Inal Syrup

Inal Syrup

levodropropizine

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab

Marketer:

MacroPhar Lab
Full Prescribing Info
Contents
Levodropropizine.
Description
Clear, red syrup with sala cider flavor.
Each 10 ml contains Levodropropizine 60 mg.
Action
Pharmacology: Pharmacodynamics: Levodropropizine is one of the therapeutic options used to treat acute and chronic bronchitis. Levodropropizine is a peripherally acting, non-opioids antitussive agent, which inhibits the cough reflex by reducing the release of sensory peptide in the peripheral region and suppresses the afferent pathway of pulmonary.
Pharmacokinetics: Levodropropizine is rapidly absorbed into the gastrointestinal tract, with time required to reach the maximum drug concentration (Tmax) ranging from 0.25 to 0.75 h. This absorption profile is due to high bioavailability (>75%) and rapid distribution of levodropropizine. The mean terminal half-life (t½) of levodropropizine is 2.73 h, which suggests rapid elimination after systemic absorption. Levodropropizine has linear pharmacokinetic (PK) characteristics at doses ranging from 30 to 90 mg.
Indications/Uses
Symptomatic treatment of cough in adults and children older than 2 years.
Dosage/Direction for Use
Recommended Dose: Adults and children over 12 years of age: 10 ml (2 teaspoonfuls; equivalent to 60 mg of levodropropizine), three times daily at intervals of at least 6 hours.
Children over 2 years of age: should take 3 mg/kg/day by divided into three times a day.
Calculated dose guideline: 10-20 kg body weight: 3 ml, three times daily.
20-30 kg body weight: 1 teaspoonful, three times daily.
Treatment duration: The treatment should be taken until the cough clears up, or as directed by physician, for a period not to exceed seven days. If symptoms have not stopped after this period, treatment should be stopped and a physician should be consulted.
Mode of Administration: The preparation is administered orally.
This medication should be taken between meals.
Overdosage
Overdose and Treatment: In case of an overdosage with enhancement of side effects, gastric lavage may be useful, followed by additional treatment under medical supervision. No specific antidote exists.
Contraindications
Contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.
Contraindicated in patients with excessive discharge of mucus.
Contraindicated in patients with limited mucociliary function Kartagener's syndrome, Ciliary dyskinesia).
Contraindicated in patients with liver function is severely limited.
Contraindicated in pregnancy and lactation.
Contraindicated in patients with bronchorrhea.
Special Precautions
Use with precaution in patients with serious renal insufficiency.
Notice to diabetics: 10 ml of this product contain 6.25 g of sucrose.
Effects on Ability to Drive Vehicles or Machines Operators: Drivers of vehicles and machine operators are warned of the possibility of drowsiness with the use of this drug.
Use in Children: The safety and efficacy of levodropropizine in children less than 24 months has not been established.
Use In Pregnancy & Lactation
This drug should not be used during pregnancy and lactation.
Adverse Reactions
Gastrointestinal tract: Nausea, vomiting, heartburn, abdominal discomfort, diarrhea.
Central nervous system: Exhaustion, faintness, somnolence, clouding of consciousness (sopor), numbness, dizziness, headache.
Cardiovascular system: Palpitations.
Hypersensitivity reactions may occur in predisposed patients because the product contains parabens.
Allergic skin reactions were observed in very rare cases.
Consult a physician or the pharmacist in the event other side effects appear.
Drug Interactions
No interaction with benzodiazepines were observed during clinical trials. However, care should be taken when sedative drugs are simultaneously administered to particularly sensitive individuals.
Storage
Keep in tight container, store below 30°C.
Once opened, store in room temperature (<30°C) and use within 3 months.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05DB27 - levodropropizine ; Belongs to the class of other cough suppressants.
Presentation/Packing
Form
Inal Syrup syr 60 mg/10 mL
Packing/Price
((sala cider flavor)) 60 mL x 1's
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