Flavoxate Hydrochloride 200 mg
Composition
Each film coated tablet contains flavoxate hydrochloride 200 mg.
Mechanism of actions
Flavoxate hydrochloride is a flavone derivative.
The basic action of Urispas® is the relaxation, of smooth muscle fibres of the urinary tract.
Indications
Urispas® is indicated for the symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as many occur in cystitis, prostatitis, urethritis, urethrocystitis, and urethrotrigonitis.
Dosage and Administration
Adults and children over 12 years of age : 200 mg, 3-4 times a day.
With improvement of symptoms, the dose may be reduced.
Precautions
Urispas® should be given cautiously to patients with suspected glaucoma. The drug should only be used during pregnancy if the anticipated benefits outweigh any risk. Not recommended for infants and children under 12 years of age since safety and
efficacy studies in this age group are not completed.
In the event of drowsiness or blurred vision, the patients should not operate a motor vehicle or any machinery, and refrain from participating in activities requiring alertness. If overdosage occur, maximum 4 hours after overdosage,
evacuation of the stomach should be performed. If overdosage is extreme, or there is a delay in removing the drug from the stomach, administration of a para-sympathomimetic drug should be considered. Administration in nursing mother only if clearly needed.
Adverse Reactions
Nausea, vomiting, dry mouth, nervousness vertigo, headache, drowsiness, blurred vision, increased ocular tension, disturbance in eye accomodation, mental confusion, dysuria, tachycardia, palpitation, hyperpyrexia, eosinophilia, leukopenia, urticaria and other dermatoses.
Contraindications
URISPAS® is contra indicated in patients who have any of the following conditions; pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the
lower urinary tract.
Storage
Keep in a cool and dry place
Packaging and Registration Number
Box, 3 blisters @ 10 film coated tablets
Reg. No. DKL9620920417A1
Manufactured by PT. INDOFARMA, Bekasi - Indonesia
under license of RECORDATI S.p.A. Italy
ON MEDICAL PRESCRIPTION ONLY
Urispas®200
Flavoxate Hydrochloride 200 mg
Komposisi
Tiap tablet salut selaput mengandung flavoxate hidroklorida 200 mg.
Cara Kerja Obat
Flavoxate hidroklorida merupakan derivat flavone yang secara langsung bekerja sebagai spasmolitik pada otot polos saluran kemih.
Indikasi
Urispas digunakan untuk mengurangi gejala-gejala akibat gangguan saluran kemih seperti dysuria, urgency, nocturia, suprapubic pain, frequency dan incontinence yang terjadi pada penderita cystitis, prostatitis, urethritis, urethrocystitis dan urethrotrigonitis.
Dosis dan Cara Pemakaian
Dewasa dan anak diatas 12 tahun : 200 mg, sehari 3 - 4 kali.
Dosis diturunkan sejalan dengan berkurangnya gejala.
Peringatan dan Perhatian
Hati-hati pemberian pada penderita glaukoma.
Pemberian pada wanita hamil hanya bila dianggap perlu.
Penggunaan pada anak dibawah usia 12 tahun, keamanan dan kemanjurannya belum diketahui dengan pasti.
Jangan mengendarai kendaraan atau menjalankan mesin yang membutuhkan kewaspadaan.
Bila terjadi overdosis, maka maksimal 4 jam setelah terjadinya overdosis harus ditakukan pencucian lambung.
Jika terjadi overdosis yang ekstrim maka pemberian obat parasimpatomimetik perlu dipertimbangkan.
Hati-hati pemberian pada wanita menyusui.
Efek Samping
Mual, muntah, mulut kering, gelisah, vertigo, sakit kepala, mengantuk. gangguan akomodasi mata, tekanan intra okular meningkat, gangguan penglihatan, bingung, disuria, takikardia, palpitasi, hiperpireksia, eosihofilia, leukopenia, urtikaria dan dermatosis lainnya.
Kontraindikasi
Pada penderita dengan obstruksi duodenal atau phyloric, luka pada usus, achalasia, pendarahan gastrointestinal dan obstruksi uropathis saluran kemih bagian bawah.
Cara Penyimpanan
Simpan di tempat sejuk dan kering.
Kemasan dan Nomor Registrasi
Kotak 3 blister @ 10 tablet salut selaput
No. Reg. DKL9620920417A1
Dibuat oleh PT. INDOFARMA. Bekasi - Indonesia
dengan lisensi RECORDATI S.p.A. Italy
HARUS DENGAN RESEP DOKTER
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