SPASMOSAFE

SPASMOSAFE
17 May

SPASMOSAFE

Antispasmodics

- Drotaverine HCL is an iso-quinoline derivative, which has

  spasmolytic action on smooth muscle of the coronary, peripheral

  arteries, and uro-genital tract.        

- Its action is due to surface activity by binding to the surface of

  smooth muscle. It acts by elevation of CAMP level, through

  phosphodiesterase inhibition, it normalizes the smooth muscle

  tone bringing the hypertonic state to a normatonic state.

- Drotaverine HCL is better tolerated by humans, it has

  spasmolytic action stronger than papaverine. Its protein binding

  is lower, its effect develops more rapidly, slowly released and

  last longer than that at papaverine and perparine.   

- The absorption of Drotaverine HCL is extremely rapid. within

  12 minutes

- The peak plasma levels reach between 45 and 60 minutes

  indicating rapid absorption.

- The half life of Drotaverine HCL is 6 hours, regardless the route

  of administration.

- Drotaverine HCL is metabolized by the liver and excreted in the

  bile  (50%) & urine (30%). The elimination of Drotaverine is

  practically completed within 72 hours.       

Indecation

 Spasmosafe®  used as antispasmodic in the management  of :

* Gastrointestinal tract, Genito-urinary tract, and billiary tract.

* Gynaecology and obsterics:- specially in spasmodic

  dysmenorrhoea, threatening abortion and to regulate the uterine

  contractions during delivery.

* Cardiovascular system:- As an adjuvant in angina pectoris, coronary insufficiency and in hypertensive patients.

* Otorhinolarynology:-Spastic disorders in meniere's disease, and

  tinnitus of vascular origin caused by spasm of tensor tympani

  muscle.    

Dosage & Administration

 

 Adults :

 Tablets:- 1- 2 tablets, 1- 3 times daily.

 

-Each tablet of Spasmosafe® 60 contains :

 Drotaverine HCL 60 mg

-Each tablet of Spasmosafe®  40 contains:-

 Drotaverine HCL 40 mg

 

 Spasmosafe®  is contraindicated in the following cases:

- Hepatic, renal- cardic disease.

- Known hypersensitivity to the Drotaverine HCL.

- Spasmosafe®  is can be enhanced by administration with other

  preparation such as parasmpatholytics and analgesics.

- The administration of Spasmosafe®  with levodopa may result in

  reduced  Antiparkinson effect of the latter.

 

 Spasmosafe®  is safe, which is non-toxic and non-teratogenic, it

 should be administered to pregnant and breast feeding mothers

 only when clearly indicated and when potential benefits outweigh

 the potential risks.

 

 

- Spasmosafe®  is generally well- tolerated, gastrointestinal

  disturbances, headache, vertigo and orthostatic hypotension may

  occur on rare occasions.

 

Over dosage :-

 In case of over dosage, symptoms include reduced gastric motility,

 hypotension drowsiness, and cardiovascular disturbance. 

 Treatment should be symptomatic.

 Spasmosafe® :

- Blisters of 10 tablets, packs of two Blisters

- Hospital packs of different sizes.

- Store in a dry place at a temperature below 30°C