Voltadol 11.6Mg/G Topical Gel 100 G

Voltadol 11.6 Mg/G Topical Gel 100 G
Active ingredient: Diclofenac diethylamine

Voltadol 11.6 mg/g is a topical gel indicated for the relief of pain and inflammation associated with muscle and joint injuries. Its formula contains diclofenac, an anti-inflammatory that provides direct relief to the affected area after cutaneous application.

ACTION AND MECHANISM
Voltadol contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that inhibits the synthesis of prostaglandins and other inflammatory mediators by inhibiting cyclooxygenase. This reduces local inflammation and pain.

PHARMACOKINETICS
Topical route

• Absorption : The bioavailability of the gel is 6%, with maximum concentrations (Cmax) between 15 and 53.8 ng/ml, reached between 10 and 14 hours after application.
• Distribution : High binding to plasma proteins (99%), mainly to albumin. Volume of distribution (Vd) of 1.3 l/kg.
• Metabolism : It is almost completely metabolized in the liver by hydroxylation and conjugation with glucuronic acid.
• Elimination : It is eliminated mainly in urine (65%) and to a lesser extent in bile (35%), mainly as conjugated metabolites. Elimination half-life (t1/2) of 2 hours.

INDICATIONS
Symptomatic treatment of acute inflammatory and/or painful processes, such as:

• Contusion or sprain caused by twisting.
• Torticollis or other muscle contractures.
• Low back pain.
• Acute or post-traumatic musculoskeletal processes, such as tendonitis, tenosynovitis and arthritis.
• Osteoarthritis.

POSOLOGY

• Adults and adolescents over 14 years : Apply a thin layer of gel (2-4 g, equivalent to the size of a cherry or walnut, respectively) 3 to 4 times a day to the affected area. For Voltadol Forte, it can be applied every 12 hours, preferably in the morning and evening.

RULES FOR CORRECT ADMINISTRATION

• Apply only to healthy skin, avoiding use in areas with dermatitis, open wounds, burns or infections.
• Do not cover the treated area with occlusive dressings to avoid increased systemic absorption.
• Avoid contact with eyes and mucous membranes.
• Wash hands after application, unless they are the area to be treated.
• Apply the gel with a gentle massage until completely absorbed.
• Consult a doctor if symptoms persist or worsen after 5 days of use.

CONTRAINDICATIONS

• Hypersensitivity to diclofenac or any other component of the medication.
• Known allergy to NSAIDs or salicylates due to possible cross-reactions.
• Active peptic ulcer, since diclofenac may aggravate it.

PRECAUTIONS

• Photosensitivity reactions : Diclofenac may cause photosensitivity, so it is recommended to avoid exposure to the sun or UV light in the treated area for at least one day after application.
• Systemic reactions : Although the risk of systemic reactions is low, it may increase if applied to damaged areas or if occlusive dressings are used. Use with caution in patients with a history of asthma, peptic ulcer, renal or cardiac insufficiency, and hypertension.

WARNINGS ON EXCIPIENTS

• This medicine contains propylene glycol, which may cause skin irritation.

ADVICE TO THE PATIENT

• Check with your doctor if you have had previous allergic reactions to other NSAIDs, including aspirin.
• Do not cover the treated area with occlusive dressings.
• Do not apply the gel to areas with burns, open wounds, dermatitis or infections.
• Avoid exposure to the sun or UVA light sources for at least one day after the last application.
• If symptoms do not improve or worsen after 3 days of use, consult your doctor or pharmacist.
• Apply the gel with a gentle massage until completely absorbed.

INTERACTIONS
No interactions have been described at the doses recommended for topical use. However, in case of significant systemic absorption, the same interactions as with oral diclofenac could occur. Simultaneous use of other topical treatments in the same area is not recommended.

PREGNANCY

• FDA Category C (D) : Category C during the first 30 weeks of pregnancy and Category D beginning at week 30. Approximately 10% of the topical dose is absorbed systemically. Although topical absorption is less than oral absorption, systemic diclofenac has shown fetal toxic effects in late pregnancy.
  • First two trimesters : Diclofenac is only accepted for use if there are no safer alternatives and the benefits outweigh the risks.
  • Third trimester : Contraindicated due to the risk of delayed delivery, premature closure of the ductus arteriosus and pulmonary hypertension in the fetus, as well as acute renal failure and oligohydramnios. In addition, it may increase bleeding time in the mother.

BREASTFEEDING
It is not known whether topical diclofenac is excreted in breast milk. Systemic diclofenac is excreted in small amounts in milk, so manufacturers recommend discontinuing breastfeeding or avoiding the use of the drug, evaluating the benefits for the mother and the risk for the infant.

CHILDREN
Not recommended for use in children under 14 years of age.

ELDERLY
Elderly people are more susceptible to adverse reactions from diclofenac, so careful use is recommended.

ADVERSE REACTIONS

• Dermatological : Common (1-10%), such as pruritus, skin irritation, erythema and exanthematous eruptions, with occasional appearance of pustules or papules.
• Allergic : Uncommon (0.1-1.0%) such as hypersensitivity reactions, contact dermatitis, anaphylaxis, angioedema and photosensitivity reactions.
  In case of significant absorption, systemic adverse reactions similar to those of oral diclofenac may occur.

OVERDOSE

• Symptoms : Unlikely given the route of administration, but accidental ingestion or improper application could cause systemic adverse effects.
• Treatment : In case of accidental ingestion, gastric lavage and symptomatic treatment according to medical criteria are recommended.

Leaflet Voltadol 10 Mg/G Topical Gel 100 G

Technical Data Sheet Voltadol 10 Mg/G Topical Gel 100 G