Biofenac – composition, dosage, action, indications, contraindications, side effects

Proven content

Biofenac is an analgesic and anti-inflammatory drug used in rheumatology. The preparation affects the musculoskeletal system, relieving severe and chronic pain in the joints. It is issued on prescription.

Biofenac – characteristics and indications

Biofenac is a prescription drug used in the symptomatic treatment of pain and inflammation of the joints, including

1. osteoarthritis,
2. rheumatoid arthritis (RA),
3. ankylosing spondylitis.

Biofenac has a general effect, it is a non-steroidal drug. The active substance of the preparation is aceclofenac, reducing the symptoms of an inflammatory response. Biofenac should be taken orally with a drink of water.

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Biofenac – mechanism of action

Biofenac is a drug whose active ingredient is aceclofenac (an anti-inflammatory drug). This substance has a strong anti-inflammatory and analgesic effect, and also counteracts the synthesis that affects the development of inflammation. The main task of aceclofenac is to inhibit the activity of cyclooxygenases:

1. cyclooxygenase-2 (COX-2),
2. to a small extent cyclooxygenase-1 (COX-1).

Biofenac alleviates the symptoms of inflammation, including swelling, pain or joint stiffness, and reduces the risk of damage to connective tissue.

After oral administration, the active ingredient in Biofenac – aceclofenac – is rapidly absorbed and its bioavailability is almost 100%. Peak plasma concentrations are reached approximately 1,25 to 3 hours after ingestion.

With food intake at the same time, the maximum time is prolonged while the degree of absorption is unchanged. Aceclofenac is highly protein bound (> 99,7%). It penetrates into the synovial fluid, where it reaches a concentration corresponding to 60% of that in plasma.

The elimination half-life of the active substance in plasma is 4 – 4,3 hours. . About two-thirds of the administered dose is excreted in the urine, mainly as conjugated hydroxy metabolites. Only 1% of a single oral dose is excreted unchanged.

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Biofenac – dosage and method of administration

Biofenac tablets are for oral use and should be taken with at least half a glass of liquid. Biofenac can be taken with food. The dosage of Biofenac depends on the age of the patient and the underlying conditions:

adults

The maximum recommended daily dose of Biofenac is 200 mg, taken in two divided doses of 100 mg, i.e. one tablet in the morning and one in the evening.

Elderly people

Normally no dose reduction is required, but precautions should be taken into account. It is best to consult your doctor before using Biofenac in the elderly.

Children and youth

The safety and efficacy of Biofenac in children and adolescents have not been established.

People with liver failure

The dose of Biofenac should be reduced in people with mild to moderate liver problems. The recommended starting dose is 100 mg daily.

People with renal insufficiency

Currently, there are insufficient data on the need to change the dosage of aceclofenac (the active ingredient of Biofenac) in people with mild renal impairment, but it is advisable to exercise caution and consult a doctor.

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Biofenac – contraindications

Biofenac is a drug that not everyone can take. The main contraindications for taking Biofenac are:

1. in people with hypersensitivity to the active substance or to any of the excipients,
2. in people whose use of substances with a similar mechanism of action (e.g. acetylsalicylic acid or other drugs from the group of non-steroidal anti-inflammatory drugs – NSAIDs) causes asthma attacks, bronchospasm, acute rhinitis or urticaria, or in people with are hypersensitive to these drugs,
3. in people with bleeding or who have a bleeding disorder,
4. in people who have had gastrointestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs,
5. in people with active or recurrent stomach ulcers or bleeding (two or more separate episodes of ulceration or bleeding)
6. in people with diagnosed congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral vascular disease and / or cerebrovascular disease,
7. in people with severe liver or kidney problems,
8. during the last three months of pregnancy.

Biofenac – precautionary measures

When using Biofenac, the simultaneous use of the drug with NSAIDs, including selective COX-2 inhibitors, should be avoided. When combined with these drugs, Biofenac can cause the following effects:

digestive system: Gastrointestinal bleeding, ulceration or perforation, which may be fatal, has been reported with the use of all NSAIDs at any time during treatment, with or without warning symptoms, or in patients with a history of severe gastrointestinal disturbances. If GI bleeding or ulceration occurs in the person taking Biofenac, treatment should be discontinued.

cardiovascular system: appropriate monitoring and care is required in those with a history of hypertension and / or mild to moderate congestive heart failure as fluid retention and edema have been reported in association with NSAID use.

respiratory system: caution should be exercised when used in people who have or have had bronchial asthma, as NSAIDs induce bronchospasm in these people,

effects on the kidneys: the administration of NSAIDs may cause a dose-dependent reduction in prostaglandin production and induce renal failure. The importance of prostaglandins in the maintenance of renal blood flow in people with cardiac or renal dysfunction, liver failure, diuretic therapy or surgery, and the elderly should be taken into account.

effects on the liver: close medical supervision is necessary in people with mild to moderate liver dysfunction,

the elderly: in the elderly, side effects associated with the use of NSAIDs are more frequent, especially gastrointestinal perforation and bleeding, which may be fatal.

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Biofenac – pregnancy and breastfeeding

Biofenac should not be taken by pregnant women, especially in the third trimester, planning pregnancy and breastfeeding women. The use of Biofenac, as with other drugs inhibiting cyclooxygenase and / or prostaglandin synthesis, may adversely affect fertility and is not recommended in women trying to become pregnant.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may cause the following damage to the fetus:

1. toxic effect on the cardiovascular and respiratory systems (pulmonary hypertension with premature closure of the Botall’s ductus arteriosus),
2. renal dysfunction which may lead to the development of renal failure with oligohydramnios).

Moreover, when administered to women at the end of pregnancy, they may cause in the mother and the newborn:

1. prolongation of bleeding time and anti-aggregation effect, even after the use of very low doses of the product,
2. inhibit uterine contractility, resulting in delayed or prolonged labor.

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Biofenac – interactions with other drugs

No pharmacokinetic interaction studies have been performed with the exception of warfarin. Aceclofenac is metabolised by cytochrome P450 2C9 and data from in vitro studies indicate that acklofenac may be an inhibitor of this enzyme. Therefore, a pharmacokinetic interaction is possible with:

1. phenytoin,
2. cimetidine,
3. tolbutamidem,
4. phenylbutazone,
5. amiodarone
6. miconazole,
7. sulfaphenazole.

Similarly to other NSAIDs, there is also a risk of pharmacokinetic interactions with other drugs excreted by active renal transport, such as methotrexate and lithium. Aceclofenac is almost completely bound to plasma albumin, and therefore, one should take into account the possibility of protein-protein binding displacement interactions with other drugs with high protein binding.

The concomitant use of Biofenac with the following drugs should be avoided:

1. methotrexate (in high doses) – tubular secretion of methotrexate may be inhibited and a slight metabolic interaction may also occur, resulting in a decreased clearance of methotrexate,
2. lithium and digoxin – the renal clearance of lithium and digoxin may be inhibited, which increases the serum levels of both drugs,
3. corticosteroids – there is an increased risk of gastrointestinal ulceration or bleeding
4. anticoagulants – the effect of anticoagulants, such as warfarin, may be increased
5. drugs that inhibit the function of platelets and selective serotonin reuptake inhibitors (SSRIs) – there is an increased risk of gastrointestinal bleeding.

Concomitant use with the following drugs may require dosage adjustment and precautions:

1. methotrexate (in low doses) – possible interaction should be considered, even when low doses of methotrexate are used, especially in people with impaired renal function. In cases where concomitant use is necessary, renal function should be monitored.
2. cyclosporine, tacrolimus – it is believed that the concomitant use of the drug with cyclosporine or tacrolimus increases the risk of nephrotoxicity due to decreased prostaglandin synthesis in the kidneys,
3. other NSAIDs, including salicylates (acetylsalicylic acid> 3g / day) – simultaneous use of the drug with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs may increase the frequency of side effects and therefore caution is recommended,
4. diuretics – aceclofenac, like other NSAIDs, may inhibit the effect of diuretics,
5. zidovudine – the risk of toxic effects on the haematopoietic system is increased during concomitant use of the drug and zidovudine.

If you experience joint problems, you may consider supplementation. Swanson’s Boswellia is a dietary supplement with anti-inflammatory and analgesic properties. It helps in reducing pain in joints and muscles.

Biofenac – side effects

Biofenac is a preparation that can lead to side effects. In the package leaflet of Biofenac, common, uncommon, rare and very rare effects are listed. Here is a list of side effects.

Common side effects (1/100 to <1/10):

1. dizziness,
2. indigestion,
3. abdominal pain,
4. nausea,
5. diarrhea,
6. increased levels of transaminases.

Uncommon side effects (1 / 1 to <000/1):

1. flatulence with gas,
2. gastritis,
3. constipation
4. vomiting,
5. mouth ulcers
6. itching
7. rash,
8. skin infection,
9. hives
10. increase in blood urea levels
11. increase in blood creatinine levels.

Rare side effects (1 / 10 to <000 / 1):

1. anemia,
2. anaphylactic reactions (including shock),
3. hypersensitivity.
4. blurred vision,
5. heart failure
6. hypertension,
7. acute arterial hypertension,
8. dyspnoea,
9. bad luck chairs
10. gastrointestinal ulceration,
11. bloody diarrhea
12. gastrointestinal bleeding
13. angioedema.

Very rare side effects (<1 / 10) include:

1. bone marrow depression,
2. granulocytopenia,
3. thrombocytopenia,
4. neutropenia,
5. paresthesia,
6. trembling,
7. somnolence,
8. Headache,
9. taste disturbance
10. depression,
11. mouth infection,
12. bloody vomiting
13. stomach ulcer
14. gastrointestinal perforation,
15. worsening of ulcerative colitis and Crohn’s disease
16. inflammation of the pancreas,
17. hepatitis,
18. other.

Biofenac – overdose

At present, there is insufficient data on the effects of overdose of aceclofenac (the active ingredient of Biofenac) in humans. However, from what is known, an overdose of non-steroidal anti-inflammatory drugs, such as Biofenac, can cause:

1. nausea,
2. vomiting,
3. stomach ache,
4. dizziness,
5. somnolence,
6. headache.

Treatment of acute poisoning with NSAIDs is based mainly on the administration of antacidsas necessary and on other supportive treatments and symptomatic complications such as hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory depression.