| COLPERMIN™ |
|R & C |
|Peppermint Oil |
|Symptomatic Relief of Irritable Bowel Syndrome |
|Action And Clinical Pharmacology: The mechanism of action of peppermint oil or its major component, menthol, in reducing lower bowel motility has not been completely elucidated. It has been postulated that peppermint oil exerts its gastrointestinal smooth muscle inhibitory effect by altering calcium ion transport.
Using intraluminal pressure recordings and ultrasound measurements of colonic activity it has been shown that topical rectally instilled peppermint oil inhibited distal colon motility, causing colonic relaxation and a fall in the intracolonic pressure.
Duthie compared the effect of 0.2 mL of peppermint oil suspension and vehicle alone on colonic motility in volunteers using a perfused tube with the tip placed in the sigmoid colon and rectum 20 cm from the anus. A statistically significant reduction in motility and motility index occurred in all 6 subjects after administration of peppermint oil. This inhibition began within 2 minutes and lasted for 7 to 23 minutes with a mean duration of 12 minutes.
Enteric coated capsules containing the carminative to be tested were prepared and their dissolution monitored by an in vivo radiographic technique. Average dissolution time in patients was 143±14.8 minutes, and dissolution occurred in the small bowel.
The urinary excretion of menthol following administration of Colpermin was significantly delayed compared to that after ingesting peppermint oil in soft gelatin capsules, suggesting that with Colpermin an appreciable amount of menthol came in contact with colonic mucosa. Total 24 hour recoveries of menthol were similar, being 35% and 40% for Colpermin and peppermint oil, respectively.
In a similar study, the pharmacokinetic parameters of Colpermin capsules measured over 24 hours in 7 patients following a single dose of 3 capsules were as follows: lag time (h) 1.07±0.39, Tmax (h) 5±2, absorption T 1/2 (h) 1.2±0.9, terminal elimination T 1/2 (h) 3.6±0.8, Auc (0-19 h) (mg) 79.5±41.3, Auc (0-inf) (mg) 84.0±42.9.
Indications And Clinical Uses: For the symptomatic relief of abdominal pain, distension, flatulence and gas associated with the irritable bowel syndrome (IBS).
Contra-Indications: Do not administer with meals or to patients with achlorhydria. tag_WarningWarnings
Manufacturers' Warnings In Clinical States: Do not administer to patients allergic to peppermint, menthol, arachis (peanut) oil, or similar essential oils. Do not chew or break the capsules as local irritation of the mouth, esophagus and stomach may occur.
Precautions: Peppermint oil should not be administered to patients with heartburn or active gastric ulcers as symptoms may be exacerbated.
Patients should be administered peppermint oil only after examination has definitely diagnosed the presence of IBS with no associated organic lesions.
The safety of peppermint oil for long-term use has not been established. Until chronic dosing studies have been completed, only occasional use is recommended.
Adverse Reactions: Reactions may include heartburn and hypersensitivity to peppermint oil or menthol, which is rare and includes erythematous skin rash, headache, bradycardia, muscle tremor and ataxia.
Symptoms And Treatment Of Overdose: Symptoms: Symptoms include mild respiratory tract symptoms (choking, coughing, dyspnea) transient excitement, ataxia and occasional convulsions and occasional painful urination. tag_Treatment
Treatment: No specific antidote is known and thus conventional management of symptoms should be instituted. Gastric lavage with tap water or weak sodium bicarbonate solution may be performed.
Dosage And Administration: Adults: 1 capsule 3 times a day swallowed whole with a small quantity of water. Increase dosage to 2 capsules 3 times a day if required. Take 30 to 60 minutes before meals. Do not chew. Do not take immediately after meals or with food.
Do not use for more than 14 days, except on the advice of a physician. The safety of peppermint oil for long-term use has not been established. Until chronic dosing studies have been completed, only occasional use is recommended.
Availability And Storage: Each enteric-coated capsule contains: peppermint oil 187 mg. Nonmedicinal ingredients: arachis oil. Lactose-, gluten- and sucrose-free. Light-resistant blister strips of 10, boxes of 2 strips (20 capsules) and 5 strips (50 capsules). Capsules packaged in blister packs have been shown to be stable for 3 years when stored at 20°C. Store in a cool, dark place.