APO-LANSOPRAZOLE

Main information

  • Trade name:
  • APO-LANSOPRAZOLE ODT lansoprazole 30mg blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-LANSOPRAZOLE ODT lansoprazole 30mg blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216794
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216794

APO-LANSOPRAZOLE ODT 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. APO-LANSOPRAZOLE ODT 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

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

Alu/Alu blister (with push through 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. APO-LANSOPRAZOLE ODT 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 07:12:01 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

APO-Lansoprazole ODT PI V2

Page 1 of 12

18 January 2016

PRODUCT INFORMATION

APO-Lansoprazole ODT

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: C16H14F3N3O2S

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 APO-Lansoprazole ODT 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) 30

per 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.

APO-Lansoprazole ODT PI V2

Page 2 of 12

18 January 2016

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.

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

pharmacokinetics

lansoprazole

were

studied

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 kg and 30 mg once daily for subjects weighing

>30 kg. 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

dose

groups

were

affected

weight

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 for T

, t

or natural

logarithms of dose-normalised C

and AUC

0-24

. None of the selected covariates (body

APO-Lansoprazole ODT PI V2

Page 3 of 12

18 January 2016

weight, age and gender) had any statistically significant effect on lansoprazole Tmax or the

natural logarithms of dose normalised C

and AUC

0-24

CLINICAL TRIALS

Helicobacter Pylori

clinical

trials,

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.

Trials

which

used

lansoprazole

combination

with

only

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. The majority of patients (69% for lansoprazole 15

mg once daily and 74% for 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

APO-Lansoprazole ODT PI V2

Page 4 of 12

18 January 2016

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.

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

study

comparing

lansoprazole

daily

with

placebo

patients

with

endoscopically documented duodenal ulcer, the percentage of patients who remained healed

after

twelve

months

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.

APO-Lansoprazole ODT PI V2

Page 5 of 12

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%)

placebo

group

(p=0.005).

3-month

follow-up

period,

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

APO-Lansoprazole ODT PI V2

Page 6 of 12

18 January 2016

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 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 of non-steroidal anti-inflammatory drugs require treatment

with

antimicrobial

agents

addition

antisecretory

drugs

whether

first

presentation or on recurrence.

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

to H2-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 not be co-administered with atazanavir due to a significant reduction in

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 APO-Lansoprazole ODT are enteric coated. Therefore, the tablets should be

sucked slowly and should not be crushed or chewed.

APO-Lansoprazole ODT PI V2

Page 7 of 12

18 January 2016

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.

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 not

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

In animal studies, retinal atrophy was observed in Sprague Dawley rats dosed orally with

lansoprazole.

Retinal

atrophy

been

found

mice,

dogs,

monkeys

humans.

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

synthesis of the amino acid taurine, which has a protective effect on the 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.

APO-Lansoprazole ODT PI V2

Page 8 of 12

18 January 2016

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

consider

monitoring

magnesium

levels

prior

initiation

treatment

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 was also reported at dose levels of 15 mg/kg/day. Two

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,

days

week.

gastric

cell

carcinoids

were

seen.

repeat

carcinogenicity study, mice were dosed with 15, 75, 150 or 300 mg/kg/day, 7 days a week.

Terminal

studies

showed

cell

hyperplasia,

mucosal

hyperplasia/hypertrophy

glandular dilatation and vacuolation at all dosages. Carcinoids were found in occasional

animals receiving 15, 150 or 300 mg/kg/day.

Hypergastrinaemia secondary to prolonged hypochlorhydria has been postulated to be the

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

Genotoxicity

Negative

results

were

obtained

gene

mutation

assays

vivo

assay

chromosomal

damage.

vitro

assays

chromosomal

damage

showed

evidence

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 in pregnant rats and rabbits at oral doses up to 300 and 30

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.

APO-Lansoprazole ODT PI V2

Page 9 of 12

18 January 2016

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 the possibility of interaction with other drugs metabolised via 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.

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 of lansoprazole with sucralfate delayed absorption and reduced lansoprazole

bioavailability by approximately 30%. Similarly, antacids may also reduce the bioavailability

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

antacid administration.

Lansoprazole causes a profound and long-lasting inhibition of 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 HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for

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.

APO-Lansoprazole ODT PI V2

Page 10 of 12

18 January 2016

Rarely, cases of colitis (macroscopic and microscopic) have been reported. In 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.

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

impotence

have

been

reported

rarely.

Hypomagnesaemia

been

reported rarely.

DOSAGE AND ADMINISTRATION

For oral administration.

APO-Lansoprazole ODT 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, APO-Lansoprazole

ODT '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

weeks

treatment

using

same

dosage

regimen

indicated.

long-term

APO-Lansoprazole ODT PI V2

Page 11 of 12

18 January 2016

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.

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

APO-Lansoprazole ODT 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.

APO-L ansoprazole ODT 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 types may be marketed.

APO-Lansoprazole ODT PI V2

Page 12 of 12

18 January 2016

APO-Lansoprazole ODT 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

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

Australia.

POISON SCHEDULE OF THE MEDICINE

Schedule 4 - prescription only

DATE

OF

FIRST

INCLUSION

IN

THE

AUSTRALIAN

REGISTER

OF

THERAPEUTIC GOODS (THE ARTG)

November 2014

DATE OF MOST RECENT AMENDMENT

05 April 2016

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

18-3-2008

Warning about Power 1 Walnut

Warning about Power 1 Walnut

The Danish Medicines Agency has been made aware that the Health Sciences Authority in Singapore has confiscated large quantities of the illegal medicinal product Power 1 Walnut, which has been marketed as a potency-enhancing product containing only herbs.

Danish Medicines Agency

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety