Pantium-20mg Tablets

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

JETPHARMA SDN. BHD.

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Units in package:

100Tablet Tablets

Manufactured by:

INTAS PHARM LTD

Patient Information leaflet

(643827- K)
No. 13, Jalan Rajawali 2, Bandar Puchong Jaya, 47100
Puchong, Selangor. Tel: [phone] Fax: [phone].
Email: [e-mail]
Date: 19/08/2022
COMMITMENT LETTER
P
antium Tablet 20mg / MAL09051573AZ
We are herewith confirming you that, we will submit variation
application of RIMUP to PHARMACOVIGILANCE
DEPARTMENT manually for evaluation, and also confirming that, we will
submit next variation application of MiV-
PA3 through online with supportive of manual variation application
approval letter.
Kindly accept the current variation (MaV-2) supportive data and
proceed for evaluation and approve it.
Naren. Veeravelli.
Regulatory Affairs officer.

Summary of Product characteristics

PANTIUM
(Pantoprazole Sodium Tablets 20mg and 40mg)
Pantoprazole is a substituted benzimidazole. It is a specific proton
pump inhibitor. It is useful for
the treatment of duodenal ulcer, gastric ulcer, and moderate to severe
reflux oesophagitis.
DOSAGE FORM
Tablet
DESCRIPTION:
PANTIUM-20
Lemon Yellow coloured, round biconvex, beveled edges enteric coated
tablets plain on both
sides.
Average Weight: 150.0 mg ± 5% (142.5 mg to 157.5 mg)
Thickness: 3.0 ± 0.2 mm (2.8 to 3.2 mm)
Diameter: 7.0 ± 0.2 mm (6.8 to 7.2 mm)
PANTIUM-40
Light brownish Yellow coloured, round biconvex, beveled edges enteric
coated tablets plain on
both sides.
Average Weight: 150.0 mg ± 5% (142.5 mg to 157.5 mg)
Thickness: 3.0 ± 0.2 mm (2.8 to 3.2 mm)
Diameter: 7.0 ± 0.2 mm (6.8 to 7.2 mm)
PHARMACODYNAMICS:
Mechanism of Action
Pantoprazole inhibits proton pump in a dose proportionate manner. It
inhibits H+ /K+- ATPase
enzyme which is responsible for acid secretion in the parietal cells
of the stomach, in the acidic
environment of the parietal cells, pantoprazole gets converted into
the active form, a cyclic
sulphenamide, which then binds to the H-/K+- ATPase, thus inhibiting
the proton pump. This
results in potent and long lasting suppression of the basal and the
stimulated gastric acid secre-
tion. Since pantoprazole acts distally to the receptor level, it can
inhibit gastric acid secretion
irrespective of the nature of the stimulus (acetylcholine, gastrin,
histamine). Pantoprazole exerts
its full therapeutic effect in a strongly acidic environment (pH<3)
remaining mostly inactive at
higher pH values. Pantoprazole has the same effect whether
administered orally or intravenously.
During treatment with antisecretory medicinal products, serum gastrin
increases in responses to
the decreased acid secretion. Also CgA increases due to decreased
gastric acidity. The increased
CgA level may interfere with investigations for neuroendocrine
tumours.
Available published evidence suggests that proton pump inhibitors
should be discontinued
between 5 day