Butadion, ointment 5% 20 g

Phenylbutazone

Indications

post-traumatic inflammation of soft tissues and joints, for example, as a result of sprains, strains and bruises;
rheumatic diseases of soft tissues (tenosynovitis, bursitis, damage to periarticular tissues);
muscle pain of rheumatic and non-rheumatic origin;
pain and swelling associated with diseases of muscles and joints;
rheumatoid arthritis;
osteoarthritis;
radiculitis;
lumbago;
sciatica.

Pharmacological effect

Pharmacotherapeutic group: NSAIDs

Pharmacological action

NSAIDs have anti-inflammatory and analgesic effects. The active substance indiscriminately inhibits the activity of cyclooxygenase (COX-1 and COX-2) and suppresses the synthesis of prostaglandins, influencing the tissue response to inflammation.

In cartilage tissue, phenylbutazone inhibits ATP-dependent biosynthesis of mucopolysaccharides. It also has a uricosuric effect by reducing tubular renal reabsorption of uric acid.

Butadione is used to eliminate pain and reduce swelling associated with the inflammatory process. When applied topically, it causes a weakening or disappearance of joint pain at rest and during movement. Reduces morning stiffness and swelling of joints, helps increase range of motion.

Pharmacokinetics

Suction

When applied topically, systemic absorption of phenylbutazone is no more than 5%. When taken orally, phenylbutazone is rapidly absorbed from the gastrointestinal tract.

Metabolism and excretion

When taken orally, it undergoes intense metabolism in the liver, is excreted in the form of metabolites mainly by the kidneys and about 1/4 through the intestines. The elimination time from blood plasma is long (on average 70 hours, in elderly people – up to 105 hours) with significant interindividual variability.

Special instructions

If irritation (redness) of the skin occurs, you should stop using Butadione and prescribe another treatment.

The ointment should be applied only to intact skin, avoiding contact with open wounds. After application, do not apply an occlusive dressing.

Do not allow the drug to come into contact with the eyes or mucous membranes.

After applying the drug, wash your hands thoroughly.

The drug should not be used to treat thrombophlebitis of the deep veins of the extremities.

To prevent photosensitivity, protect the skin from direct sunlight.

The drug contains methyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed).

This product contains propylene glycol, which may cause skin irritation.

Impact on the ability to drive vehicles and machinery

There is no information on the effect of the drug Butadion on the ability to drive a car and perform other activities that require concentration and speed of psychomotor reactions.

Active ingredient

Phenylbutazone

Composition

Active substance: phenylbutazone

Excipients: methyl parahydroxybenzoate, sodium carmellose, colloidal silicon dioxide, polysorbate 60, glycerol (85%), propylene glycol, liquid paraffin, water.

Pregnancy

During pregnancy and breastfeeding, the use of the drug should be avoided. The drug is contraindicated in the first and third trimester of pregnancy due to the ability of NSAIDs to cause fetal development disorders. In the second trimester of pregnancy, Butadione can be used only after a thorough assessment of the expected benefit to the mother and the potential risk to the fetus. Animal studies have revealed the fetotoxicity of butadione.

If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Contraindications

hypersensitivity to phenylbutazone or other components of the drug, to acetylsalicylic acid and other NSAIDs;
data on a history of an attack of bronchial obstruction (an attack of bronchial asthma), other allergic reactions (such as rhinorrhea, urticaria) after taking acetylsalicylic acid or another NSAID;
application to the skin around the eyes, mucous membranes, open wounds or fractures;
violation of the integrity of the skin at the site of intended application;
use under an occlusive dressing;
treatment of deep vein thrombosis;
I and III trimesters of pregnancy;
breastfeeding period;
children under 14 years of age;
simultaneous use with other drugs containing phenylbutazone.

Side Effects

From the immune system: allergic reactions (including angioedema, bronchospasm, urticaria, generalized skin rash).

For the skin and subcutaneous tissues: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated skin area; papules, vesicles, peeling

If any of the side effects indicated in the instructions are aggravated or any other side effects not specified in the instructions are noted, the patient should inform the attending physician.

Interaction

No interaction was detected with external use, but the possibility of interaction with systemic use of phenylbutazone cannot be excluded.

The simultaneous use of Butadione with other NSAIDs should be avoided. The drug may enhance the effect of drugs that cause photosensitivity.

Overdose

The extremely low absorption of the active components of the drug when applied externally makes overdose almost impossible.

Symptoms: if large quantities of ointment (more than 20 g) are accidentally ingested, systemic adverse reactions characteristic of NSAIDs may occur.

Treatment: gastric lavage is necessary, taking activated carbon.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 2° to 8°C.

Shelf life

Shelf life – 3 years

Manufacturer

Ozon, Russia