Description and Composition of Ulsakit
Ulsakit is a kit used in the eradication of H. Pylori in active chronic gastritis, duodenal and gastric ulcers. It contains Softgels of Omeprazole 20 mg, Clarithromycin 250 mg, and Tinidazole 500 mg as its active pharmaceutical ingredients. In addition, it contains other inactive ingredients called excipients in sufficient quantities. Approved colours were used in the capsule shells.
Rational for Ulsakit Formulation
Infection with Helicobacter pylori is now known to be a significant risk factor for such gastroduodenal diseases as chronic type B gastritis, duodenal ulcer, mucosa-associated lymphoid tissue (MALT), low-grade B-cell gastric lymphoma, gastric ulceronic carcinoma. Up to 90% of duodenal ulcer (DU) patients have H.Pylori infection and the eradication of this organism is followed by healing of the DU.
Failure to eradicate H.Pylori results in ulcer recurrence in 67% of cases while the figure for H. Pylori cured DU patients is 6%. The eradication of H.Pylori has therefore become a vital therapeutic goal in the management of of peptic ulcer disease.
A Proton pump inhibitor plus two antimicrobials is the best validated highly effective type of eradication therapy.
Omeprazole, a gastric proton pump inhibitor (PPI), is a potent suppressor of both basal and stimulated gastric acid secretion. Omeprazole-induced elevation of intra-gastric pH may help to destroy H.Pylori and increase the efficacy of antibacterial agents against organism. Omeprazole has a plasma half-life of 0.5-1.0 hour with peak plasma concentration time of 05 -3.5 hours. It is the most commonly available proton pump inhibitor, its affordable and shor term safety well established.
Tinidazole is 5-nitroimidazole with rapid bactericidal antimicrobial action against H pylori.It more potent and has less side effects that metronidazole.
Clarithromycin has good in vitro activity (MIC 90 value-0.03 µg/L) against H. pylori which make it suitable for incorporation into regimen for the eradication of H. pylori infection.
Uses and Indications of Ulsakit
Ulsakit is indicated for the eradication of H. pylori in active chronic gastritis, duodenal and gastric ulcers.
Dosage and Administration of Ulsakit
One Ulsakit pack contains two capsules of Omeprazole (20 mg), two capsules of Tinidazole (500 mg) and two capsules of Clarithromycin (250 mg).
One blister is for one day treatment. The dose is one capsule of omeprazole, one capsule of tinidazole and one capsule of clarithromycin to be taken in the morning and similarly one each in the evening(12 hourly). The duration of therapy recommended is for seven days.
Renal And Hepatic impairment
Caution should be exercised while administering ULSAKIT to patients with renal impairment and hepatic disease.
Contraindications of Ulsakit
Hypersensitivity to omeprazole or tinidazole or clarithromycin.
Warning and Precautions to Observe While Using Ulsakit
Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazards to the foetus. Clarithromycin has demonstrated adverse effects of pregnancy outcome and or embryo foetal development in monkeys, rats, mice and rabbits at doses that produced plasma levels 2 to 17 times the serum levels achieved in humans treated at the maximum recommended human doses.
Pseudomembranous colitis has occurred with nearly all antibacterial agents including clarithromycin and may range in severity from mild to life-threatening. Therefore it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of Ulsakit.
Drugs Interactions with Ulsakit
- Theophylline: clarithromycin use in patients who are receiving theophylline may be associated with an increase in serum theophylline concentrations.
- Carbamazepine: Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine.
- Warfarin. The use of clarithromycin in patients receiving warfarin may result in potentiation of the effect of Warfarin. Prothrombin time should be frequently monitored in these patients.
- Digoxin: The effects of digoxin may be potentiated with concomitant administration of clarithromycin
- Terfenadine: Concomitant administration of single dose clarithromycin and terfenadine have been shown to result in increased plasma concentrations of terfenadine. Clarithromycin should not be given to patients receiving terfenadine therapy who have pre existing cardiac abnormalities (arrhythmia, bradycardia, QT interval prolongation, ischemic heart disease, congestive heart failure) or electrolyte disturbances.
- Ergot: The theoretical possibility of ergotism contraindicates the concurrent use of clarithromycin with ergot derivatives.
- Cyclosporin: Clarithromycin increases the serum concentration of cyclosporin hence the dosage of latter may be reduced to avoid renal toxicity.
- The use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system may be associated with elevations in serum levels of these drugs.
- Ketoconazole, Ampicillin esters, Iron salts: Omeprazole causes a profound and long lasting inhibition of gastric acid secretion. Therefore it is possible that omeprazole may interfere with the absorption of these drugs.
- Alcohol: Intake of alcohol during this therapy can precipitate an antabuse effect and hence should be avoided. Disulfiram: Concomitant administration can cause delirium and confusion.
Omeprazole, Tinidazole, Clarithromycin: There are no well controlled studies of Omeprazole or tinidazole or clarithromycin in pregnant women. Clarithromycin is not indicated during pregnancy, Hence this combination is not indicated in pregnancy.
It is not known whether Omeprazole or tinidazole or clarithromycin is excreted in breast milk. Caution should be exercised when administering to a nursing woman.
Safety and effectiveness of Ulsakit in pediatric population has not been established.
Side Effects of Ulsakit
The combined drugs in ULSAKIT are well tolerated. Side effects include:
- Diarrhoea and
- Abdominal pain.
Other rare side effects include:
- Skin rash
- Metallic taste (change in taste)
- Rarely glossitis, stomatitis, urticaria, eruptions and
- Moderate leucopenia.
Overdosage of Ulsakit
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required.
How to Store Ulsakit
Store in a cool (below 25° C.) & dry place. Protect from light. Keep out of the reach of children.