Expas Forte

COMPOSITION:

Drotaverine HCl ............................................................ 80 mg

Excipients q.s ............................................................. 1 tablet

(Lactose monohydrate, wheat starch, talc, magnesium stearate).

DOSAGE FORM: Tablet.

PRESENTATIONS: Box of 3 blisters x 10 tablets.        

                            Box of 10 blisters x 10 tablets.

PHARMACODYNAMICS: 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.

It is effective in case of smooth muscle spasms of both neural- and muscular origin.

Independently from the type of autonomous innervation, drotaverine acts on the smooth muscles found in the gastrointestinal, biliary, urogenital and the vascular system. Drotaverine is free of anticholinergic effects

PHARMACOKINETICS:

Drotaverine is rapidly absorbed after oral administration. It is highly bound to plasma albumin (95-98%), gamma and beta globulins. Peak plasma concentration 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.

Drotaverine is metabolized in the liver. Its biological half-life is 8 - 10 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 metabolites; its unchanged form cannot be detected in the urine.

INDICATIONS:

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, constipation and irritable colon syndrome.

+ Dysmenorrhoea.

CONTRAINDICATIONS:

Hypersensitivity to any ingredients of the drug.

Children aged less than 12 years.

Severe renal, hepatic insufficiency, A-V block of II-III degree. Severe cardiac failure.

PRECAUTIONS: Drotaverine's administration requires increased caution in case of low blood pressure.

Related to lactose excipient

Expas forte contains lactose, intake of lactose is unsuitable for people with lactase insufficiency, galactosaemia or glucose-galactose malabsorption syndrome. It is required to consult a physician before use.

PREGNANCY AND LACTATION:

There is no evidence of teratogenicity and embryotoxicity from retrospective human and animal studies. 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.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

In therapeutic doses, drotaverine has no effect on ability to drive or operate machinery during oral treatment.

Patients should be instructed that if they experience vertigo, they should avoid potentially hazardous tasks such as driving or operating machines.

INTERACTIONS: Together with levodopa, drotaverine may decrease the effect of antiparkinson and increase tremor, rigidity.

ADVERSE EFFECTS: Headache, dizziness, nausea, palpitation, insomnia, constipation, and hypotension have been rarely reported.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSE: No data concerning overdose are available. In over-dosage case, patient needed tightly critical care supervision, and symptomatic treatment and adjuvant care.

Suggested measures include emesis and/or gastric lavage.

DOSAGE & ADMINISTRATION:

Adults: oral dose of 1 tablet, 1 to 3 times daily.

Children aged more than 12 years: oral dose of 1 tablet, once to twice daily.

Or as directed by a physician.

Keep out of the reach of children

Read the directions carefully before use

Consult the physician for more information

This drug is for prescription only

Shelf-life: 36 months from the manufacturing date.

Storage conditions:

Store in a dry place, not exceeding 30^oC, protect from light.

Specifications: Manufacturer's.