Ambroxol Sopharma

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

Ambroxol Sopharma is a metabolite of Bromhexine. It possesses mucokinetic (improvement in mucus transport) and secretolytic (liquefies secretions) properties. Ambroxol Sopharma 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. Ambroxol Sopharma stimulates production of phospholipids of surfactant by alveolar cells. Ambroxol Sopharma has anti-inflammatory properties. In patients with COPD, it improves airway patency. Beside these, Ambroxol Sopharma also exhibits anti-oxidant activity. Long-term use is possible because of the good tolerability of the preparation.

Trade Name Ambroxol Sopharma
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 Georgia
Last Updated: September 19, 2023 at 7:00 am
Ambroxol Sopharma
Ambroxol Sopharma

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.

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

How Ambroxol Sopharma works

Ambroxol Sopharma 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. Ambroxol Sopharma 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

Ambroxol Sopharma 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: Ambroxol Sopharma 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

Ambroxol Sopharma 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

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

Interaction with other Medicine

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

Innovators Monograph

You find simplified version here Ambroxol Sopharma

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

FAQ

What is Ambroxol Sopharma used for?

Ambroxol Sopharma is used for conditions where there are a lot of thick mucus in the airway passages. Ambroxol Sopharma 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 Ambroxol Sopharma?

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

How does Ambroxol Sopharma work?

Ambroxol Sopharma 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 Ambroxol Sopharma?

Common side effects of Ambroxol Sopharma 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 Ambroxol Sopharma safe during pregnancy?

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

Is Ambroxol Sopharma safe during breastfeeding?

As Ambroxol Sopharma 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 Ambroxol Sopharma?

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 Ambroxol Sopharma?

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 Ambroxol Sopharma?

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

How long does Ambroxol Sopharma take to work?

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

How long should I take Ambroxol Sopharma?

Ambroxol Sopharma 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 Ambroxol Sopharma?

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 Ambroxol Sopharma Hydrochloride Syrup, please go to the nearest hospital or nursing home emergency room. 

Who should not take Ambroxol Sopharma?

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

Can I take Ambroxol Sopharma on an empty stomach?

The tablets may be taken with or without food.

Is Ambroxol Sopharma for dry cough?

Ambroxol Sopharma 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.Ambroxol Sopharma reduces its thickness and makes its removal easier from the airways passage.

Is Ambroxol Sopharma good for itchy throat?

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

Is Ambroxol Sopharma 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 Ambroxol Sopharma?

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 Ambroxol Sopharma an antibiotic?

Ambroxol Sopharma 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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