Napro – composition and mode of action

The active substance of Apo-Napro, with which the mechanism of action is related, is naproxen. Thanks to it, the preparation has analgesic, antipyretic and antirheumatic properties.

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) from the group of propionic acid derivatives (naphthalene derivative). The mechanism of action of this substance is based on the inhibition of the activity of cyclooxygenases (both COX-1 and COX-2). These enzymes are involved in the reactions that lead to the formation of prostaglandins from the lipids of cell membranes.

Naproxen reduces the symptoms of an inflammatory response (swelling, raised body temperature, pain, joint stiffness). In addition, Apo-Napro has an anti-platelet aggregation effect.

One tablet of Apo-Napro contains 250 mg or 500 mg of naproxen and additional excipients such as methylcellulose, croscarmellose sodium, magnesium stearate and colloidal anhydrous silica.

The big advantage of Apo-Napro is almost complete absorption from the gastrointestinal tract. As a result, the maximum concentration in the blood is obtained on average within 2-4 hours after administration, it is highly bound to plasma proteins.

Naproxen penetrates slowly into the joint cavities (steady state concentration of naproxen in the synovial fluid is achieved after about 7 days of using the preparation). It is mainly excreted in the urine in the form of naproxen conjugation products.

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Apo-Napro – indications for use

Apo-Napro is a general-purpose preparation containing a non-steroidal anti-inflammatory drug. This product is indicated for use in cases of:

1. therapy of rheumatoid arthritis and other rheumatoid diseases, in particular in osteoarthritis, ankylosing spondylitis or in juvenile rheumatoid arthritis;
2. in the symptomatic treatment of fever of any type;
3. in the treatment of acute musculoskeletal disorders and acute gout;

Apo-Napro is also used to combat various types of pain, including headache, toothache, back pain, muscle and joint pain or period pains.

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Apo-Napro – contraindications to use

Apo-Napro, although there are indications for its use, may not always be used in every patient.

The main contraindication to the use of this drug is hypersensitivity, i.e. allergy to the active substance naproxen, naproxen sodium or any of the excipients.

The contraindications to the use of Apo-Napro also include certain diseases and circumstances that may require you to completely abandon the drug or change the dosage of the preparation.

The use of Apo-Napro may require specific check-ups and a careful medical history.

Naproxen may undergo cross-allergic reactions and therefore the drug should not be used in patients suffering from, among others, for asthma who experienced angioedema, rhinitis or urticaria.

In addition, allergic reactions may occur after administration of a drug containing acetylsalicylic acid or any other drug from the group of non-steroidal anti-inflammatory drugs.

The other contraindications to the use of Apo-Napro include:

1. active or recurrent gastric ulcer disease;
2. occurring bleeding from the stomach or duodenum;
3. gastrointestinal bleeding which has been induced as a result of past use of non-steroidal anti-inflammatory drugs;
4. a tendency to bleed or treatment with anticoagulants (drugs that thin the blood);
5. severe renal dysfunction;
6. severe liver dysfunction;
7. severe heart failure;
8. III trimester of pregnancy.

If the above-described situations apply to a patient, discontinue the drug and contact a doctor who will individually assess the risk of using Apo-Napro in a given patient.

What should you know about drug hypersensitivity? Check: Drugs are also allergenic

Apo-Napro – possible side effects

The use of Apo-Napro can cause side effects, which, however, do not necessarily occur in every person using this medicine.

After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The side effects are usually mild and transient, and the expected benefits of the drug are usually greater than the harm resulting from the side effects.

Side effects may appear while taking, but also up to several weeks after discontinuing the drug.

Treatment with Apo-Napro should be discontinued in the event of the following possible side effects:

1. vomiting blood or dark grounds like vomiting;
2. temporary black tarry stools or blood in stools
3. stomach ulcer;
4. severe diarrhea;
5. lower abdominal pain;
6. mouth ulceration;
7. worsening of ulcerative colitis or Crohn’s disease;
8. rash;
9. signs of hypersensitivity: difficulty breathing, wheezing, tightness in the chest, swelling of the eyelids, face, lips, throat or tongue, rash or itching.

The use of Apo-Napro may also result in the occurrence of:

1. high blood pressure;
2. increased risk of heart attack or stroke;
3. asthma, pneumonia, pulmonary edema;
4. nausea, vomiting, abdominal discomfort, flatulence, constipation, pancreatitis;
5. skin rash, itching, redness, bruising, swelling of the neck and face, swelling of the hands and feet;
6. excessive sweating;
7. blistering hands or feet (Stevens-Johnson syndrome), sore bruises with pressure, purulent exudation, peeling skin;
8. photosensitivity;
9. liver dysfunction, hepatitis, jaundice;
10. kidney problems including blood in the urine, inflammation of the kidneys;
11. difficulty getting pregnant;
12. increased thirst;
13. fever;
14. swelling, weakness or pain in your muscles;
15. allergic reactions;
16. hair loss;
17. decrease in platelets or white blood cells, decrease in hemoglobin, increase in potassium in the blood;
18. blood vessel inflammation;
19. feeling tired or generally unwell;
20. seizures;
21. headache, dizziness and light-headedness;
22. sleep disturbances, nightmares;
23. problems with concentration and memory;
24. tingling;
25. confusion;
26. non-infectious meningitis;
27. feelings of depression;
28. visual disturbances, hallucinations;
29. disorders of balance and hearing, ringing in the ears.

If you notice any of the above or other symptoms during or after treatment with Apo-Napro, please inform your doctor or pharmacist immediately. It allows continued monitoring of the benefit / risk balance of the medicinal product.

Apo-Napro – dosage and method of administration

Apo Napro should be used according to the instructions attached to the package and the doctor’s instructions.

The drug should be taken during or after meals with a glass of water. The dose, frequency of use, and duration of treatment with Apo-Napro are determined by the doctor, based on individual factors for each patient, as well as the reason for starting treatment.

On the other hand, the manufacturer of the drug emphasizes that Apo-Napro should be used in the smallest effective doses, and also for the shortest possible period.

The physician should prescribe the most appropriate pharmaceutical form and strength according to age and weight.

Recommended daily dose of Apo-Napro for adults and adolescents over 16 years of age:

1. rheumatic diseases: 500-1000 mg in two divided doses, every 12 hours, the dose may be changed by the doctor in case of severe pain at night or morning stiffness. a loading dose of 750 mg, which is dedicated to people who have already taken high-dose anti-rheumatic drugs;
2. musculoskeletal disorders and painful periods: the initial dose is 500 mg, and then 1 tablet of 250 mg, every 6-8 hours as needed;
3. fever of various origins: 250 mg, every 8 hours as needed for a period not longer than 3-5 days;
4. acute gout: the starting dose is 750 mg (three 250 mg tablets) followed by 250 mg every 8 hours until the seizure is resolved.

The use of Apo Napro is limited in children. The preparation is allowed only in the treatment of children over 5 years of age in the case of juvenile rheumatoid arthritis. In this case, the permitted dose is 10 mg / kg body weight daily, divided into two doses.

Elderly patients should also be individually dosed, as they are at increased risk of serious side effects associated with the use of NSAIDs.

Patients in this group should be periodically monitored for gastrointestinal bleeding during treatment with Apo-Napro.

The drug should be used as prescribed by the doctor and do not exceed the recommended doses, as this will not increase the effectiveness of the drug and may harm your health and life.

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Apo-Napro – overdose or missed dose

Apo-Napro should always be used exactly as prescribed by your doctor. If you accidentally take too much medicine, tell your doctor immediately and go to the nearest hospital. It is best to take the medicine pack or leaflet with you, which will help you take specific actions.

Among the most frequently indicated symptoms that may indicate that the patient has taken too much of the drug, the following symptoms can be mentioned: headache, drowsiness, heartburn, indigestion, nausea, vomiting, stomach pain, diarrhea, feeling disoriented, bleeding from the digestive system , convulsions, acidification of the blood.

In the event of massive overdose, acute renal failure and liver damage are possible.

However, if you miss a dose of Apo-Napro, take it as soon as possible and then continue treatment as prescribed by your doctor.

Do not use a double dose of the drug to make up for the forgotten one. The duration of the treatment prescribed by the doctor should be strictly adhered to by the patient. It may be dangerous to withdraw the drug without consulting your doctor.

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Apo-Napro – interactions with other medicinal products

The initiation of treatment with Apo-Napro requires a detailed interview with regard to all current and recent medications, including over-the-counter medications.

Taking certain medications together with Apo-Napro can cause serious side effects. Before taking the drug, tell your doctor or pharmacist about all the drugs you are taking, or have recently taken, and about the drugs you plan to start taking.

Concomitant use of naproxen with other NSAIDs, including selective COX-2 inhibitors, should be avoided.

In addition, caution should be exercised when using Apo-Napro with:

1. anticoagulants (e.g. warfarin) and drugs that inhibit platelet aggregation (possible intensification of their effect; increased risk of haemorrhage; the patient should be under close medical supervision);
2. potassium-sparing diuretics (risk of hyperkalaemia);
3. diuretics, e.g. furosemide (possible reduction in their effectiveness);
4. antihypertensive drugs, including angiotensin converting enzyme inhibitors or angiotensin antagonists and beta-blockers (possible reduction in their effectiveness; increased risk of damaging the kidneys);
5. hydantoin derivatives (used to treat epilepsy) or sulphonamides (risk of increasing their effects);
6. acetylsalicylic acid (acetylsalicylic acid reduces the effect of naproxen);
7. methotrexate and lithium (possible increase in plasma levels of both lithium and methotrexate and intensification of their toxic effects);
8. cyclosporine and tacrolimus (increased risk of damaging the kidneys),
9. probenecid – used to treat acute gout (intensification and prolongation of the action of naproxen);
10. zidovudine (prolonged bleeding time);
11. cardiac glycosides, e.g. digoxin (risk of increasing heart failure and increasing the concentration of cardiac glycosides in the blood);
12. corticosteroids or serotonin reuptake inhibitors (increased risk of side effects, especially gastrointestinal bleeding);
13. quinolone antibiotics (increased risk of convulsions);
14. sulfonylurea derivatives.

Always tell your doctor or pharmacist what prescription drugs, over-the-counter drugs, or herbal products are already being taken. With this knowledge in mind, the physician can individually assess the patient’s risk of using Apo-Napro with other medicinal products.

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Apo-Napro interaction with alcohol

Combining alcohol with any medicinal product is not recommended and may pose a threat to our health or life.

In the case of Apo-Napro, an increase in side effects has been observed when the drug is combined with ethyl alcohol.

The mechanism of action is associated with a significant multiplication of the risk of renal dysfunction, as well as an increase in the frequency of intra-gastrointestinal bleeding.

In addition, it has been observed in clinical trials that there have been occasions when alcohol abuse by patients taking NSAIDs has led to acute renal failure.

Consuming alcoholic beverages during treatment with Apo-Napro increases the risk of discomfort and side effects from the digestive system.

The combination of the drug with ethyl alcohol may increase the risk of bleeding. Therefore, during the treatment with Apo-Napro, you should absolutely give up drinking alcohol to minimize the risk of side effects.

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Use of Apo-Napro during pregnancy and lactation

The use of any drug during pregnancy or breastfeeding requires prior consultation in order to clarify all the potential risks and benefits associated with the use of the drug.

Apo-Napro is not recommended for use in women in the third trimester of pregnancy due to the risk of premature closure of the arterial duct in the fetus and inhibition of uterine contractions.

However, in the first and second trimesters, taking the drug should be preceded by a careful analysis of the benefits and risks for the mother and the fetus developing inside the uterus.

In addition, Apo-Napro may increase the risk of bleeding in both the mother and the baby and delay and prolong labor, and therefore cannot be used during labor.

The available data suggest that NSAIDs can pass into breast milk at very low levels. Naproxen has been found in women using this drug, so it should not be used during lactation.

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