Ulsikur

ULSIKUR^®
Cimetidine

Composition

Each tablet contains:
Cimetidine	200 mg
Each ampoule of 2 ml contains:
Cimetidine HCl equivalent to Cimetidine	200 mg
Each caplet contains:
Cimetidine	400 mg

Pharmacology
ULSIKUR^® is a competitive antagonist of histamine at histamine H2 receptors of the parietal cells and thus effectively inhibits gastric acid secretion.

ULSIKUR^® inhibits both daytime and nocturnal basal gastric acid secretion. It also blocks gastric acid secretion stimulated by food, histamine, acetylcholine, pentagastrin, caffeine and insulin.

ULSIKUR^® is rapidly absorbed after oral administration and peak levels occur in 45 - 90 minutes. The half - life is approximately 2 hours. The drug is eliminated mainly by urinary excretion. After 24 hours, the unchanged drug recovered from the urine is 48 % following an oral dose and 75% following i.v. or i.m. administration.

Indications
ULSIKUR^® is indicated in the treatment of active duodenal ulcer, active nonmalignant gastric ulcer, peptic esophagitis, and pathological hyper-secretory conditions such as Zollinger - Ellison syndrome. It is also indicated in the prophylaxis of recurrent duodenal ulcer.

Contraindications
There are no known contraindications to the use of ULSIKUR^®


Precautions

1. Symptomatic response to ULSIKUR^® therapy (transient healing) does not preclude gastric malignancy.
2. Since cimetidine has been shown to cross the placental barrier in animals, the drug should not be used in pregnant patients or in women of childbearing potential unless the anticipated benefits are considered to outweigh the potential risks.
3. Cimetidine is secreted in human milk and thus nursing should not be undertaken while the mother is on this drug.
4. ULSIKUR^® is not recommended for children under 16, unless the benefits risks ratio is considered favourable. In such a case, the dosage used is 20-40 mg/kg/day.
5. ULSIKUR^® reduces the hepatic metabolism of warfarin type anticoagulants. phenytoin, lidocaine, and theophylline. thereby delaying elimination and increasing blood levels of these drugs. Since the increased blood levels have been reported to produce clinically significant effects. dosage of these drugs may require adjustment when starting or stopping concomitantly administered ULSIKUR^®, particularly in patients with renal and/or hepatic impairment

Adverse reactions
ULSIKUR^® therapy may cause mild and transient diarrhoea, dizziness. somnolence and rash Reversible headache, arthralgia and myalgia have been reported. Reversible confusional states (mental confusion, agitation, depression, anxiety, hallucinations, disorientation) have been reported predominantly In severely ill patients, advanced age and preexisting liver and/or renal disease.

Mild gynaecomastia has occurred in patients treated for one month or longer, particularly in patients with pathological hyper-secretory states. This condition remained unchanged. or reversible with continuing treatment.

Reversible impotence has been reported in patients with pathological hyper-secretory disorders treated for at least 12 months with high doses of ULSIKUR^®. Reversible alopecia, neutropenia/ agranulocytosis, thrombocytopenia. aplastic anemia, fever, interstitial nephritis. hepatitis and pancreatitis, which cleared on withdrawal of the drug, have been reported very rarely.

Overdosage
There is no antidote for cimetidine toxicity. The usual measures to remove unabsorbed drug from the gastrointestinal tract, clinical monitoring and supportive therapy should be employed. Toxic doses in animals are associated with respiratory failure and tachycardia which may be controlled by assisted respiration and a beta blocker. In human, overdoses up to 10 grams have been reported and have not been associated with any untoward effects.

Dosage and administration

Adult oral dosage:
-	Active duodenal ulcer: The recommended dosage is 400 mg b.i.d. (400 mg with breakfast and 400 mg at bedtime) or 200 mg t.i.d. With meals and 400 mg at bedtime, for 4 - 8 weeks. Concomitant antacids should be given as needed for quick relief of pain; however. simultaneous administration should be avoided because antacids reduces the absorption of ULSIKUR®.
-	Prophylaxis of recurrent duodenal ulcer: The recommended dosage is 400 mg at bedtime. This use should be limited to not more than one year.
-	Acute benign gastric ulcer: Recommended dosage is 200 mg t.i.d. with meals and 400 mg at bedtime, for 6 - 8 weeks.
-	Pathological hyper-secretory conditions, such as Zollinger- Ellison syndrome: Recommended dosage is 200 mg t.i.d. with meals and 400 mg at bedtime. It may be necessary to increase the doses to 400 mg q.i.d. with meals and at bedtime. Doses should be adjusted to individual patient needs, but should not exceed 2 grams per day and should continue as long as clinically indicated.
Adult parenteral dosage:
-	i.m, injection: 200 mg (one ampoule) without dilution, every 4-6 hours. It may cause transient pain at the injection site.
-	i.v. infusion: 200 mg (one ampoule), dilute in 100 ml of Dextrose injection (5%) or other i.v. solution, and infuse over 15-20 minutes. Repeat every 4-6 hours. or it may be necessary to repeat more frequently, but should not exceed 2 g/day.
-	i.v. injection: 200 mg (one ampoule), dilute in NaCl injection (0,9%) or other i.v. solution to a total volume of 20 ml, and inject slowly over a period of at least 2 minutes. (Too rapid i.v. injection may cause cardiac arrhythmia's and hypo tension). Repeat every 4 - 6 hours.

Patients with impaired renal function:
Dosage should be adjusted according to the severity of the renal impairment. In patients with severely impaired renal function, the recommended dosage is 200 mg every 12 hours orally or by i.v. injection. If necessary, the dosing frequency may be increased to every 8 hours with caution.

When liver impairment is also present, further reduction in dosage may be required. Since ULSIKUR^® is removed by hemodialysis, the timing of administration should be adjusted to coincide with the end of hemodialysis.

Stability of ULSIKUR^® Injection:
Stable for 48 hours at room temperature when diluted with most commonly used i.v.  solutions, e.g. NaCl injection 0,9%, Dextrose Injection (5% or 10%), Lactated Ringer's Solution, 5% Sodium Bicarbonate injection.

Presentations
ULSIKUR^® tablet 200 mg:
Box of 10 strips x 10 tablets in strip. Reg. No. D. 7812608
Box of 25 strips x 10 tablets in strip. Reg. No. DKL8311601810A1

ULSIKUR^® caplet 400 mg:
Box of 5 strips x 10 caplets in strip. Reg. No. DKL8511601809A1

ULSIKUR^® injection 200 mg:
Box of 5 ampoules: Reg. No. D. 7813104 .

Store at room temperature (below 30°C)

ON MEDICAL PRESCRIPTION ONLY

PT KALBE FARMA Tbk.
Bekasi - Indonesia

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