Voltadol forte 20 mg/g gel topico 50 g

Voltadol Forte: Action and mechanism

- Anti-inflammatory and topical analgesic. Diclofenac is a non-steroidal anti-inflammatory derived from phenylacetic acid, which acts by preventing the synthesis of prostaglandins and other prostanoids, by inhibiting the cyclo-oxygenase involved in inflammatory processes.

Pharmacokinetics

Topical:

- Absorption:

* Gel: 6% bioavailability. The Cmax is 15-53.8 ng/ml, reached after 10-14 h of application.

- Distribution: High binding to plasma proteins (99%), mainly to albumin. You of 1.3 l/kg.

- Metabolism: It is almost completely metabolized in the liver, through hydroxylation and conjugation reactions with glucuronic acid.

- Elimination: It is eliminated in urine (65%) and bile (35%), mainly as conjugated metabolites. Small amounts of unaltered diclofenac are detected in urine and bile. The t1/2 is 2 h.

Indications of Voltadol Forte: 

- [PAIN]. Symptomatic treatment of acute inflammatory and/or painful processes, such as

* CONTUSION] or [SPINNING] produced by twisting.

* [TORTICOLIS] or other [CONTRACT].

* [LUMBALGIA].

Posology of Voltadol Forte: 

- Diclofenaco Kern Pharma, Diclokern, Voltadol and Voltadol Forte (adults and adolescents over 14 years old): apply a thin layer (2-4 g of gel, equivalent to the size of a cherry or nut, respectively), 3-4 times a day or 1 application every 12 hours (preferably morning and evening) in the case of Voltadol Forte.

Rules for the correct administration of Voltadol Forte: 

Its application should be avoided in areas of skin that present dermatitis, open wounds, burns or infections, as well as covering the area with occlusive bandages, since it could favor a greater systemic absorption of diclofenac.

Application near the eyes, as well as on mucous membranes, should be avoided.

After application, hands should be washed unless they are the site of treatment.

If the symptoms continue or worsen after 5 days of use, it is recommended that you consult your doctor and/or pharmacist.

- Emulsion, gel: Apply to the area to be treated, massaging until the gel is absorbed. Wash your hands afterwards.

Contraindications of Voltadol Forte: 

- Hypersensitivity to diclofenac or any other drug component. There are reports of cross-allergic reactions between different NSAIDs, as well as with salicylates, so diclofenac is not recommended for [NSAID ALLERGY] or [SALICYLATE ALLERGY] either.

- [PEPTIC ULCER] active. Although topical application limits diclofenac absorption, its use is not recommended in patients with peptic ulcer disease because of the potential for ulcer aggravation.

Precautions with Voltadol Forte: 

- [PHOTOSENSITIVITY REACTIONS]. Diclofenac has given rise to photosensitivity reactions. It is recommended not to expose the treated areas to the sun or UV light for at least one day.

- Systemic reactions. The risk of systemic reactions from topical diclofenac is minimal, although it cannot be ruled out if significant systemic absorption occurs, as can happen if applied to areas of damaged skin (dermatitis, burns, wounds) or with an occlusive dressing. It is recommended that posology recommendations be adhered to in patients with asthma, history of peptic ulcer, renal or heart failure, as well as hypertension.

Excipient warnings:

- Because it contains butyl hydroxytoluene as an excipient it can produce local skin reactions, such as contact dermatitis, or irritation of the eyes or mucous membranes.

Excipient warnings:

- This medicine contains propylene glycol, so it can cause skin irritation.

Advice to the patient

- A doctor and/or pharmacist should be consulted if previous allergic reactions to other anti-inflammatory drugs, including acetylsalicylic acid, have been described.

- Do not cover the area with occlusive bandages.

- It should not be applied to skin areas with burns, open wounds, dermatitis or infections.

- Do not expose treated areas to sun or UVA light sources until at least one day after the last application.

- If symptoms continue or worsen after 3 days of use, consult your doctor and/or pharmacist.

- Apply to the skin and massage until the gel is absorbed.

Interactions

No interactions at recommended doses have been described. However, in case of significant systemic absorption the same interactions as with systemic diclofenac could occur.

Also, as with any topical treatment, it is not advisable to administer two topical medications at the same time to the same area.

Pregnancy and Voltadol Forte: 

- FDA category C(D). Category C during the first 30 weeks of pregnancy and category D from the 30th week of pregnancy. Approximately 10% of the topical dose is absorbed systemically with considerably less bioavailability topically than orally. There are no adequate and well-controlled studies in humans with topical diclofenac, but systemic diclofenac has led to fetal toxic effects in late pregnancy. Although skin absorption is minimal, it cannot be ruled out that systemic effects will not appear.

Topical use of diclofenac during the first two trimesters of pregnancy is only accepted if, in the absence of other safer therapeutic alternatives, the benefits outweigh the possible risks.

The use of diclofenac during the third trimester of pregnancy is contraindicated, as diclofenac has been associated with delayed delivery and adverse cardiovascular effects on the fetus, such as premature closure of the ductus arteriosus and pulmonary hypertension, and renal effects, such as acute renal failure and oligohydramnios. It can also increase the bleeding time in the mother.

Breastfeeding and Voltadol Forte:

It is not known whether topical diclofenac is excreted with milk, and the consequences it may have for the infant. Approximately 10% of the topically applied dose is absorbed systemically. Systemic Diclofenac is excreted in small amounts in breast milk. Some experts accept the use of topical diclofenac during lactation. The manufacturers advise to stop breastfeeding or to avoid its administration.

Children

See Posology.

Elders

The elderly may be especially susceptible to adverse reactions to diclofenac, so use with caution.

Adverse reactions of Voltadol Forte:

- Dermatological: Frequent (1-10%) local reactions in the area of application, such as [PRURITUDE], [CUTANEOUS IRRITATION], [ERYTHEM], [EXANTHEMATIC ERUPTIONS], with occasional appearance of pustules or papules.

- Allergic: Infrequent (0.1-1.0%) [HYPERSENSITIVITY REACTIONS], [CONTACT DERMATITIS]; occasional cases of [ANAPHILAXY], [ANGIOEDEMA] and [PHOTOSENSITIVITY REACTIONS].

In case of significant absorption, systemic adverse reactions to diclofenac may occur.

Overdose

Symptoms: Due to its route of administration, symptoms are unlikely to appear in the event of an overdose, although accidental ingestion or improper application may produce the typical systemic adverse effects.

Treatment: In case of accidental ingestion, the stomach should be pumped and treated symptomatically.