INTAPAN INJECTION 1ML (10MGML) AMPOULE

Country: Malaysia

Language: English

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

Active ingredient:

NALBUPHINE HYDROCHLORIDE

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

NALBUPHINE HYDROCHLORIDE

Units in package:

1ml10Units mL

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Summary of Product characteristics

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[REVISION DATE: 12.08.2020]
[DUOPHARMA (M) SDN BHD]
INTAPAN INJECTION 1ML (10MG/ML) AMPOULE
DESCRIPTION: Clear, colourless liquid.
COMPOSITION:
Each ampoule contains Nalbuphine Hydrochloride 10 mg per ml.
PHARMACODYNAMICS:
Nalbuphine HCl has the effect of lowering the cardiac work load and
can be used immediately in myocardial infarction (use caution where
emesis is involved). Haemodynamic studies
in patients with severe arteriosclerotic heart changes reveal that
Nalbuphine has circulatory effects similar to those of morphine, i.e.
a minimal decrease in oxygen consumption,
cardiac index, left ventricular end diastolic pressure and cardiac
work. The antagonist activity of Nalbuphine is ¼ as potent as
nalorphine and approximately 1/40 that of naloxone.
PHARMACOKINETICS:
Nalbuphine HCl is a potent analgesic. Its analgesic potency is
essentially equivalent to that of morphine on a milligram basis. The
onset of action occurs within 2-3 min. after IV
administration and in < 15 min. following SC or IM injection. The
plasma half-life of Nalbuphine is ¼ as potent as nalorphine and 10
times that of pentazocine._ _
INDICATION:
Moderate to severe pain. Preoperative and postoperative analgesics, as
a supplement to surgical anaesthesia, for obstetrical analgesia,
during labour.
RECOMMENDED DOSAGE:
The usual recommended adult dose is 10 mg for 70 kg individual,
administered SC, IM or IV; this dose may be repeated every 3-6 hours
as necessary. Dosage should be adjusted
according to the severity of the pain, physical status of the
patients, and other medications which the patients may be receiving,
see Interactions (other CNS depressants). In non-
tolerant individuals, the recommended single maximum dose is 20 mg,
with a maximum total daily dose of 160 mg.
The use of Nalbuphine as a supplement to balanced anaesthesia requires
larger doses than those recommended for analgesic. Induction doses of
nalbuphine range from 0.3 – 3
mg/kg IV to be administered over 10 to 15 min period with maintenance
doses of 0.25 – 0.5