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PREVACID FASTAB is a brand name for Lansoprazole, supplied as a tablet (delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PREVACID® (lansoprazole delayed-release capsules) and PREVACID® FasTab (lansoprazole delayed- release tablets) are indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as: ● Duodenal ulcer ● Gastric ulcer ● Reflux esophagitis including patients with Barrett's…
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS). 1 Pediatrics Pediatrics (1 to 17 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of PREVACID in pediatric patients has been established. 3 Pediatrics). PREVACID® is indicated for treatment of erosive and non-erosive GERD in children, aged 1 to 17 years.
The clinical trial treatment period did not extend beyond 12 weeks. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.
4 Geriatrics). PREVACID® (lansoprazole delayed-release capsules) Page 6 of 89 PREVACID® FasTab (lansoprazole delayed-release tablets) 2 CONTRAINDICATIONS • Lansoprazole is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
). The chronic use of PPIs may lead to hypomagnesemia.
Cyanocobalamin (Vitamin B12) Deficiency:
The prolonged use of PPIs may impair the absorption of protein-bound Vitamin B12 and may contribute to the development of cyanocobalamin (Vitamin B12) deficiency. Gastrointestinal When gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with PREVACID® capsules or PREVACID® FasTab tablets are instituted as treatment with these drugs may alleviate symptoms and delay diagnosis.
5 Post-Market Adverse Reactions). Most fundic gland polyps are asymptomatic. Use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Genitourinary In the 24-month toxicology study in rats, after 18 months of treatment, Leydig cell hyperplasia increased above the concurrent and historical control level at dosages of 15 mg/kg/day or higher.
Testicular interstitial cell adenoma also occurred in 1 of 30 rats treated with 50 mg/kg/day (13 times the recommended human dose based on body surface area) in a 1-year toxicity study. These changes are associated with endocrine alterations which have not been, to date, observed in humans.
For further details, see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity.
Hepatic/Biliary/Pancreatic Use in Patients with Hepatic Impairment:
It is recommended that the initial dosing regimen need not be altered for patients with mild or moderate liver disease, but for patients with moderate impairment, doses higher than 30 mg per day should not be administered unless there are compelling clinical indications.
Dose reduction in patients with severe hepatic disease should be considered. Immune Allergic reactions (including anaphylaxis) have been reported in patients receiving clarithromycin orally. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy.
,Hepatic/Biliary/Pancreatic) Patients with Renal Impairment • No dosage modification of PREVACID® or PREVACID® FasTab is necessary (see 7 WARNINGS AND PRECAUTIONS, Renal). 4 Geriatrics). 4 Administration PREVACID® and PREVACID® FasTab should be taken daily before breakfast.
Where the product may be used twice daily, it should be taken prior to breakfast and another meal. PREVACID® capsules and PREVACID® FasTab SHOULD NOT BE CRUSHED, CHEWED, BROKEN OR CUT. For adults and children who have difficulty swallowing capsules, there are the following alternative administration options: PREVACID® (lansoprazole delayed-release capsules) - Oral: PREVACID® capsules can be opened, and the intact granules contained within can be sprinkled on 1 tablespoon of applesauce and swallowed immediately.
The granules should not be chewed or crushed. For patients who have a nasogastric tube (≥16 French) in place, PREVACID® capsules can be opened and the intact granules mixed into 40 mL of apple juice or water and then injected through the nasogastric tube into the stomach.
After administering the granules, the nasogastric tube should be flushed with additional apple juice or water to clear the tube. The granules have also been shown in vitro to remain intact for up to 30 minutes when exposed to apple, cranberry, grape, orange, pineapple, prune, tomato, and V-8® vegetable juice.
PREVACID® FasTab (lansoprazole delayed-release tablets) - Oral:
PREVACID® FasTab tablets are available in 15 mg and 30 mg strengths. PREVACID® FasTab should not be broken, cut or chewed. Place the tablet on the tongue and allow it to disintegrate with or without water until the particles can be swallowed.
The tablet typically disintegrates in less than 1 minute. PREVACID® FasTab tablets are not designed to be swallowed intact or chewed. Do not chew the granules. Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID® FasTab can also be delivered in two different ways.
• Lansoprazole is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• When lansoprazole is used for the eradication of H. pylori infection and active duodenal ulcer disease, the contraindications for amoxicillin and clarithromycin, as found in their corresponding Product Monographs, should be considered.
• Co-administration with rilpivirine is contraindicated. 4 Drug-Drug Interactions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lansoprazole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been well documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin.
Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and the appropriate therapy instituted.
Serious anaphylactic reactions require immediate emergency treatment with epinephrine, oxygen, corticosteroids, and airway management, including intubation, as indicated. PREVACID® (lansoprazole delayed-release capsules) Page 15 of 89 PREVACID® FasTab (lansoprazole delayed-release tablets) Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCARs), including Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) and erythema multiforme have been reported in association with the use of PPIs.
Discontinue lansoprazole at the first signs or symptoms of SCARs or other signs of hypersensitivity and consider further evaluation. At the time of prescription, patients should be informed of the signs and symptoms, and advised to monitor closely for skin reactions.
5 Post-Market Adverse Reactions.
Subacute cutaneous lupus erythematosus:
Subacute cutaneous lupus erythematosus (SCLE) has been reported with the use of PPIs. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PREVACID® or PREVACID® FasTab.
5 Post-Market Adverse Reactions). Monitoring and Laboratory Tests During treatment with antisecretory drugs, Chromogranin A (CgA) increases due to decreased gastric acidity. Increased CgA levels may interfere with investigations for neuroendocrine tumours.
7 Drug-Laboratory Test Interactions).
Musculoskeletal Bone Fracture:
Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines (see 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS).
Ophthalmologic Retinal atrophy:
In animal studies, retinal atrophy was observed in rats dosed orally for 2 years with lansoprazole at doses of 15 mg/kg/day and above. These changes in rats are believed to be associated with the effects of taurine imbalance and phototoxicity in a susceptible animal model.
Clinical data available from long-term PREVACID® capsules studies are not suggestive of any drug- induced eye toxicity in humans. In humans, there are presently no concerns for ocular safety with short-term lansoprazole treatment and the risks associated with long-term use for nearly 5 years appear to be negligible.
The finding of drug-induced retinal atrophy in the albino rat is considered to be species-specific with little relevance for humans. For further details, see 16 NON-CLINICAL […]
PREVACID® FasTab – Oral Syringe:
For administration via oral syringe, PREVACID® FasTab can be administered as follows: • Place a 15 mg tablet in an oral syringe and draw up approximately 4 mL of water, or place a 30 mg tablet in an oral syringe and draw up approximately 10 mL of water.
• Shake gently to allow for a quick dispersal. PREVACID® (lansoprazole delayed-release capsules) Page 10 of 89 PREVACID® FasTab (lansoprazole delayed-release tablets) • After the tablet has dispersed, administer the contents within 15 minutes.
• Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.
PREVACID® FasTab – Nasogastric Tube Administration (≥8 French):
For administration via a nasogastric tube, PREVACID® FasTab can be administered as follows: • Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water. • Shake gently to allow for a quick dispersal.
• After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes. • Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube. 5 Missed Dose If a dose of this medication is missed, patients should be instructed to take it as soon as possible.
However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take two doses at one time to make up for a missed dose.
5 OVERDOSAGE As in all cases where overdosing is suspected, treatment should be supportive and symptomatic. Any unabsorbed material should be removed from the gastrointestinal tract, and the patient should be carefully monitored. Lansoprazole is not removed from the circulation by hemodialysis.
In one reported case of overdose, the patient consumed 600 mg of lansoprazole with no adverse reaction. 7 times the recommended human dose based on body surface area) did not produce deaths or any clinical signs. For management of a suspected drug overdose, contact your regional poison control centre.
PREVACID® (lansoprazole delayed-release capsules) Page 11 of 89 PREVACID® FasTab (lansoprazole delayed-release tablets) 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1. Dosage Forms, Strengths, Composition and Packaging PREVACID® (lansoprazole delayed-release capsules) PREVACID® is supplied in delayed-release capsules for oral administration.
The delayed-release capsules contain the active ingredient, lansoprazole, in the form of enteric-coated granules and are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. PREVACID® 15 mg capsules are supplied as opaque, hard gelatin capsules with a pink cap printed with “PREVACID 15” and a bluish-green body printed with “TAP” logo.
PREVACID® 15 mg capsules are available in bottles of 30 and 100. PREVACID® 30 mg capsules are supplied as opaque, hard gelatin capsules with a pink cap printed with “PREVACID 30” and a black body printed with “TAP” logo. PREVACID® 30 mg capsules are available in bottles of 30 and 100.
PREVACID® FasTab (lansoprazole delayed-release tablets) PREVACID® FasTab contain the active ingredient, lansoprazole in the form of enteric-coated microgranules. The tablets are available in 15 mg and 30 mg dosage strengths. PREVACID® FasTab 15 mg tablets are supplied as white to yellowish white with orange to dark brown speckles, round, flat-faced, bevel-edged, uncoated, orally disintegrating tablets with “15” debossed on one side with a strawberry flavor.
PREVACID® FasTab 15 mg tablets are available in blister packages of 30. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral, […]