AMBROXOL HCL 30mg/5ml Syrup

Ambroxol HCl 30 mg / 5 ml

Category:

COMPOSITIONS :

Ambroxol HCl Elixir 30 mg/5 ml, each 5 ml (a measurement spoonful) elixir contains : Ambroxol HCl 30 mg, contains alcohol 5.0%.

 

DESCRIPTIONS : 

Ambroxol HCl containing Ambroxol HCl is available in 15 mg/5 ml and 30 mg/5 ml elixir and 30 mg tablet.

 

INDICATIONS : 

Ambroxol HCl is indicated as secretolytic in acute and chronic respiratory tract diseases particularly in chronic bronchitis exacerbation and asthmatic bronchitis.

 

DOSAGE AND ADMINISTRATIONS : 

Ambroxol HCl Elixir 30 mg/5 ml :

  • Adults and children over 12 years : 5 ml (1 measuring spoonful), 2 – 3 times daily.
  • Children 6 – 12 years : 2.5 ml (½ measuring spoonful), 2 – 3 times daily.

 

CONTRAINDICATIONS : 

Patients known to be hypersensitive to Ambroxol.

 

WARNINGS AND PRECAUTIONS : 

  • Ambroxol can be administered during pregnancy (especially in the 1st trimester) and lactation only after careful risk/benefit assessment. Administration during pregnancy and lactation still needs further research.
  • Ambroxol should not be used in the long term without physician’s consultation.
  • In some cases of renal insufficiency, accumulation of Ambroxol metabolites takes place in the liver.
  • There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of Ambroxol HCl. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, Ambroxol HCl treatment should be discontinued immediately and medical advice should be sought.

 

DRUG INTERACTIONS : 

Administration of Ambroxol together with antibiotics (Amoxicillin, Cefuroxime, Erythromycin, Doxycycline) leads to higher antibiotic concentration in the lungs tissue.

 

ADVERSE REACTIONS : 

  • Intolerance reactions after Ambroxol administration have been reported in rare cases.
  • Mild gastrointestinal side effects have been reported in some patients.
  • Allergic reactions have been reported in rare cases and some of these patients have also shown allergic reactions to other substances. Some of the allergic reactions are : Skin rashes, swelling on the face, dyspnea, fever.
  • It is not known whether Ambroxol has an impact in the ability to drive or operate machinery.
  • Immune system disorder

Rare : Hypersensitivity reactions.

Not known : Anaphylactic reactions including anaphylactic shock, angioedema and pruritus.

  • Skin and subcutaneous tissue disorders

Rare : Rash, urticaria.

Not known : Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)

 

PRESENTATIONS :

Ambroxol HCl Elixir 30 mg/5 ml          Bottle @ 60 ml                         Reg. No. GKL1102343934B1

 

STORAGE :

STORE BELOW 30OC, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

BERNOFARM

Sidoarjo – Indonesia

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