Project Description

Ibuprophenum

ointment 5% – Unguentum Ibupropheni 5%

international nonproprietary name

Ibuprophenum

Ref

BP-0065

Pharmacotherapeutic group

Not narcotic analgesics (non-steroid anti-inflammatory drug)

Composition of the preparation

100 g of the ointment contain ibuprophenum (calculated for the basic sunstance) – 5.0 g, excipients: dimethylsulfoxide, polyethilenoxide – 400, polyethylenoxide – 1500.

Pharmacological action

Pharmacodynamics

The preparation is a non-steroid anti-inflammatory drug for external appliance. Ibuprophenum exerts analgesic and anti-inflammatory actions. It suppresses the inflammation mediators production. It inhibits cyclooxygenase and blocks the prostaglandins biosynthesis. The anti-inflammatory action is caused the increased vessels permeability normalization, the microcirculation improvement, the histamine, bradikinin, and other inflammation mediators liberation reduction, the ACE formation hindering thus causing the inflammatory process energy supply decrease. The ibuprophenum analgesic action is caused by the inflammation intensity reduction, by the bradikinin production and algogeneity reduction. Dimethylsulfoxide has local non-specific anti-inflammatory, analgesic effects, favors the ibuprophenum better and deeper penetration into tissues.

Ibuprophenum ointment has a quick and pronounced effect – it reduces the pain syndrome including arthralgia on rest and in movement. It reduces edema and hyperemia.

It reduces morning constrain and joints movements restriction.

Pharmacokinetics

When applied locally 5% ibuprophenum ointment is absorbed in small quantity causing no pronounced systemic action of the body. It penetrates the joint cavity slowly delaying in the synovial tissue forming concentrations in it larger than in the plasma. It is biotransformed forming three basic metabolites. The metabolic degradation products are eliminated from the body by the kidneys. Dimethylsulfoxide quickly passes the biologic membranes including the intact skin, mucous membranes. It is metabolized forming dimethylsulfone and dimethylsulfide. The dimethylsulfoxide unchanged and dimethylsulfone are excreted with urine and feces, dimethylsulfide is eliminated through the lungs and skin.

Indications 

Inflammatory and degenerative diseases of the locomotor system: arthritis (rheumatoid, psoriatic, gouty ones), humeroscapular periarthritis, ankylosing spondoarthritis (Behterev disease), osteoarthrosis, osteochondrosis, radiculitis, tendivitis, tendovaginitis, bursitis, lumbago, ischialgia, myalgia, traumas without soft tissues intactness impairment (dislocation, strains or ruptures of muscles and tendons, soft tissues contusions and posttraumatic edema, etc.).

special indication

Not established

special warning

The preparation is for the external appliance only. When the pathology is severe the local treatment should be combined with non-steroid anti-inflammatory drugs intake.

The ibuprophenum ointment getting on the mucous membranes or into eyes should be avoided.

Sharp reddening and pruritus appearance evidence about a hypersensitivity to the preparation (appliance is not recommended).

Dosage and method of administration

The preparation is applied externally. A strip of the ointment 5 – 10 cm long is put on the skin in the area of pain and is rubbed in by easy motions thoroughly. The ointment is applied 3 – 4 times a day every day. The treatment duration is determined individually considering the disease severity and the damage character.

overdosage

No cases of the ibuprophenum ointment appliance have been reported.

When applied on extensive damaged areas in high doses (exceeding the recommended ones) for a long time systemic side effects may develop.

safety measures

Not established

Side effects

No unfavorable effects when the preparation is applied are observed.

Dermal hyperemia, feeling of burning or pricking may occur.

In care cases allergic reactions are possible (dermal eruption, pruritus, Quincke’s edema). When allergic reactions appear the preparation appliance should be stopped, in case of necessity the desensitizing therapy should be performed).

Contraindications

Individual hypersensitivity to the preparation components including that to dimethylsulfoxide, ibuprophenum as well as to other non-steroid anti-inflammatory drugs. Wetting dermatoses, eczema, infected excoriations and wounds, pregnancy, period of lactation.

Interactions with other medicinal preparations

No cases of a negative interaction with other medicines included into the conventional therapeutic schemes while the ibuprophenum ointment appliance have been reported. Caffeine increases the ibuprophenum analgesic effect.

The form of release

15 g tubes.