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MYLAN-LANSOPRAZOLE FDT 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: MYLAN-LANSOPRAZOLE (lansoprazole delayed-release capsules) and MYLAN-LANSOPRAZOLE FDT (lansoprazole fast-disintegrating, delayed-release tablets) are indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as: • Reflux esophagitis including patients with Barrett's…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Patients should use the lowest dose and shortest duration of proton pump inhibitor (PPI) therapy appropriate to the condition being treated. • Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion.
2 Recommended Dose and Dosage Adjustment Reflux Esophagitis or Poorly Responsive Reflux Esophagitis Including Patients with Barrett’s Esophagus • The recommended adult oral dose is 30 mg once daily before breakfast for 4 to 8 weeks (see 1 INDICATIONS).
Maintenance Treatment of Healed Reflux Esophagitis • For the long-term management of patients with healed reflux esophagitis, 15 mg lansoprazole given once daily before breakfast has been found to be effective in controlled clinical trials of 12 months (see 14 CLINICAL TRIALS).
• The recommended adult oral dose of MYLAN-LANSOPRAZOLE or MYLAN-LANSOPRAZOLE FDT for maintenance treatment of patients with healed reflux esophagitis is 15 mg once daily before breakfast (see 1 INDICATIONS). Treatment and Maintenance of Pathological Hypersecretory Conditions Including Zollinger- Ellison Syndrome • The dosage of MYLAN-LANSOPRAZOLE or MYLAN-LANSOPRAZOLE FDT in patients with pathologic hypersecretory conditions varies with the individual patient.
Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. • The recommended adult oral starting dose is 60 mg once a day. Dosages up to > 180 mg per day have been administered. Daily dosages of greater than 120 mg should be administered in divided doses.
• Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 12 years (see 14 CLINICAL TRIALS, Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome). MYLAN-LANSOPRAZOLE (Lansoprazole Delayed-Release Capsules) MYLAN-LANSOPRAZOLE FDT (Lansoprazole Fast-Disintegrating, Delayed-Release Tablets) Page 6 of 81 Gastroesophageal Reflux Disease (GERD) • Short-Term Treatment of Symptomatic GERD: The recommended adult oral dose for the treatment of heartburn and other symptoms associated with GERD is 15 mg once daily before breakfast for up to 8 weeks.
• If significant symptom relief is not obtained within 4 to 8 weeks, further investigation is recommended. Pediatric GERD (erosive and non-erosive esophagitis) • In clinical studies, lansoprazole was not administered beyond 12 weeks in 6 to 11 year olds.
). 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. 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 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 MYLAN-LANSOPRAZOLE (Lansoprazole Delayed-Release Capsules) MYLAN-LANSOPRAZOLE FDT (Lansoprazole Fast-Disintegrating, Delayed-Release Tablets) Page 13 of 81 (AGEP) and erythema multiforme have been reported in association with the use of PPIs.
, Hepatic/Biliary/Pancreatic). Patients with Renal Impairment • No dosage modification of MYLAN-LANSOPRAZOLE or MYLAN-LANSOPRAZOLE FDT is necessary (see 7 WARNINGS AND PRECAUTIONS, Renal). 4 Geriatrics). 4 Administration MYLAN-LANSOPRAZOLE and MYLAN-LANSOPRAZOLE FDT should be taken daily before breakfast.
Where the product may be used twice daily, it should be taken prior to breakfast and another meal. MYLAN-LANSOPRAZOLE capsules and MYLAN-LANSOPRAZOLE FDT SHOULD NOT BE CRUSHED, CHEWED, BROKEN OR CUT. MYLAN-LANSOPRAZOLE capsules should be swallowed whole with sufficient water before meal.
MYLAN-LANSOPRAZOLE (Lansoprazole Delayed-Release Capsules) MYLAN-LANSOPRAZOLE FDT (Lansoprazole Fast-Disintegrating, Delayed-Release Tablets) Page 7 of 81 MYLAN-LANSOPRAZOLE FDT Tablets - Oral: MYLAN-LANSOPRAZOLE FDT tablets are available in 15 mg and 30 mg strengths.
MYLAN- LANSOPRAZOLE FDT 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.
MYLAN-LANSOPRAZOLE FDT 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, MYLAN- LANSOPRAZOLE FDT can also be delivered in two different ways.
MYLAN-LANSOPRAZOLE FDT — Oral Syringe:
For administration via oral syringe, MYLAN-LANSOPRAZOLE FDT 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. • 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.
• 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.
• Co-administration with rilpivirine is contraindicated. 4 Drug-Drug Interactions. MYLAN-LANSOPRAZOLE (Lansoprazole Delayed-Release Capsules) MYLAN-LANSOPRAZOLE FDT (Lansoprazole Fast-Disintegrating, Delayed-Release Tablets) Page 5 of 81
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.
It is not known if lansoprazole is safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in children as outlined below. • Children (6 to 11 years): The recommended pediatric oral dose is 15 mg (≤ 30 kg) and 30 mg (>30 kg) once daily for up to 12 weeks.
• Children (12 to 17 years): The same approved regimen for adults can be used. Patients with Hepatic Impairment • The daily dose of MYLAN-LANSOPRAZOLE or MYLAN-LANSOPRAZOLE FDT should not exceed 30 mg (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Patients with Renal Impairment • No dosage modification of MYLAN-LANSOPRAZOLE or MYLAN-LANSOPRAZOLE FDT is necessary (see 7 WARNINGS AND PRECAUTIONS, Renal). 4 Geriatrics). 4 Administration MYLAN-LANSOPRAZOLE and MYLAN-LANSOPRAZOLE FDT should be taken daily before breakfast.
Where the product may be used twice daily, it should be taken prior to breakfast and another meal. MYLAN-LANSOPRAZOLE capsules and MYLAN-LANSOPRAZOLE FDT SHOULD NOT BE CRUSHED, CHEWED, BROKEN OR CUT. MYLAN-LANSOPRAZOLE capsules should be swallowed whole with sufficient water before meal.
MYLAN-LANSOPRAZOLE (Lansoprazole Delayed-Release Capsules) MYLAN-LANSOPRAZOLE FDT (Lansoprazole Fast-Disintegrating, Delayed-Release Tablets) Page 7 of 81 MYLAN-LANSOPRAZOLE FDT Tablets - Oral: MYLAN-LANSOPRAZOLE FDT tablets are available in 15 mg and 30 mg strengths.
MYLAN- LANSOPRAZOLE FDT 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.
MYLAN-LANSOPRAZOLE FDT 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, MYLAN- LANSOPRAZOLE FDT can also be delivered in two different ways.
MYLAN-LANSOPRAZOLE FDT — Oral Syringe:
For administration via oral syringe, MYLAN-LANSOPRAZOLE FDT 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. • 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.
MYLAN-LANSOPRAZOLE FDT — Nasogastric Tube Administration ( ≥ 10 French):
For administration via a nasogastric tube, MYLAN-LANSOPRAZOLE FDT can be administered as follows: • Place a 15 mg tablet in a syringe and draw up 5 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 […]
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 MYLAN-LANSOPRAZOLE or MYLAN-LANSOPRAZOLE FDT.
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 lansoprazole delayed-release 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.
MYLAN-LANSOPRAZOLE (Lansoprazole Delayed-Release Capsules) MYLAN-LANSOPRAZOLE FDT (Lansoprazole Fast-Disintegrating, Delayed-Release Tablets) Page 14 of 81 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 TOXICOLOGY. Renal No dosage adjustment of MYLAN-LANSOPRAZOLE or MYLAN-LANSOPRAZOLE FDT is necessary in patients with renal impairment. 2 Recommended Dose and Dosage Adjustment and 10 CLINICAL PHARMACOLOGY.
Skin See 7 WARNINGS AND PRECAUTIONS - Immune Use in Women Over 4000 women were treated with lansoprazole delayed-release capsules. The incidence rates of adverse events are also similar to those seen in males. 1 Pregnant Women Reproductive studies conducted in pregnant rats at oral doses up to 150 mg/kg/day (40 times the recommended human dose based on body surface area), and in rabbits at oral doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area), revealed no lansoprazole-related impairment of fertility, fetal malformations or developmental toxicity to fetuses or suckling neonates.
Lansoprazole is not considered to be teratogenic. Maternal toxicity and a significant increase in fetal mortality were observed in the rabbit study at doses […]
MYLAN-LANSOPRAZOLE FDT — Nasogastric Tube Administration ( ≥ 10 French):
For administration via a nasogastric tube, MYLAN-LANSOPRAZOLE FDT can be administered as follows: • Place a 15 mg tablet in a syringe and draw up 5 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.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1. Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsule (delayed- release) 15 mg and 30 mg Corn starch, D&C red #28, FD&C blue #1, FD&C red #40, FD&C yellow #6 (15 mg capsules only), gelatin, hydroxypropyl cellulose, iron oxide black (30 mg capsules only), magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, silicon dioxide, sucrose, sugar spheres, talc, titanium dioxide, white imprinting ink (butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide).
Oral, nasogastric Tablet (fast- disintegrating, delayed- release) 15 mg and 30 mg Aspartame*, citric acid monohydrate, crospovidone, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, magnesium carbonate, magnesium stearate, mannitol, MYLAN-LANSOPRAZOLE (Lansoprazole Delayed-Release Capsules) MYLAN-LANSOPRAZOLE FDT (Lansoprazole Fast-Disintegrating, Delayed-Release Tablets) Page 9 of 81 methacrylic acid-ethylacrylate copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium bicarbonate, sodium hydroxide, sodium lauryl sulphate, sodium starch glycolate, strawberry flavour, sugar spheres, talc, triethyl citrate.
74 mg per 30 mg tablet) MYLAN-LANSOPRAZOLE MYLAN-LANSOPRAZOLE (lansoprazole delayed-release capsules) 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.
MYLAN-LANSOPRAZOLE (lansoprazole delayed-release capsules) is available as follows: 15 mg: Pink and green capsule filled with white to off white pellets, imprinted axially with 'MYLAN' over 'LR 15' on both cap and body in white ink.
The capsules are available in bottles of 30’s and 100’s. 30 mg: Pink and black capsules filled with white to off white […]