Ukraine Product

Ambroxol Tablets

Ambroxol Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Ambroxol is indicated as secretory therapy for liquefaction of tenacious sputum in acute and chronic bronchopulmonary diseases, associated with difficult to expectorate, viscous and tenacious sputum and mucus.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Immune System:hypersensitivity reactions (skin rash, reactions of the mucous membranes, angioedema, dyspnea, pruritus and other allergic reactions), anaphylactic reactions, including anaphylactic shock; urticaria.
General disorders:fever.
Skin and subcutaneous tissue:erythema, severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
Gastro-intestinal tract:diarrhea, nausea, vomiting, dyspepsia, abdominal pain, dry mouth, heartburn, constipation, excessive salivation.
Respiratory system:rhinorrhea, dry airways.
Urinary system:dysuria.

WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Not specified

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms: Ambroxol was well tolerated after parenteral administration of doses up to 15 mg /kg/day and after oral administration up to 25 mg /kg/day. Severe signs of intoxication were not observed after an overdose of Ambroxol. Cases of short-term anxiety and diarrhea were reported.
Similar to preclinical studies overdose can lead to hygrostomia, urge to vomit, vomiting and decreased blood pressure.
Treatment: Emergency measures, such as stimulation of vomiting and gastric lavage are not, generally, recommended and should be taken in the case of acute intoxication. Symptomatic treatment is recommended.

Is it safe in pregnancy and breast-feeding?

Pregnancy: Ambroxol hydrochloride passes through the placental barrier. Animal studies have shown no direct or indirect harmful effects on pregnancy, the embryo/fetal development, parturition or postnatal development.
Data shows of the drug administration after 28th week of pregnancy showed no harmful effect on the fetus. However, the usual precautions regarding drug administration during pregnancy should be adhered. Administration of Ambroxol tablets is not recommended, especially, in the first trimester of pregnancy.
Lactation: Ambroxol hydrochloride passes into breast milk. Despite the undesirable effects on infants are not expected, it is not recommended to administrate Ambroxol tablets during lactation.

Storage Conditions:

Store at a temperature not more 25°С in the original package.
Keep it out of reach of children.

Drug Description

Composition:
Active substance: Ambroxol Hydrochloride;
1 tablet contains 30 mg of Ambroxol Hydrochloride
Excipients: Colloidal anhydrous silica, Croscarmellose sodium, microcrystalline, Cellulose, magnesium stearate.
Dosage form: Tablets.
Basic physical and chemical properties: White round tablets scored on one side.


Indications and dosage.

Indications
Ambroxol is indicated as secretory therapy for liquefaction of tenacious sputum in acute and chronic bronchopulmonary diseases, associated with difficult to expectorate, viscous and tenacious sputum and mucus.
Dosage:
Unless otherwise prescribed, the recommended dose for Ambroxol tablets as follows:
Children over 6 or 12 years of age: as a rule, the dose is 1/2 of tablet 2-3 times daily (equivalent to 30-45 mg of ambroxol hydrochloride/day);
Adults and children over 12 years of age: as a rule, the dose is 1 tablet 3 times a day during first 2-3 days (equivalent to 90 mg of ambroxol hydrochloride/day). Continue treatment, using 1 tablet 2 times daily (equivalent to 60 mg of ambroxol hydrochloride/day).
If necessary therapeutic effect for adults and children over 12 years may be enhanced using 2 tablets 2 times a day (equivalent to 120 mg of ambroxol hydrochloride/day).
The tablets should be swallowed whole with sufficient amount of fluid (e.g. water, tea or fruit juice) after meals.
Ambroxol tablets should not be used more than 4-5 days without medical consultation.
Children:
Use in children over 6 years of age.

Side effects and drug interactions.

Side effect
Immune System:hypersensitivity reactions (skin rash, reactions of the mucous membranes, angioedema, dyspnea, pruritus and other allergic reactions), anaphylactic reactions, including anaphylactic shock; urticaria.
General disorders:fever.
Skin and subcutaneous tissue:erythema, severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
Gastro-intestinal tract:diarrhea, nausea, vomiting, dyspepsia, abdominal pain, dry mouth, heartburn, constipation, excessive salivation.
Respiratory system: rhinorrhea, dry airways.
Urinary system:dysuria.

Drug interactions
Simultaneous administration of Ambroxol tablets and agents that decrease the cough, can lead to excessive accumulation of mucus due to inhibition of the cough reflex. Therefore, this combination is possible only after careful physician assessment of ratio of expected benefits and possible risks of administration.

Warnings and precautions

Not specified

Overdosage and Contraindications

Symptoms: Ambroxol was well tolerated after parenteral administration of doses up to 15 mg /kg/day and after oral administration up to 25 mg /kg/day. Severe signs of intoxication were not observed after an overdose of Ambroxol. Cases of short-term anxiety and diarrhea were reported.
Similar to preclinical studies overdose can lead to hygrostomia, urge to vomit, vomiting and decreased blood pressure.
Treatment: Emergency measures, such as stimulation of vomiting and gastric lavage are not, generally, recommended and should be taken in the case of acute intoxication. Symptomatic treatment is recommended.

Clinical pharmacology.

Pharmacotherapeutic group: Mucolytics, Medicines used in cough and cold.
АТС R05C B06.

Pharmacological properties.
Pharmacodynamics:
Ambroxol is substituted benzylamine and bromhexine metabolite. Absence of the methyl group and presence of the hydroxyl group in para-trans position of cyclohexyl ring differ ambroxol from bromhexine. Various studies have shown evidences of mucolytic and secretolytic action. In general, onset of action is 30 minutes after oral administration; the effect persists for 6-12 hours, depending on individual dose.
In preclinical studies, it has increased serous component of bronchial secretion.
It is considered that it enhances mucus clearance by reducing viscosity and activating the ciliary epithelium.
Ambroxol activates the surfactant system, acting directly on type II pneumocytes in the alveoli and Clara cells in bronchioles. It stimulates formation and secretion of surfactant in the alveolar and bronchial area of lungs of the fetus and adult human. These effects have been demonstrated in cell culture and in vivo.
Preclinical studies with ambroxol have shown evidences of antioxidant effect. The use of ambroxol increases the concentration of antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline in sputum and bronchopulmonary secretions.

Pharmacokinetics:
Ambroxol is almost completely absorbed after oral administration. Tmax is 1-3 hours after oral administration.  Absolute bioavailability of ambroxol reduces by 1/3 after oral administration due to primary metabolism. The formed metabolites are excreted in the urine (e.g. dibromo anthranilic acid, glucuronides). Plasma protein binding is 85 % (80-90 %). Terminal elimination half-life in plasma is 7-12 hours. The half-life of ambroxol and its metabolites is approximately 22 hours.
Ambroxol is detected in cerebrospinal fluid, passes through the placental barrier and is excreted in breast milk.About 90% of ambroxol is excreted by the kidneys as metabolites, formed in the liver. Less than 10% of ambroxol is excreted by the kidneys in unchanged form.
It is not expected that dialysis or the rapid diuresis will stimulate ambroxol excretion due to the high degree of protein binding, a large volume of distribution and slow redistribution from tissues into the blood.
Clearance of ambroxol reduces by 20-40 % in the case of severe liver disease. The accumulation of ambroxol metabolites should be expected in patients with severe lesions of liver function.

Shelf life 3 years.
Storage condition
Store at a temperature not more 25°С in the original package.
Keep it out of reach of children.

Package
10 Tablets are in a blister pack, 2 blisters in a carton.

Conditions of supply
On prescription.

Manufacturer
KUSUM HEALTHCARE PVT LTD.

Address
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575