Solmux Throat

Solmux Throat

Manufacturer:

UNILAB, Inc

Distributor:

Unilab Consumer Health
Full Prescribing Info
Contents
Benzydamine hydrochloride, chlorhexidine digluconate.
Description
See Table 1.

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Each mL oromucosal spray contains: Benzydamine hydrochloride 1.5 mg, Chlorhexidine digluconate 1.2 mg.
Action
Nonsteroidal Anti-inflammatory Drug (NSAID)/Antiseptic.
This medicine contains benzydamine and chlorhexidine.
Benzydamine is a locally acting nonsteroidal anti-inflammatory drug that reduces inflammation and provides fast relief from symptoms of irritation caused by infection such as swelling, redness and pain.
Chlorhexidine is a local antiseptic agent which kills viruses and bacteria in the mouth and throat that cause infections like tonsillitis (inflammation of the tonsils), pharyngitis (inflammation of the pharynx), laryngitis (inflammation of the larynx), thereby also preventing the worsening of symptoms such as cough, colds, pain, swelling and sore/itchy throat including COVID and other infections of the upper respiratory tract triggering symptoms of allergy and flu.
A clinical study by Huang, et al. demonstrated that the use of chlorhexidine as an oral rinse and mouth spray eliminated 86% of oropharyngeal severe acute respiratory syndrome coronavirus (SARS-CoV) 2 versus control.
Indications/Uses
This medicine is used for the relief of painful inflammatory conditions of the throat including: Traumatic conditions: Pharyngitis following tonsillectomy or the use of a nasogastric tube.
Inflammatory conditions: Tonsillitis, sore throat, pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy.
Dentistry: For use after dental operations.
It is also used as a local antiseptic.
Dosage/Direction for Use
This medicine should be directly administered in the throat or inflamed area. (See Table 2.)

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Each spray (0.2 mL) contains 0.30 mg of benzydamine hydrochloride and 0.24 mg chlorhexidine digluconate.
Do not administer in children below 6 years old.
For symptomatic and short-term use only. Uninterrupted treatment should not exceed 7 days, unless under medical supervision. It should not be used without consulting a doctor if sore throat is severe or has lasted for more than 2 days or is accompanied by high fever, headache, nausea or vomiting.
Method of administration: This medicine is used undiluted (without adding water). It should not be swallowed and should be expectorated after each use.
Before first use, the pumping switch should be pressed until a uniform spraying is achieved by directing away from the face.
Tip of the spray should be inserted in the mouth and sprayed into the oral cavity when the mouth is fully opened.
Upon administration, the medicine should be placed in the box of the bottle and stored in vertical direction.
Special Instructions: Avoid contact with the eyes and ears. If the medicine comes in contact with the eyes, wash the eyes with water immediately.
This medicine may lead to reversible color change in the mouth, on the tongue and teeth due to its chlorhexidine content. In order to minimize discoloration, brushing of the teeth is advised before administration.
What should the patient do if they miss a dose: If the patient misses a dose, just administer the next dose if still needed for the condition being treated, and the subsequent doses at the recommended time or schedule.
Do not double the dose.
Overdosage
Signs and Symptoms of Overdosage: Benzydamine: Intoxication is only expected in case of accidental ingestion of large quantities of benzydamine (>300 mg).
Signs and symptoms of benzydamine overdose include nausea, vomiting, abdominal pain, esophageal irritation, dizziness, hallucinations, agitation, anxiety, and irritability.
Chlorhexidine: Chlorhexidine is poorly absorbed from the gastrointestinal tract and serious poisoning from ingestion is unlikely.
What to do when the patient has taken more than the recommended dosage: If the patient has used more than the recommended dosage, consult a doctor.
Contraindications
If the patient is allergic to benzydamine, chlorhexidine or to any ingredient in the product.
If the patient is pregnant or breastfeeding.
Special Precautions
Care that should be taken when taking this medicine: Use with caution if the patient has renal (kidney) or liver disorders.
If sore throat occurred with bacterial inflammation or accompanied by an inflammation, antibiotic treatment upon medical advice may be required in addition to the use of this medicine.
This medicine contains FD&C Yellow #5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible individuals.
This medicine contains alcohol in small amounts (less than 100 mg per dose).
Do not use more than the recommended dose.
When should the patient consult a doctor: Stop administering the medicine and consult a doctor immediately if the patient develops any of the following: Shortness of breath, skin rash, swelling on the face and/or tongue.
Hypersensitivity reactions.
Allergic reactions.
Skin reactions due to irritation.
Rash in the mouth.
Throat irritation and cough.
Growing of salivary gland.
Adverse Reactions
Benzydamine: Immune system disorders: Anaphylactic reactions (rare, life-threatening allergic reaction), angioedema (deep swelling around the eyes and lips and sometimes of the hands and feet), hypersensitivity.
Psychiatric disorders: Drowsiness.
Nervous system disorders: Dizziness, headache.
Respiratory, thoracic, and mediastinal disorders: Bronchospasm (narrowing of airways in the lungs), cough, laryngospasm (sudden, uncontrolled cramp in the voice box).
Gastrointestinal disorders: Dry mouth, dysgeusia (taste disturbance), nausea, numbness or stinging sensation of the oral mucosa, retching, tooth discoloration, vomiting.
Skin and subcutaneous tissue disorders: Erythema (redness), photosensitivity, rash, pruritus (itching), urticaria (itchy rash).
General disorders and administration site conditions: Thirst.
Chlorhexidine: Immune system disorders: Anaphylaxis (rare, life-threatening allergic reaction) and hypersensitivity.
Nervous system disorders: Ageusia (absence of sense of taste), glossodynia (burning or tingling sensation in or around the mouth), hypoesthesia (reduced sensation to touch, pain and temperature), paresthesia (sensation of tingling, pricking or numbness of the skin).
Gastrointestinal disorders: Coated tongue, dry mouth, dysgeusia (taste disturbance), desquamation/swelling of the oral mucosa, discoloration of the teeth and tongue, gingivitis (inflammation of the gums), glossitis (inflammation of the tongue), mucocele (dilatation of a cavity with accumulated mucus secretion), sialadenosis (disease of a salivary gland), irritation of the mouth, parotid gland swelling.
Skin and subcutaneous tissue disorders: Erythema (redness), generalized allergic reactions.
Drug Interactions
Benzydamine: There are no known interactions with benzydamine.
Chlorhexidine: Chlorhexidine is incompatible with other anionic compounds.
Storage
See Table 3.

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MIMS Class
Preparations for Oral Ulceration & Inflammation
ATC Classification
R02AX03 - benzydamine ; Belongs to the class of other throat preparations.
R02AA05 - chlorhexidine ; Belongs to the class of antiseptics used in throat preparations.
Presentation/Packing
Form
Solmux Throat oromucosal spray
Packing/Price
30 mL x 1's (P350/bottle)