Zora c Lozenges
Composition :
Active ingredients: Each lozenge contains:
Benzalkonium chloride 0.50 mg.
Benzocaine 1 mg.
Ascorbic acid ( vitamin C coated) 50 mg.
Inactive ingredients:
Manitol , Povidone ( PVC K90), Saccharine sodium, Menthol, Orange oil, Sunset yellow FCF ( FD& C yellow No # 6) (E110), Talc, Colloidal silicon dioxide (AerosiI200), Magnesium stearate.
Pharmacological actions :
Benzalkonium chloride is a quaternary ammonium compound with antiseptic activity typical of this group. Benzocaine is a local anaesthetic 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 delivery of the anaesthetic direct to the site of action, rapid absorption, and the surface analgesic effect. The local anesthesia induced by benzocaine is temporary but has not been tested for duration of action.
Ascorbic Acid is a synthetic vitamin C.The most established function of vitamin C in the body is the control of the formation of colloidal intercellular substances. Deficiency of vitamin C leads to scurvy and in the absence of this water-soluble vitamin, a typical nutritional anaemia develops: the vitamin acts directly on the blood-forming centres and is essential for the maturation of the red blood cells.
Pharmacokinetic :
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 amoniohippuric acid in the liver, the metabolites and unchanged benzocaine are excreted in the urine.
Ascorbic acid is readily absorbed from the gastrOintestinal tract and is widely distributed in the body tissues. Ascorbic acid in excess of the body’s needs is rapidly eliminated in the urine.
Indications & Usage :
Symptomatic relief of sore throat, the associated pain and pharyngitis.
Contra-Indications :
– Hypersensitivity to any of the active ingredients or excipients.
– Children under 2 years.
– Epiglottitis.
– Methaemoglobinaemia.
– Hyperoxaluria.
Side Effects :
– Gastrointestinal Disorders: Local irritations or inflammations in the mouth and throat
– Allergic reactions have been reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face or mouth swelling.
– Methaemoglobinaemia has been reported with benzocaine use.
Drug Interactions :
– Concomitant administration of aluminium-containing antacids may increase urinary aluminium elimination. Concurrent administration of antacids and ascorbic acid is not recommended,
especially in patients with renal insufficiency.
– Concomitant administration of aspirin and ascorbic acid may interfere with absorption of ascorbic acid. Renal excretion of salicylate is not affected and does not lead to reduced anti-inflammatory effects of aspirin.
– Concurrent administration of ascorbic acid with desferrioxamine enhances urinary iron excretion. Cases of cardiomyopathy and congestive heart failure have been reported in patients with idiopathic haemochromatosis and thalassaemias receiving desferrioxamine who were subsequently given ascorbic acid. Ascorbic acid should be used with caution in these patients and cardiac function monitored.
– Ascorbic acid may interfere with biochemical determinations of creatinine, uric acid and glucose in samples of blood and urine •
Incompatabilities :
Benzalkonium chloride is incompatible with other anionic surfactants, citrates, iodides, nitrates, perrnanganates, salicylates, tartrates and alkalis. Incompatibilities have also been reported
with other substances induding aluminium, hydrogen peroxide, kaolin and some sulphonamide.
Warning and precautions :
– Benzocaine causes methaemoglobinaemia in children, so it is contraindicated in children less than 2 years without medical supervision.
– Do 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.
– If sore throat is severe or persistent, or accompanied by fever, headache or nausea consult your doctor. Do not exceed the stated dose.
– Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance and deficiency may result if it is withdrawn too rapidly.
– Keep out of the reach and sight of children.
Use during pregnancy and lactation:
Benzalkonium chloride: There is a lack of evidence of safety of the product in human pregnancy and in animals, but benzalkonium chloride has been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.
Benzocaine: Animal studies are insufficient with respect to effects on pregnancy and lactation. The potential risk for humans is unknown. Therefore benzocaine is not recommended during
pregnancy or breast-feeding.
Ascorbic acid : Ascorbic acid in doses greater than 1 g should not be administered during pregnancy as the effect of large doses on the foetus is not known. No problems are anticipated with the administration of ascorbic acid tablets during lactation.
Dosage and Administration :
Adults (including the elderly) and children over the age of 12 : One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 8 lozenges in 24 hours.
Children aged 7 to 12 years: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 4 lozenges in 24 hours. Not to be given to children under 7 years.
Overdosage :
Benzalkonium chloride: The oral toxic dose of benzalkonium chloride is between 1 and 3 g, symptoms of overdose are unlikely with a product containing such a low level. Theoretically symptoms are possible in children if at least 50 lozenges are consumed in a short space of time. In such extreme overdose related to menthol ingestion, symptoms may include nausea, vomiting, diarrhoea, profuse sweating and intense thirst.
Benzocaine: Pronounced reversible anaesthesia would be observed. No systemic adverse effects are expected due to the poor systemic absorption and low administered dose of benzocaine
Ascorbic acid: Ascorbic acid may cause acidosis or haemolytic anaemia in certain individuals with a deficiency of glucose 6-phosphate dyhydrogenase. Renal failure can occur with massive
ascorbic acid overdosage. Gastric lavage may be given if ingestion is recent otherwise general supportive measures should be employed as required.
Packing :
A carton box contains 2 blister pack strips (AI/PVC), each strip of 10 tablets and an inner pack.
Storage :
Store at a temperature not exceeding 30′ C, in a dry place .
Keep medicament out of children reach .
Produced by :
Chemical Industries Development (CID) – Giza – A.R.E. – G.C.R.
