Avomack solution is indicated for the treatment of warts, calluses, corns, and hardened skin.

Adults and the elderly: Apply daily to the affected areas only.
Children: Children under the age of 12 years should be treated under supervision. Treatment of
children under the age of 2 years is not recommended.
Procedure for application:
1. The wart should be soaked in warm water for 5 minutes and dried thoroughly with a clean towel.
2. The surface of the wart should be rubbed with a nail file, pumice stone, emery board or coarse washcloth,
with care taken not to cause bleeding.
3. A thin layer of Avomack should be applied directly to the wart. Care should be taken to avoid the healthy
surrounding skin.
4. The solution should be allowed to dry thoroughly. The wart should be covered with a plaster (dressing) if it is
large or if it is on the foot to help penetration of ingredients.
It is recommended that treatment continues until whichever of the following occurs first:
• Warts have been treated for 12 weeks
• The wart is completely cleared, and the normal ridgelines of the skin have been restored.
For warts, clinically visible improvement should occur in 1-2 weeks, but the maximum effect may be expected
after 4-8 weeks.
If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their pharmacist or
doctor.
Consider alternative treatments if warts cover a large area of the body (more than 5 cm2) (see Warnings and
Precautions).

Patients should be advised to consult a pharmacist or doctor if skin irritation develops.
Due to the flammable nature of Avomack, patients should avoid smoking or being near an open flame during
application and immediately after use.

 

Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Do not use on open wounds, irritated or reddened skin, or any area that is infected. Avomack solution should not be used on the face or anogenital regions moles, birthmarks, mucous membranes, warts with hair growing from them, red edges or an unusual colour . Avoid applying to normal skin.

Avomack may cause eye irritation. Avoid contact with eyes and other mucous membranes. In case of
accidental contact with the eyes or other mucous membranes, flush with water for 15 minutes.
Avoid exposure to healthy skin (see Adverse Reactions). Avomack may cause skin irritation. If undue
skin irritation develops treatment should be discontinued.
Consider alternative treatments if warts cover a large area of the body (more than 5 cm2) due to the
potential risk of salicylate toxicity.
Avomack is not recommended in patients with diabetes, circulatory problems or peripheral neuropathy
except under the supervision of a doctor.
Oral salicylates taken during or immediately after a viral illness have been associated with Reye's
syndrome and hence there is a theoretical risk with topical salicylates.
Therefore, use is not advised in children or teenagers during or immediately after chickenpox, influenza,
or other viral infections.
It has been reported that salicylates are excreted via breastmilk (see Pregnancy and Lactation).
Patients should be advised not to inhale the vapour.
Keep out of the sight and reach of children.

 

Topical Avomack may increase the absorption of other topically applied medicines. Therefore, concomitant use of Avomack and other topical medicines on the treated area should be avoided. As systemic exposure oftopically applied Avomack is low, interaction with systemically administered medicines is not anticipated.

 

Pregnancy
The safety of Avomack during human pregnancy has not been established. Studies in animals given salicylic
acid orally demonstrated embryo toxicity at high doses (see Non-Clinical Information).
Avomack is not recommended during pregnancy.
Lactation
Salicylates are excreted in human milk. Avomack is not recommended during lactation.
If used or administered during lactation, care should be taken to avoid contact with the breast area in order to
avoid accidental ingestion by the infant.

None.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and
<1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Clinical Trial Data
Immune system disorders
Common: Rash
Skin and subcutaneous tissue disorders
Very common: Application site reaction, pruritus, burning sensation, erythema, scaling, dryness
Common: Skin hypertrophy
Post Marketing Data
Immune system disorders
Rare: Application site hypersensitivity including inflammation
Skin and subcutaneous tissue disorders
Rare: Application site pain and irritation
Application site discoloration/skin discoloration
Exposure to healthy skin can lead to application site blistering and skin exfoliation (see
Warnings and Precautions).
Allergic dermatitis

Reporting of suspected adverse reactions
To report any side effect(s):
Saudi Arabia:

The National Pharmacovigilance Centre (NPC)
o SFDA call center: 19999
o E-mail: npc.drug@sfda.gov.sa
o Website: https://ade.sfda.gov.sa

Other GCC States:
- Please contact the relevant competent authority

 

Symptoms and Signs
In the event of accidental oral ingestion symptoms of salicylate toxicity may occur.
The risk of developing symptoms of salicylate poisoning or salicylism is increased if Avomack is used
excessively or if it is used for prolonged periods of time. Therefore, duration of use and recommended
frequency compliance is very important.
Treatment
Management should be as clinically indicated.

Lactic acid affects the keratinisation process, reducing the hyperkeratosis which is
characteristic of warts. It is caustic, leading to the destruction of the keratotic tissue of the
wart and of the causative virus.
Salicylic acid is keratolytic, producing desquamation by solubilising the intercellular cement in the
stratum corneum.

Absorption
Salicylic acid is absorbed through the skin; where detectable, maximum plasma levels are found 6 to
12 hours after application. Systemic absorption of salicylic acid has been reported to range from 9%
to 25% after topical application of other salicylic acid-containing preparations. The extent of
absorption is variable depending on the duration of contact and the vehicle. Despite percutaneous
absorption, the systemic exposure is low given the low dose topically administered to small,
localised areas of hyperkeratotic tissue.
Human abdominal skin in a flow-through diffusion system was used to assess the in
vitro percutaneous absorption of lactic acid. At a pH of 3, the amount of radioactivity detected in
the receptor fluid, stratum corneum, epidermis, and dermis was 3.6, 6.3, 6.6, and 13.9%,
respectively.
Distribution
Following percutaneous absorption, salicylic acid is distributed in the extracellular space;
approximately half of which is protein bound to albumin.

Metabolism
Salicylates are metabolised in the liver by microsomal enzymes to salicyluric acid and phenolic
glucuronides of salicylic acid. That which is not metabolised is excreted in the urine as unchanged
salicylic acid.
Elimination
Within 24 hours of salicylic acid being absorbed and distributed in the intercellular space,
approximately 95% of the absorbed dose can be recovered in the urine.

Not applicable.

Hydroxypropylcellulose
Diethyl Phthalate
Acetone

Not applicable.

30 days after first opening.

Store below 30°C. Keep away from flame source, protect from light.

The Avomack is supplied in 10ml and 15ml amber colored glass .

There are no special instructions for use or handling of Avomack Solution.