Diclosafe Forte emulsion gel for external use 2.32%, 100g — Made in India — Free Delivery

Pharmacological properties

Pharmacodynamics. Diclosafe / Diclosafe forte with the active ingredient diclofenac is an NSAID for external use.

Diclofenac is an NSAID that has a pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic effect. The main mechanism of action is the suppression of the biosynthesis of prostaglandins.

In case of inflammation caused by injuries or rheumatic diseases, diclofenac gel leads to a decrease in the severity of pain, tissue edema and a reduction in the period of renewal of the functions of damaged joints, ligaments, tendons and muscles. Clinical data have shown that diclofenac gel reduces acute pain as early as 1 hour after the initial application. The preparation reduces pain on movement by 75% within two days. 94% of patients responded positively to the diclofenac gel after 2 days of treatment, compared with 8% of patients who responded positively to placebo. Overcoming of pain and functional disorders was achieved after 4 days of treatment with diclofenac gel. Due to the water-alcohol base, the preparation also has a local anesthetic and cooling effect.

Pharmacokinetics. The amount of diclofenac absorbed through the skin is proportional to the area of ​​its application and depends both on the total dose of the preparation and on the degree of skin hydration. After topical application of 2.5 g of diclofenac gel to a skin surface of 500 cm2, the absorption rate of diclofenac is approximately 6%. The use of an occlusive dressing for 10 hours leads to a threefold increase in the absorption of diclofenac.

After applying the gel with diclofenac to the skin of the joints of the hand and knee, diclofenac is determined in blood plasma (where its Cmax is about 100 times lower than after oral administration of the same amount of diclofenac), in the synovial membrane and synovial fluid. The protein binding of diclofenac is 99.7%.

Diclofenac accumulates in the skin, which serves as a reservoir from where the substance is gradually released into nearby tissues. From there, diclofenac predominantly enters deeper inflamed tissues, such as joints, where it continues to act and is determined at concentrations up to 20 times higher than in blood plasma.

Diclofenac is metabolized by hydroxylation to form several phenolic derivatives, two of which are pharmacologically active, but to a much lesser extent than diclofenac.

Diclofenac and its metabolites are excreted mainly in the urine. The total systemic clearance of diclofenac is 263 ± 56 ml / min, and the final T1 / 2 is on average 1-3 hours.

In renal or hepatic insufficiency, the metabolism and excretion of diclofenac from the body do not change.

Indications

Diclosafe. local treatment of pain and inflammation of joints, muscles, ligaments and tendons of rheumatic or traumatic origin.

Diclosafe forte. Treating pain, inflammation and swelling in:

damage to soft tissues: injuries to tendons, ligaments, muscles and joints (for example, due to dislocation, sprains, bruises) and back pain (sports injuries);

localized forms of soft tissue rheumatism: tendinitis (including "tennis elbow"), bursitis, shoulder syndrome and periarthropathy.

Symptomatic treatment of osteoarthritis of small and medium-sized joints located superficially, such as finger joints or knee joints.

Application

Diclosafe

Adults and children over the age of 14: Diclosafe gel should be applied 3-4 times a day, rubbing lightly into the skin. The amount of the preparation that is used depends on the size of the affected area (for example, 2–4 g, the size of a cherry or walnut, is enough to be applied to an area of ​​400–800 cm2).

After applying the preparation, you need to wash your hands, except for those cases when this particular area is subject to treatment.

Elderly patients: no dose adjustment is required.

If Diclosafe gel is applied to large areas of the body, the systemic absorption of Diclofenac will be greater and the risk of adverse reactions will increase, especially if therapy is used frequently.

Diclosafe forte

Adults and children over the age of 14: apply Diclosafe Forte gel 2 times a day (morning and evening), rubbing lightly into the skin at the site of pain localization. The amount of the preparation used depends on the size of the affected area (for example, 2–4 g, the size of a cherry or walnut, is enough to be applied to an area of ​​400–800 cm2).

After applying the preparation, you need to wash your hands, except when this particular area is to be treated.

If Diclosafe Forte gel is applied to large areas of the body, the systemic absorption of Diclofenac will be greater and the risk of adverse reactions will increase, especially if therapy is used frequently.

The duration of therapy depends on the nature of the disease and the effectiveness of the treatment.

Diclosafe / Diclosafe forte should not be used for more than 14 days in a row for soft tissue injuries or rheumatism and for more than 21 days for joint pain in arthritis, unless otherwise recommended by a doctor.

It is necessary to seek the advice of a doctor if the severity of the symptoms of the disease does not decrease or the manifestations intensify after 7 days of treatment.

Children. Since there is insufficient data on the efficacy and safety of diclofenac gel for children under 14 years of age, the preparation is contraindicated in children of this age group (see CONTRAINDICATIONS). When using the preparation in children over the age of 14 for more than 7 days or if the symptoms of the disease intensify, you should consult a doctor.

Contraindications

Diclosafe

• hypersensitivity to diclofenac or other components of the preparation;
• a history of asthma attacks, urticaria or acute rhinitis caused by the intake of acetylsalicylic acid or other NSAIDs;
• the last trimester of pregnancy;
• children under 14 years of age.

Diclosafe forte

• hypersensitivity to diclofenac, acetylsalicylic acid, other NSAIDs or other components of the preparation;
• a history of asthma attacks, urticaria, or acute rhinitis caused by the intake of acetylsalicylic acid or other NSAIDs;
• combined use with other preparations containing diclofenac;
• combined use with other NSAIDs;
• the last trimester of pregnancy.

Side effects

Diclofenac gel is generally well tolerated. adverse events include mild temporary skin reactions at the site of application. in rare cases, allergic reactions may occur.

Infections and invasions: pustular eruptions.

From the immune system: hypersensitivity reactions (including urticaria), angioedema.

From the respiratory system, chest and mediastinal organs: BA.

On the part of the skin and subcutaneous tissue: rash, itching, eczema, erythema, dermatitis, including contact dermatitis, bullous dermatitis, photosensitivity reactions, burning of the skin.

With topical use of diclofenac, the possibility of adverse reactions, which are usually associated with its systemic use *, cannot be excluded (see SPECIAL INSTRUCTIONS).

In case of adverse reactions, discontinue treatment and consult a doctor.

* Information on adverse reactions associated with systemic use of diclofenac is contained in the relevant sources.

Special instructions

The likelihood of developing systemic side effects with topical application of diclofenac is insignificant compared with the use of its oral forms, but it is not excluded when the preparation is used on relatively large areas of the skin for a long time.

The preparation should be used with caution at the same time as oral NSAIDs, as the frequency of undesirable, especially systemic, side effects may increase (see INTERACTIONS).

Dicloseif / Diclosef forte gel should not be used concurrently with other preparations containing diclofenac.

Diclosafe / Diclosafe forte gel is recommended to be applied only to intact, undamaged skin areas, avoiding contact with inflamed, wounded or infected skin. Avoid contact of the preparation with the mucous membrane of the eyes and other mucous membranes. The preparation should not be swallowed.

If any skin rash appears, treatment with the preparation should be discontinued.

Diclosafe / Diclosafe forte gel should not be used under an airtight occlusive dressing, but it can be used under a non-occlusive dressing. In the event of a sprain, the affected area can be tied with a bandage.

With topical application of diclofenac, there is some possibility of gastrointestinal bleeding in those patients who have had it in the past.

Diclosafe / Diclosafe forte gel contains propylene glycol and butylhydroxytoluene. Propylene glycol can irritate the skin. Butylhydroxytoluene may cause local skin reactions (eg contact dermatitis) or irritation of the eye and other mucous membranes.

Use during pregnancy and lactation. Pregnancy. After topical application of diclofenac, its systemic concentration is lower compared with oral administration. Given the experience of therapy with systemic NSAIDs, it is recommended to take into account the following.

Inhibition of prostaglandin synthesis can adversely affect the course of pregnancy and / or the development of the embryo / fetus. Epidemiological data indicate an increased risk of miscarriage and / or the risk of developing heart defects and gastroschisis after using an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular disease was increased from less than 1% to 1.5%. The risk is thought to increase with dose and duration of treatment. It has been shown that in animals the administration of an inhibitor of prostaglandin synthesis leads to an increase in pre- and post-implantation loss and mortality of the embryo / fetus.

In addition, in animals that received an inhibitor of prostaglandin synthesis during the period of organogenesis, an increased frequency of various malformations, including those of the cardiovascular system, was recorded. During the first and second trimester of pregnancy, diclofenac should not be used unless it is necessary. If diclofenac is used by a woman planning pregnancy, or if the preparation is used during the first or second trimester of pregnancy, the dose of the preparation should be as low as possible, and the duration of treatment should be as short as possible.

In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can affect the fetus as follows:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• impaired renal function, which can progress to renal failure with oligohydramnios.
• The use of inhibitors of prostaglandin synthesis at the end of pregnancy can affect the mother and newborn as follows:
• possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses;
• inhibition of uterine contractions, which leads to a delay or lengthening of labor.

So, diclofenac is contraindicated during the third trimester of pregnancy (see CONTRAINDICATIONS).

Lactation. Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, when used in therapeutic doses of Dicloseif / Diclosef forte gel, no effect on breastfeeding is expected. Due to the lack of controlled studies in women who are breastfeeding, Diclosafe / Diclosafe forte gel during this period should be used only as directed by a doctor. During breastfeeding, the preparation should not be applied to the mammary glands or large areas of the skin and should not be used for a long time (see SPECIAL INSTRUCTIONS and APPLICATION).

Fertility There are no data on the effect of diclofenac on human fertility when used externally.

The ability to influence the reaction rate when driving or working with other mechanisms. Does not affect.

Interactions

Since the systemic absorption of diclofenac due to topical application of the preparation is very low, the likelihood of interactions is negligible. to date, there are no data on the interaction of diclofenac in the case of its topical application. information on the known interactions of oral forms of diclofenac is contained in the relevant sources.

Overdose

Symptoms overdose is unlikely due to the low absorption of diclofenac into the systemic circulation when applied topically. at the same time, the development of systemic adverse reactions can be observed in case of accidental ingestion of diclosef / diclosef forte gel (it should be borne in mind that 1 tube of the preparation, 30 g each, contains the equivalent of 0.3 g of diclofenac sodium). in case of accidental ingestion of the preparation and the occurrence of significant systemic adverse reactions, the general therapeutic measures that are used in the treatment of NSAID poisoning should be used. it is recommended to wash the stomach and take activated charcoal, especially in cases where the preparation has been swallowed recently.

Treatment. Treatment of an NSAID overdose consists in the use of supportive and symptomatic therapy. There is no typical clinical picture caused by an overdose of diclofenac gel. Supportive and symptomatic treatment is indicated for complications such as arterial hypotension, renal failure, convulsions, gastrointestinal disorders and respiratory depression. It is unlikely that forced diuresis, hemodialysis or hemoperfusion are useful for the elimination of NSAIDs, since the active substances of these preparations are largely bound to blood plasma proteins and are extensively metabolized.

Storage conditions

At a temperature not higher than 25 ° C.