COMPOSITION: Each lozenge contains:
Composition of active ingredients:
Tyrothricin………………………………… 4 mg
Cetrimonium bromide…………………. 2 mg
Lidocaine………………………………….. 1 mg
Composition of excipients: Sorbitol, mannitol, lemon flavor powder, magnesium stearate, colloidal anhydrous silica, quinoline yellow lake, lake pigment green, aspartame, peppermint flavor powder, menthol.
DOSAGE FORM:
Lozenge.
Round tablet 20 mm in diameter, green, aroma flavor, engrave “STAR” on both sides, tablet is intact.
INDICATIONS:
Treats throat soreness and infection, infections of the mouth, throat and gums.
DOSAGE AND ADMINISTRATION:
Administration:
Let the lozenge melt slowly in the mouth. Do not chew or swallow.
Dosage:
Adults and children over 6 years old:
Mild to moderately infections: Allow one lozenge to dissolve in the mouth every 2-3 hours.
Severe acute infections: Allow one lozenge to dissolve slowly in the mouth every 1-2 hours.
Children 6 to 12 years old do not exceed 3 lozenges in a day. Adults and children over 12 years old do not exceed 8 lozenges in a day.
Duration of treatment: STAR SORE THROAT is only used for 5-7 days of a short term treatment. In case of inflammation or pain of throat accompanied by high fever, headache, nausea or vomiting, do not use more than 2 days without medical advice.
Elderly: It is not necessary to reduce the dose in elderly patients.
Do not exceed the recommended dosage.
CONTRAINDICATIONS:
– Hypersensitivity to tyrothricin, cetrimonium bromide, lidocaine or any ingredient in the formulation.
– Children under 6 years old.
– Hypersensitivity to local anaesthesia others amide types.
WARNINGS AND PRECAUTIONS FOR USE:
– According FDA, when too much lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.
– STAR SORE THROAT cannot be taken while you drink or eat or just after: the local anesthetic effect of lidocaine can cause temporary numbness of the mouth and throat and influence swallowing. Avoid eating and drinking as the insensitivity persists.
– Use with caution in patients with hepatic disease, cardiac failure, severe anoxaemia, severe respiratory failure, hypovolemia, or shock, incomplete heart block or bradycardia, class-I arrhythmias, atrial fibrillation.
– Use with caution in severe ill patients or debilitated patients, due to systemic toxicity resulting from systemic absorption of lidocaine.
– Do not brush teeth before or just after taking STAR SORE THROAT. The simultaneous use of surfactants (eg toothpaste) may decrease the action of cetrimide.
Talk to your doctor or pharmacist before using drugs:
– If you had a sore throat for several days and if you have a fever.
– If symptoms do not improve or persist for more than 5 to 7 days.
– If the sore throat is accompanied by high fever, dizziness, vomiting or severe swallowing problem.
– If you have open wounds or extensive lesions of the mucous membranes of the throat or mouth because the contact with STAR SORE THROAT damaged mucosa increases the risk of lidocaine overdose.
This medicine contains:
– 1592 mg sorbitol/tablet. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
– 15 mg aspartame/tablet. Aspartame is a source of phenylalanine. It may be harmful if patients have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
PREGNANCY AND LACTATION:
Pregnancy:
Lidocaine crosses the placenta but no harmful effects on the fetus were observed. However, there are no clinical data on taking drug during pregnancy, and the data collected from laboratory animals are limited. Therefore, STAR SORE THROAT should be used in women during pregnancy only if absolutely necessary.
Lactation:
Lidocaine can appear in the breast milk in very low concentrations. Unlikely to risk affect the breast-fed infant. However, there are no clinical data on taking drug during lactation. Therefore, STAR SORE THROAT should be used in women during lactation only if absolutely necessary.
EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINERY:
There is no evidence on the effect of drug on ability to drive or operate machinery.
INTERACTIONS AND INCOMPATIBILITIES:
Interactions:
Tyrothricin
– No systemic clinical interactions are expected for the tyrothricin since it is not absorbed from the gastrointestinal tract.
Cetrimonium bromide:
– Concurrent use of surfactants (e.g toothpaste) may decrease action of cetrimonium bromide (cetrimide).
Lidocaine:
– Adrenaline combined with lidocaine decreases the rate of absorption and the toxicity, prolongs the duration of action of lidocaine.
– Concurrent use of local anaesthesia others amide types and antiarrhythmic agents may increase the risk of inhibited myocardium.
– Beta blocking agents: Concurrent use of beta blocking agents and lidocaine may delay metabolism of lidocaine due to reducing hepatic blood flow, leading to increase the risk of lidocaine toxicity.
– Cimetidine may inhibit hepatic metabolism of lidocaine, leading to increase the risk of lidocaine toxicity.
– Succinylcholine: Concurrent use of lidocaine may increase the effect of succinylcholine.
– Lidocaine increases the effect of colchicine, tamoxifen, salmeterol, tolvaptan.
– The effect of lidocaine may be additive by aminodarone, beta blocking agents, conivaptan; may be reduced by cyproterone, etravirin, peginterferon alfa-2b, tocilizumab.
Incompatibilities: NA.
SIDE EFFECTS:
Rare, 1/10000 < ADR < 1/1000
– Difficulty breathing or swallowing
– Swelling of face, lips, tongue or throat
– Tingling in the mouth or throat (oral discomfort)
– Local oral irritation if it sucked too many lozenges for too long.
Very rare, ADR < 1/10000
– Nausea when the lozenges are sucked overnight fast or too much.
Immediately inform doctors or physicians on any adverse drug reactions happened when using this drug.
OVERDOSE AND TREATMENT:
Symptoms:
No overdose symptoms have been reported in patients treated with STAR SORE THROAT. Accidental overdose or consequential injury to the oropharyngeal mucosa, following symptoms may occur: nausea, vomiting, nervousness, convulsions. These are due to the presence of lidocaine.
Treatment:
In case of overdose occurs, contact a doctor or come to the nearest hospital immediately. Monitor carefully to provide timely treatment if needed.
PHARMACODYNAMICS:
Pharmacotherapeutic group: Drug for oral and pharyngeal infections
ATC code: R02AB02
Tyrothricin: Tyrothricin from Bacillus brevis is a complex mixture of several polypeptides and its main action stems from the content of neutral gramicidins (20%), which neutralise the phosphorylation of the respiration chains. It is effective mainly against gram positive bacteria and cocci, against some fungi and some gram negative bacteria and has been used either alone or with other antibacterials in the local treatment of infections mainly of the skin and mouth.
Cetrimonium bromide: The name cetrimonium bromide was often formerly used for cetrimide. Cetrimide is a quaternary ammonium antiseptic with actions and uses typical of cationic surfactants. These surfactants dissociate in aqueous solution into a relatively large and complex cation that is responsible for the surface activity and a smaller inactive anion. In addition to emulsifying and detergent properties, quaternary ammonium compounds have bactericidal activity against Gram-positive and, at a higher concentration, against some Gram-negative bacteria. Some Pseudomonas spp. are particularly resistant as are strains of Mycobacterium tuberculosis. They are ineffective against bacterial spores, have variable antifungal activity, and are effective against some viruses.
Lidocaine: is a local anaesthetic of the amide type with an intermediate duration of action. Mechanism is blocking the initiation and conduction of nervous impulses by reducing the nervous cell membrane’s permeability to sodium ions, therefore, stabilizes the neuronal membrane and inhibiting the depolarization, leading to reducing the action potential and subsequence is block conduction of nervous impulses. Lidocaine relieves sore throat and painful swallowing caused by inflammation.
PHARMACOKINETICS:
Tyrothricin: Tyrothricin act locally in the mouth and throat and it is expected that only small amounts are absorbed by the buccal tissues.
Cetrimonium bromide: Rapidly absorbed from the gastrointestinal tract and is excreted unchanged in the faeces and in urine.
Lidocaine: Lidocaine is absorbed from the GI tract, it passed into the hepatic portal circulation and only about 35% of an oral dose reaches systemic circulation unchanged. Lidocaine is widely distributed into body tissues. Binding of lidocaine to plasma protein is variable and concentrations dependent. At concentrations of 1 – 4 mcg/ml, the drug is approximately 60 -80% bound plasma protein. Lidocaine partially bound to α1 – acid glycoprotein (α1-AGP), and the extent of binding to α1-AGP depends on the plasma concentration of the protein. Lidocaine readily crosses the blood-brain barrier and the placenta. Lidocaine also is distributed into milk, in one lactating woman, milk lidocaine concentration was approximately 40% of the serum concentration. Lidocaine has an initial half-life of 7 – 30 minutes and a terminal half-life of 1.5 – 2 hours. Systemically absorbed lidocaine is rapidly metabolized in the liver. Pharmacological or toxicological effects of metabolites are similar to but less potent than those of parent drug. Excreted principally in urine as metabolites (90%) and small amounts (<10%) of unchanged drug.
DESCRIPTION OF PACKAGING:
Box of 2 alubags, 1 alubag contains 1 blister x 12 lozenges
Box of 5 alubags, 1 alubag contains 1 blister x 12 lozenges
Box of 10 alubags, 1 alubag contains 1 blister x 12 lozenges
STORAGE, SHELF-LIFE, SPECIFICATION OF DRUG:
Storage: Store at temperature below 30oC, in a dry place, protect from light.
Shelf-life: 36 months from manufacturing date. Do not use after expiry date
Specification of drug: Manufacturer’s.
