Lansoprazole

Main information

  • Trade name:
  • Lansoprazole ODT GH lansoprazole 30mg blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Lansoprazole ODT GH lansoprazole 30mg blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216792
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216792

Lansoprazole ODT GH lansoprazole 30mg blister pack

ARTG entry for

Medicine Registered

Sponsor

Lupin Australia Pty Limited

Postal Address

Generic Health Pty Ltd,Level 1 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

19/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Lansoprazole ODT GH lansoprazole 30mg blister pack

Product Type

Single Medicine Product

Effective date

2/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Adults:,1.Healing and long-term management of reflux oesophagitis.,2.Healing and long-term management for patients with duodenal ulcer.,3.Healing of

benign gastric ulcer. Patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment

with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,4.Lansoprazole is also effective in patients with

benign peptic lesions that do not respond to H2-receptor antagonists.,5.Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic

ulcer or chronic gastritis when used in combination with appropriate antibiotics (see Clinical Trials).,6.Relief of reflux-like and/or ulcer-like symptoms

associated with acid-related dyspepsia.,Paediatric patients 6 to 17 years of age.,1.Treatment of gastro-oesophageal reflux disease, including all grades

of oesophagitis.,2.Healing of erosive oesophagitis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

Alu/Alu blister (with push through Al foil) 7's and 28's

(S4) Prescription Only Medicine

Cold form dessicant blister (with Peelable Al foil) 7's and 28's

(S4) Prescription Only Medicine

Alu/Alu blister (with Peelable Al foil) 7's and 28's

(S4) Prescription Only Medicine

Cold form dessicant blister (with push through Al foil) 7's and 28's

(S4) Prescription Only Medicine

Components

1. Lansoprazole ODT GH lansoprazole 30mg blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

White to yellowish white uncoated tablets,speckled with orange to dark

brown pellets debossed with '30' on one side and plain on the other side.

Active Ingredients

Lansoprazole

30 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:13:11 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Summary of Product characteristics

Lansoprazole ODT GH PI V2

Page 1 of 12

18 January 2016

PRODUCT INFORMATION

Lansoprazole ODT

GH

NAME OF THE MEDICINE

Non-proprietary name:

lansoprazole

The structural formula of lansoprazole is shown below:

CAS Registry Number: CAS No. 103577-45-3

Chemical name: 2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulphinyl]-1H-benzimidazole

Molecular formula: C

Molecular weight: MW 369.4

DESCRIPTION

Lansoprazole is a substituted benzimidazole. It is a white or brownish powder, Freely soluble in

dimethylformamide soluble in methanol, very slightly soluble in acetonitrile and practically insoluble

in water. Lansoprazole is a racemic mixture of R and S enantiomers. Lansoprazole has a pKa of 4.29

and 8.8.

Each Lansoprazole ODT GH contains 15 mg or 30 mg of lansoprazole and the following inactive

ingredients:

Enteric

coated

pellets:

Cellulose-microcrystalline,

magnesium

carbonate-light,

low-substituted

hydroxypropyl

cellulose,

hydroxypropyl

cellulose,

hypromellose,

titanium

dioxide,

talc-purified,

mannitol,

methacrylic

acid-ethyl

acrylate

copolymer

dispersion

(1:1)

cent,

polyacrylate

dispersion 30 per cent, macrogol 6000, citric acid-anhydrous, glyceryl monostearate, polysorbate 80,

triethyl citrate, Ferric Oxide yellow (E172) and Ferric oxide red (E172).

Other

excipients:

F-Melt

Type

(ARTG

106551)

Crospovidone,

Cellulose-microcrystalline,

magnesium stearate, strawberry flavor (ARTG no.

105990)

and aspartame.

PHARMACOLOGY

Actions

Lansoprazole reduces gastric acid secretions by inhibiting the H+/K+-ATPase (proton pump) of the

parietal cells in the gastric mucosa, the terminal phase of acid secretion. The drug is effective in the

treatment of acid-related disorders of the upper gastrointestinal tract.

Lansoprazole ODT GH PI V2

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18 January 2016

A single dose of 30 mg lansoprazole inhibits stimulated acid secretion by approximately 80%. Basal

acid secretion and basal and stimulated secretion volumes are affected to a lesser degree.

After repeated dosing (for 7 days) 90% inhibition of stimulated acid secretion is achieved. Despite its

short elimination half-life, lansoprazole has a prolonged pharmacological action, providing effective

suppression of gastric acid secretion over 24 hours.

When used in combination with the recommended antibiotics, lansoprazole is associated with H.

pylori eradication rates of up to 90%.

Pharmacokinetics

Adults

Lansoprazole is well absorbed and exhibits high bioavailability (80-90%) following an oral dose. The

bioavailability has been shown to be affected by the presence of food; however, acid inhibition (which

is an endpoint for efficacy), as measured from sampling of gastric juice in healthy volunteers, is not

significantly affected by food. It was shown in one study that a.m. dosing produced higher mean

gastric pH values than p.m. dosing.

Plasma protein binding is high (98%) and is gender and concentration independent. Binding does not

change as a result of multiple dosing. The plasma elimination half-life in healthy subjects ranges from

1 to 2 hours following a single dose or multiple doses. Peak plasma levels occur within 1.5 to 2.0 hours

after dosing in these subjects.

After IV administration, the volume of distribution is 29 ± 4 L, total clearance is 31 ± 8 L/h and

elimination half-life is 0.9 ± 0.44 h.

Following absorption, lansoprazole is extensively metabolised and the metabolites are excreted by

both the renal and biliary route. A study with

C-labelled lansoprazole showed that up to 50% of the

label was excreted in the urine, although unchanged drug does not appear to be excreted by this

route; unchanged drug is eliminated, however, by biliary excretion.

Paediatric patients 1 to 11 years of age

The pharmacokinetics of lansoprazole were studied in paediatric patients with gastro-oesophageal

reflux disease (GORD) aged 1 to 11 years, with lansoprazole capsule doses of 15 mg once daily for

subjects

weighing

<30

once

daily

subjects

weighing

>30

Lansoprazole

pharmacokinetics in these paediatric patients were similar to those previously observed in healthy

adult subjects. The mean C

and AUC values were similar between the two dose groups and were

not affected by weight or age within each weight-adjusted dose group used in this study.

Paediatric patients 12 to 17 years of age

In a study of paediatric patients aged 12 to 17 years with GORD, the pharmacokinetics of lansoprazole

were shown to be similar to those previously observed in healthy adult subjects. No statistically

significant

differences

were

observed

between

doses

natural

logarithms

dose-normalised C

and AUC

0-24

None of the selected covariates (body weight, age and gender) had

any statistically significant effect on lansoprazole T

or the natural logarithms of dose normalised C

and AUC

0-24

CLINICAL TRIALS

Helicobacter Pylori

In clinical trials, the recommended dosage regimens were associated with H. Pylori eradication rates

of up to 90%. The best eradication rates were obtained with regimens which included clarithromycin.

Lansoprazole ODT GH PI V2

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18 January 2016

Trials which used lansoprazole in combination with only one antibiotic resulted in significantly lower

eradication rates. Therefore, such regimens are not recommended.

Reflux oesophagitis

Paediatrics

In an open-label, U.S. multicentre study, 66 children, 1 to 11 years of age, with GORD were assigned

to receive an initial dose of either lansoprazole 15 mg capsules once daily, if the body weight was <30

kg, or lansoprazole 30 mg capsules once daily, if the body weight was >30 kg, administered for 8 to 12

weeks. The lansoprazole dose was increased up to 60 mg daily in some children after 2 weeks of

treatment.

Erosive and Non Erosive GORD

Final Visit

a

% (n/N)

Erosive GORD healing rate

100% (27/27)

Improvement in overall GORD symptoms

76% (47/62

At week 8 or 12.

No data were available for 4 children.

Treatment with lansoprazole also demonstrated significant reduction in frequency and severity of

GORD symptoms (p<0.001).

In a double blind, U.S. multicentre study, 63 patients 12 to 17 years of age with proven GORD were

randomised to receive either lansoprazole 15 mg once daily or 30 mg once daily for five days. Subjects

in both groups demonstrated improvement in symptoms of reflux disease. A reduction in heartburn

severity was shown to be statistically significant for patients treated with either 15 mg or 30 mg

lansoprazole.

majority

patients

(69%

lansoprazole

once

daily

lansoprazole 30 mg once daily) reported that their reflux symptoms were better after treatment.

Adults

In two double-blind, placebo controlled multicentre studies (of 336 patients) examining the efficacy of

lansoprazole 15 mg and 30 mg tablets in maintaining healed erosive reflux oesophagitis, lansoprazole

was significantly superior to placebo in maintaining endoscopic and symptomatic freedom from

disease. The time to median recurrence of either symptoms or endoscopic evidence of disease was

less than 1 month for the placebo and greater than 12 months for 15 mg and 30 mg lansoprazole

(p<0.001). There was a slight trend for a better outcome with 30 mg lansoprazole, although this was

not statistically significant.

A study in 266 patients, comparing lansoprazole 15 mg and 30 mg daily with ranitidine 300 mg twice

daily, found both lansoprazole 15 mg and 30 mg increased the time to relapse and probability of no

relapse in comparison to ranitidine. The percentage of patients who relapsed endoscopically during

the 12-month maintenance period was 31% in the lansoprazole 15 mg group, 20% in the lansoprazole

30 mg group and 68% in the ranitidine group. The difference between the lansoprazole groups and

the ranitidine was apparent from the earliest time point in the study and maintained throughout the

12-month period. Comparison of treatment groups with regard to symptom control showed similar

superiority of lansoprazole over ranitidine (p <0.001 for each comparison).

A study in 882 patients comparing lansoprazole 15 mg and 30 mg daily with omeprazole 20 mg daily

showed endoscopic remission rates (after 12 months) of 75% with lansoprazole 15 mg daily, 88 %

with lansoprazole 30 mg daily and 89% with omeprazole 20 mg daily. The results demonstrate that

lansoprazole 30 mg daily achieved significantly better remission rates compared to lansoprazole 15

mg daily and is of equal efficacy to omeprazole 20 mg daily.

Lansoprazole ODT GH PI V2

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18 January 2016

The results of the 4 pivotal studies examining the use of lansoprazole in the long-term management of

reflux oesophagitis are tabulated below.

Endoscopically Proven Relapse Rates at 12 Months

Lansoprazole

Lansoprazole

Ranitidine

Omeprazole

Placebo

Study

15 mg once

30 mg once

300 mg twice

20 mg once

daily

daily

daily

daily

1 (n=163)

92%*

2(n=184)

3 (n=569)

68%*

4(n=882)

25%#

- not included in the study; * (p≤0.001) versus lansoprazole 15 mg and 30 mg; # (p≤0.001) versus omeprazole 20

mg and lansoprazole 30 mg

Duodenal ulcer

In a study comparing lansoprazole 15 mg daily with placebo in 180 patients with endoscopically

documented duodenal ulcer, the percentage of patients who remained healed after twelve months

was significantly higher with lansoprazole than with placebo. Lansoprazole 15 mg was significantly

superior to placebo in preventing endoscopic and symptomatic relapses of disease.

Duodenal Ulcer Recurrence Rates

Interval(Months)

Treatment

0-1

1-2

2-3

3-6

6-9

9-12

Placebo

20%

36%

52%

60%

60%

62%

Lansoprazole 15 mg

2%*

8%*

10%*

14%*

15%*

17%*

*(p≤0.001) versus placebo

The maintenance studies discussed, using lansoprazole 15 mg and 30 mg, did not extend beyond 12

months

Acid-related dyspepsia

The efficacy of lansoprazole 15-30 mg daily has been examined in a total of 531 patients, compared

with ranitidine (n=171), omeprazole (n=281) and placebo (n=138).

The efficacy of lansoprazole (30 mg mane) was compared to ranitidine (150 mg bd) for the treatment

of acid-related dyspepsia in a double-blind, parallel, 4-week study. The results are presented in the

following table.

Lansoprazole ODT GH PI V2

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18 January 2016

Number of Patients with No Symptoms

Lansoprazole

Week2

Ranitidine

P value

Lansoprazole

Week4

Ranitidine

P value

No symptoms

95/171

56/171

0.001

95/137

63/145

0.001

(55%)

(33%)

(69%)

(44%)

No DT.H

91/138

68/139

0.006

89/111

66/120

0.001

(66%)

(49%)

(80%)

(55%)

No NT.H

89/128

64/124

0.005

86/103

68/106

0.003

(69%)

(52%)

(83%)

(64%)

No DT.EP

78/127

62/140

0.007

72/100

71/120

0.06

(61%)

(45%)

(72%)

(60%)

No NT.EP

79/115

59/120

0.004

74/91

67/104

0.01

(68%)

(50%)

(81%)

(65%)

DT = Daytime

H = Heartburn

NT = Night-time

EP = Epigastric Pain

There was also a significant difference in the usage of "rescue" antacid treatment in the two groups,

with 67% of the lansoprazole group taking antacids in the first two weeks of treatment compared with

83% of the ranitidine group (p=0.001).

In patients with symptoms of ulcer-like and reflux-like dyspepsia, lansoprazole 15 mg mane was

compared to omeprazole 10 mg mane for a 4-week period in a double-blind, parallel study. In the

primary efficacy analyses in the intent to treat population, the study revealed that more patients

were free of overall primary symptoms of dyspepsia in the lansoprazole-treated group compared to

the omeprazole-treated group (p=0.007 and 0.078 respectively).

Non-ulcer dyspepsia

A randomised, double-blind parallel study 15 mg lansoprazole mane was compared to placebo in 269

patients suffering from non-ulcer dyspepsia. In the intent-to-treat population the healing rate was

81/131 (61.8%) in the lansoprazole group after 2-3 weeks treatment, compared to 61/138 (44.2%) in

the placebo group (p=0.005). In the 3-month follow-up period, the recurrence of non-ulcer dyspepsia

symptoms was reported by 32/86 (37.2%) patients in the lansoprazole group and by 29/79 (36.7%) in

Lansoprazole

Omeprazole

Overall Primary Symptoms

2 weeks

150 (53%)

115 (41%)

0.007

4 weeks

167 (59%)

143 (51%)

0.078

Relief of Daytime Heartburn

2 weeks

164 (70%)

131 (58%)

0.011

4 weeks

163 (70%)

145 (64%)

0.28

Relief of Night-time Heartburn

2 weeks

140 (69%)

132 (63%)

0.23

4 weeks

146 (72%)

144 (68%)

0.53

Relief of Daytime Epigastric Pain

2 weeks

129 (63%)

88 (46%)

0.001

4 weeks

137 (67%)

114 (60%)

0.17

Relief of Night-time Epigastric

2 weeks

108 (61%)

91 (52%)

0.11

Pain

4 weeks

113 (64%)

104 (60%)

0.46

% of Patients with No Symptoms (heartburn and epigastric pain): ITT Analysis

Treatment

Symptom Free Patients n (%)

P value

Lansoprazole ODT GH PI V2

Page 6 of 12

18 January 2016

the placebo group (p=1.0). Healing was defined as the percentage of patients with no heartburn or

acid regurgitation, as well as no nausea and vomiting and a reduction in the Visual Analogue Scale

value of ≤ 20% during the last 5 days of treatment.

INDICATIONS

Adults

Healing and long-term management of reflux oesophagitis.

Healing and long-term management for patients with duodenal ulcer.

Healing of benign gastric ulcer. Patients whose gastric or duodenal ulcer is not associated with

ingestion

non-steroidal

anti-inflammatory

drugs

require

treatment

with

antimicrobial

agents in addition to antisecretory drugs whether on first presentation or on recurrence.

Lansoprazole is also effective in patients with benign peptic lesions that do not respond to

-receptor antagonists.

Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or

chronic gastritis when used in combination with appropriate antibiotics (see Clinical Trials).

Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia.

Paediatric patients 6 to 17 years of age.

Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis.

Healing of erosive oesophagitis.

CONTRAINDICATIONS

Hypersensitivity to lansoprazole, other proton pump inhibitors or any of the excipients in the tablets.

Severe hepatic impairment.

Lansoprazole

should

co-administered

with

atazanavir

significant

reduction

atazanavir exposure.

PRECAUTIONS

As with other anti-ulcer therapies, the possibilities of malignancy should be excluded when a gastric

ulcer is suspected, since treatment with lansoprazole may alleviate the symptoms of a malignancy and

possibly delay its diagnosis.

Similarly, the possibility of serious underlying disease such as malignancy should be excluded before

treatment for dyspepsia commences, particularly in patients of middle age or older who have new or

recently changed dyspeptic symptoms.

The pellets in Lansopazole ODT GH are enteric coated. Therefore, the tablets should be sucked slowly

and should not be crushed or chewed.

Use with caution in the following circumstances

Agents that elevate gastric pH may increase the already-present risk of nosocomial pneumonia in

intubated ICU patients receiving mechanical ventilation.

When using lansoprazole with antibiotics to eradicate H. pylori, it is recommended that prescribers

refer to the approved product information for the antibiotics selected.

Lansoprazole ODT GH PI V2

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18 January 2016

Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts

of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may

lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

Proton pump inhibitor therapy may be associated with an increased risk of Clostridium difficile

infection.

Enterochromaffin-like (ECL) cell effects

Safety concerns of long-term treatment relate to hypergastrinaemia and possible ECL effects. ECL cell

hyperplasia and gastric carcinoid tumour were observed in animal studies.

Human

gastric

biopsy

specimens

from

patients

treated

with

proton

pump

inhibitors

have

detected ECL cell effects similar to those seen in rats. Gastric biopsies taken in all the long-term

maintenance studies have revealed:

a slight increase in mean endocrine cell count during 12 months maintenance treatment with

lansoprazole 15 or 30 mg, observed in 3 of 4 studies. Cell density averages were slightly higher

under 30 mg lansoprazole than under 15 mg lansoprazole once daily. These observations were

reversible approximately 3 months after maintenance therapy stopped in two of the studies.

single cases of changes from normal to simple hyperplasia which persisted in one patient 3

months after discontinuation of treatment.

for antral biopsies a greater mean gastrin-positive cell density and mean serotonin-positive cell

density was found for lansoprazole 30 mg compared to lansoprazole 15 mg once daily.

no evidence of carcinoid tumours or visible endocrine cell proliferation was seen in any patient

for either fundus or antral biopsies.

(There are currently biopsy data on over 400 patients treated between 9 months and one year and

over 230 patients treated for more than one year.)

Retinal atrophy

animal

studies,

retinal

atrophy

observed

Sprague

Dawley

rats

dosed

orally

with

lansoprazole. Retinal atrophy has not been found in mice, dogs, monkeys or humans. Mechanistic

studies have indicated that the effect is specific to species dependent on hepatic synthesis of the

amino

acid

taurine,

which

protective

effect

retina.

Lansoprazole

inhibits

hepatic

synthesis of taurine; however, humans obtain their taurine requirements from the diet.

Impaired hepatic and renal function

Lansoprazole is metabolised substantially by the liver. The results of clinical trials in adult patients

with liver disease indicate that the metabolism of lansoprazole is prolonged in patients with severe

hepatic impairment. There is no need to alter the dosage in adult patients with impaired renal

function.

There is insufficient experience to recommend the use of lansoprazole in paediatric patients with

hepatic or renal impairment.

Hypomagnesaemia

Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated

with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events

include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesaemia required

magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as

digoxin or drugs that may cause hypomagnesaemia (e.g. diuretics), health care professionals may

Lansoprazole ODT GH PI V2

Page 8 of 12

18 January 2016

consider monitoring magnesium levels prior to initiation of PPI treatment and periodically during PPI

treatment.

Carcinogenicity

In a 2-year carcinogenicity study in rats, oral doses of 5, 15 or 50 mg/kg/day, 5 days per week

produced gastric ECL cell hyperplasia and carcinoid tumours in a dose-related manner in both male

and female rats. The incidence of these effects was markedly higher in female rats. A "no effect" dose

was not established for female rats. An increased incidence of benign Leydig cell tumours and

testicular

hyperplasia

also

reported

dose

levels

mg/kg/day.

repeat

2-year

carcinogenicity studies in rats using doses ranging from 5-150 mg/kg/day, 7 days per week confirmed

these findings.

In mice, a 78-week carcinogenicity study was performed at doses of 1.5, 5, 15 and 50 mg/kg/day, 5

days per week. No gastric ECL cell carcinoids were seen. In a repeat carcinogenicity study, mice were

dosed

with

mg/kg/day,

days

week.

Terminal

studies

showed ECL

cell

hyperplasia, mucosal hyperplasia/hypertrophy and glandular dilatation and vacuolation at all dosages.

Carcinoids were found in occasional animals receiving 15, 150 or 300 mg/kg/day.

Hypergastrinaemia

secondary

prolonged

hypochlorhydria

been

postulated

mechanism by which ECL cell hyperplasia and gastric carcinoid tumours develop.

Genotoxicity

Negative results were obtained in gene mutation assays and in an in vivo assay of chromosomal

damage. In vitro assays of chromosomal damage showed evidence of chromosomal aberrations,

though this may reflect cytotoxicity rather than genotoxic activity.

Effect on fertility

The effects of lansoprazole on human male fertility have not been evaluated.

Use in pregnancy: Category B3

Reproductive studies

conducted

pregnant

rats and

rabbits

oral

doses

to 300

mg/kg/day, respectively, did not disclose any evidence of a teratogenic effect. A significant increase in

foetal mortality was observed in the rabbit study at doses above 10 mg/kg/day. In rats a slight

reduction in litter survival and weights was noted at doses above 100 mg/kg/day.

Use in lactation

Animal studies indicate that lansoprazole is secreted into breast milk. There is no information on the

secretion of lansoprazole into breast milk in humans. The use of lansoprazole during breast feeding

should be avoided.

Use in the elderly

Dosage adjustment is not required in the elderly.

INTERACTIONS WITH OTHER MEDICINES

Lansoprazole is metabolised in the liver and is a weak inducer of cytochrome P450. Therefore, there is

possibility

interaction

with

other

drugs

metabolised

this

system,

e.g.

theophylline,

phenytoin,

carbamazepine

warfarin.

Patients

receiving

such

drugs

concomitantly

with

lansoprazole should be monitored to determine if any dosage adjustment is necessary.

There have been isolated cases of a suspected drug interaction with warfarin, but a definitive

relationship to lansoprazole therapy has not been established.

Lansoprazole ODT GH PI V2

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18 January 2016

No clinically significant effects on plasma levels of non-steroidal anti-inflammatory drugs, phenytoin

(single IV doses only) and diazepam have been found.

Concomitant administration of lansoprazole and tacrolimus may increase whole blood levels of

tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

The possibility of interaction between lansoprazole and low-dose oral contraceptives cannot be

excluded.

Coadministration

lansoprazole

with

sucralfate

delayed

absorption

reduced

lansoprazole

bioavailability

approximately

30%.

Similarly,

antacids

also

reduce

bioavailability

lansoprazole. Therefore, lansoprazole should be taken at least an hour prior to sucralfate or antacid

administration.

Lansoprazole

causes

profound

long-lasting

inhibition

gastric acid secretion;

therefore,

lansoprazole may interfere with the absorption of drugs where gastric pH is an important determinant

of bioavailability (e.g. ketoconazole, ampicillin esters, iron salts, digoxin).

Lansoprazole and other PPIs are likely to substantially decrease the systemic concentrations of the

protease

inhibitor

atazanavir,

which

dependent

upon

presence

gastric

acid

absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV

resistance. Therefore, lansoprazole and other PPIs should not be co-administered with atazanavir.

ADVERSE EFFECTS

Lansoprazole is well-tolerated, with adverse events generally being mild and transient. The most

commonly reported adverse events are headache, dizziness, fatigue and malaise.

Gastrointestinal effects include diarrhoea, constipation, abdominal pain, dyspepsia, nausea, vomiting,

flatulence and dry or sore mouth or throat.

Rarely,

cases

colitis

(macroscopic

microscopic)

have

been

reported.

severe

and/or

protracted cases of diarrhoea, discontinuation of therapy should be considered. In the majority of

cases symptoms resolve on discontinuation of therapy.

As with any broad-spectrum antibiotic treatment, the risk of pseudomembranous colitis should be

considered in patients using triple therapy for the eradication of H. pylori.

Alterations in liver function test values and, rarely, jaundice or hepatitis, have been reported.

However, routine monitoring of liver function tests is not required.

Dermatological reactions include skin rashes, urticaria and pruritus. These generally resolve on

discontinuation of drug therapy. Serious dermatological reactions are rare but there have been

occasional reports of Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythematous or

bullous rashes including erythema multiforme. Cases of hair thinning and photosensitivity have also

been reported.

Other hypersensitivity reactions include angioedema, wheezing, and very rarely, anaphylaxis. Cases of

interstitial nephritis have been reported which have sometimes resulted in renal failure.

Haematological effects (thrombocytopenia, agranulocytosis, eosinophilia, leucopoenia, neutropenia

and pancytopenia) have occurred rarely. Bruising, purpura and petechiae have also been reported.

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Other reactions include arthralgia, myalgia, depression, peripheral oedema, upper respiratory tract

infections, urinary tract infections and, rarely, paraesthesia, blurred vision, taste disturbances, vertigo,

confusion and hallucinations.

There have been isolated reports of interstitial pneumonia and hyponatraemia, but a definitive

relationship to lansoprazole therapy has not been established.

Gynaecomastia and impotence have been reported rarely. Hypomagnesaemia has been reported

rarely.

DOSAGE AND ADMINISTRATION

For oral administration.

Lansoprazole ODT GH is strawberry flavoured and should be placed on the tongue and gently sucked.

The tablet rapidly disperses in the mouth, releasing the enteric-coated pellets, which are swallowed

with the patient's saliva. Alternatively, the tablet can be swallowed whole with a drink of water. The

tablets must not be chewed.

The tablets should not be crushed or chewed (see PRECAUTIONS). To achieve the optimal acid

inhibitory effect, and hence most rapid healing and symptom relief, Lansoprazole ODT GH 'once daily'

should be administered in the morning before food.

Adults

Reflux oesophagitis: 30 mg lansoprazole once daily for 4 weeks. The majority of patients will be

healed after the first course. For patients who have not fully healed within this time, a further 4 weeks

treatment using the same dosage regimen is indicated. For long-term management, a maintenance

dose of 15 mg or 30 mg once daily can be used dependent upon patient response.

Duodenal ulcer: 30 mg lansoprazole once daily for 4 weeks. For the prevention of relapse, the

recommended maintenance dose is 15 mg once daily.

Gastric ulcer: 30 mg lansoprazole once daily for 8 weeks.

Acid-related dyspepsia: Lansoprazole 15 mg or 30 mg once daily for 2-4 weeks, depending on the

severity and persistence of symptoms. Patients who do not respond after 4 weeks, or who relapse

shortly afterwards, should be investigated.

Eradication of H. pylori: The following combinations have been shown to be effective when used for 7

days:

• Lansoprazole 30 mg twice daily plus two of the following antibiotics:

amoxycillin 1g twice daily,

metronidazole 400 mg twice daily and clarithromycin 250 mg twice daily.

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Paediatrics

Short-term treatment (8-12 weeks). In patients aged 6-17 years with gastro-oesophageal reflux

disease, including all grades of oesophagitis, the recommended initial dosage is:

Body weight

Recommended Dose

≤30 kg

15 mg lansoprazole once daily

>30 kg

30 mg lansoprazole once daily

After 2 weeks, an increase in dose up to 60 mg lansoprazole daily may be beneficial for patients who

are not responding satisfactorily.

For patients requiring an oral suspension, an alternative brand must be sought.

OVERDOSAGE

There is no information on the effect of acute overdosage. In a case of overdose, supportive and

symptomatic therapy should be initiated. Doses of up to 180 mg/day for more than a year have been

used to treat Zollinger Ellison syndrome with no serious adverse effects.

For advice on the management of an overdose, contact the Poisons Information Centre on

131126 (Australia).

PRESENTATION AND STORAGE CONDITIONS

Lansoprazole ODT GH 15 mg and 30 mg.

White to yellowish white uncoated tablets speckled with orange to dark brown pellets, with "I5" or

"30" debossed on one side of the tablet and plain on the other side.

Lansoprazole ODT GH are available in cartons with following blister types:

Alu-Alu blister pack of 7 or 28 tablets*

Alu-Alu blister with Peelable Lidding foil pack of 7 or 28 tablets*

Cold form desiccant blister pack of 7 or 28 tablets*

Cold form desiccant blister with Peelable Lidding foil of 7 or 28 tablets*

*Not all pack sizes may be marketed

Lansoprazole ODT GH should be stored below 25

NAME AND ADDRESS OF THE SPONSOR

Lupin Australia Pty Ltd

Level 1, 1102 Toorak Road,

Camberwell VIC 3124,

Australia.

DISTRIBUTED BY

Generic Health Pty Ltd

Level 1, 1102 Toorak Rd

Camberwell VIC 3124

Australia.

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POISON SCHEDULE OF THE MEDICINE

Schedule 4 - prescription only

DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (THE

ARTG)

19 November 2014

DATE OF MOST RECENT AMENDMENT

05 April 2016