Keep out of reach of children.
Read the directions carefully before use.
For prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active ingredient:
Drotaverine HCl ...............................40 mg
Excipients: q.s ………………………….. 1 tablet
Tablet.
Product description: Triangular, yellow tablet, plain on both sides, undamaged edges.
Box of 10 blisters x 10 tablets.
Box of 5 blisters x 10 tablets.
Drotaverine belongs to smooth muscle spasmolytic agent indicated for treatment of pain syndromes of various organs: gastrointestinal, biliary, urogenital and vascular systems.
Drotaverine is an isoquinoline derivative, having smooth muscle spasmolytic due to inhibit PDE IV (cAMP specific phosphodiesterases) in vitro without inhibiting the PDE III and PDE V isoenzymes. PDE IV inhibitors have myorelaxant properties and anti-inflammatory activity.
As a consequence of inhibiting the phosphodiesterases enzyme it results in the increase of the intracellular cAMP concentration which by inactivating the myosin light chain kinase enzyme (MLCK) and the intracellular calcium ion concentration declines, thus leading to the relaxation of the smooth muscle.
Functionally, PDE IV appears to be very important in reducing smooth muscle contractile activity, suggesting that selective PDE IV inhibitors might be useful in the treatment of hypermotility disorders and various diseases associated with spastic conditions of the gastrointestinal, urogenital system.
The enzyme that hydrolyses cAMP in myocardial and vascular smooth muscle cells is mainly the PDE III isoenzyme, this explains, that drotaverine is an effective spasmolytic agent without serious cardiovascular adverse effects and strong cardiovascular therapeutic activity.
It is effective in case of smooth muscle spasms of both neural- and muscular origin.
Due to its vasodilatator effect it increases the tissue circulation.
Independently from the type of autonomous innervation, drotaverine acts on the smooth muscles found in the gastrointestinal, biliary, urogenital and the vascular system.
Drotaverine's effect is stronger than papaverine's; its absorption is more rapid and more complete; and it bonds less to the serum proteins.
Drotaverine frees of anticholinergic effects.
Drotaverine is rapidly absorbed after oral administration. Volume of distribution is approximately 200 litres.
It is highly bound to human plasma proteins (95-98%), especially to albumin, gamma and beta globulins. Drotaverine might cross the placental barrier.
Cmax is reached within 45-60 min after oral administration and after its first pass metabolism the 65% of the administered dose reaches the circulation unchanged.
It is metabolized in the liver. Its biological half-life is 16-22 hours. Practically within 72 hours it disappears from the body. More than 50% of it is excreted in the urine and about 30% in the faeces. It is mainly excreted in the form of main metabolites; its unchanged form cannot be detected in the urine.
In therapeutic doses, drotaverine has no effect on ability to drive and operate machinery.
Patients should be instructed that if they experience vertigo, they should avoid potentially hazardous tasks such as driving or operating machines.
There is no evidence of teratogenicity and embryotoxicity from retrospective human and animal studies by oral route. Nevertheless, caution should be taken when prescribed during pregnancy.
There are no adequate data on the use of drotaverine in lactation women; this medicine should not recommended for prescribing in these subjects.
Together with levodopa, drotaverine may decrease the effect of antiparkinson and increase tremor, rigidity.
The following related drotaverine adverse reactions were listed below by frequency grouping: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100). rare (>1/10,000, <1/1000) and very rare (<1/10,000) and system organ class:
- Gastrointestinal disorders: Rare: nausea, constipation.
- Nervous system disorders: Rare: headache, dizziness, insomnia.
- Cardiovascular system disorders: Rare: palpitation, hypotension.
Please inform your doctor of all undesirable effects upon drug administration.
No data concerning overdose are available. In overdosage case, patient needed tightly critical care supervision, and symptomatic treatment and adjuvant care.
Suggested measures include emesis and/or gastric lavage.
Store in dry places, not exceeding 30°C, protect from light.
Drotaverine's administration requires increased caution in case of low blood pressure.
Excipients:
Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. If you have wheat allergy you should not take this medicine.
Lactose monohydrate: Patients with problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Drotaverine is a smooth muscle spasmolytic medicine.
Colic biliary pain due to smooth muscle spasm in connection with biliary tract diseases: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecyctitis, cholangitis and papillitis.
Colic renal pain due to smooth muscle spasm in urinary tract diseases: nephrolithiasis, ureterolithiasis, pyelitis, cystitis and cramp of urinary bladder.
As adjuvant treatment:
+ Abdomen pain or colic abdomen pain due to smooth muscle spasm of gastrointestinal origins: gastric and duodenal ulcer, gastritis, cardia and pylorus spasm, enteritis and colitis, spastic colitis with constipation and meteoristic forms of irritable colon syndrome.
Drotaverine improves quickly and effectively anti-spasmolytic abdomen pain but not faints the emergency abdomen symptoms.
-In gynaecological diseases: dysmenorrhoea.
Hypersensitivity to any ingredients of the drug.
Children aged less than 6 years.
Renal, hepatic or cardiac insufficiency, A-V block of II-III degree.
Adults: The usual average daily dose is 120 - 240 mg/day (in 2 - 3 divided doses).
Similar dosage: oral dose of 1 - 2 tablets, 3 times/day.
Children over 6 years of age: The recommended dose is 80 - 200 mg/day (in 2 - 5 divided doses).
Similar dosage: oral dose of 1 tablet, 2 - 5 times/day.
Or as directed by the physician.
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