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KOMPOSISI
:
Tiap PROCETAM® 400 kapsul mengandung,
Piracetam.........................................................................
400 mg
Tiap PROCETAM® 800 tablet salut selaput mengandung,
Piracetam.........................................................................
800 mg
Tiap PROCETAM® 1200 tablet salut selaput mengandung,
Piracetam.........................................................................
1200 mg
FARMAKOLOGI :
PROCETAM® mengandung Piracetam (2-Pyrrolidon-acetamida)
suatu zat Nootropic.
INDIKASI :
PROCETAM® diindikasikan untuk :
- Mengobati gejala-gejala involusi yang berhubungan dengan usia
lanjut seperti kemunduran daya pikir, astenia, gangguan adaptasi
reaksi psikomotorik yang terganggu.
- Pre-delirium, delirium tremens, gangguan fungsi dan kemunduran
intelegensia yang diakibatkan oleh alkoholisme kronik (gangguan
ingatan, konsentrasi pikiran, perhatian dan intelegensia). Pengobatan
detoksikasi (untuk gangguan karena penghentian obat yang mendadak,
gangguan selera makan dan defisiensi).
- Disfungsi serebral sehubungan dengan paska trauma (vertigo,
sakit kepala, agitasi, gangguan ingatan dan astenia).
KONTRA INDIKASI :
- Hipersensitivitas terhadap piracetam.
- Penderita dengan insufisiensi ginjal yang berat (bersihan
kreatinin < 20 ml/menit).
PERINGATAN DAN PERHATIAN :
- Hati-hati bila diberikan pada penderita insufisiensi ginjal,
wanita hamil dan wanita menyusui.
- Hindari penghentian obat secara tiba-tiba terutama pada pasien
dengan mioklonik, karena dapat mengakibatkan mioklonik.
EFEK SAMPING :
- Efek samping biasanya terjadi pada orang dewasa dengan dosis
di atas 2,4 gram/hari.
- Efek samping yang pernah dilaporkan : gelisah, agitasi, iritabilitas,
gangguan tidur, sakit kepala, tremor.
- Pada beberapa pasien pernah mengalami kelelahan dan somnolence.
- Gangguan pada saluran pencernaan : nausea, vomiting, diare,
gastralgia.
INTERAKSI OBAT :
Pemberian bersama-sama dengan suplemen yang mengandung ekstrak
tiroid menyebabkan gangguan konfusi, iritabilitas dan tidur.
DOSIS :
- Gejala involusi / psikoorganik yang disebabkan karena usia
lanjut :
Dosis awal : 2,4 gram/hari dalam dosis terbagi tiga (3 x 2 kapsul
400 mg, atau 3 x 1 tablet 800 mg) selama 6 minggu.
Dosis pemeliharaan : 1,2 gram/hari dalam dosis terbagi tiga
(3 x 1 kapsul 400 mg).
- Gejala pasca trauma serebral :
Dosis awal : 3 x 800 mg/hari (3 x 1 tablet 800 mg atau 3 x 2
kapsul 400 mg). Setelah tercapai efek yang diinginkan dosis
dapat diturunkan menjadi : 3 x 400 mg/hari (3 x ½ tablet
800 mg atau 3 x 1 kapsul 400 mg).
- Bagi penderita yang memerlukan dosis yang besar :
Dosis lazim : 1,2 gram - 4,8 gram/hari dalam dosis terbagi 2
atau 3 kali.
KEMASAN :
PROCETAM® 400 mg kapsul
Dus, isi 10 strip @ 10 kapsul
No. Reg. : DKL 0315616601 A1
PROCETAM® 800 mg tablet salut selaput
Dus, isi 5 strip @ 10 tablet salut selaput
No. Reg. : DKL 0315616209 A1
PROCETAM® 1200 mg tablet salut selaput
Dus, isi 5 strip @ 6 tablet salut selaput
No. Reg. : DKL 0315616209 B1
HARUS DENGAN RESEP DOKTER
Simpan pada suhu kamar (25º
C - 30º C)
ENGLISH VERSION
COMPOSITION:
- PROCETAM 400 capsule, each capsule contains:
Piracetam ………….. 400 mg
- PROCETAM 800 film-coated tablet, each tablet contains:
Piracetam ………….. 800 mg
- PROCETAM 1200 film-coated tablet, each capsule contains:
Piracetam ………….. 1200 mg
- PROCETAM 3 g injection, each 1 mL contains:
Piracetam ………….. 200 mg
PHARMACOLOGY:
Piracetam is a nootropic agent, is a psychotropic drug which
improves directly the efficiency of the higher telencephalic
function of the brain involved in cognitive processes, eg those
related to learning, memory, thought and consciousness, both
in normal and deficient situations, without being sedative or
psychostimulant.
Piracetam exerts these various CNS activities by different ways
of action: It modulates brain neurotransmission, promotes metabolic
conditions for neuronal plasticity and improves microcirculation
without being a vasodilator.
INDICATIONS:
Involutional syndromes related to aging eg memory deficit, asthenia,
adaptation disorders and disturbed psychomotor reactions.
Treatment of chronic alcoholism and addiction as well as post-traumatic
syndrome
Procetam injection for cerebral haemorrhage
CONTRAINDICATIONS:
Hypersensitivity to piracetam
Severe renal insufficiency
PRECAUTIONS AND WARNINGS:
Caution should be taken when treating patients with known kidney
impairment
Safety for use in human pregnancy and lactation has not been
established
ADVERSE REACTIONS:
Seen more often in the elderly at the higher dosages (>2.4
g/day).
Adverse reactions, which may be reported during treatment with
piracetam, are nervous, agitation, irritability, restlessness
and sleep disturbance
Some patients may complain of tiredness or somnolence.
Gastrointestinal disturbances, eg nausea, vomiting, diarrhoea,
gastralgia may also reported.
DRUG INTERACTION:
Concomitant use with thyroid extract has caused confusion, irritability
and sleep disturbance.
DOSAGE AND ADMINISTRATION:
Involution symptoms/psycho-organic related to elderly
Initial dose: 2.4 g/day in 3 divided dosage (3 x 2 capsules
or 3 x 1 tablet 800 mg) for 6 weeks
Maintenance dose: 1.2 g/day in 3 divided dosage (3 x 1 capsule)
Cerebral post-traumatic syndrome
Initial dose: 3 x 800 mg/day (3 x 2 capsules or 3 x 1 tablet
800 mg) If desired effect has been obtained, reduce dose gradually
to 3 x 400 mg/day (3 x 1 capsule)
Dose up to 4.8 g/day may be administered if necessary.
PRESENTATIONS:
PROCETAM 400 capsule : Box, 10 strips @ 10 capsules
PROCETAM 800 film-coated tablet : Box, 5 strips @ 10 tablets
PROCETAM 1200 film-coated tablet : Box, 5 strips @ 6 tablets
PROCETAM 3 g injection : Box, 5 ampoules @ 15 ml
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