local anesthetic, antiseptic, anti-inflammatory & analgesic spray for oropharyngeal disorders
I. Name of the medicinal product :
2. Qualitative and quantitative composition :
Active ingredients : Each 1 ml contains
Benzocaine 15 mg
Benzydamine hydrochlorid 1.5 mg
Cetalkonium Chloride 0. 413 mg
Inactive ingredients: Propytene glycol, Glycerol, Ethanol, Aspartame,Disodium hydrogen phosphate 12H20, Monosodium hydrogen Phosphate 2H20, Cherry flavour , Purified water.
3. Pharmaceutical form :
4. clinical particulars :
4.1 Therapeutic indications
– Symptomatic relief of sore throat pain. B.B.C.. Spray is a l0ca1Iy acting analgesic and anti-inflammatory treatment for the throat and mouth.
– It is especially useful for the relief of pain in traumatic conditions such as following tonsillectomy or the use of a naso-gastric lube &. dental surgery.
– It is used in treatment of minor infections (‘If U\e mouth and throat It has a broad-spectrum antiseptic effect against many Gram+. Gram- bacteria and some fungi & viruses.
4.2 Posology and method of administration
Adults and children 13 years and over Adminrster 3 sprays 3mg to the back of the throat Repeat every 2-3 hours up to a maximum of 8 doses per day.
children 6-12 years Use only under adults supervision Administer 1 spray 1 mg) to the back of the throat.
Repeat every 2-3 hours up to a maximum of 8 doses per day.
This product is contraindicated in children under 6 years.
Method of administration: oromucosal Hold breath and spray to the back of the throat
Do not use in a child who is unable to hold their breath whilst spraying.
Befor first use, or after prolonged storage. activate the pump by spraying 3 limes away from the face into the sink.
**children under 6 years **epiglottitis
** Known hypersensitivity to benzocaine benzydamine cetalkonium cloride of any of the other inactive ingredients.
4.4 Special warnings and precautions for use
-Avoid contact with the eyes
– If sore throat is severe or persistenl or accompanied by fever, headache or nausea consult your doctor.
– You should experience temporary numbness in your throat after using the spray. This indicates that the product is working. Avoid eating or drinking as long as the numbness lasts.
– D0 not use if you have any difficulty in breathing. noisy breathing or severe difficulty in swallowing.
– Do not use if you have been told that you have a rare blood condition called methaemoglobinaemia.
– Contain Aspartame a source of phenyl alanine. May be harmful for people with phenyl ketonuria
4.5 interaction with medicinal products and other forms of interaction
4.6 Pregnancy and lactation
animal studies are insufficient with respect to effects on pregnancy and lactation the potential risk for humans is unknown therefore B.B.C spray is not recommended during pregnancy or breast feeding
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
The most common side effects are numbness and a stinging feeling in the mouth.
Respiratory, thoracic and mediastinal disorders. Allergic reactions have hem reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face of mouth swelling.
Methaemoglobinaemia has been reported with benzocaine use.
Pronounced reversible anesthesia would be observed No systemic adverse effects are expected due to the poor systemic absorption and low administered dose of benzocaine.
5. Pharmacological properties :
5.1 Pharmacodynamic properties
– Benzocaine is a local anesthetic of the ester type. The mode of action is a reversible inhibition of the flux of sodium and potassium ions through the axonal membranes of peripheral pain receptors. As a consequence, the depolarization and propagation of nerve impulses are inhibited. The onset of action of benzocaine on mucous membranes is rapid due to the spray delivery of the anesthetic direct to the site of action rapid absorption and the analgesic effect the local anesthesia induced by benzocaine is temporary.
– Benzydamine exerts an anti-inflammatory and analgesic action by stabilizing the cellular membrane and inhibiting prostaglandin synthesis.
– Cetalkonium chloride is a quaternary ammonium antiseptic compound ” has a bactericidal activity against Gram-positive & cream negative bacteria, variable fungi and some viruses. .
5.2 Pharmacokinetic properties
Benzocaine is absorbed into the mucosal membranes after systemic absorption which is negligible. the drug is thought to be metabolized to ethanol and aminobenzoic acid by plasma esterases Aminobenzoic acid is excreted unchanged or conjugated with glycerine to all’lOlliohippunc. acid in the liver, the metabolites and unchanged benzocaine are excreted in the urine. Following oral administration, benzoydamine is rapidly absorbed from the gastrointestinal tract and maximum plasma levels reached after 2-4 hours. The most important aspect of the ussue distribution of
benzydamine is its tendency to concentrate at the site of inflammation. About half of the benzydamine is excreted unchanged via the kidney at a rate of 10’lb of the dose within the first 24 hours. The remainder is metabolized. mostly to N Oxide.
6 PHARMACEUTICAL PARTICULARS :
6.1 shelf life
6.2 Special precautions for storage
Store at temperature not exceeding 25° c.
1-2 applications , 3-4 times daily or as prescribed by the physician
6.4 How Supplied
Carton Box Containing Printed aluminium container contairnng 25 ml solution capped with (tDPE) Suction tube pumping atomizer &0 (HOP£) plastic nozzle for deep application to throat
Keep all medicaments out of reach of children
Product of :
AMOUN PHARMACEUTICAL CO. SAE.
EI-Obour City, Cairo, Egypt.