| DICETEL® |
|Solvay Pharma |
|Pinaverium Bromide |
|Gastrointestinal Calcium Antagonist |
|Action And Clinical Pharmacology: Pinaverium is a calcium antagonist which inhibits the calcium influx by blocking the voltage-dependent calcium channel at the smooth muscle cell level. It possesses a high degree of selectivity for the intestinal smooth muscle.
Many studies showed that pinaverium induces a relaxation of the gastrointestinal and the biliary tracts and mainly of the colon, an inhibition of the motor colonic response to food and/or pharmacological stimulations, implying the action of the drug in irritable bowel syndrome.
Indications And Clinical Uses: For the treatment and relief of symptoms associated with irritable bowel syndrome (IBS): abdominal pain, bowel disturbances and intestinal discomfort.
For the treatment of symptoms related to functional disorders of the biliary tract.
Contra-Indications: Patients with known hypersensitivity to pinaverium or any of the excipients.
No other contraindications have been identified at this time.
Manufacturers' Warnings In Clinical States: Contact of pinaverium with the esophageal mucosa may be irritating. Therefore, it is strongly recommended that the tablet be taken with a glass of water during mealtime. If more than 3 tablets are prescribed per day, the additional tablet(s) should be taken concurrently with a glass of water and a snack.
Precautions: Pinaverium should not be administered for the relief of motility dysfunction due to underlying organic disease.
Pregnancy: Reproductive studies performed in animals have not revealed the presence of teratogenic effects. However, the safety of pinaverium during pregnancy has not been established. Consequently, in the pregnant patient, this drug should only be administered if, in the judgement of the physician, its use is essential to the welfare of the patient.
Lactation: There have been no controlled studies in nursing women; therefore, the drug should be avoided during lactation.
Adverse Reactions: Minor adverse events were reported and listed as mild and moderate. They were mainly minor digestive disorders that may be related to the disease, such as epigastric pain and/or fullness (0.8%), nausea (0.5%), constipation (0.4%), heartburn (0.3%), distension (0.3%) and diarrhea (0.2%).
Other Systems: headache (0.3%), dryness of the mouth (0.3%), drowsiness (0.2%), vertigo (0.2%) and skin allergy (0.2%).
Symptoms And Treatment Of Overdose: Symptoms and Treatment: In man, apart from diarrhea and/or flatulence, pinaverium induced no undesirable effects in daily dosages of up to 1 200 mg.
No cases of overdosage of pinaverium have been reported to date. However, if overdosage occurs, gastric lavage is recommended and symptomatic treatment initiated if deemed necessary.
Dosage And Administration: The usual adult dosage is 3 film-coated tablets of 50 mg a day (1 tablet 3 times a day). In exceptional cases, the dosage may be increased up to 6 tablets a day (2 tablets 3 times a day).
It is recommended that the tablet be taken with a glass of water during meals or snacks. The tablet should not be swallowed when in the lying position or just before bedtime.
The duration of treatment depends on the disorders for which pinaverium is given.
Availability And Storage: Each orange-colored, circular-shaped, film-coated tablet, with a slightly convex surface, contains: pinaverium bromide 50 mg. Nonmedicinal ingredients: in the core: hydrophobic anhydrous silica, magnesium stearate, microcrystalline cellulose, modified cornstarch, modified lactose and talc; in the film coating: gastrosoluble acrylic resin, micronized talc, polyoxyethylene glycol 6000 and Sepisperse orange K3020 [titanium dioxide (E 171), sunset yellow lake (E 110), hydroxy propylcellulose (E 463)]; intermediary solvents: acetone, ethanol and isopropanol. Boxes of 100 in blister packs. Store at room temperature (15 to 30°C) in dispensing box.