Voltadol Forte 23.2 Mg/G Topical Gel 100 G

Voltadol Forte 20 Mg/G Topical Gel 100 G
Active ingredient: Diclofenac diethylamine

Voltadol Forte is an anti-inflammatory and analgesic gel for topical use, indicated for the treatment of pain and inflammation associated with muscle and joint injuries. It is designed to relieve acute localized pain by direct application to the skin, allowing effective absorption of the active ingredient, diclofenac.

ACTION AND MECHANISM
Voltadol Forte contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) derived from phenylacetic acid. It acts by inhibiting the synthesis of prostaglandins and other inflammatory mediators by blocking the action of the enzyme cyclooxygenase, which contributes to reducing both inflammation and local pain.

PHARMACOKINETICS
Topical route

• Absorption : The bioavailability of the gel is 6%, reaching maximum concentrations (Cmax) of between 15 and 53.8 ng/ml 10-14 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 reactions and conjugation with glucuronic acid.
• Elimination : It is eliminated mainly in urine (65%) and to a lesser extent in bile (35%), mainly in the form of 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.

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. In the case of Voltadol Forte, it can be applied every 12 hours, preferably in the morning and in the evening.

RULES FOR CORRECT ADMINISTRATION

• Apply only to healthy skin, avoiding areas with dermatitis, open wounds, burns or infections.
• Do not cover the treated area with occlusive dressings, as this may increase the systemic absorption of diclofenac.
• Avoid contact with eyes and mucous membranes.
• After application, wash hands unless they are in the area to be treated.
• Apply the gel with a gentle massage until completely absorbed.
• If symptoms persist or worsen after 5 days of use, it is recommended to consult a doctor or pharmacist.

CONTRAINDICATIONS

• Hypersensitivity to diclofenac or any other component of the medication.
• Known allergy to NSAIDs or salicylates due to possible allergic cross-reactions.
• Patients with active peptic ulcer, since diclofenac could aggravate it.
• Do not use during the third trimester of pregnancy.
• Not recommended for children under 14 years of age.

PRECAUTIONS

• Photosensitivity reactions : Diclofenac may cause photosensitivity, so it is recommended not to expose the treated area to the sun or UV light for at least one day after application.
• Systemic reactions : Although the risk of systemic effects is minimal, it may be increased if applied to damaged areas or used with occlusive dressings. 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.
• It also contains butylhydroxytoluene, which may cause local skin reactions such as contact dermatitis, as well as irritation of the eyes or mucous membranes.

ADVICE TO THE PATIENT

• Consult 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 of skin 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 may occur. Simultaneous use of other topical medications 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, with lower bioavailability compared to the oral route.
  • First two trimesters : Diclofenac is only accepted for use if the benefits outweigh the risks and there are no safer alternatives.
  • 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 breast milk. Manufacturers advise discontinuing breastfeeding or avoiding its administration, weighing 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 may be 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, occasionally with the 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, although accidental ingestion or excessive application could cause systemic adverse effects of diclofenac.
• Treatment : In case of accidental ingestion, gastric lavage and symptomatic treatment according to medical criteria are recommended.