| |
| P-Alaxin Tablets |
| Composition |
P-ALAXIN TABLETS:
Each
coated tablet contains
Dihydroartemisinin
40 mg
Piperaquine
Phosphate 320 mg
Excipients
:q.s. |
| Pharmacology
& Pharmacokinetics |
Mode
of action of Dihydroartemisinin:
Dihydroartemisinin
mainly interferes with the membrane structures of
trophozoites
(erythrocytic asexual forms), i.e. whorled food vacuole
membrane,
distended mitochondria, swollen nuclear membranes,
dissociation
of ribosomes from endoplasmic reticulum leading to
cytoplasmic
vacuolization and autophagocytosis- In addition,
biochemical
depression of protein synthesis and nucleic acid synthesis
are
exhibited.
Upon
oral administration Dihydroartemisin is rapidly absorbed and
maximum
blood concentration attained 1 hour afterwards, with a half-life
of about
4 hours. It
is
widely distributed in the liver, kidneys and bile.
Approximately
80% is excreted through the urine and feces within 24 hrs
after
administration It is metabolized to two inactive metabolites,
deoxydihydroartemisinin
and dihydroxydihydroartemisinin. |
| Mode
of action of Piperaquine Phosphate |
Experimental
results show that POP interferes with physiological
function
of the food vacuole membrane
of the trophozoites leading to
autophagocytosis
of the parasites. It has no marked effect on the ring
forms,
immature or mature schizonts and the male or female
gametocytes.
Upon
oral administration about 80-90% is absorbed within 24 hrs. It is
widely
distributed in the
body
mainly in
the liver, kidneys, lungs and
spleen.
About 25% of the total dose is partitioned in the liver within 8 hrs
of
intake. Elimination is very slow with the half life of about 9.4 days It is
excreted
through bile
by hepatoenteral
circulation. |
| Indications |
Treatment of clinical
attacks of Malaria caused by P. falciparum, P, Vivax
and P. malariae |
| Contraindications |
| The
product is not recommended for use in women during the first 3
months
of pregnancy. |
| Storage |
| Preserve
in well closed, light resistant containers |
| Packaging |
| 8
Tablets per blister pack. |
| Administration
and Dosage |
Adults: 2Tablets to be taken
orally as per the following schedule.
Children
(7-10 years) : 1 Tablet to be taken orally as per the following
schedule. |
| Age Group |
7 to 10 yrs. |
11 to 15 yrs. |
Above 16 yrs. |
| Commencement |
1 Tablet |
11/2 Tablets |
2 Tablets |
| 8th hrs |
1 Tablet |
11/2 Tablets |
2 Tablets |
| 24th hrs |
1 Tablet |
11/2 Tablets |
2 Tablets |
| 32nd hrs |
1 Tablet |
11/2 Tablets |
2 Tablets |
|
| Adverse Reactions |
- Nausea or vomiting may occur
occasionally with incidence of less
than 6%
- No noticeable side effect of Dihydroartemisinin
is reported. The
Dihydroartemisinin
would, for certain individuals, bring effects of
greater
or lesser severity for example, a reversible reduction in
reticulocyte counts.
- Possible
side-effect of PQP include mild dizziness, vertigo,
headache,
nausea, vomiting
and
abdominal discomfort. Reversible
leucopenia
was infrequently
reported;
dyspnea and palpitations were
also reported but not further
specified.
|
| Precautions |
- Do not exceed the stated dosage.
- Lactation . excretion
of P-ALAXIN TABLETS through breast milk has
not been established.
|
| Shelf Life |
| 3 Years |
| Dispensing Category |
| Prescription Medicine. |
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