Etafedrine manufacturing in india

(l)-Etafedrine Hydrochloride

Molecular Formula : C12H19NO.HCl Molecular Weight : 229.75 CAS No. : [5591-29-7] Chemical Name : 1. (1R,2S)-2-[Ethyl (methyl)amino]-1-phenylpropan-1-ol Hydrochloride. 2. (1R,2S)-2-Ethylmethylamino-1-phenyl-1-propanol Hydrochloride Specifications :

1.	Description :	White to off white crystalline powder
2.	Identification:	Infrared spectrum of sample is concordant with standard.
3.	Melting range :	183° - 186°C
4.	Specific rotation :	- 17.5° - 19.5° (5 % solution in water)
5.	Moisture content :	Not more than 0.5 % w/w
6.	Sulphated ash :	Not more than 0.1 % w/w
7.	Assay (Non.Aq. Titration) :	Between 99.0 and 100.5 % w/w (dried basis)

Therapeutic indications : Bronchodilator
Packing : Packed in double lined polyethylene bags in 10 kg
/ 25 kg fiber drums.
Storage : Store below 35°C

IUPAC Name: 2-[ethyl(methyl)amino]-1-phenylpropan-1-ol hydrochloride
CAS Registry Number: 5591-29-7

Synonyms: Nethamine, Nethaphyl, Etafedrine hydrochloride, Nethamine (TN), Etafedrine hydrochloride (USAN), Etafedrine hydrochloride [USAN], CID68646, EINECS 227-000-5, D04072, alpha-(1-(Ethylmethylamino)ethyl)benzyl alcohol hydrochloride, Benzenemethanol, alpha-(1-(ethylmethylamino)ethyl)-, hydrochloride, 5591-29-7, BENZYL ALCOHOL, alpha-(1-(ETHYLMETHYLAMINO)ETHYL)-, HYDROCHLORIDE, (-)-, 530-35-8, 7681-79-0

Molecular Formula: C12H20ClNO
Molecular Weight: 229.746300 [g/mol]
H-Bond Donor: 2 H-Bond Acceptor: 2

Etafedrine were studied on the tracheal chain preparation and the atria of the guinea pig and on the rabbit perfused heart.

Contraction of the tracheal chain by acetylcholine or histamine was antagonized by epinephrine (adrenaline), etafedrine and ephedrine, the relative potencies being 91:1:0.3, respectively.

Propranolol (5 X 10(-7) mol/l) completely antagonized the bronchodilator effect of 10(-4) mol/l etafedrine on the acetylcholine-evoked contraction. Etafedrine up to 3 X 10(-4) mol/l did not increase heart rate or force of contraction in guinea pig atria. In contrast to tyramine and ephedrine (both 10(-5) mol/l), etafedrine (10(-4) mol/l) failed to release 3H-norepinephrine (noradrenaline) in the perfused rabbit heart. Moreover, the concentration-dependent positive chronotropic and inotropic effects of norepinephrine in isolated atria were slightly, but not significantly enhanced by etafedrine.

It is concluded that N-ethylation of ephedrine suppresses the indirect sympathomimetic activity and markedly enhances the efficacy on beta 2-adrenoceptors.

Etafedrine appears to be a sympathomimetic agent with a selective activity on beta 2-adrenoceptors.

PHARMACOLOGICAL ACTION:
Etafedrine a sympathomimetic agent, acts on the sympathetic receptors of the bronchial tree relaxing spasm in a manner similar to that of ephedrine.

It helps to control cough associated with inflammation of the mouth and throat that is not helped by cough medications that are less strong.

Hydrocodone is a narcotic medication that is an antitussive (cough suppressant). It helps to reduce cough by affecting the cough centre in the brain.

Etafedrine belongs to the family of medications called decongestants. It works by narrowing blood vessels in the nasal passages, helping to relieve nasal stuffiness.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of this medication is

Adults: 5 mL (1 teaspoonful) every 3 to 5 hours as needed, but not more than 30 mL in any 24-hour period.

Children 6 to 12 years of age: 2.5 mL to 5 mL every 3 to 5 hours as needed to a maximum of 15 mL in any 24-hour period.

Children 1 to 6 years of age: 1.25 mL to 2.5 mL every 3 to 5 hours as needed to a maximum of 3 doses in any 24-hour period.

Use an oral syringe to measure each dose of the liquid as it gives a more accurate measurement than household teaspoons.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Side effects occur

* fast, slow, or pounding heartbeat
* hallucinations (seeing, hearing, or feeling things that are not there)
* hives, itching, or skin rash
* increased sweating
* irregular breathing
* mental depression or other mood or mental changes
* redness or flushing of face
* ringing or buzzing in the ears
* shortness of breath, wheezing, or troubled breathing
* swelling of face
* trembling or uncontrolled muscle movements
* unusual excitement or restlessness (especially in children)

Stop taking the medication and seek immediate medical attention if any of the following occur:

* cold, clammy skin
* headache (severe or continuing)
* low blood pressure
* pinpoint pupils of eyes
* seizures
* severe confusion or disorientation
* severe dizziness
* severe drowsiness
* severe nausea or vomiting
* severe nervousness or restlessness
* severe weakness
* shortness of breath or troubled breathing (severe or continuing)
* signs of a severe allergic reaction such as hives; difficulty breathing; swelling of the tongue, face, mouth, or throat
* slow heartbeat

Etafedrine (INN) or ethylephedrine is a long-acting bronchodilator and has the brand name Nethaprin. It is commercially available as both the free base, and as the hydrochloride.

Ethylephedrine may be synthesized by alkylating ephedrine with ethyl iodide. The hydrochloride may be prepared by passing hydrogen chloride through a solution of ethylephedrine in diethyl ether.

Note: These API/ chemicals are designated as those that are used in the manufacture of the controlled substances and are important to the manufacture of the substances. For any (Control Substance) products Import and Export *** subjected to your country government laws /control substance ACT.

Note /Government Notification: These chemicals are designated as those that are used in the manufacture of the controlled substances and are important to the manufacture of the substances. For any (Control Substance) products Import and Export *** subjected to your country government laws /control substance ACT.
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The Controlled Substances Act (CSA) was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970.[1] The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated. The Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs.

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COUGH/COLD COMBINATIONS (Systemic)

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Some commonly used brand names are:

In the U.S.—

* Alka-Seltzer Plus Cold and Cough 21

* Alka-Seltzer Plus Cold and Cough Medicine Liqui-Gels 34

* Alka-Seltzer Plus Night-Time Cold Liqui-Gels 35

* Ami-Tex LA 69

* Anatuss LA 70

* Benylin Expectorant 54

* Bromfed-DM 17

* Broncholate 68

* Carbinoxamine Compound-Drops 18

* Cardec DM 18

* Children's Tylenol Cold Plus Cough Multi Symptom 34

* Co-Apap 34

* Codeprex 1

* Comtrex Daytime Maximum Strength Cold, Cough, and Flu Relief 60

* Comtrex Daytime Maximum Strength Cold and Flu Relief 60

* Comtrex Multi-Symptom Maximum Strength Non-Drowsy Caplets 60

* Comtrex Nighttime Maximum Strength Cold and Flu Relief 34

* Congestac Caplets 70

* Contac Cold/Flu Day Caplets 60

* Contac Severe Cold and Flu Caplets 34

* Co-Tuss V 56

* Deconsal II 70

* Despec 69

* Despec-SR Caplets 70

* Donatussin 42

* Donatussin DC 62

* Duratuss 70

* Duratuss HD 65

* ED-TLC 22

* ED Tuss HC 22

* Endagen-HD 22

* Endal Expectorant 61

* Entex LA 69

* Father John's Medicine Plus 43

* Genatuss DM 54

* GP-500 70

* Guaifed 70

* Guaifenex PSE 60 70

* Guaifenex PSE 120 70

* GuaiMAX-D 70

* Guai-Vent/PSE 70

* Guiatuss A.C. 53

* Guiatuss CF 64

* Guiatuss DAC 63

* Guiatuss PE 70

* Histinex HC 22

* Histinex PV 25

* Hycodan 51

* Hycomine Compound 32

* Hydropane 51

* Iobid DM 54

* Iodal HD 22

* Iosal II 70

* Iotussin HC 22

* Kolephrin/DM Cough and Cold Medication 34

* Kolephrin GG/DM 54

* Kwelcof Liquid 56

* Mapap Cold Formula 34

* Marcof Expectorant 57

* Nalex DH 58

* Novahistine DH Liquid 23

* Nucofed Expectorant 63

* Nucofed Pediatric Expectorant 63

* Nucotuss Expectorant 63

* Nucotuss Pediatric Expectorant 63

* Nytcold Medicine 35

* Nytime Cold Medicine Liquid 35

* Ornex Severe Cold No Drowsiness Caplets 60

* PanMist-JR 70

* PediaCare Cough-Cold 24

* PediaCare Night Rest Cough-Cold Liquid 24

* Pediacof Cough 41

* Phanatuss 54

* Phenameth VC 14

* Phenergan with Codeine 5

* Phenergan with Dextromethorphan 6

* Phenergan VC with Codeine 29

* Pneumotussin HC 56

* Poly-Histine 15

* Primatuss Cough Mixture 4 2

* Primatuss Cough Mixture 4D 64

* Profen II 70

* Promethazine DM 6

* Promethazine VC w/Codeine 29

* Prometh VC with Codeine 29

* Protuss-D 66

* Pseudo-Car DM 18

* P-V-Tussin 26

* Quelidrine Cough 39

* Rentamine Pediatric 20

* Rescon-DM 24

* Rescon-GG 69

* Respa-1st 70

* Respa-DM 54

* Respaire-60 SR 70

* Respaire-120 SR 70

* Rhinosyn-DM 24

* Rhinosyn-DMX Expectorant 54

* Rhinosyn-X 64

* Robafen AC Cough 53

* Robafen DAC 63

* Robafen DM 54

* Robitussin A-C 53

* Robitussin Cold and Cough Liqui-Gels 64

* Robitussin Cold, Cough and Flu Liqui-Gels 67

* Robitussin-DAC 63

* Robitussin-DM 54

* Robitussin Night Relief 36

* Robitussin Night-Time Cold Formula 35

* Robitussin-PE 70

* Robitussin Pediatric Cough and Cold 59

* Robitussin Severe Congestion Liqui-Gels 70

* Rondamine-DM Drops 18

* Rondec-DM 18

* Rondec-DM Drops 18

* Ru-Tuss DE 70

* Ru-Tuss Expectorant 64

* Ryna-C Liquid 23

* Ryna-CX Liquid 63

* Rynatuss 20

* Rynatuss Pediatric 20

* Safe Tussin 30 54

* Scot-Tussin DM 2

* Scot-Tussin Senior Clear 54

* Sildec-DM 17

* Silexin Cough 54

* Siltussin DM 54

* Sinufed Timecelles 70

* Sinutab Non-Drying No Drowsiness Liquid Caps 70

* Stamoist E 70

* Statuss Green 19

* S-T Forte 2 3

* Sudafed Children's Non-Drowsy Cold and Cough 64

* Sudafed Cold and Cough Liquid Caps 67

* Sudafed Children's Cold and Cough 64

* Sudal 60/500 70

* Syracol CF 54

* TheraFlu Flu, Cold and Cough Medicine 34

* TheraFlu Maximum Strength Non-Drowsy Formula Flu, Cold and Cough Medicine 60

* TheraFlu Maximum Strength Non-Drowsy Formula Flu, Cold and Cough Medicine Caplets 60

* TheraFlu Nighttime Maximum Strength Flu, Cold and Cough 34

* Tolu-Sed DM 54

* Touro DM 54

* Touro LA Caplets 70

* Triacin C Cough 30

* Triafed w/Codeine 30

* Triaminic AM Non-Drowsy Cough and Decongestant 59

* Triaminic Night Time 24

* Triaminic Sore Throat Formula 60

* Tri-Tannate Plus Pediatric 20

* Tussafed 18

* Tussafed Drops 18

* Tussar DM 21

* Tussigon 51

* Tussionex Pennkinetic 3

* Tussi-Organidin DM NR Liquid 54

* Tussi-Organidin DM-S NR Liquid 54

* Tussi-Organidin NR Liquid 53

* Tussi-Organidin-S NR Liquid 53

* Tussirex 47

* Tuss-LA 70

* Tusso-DM 55

* Tylenol Cold and Flu No Drowsiness Powder 60

* Tylenol Cold Medication 34

* Tylenol Cold Medication Caplets 34

* Tylenol Cold Medication, Non-Drowsy Caplets 60

* Tylenol Cold Medication, Non-Drowsy Gelcaps 60

* Tylenol Cold Multi-Symptom 34

* Tylenol Maximum Strength Flu Gelcaps 60

* Tylenol Multi-Symptom Cough 60

* Uni-tussin DM 54

* Vanex-HD 22

* V-Dec-M 70

* Versacaps 70

* Vicks Children's NyQuil Cold/Cough Relief 24

* Vicks 44 Cough and Cold Relief Non-Drowsy LiquiCaps 59

* Vicks 44D Cough and Head Congestion 59

* Vicks DayQuil Multi-Symptom Cold/Flu LiquiCaps 60

* Vicks DayQuil Multi-Symptom Cold/Flu Relief 60

* Vicks 44E Cough and Chest Congestion 54

* Vicks 44M Cough, Cold and Flu Relief 34

* Vicks NyQuil Hot Therapy 35

* Vicks NyQuil Multi-Symptom Cold/Flu LiquiCaps 35

* Vicks NyQuil Multi-Symptom Cold/Flu Relief 35

* Vicks Pediatric 44D Cough and Head Decongestion 59

* Vicks Children's Cough Syrup 54

* Vicks Pediatric 44M Multi-Symptom Cough and Cold 24

* Vicodin Tuss 56

* Zephrex 70

* Zephrex-L

Stockley's Herbal Medicines Interactions covers herb-drug, herb-food and herb-supplement interactions in over 150 of the most commonly used herbal medicines, dietary supplements and nutraceuticals. The interactions are rated using three categories. The weight of evidence behind the interaction, the severity of the interaction and the action needed to accommodate the interaction.

Dalmacol

(etafedrine - doxylamine - hydrocodone)

* In this factsheet: How does Dalmacol work? What will it do for me?

* How should I use Dalmacol?

* What form(s) does Dalmacol come in?

* Who should NOT take Dalmacol?

* What side effects are possible with Dalmacol?

* Are there any other precautions or warnings for Dalmacol?

* What other drugs could interact with Dalmacol?

DIN (Drug Identification Number) 02230769 DALMACOL ORAL LIQUID

How does Dalmacol work? What will it do for me?

This medication contains 3 active ingredients: etafedrine, doxylamine, and hydrocodone. It helps to control cough associated with inflammation of the mouth and throat that is not helped by cough medications that are less strong.

Hydrocodone is a narcotic medication that is an antitussive (cough suppressant). It helps to reduce cough by affecting the cough centre in the brain.

Etafedrine belongs to the family of medications called decongestants. It works by narrowing blood vessels in the nasal passages, helping to relieve nasal stuffiness.

Doxylamine belongs to the family of medications called antihistamines. It works by drying up the excess fluid that causes a runny nose and watery eyes.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use Dalmacol?

The recommended dose of this medication is:

Adults: 5 mL (1 teaspoonful) every 3 to 5 hours as needed, but not more than 30 mL in any 24-hour period.

Children 6 to 12 years of age: 2.5 mL to 5 mL every 3 to 5 hours as needed to a maximum of 15 mL in any 24-hour period.

Children 1 to 6 years of age: 1.25 mL to 2.5 mL every 3 to 5 hours as needed to a maximum of 3 doses in any 24-hour period.

Use an oral syringe to measure each dose of the liquid as it gives a more accurate measurement than household teaspoons.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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