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Casasco S.A.I.C. - Argentina

Danlox Quick
DIFEN B12
DIFEN FLEX Inj.
DIFEN FLEX Tablets
DIFEN GESIC
DIFEN PLUS
UROKIT

Formulation

Danlox Quick is an Oral Suspension Powder.

Each pack contains: omeprazole 20 mg; sodium bicarbonate 1.680,0 mg.

 

Therapeutic Action:

Inhibitor of gastric acid secretion - antiulcerous drug.

 

Indications:

Treatment of active duodenal ulcer, gastric ulcer, symptomatic gastroesophagic reflux, erosive esophagitis diagnosed by endoscopy. Maintenance treatment of healed erosive esophagitis.

 

Pharmacological action:

Omeprazole inhibits gastric acid secretion by inhibition of Hydrogen/ Potassium
ATPase (“Proton Bomb”) of gastric parietal cells. Its action is fast, and a single daily dose produces a reversible
control of gastric acid secretion. It inhibits both baseline acid secretion and stimulated acid secretion.
Omeprazole is rapidly degraded by gastric acid. By administering omeprazole with sodium bicarbonate,
omeprazole is protected against acid degradation until it can be absorbed. Furthermore, the concomitant
administration of omeprazole with sodium bicarbonate may also provide a temporary stimulus to gastrin release
which may stimulate the parietal cell mass and promote omeprazole entry into and inhibition of the H+/K+
ATPase pumps. Sodium bicarbonate may be responsible for the rapid rise in intragastric pH seen after
administration, while prolonged antisecretory effects are due to omeprazole absorption.
 

Pharmacokinetics:

Absorption: Omeprazole is rapidly absorbed when administered on an empty stomach one
hour before meals. If administered together with or after meals, the area under the curve is reduced by 24%. The
maximum plasma concentration is reached after around 30 minutes. Omeprazole is bound to plasma proteins
in 95%. Most of the dose (77%) is eliminated in the urine in the form of six metabolites, two of them being
hydroxyomeprazole and a carboxylic acid. The rest of the dose administered is excreted in the feces. Three
omeprazole metabolites having little antisecretory activity have been identified in plasma. The excretion of
unaltered drug is virtually null. Omeprazole half-life is of about 1 hour. Geriatric Use: Elimination of the drug is
reduced in the elderly population, its bioavailability increasing (from 58% to 76%). Pediatric Use: The pharmacokinetics
of the drug have not been studied in patients under 18 years of age. Hepatic Failure: In these cases,
bioavailability increases to 100% and half-life is 3 hours, thus reflecting the diminished hepatic metabolism

Posology

- Short-term treatment of duodenal ulcer: 20 mg once a day for 4 weeks. Some patients require 4 additional
weeks.
- Treatment of gastric ulcer: 40 mg once a day for 4 to 8 weeks.
- Symptomatic gastroesophagic reflux: 20 mg once a day for 4 weeks.
- Erosive esophagitis: 20 mg a day for 4-8 weeks. Its efficacy after 8 weeks of dosage has not been established.
- Maintenance treatment of healed erosive esophagitis: 20 mg a day. The duration of the carried out controlled
studies was less than 12 months.
 
Administration Mode
Adults
• DANLOX QUICK Oral Suspension Powder should be taken with an empty stomach.
• DANLOX QUICK Oral Suspension Powder is supplied in single-dose packs containing omeprazol 20 mg and
sodium bicarbonate 1.680 mg in an immediate release formulation.
• Pour the pack content in a small vessel with not less than two tablespoons of WATER (20 ml). DO NOT USE
OTHER LIQUIDS OR FOODS.
• Mix well and take immediately.
• Put some water again in the vessel and drink the content.
 
Preparation of a suspension for paediatric use
The total daily dose may be administered in 1 or 2 intakes.
• Place in a vessel 17 ml of water (for calculation it is suggested to use for example a 20 mL-syringe).
• Add the content of a pack and stir well.
• Thus, 20 ml of suspension will be obtained with 1 mg of omeprazol per millilitre.
• Measure (for example with a 20 mL-syringe) the millilitre quantity indicated by the physician, separate and
administer orally (directly or diluted in water, as appropriate).
• The non-used prepared amount of suspension may be stored in refrigerators, during 24 hours. Stir or mix well
the suspension which is stored in the refrigerator before each use.

 

Contraindications

Hypersensitivity to omeprazole or any of the formula components.

Warnings

The favorable evolution of the symptoms with the treatment does not rule out the presence of
stomach cancer, so the lesion should be confirmed to be benign before therapy initiation. In patients under
long-term treatment with omeprazole, there have been occasional cases of gastric atrophy.

Precautions

- Patients with renal disorders: Dose adjustment is not necessary in these patients.
- Patients with liver disorders: An increased plasma half-life of omeprazol is produced in these cases, so it is
possible to require a dosage adaptation.
- Geriatric patients: special precaution due to sodium supplementation.
In pharmacosurveillance studies carried out in geriatric patients who were extended dosed with proton pump
inhibitors, and particularly with high doses, a slight increase of the bone fracture frequency was observed.
Therefore, special control in long-term use of these products is advised.

Drug interactions:

The decreased intragastric acidity may modify the absorption of some drugs. Ketoconazole
decreases its absorption during treatment with omeprazole or other inhibitors of acid secretion, as well as
ampicillin esters and iron salts. As omeprazole is metabolized at hepatic level by the P450 cytochrome, it may
prolong the half-life of diazepam, warfarin, phenytoin, cyclosporine, and disulfiram, so patients who receive
these drugs should be controlled in case they need an eventual reduction of the dose.
Plasma concentrations of omeprazole and clarythromycin are increased when they are supplied concomitantly.
 
Pregnancy and Lactation:
Omeprazole should only be administered to pregnant women if considered essential.
Animal studies up to date have not shown damage caused by omeprazole administered during pregnancy and
lactation, nor evidence of fetal toxicity or teratogenic effects. In human beings, doses up to 80 mg have been
administered for 24 hours to women in labor without adverse reactions in newborns.
 
Pediatric Use:
The safety and efficacy of omeprazole in pediatric patients have not been established.
 
Geriatric Use:
Although no dose adjustment is necessary in the elderly population, the impact of the additional
sodium intake and increased sensitivity should be considered in some cases.

Adverse reactions:

Omeprazole is usually well tolerated and adverse reactions are mild. The following adverse effects have been described:
 
- Skin: Rarely, rash or pruritus; isolated cases of photosensitivity, multiform erythema, and alopecia.
- Musculoskeletal: Arthralgias, myalgias, cramps, and muscle weakness have been rarely described.
- Central and Peripheral Nervous System: Occasionally migraines and dizziness; in isolated cases depression,
agitation, mental confusion, and hallucinations have been described.
- Gastrointestinal System: Constipation, diarrhea, nausea, and/or vomiting, flatulence and abdominal pain. In
isolated cases, dry mouth, stomatitis, and gastrointestinal candidiasis.
- Hepatic: An increase in hepatic enzymes has been very rarely observed. In isolated cases, in patients with
preexisting severe hepatic disease, hepatitis, encephalopathy, and hepatic failure have been observed.
- Endocrine: Gynecomastia in isolated cases.
- Hematological: Leukopenia, thrombocytopenia, agranulocytosis, and pancytopenia have been rarely
described.
- Respiratory System: Epistaxis and pharyngeal pain have been rarely described.
- Cardiovascular System: Chest pain, tachycardia, bradycardia, palpitations, blood hypertension.
- Urogenital: Urinary infection, pollakiuria, microscopic pyuria, testicular pain, proteinuria, hematuria, glucosuria,
serum creatinine increase.
- Metabolic: Hyperglycemia and weight gain.
- Other types of adverse effects: General discomfort, hypersensitivity reactions (urticaria, angioedema, fever,
bronchospasm, interstitial nephritis) and anaphylactic shock), hyperhydrosis, peripheral edema, blurred vision,
dysgeusia, etc.

Overdose:

There may be cases of blurred vision, sweating, dry mouth, headache, reddening, tachycardia,
nausea, confusion, and somnolence. Treatment should be symptomatic and of clinical support. Omeprazole is
not dialyzable since it is highly bound to plasma proteins.
In the event of an overdosage, go to the nearest Hospital.

How supplied:

Packages containing 15 monodoses.

 

Conservation

- Store protected from heat (<30°C) and excessive humidity.
- Keep out of the reach of children.

 

Origin: Argentina

Laboratories: Laboratorios Casasco S.A.I.C.

Distributor: Droguerie Phenicia