ULSANIC is a widely used medication for the treatment and management of gastrointestinal disorders, particularly peptic ulcers and reflux oesophagitis. Its active ingredient, sucralfate, is known for its protective and healing action on the gastrointestinal mucosa.
SCHEDULING STATUS
ULSANIC is a Schedule 0 medication, which means it is considered safe enough to be sold without a prescription under South African health regulations. However, it should still be used responsibly and under the guidance of a healthcare provider when necessary.
PROPRIETARY NAME AND DOSAGE FORM
ULSANIC is available in several dosage forms, making it suitable for different patient needs:
| Dosage Form | Description |
|---|---|
| ULSANIC 1 g Tablets | Solid, oral tablets |
| ULSANIC Effervescent Tablets | Dissolvable tablets for oral use |
| ULSANIC Suspension | Liquid form, often for pediatric or special use |
These options allow for flexible dosing and ease of administration across various age groups and patient profiles.
COMPOSITION
ULSANIC contains sucralfate as its active ingredient across all its formulations. Each form also includes specific excipients to ensure efficacy, stability, and patient compliance.
ULSANIC 1 g Tablets:
- Active Ingredient: Sucralfate 1 g
- Excipients: Carmellose calcium, macrogol, magnesium stearate, microcrystalline cellulose
ULSANIC Effervescent Tablets:
- Active Ingredient: Sucralfate 1 g
- Excipients: Lactose monohydrate, flavourings, macrogol, saccharin sodium, quinoline yellow, sodium cyclamate
Contains Sweeteners and Lactose
ULSANIC Suspension:
- Active Ingredient: Sucralfate 1 g per 5 ml
- Excipients: Orange flavour, glycerol, saccharin sodium, xanthan gum, sodium methyl hydroxybenzoate (0.09% m/v), sodium propyl hydroxybenzoate (0.048% m/v)
CATEGORY AND CLASS
ULSANIC falls under:
- Category: A
- Class: 11.4.3 – Medicines acting on the gastrointestinal tract: Other
This class typically includes medications that protect and soothe the stomach lining or assist in ulcer healing.
PHARMACOLOGICAL ACTION
Pharmacodynamic Properties
ULSANIC’s active ingredient, sucralfate, is anti-ulcerogenic, forming a protective barrier over the mucosa of the stomach and duodenum. It:
- Binds to ulcerated tissue
- Shields against acid, pepsin, and bile salts
- Absorbs digestive enzymes like pepsin and trypsin
This dual protective and therapeutic action enhances healing and symptom relief in patients with gastrointestinal ulcers.
INDICATIONS
ULSANIC is indicated for the following conditions:
- Gastric and Duodenal Ulcers
- Chronic Gastritis
- Reflux Oesophagitis
It also offers relief from peptic ulcer symptoms such as:
- Epigastric pain
- Vomiting
- Hyperchlorhydria (excess stomach acid)
Moreover, ULSANIC is effective in maintenance therapy after the successful treatment of duodenal ulcers.
CONTRAINDICATIONS
Do not use ULSANIC if you are:
- Allergic to sucralfate or any of its excipients (see COMPOSITION section)
- Intolerant to lactose, especially in the case of effervescent tablets
Always consult a healthcare provider before starting treatment, especially in cases of allergy or food intolerances.
WARNINGS AND SPECIAL PRECAUTIONS
ULSANIC should be used with caution in patients with:
- Renal impairment or those on dialysis: Due to the risk of aluminium absorption and related toxicity (osteodystrophy, encephalopathy)
- Phosphate deficiency: As aluminium can bind phosphate and hinder its absorption
- Delayed gastric emptying or those receiving enteral feeds: Risk of bezoar formation (a solid mass in the stomach)
- Elderly patients: May require dose adjustment due to reduced physiological function
Use in premature infants is not recommended.
Effects on Ability to Drive and Use Machines
ULSANIC may cause:
- Drowsiness
- Dizziness
Caution is advised when operating machinery or driving until you understand how the medication affects you.
Excipients
ULSANIC Effervescent Tablets contain:
- Lactose: May impact diabetic patients’ glycaemic control
- Not suitable for individuals with:
- Galactosaemia
- Lactase deficiency
- Glucose-galactose malabsorption
Patients with fructose intolerance should also avoid this formulation.
INTERACTIONS
ULSANIC can interfere with the absorption of other medications. It’s advised to:
- Take other medicines at least 2 hours apart
- Take antacids at least 30 minutes before or after ULSANIC
- Avoid combining with enteral feeds; allow a 1-hour gap
Medications affected by sucralfate include:
- Cimetidine, Ranitidine
- Digoxin, Phenytoin
- Ketoconazole, Warfarin
- Tetracyclines, Theophylline
- Fluoroquinolones
- Levothyroxine, Quinidine
If you’re on any of the above, speak with your doctor or pharmacist to plan appropriate spacing and dosage adjustments.
HUMAN REPRODUCTION
Pregnancy and Lactation
- Pregnancy: Safety not established; use only if clearly needed and under medical advice
- Lactation: It is unknown whether ULSANIC passes into breast milk; exercise caution
DOSAGE AND DIRECTIONS FOR USE
The standard adult dose is:
- 1 g tablet, 1 effervescent tablet, or 5 ml of suspension
- Three to four times daily, between meals and at bedtime
Effervescent Tablet Use
- Dissolve completely in a glass of water before drinking.
Alternate Regimen
- 2 g twice daily (2 tablets or 10 ml of suspension) has proven effective, especially in duodenal ulcer treatment.
Reflux Oesophagitis
- 1 g (tablet or suspension) four times daily
- Taken between meals and at bedtime
Maintenance Treatment (Duodenal Ulcers)
- 1 tablet twice daily:
- Half an hour before breakfast and supper
- Recommended duration: 12 months
Relief may be enhanced by combining ULSANIC with analgesics or spasmolytics for patients with severe epigastric pain.
SIDE EFFECTS
Nervous System Disorders
| Frequency | Effects |
|---|---|
| Less frequent | Dizziness, drowsiness |
| Unknown | Vertigo |
Skin Disorders
| Frequency | Effects |
|---|---|
| Less frequent | Rash, itching |
Gastrointestinal Effects
| Frequency | Effects |
|---|---|
| Frequent | Constipation |
| Less frequent | Diarrhoea, nausea, dry mouth, gastric upset |
| Rare | Bezoar (especially with enteral feeds) |
General Disorders
| Frequency | Effects |
|---|---|
| Unknown | Back pain |
If you experience severe side effects, consult your healthcare provider immediately.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
There is no specific antidote. In case of overdose:
- Symptomatic and supportive treatment is recommended
- Seek medical help promptly if an overdose is suspected
IDENTIFICATION
| Form | Appearance Description |
|---|---|
| ULSANIC Tablets | White, oblong, biconvex, “ULSANIC” embossed |
| Effervescent Tablets | Flat, peach-colored with orange speckles |
| Suspension | Thick, off-white liquid with orange odour |
PRESENTATION
| Product Form | Packaging Details |
|---|---|
| Tablets | 20 or 120 in plastic or foil packs |
| Effervescent Tablets | 10 or 20 in sealed tubes inside cartons |
| Suspension | 100 ml, 250 ml, or 600 ml bottles |
Not all pack sizes are available in all markets.
STORAGE INSTRUCTIONS
- Store in a dry place below 25°C
- Protect from light
- Keep in original packaging
- Keep out of reach of children
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Pharmacare Limited
Healthcare Park
Woodlands Drive
Woodmead 2191
South Africa
Final Thoughts
ULSANIC remains a trusted medication in the management of gastric and duodenal ulcers, with a proven record of efficacy and safety when used correctly. This guide, drawn from validated medical sources, aims to empower patients with the knowledge needed to use ULSANIC effectively and responsibly.
Always consult a healthcare professional for personal advice and never start or stop treatment without guidance.
Sources:SAHPRA
Education:
Sochi Medical College 2014 – 2017
Work experience:
2017 – to date Sochi Pharmacy – Pharmacist
