Stefolant

Stefolant Uses, Dosage, Side Effects, Food Interaction and all others data.

Stefolant is a metabolite of Bromhexine. It possesses mucokinetic (improvement in mucus transport) and secretolytic (liquefies secretions) properties. Stefolant stimulates the serous cells of the glands of the mucous membrane of bronchi, increasing the content of mucus secretion. The mucolytic effect is associated with depolymerization and splitting of mucoproteins and mucopolysaccharide fibres, which leads to reduction in the viscosity of mucus. Expectoration of mucus is facilitated and breathing is eased considerably. Stefolant stimulates production of phospholipids of surfactant by alveolar cells. Stefolant has anti-inflammatory properties. In patients with COPD, it improves airway patency. Beside these, Stefolant also exhibits anti-oxidant activity. Long-term use is possible because of the good tolerability of the preparation.

Trade Name Stefolant
Generic Ambroxol
Ambroxol Other Names Ambroxol, Ambroxolum, Bisolvon metabolite vIII, Bromhexine metabolite vIII, Bromhexine-metabolite vIII
Type
Formula C13H18Br2N2O
Weight Average: 378.108
Monoisotopic: 375.978589
Protein binding

Approximately 90%

Groups Approved, Investigational
Therapeutic Class Cough expectorants & mucolytics
Manufacturer
Available Country Greece
Last Updated: September 19, 2023 at 7:00 am
Stefolant
Stefolant

Uses

  • • Acute and chronic diseases of respiratory tracts associated with viscid mucus including acute and chronic bronchitis
  • • Productive cough
  • • Inflammatory diseases of Rhinopharyngeal tract (e.g. Laryngitis, Pharyngitis, Sinusitis and Rhinitis) associated with viscid mucus
  • • Asthmatic bronchitis, Bronchial asthma with difficult departure of mucus
  • • Bronchiectasis
  • • Chronic pneumonia.

Stefolant is also used to associated treatment for these conditions: Airway secretion clearance therapy

How Stefolant works

Stefolant is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Stefolant has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions.

Dosage

Stefolant dosage

Average daily dose (preferably after meal):Pediatric Drops:

  • 0-6 months: 0.5 ml 2 times a day
  • 6-12 months: 1 ml 2 times a day
  • 1-2 years: 1.25 ml 2 times a day

Syrup:

  • 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
  • 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
  • 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule:

  • Adult and children over 12 years old: 1 capsule once daily

Specific application features: Stefolant may be prescribed to patients suffering from diabetes mellitus.

Side Effects

Gastrointestinal side-effects like epigastric pain, gastric fullness may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema may occur.

Precaution

Stefolant should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Interaction

Stefolant has no interaction with cardioactive glycosides, corticosteroids, bronchodilators, diuretics and antibiotics (normally used in the treatment of bronchopulmonary affections). But Stefolant should not be taken simultaneously with antitussives (e.g. Codeine) because mucus, which has been liquefied by Stefolant, might not be expectorated.

Elimination Route

Rapid and almost complete.

Half Life

7-12 hours

Pregnancy & Breastfeeding use

Pregnancy: Teratogenic and fetal toxicity studies have shown no harmful effect of Stefolant. However, it is advised not to use during pregnancy, especially in the 1st trimester.

Lactation: Safety during lactation has not been established.

Contraindication

Contraindicated in known hypersensitivity to Stefolant or Bromhexine.

Interaction with other Medicine

Stefolant has no interaction with cardioactive glycosides, corticosteroids, bronchodilators, diuretics and antibiotics (normally used in the treatment of bronchopulmonary affections). But Stefolant should not be taken simultaneously with antitussives (e.g. Codeine) because mucus, which has been liquefied by Stefolant, might not be expectorated.

Innovators Monograph

You find simplified version here Stefolant

Stefolant contains Ambroxol see full prescribing information from innovator Stefolant Monograph, Stefolant MSDS, Stefolant FDA label

FAQ

What is Stefolant used for?

Stefolant is used for conditions where there are a lot of thick mucus in the airway passages. Stefolant belongs to a group of medications called mucolytics.It is used in the treatment of respiratory diseases associated with viscid or excessive mucus.

How safe is Stefolant?

Stefolant is a safe and well-tolerated treatment of bronchopulmonary diseases with a well-balanced and favorable benefit-risk profile.

How does Stefolant work?

Stefolant works by thinning down the mucus in the airway passages, thus making the mucus less sticky and it also facilitates the removal of the mucus from the airways.

What are the common side effects of Stefolant?

Common side effects of Stefolant are include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Gastrointestinal side effects
  • Skin rash
  • itching
  • Infections
  • Allergies
  • Upset stomach
  • Dizziness
  • Weakness
  • Dry mouth
  • Indigestion
  • Numbness in throat
  • Numbness in mouth
  • Taste disturbances

Is Stefolant safe during pregnancy?

Stefolant is not advisable to taken during the first trimester of pregnancy. Please seek your doctor's or pharmacist's advice before using Stefolant if you are pregnant.

Is Stefolant safe during breastfeeding?

As Stefolant is excreted in breast milk, it is not recommended to be taken while breastfeeding. Please seek your doctor's or pharmacist's advice before using this medication if you breastfeeding.

Can I drink alcohol with Stefolant?

No. Even though you can readily find products containing dextromethorphan OTC, these medicines can be very dangerous when mixed with alcohol.

Can I drive after taking Stefolant?

It is advisable not to drive any motor vehicle or operate heavy machinery as increased drowsiness and dizziness can occur after taking.

When should be taken of Stefolant?

The recommended dose is 30mg to be taken three times a day. 

How long does Stefolant take to work?

When administered orally onset of action occurs after about 30 minutes.

How long should I take Stefolant?

Stefolant was administered intramuscularly daily for 6-10 days at the following dosages: 1.7 mg/kg (children <2 years), 1.6 mg/kg (children 2-5 years) and 1.2 mg/kg (6-10 years).

What happens if I miss a dose?

If you miss a dose, use this drug as soon as you find it. Skip the missed dose and restart your dosing schedule if it is close to the time of your next dose. Do not use an additional dose in order to make up for the missing dose. 

What happens if I overdose of Stefolant?

Do not take more than the dosage given. Your symptoms will not be changed by taking more medication; they can instead cause poisoning or severe side effects. If you believe that you or someone else might have overdosed on Stefolant Hydrochloride Syrup, please go to the nearest hospital or nursing home emergency room. 

Who should not take Stefolant?

If you have serious gastric ulceration, liver or kidney issues, notify your healthcare professionals. If you have a confirmed history of an allergy to Stefolant, or any of the other ingredients mentioned in the medicine, this drug should be avoided.

Can I take Stefolant on an empty stomach?

The tablets may be taken with or without food.

Is Stefolant for dry cough?

Stefolant is more effective in productive cough treatment associated with the formation of sticky and thick mucus in the airway passages and is difficult to clear.Stefolant reduces its thickness and makes its removal easier from the airways passage.

Is Stefolant good for itchy throat?

Stefolant has a beneficial pain-relieving effect in patients with acute sore throat, superior to that achieved by sucking a placebo lozenge.

Is Stefolant a steroid?

No, it is not an antibiotic or steroid; it belongs to a class of medicines called Expectorants or Mucolytics. It has no known effect against infections.

How often should I take Stefolant?

The recommended dose for adults is 1 tablet 3 times daily. For better effect, the patient may administer 2 tablets 2 times daily. The tablets should be taken with liquid.

Is Stefolant an antibiotic?

Stefolant is a mucolytic agent used in the treatment of respiratory diseases.

*** Taking medicines without doctor's advice can cause long-term problems.
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