Prega-75 (Pregabalin Capsule 75mg)

国家: 马来西亚

语言: 英文

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

有效成分:

PREGABALIN

可用日期:

CAMBER LABORATORIES SDN. BHD.

INN（国际名称）:

PREGABALIN

每包单位数:

10 x 10's capsule Capsules

厂商:

Hetero Labs Limited

产品特点

PATIENTS WITH HEPATIC IMPAIRMENT:
No dosage adjustment is required for patients with hepatic impairment.
CHILDREN AND ADOLESCENTS:
Pregabalin is not recommended for use in children <12 years and
adolescents (12-17
years) due to insufficient data on safety and efficacy.
Elderly (>65 years): Elderly patients may require a dose reduction of
pregabalin due to decreased renal function.
DISCONTINUATION OF PREGABALIN:
In accordance with current clinical practice, if pregabalin has to be
discontinued, it is recommended that this should be done gradually
over a minimum of 1 week independent of the
indication.
MODE OF ADMINISTRATION
Oral route of administration
CONTRAINDICATIONS
Hypersensitivity to pregabalin or to any of the excipients of
pregabalin
WARNINGS AND PRECAUTIONS
ANGIOEDEMA:
There have been reports of angioedema in patients during initial and
chronic treatment with
pregabalin. Specific symptoms included swelling of the face, mouth
(tongue, lips and gums), and neck (throat and
larynx). There were reports of life-threatening angioedema with
respiratory compromise requiring emergency
treatment. Pregabalin should be discontinued immediately in patients
with these symptoms.
Caution should be exercised when prescribing pregabalin to patients
who have had a previous episode of
angioedema. In addition, patients who are taking other drugs
associated with angioedema (eg, angiotensin
converting enzyme ACE inhibitors may be at increased risk of
developing angioedema.
HYPERSENSITIVITY:
There have been reports of hypersensitivity in patients shortly after
initiation of treatment with
pregabalin. Adverse reactions included skin redness, blisters, hives,
rash, dyspnea and wheezing. Pregabalin
should be discontinued immediately in patients with these symptoms.
WITHDRAWAL OF ANTIEPILEPTIC DRUGS (AEDS):
As with all AEDs, withdraw pregabalin gradually to minimize the
potential of increased seizure frequency in patients with seizure
disorders. If pregabalin is discontinued, taper the
drug gradually over a minimum of 1 week.
PERI