Drug Information

Drug Interaction:

Anti-tissue agents

Antibiotics

Indication:

U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

95. Ambroxol HCL 15mg 26-03-08

+ Guphenesin 50mg

+ Terbutalin sulphate 1.25mg

+ Menthol 2.5mg per 5ml of syrup

For symptomatic relief of bronchospasm in bronchial

asthma and chronic bronchitis

96. Ambroxol HCL 30mg 26-03-08

+ Guiaphenasin 100mg

+ Terbutaline sulphate 2.5mg

per 10ml syrup

For symptomatic relief of bronchospasm in bronchial

asthma and chronic bronchitis

177. Ambroxol 18-08-08

+Loratidine

+Guiaphensesin syrup (30mg+ 5mg+50mg per 5ml)

For the treatment of productive cough

Mucolytic therapy in acute and chronic diseases of the bronchi

Approved by (DCI) Drug Controller GENERAL - India For Marketing

( Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Ambroxyl Hcl 1-12-1995

Acute and chronic disease of the respiratory tract associated with

bronchial secretions in particular acute attacks of chronic bronchitis

asthamatic bronchitis, bronchial asthma

2.Ambroxyl+ Loratidine + Guiaphenesin syrup 18-08-2008

(30mg+5mg)/ 5ml per 5ml

For the treatment of productive cough

3.Ambroxyl 30mg + Terbutaline 2.5mg + 27-10-2009

Guiaphenesin 100mg+ Menthol 2.5mg/ 5ml syrup

Additional strength

4.Ambroxyl 30mg + Levo salbutamol 1mg + 19-03-2009

Guiaphensin 50mg/5ml syrup

For the symptomatic relief of bronchospasm in bronchial asthma

and chronic bronchitis

5.Ambroxyl Hcl 30mg +Guiaphenesin 100mg+ 26-03-2008

Terbutaline sulphate 2.5mg/10ml syrup

For the symptomatic relief of bronchospasm in bronchial asthma

in chronic bronchitis

6.Ambroxol Hcl 15mg + Guiaphenesin 50mg + 26-03-2008

Terbutaline sulphate 1.25mg +

Menthol 2.5mg/ /5ml of syrup

For the symptomatic relief of bronchospasm in bronchial asthma

and chronic bronchitis

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)

FROM JANUARY 1961 TILL NOVEMBER 2014

Name of Drug Indication Date of Approval

1.Ambroxol Hcl SR 7.5mg+ 23-08-2001

Doxycycline Hcl 100mg tablet

Acute and chronic illness of RT with pathological inspiration of

mucous ( in case of acute attacks of chronic bronchitis, inflammation

of the prenasal sinuses) caused by doxycycline sensitive actiological

agents

2.Ambroxol 30mg + 29-10-1999

Guaiphenesin 100mg +

Menthol 1mg +

Pseudoephedrine 60mg 5ml syrup

Cough congestion

3.Ambroxol Hcl 15mg+ 18-08-2000

Guaiohensesin 100mg +

Ethanol 95% eq. to Ethanol 5% w/v per 5ml liquid

For treatment of cough

4.Ambroxol Hcl 15mg + 16-06-1999

Sabutamol 1mg+

Guiaphenesin 50mg+

Menthol 1mg per 5ml syrup

For the symptomatic relief of bronchospasm in bronchial asthma

and chronic bronchitis

5.Ambroxol Hcl 30mg+ 20-03-2008

Guiaphenesin 100mg+

Terbutaline sulphate 2.5mg pr 10ml syrup

For the symptomatic relief of bronchospasm in bronchial asthma and

chronic bronchitis

6.Ambroxol Hcl 30mg + 10-09-2001

Guiaphenesin 200mg tablet

For cough and congestion

7. Ambroxol Hcl 75mg SR + 11-10-2005

Desloratadine 5mg capsule

For the relief of productive cough

8.Ambroxol + 26-02-1998

Pseudoeohedrine +

Chloramine maleate tabs/suspn/syrup

For the symptomatic relief of bronchospasm in bronchial asthma

and chronic bronchitis

Adverse Reaction:

Epigastric distress

Nausea

Contra-Indications:

Gastric ulcer severe renal or hepatic impairment

Lactation First trimester of pregnancy

Dosages/ Overdosage Etc:

Date of approval- 1995

Indication-

Mucolytic therapy in acute and chronic diseases of the bronchi

Dosage-

1 tab 2-3 times a daily Not recommended for children below 10 years

Other Information:

For Availability/supplies

Contact -

1.Indian Drug Manufacturers Association (IDMA)

Phone- 022- 24944624/ 24974308

Fax- 022- 24950723

Email- idma@vsnl.com

Website: www.idma-assn.org

2.Bulk Drug Manufacturers Association (India)(BDMA)

Phone - 040-23703910/ 23706718

Fax- 040-23704804

Email- info@bdmai.org

Website: www.info@bdmai.org

Patient Information:

Take with food

Interaction with Food:

Take with food

Pregnancy and lactation:

Use contraindicated Observe caution if use is required

Ambroxol - Mucolytic Agents- (FDC List)- (Dec 1995)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Other Information

Patient Information

Interaction with Food

Pregnancy and lactation

Drug Interaction:

Indication:

Adverse Reaction:

Contra-Indications:

Dosages/ Overdosage Etc:

Other Information:

Patient Information:

Interaction with Food:

Pregnancy and lactation:

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