Ulsakit Softgel: Dose, Indication and Side Effects

Ulsakit is a combination therapy for treating Helicobacter pylori, also called Campylobacter pylori. The gram-negative bacteria infects the stomach or duodenum (first part of the small intestine). It causes chronic inflammation (gastritis) producing a cytotoxin that causes ulcer. They can also increase the risk of stomach cancer.

Peptic ulcer, or stomach ulcer, are open sores in the lining of the stomach or upper part of the small intestine. Infections with the H. pylori can also cause abdominal pain, heartburn, bad breath, poor appetite, diarrhea, nausea, vomiting, etc.

Excessive use of non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, aspirin can cause peptic ulcer.

Ulsakit is better used for a patient that have active duodenal or gastric ulcer for at least one-year period.

Ulsakit Combination

Ulsakit combikit by Zolon Healthcare Ltd. contains 7 × 6’s:

• Two enteric coated soft gel capsule Omeprazole 20 mg capsule
• 2 red soft gelatin capsules of Tinidazole 500 mg.
• 2 green soft gelatin capsules of Clarithromycin 250 mg.

This combination has one proton pump inhibitor, two antibiotics: a macrolide and a nitroimidazole.

Omeprazole is a proton pump inhibitor. It inhibits the secretion of the gastric acid. A cascade of reaction eventually ends with the omeprazole stopping the final transport of hydrogen ion into the gastric lumen, a late step in gastric acid secretion.

Clarithromycin is a macrolide antibiotics. It stops the bacteria (bacteriostatic) by inhibiting the bacterial ribosomal protein synthesis.

Tinidazole is a 5-nitroimidazole derivative. The action is similar to metronidazole (Flagyl) with both antibacterial and antiprotozoal action. It damages bacteria DNA strands.

Dosage of Ulsakit

The 7-day blister contains Omeprazole 20 mg + clarithromycin 250 mg + tinidazole 500 mg. The drug is oral dosage form (by mouth). Take the combination of one tablet of omeprazole 20 mg plus one tablet of clarithromycin and one tablet of tinidazole in the morning. Take the same combination in the evening. It is better to take the medication with food.

Give 12 hours interval between the doses (Let’s say you took the combination by 8 am, the second doses should be by 8 pm). Take this medication consecutively for 7 day duration.

While taking your medication, you should avoid alcohol, smoking, coffee (due to caffeine) or NSAIDs medications.

Precaution

Do not use this kit with colchicine. It can cause death in the elderly, especially those with renal disease. Clarithromycin also worsens myasthenia gravis symptoms and causes clostridium difficile-associated diarrhea.

The medication may increase the risk of acute interstitial nephritis, cutaneous and systematic lupus erythematosus.

Interactions

Tinidazole interacts with alcohol, causing disulfiram-like reactions (flushing, abdominal cramps, tachycardia, vomiting). Anti-arrhythmic drugs like quinidine, disopyramide interact with clarithromycin, increasing the risk of arrythmia, and torsades de pointes.

Omeprazole reduces plasma concentration of atazanavir, and increases that of tacrolimus, saquinavir.

Clarithromycin increases plasma concentration of theophylline, carbamazepine, digoxin. Do not use clarithromycin with HMG-CoA reductase inhibitors like atorvastatin, simvastatin, lovastatin due to risk of rhabdomyolysis, a life-threatening condition that causes muscle breakdown and death. Alternative to these are rosuvastatin.

Oral anticoagulant like warfarin, clopidogrel may be potentiated by clarithromycin or omeprazole.

Ulsakit in Pregnancy and Lactation

There are few studies on the effect of ulsakit on pregnant and breastfeeding mums, but it is necessary to consult your doctor before taking the combination due to adverse effects. Tinidazole is the FDA pregnancy category C, they do not recommend it in the first trimester.

They do not recommend Clarithromycin in early pregnancy. According to a study as it may increase the risk of miscarriage.

Omeprazole is an FDA pregnancy category C drug. Experiments on pregnant rats and rabbits with some doses of omeprazole led to fetal mortality. However, studies on pregnant women on the first trimester did not point to any abnormalities or malfunction in the fetus. FDA still classifies it as category C even as evidence suggests it is safe in pregnancy.

Side Effects of Ulsakit

Some common side effects of ulsakit are constipation, taste disturbance, nausea, vomiting, dark-colored urine, headache, tiredness, ataxia, dizziness, metallic taste, flushing, abdominal pain, fever, furry tongue, hypersensitivity, anorexia, sensory disturbances. Some of the side effects are drug-specific.