VOLINI GEL

VOLINI GEL

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VOLINI GEL

Composition

  • Diclofenac Diethylamine BP 1.16%w/w equivalent to Diclofenac sodium BP 1.00% w/w
  • Methyl Salicylate BP 10.0%w/w
  • Racementhol BP 5.00%w/w
  • Linseed Oil BP 3.00%w/w
  • Gel base q.s.

Diclofenac diethylamine is a benzene-acetic acid derivative, a non-steroid anti-inflammatory drug (NSAID). It is chemically designated as diethylammonium 2-[(2,6-dichloroanilino)phenyl]acetate. The molecular weight is 369.29. its molecular formula is C18H22CL2N2O2.

Linseed oil contains predominantly essential fatty acid-linolenic. Alpha-linolenic acid (ALA) is a polyunsaturated omega-3 fatty acid. It is chemically designated as (9Z, 12Z, 15Z)-Octadecatrienoic acid. Its molecular formula is C18H30O2 and molecular weight is 278.4.

Methyl salicylate is a salicylic acid derivative which is chemically designated as methyl 2-hydroxybenzoate. Its molecular formula is C8H8O3. Its molecular weight is 152.1

Racementhol is a racemic mixture of menthol. Menthol is chemically designated as 2-Isopropyl-5-methylcyclohexanol. Its molecular formula C10H20O and molecular weight is 156.3

Indications

  • Trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains,strains and bruises
  • Localised forms of soft tissue rheumatism
  • muscle and joint diseases (rheumatoid arthritis and osteoarthritis, rediculitis, low back pain, ischias)

It is recommended that treatment be reviewed after 14 days in these indications except osteoarthritis. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.

Mechanism of action

Diclofenac: The mechanism of action of Diclofenac is similar to that of other non-steroid anti-inflammatory drugs. Diclofenac inhibits the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin. It is not completely understood how reduced synthesis of these compounds results in the therapeutic efficacy.

Linseed oil: Alpha-Linolenic acid is the main constituent of linseed oil. Alpha-Linolenic acid gets converted to eicosapentaenoic acid (EPA). EPA is acted upon by cyclo-oxygenase enzyme to produce Prostaglandin E3, which decreases inflammation. Presence of EPA prevents the action of cyclo-oxygenase on arachidonic acid, which reduces its conversion to PEG2 (a highly inflammatory agent).

Methyl salicylate: Methyl salicylate is an irritant to the skin and is used topically in rubefacient preparations for the relief of pain in musculoskeletal, joint, and soft tissue disorders.

Racementhol: Racementhol is a racemic mixture of menthol. When menthol is used topically to the skin it dilates the blood vessels causing a sensation of coldness followed by an analgesic effect. In addition it also helps to relieve itching and is used in pruritus and urticaria. It has also been applied to the forehead, presumably as a counter-irritant.

Dosage and administration

Adults: VOLINI GEL should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) should be applied 3-4 times daily. After application, the hands should be washed unless they are the site being treated.

Use in the elderly: the usual adult dosage may be used.

Children: there are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age. In children 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/ parents of the adolescent is/are advised to consult a doctor.

VOLINI GEL is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially if the therapy is used frequently.

Use in special populations

Pregnancy

The systemic concentration is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended.

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Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and/or cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy.

During the first and second trimester of pregnancy, Diclofenac should not be given unless clearly necessary. If Diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandins synthesis inhibitors may expose the fetus to:

  • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension)
  • renal dysfunction, which may progress to renal failure with oligo-hydroaminiosis

The mother and the neonate, at the end of pregnancy, to:

  • possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
  • Inhibition of uterine contractions resulting in delayed or prolonged labor

Consequently, Diclofenac is contraindicated during the third trimester of pregnancy.

Lactation

It is not known whether Diclofenac is excreted in human milk; however, studies in animals detected Diclofenac in the milk after oral administration. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Diclofenac a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Because of lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstances, gel should not be applied on the breast of nursing mothers nor do elsewhere on large areas of skin for a prolonged period of time

Labor and delivery

in reported rat studies with oral NSAIDs, including Diclofenac, as with other drugs known to inhibit prostaglandin synthesis, there is an increased incidence of dystocia and delayed parturition corresponding to a human equivalent dose approximately similar to the maximum recommended clinical dose (based on bioavailability and body surface area comparison). The effects of Diclofenac diethylamine, linseed oil, methyl salicylate and racementhol gel on labor and delivery in pregnant women are unknown.

Pediatrics

Safety and effectiveness in pediatric patients have not been established.

Geriatrics

of the total number subjects treated with Diclofenac gel in reported clinical studies, 498 were 65 years of age and over. No overall differences in effectiveness or safety were reported between these subjects and younger subjects, but greater sensitivity to the effects of NSAIDs in some older individuals can not be ruled out.

Contraindications
  • patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
  • Setting of coronary artery bypass graft (CABG) surgery.
  • Patients with a known hypersensitivity to Diclofenac, linseed oil, racementhol and methyl salicylate or any of the excipients
  • third trimester of pregnancy
  • children and adolescents aged less than 14 years.
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