Avera

Avera

Manufacturer:

Aeva

Distributor:

Apex
Full Prescribing Info
Contents
Cetalkonium chloride, choline salicylate.
Description
AVERA is a translucent colourless gel containing Choline Salicylate 8.71% w/w and Cetalkonium Chloride 0.01% w/w.
Contains Ethanol 33.46% w/w.
Action
Pharmacology: AVERA contains non-steroidal anti-inflammatory (NSAID) and anti-infective substances.
Choline Salicylate is a NSAID that reduces pain and inflammation. Cetalkonium Chloride is an anti-infective agent that fights against microbial growth.
Pharmacodynamics:
Choline salicylate is the choline salt of salicylic acid and its pharmacology is essentially that of salicylic acid. It has exhibited antiinflammatory, analgesic and antipyretic actions in animals models, and is taken orally or is applied topically in man for the relief of pain and inflammation. Like salicylic acid it has no antithrombotic activity and shows a low potential for production of gastrointestinal injury when given by the oral route. The pharmacological actions of choline salicylate are thought to be primarily mediated through inhibition of prostaglandin production, although effects on leukotriene pathways, kinin release and nerve conduction have been proposed. Cetalkonium chloride is a quanternary ammonium antimicrobial agent, being bactericidal towards both Gram positive and Gram negative organisms, but with preferences for the former.
Pharmacokinetics: Choline salicylate is absorbed from the gut and is likely to be absorbed across mucous membrane such as all buccal mucosa. Metabolism of salicylic acid is by glycine and phenolic or acyl glucoronate conjunction with small amounts undergoing hydroxylation. The plasma half-life of salicylic acid is 2-4 hours. Both metabolites and a small amount of intact salicylic acid are excreted, mainly in the urine. Salicylic acid is highly protein bound (80-90%) and although it has a low apparent volume of distribution of around 0.15 l/kg, it is widely distributed throughout most tissues and extracellular water.
Indications/Uses
AVERA helps to relieve pain, inflammation, and to treat minor infection due to common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots due to orthodontic devices. To help to fight minor mouth infection and healing of sore spots and ulcers to dentures and orthodontic devices.
Dosage/Direction for Use
AVERA gel is for topical oral use only.
Always wash hands before applying the gel. Make sure the hand is clean.
Babies (4 month-old and above) and Children: With clean finger, massage approximately one half centimeter of AVERA gel onto the sore area. This can be repeated after 3 hours.
Not to exceed 6 doses in 24 hours. Not to be used in babies less than 4 month-old.
Contraindication for patients suffering from active peptic ulceration or known to be allergic to salicylates.
Adults: Massage approximately one centimeter of AVERA gel onto the sore area. This can be repeated after 3 hours.
Denture Sores: Massage approximately one centimeter of AVERA gel onto the sore area and leave at least 30 minutes before reinserting the dentures.
Do not apply directly to the dentures.
Overdosage
In case of overdose, seek medical attention immediately.
Overdose may lead to salicylate toxicity. Symptoms of salicylate poisoning are such as nausea, vomiting, tinnitus and excessive sweating. The usual procedure for salicylate overdosage should be followed, including general supportive measures and gastric lavage if necessary.
Special Precautions
Please always consult a doctor, dentist or pharmacist before using AVERA gel.
Tell the doctor, dentist or pharmacist if the patient: is allergic to choline salicylates. cetalkonium chloride, ethanol or glycerin; is taking medicines for blood clotting and/or gout treatment; has stomach or intestinal bleeding; has blood clotting disorders; is pregnant or breast-feeding.
Do not exceed the stated dose. If symptoms persist for more than seven days consult the doctor or dentist. Keep out of the reach of children. Contains ethanol.
Use in Pregnancy: There is clinical evidence of the safety of salicylates in pregnancy, but may prolong bleeding and lead to maternal and neonatal bleeding, and are best avoided at term.
Use in Lactation: Salicylates are excreted at low concentrations in breast milk, but are unlikely to adversely affect the infant.
Use In Pregnancy & Lactation
Use in Pregnancy: There is clinical evidence of the safety of salicylates in pregnancy, but may prolong bleeding and lead to maternal and neonatal bleeding, and are best avoided at term.
Use in Lactation: Salicylates are excreted at low concentrations in breast milk, but are unlikely to adversely affect the infant.
Side Effects
Asthma attacks may occasionally occur in people who are sensitive to salicylates. Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients.
As this product containing glycerin, some people may experience headache, stomach upset and diarrhea.
If the patient experiences any symptoms persistently for more than 7 days, please consult a doctor, dentist or pharmacist.
Drug Interactions
Interactions with other medicaments: Choline Salicylate may enhance the effect of anticoagulants and inhibit tho action of uricosurics.
Storage
Store below 30°C. Keep out of reach of children.
ATC Classification
A01AD11 - various ; Belongs to the class of other agents for local oral treatment.
Presentation/Packing
Oral gel 10 g.
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