RiteMED Ambroxol hydrochloride 30 mg tablet: White, round, flat, bevel-edged tablet, bisected on one side and plain on the other side.
Each tablet contains: Ambroxol hydrochloride 30 mg. RiteMED Ambroxol hydrochloride 15 mg/5 mL syrup and 30 mg/5 mL syrup: Colorless to slightly yellowish, clear syrup with the odor and taste of strawberry.
Each 5 mL (1 teaspoonful) syrup contains: Ambroxol hydrochloride 15 mg or 30 mg.
Action
This medicine contains ambroxol, a mucolytic, which stimulates fluid secretion in the respiratory tract and breaks down mucus resulting in the production of less thick and less sticky mucus/phlegm. Ambroxol improves mucociliary clearance (mucus flow and transport) making phlegm easier to cough up and expel.
Indications/Uses
This medicine is used for the relief of cough secondary to acute and chronic diseases of the respiratory tract accompanied by excessive lung secretions such as chronic bronchitis, asthmatic bronchitis and bronchial asthma.
Dosage/Direction for Use
How much and how often the patient should use this medicine: This medicine should be taken orally (by mouth), preferably after a meal. (See table.)
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What to do if the patient misses a dose: If the patient misses a dose, just take 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
Symptoms of overdose are consistent with the known undesirable effects of ambroxol at recommended doses. What to do when the patient has taken more than the recommended dosage: If the patient has taken more than the recommended dosage, consult a doctor.
Contraindications
If the patient is allergic to ambroxol or other ingredients in the product.
Special Precautions
Severe skin lesions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported rarely with the administration of mucolytics such as ambroxol. These may be due to the severity of the underlying disease or concomitant medication. If new skin or mucosal lesions appear, discontinue ambroxol and consult a doctor immediately.
In the presence of impaired kidney function, a doctor must be consulted.
Do not take this medicine if the patient is pregnant or breastfeeding unless advised by the doctor.
The use of ambroxol in the first trimester is not recommended.
Do not take more than the recommended dose. When should the patient consult a doctor: Ask a doctor before use if: Patient has kidney or liver disease; patient is pregnant or breastfeeding.
Stop use and ask a doctor if: Symptoms worsen or do not improve; new symptoms occur; any undesirable effect occurs.
Adverse Reactions
For syrup and tablet:Immune system disorders: Anaphylactic reactions (rare, life-threatening allergic reactions) [including anaphylactic shock, angioedema (rapid swelling of the skin), pruritus (itchiness), rash, urticaria, and other hypersensitivity], severe allergic reactions, severe cutaneous allergic reactions (SCARs) [which includes erythema multiforme and Stevens-Johnson syndrome]. Gastrointestinal disorders: Abdominal pain, diarrhea, dyspepsia (indigestion, feeling of fullness), heartburn, nausea, vomiting. Additional undesirable effects for syrup only:Nervous system disorders: Dysgeusia (changed taste). Respiratory, thoracic and mediastinal disorders: Dry throat, oral and pharyngeal hypoesthesia (partial loss of sensation). Gastrointestinal disorders: Dry mouth.
Administration of ambroxol with antibiotics (e.g., amoxicillin, cefuroxime, erythromycin) leads to higher antibiotic concentration in bronchopulmonary secretions and in sputum.
Tell the doctor if the patient is taking other medicines, including vitamins, supplements, and herbal medicines.
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