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Monday, February 28, 2011

Emposil

Emposil
Sildenafil

Description
Emposil 50 mg:
Each tablet contains sildenafil citrate corresponding to sildenafil base 50 mg
Emposil 100 mg:
Each tablet contains sildenafil citrate corresponding to sildenafil base 100 mg

Actions
Sildenafil citrate is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Pharmacology
Mechanism of Action: The physiologic mechanism of erection of the penis Involves release of nitric.
The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil, at recommended doses, has no effect in the absence of sexual stimulation.

Pharmacokinetics
Sildenafil and it's major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins. Protein-binding is independent of total drug concentrations. Metabolism and Excretion: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.

Indications
Treatment of erectile dysfunction

Dosage and Administration
For most patients, the recommended dose is 50 mg taken as needed, approximately 1 hr before sexual activity. However, Emposil may be taken anywhere from 4 hrs to 0.5 hr before sexual activity.
Based on the effectiveness and tolerance, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.The maximum dosing frequency is once per day. The following factors are associated with increased plasma levels of sildenafil: Age › 65 (increase in AUC, 40%), hepatic impairment (eg, cirrhosis, 80%), severe renal impairment (creatinine clearance ‹ 30 mL/min, 100%), and concomitant use of potent cytochrome P-450 3A4 inhibitors [ketoconazole, itraconazole, erythromycin (182%), saquinavir (210%)]. Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients. Ritonavir greatly increased the systemic level of sildenafil in a study of healthy, non-HIV-infected volunteers (11-fold increase in AUC, see Interactions). Based on these pharmacokinetic data, it is recommended not to exceed a minimum single dose of 25 mg of Emposil in a 48-hr period.

Overdosage
In studies with healthy volunteers, of single doses up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

Contra Indications
Patients with a known hypersensitivity to any component of Emposil. Consistent with its known effects on the nitric oxide/cGMP pathway (see Actions), Emposil was shown to potentiate the hypotensive effects of nitrates, and its administration in patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated. After patients have taken Emposil, it is unknown when nitrates, if necessary can be safely administered. Based on the pharmacokinetic profile of a single 100-mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hrs post-dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL) (see Pharmacokinetics under actions). In the following patients, age › 65 years, hepatic impairment (eg, cirrhosis), severe renal impairment (eg, creatinine clearance ‹ 30 mL/min), and concomitant use of potent cytochrome P-450 3A4 inhibitors (erythromycin), plasma levels of sildenafil at 24 hrs post-dose have been found to be 3-8 times higher than those seen in healthy volunteers. Although plasma levels of sildenafil at 24 hrs post-dose are much lower than at peak concentrations, it is unknown whether nitrates can be safely co-administered at this time point. Emposil is not indicated for use in newborns, children or women.

Warnings
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including Emposil should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
Serious cardiovascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage and transient ischemic attack have been reported post-marketing in temporal association with the use of sildenafil for erectile dysfunction. Most, but not all, of these patients had pre existing cardiovascular risk factors.
Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without the sexual activity Others were reported to have occured hours to days after the use of sildenafil and sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient is underlying cardiovascular disease, to a combination of these factors, or to other factors.
Emposil has systemic vasodilatory properties that resulted in transient decreases in supine blood  pressure in healthy volunteers (mean maximum decrease of 8.3/5.5 mm Hg) (see Pharmacodynamics under Actions). While this normally would be expected to be of little consequence in most patients, prior to prescribing Emposil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity/There Is no controlled clinical data on the safety or efficacy of Emposil in the following groups; if prescribed, this should be done with caution: Patients who have suffered a myocardial Infarction, stroke or life-threatening arrhythmia within the last 6 months; patients with resting hypotension (BP ‹ 90/50) or hypertension (BP › 170/110); patients with cardiac failure or coronary artery disease causing unstable angina; patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Prolonged erection › 4 hrs and priapism (painful erections › 6 hrs in duration) have been reported infrequently since market approval of Emposil. In the event of an erection that persists › 4 hrs, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. The concomitant administration of the protease inhibitor, ritonavir, substantially increases serum concentrations of sildenafil (11 -fold increase in AUC). If Emposil is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildsnafil are limited. Visual disturbances occurred more commonly at higher levels of sildenafil exposure. Decreased blood pressure syncope and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mgl.To decrease the chance of adverse events in patients taking ritonavir, a decrease in sildenafil dosage is recommended (see Interactions, Adverse Reactions and Dosage & Administration).
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision or loss of vision, has been reported rarely post-marketing with the use of all PDE5 inhibitors, including sildenafil. Most of these patients had risk factors such as low cup to disc ratio (icrowded disk), age over 50, diabetes, hypertension, coronary artery disease, hypcrlipidemia and smoking. No casual relationship has been made between us of PDE5 inhibitors and NAION. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION. The patients should be advised that in case of sudden visual loss, to stop taking sildenafil and consult a physician Immediately Patients with the following underlying conditions can be particularly sensitive to the actions of vasodilators Including Sildenafil - those with left ventricular outflow obstruction (e.g.aortic stenosis, idiopathic hyperthropic subaortic stenosis) and those with severity impaired autonomic control of blood pressure.

Precautions
The evaluation of erectile dysfunction should Include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
Simultaneous administration of Emposil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in some patients. Therefore, Emposil doses above 25 mg should not be taken within 4 hours of taking an alpha-blocker.

Before prescribing Emposil, it is important to note the following:
Patients on multiple antihypertensive medications were included in the pivotal clinical trials for Emposil. In a separate drug interaction study, when arnlodipine 5 or 10 mg, and Emposil 100 mg were orally administered concomitantly to hypertensive patients, mean additional blood pressure reduction of 8 mm Hg systolic and 7 mm Hg diastolic were noted (see Interactions). Controlled studies of drug interactions between Emposil and other antihypertensive medications have not been performed. The safety of Emposil is unknown in patients with bleeding disorders and patients with active peptic ulceration.
Emposil should be used with caution in patients with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma or leukemia).The safety and efficacy of combinations of Emposil with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
In humans, Emposil has no effect on bleeding time when taken alone or with acetylsalicylic acid. In vitro studies with human platelets Indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (as nitric oxide donor). The combination of heparin and Emposil had an additive effect on bleeding time in the anesthetized rabbit.but this interaction has not been studied in humans.
Information for Patients: Physicians should discuss with patients the contraindication of Emposil with regular and/or intermittent use of organic nitrates.
Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (eg, angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician.
Physicians should warn patients that prolonged erections › 4 hrs and priapism (pain erections › 6 hrs in duration) have been reported infrequently since market approval of Emposil. In the event of an erection that persists › 4 hrs, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. The use of Emposil offers no protection against sexually transmitted diseases. Counseling the patients about the protective measures necessary to guard against sexually transmitted diseases, including the human immunodeficiency virus (HIV), may be considered.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 29 and 42 times, for male and female rats, respectively, the exposures observed in human males given the maximum recommended human dose (MRHD) of 100 mg.
Sildenafil was not carcinogenic when administered to mice for 18-21 months at dosages up to the maximum tolerated dose (MTD) of 10 mg/kg/day, approximately 0.6 times the MRHD on a mg/m2 basis.
Sildenafil was negative In in-vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes. and in vivo mouse micronucleus assays to detect clastogenicity.
There was no impairment of fertility in rats given sildenafil up to 60
mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of › 25 times the human male AUC.
There was no effect on sperm motitity or morphology after single 100-mg oral doses of Emposil in healthy volunteers,
Use in pregnancy: Pregnancy Category B: No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 200 mg/kg/day during organogenesis. These doses represent, respectively, about 20 and 40 times the MRHD on a mg/m2 basis in a 50-kg subject. In the rat pre-and postnatal development study, the no-observed adverse effect dose was 30 mg/kg/day given for 36 days. In the nonpregnant rat, the AUC at this dose was about 20 times the human AUC. There are
no adequate and well-controlled studies of sildenafil in pregnant
women.
Use in the elderly; Healthy elderly volunteers (a 65 years) had a reduced clearance of sildenafil (see Pharmacokinetics in Special Populations under Actions). Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered (see Dosage & Administration).

Adverse Reaction
In fixed-dose studies, the incidence of some adverse events increased with dose. The nature of the adverse events in flexible-dose studies, which more closely reflect the recommended dosage regimen, was similar to that for fixed-dose studies.
Other adverse reactions occurred at a rate of › 2%, but equally common on placebo: Respiratory tract infection, back pain, flu syndrome and arthralgia.
In fixed-dose studies, dyspepsia (17%) and abnormal vision (11%) were more common at 100 mg than at lower doses. At doses above the recommended dose range, adverse events were similar to those detailed previously but generally were reported more frequently.
The following events occurred in ‹ 2% of patients in controlled clinical trials; a causal relationship to Emposil is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful. Body as a Whole: Face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Cardiovascular: Angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy. Digestive: Vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, abnormal liver function tests, rectal hemorrhage, gingivitis. Hem ic and Lymphatic: Anemia and leukopenia. Metabolic and Nutritional: Thirst, edema, gout, unstable diabetes, hyperglycemla, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Musculoskeletal: Arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis. Nervous: Ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnormal dreams, decreased reflexes, hypesthesia. Respiratory: Asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum, increased cough. Skin and Appendages: Urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Special Senses: Mydriasis, conjunctivitis, photophobia, tinnitus, eye pain, deafness, ear pain, eye hemorrhage, cataract, dry eyes. Urogenital: Cystitis, nocturia, urinary frequency, breast enlargement, urinary Incontinence, abnormal ejaculation, genital edema and anorgasmia.

Interactions
Effects of Other Drugs on Emposil:
In Vitro Studies: Sildenafil metabolism is principally mediated by the cytochrome P-450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these Isoenzymes may reduce sildenafil clearance. In Vivo Studies: Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with Emposil (50 mg) to healthy volunteers. When a single 100-mg dose of Emposil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC). In addition, in a study performed in healthy male volunteers, co-administration with the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor at steady state (1200 mg 3 times a day) with Emposil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and 210% increase in sildenafil AUC. Emposil had no effect on saquinavir pharmacokinetics. Stronger CYP3A4 inhibitors eg, ketoconazole or itraconazole would be expected to have still greater effects, and population data from patients in clinical trials did indicate a reduction in sildenafil clearance when it was co-administered with CYP3A4 inhibitors (eg, ketoconazole, erythromycin or cimetidine). (See Dosage & Administration). In another study in healthy male voiunteers, co-administration with the HIV protease inhibitor ritonavir, which is a highly potent P-450 inhibitor, at steady state (500 mg twice daily) with Emposil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1000% (11-fold) increase in sildenafil plasma AUC. At 24 hrs, the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was dosed alone. This is consistent with ritonavir's marked effects on a broad range of P-450 substrates. Emposil had no effect on ritonavir pharmacokinetics (see Dosage & administration). Although the interaction between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels. It can be expected that concomitant administration of CYP3A4 inducers eg, rifampin, will decrease plasma levels of sildenafil. Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Emposil. Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics ofCYP2C9 inhibitors (eg, tolbutamide, warfarin), CYP2D6 inhibitors (eg, selective serotonin re-uptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, ACE inhibitors, and calcium-channel blockers. The AUC of the active metabolite, N-desmethyl sildenafil, was increased 62% by loop and potassium-sparing diuretics and 102% by nonspecific.-blockers. These effects on the metabolite are not expected to be of clinical consequence, Effects of Emposil on Other Drugs: In Vitro Studies: Sildenafil is a weak inhibitor of the cytochrome P-450 isoforms 1A2, 2C9, 2C19.2D6, 2E1 and 3A4 (IC50 › 150 micromolar). Given sildenafil peak plasma concentrations of approximately 1 micromolar after recommended doses, it is unlikely that Emposil will alter the clearance of substrates of these isoenzymes.
No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by
CYP2C9.
Emposil (50 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (150 mg).
Emposil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08%.
In a study of healthy male volunteers, sildenafil (100 mg) did not affect the steady-state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrate.
Emposil was shown to potentiate the hypotensive effects of nitrates and its administration in patients who also use nitric oxide donors or nitrates in any form is therefore contraindicated.

Storage
Store below 30°C and keep in dry place.
Keep out the reach of children

PRESENTATION
Emposil 50 mg film - coated tablet:
Available in boxes containing 1 blister @ 4 film coated tablets.
Reg.No:DKI1027700417A1
Emposil 100 mg film - coated tablet:
Available in boxes containing 1 blister @ 4 film coated tablets.
Reg.No: DKI1027700417B1

HARUS DENGAN RESEP DOKTER
Manufactured by
Actavis Ltd, Malta
Imported and packed by
PT Actavis Indonesia, Jakarta
(Actavis Group, Iceland)
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Sunday, February 27, 2011

Simryl

SIMRYL®
Kaplet
Glimepiride

KOMPOSISI:
SIMRYL® - 2 : Tiap kaplet mengandung glimepiride 2 mg.
SIMRYL® - 3 : Tiap kaplet mengandung glimepiride 3 mg.

FARMAKOLOGI:
Farmakodinamik
Glimepiride adalah antidiabetik oral golongan sulfonilurea yang bekerja dengan merangsang pelepasan insulin dari sel-sel beta pankreas.

Farmakokinetik
Glimepiride diabsorpsi hampir sempurna melalui saluran cerna dan kadar puncak ( C max ) dalam darah dicapai dalam 2 - 3 jam. Kadar glimepiride darah akan menurun bila diberikan bersama-sama dengan makanan. Volume distribusi glimepiride adalah 8.8 L, dan berikatan dengan protein plasma lebih dari 95 %. Glimepiride mengalami metabolisme oksidasi di hati terutama oleh enzim sitokrom P450 II C9. Metabolit glimepiride diekskresi melalui urin sebesar 80-90%, dan sisanya melalui feses.

INDIKASI
Untuk penderita diabetes melitus yang tidak bergantung pada insulin (Non Insulin Dependent Diabetes Mellitus, NIDDM atau diabetes melitus tipe II) yang kadar gula darahnya tidak dapat terkontrol walaupun telah melakukan diet, olahraga, atau dengan program penurunan berat badan.

KONTRA INDIKASI
  • Insulin Dependent Diabetes Mellitus {IDDM, atau diabetes melitus tipe I).
  • Diabetik ketoasidosis atau riwayat diabetik ketoasidosis.
  • Prekoma atau koma diabetikum.
  • Hipersensitif terhadap glimepiride, sulfonilurea lain, sulfonamid, penderita yang mempunyai resiko untuk terjadi reaksi hipersensitif.
  • Gangguan fungsi hati dan ginjal.
  • Wanita hamil dan menyusui.

ATURAN PAKAI
  • Dosis glimepiride harus dimulai dari dosis terendah dan harus di bawah pengawasan dokter.
  • Bila terjadi kealpaan, misalnya lupa minum obat, tidak boleh dikoreksi dengan dosis yang lebih tinggi.
  • Dosis awal dan dosis pemetiharaan ditetapkan berdasarkan hasil pemeriksaan kadar gula darah dan tes urin secara rutin.
    • Dosis awal dan dosis titrasi: Selalu diawali dengan dosis 1 mg glimepiride sekali sehari. Jika perlu dosis dinaikkan secara bertahap berdasarkan monitoring kadar guia darah dan tes urin, dengan interval misalnya satu sampai 2 minggu, yaitu : 1 mg - 2 mg - 3 mg - 4 mg - 6 mg, dan 8 mg pada kasus tertentu (luar biasa).
    • Rentang dosis pada penderita diabetes yang terkontrol dengan baik adalah pada dosis 1 sampai 4 mg glimepiride sehari. Hanya sebagian kecil penderita yang memerlukan dosis lebih dari 6 mg sehari untuk dapat mencapai kadar gula darah yang diharapkan.
    • Distribusi dosis : waktu dan distribusi dosis ditetapkan oleh dokter. Tetapi biasanya dosis tunggal glimepiride sudah memadai. Glimepiride diberikan segera sebelum makan pagi atau sebelum makan makanan utama yang merupakan makanan pertama pada pagi hari tersebut. Penting diperhatikan agar jangan menggunakan glimepiride tanpa dilanjutkan dengan makan.
Pertimbangan lain dalam pemberian dosis :
Bila terdapat sensitivitas berupa peningkatan insulin yang berlebihan akibat glimepiride sebaiknya pemberian glimepiride dihentikan. Untuk menghindari terjadinya hipoglikemia harus dipertimbangkan pengurangan dosis glimepiride yang diiakukan secara bertahap. Pemberian dosis sebaiknya disertai dengan perbaikan berat badan dan perbaikan pola makan.

Lama Pengobatan
Pengobatan dengan glimepiride merupakan pengobatan jangka panjang.

Peralihan dari obat antidiabetik oral lain ke glimepiride :
Tidak terdapat hubungan yang nyata antara dosis dengan obat antidiabetik oral lainnya.
Harus dipertimbangkan efek potensiasi dan pengaruh duration of action masing-masing obat berkaitan dengan resiko hipoglikemia.

Cara pemberian :
Glimepiride harus ditelan (tanpa dikunyah) dengan air secukupnya (+ 1/2 gelas).

EFEK SAMPING
  • Hipoglikemia dengan gejala - gejala seperti sakit kepala, takikardia, lapar, dan lain - lain.
  • Mata : gangguan penglihatan yang sesaat.
  • Saluran cerna : mual, muntah, perasaan penuh / tertekan pada epigastrium, nyeri abdomen, dan diare.
  • Hati: gangguan fungsi hati.
  • Darah : dapat terjadi gangguan pada darah walaupun relatif jarang terjadi seperti anemia hemolitik, eritrositopenia, leukopenia, granulositopenia, agranulositosis, trombositopenia, dan pansitopenia.
  • Lain-lain : reaksi alergi, misalnya urtikaria atau kulit kemerahan yang dapat berianjut atau disertai gejala sesak nafas dan hipotensi sampai terjadi syok. Jika gejala urtikaria timbul, dokter harus waspada akan timbulnya gejala-gejala lanjutan tersebut. 
PERINGATAN DAN PERHATIAN
Sebelum memulai pengobatan, penderita harus diberitahu efek samping atau resiko penggunaan glimepiride dan pentingnya diet dan atau olah raga agar tercapai kadar gula yang diharapkan.
Pada minggu-minggu pertama pengobatan dapat terjadi resiko hipoglikemia. Faktor-faktor yang mempermudah timbulnya hipoglikemia adalah :
  • Kemalasan / ketidakpatuhan ( unwillingness ),
  • makan tidak teratur, undernutrition, sedang puasa,
  • perubahan pola diet.
  • mengkonsumsi alkohol (terutama bila disertai intake makanan yang kurang).
  • kelainan fungsi ginjal,
  • kelainan fungsi hati yang parah,
  • dosis berlebihan (overdosis),
  • adanya penyakit-penyakit sistem endokrin yang mempengaruhi metabolisme karbohidrat (misalnya : tirotoksikosis),
  • menggunakan obat-obat lain (lihat "interaksi obat" ).
Selama pengobatan dengan glimepiride, kadar gula harus diperiksa secara periodik, karena dapat terjadi hipoglikemia atau hiperglikemia khususnya pada awal - awal pengobatan atau bila penggunaan glimepiride yang tidak teratur, maka sebaiknya hindarilah aktivitas - aktivitas yang memerlukan perhatian khusus.
Khasiat dan keamanan penggunaan pada anak-anak belum diketahui dengan pasti.

INTERAKSI OBAT
Efek potensiasi penurunan kadar gula darah sampai hipoglikemia dapat terjadi, bila glimepiride diberikan bersama - sama dengan insulin atau obat antidiabetik oral yang lain, obat golongan ACE Inhibitor, atopurinol, steroid anabolik dan hormon seks, kloramfenikol, derivat kumarin, penghambat MAO, mikonazol, parasetamol, pentoksifilin ( dalam dosis tinggi secara parenteral ), fenilbutazon, azapropazon, oksifenbutazon, probenesid, kuinolon, salisilat, sulfinpirazon, sulfonamid. tetrasiklin, tritoqualine, trofosfamid.
Penurunan sedikit kadar gula darah atau bahkan dapat menimbulkan kenaikan kadar gula darah, apabila glimepiride diberikan bersama - sama dengan asetazolamid, barbiturat, kortikosteroid, diazoksid, diuretik, epinefrin ( adrenalin ), dan golongan simpatomimetik lain, glukagon, laksatif, asam nikotinat ( dalam dosis tinggi ), estrogen dan progesteron, fenotiazin, rifampisin, hormon tiroid. Antagonis reseptor H,, klonidin, dan reserpin dapat menimbulkan efek potensiasi atau bahkan melemahkan efek hipoglikemik glimepiride.
Di bawah pengaruh obat - obat simpatolitik misalnya antagonis reseptor beta, klonidin, guanetidin, dan reserpin, tanda - tanda adrenergik counter regulation karena hipoglikemia berkurang sampai hilang, sehingga bila diberikan bersama dengan glimepiride akan menutupi gejala - gejala hipoglikemia.
Efek derivat kumarin dapat melemahkan atau bahkan menimbulkan efek potensiasi dengan glimepiride. Sedangkan efek yang timbul pada penggunaan alkohol, akut maupun kronik belum dapat diprediksi.

KEMASAN:
SIMRYL® - 2 : Kotak, 5 blister@ 10 kaplet, No. Reg. DKL0928204304B1
SIMRYL® - 3 : Kotak, 5 blister@ 10 kaplet, No. Reg. DKL0928204304C1

HARUS DENGAN RESEP DOKTER
Simpan di tempat sejuk (15 - 25°C) dan kering.

Diproduksi oleh :
PT. LAPI LABORATORIES, SERANG - INDONESIA
Untuk
PT. SIMEX PHARMACEUTICAL INDONESIA
Sukabumi - Indonesia
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Saturday, February 26, 2011

Esilgan

ESILGAN® Tablets
Estazolam 2 mg
For Sleep Disturbances

COMPOSITION :
Esilgan is available as a white, scored tablet.
Each tablet contains: Estazolam 2 mg

MECHANISM OF ACTION :
Estazolam inducing sleep action through the sleep centre of the brain which control the physiologic function when sleeping.

INDICATIONS :
All types of sleep disturbances due to nervousness, anxiety, tension, psychosis and other disorders such as post-operative pain, trauma.

ADMINISTRATION AND DOSAGE :
The usual dosage in adults is as follows :
Neurosis, internal disorders:1/2 to 1 tablet orally at bedtime
Psychosis, schizophrenia:1 to 2 tablets orally at bedtime
Night before operation:1/2 to1 tablet orally at bedtime
Dosage should be adjusted according to age, symptom and condition of the patient.

CONTRA-INDICATIONS :
- Should not be administered in patient with myasthenia gravis.
- Patient with known hypersensitivity to the drugs.

ADVERSE REACTIONS :
Drowsiness, dizziness, light-headed feeling and lassitude may occur.

PRECAUTIONS :
  • Should not be administered in patients with myasthenia gravis.
  • In principle, should not be administered in the patients whose respiratory function is severely depressed, but when required, must be administered cautiously.
  • Administration of Esilgan must be promptly discontinued if signs of hypersensitivity occur.
  • As with other CNS drugs, the effect of Esilgan may be intensified with the combined use of other CNS depressants (hypno-sedatives and phenothiazine derivatives), anti-depressants and MAO inhibitors.
  • Alcohol should be avoided.
  • Esilgan may modify reaction of patients in driving, operating machines etc. depending on individual sensitivity.
  • Dependence to Esilgan may develop when taken for a long period.
  • Administer carefully in the debilitated or elderly patients (Administration should be initiated at the dose of 1 mg).
  • Use in caution in the presence of cardiac, renal and hepatic dysfunction.
  • Safety of Esilgan in infants and in women who are or who may become pregnant has not been established.
INTERACTION :
Concomitant administration of estazolam with other depressant drugs (hypno-sedative and derivate phenothiazine), antidepressant, MAO inhibitor and alcohol may result in increase effect of estazolam.

STORAGE:
At room temperature (25 - 30°C)

PACKAGE:
Box, 10 strips @ 10 tablets

REGISTRATION NO. :
DPL7825102910B1

ON MEDICAL PRESCRIPTION ONLY

P.T. TAKEDA INDONESIA, Bekasi, Indonesia
Licensed by TAKEDA PHARMACEUTICAL COMPANY LTD., Osaka, Japan




ESILGAN®
Estazolam 2 mg
Untuk Gangguan Tidur

KOMPOSISI :
Esilgan adalah tablet berwarna putih dan bergaris.
Tiap tablet mengandung : Estazolam 2 mg

CARA KERJA:
Estazolam bekerja terhadap pusat tidur di otak (susunan sambungan) yang mengatur fungsi fisiologi waktu tidur.

INDIKASI :
Untuk segala macam gangguan tidur karena gugup, cemas, tegang, psikosis dan gangguan lain seperti nyeri setelah operasi, trauma.

CARA PEMAKAIAN DAN DOSIS :
Dosis untuk orang dewasa biasanya sebagai berikut:
Neurosis, gangguan dalam:1/2 -1 tablet sebelum tidur
Psikosis, skizofrenia:1 - 2 tablet sebelum tidur
Malam sebelum operasi:1/2 -1 tablet sebelum tidur
Dosis harus disesuaikan menurut umur, gejala dan kondisi pasien.

KONTRA-INDIKASI :
- Tidak boleh diberikan pada penderita myasthenia gravis.
- Penderita yang hipersensitif terhadap komponen obat.

EFEK SAMPING :
Seperti gejala drowsiness, dizziness, lightheadedness dan lassitude.

PERHATIAN :
  • Tidak boleh diberikan pada penderita myasthenia gravis.
  • Pada prinsipnya jangan diberikan pada pasien yang fungsi pernapasannya sangat tertekan, tetapi bila diperlukan, maka pemakaiannya harus berhati-hati.
  • Bila terjadi gejala hipersensitif, pemakaian Esilgan harus dihentikan.
  • Khasiat Esilgan dapat diperkuat bila dipakai bersamaan dengan CNS depressant yang lain (hypno-sedative dan derivat phenothiazine), obat anti-depresi dan MAO inhibitor.
  • Hindari minuman alkohol bila mengkonsumsi Esilgan.
  • Tergantung pada kepekaan seseorang, Esilgan dapat mempengaruhi reaksinya sewaktu mengendarai mobil, menjalankan mesin dan lain-lain.
  • Pemakaian Esilgan dalam jangka waktu yang lama mungkin dapat menimbulkan ketergantungan.
  • Pemakaiannya harus berhati-hati bagi pasien yang lemah atau lanjut usia (pemakaian harus dimulai dengan dosis 1 mg).
  • Bila ada gangguan fungsi jantung, ginjal dan hati, maka pemakaian Esilgan harus berhati-hati.
  • Akibat pemakaian Esilgan pada bayi dan pada wanita yang sedang atau mungkin sedang hamil, aman atau tidaknya belum dapat dipastikan.
INTERAKSI OBAT :
Khasiat diperkuat bila dipakai bersamaan dengan CNS depressant yang lain (hypno-sedative dan derivat phenothiazine), obat anti-depresi dan MAO inhibitor. Juga diperkuat oleh alkohol.

CARA PENYIMPANAN :
Pada suhu kamar (25 - 30°C)

KEMASAN:
Dus berisi 10 strip @ 10 tablet

NO. REGISTRASI :
DPL7825102910B1

HARUS DENGAN RESEP DOKTER


P.T. TAKEDA INDONESIA, Bekasi, Indonesia
Dengan lisensi dari TAKEDA PHARMACEUTICAL COMPANY LTD., Osaka, Jepang
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Friday, February 25, 2011

Retaphyl SR

Retaphyl SR
Theophylline
SUSTAINED RELEASE CAPLET

COMPOSITION:
Each sustained release caplet contains:
Theophylline .......... 300 mg

PHARMACOLOGY:
Theophylline is methylxanthine derivate which act by stimulating the respiratory center and by relaxing the bronchial smooth muscles.

INDICATION:
To alleviate and control attacks of bronchial asthma.

CONTRA INDICATION:
- Patient with known hypersensitive to theophylline and derivate xanthin.
- Patient with gastric ulcer and diabetes mellitus.

DOSAGE AND ADMINISTRATION:
Adult : 1 caplet 2 times daily, morning and night.
Children › 6 years : 1/2 caplet 2 times daily, morning and night.
Caplets should not be chewed or crushed.

SIDE EFFECTS:
  • In usually dosage: nausea, vomiting, headache, diarrhea, palpitation, insomnia. In high dosage: gastric irritation, convulsions, toxicity acute such as arrhythmia, in children continuous vomiting can be hematemesis, CNS stimulation, diaphoresis and fever.
  • Cardiovascular: palpitation, tachycardia, ventricular arrhythmia.
  • Respiratory system: tachypnea.
  • Rash, hyperglycemia.
DRUG INTERACTION :
  • Theophylline increased excretion of lithium and effect anticoagulant. Concentration Theophylline at serum increased if used with Cimetidine, high dose Allopurinol, Erythromycin, Propanolol, Troleandomicin and oral contraception.
  • Theophylline should not be administered concurrently with other xanthine medications.
  • Rifampicin may result reduced serum theophylline.
WARNING AND PRECAUTION:
  • Should not be used during pregnancy and lactation unless in the judgement of the physician. Concurrent with ephedrine will increase toxicity, caution used in patient with hepatic Impairment, epilepsy.
  • Care should be taken in patient with hipoxemia, hypertension or patient with a history of gastric ulcer.
  • Theophylline may irritate the gastrointestinal tract
  • Do not given higher than the recommended dosage. If within 1 hour symptoms, persist or deteriote, contact the nearest primary care clinic, hospital or physician.
  • Caution should be exercised in patient › 55 years, particularly male and patients with chronic lung disease.
  • Safety and effectivity used in children ‹ 6 years not known.
STORAGE:
Store at room temperature (25 - 30° C), protected from light.

PACKAGING; REG. NO:
Box, 10 strips @ 10 Sustained release caplets / DKL9312514106A1

ON MEDICAL PRESCRIPTION ONLY

PT. KIMIAFARMA
BANDUNG - INDONESIA



Retaphyl SR
Theophylline
KAPLET LEPAS LAMBAT

KOMPOSISI:
Tiap kaplet lepas lambat mengandung:
Theophylline .......... 300 mg

FARMAKOLOGI:
Theophylline merupakan turunan metilxantin yang mempunyai efek antara lain merangsang susunan syaraf pusat dan melemaskan otot polos, terutama bronkhus.

INDIKASI:
Untuk meringankan dan mengatasi serangan asthma bronkhial.

KONTRA INDIKASI:
- Hypersensitivitas terhadap theophylline dan senyawa golongan xantin
- Penderita tukak lambung, diabetes.

ATURAN PAKAI:
Dosis dewasa : 2 kali sehari 1 kaplet, pagi dan malam.
Dosis anak lebih dari 6 tahun : 2 kali sehari 1/2 kaplet. pagi dan malam.
Tidak boleh dikunyah atau dihancurkan.

EFEK SAMPING:
  • Retaphyl pada dosis biasa dapat menimbulkan rasa mual, muntah, sakit kepala, diare, jantung berdebar, insomnia dan lain-lain. Pada dosis yang sangat tinggi dapat menimbulkan efek toksis, yaitu iritasi lambung dan konvulsi, toksisitas berat berupa aritmia, muntah terus menerus, pada anak-anak bisa terjadi hematemesis, stimulasi SSP, diaphoresis dan demam.
  • Kardiovaskuler, misalnya: palpitasi, takikardia, aritmia ventrikuler.
  • Pernafasan, misalnya: tachypnea.
  • Rash, hiperglikemia. 
INTERAKSI OBAT:
  • Theophylline meningkatkan ekskresi litium, meningkatkan efek antikoagulan. Dengan Cimetidin, Allopurinol dosis tinggi, Erythromicin, Propanolol, Troleandomisin dan kontrasepsi oral, konsentrasi Theopylline dalam serum meningkat.
  • Jangan diberikan bersamaan dengan preparat xantin yang lain.
  • Rifampicin menurunkan serum Theophylline. 
PERINGATAN DAN PERHATIAN:
  • Jangan diberikan pada wanita hamil dan menyusui, kecuali atas perintah dokter. Pemberian bersama efedrin akan meningkatkan toksisitas. Hati-hati diberikan pada penderita penyakit hati, epilepsi.
  • Hati-hati pada penderita hipoksemia, hipertensi atau penderita yang mempunyai riwayat tukak lambung.
  • Dapat mengiritasi saluran gastrointestinal.
  • Jangan melampaui dosis yang dianjurkan dan bila dalam satu jam gejala-gejalanya masih tetap atau bertambah buruk, agar menghubungi Puskesmas atau rumah sakit terdekat.
  • Hati-hati pemberian pada penderita diatas 55 tahun terutama pria dan pada penderita penyakit paru-paru kronik.
  • Keamanan dan efektifitas penggunaan sediaan pada anak-anak dibawah 6 tahun belum diketanui dengan pasti. 
PENYIMPANAN:
Simpan pada suhu kamar (25 - 30°C), terlindung dari cahaya

KEMASAN / NO.REG.:
Dus, 10 strip @ 10 kaplet lepas lambat; DKL9312514106A1

HARUS DENGAN RESEP DOKTER

PT. KIMIA FARMA
BANDUNG - INDONESIA
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Thursday, February 24, 2011

Proviron

Proviron®
For oral androgen therapy in the male
Important information, please read carefully!

Composition
1 tablet Proviron contains 25 mg Mesterolone

Properties
Proviron balances a deficiency of androgen formation which begins to fall gradually with increasing age. Therefore, Proviron is suitable for the treatment of all conditions caused by deficient endogenous androgen formation. In the recommended therapeutic dosage, Proviron will not impair spermatogenesis.
Proviron is especially well tolerated by the liver.

Indications
Androgen deficiency and Infertility in man.

Dosage and Administration
The tablets are to be swallowed whole with some liquid. Unless otherwise prescribed by the doctor the following dosages are recommend
  • Androgen deffidency: first dose 1 tablet 3-4 times (75-100 mg) per day, for several months and for maintenance dose 2-3 tablets (50-75 mg) per day.
  • Infertility in man: 4 tablets (100 mg) per day for several months.
Side effects
If, in individual cases, frequent or persistent erections occur, the dose should be reduced or the treatment discontinued in order to avoid injury to the penis.

Contraindications
Carcinoma of the prostate, previous or existing liver tumours.

Precautions
Androgens are not suitable for enhancing muscular development in healthy individuals or for increasing physical ability.
Proviron is for use in male patients only.
Regular examinations of the prostate should be carried out prophylactically.
In rare cases benign and in even rarer cases malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Proviron. The doctor must therefore be informed of the
occurrence of unusual upper abdominal complaints which do not disappear spontaneously within a short time, and stop take ttw medicine ifnecessary.
Please be careful in using androgen hormon or chorionik gonadotropin for a younger man which has postponed pubersitas because of early epiphysis fusion and decreased body postur.
The scientific brochure contains further information for the doctor.

Presentations
Box of 3 strips x 6 tablets Reg.No.:DKL7222806710Al

Harus dengan resep dokter

Store all drugs properly and keep them out of reach of children.

P.T. Schering Indonesia, Jakarta - Indonesia
manufactured under licence from
Schering AG, Germany



Proviron®
Pengobatan androgen oral untuk pria
Keterangan penting, bacalah dengan teliti!

Komposisi
1 tablet Proviron mengandung 25 mg Mesterolon.

Cara kerja obat
Proviron mengimbangi kekurangan pembentukan androgen yang mulai berangsur menurun dengan bertambahnya usia.
Karena itu, Proviron sesuai untuk pengobatan kondisi-kondisi yang disebabkan oleh kekurangan pembentukan androgen di dalam tubuh. Pada dosis pengobatan yang dianjurkan, Proviron tidak akan mengganggu spermatogenesis. Proviron mempunyai toleransi yang baik terhadap hati.

Indikasi
Defisiensi androgen dan infertilitas pada laki-laki.

Dosis dan cara pemakaian
Tablet Proviron ditelan bersama dengan air minum.
Jika tidak dianjurkan lain oleh dokter, dosis berikut ini dianjurkan:
  • Defisiensi androgen:
    • Dosis awal 3-4 x 1 tablet (75-100 mg) sehari, selama beberapa bulan.
    • Dosis pemeliharaan 2-3 tablet (50-75 mg) sehari.
  • Infertilitas pada laki-laki: 4 tablet (100 mg) sehari selama beberapa bulan.
Efek Samping
Bila, dalam kasus-kasus individual, terjadi ereksi yang sering atau terus-menerus, dosis harus diturunkan atau pengobatan dihentikan untuk mencegah luka pada penis.

Kontraindikasi
Kanker prostat, tumor hati yang sedang atau baru saja diderita.

Peringatan dan Perhatian
Androgen tidak diindikasikan untuk memperkuat perkembangan otot pada individu-individu yang sehat atau untuk meningkatkan kemampuan fisik.
Proviron hanya digunakan pada penderita pria saja.
Pemeriksaan prostat secara berkala harus dilakukan sebagai tindakan pencegahan.
Walaupun jarang, tumor hati yang jinak dan walaupun jarang sekali, tumor hati yang ganas yang dalam kasus tertentu dapat menimbulkan perdarahan intraabdominal yang membahayakanjiwatelah didapati setelah penggunaanbahan hormon seperti yang terdapat dalam Proviron. Dokter harus diberitahu jika ada keluhan-keluhan abdominal bagian atas yang tidak biasa terjadi, dan yang tidak bisa hilang secara spontan dalam waktu yang singkat, apabila perlu pengobatan dihentikan.
Hati-hati penggunaan hormon androgen atau gonadotropin korionik pada pengobatan anak laki-laki yang mengalami penundaan pubertas karena fusi epiphysis dipercepat dan menyebabkan posturtubuh menjadi pendek.
Keterangan lebih lanjut terdapat dalam brosur ilmiah untuk dokter.

Kemasan
DOS berisi 3 strip x 6 tablet No.Pend.:DKL7222806710Al

Simpanlah semua obat dengan baik dan jauhkan dari jangkauan anak-anak.

Harus dengan resep dokter

P.T. Schering Indonesia, Jakarta - Indonesia
dibuat atas lisensi dari
Schering AG, Germany
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Wednesday, February 23, 2011

Lutenyl

Lutenyl®
Nomegestrol acetate
Hormone

Composition
Each caplet contains Nomegestrol Acetate 5 mg

Mode of actions
Hormones - progestogens
  • Synthesis progestogen derived from 19-norprogesterone
    1. True pseudogestagen, compensates for progesterone deficiency Lutenyl's affinity for the progesterone receptor is 2.5 times greater than that of the natural hormone.
    2. Devoid of any androgenic, anabolizing, estrogenic, corticoadrenal and anti-inflammatory effect. It does not interfere with glucide metabolism nor with water and electrolyte metabolism. It does not affect BSP clearance.
  • Administered from the 5th to 25th day at the usual dose of 5 mg per day, Lutenyl suppresses the ovulatory peak of the gonadotrophins, reduces the level of circulating oestrogens and prevents progesterone secretion.
  • Clinical and biological studies show Lutenyl has good general and digestive tolerance without parallel adverse effects (hormonal, vascular, hepatic or metabolic).
Indications
  • Symptoms linked to progesterone deficiency, particularly in the perimenopausal period (menstrual irregularities, premenstrual syndrome, mastodynia)
  • Functional uterine bleedings and menorrhagia of fibromas
  • Endometriosis
  • Dysmenorrhoea
  • Hormone replacement therapy combination with estrogens
Dosage and administration
The average daily dose is 5 mg. Usual treatment length is 10 days per cycle, from the 16th to the 25th day
inclusive.
Nevertheless, both the dose and duration of treatment can be adjusted according on the type of indication and the patients response.

Warning and precautions
Women who are breast-feeding because of the passage of steroids into breast milk.
In some indications, particularly dysmenorrhoea, uterine haemorrhage and amenorrhoea. it is essential to ensure the disorder is functional in nature before treatment is started.
Before starting treatment, the doctor should ascertain no adenocarcinoma of the breast or endometrium exists.
Although no cases have been reported with Lutenyl, thromboembolic and metabolic risk cannot be completely discounted. Consequently, the administration of the product must be stopped should any of the following signs occur ; ocular disorders such as unilateral loss of vision, diplopia, vascular lesions of the retina, thrombotic or venous thromboembolic incidents, severe headaches.
As with all steroid hormones, care must be taken with patients with a history of myocardial infarction or
cerebrovascular disease, arterial hypertension or diabetes.

Side Effects
  • Menstrual disorders, amenorrhoea, breakthrough bleeding
  • Exceptionally: weight gain, insomnia, pilosis, gastrointestinal disorders
  • Although these have never yet been reported with Lutenyl:
    • Aggravation of venous insufficiency in the legs
    • Possibility of cholestatic icterus and pruritus
Contraindications
These are common to all synthetic progestogens:
  • History of thrombophlebitis
  • Serious liver dysfunction
  • Non-diagnosed genital haemorrhage
  • Pregnancy
Drug Interactions
Association requiring precautions for use
Anti diabetic drugs because of the diabetogenic effect of high doses of progestogens. The patient should be
warned and urine and glycaemia monitoring must be more frequent.
If needed, the anti diabetic posology can be adjusted during and after treatment with progestogens.

inadvisable associations
Anti-convulsants (carbamazepine, phenobarbitone, phenytoin, primidone), barbiturates, griseofulvin,
rifampicin.These drugs reduce the efficacy of progestogens through enzyme induction..

Pregnancy and lactation
The risks concerning the sexual differentiation of the foetus (particularly female), previously described for the
older extremely androgenomimetic progestogens, do not extend to the more recent progestogens which are
much less or not at all androgenomimetic (as it the case for the one used in this preparation).
The passage of steroids into breast milk should betaken into consideration.

Presentation
Box of 3 x 10 caplets in blister

Storage
Store below 25°C

On medical prescription only
"Harus dengan resep dokter"

Manufactured by
Theramex, Monaco Cedex
Imported by
PT. Merck Tbk., Jakarta
Reg.No.: DKI0272600104A1
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Tuesday, February 22, 2011

Myores

MYORES®
Tablet

KOMPOSISI:
Tiap tablet mengandung;
Tizanidine HCl setara dengan Tizanidine .................... 2 mg

FARMAKOLOGI:
MYORES® mengandung Tizanidine HCl suatu agonis reseptor alpha-2 adrenergik, yang bekerja secara sentral dalam merelaksasi otot, dengan cara meningkatkan hambatan presinap pada neuron motorik, tempat kerja utama yaitu pada saraf spinal. Pada hewan percobaan Tizanidine tidak memiliki efek langsung terhadap sarat otot rangka atau sambungan neuromuskuler, dan tidak berefek pada reftekg spinal monosinap. Tizanidine lebih banyak bekBrja pada jalur polisinap yang bertanggung jawab lerhadap tonus otot secara menyeluruh.

INDIKASI:
MYORES® diindikasikan untuk nyeri otot karena spasme yang dihubungkan dengan gangguan statis dan fungsional tulang belakang (sindroma servikal dan lumbal); nyeri otot karena spasme setelah operasi seperti pada hernia diskus intervertebralis atau osteoartritis pada panggul; sebagai terapi tambahan pada spasme karena gangguan saraf seperti multiple sclerosis, myelopathy kronis, penyakit degenerate pada saraf spinal, kelainan pembuluh darah otak dan kelumpuhan saraf otak.

KONTRA INDIKASI:
- Hipersensitif terhadap Tizanidine dan komponen obat lainnya.
- Penderita kerusakan fungsi hati

PERINGATAN PERHATIAN:
  • Hati-hati penggunaan pada penderita dengan gagal fungsi ginjal dan hati, diperlukan penyesuaian dosis.Karena Tizanidine kemungkinan dapat menyebabkan kantuk, perhatian harus diberikan terutama untuk mengoperasikan mesin dan mengendarai kendaraan bermotor.
  • Hati-hati pada penderita dengan hipotensi ortostatik karena Tizanidine dapat menurunkan tekanan darah.
  • Tidak dianjurkan penggunaan pada anak di bawahl8tahun.
  • Keamanan penggunaan pada wanita hamil & menyusui belum diketahui dengan pasti.
  • Tidak dianjurkan penggunaan pada penderita usia lanjut.
  • Selama minum obat ini dianjurkan untuk melakukan pemantauan fungsi hati.

EFEK SAMPING:
Pada dosis rendah sesuai dengan yang dianjurkan untuk mengatasi nyeri otot karena spasme, efek samping biasanya ringan dan bersifat sementara antara lain : mulut kering, mengantuk, pusing, rasa lelah.
Pada dosis yang lebih tinggi efek samping akan lebih sering terjadi walaupun jarang sampai menyebabkan penghentian pengobatan, antara lain lemah otot, insomnia, hipotensi, bradikardi.

OVER DOSIS:
Sejauh ini baru dilaporkan 1 kasus pada penggunaan Tizanidine 400 mg dengan gejala-gejala mual, muntah, sakit kepala, hipotensi, miosis, sesak nafas sampai koma.
Tindakan perawatan : bUas lambung, dilanjutkan dengan pemberian karbon aktif dan diuresis paksa. Lakukan pengukuran penunjang untuk sistem pernafasan dan kardiovaskular.

INTERAKSI OBAT:
Alkohol dapat meningkatkan AUC Tizanidine, hal ini dihubungkan dengan jaeningkatan efek samping Tizanidine yaitu efek depresan terhadap sistim saraf pusat.
Tizanidine dapat memperlambat Tmax Acetaminophen sampai 16 menit, tetapi Acetaminophen tidak mempengaruhi farmakokinetik Tizanidine.
Tizanidine dapat meningkatkan efek obat-obat antihipertensi (termasuk diuretik), sehingga menyebabkan hipotensi dan bradikardi.
Jangan diberikan bersamaan dengan agonis alpha-2 adrenergik lainnya.

DOSIS:
Nyeri otot karena spasme: 2 mg - 4 mg /I - 2 tablet, 3 kah sehari.
Pada kasus yang berat: dapat ditambah dosis tambahan 2 mg atau 4 mg (1 atau 2 tablet) diberikan pada malam hari.
Pengobatan tambahan untuk spasme yang disebabkan karena gangguan saraf : Dosis awal: tidak boleh lebih besar dari 6 mg sehari dalam 3 dosis terbagi, dapat ditingkatkan bertahap 2 mg - 4 mg dengan interval 1/2 minggu atau 1 minggu.
Respon terapi optimal biasanya dicapai dengan dosis sehari 12 - 24 mg dalam 3-4 dosis terbagi. Dosis maksimal 36 mg sehari,

KEMASAN:
Dus, isi 10 strip @ 10 tablet
No. Reg.: DKL0515618510A1

HARUS DENGAN RESEP DOKTER

Simpan pada suhu kamar (25 - 30 )° C, kering dan terlindung dari cahaya

p.t. meprofarm
BANDUNG - INDONESIA
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Monday, February 21, 2011

Sohobion

SOHOBION®
Vitamin neurotropik

KOMPOSISI:
SOHOBION®
Tiap tablet salut selaput mengandung :
Vit B1 100 mg
Vit B6 200 mg
Vit B12 200 mcg

SOHOBION® 5000
Tiap tablet salut selaput mengandung :
Vit B1 100mg
Vit B6 100mg
Vit B12 5000 mcg

INDIKASI:
Untuk pencegahan dan pengobatan penyakit karena kekurangan vitamin B1, B6 dan B12 seperti beri-beri, neuritis perifer dan neuralgia.

DOSIS DAN CARA PEMAKAIAN :
SOHOBION®: 1 tablet salut selaput sehari sesudah makan.
SOHOBION® 5000: 1 tablet salut selaput sehari sesudah makan.
Dalam keadaan tertentu dosis dapat ditingkatkan sesuai petunjuk dokter.

SIFAT :
Vitamin B1 berperan sebagai koenzim pada dekarboksilasi asam alfa-keto dan berperan dalam metabolisme karbohidrat.
Vitamin B6 di dalam tubuh berubah menjadi piridoksal fosfat dan piridoksamin fosfat yang dapat membantu dalam metabolisme protein dan asam amino.
Vitamin B12 berperan dalam sintesis asam nukleat dan berpengaruh pada pematangan sel dan memelihara integritas jaringan saraf.

PERINGATAN DAN PERHATIAN :
Sebaiknya tidak digunakan untuk pasien yang sedang menerima terapi levodopa.

EFEK SAMPING :
Penggunaan vitamin B6 dosis besar dalam jangka waktu lama dapat menimbulkan sindroma neuropati.

KONTRA INDIKASI :
Hipersensitif terhadap komponen obat ini.

KEMASAN:
SOHOBION®: Box, 10 strip @ 10 tablet salut selaput DBL 0624222417A1
SOHOBION® 5000: Box, 10 strip @ 10 tablet salut selaput DBL 0624222417B1

SIMPAN DI BAWAH SUHU 30°C TERLINDUNG DARI CAHAYA

PT SOHO INDUSTRI PHARMASI
JAKARTA - INDONESIA
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Sunday, February 20, 2011

Pankreon For Children

Pankreon®
Pancreatin-Vitamin
FOR CHILDREN
Orange Flavour

NATURAL DIGESTIVE ENZYMES WITH VITAMINS

COMPOSITION
One bag of 5 gram granules contains :
Pancreatin 494 mg corresponding to
Lipase17500 FIP* units
Amylase10000 FIP* units
Protease1000 FIP* units
Vitamin A2000 IU
Vitamin B120.001 mg
Folic acid0.4 mg
*FIP = Federation Internationale Pharmaceutique

PROPERTIES
Pankreon for children is a granulate specially formulated to meet the children's taste. It provides highly concentrated natural pancreatic enzymes as well as Vitamin A, 812 and folic acid to restore inadequate digestive activity. Vitamin A regulates the anabolism and activity of epithelial tissues and increases resistance to infection. Vitamin B12 is essential for normal erythropoiesis and also exerts a general tonic effect. Similary, folic acid is essential for normal naemopoiesis and for the functioning of the intestinal mucosa.

INDICATIONS
- Failure to thrive
- Loss of appetite
- Chronic recurrent diarrhoea
- Dystrophy and atrophy as a result of nutritional deficiency
- Dyspepsia in the weaning stage
- Reduced tolerance to food
- Post-infective dyspepsia
- Digestive disorders following antibiotics
- Meteorism
- Cystic fibrosis of the pancreas (mucoviscidosis)

DOSAGE
Infants : 1/2 bag (2.5 grams)
Children : 1 bag (5 grams)
To be given with the meals.

PREPARATION AND ADMINISTRATION
Mix the indicated quantity of Pankreon for children with an equal volume of water and leave it to stand for 2-3 minutes until a jelly is formed. The jelly can be given neat, or with fruit juice, lukewarm tea or apple puree. It should not be mixed with hot liquids, milk or flour and starch mixtures.

PRESENTATION
Boxes, containing 10 bags @ 5 grams. (Reg. No. : D.2017076)

Manufactured by
PT. Kimia Farma, Jakarta - Indonesia



Pankreon®
Pancreatin-Vitamin
UNTUK ANAK-ANAK
Rasa Jeruk

ENZIM PENCERNAAN ALAMIAH DENGAN VITAMIN

KOMPOSISI
Tiap kantong @ 5 gram granul mengandung:
Pancreatin 494 mg yang setara dengan
Lipase17500 satuan FIP*
Amylase10000 satuan FIP*
Protease1000 satuan FIP*
Vitamin A2000 IU
Vitamin B120.001 mg
Folic acid0.4 mg
*FIP = Federation Internationale Pharmaceutique

SIFAT-SIFAT
Pankreon untuk anak-anak adalah granul yang khusus dibuat sesuai dengan selera anak-anak. Obat ini mengandung enzim-enzim pankreas alamiah dalam konsentrasi tinggi dan juga vitamin A, vitamin 612 serta asam folat, yang bertujuan untuk memperbaiki aktivitas alat pencernaan. Vitamin A mengatur anabolisme dan aktivitas jaringan epitel serta meningkatkan resistensi terhadap infeksi. Vitamin B12 sangat dibutuhkan untuk eritropoiesis normal dan juga mempunyai efek penguat.Demikian pula asam folat sangat diperlukan untuk hemopoiesis normal dan berfungsinya mukosa usus halus.

INDIKASI
- Gangguan pertumbuhan
- Kehilangan nafsu makan
- Diare kronis yang berulang-ulang
- Distrofi dan atrofi akibat kurang gizi
- Dispepsia pada masa penyapihan
- Berkurangnya toleransi terhadap makanan
- Dispepsia setelah infeksi
- Gangguan pencernaan setelah pemberian antibiotik
- Meteorisme
- Fibrosis kistik pada pankreas (mucoviscidosis)

DOSIS
Bayi : 1/2 kantong (=2,5 gram)
Anak-anak : 1 kantong (= 5 gram)
Diberikan bersama-sama dengan makanan.

CARA PEMBERIAN DAN PENCAMPURAN
Campurkan sejumlah tertentu Pankreon untuk anak-anak dengan air dalam jumlah yang sama, lalu diaduk. Biarkan selama 2-3 menit sampai terbentuk selei. Selei dapat diberikan tersendiri atau dapat pula diberikan bersama sari buah atau air teh hangat.
Jangan dicampur dengan cairan-cairan yang panas, susu, campuran tepung terigu atau sagu.

KEMASAN
Dalam dus berisi 10 kantong 0 5 gram (No. Reg.: D.2017076)

Diproduksi oleh
PT. Kimia Farma, Jakarta - Indonesia
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Saturday, February 19, 2011

Arcalion 200

arcalion
sulbutiamine

COMPOSITION
Each sugar-coated tablet contains 200 mg of sulbutiamine.

INDICATIONS
Treatment of certain physical or mental inhibition states involving reduced activity and apathy.
In confirmed depressive states, this medicine does not eliminate the need for specific antidepressant treatment.

DOSAGE AND ADMINISTRATION
FOR ADULT USE ONLY.
2 to 3 tablets daily.
Tablets should be swallowed whole with a large glass of water, dividing the doses between the morning and midday meals.
Duration of treatment is limited to 4 weeks.

CONTRA-INDICAT10NS
ARCALION is contra-indicated in case of past-history of hypersensibility to one of the ingredients of the tablets.

WARNINGS AND PRECAUTIONS
Due to the presence of lactose, this drug is contra-indicated in the case of congenital galactosemia, the syndrome of malabsorption of glucose and galactose or a deficit in lactase.

Pregnancy and Lactation
There have been no teratogenic studies in animals.
Clinically, no fetal toxicity or malformation has been reported. However, follow-up of women exposed to ARCALION during pregnancy is insufficient to exclude such a risk.

Due to the absence of data concerning the excretion of ARCALION in breast milk, its use should be avoided in breastfeeding women.

SIDE EFFECTS
Possibility of neuro-physic side effects (tremor, malaise, headaches, agitation), of skin allergy and digestive disorders.
Due to the presence of sunset yellow FCF, risk of allergic reactions.

OVERDOSAGE
In cases of massive absorption, there may be agitation with euphoria and tremor of the extremities.
These disorders are transient and rapidly resolved.

PHARMACODYNAMIC PROPERTIES
In man:
ARCALION has been studied in controlled clinical trials versus placebo or reference products by using psychometric evaluation scales and tests. These trials demonstrate the psychoactive effect of this drug, with a predominant action on psychological and physical inhibition.

PHARMACOKINETIC PROPERTIES
Sulbutiamine is rapidly absorbed and the peak blood concentration is reached between one and two hours after administration.
The half-life is about five hours.
The elimination is urinary.

STORAGE
Store at room temperature (25°-30°C)
Shelf life: 3 years

PRESENTATION
Box of 60 sugar-coated tablets in 10 strips of 6 tablets

Reg. No.: DKL7604519516A1

HARUS DENGAN RESEP DOKTER

Manufactured by:
PT Darya-Varia Laboratoria Tbk
Gunung Putri, Bogor-lndonesia

Under licence of:
SERVIER
Les Laboratoires Servier
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Friday, February 18, 2011

Lesifit

Lesifit® Kapsul
Essential Phospholipid and Multivitamin

KOMPOSISI
Tiap kapsul mengandung:
%AKG
Lecithin300mg*
Vitamin Bl1,4mg116,67
Vitamin B21,6mg123
Vitamin B62mg153,85
Vitamin Bi23mcg125
Nicotinamide18mg111,59
Vitamin E10mg100
β-Carotene1,25mg34,7

% AKG berdasarkan diet 2.000 kkal.
* AKG belum ditetapkan.

KEGUNAAN
Lesifit® merupakan suplemen yang dapat digunakan untuk membantu metabolisme dan membantu memenuhi kebutuhan vitamin B kompleks, β-Carotene dan vitamin E.

PETUNJUK PENGGUNAAN
Diberikan pada saat makan, setiap hari 1 kali 1 kapsul atau sesuai kebutuhan.

KEMASAN
Dus, 10 strip @ 10 kapsul
Dus, 5 strip @ 10 kapsul

POM SD.061 327 551

SUPLEMEN MAKANAN

Simpan pada suhu kamar (25°-30°C).

Diproduksi oleh
PT Vitabiotics Healthcare
Bandung - Indonesia
Untuk
PT Sandoz Indonesia
Jakarta-Indonesia
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Thursday, February 17, 2011

Spasmium

SPASMIUM®

KOMPOSISI:
Tiap dragee mengandung:
Chlordiazepokside HCl ..... 5 mg
Phenylpropylethylamine ..... 30 mg

FARMAKOLOGI:
Spasmium® merupakan suatu kombinasi antispasmodik dan tranquilizer sehingga dapat menstabilkan fungsi viceromotor dengan cepat dengan cara menghilangkan hipermotilitas atau kejang dan sekaligus menghilangkan faktor-faktor emosional yang seringkali menjadi penyebab utamanya.

INDIKASI:
Gangguan-gangguan saluran cerna dan sistem urogenital seperti hipermotilitas, kejang saluran kemih dan rahim.

TAKARAN PEMAKAIAN :
Sehari 3 kali 1-2 dragee menurut umur, indikasi dan keadaan penderita. Untuk penderita yang lanjut usia dan penderita yang lemah diberikan takaran yang lebih kecil, yang dapat dinaikkan sampai takaran paling efektif yang dapat ditolerir dengan baik.

PERINGATAN DAN PERHATIAN :
Karena mengandung Chlordiazepokside HCl, Spasmium® dapat menyebabkan mengantuk pada penderita lanjut usia dan penderita yang lemah, tetapi pengaruh ini dapat dihindari dengan menyesuaikan takaran pemakaian yang tepat.
Selama penggunaan Spasmium®, hindari minum alkohol dan mengerjakan pekerjaan yang membutuhkan lebih banyak konsentrasi (misalnya mengemudi) harus berhati-hati, karena Chlordiazepokside HCl dapat mengurangi reaksi penderita.
Hindari pemakaian pada wanita hamil terutama trimester pertama. Penggunaan jangka lama dapat menyebabkan ketergantungan fisik atau psikis. Hati-hati bila diberikan pada penderita dengan gangguan hati dan ginjal.

EFEK SAMPING :
Perasaan lelah, pusing dan mengantuk.

KONTRA INDIKASI:
Penderita yang hipersensitif.

KEMASAN:
- Botol @ 200 dragee DPL 7224207216A1
- Box, 10 strip @ 10 dragee D2015874-I

HARUS DENGAN RESEP DOKTER

SIMPAN DI BAWAH SUHU 30°C
TERLINDUNG DARI CAHAYA

PT SOHO INDUSTRI PHARMASI
Jl. Pulogadung No. 6
JAKARTA - INDONESIA
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Wednesday, February 16, 2011

Enatin

Enatin®

Batu urin pada saluran kemih adalah timbunan keras zat padat yang membatu di saluran pembuangan air seni. Sekitar 10% batu ginjal berasal dari masalah metabolisme dimana diperkirakan bahwa kelebihan asam urat dalam urin, tingkat kalsium yang tinggi dalam darah atau penyerapan garam dari asam oksalat di usus yang berlebihan dapat menyebabkan terbentuknya batu ginjal. Protein juga berperan dalam pembentukan batu urin dengan meningkatkan keasaman air seni dan meningkatkan pengeluaran air seni yang mengandung asam urat, fosfor dan kalsium.

Gejala-gejala yng khas adalah rasa nyeri yang mencengkram yang muncul sebentar-sebentar, atau sering disebut kolik, anyang-anyangan (rasa ingin buang air kecil).
Umumnya batu urin terbentuk di dalam ginjal, dimana zat-zat sisa metabolisme berkumpul. Oleh karenanya batu urin sering disebut juga sebagai batu ginjal. Batu urin/ ginjal yang relatif kecil dapat keluar dengan sendirinya bersama dengan urin. Dalam perjalanannya keluar, batu urin/ ginjal sering kali mengendap/ tertinggal di kandung kemih, ureter maupun uretra dan bisa bertambah besar. Jika batunya sudah besar, maka perawatan lanjutan akan diperlukan, baik berupa operasi atau litotripsi (memecahkan batu dengan kejutan gelombang listrik/operasi sinar "laser"). Pengobatan dapat juga dilakukan dengan obat-obatan baik dari zat-zat kimiawi maupun dari bahan-bahan alami untuk meluruhkan batu urin/ ginjal serta mengeluarkannya. Obat-abatan dari bahan alami umumnya bersifat diuresis dan obat-obatan ini dapat membantu mencegah pembentukan batu urin/ ginjal, sehingga berkisar antara beberapa hari sampai maksimal 6 minggu pemakaian.

Pengobatan batu urin/ ginjal yang ideal tidak hanya meluruhkan dan mengeluarkan batu tersebut dari dalam tubuh, tetapi juga mengurangi rasa nyeri yang timbul dan mencegah pembentukan kembali dari batu urin/ ginjal itu sendiri. Disamping itu, bagi para penderita batu urin/ginjal, sangat disarankan untuk banyak minum air putih, sedikitnya 8 gelas per hari sehingga aliran air seni bisa ditingkatkan untuk mengencerkan konsentrasi
zat-zat pembentuk batu. Disarankan pula untuk tidak berlebihan mengkonsumsi makanan/minuman yang dapat memicu pembentukan batu urin/ ginjal seperti teh, kopi, gorengan, jerohan.

KOMPOSISI
Tiap kapsul lunak mengandung :
Oleum Lini150,00mg
Oleum Juniperi50,00mg
Oleum Menthapiperitae50,00mg

INDIKASI
Membantu meluruhkan batu oksalat di ginjal dan saluran kemih.

KONTRAINDIKASI
  • Penderita yang hipersensitif terhadap salah satu bahan obat.
  • Penderita yang memiliki kelainan fungsi/infeksi ginjal.
ATURAN PAKAI
2 kapsul, 3-4 kali sehari, 1 jam sebelum makan.

PERINGATAN DAN PERHATIAN
  • Dilarang digunakan oleh wanita hamil.
  • Pemakaian tidak boleh lebih dari 6 minggu berturut-turut.
  • Pemakaian jangka panjang dan dosis beriebih dapat menyebabkan iritasi dan kerusakan pada ginjal.
  • Hanya untuk penderita batu ginjal dan batu kandung kemih yang telah ditetapkan oleh dokter.
  • Selama penggunaan konsultasikan pada dokter secara berkala.
Simpan pada suhu ruangan terkontrol (dibawah 25°C)


KEMASAN
Botol isi 50 kapsul lunak No. Reg. POM TR. 091 304 961
Dus isi 2 blister @ 9 kapsul lunak No. Reg. POM TR. 091 304 971

Diproduksi oleh:
PT. Nova Chemie Utama

Untuk:
NOVELL PHARMACEUTICAL LABORATORIES
BOGOR-INDONESIA
JYFAQZ4P824Z
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Tuesday, February 15, 2011

Biosin

BIOSIN®

KOMPOSISI / COMPOSITION
Bilberry Extract 35 mg, Ginkgo Biloba Extract 20 mg, Beta Carotene Extract 50 mg, Phosphatidyl Choline 100 mg.

URAIAN / DESCRIPTION
BIOSIN Kapsul mengandung ekstrak Bilberry, Ginkgo Biloba, Beta Carotene dan Phosphatidyl Choline yang dapat membantu memelihara kesehatan mata. Bilberry merupakan antioksidan alami yang dapat melindungi fungsi mata dan meningkatkan ketajaman mata karena Bilberry dapat meningkatkan suplai darah
ke mata. Ginkgo Biloba memiliki efek kuat sebagai antioksidan di otak, retina dan sistem kardiovaskular. Beta Carotene merupakan Prekursor vitamin A yang mempunyai efek antioksidan dan Phosphatidyl Choline membantu memperbaiki aliran darah.
BIOSIN capsule contains Bilberry, Ginkgo Biloba, Beta Carotene and Phosphatidyl Choline extract which can help to maintain eyes health. Bilberry is pure antioxidant which can protect eyes function and sharpen eyes vision because Bilberry can increasing blood supply to eyes. Ginkgo Biloba has strong effect as antioxidant in brain, retina and cardiovascular system. Beta Carotene is vitamin A precursor which has antioxidant effect and Phosphatidyl Choline helps to maintain blood circulation.

KHASIAT / INDICATION
Sebagai antioksidan dan memelihara kesehatan fungsi mata.
As antioxidant and maintain eyes function.

KONTRAINDIKASI / CONTRAINDICATION
  • Hipersensitif terhadap Ginkgo Biloba.
  • Penderita yang mempunyai kecenderungan mengalami pendarahan intracranial.
  • Tidak boleh digunakan bersama dengan obat-obat yang menghambat pembekuan darah seperti warfarin, asetosal.
  • Hypersensitive with Ginkgo Biloba
  • Patient with intracranial bleeding.
  • Not to be taken with anticoagulant (warfarin and acetosal).
PERINGATAN DAN PERHATIAN / PRECAUTION
  • Tidak dianjurkan untuk anak-anak dibawah 12 tahun
  • Hati-hati penggunaan pada wanita hamil dan menyusui.
  • Not recommended for child under 12 years old.
  • Caution pregnant woman and nursing mother.
EFEK SAMPING / SIDE EFFECT
  • Kadang-kadang menyebabkan sakit kepala, gangguan saluran cerna ringan, alergi kulit, trombositopeni, epistaksis dan purpura.
  • Rarely can cause headache, mild digestive disturbance, skin allergy, trombocytopenia, epistaxis and purpura.
CARA PEMAKAIAN / DIRECTION
3 kali sehari 1 kapsul / 3 times a day 1 capsule

KEMASAN/ PACKAGE
Box, 5 strips @ 6 capsule
POM SD. 041 316921

SIMPAN DI TEMPAT SEJUK DAN KERING
STORE IN COOL AND DRY PLACE

PT. BIOVIT NUTRACEUTICAL FARMA
Jakarta - INDONESIA
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Monday, February 14, 2011

Opibright

OPIBRIGHT®

Formula OPIBRIGHT® mengandung ekstrak billberry yang dimaksudkan untuk membantu kesehatan mata.

KOMPOSISI :
Tiap tablet salut selaput mengandung:
Ekstrak Billberry80mg
Beta Karoten5mg
Retinol1.600IU
Vitamin E40mg

PETUNJUK PENGGUNAAN :
Sehari 2-3 kali 1 tablet.

PETUNJUK PENYIMPANAN :
Simpan di tempat sejuk dan kering, terlindung dari cahaya.
Simpan di luar jangkauan anak-anak.

KEMASAN DAN NO. REGISTRASI :
OPIBRIGHT® tablet salut selaput :
Box isi 3 blister @ 10 tablet @ 425 mg
POM SD.031505681

PT Otto Pharmaceutical Industries
BANDUNG - INDONESIA
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Sunday, February 13, 2011

ASTHIN B-OND

ASTHIN® B-OND Soft Capsule
Natural Astaxanthin 4 mg (AstaREAL® L10 40 mg), Extramel® 10 mg (Melon Extract)

KOMPOSISI :
Tiap soft capsule mengandung:
Natural Astaxanthin (AstaREAL® L10 40 mg) ... 4 mg
Extramel® (Melon Extract) ... 10mg

KEGUNAAN :
Memelihara kesehatan

TAKARAN PEMAKAIAN :
Sehari 1 kali 1 soft capsule

KEMASAN :
Box, botol @ 30 soft capsule
POM SD. 091 336 021

SIMPAN DI TEMPAT KERING DI BAWAH SUHU 25°C
TERLINDUNG DARI CAHAYA

Diproduksi oleh :
PT. PERTIWI AGUNG
Jl. DDN No 16. Sukadanau, Cikarang Barat
BEKASI 17843 - INDONESIA

Untuk :
PT SOHO INDUSTRI PHARMASI
JAKARTA-INDONESIA
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Saturday, February 12, 2011

Imforce

IMFORCE
SIRUP

Komposisi:
Tiap 5 ml mengandung:
Echinacea angustifolia 125 mg
Black elderberry 200 mg
Zinc picolinate 5 mg

Kegunaan:
Sebagai suplemen untuk membantu memperbaiki daya tahan tubuh.

Petunjuk Penggunaan:
Dewasa : 1 - 2 sendok makan sehari
Anak-anak : 1 sendok teh (5ml), 3 x sehari

Peringatan dan perhatian:
  • Tidak boleh digunakan oleh penderita multiple sklerosia, penyakit kolagen, leukosis, tuberkulosis, AIDS, kehamilan.
  • Tidak boleh digunakan bersama dengan produk immunosupresan.
  • Dapat terjadi reaksi alergi.
  • Tidak dianjurkan digunakan lebih dari 8 minggu.

Kontra Indikasi:
Penyakit Autoimun

Kemasan:
Botol @ 60 ml
Simpan di tempat sejuk dan kering terlindung dari cahaya.
No. Reg : POM SD.061 628 151

Dibuat oleh:
PT Ikapharmindo Putramas
Jakarta - Indonesia

Untuk:
PT Mahakam Beta Farma
Jakarta - Indonesia
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Friday, February 11, 2011

Primperan

PRIMPERAN
Gastro intestinal Tract Regulator

Primperan is a drug which is original in its chemical, pharmacological and therapeutic properties. Its active ingredient is a French discovery, i.e. Metoclopramide. The interest of Primperan resides in the effective character of its action in various digestive manifestations, commonly seen in medical practice: nausea, vomiting, persistent post prandial fullness, meteorism, epigastric discomfort or anorexia, abdominal discomfort or pain, hiccup and headaches associated with disorders of digestion.

COMPOSITION :
PRIMPERAN tablets 5 mg:Each tablet contains Metoclopramide HCl 5 mg
PRIMPERAN tablets 10 mg:Each tablet contains Metoclopramide HCl 10 mg
PRIMPERAN syrup:Each 5 ml syrup contains Metoclopramide HCl 5 mg
PRIMPERAN drops:Each 1 ml drops contains Metoclopramide HCl 2.6 mg
PRIMPERAN injection:Each 1 ml injection contains Meloclopramide HCl 5 mg
PRIMPERAN suppositories for adults:Each suppository contains Metoclopramide Base 20 mg
PRIMPERAN suppositories for children:Each suppository contains Metoclopramide Base 10 mg

INDICATIONS :
- Acute and recurrent gastroparesis.
- Heartburn associated with reflux esophagitis.
- Anaesthetic or post operative nausea and vomiting.

CONTRA INDICATIONS :
- Epilepsi.
- Gastrointestinal bleeding, mechanic obstruction or perforation.
- Pheochromocytoma.

PRECAUTION :
Dosage should be reduced in patients with renal distrubance as extrapiramidal symptoms may be enhanced.

ADVERSE REACTIONS:
Large doses may cause headache, anxiety, fatique, extrapyramidal symptoms.

DOSAGE AND DIRECTIONS FOR USE :
Primperan being a prescribed drug. the doses mentioned below are merely given as a recommendation :

ADULTS :
  • tablets : ½ to 1 tablets three times a day before meals.
  • syrup : 1 to 2 teaspoonful three times a day before meals.
  • suppositories for adults : 1 suppository to be inserted as required.
  • ampoules : in case of an acute syndrome 1 I.M. or I.V. injection which may be repeated if necessary.
CHILDREN :
  • syrup : 0,5 mg per kg of body wieght a day, in several divided doses.
  • oral drops : 0,1 mg per kg body weight per dose, three times daily according to doctor's prescription. To be given 30 minutes before meals and at bedtime.
  • suppositories for children : 1 suppository to be inserted, ½ mg per kg of body weight a day, according to the physician.
INFANT :
  • Use the oral drops only, 0,1 mg per kg body weight per dose, three times daily or according to doctor's prescription. To be given 30 minutes before meals and at bedtime.
Primperan may be associated with all classical drugs use in gastro-enterology. It does affect neither blood pressure nor the heart, if given simultaneously with digitalic coumpound. It has no action on the renal function and does not cause retention of any sort.

AVAILABILITY :
  • Primperan tablets of 5 mg in boxes of 100 Reg. No. DKL 8324202010A1
  • Primperan tablets of 10 mg in boxes of 100 Reg. No. DL. 2011640-I
  • Primperan syrup of 5 mg (a teaspoonfull) in bottles of 50 ml Reg. No. DKL 8924208337A1
  • Primperan drops of 0,1 mg per drop in bottles of 10 ml Reg. No. DKL 8924208236A1
  • Primperan injectie of 2 ml (10 mg) in boxes of 6 ampoules Reg. No. DL 2011649
  • Primperan suppositories for adults 20 mg per suppository in boxes of 6 Reg. No. D 6016003
  • Primperan suppositories for children of 10 mg per suppository in boxes of 6 Reg. No. D 6016002
Keep out of reach of children
With doctor's prescription only

KEEP IN A COOL AND DRY PLACE, PROTECTED FROM LIGHT

Manufactured in Indonesia under licence of
SESIF - PARIS - FRANCE

Tablet, Suppository, Syrup, Drops by ;
PT SOHO INDUSTRI PHARMASI, JAKARTA-INDONESIA

Injection by :
PT ETHICA, JAKARTA- INDONESIA
For
PT SOHO INDUSTRI PHARMASI, JAKARTA - INDONESIA



PRIMPERAN
Pengatur Fungsi Pencernaan

Primperan adalah suatu obat yang tersendiri dalam sifat-sifat kimiawi, farmakologi dan terapi. Zat aktifnya adalah penemuan dari Perancis, yaitu: Metoclopramide.
Primperan menarik perhatian karena memiliki cara kerja khusus pada berbagai kelainan pencernaan yang urnum dijumpai dalam bidang kedokteran; mual (nausea), muntah-muntah (vomiting); perasaan kenyang (sensation of heaviness), kembung (meteorism), tidak enak pada ulu hati (epigastric discomfort) atau kehilangan nafsu makan (anorexia), perut merasa tidak enak atau sakit (abdominal discomfort or pain), ceklukan (hiccup) dan sakit kepala karena gangguan pencernaan.

KOMPOSISI:
PRIMPERAN 5 mg tablet:Tiap tablet mengandung : Metoclopramide HCl 5 mg
PR1MPERAN 10 mg tablet:Tiap tablet mengandung : Metoclopramide HCl 10 mg
PRIMPERAN sirup:Tiap 5 ml sirup mengandung : Metoclopramide HCl 5 mg
PRIMPERAN drops:Tiap 1 ml drops mengandung : Metoclopramide HCl 2,6 mg
PRIMPERAN injeksi:Tiap 1 ml injeksi mengandung : Metoclopramide HCl 5 mg
PRIMPERAN suppositoria untuk dewasa:Tiap suppositoria mengandung : Metoclopramide Base 20 mg
PRIMPERAN suppositoria untuk anak:Tiap suppositoria mengandung : Metoclopramide Base 10 mg

INDIKASI :
- Meringankan/mengurangi gastroparesis akut dan yang kambuh kembali.
- Menghilangkan rasa panas sehubungan dengan reflux esophagitis.
- Menanggulangi mual dan muntah metabolik karena obat atau sesudah operasi.

KONTRA INDIKASI :
Penderita epilepsi, keadaan perdarahan gastrointestinal, obstruksi mekanik atau perforasi, heochromocytamas.

PERINGATAN DAN PERHATIAN:
Takaran harap dikurangi pada penderita dengan gangguan renal karena dapat meningkatkan gajala extrapiramidal.

EFEK SAMPING :
Pada takaran tinggi dapat menimbulkan pusing, ksgelisahan, lelah yang bertebihan, gejala extrapiramidal.

TAKARAN DAN CARA PEMAKAIAN :
Karena Primperan hanya dapat diperoleh melalui resep, takaran yang tercantum di bawah ini diberikan hanyalah sebagai pedoman;

DEWASA :
  • tablet Sehari tiga kali ½-1 tablet (1 tablets 10 mg), sebelum makan.
  • sirup Sehari tiga kali 1-2 sendok ten (1 sendoh teh = 5 ml = 5 mg), sebelum makan.
  • injeksi Pada keadaan akut 1 suntikan I.M. atau I.V. dapat diulang bilamana perlu (1 ampul = 2 cc = 10 mg). Pada pemeriksaan radiologik : 1-2 ampul I.V. atau 1-2 sendok makan sirup 5-15 menit sebelum pemeriksaan.
  • suppositoria : (untuk dewasa) 1 suppositoria dimasukkan ke dalam dubur sesuai dengan petunjuk dokter.
ANAK-ANAK :
  • sirup : 0,5 mg per kg berat badan/hari, dibagi dalam beberapa dosis.
  • drops : 0,1 mg/kg berat badan/kali sehari 3 kali atau menurut petunjuk dokter. Diberikan 30 menit sebelum makan dan waktu sebelum tidur.
  • suppositoria : (untuk anak-anak) 1 suppositoriaoria (for children) dimasukkan ke dalam dubur sesuai dengan petunjuk dokter dengan dosis 1/2 mg per kg berat badan.
BAYI :
  • Hanya drops, 0,1 mg/kg berat badan/kali, sehari 3 kali atau menurut petunjuk dokter. Diberikan 30 menit sebelum makan atau sebelum tidur.
Primperan dapat dipakai bersama-sama dengan semua obat yang umum dipakai pada gastro-enterologi. Primperan tidak mempengaruhi tekanan darah maupun jantung bila diberikan bersamaan dengan komponen digitalis. Primperan tidak mempengaruhi fungsi ginjal dan sama sekali tidak menyebabkan retensi.

KEMASAN:
  • Primperan tablet @ 5 mg dalam dus @ 100 No. Reg. DKL 8324202010A1
  • Primperan tablet @ 10 mg dalam dus @ 100 No. Reg. DL. 2011640-I
  • Primperan sirup (5 mg per 5 ml) dalam botol 0 50 ml No. Reg. DKL 8924208337A1
  • Primperan drops (0,1 mg per tetes) dalam botol @ 10 ml No. Reg. DKL 8924208236A1
  • Primperan injeksi (5 mg per 1 ml) dalam dus @ 6 ampul @ 2 ml per ampul No. Reg. DL 2011649
  • Primperan suppositoria untuk dewasa (20 mg per suppositoria) dalam dus @ 6 biji No.Reg.D6016003
  • Primperan suppositoria untuk anak-anak (10 mg per suppositoria) dalam dus @ 6 biji No. Reg. D 6016002
Jauhkanlah obat ini dari jangkauan anak-anak
Harus dengan resep dokter

SIMPAN DI TEMPAT SEJUK DAN KERING, TERLINDUNG DARI CAHAYA

Dibuat oleh
PT SOHO INDUSTRI PHARMASI, JAKARTA-INDONESIA

Dengan lisensi :
SESIF - PARIS - FRANCE
Untuk sediaan tablet, sirup, drop dan suppositoria

Untuk sediaan injeksi dibuat oleh :
PT ETHICA, JAKARTA - INDONESIA
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Aminovel 600

AMINOVEL® 600
Amino Acids, Carbohydrates, Electrolytes, Vitamins
For Intravenous Administration

AMINOVEL® 600 is a well-balanced mixture of L-Amino acids optimally proportioned for maximum protein synthesis. Sorbitol, vitamins and electrolytes supplement or nutritional needs for the body.

COMPOSITION (Each 500 mL contains):
Amino acids (L-form)25.0gSodium35mEq/L
D-Sorbitol50.0gPotassium25mEq/L
Ascorbic acid200.0mgMagnesium5mEq/L
Inositol250.0mgAcetate35mEq/L
Nicotinamide30.0mgMalate22mEq/L
Pyridoxine HCl20.0mgChloride38mEq/L
Riboflavin Sodium Phosphate1.25mg
Water for Injectionad 500 mLOsmolarityApprox.1160 mOsm/L

CONTENTS OF 25.0 g AMINO ACIDS:
L-Isoleucine1.60gL-Valine1.60g
L-Leucine1.20gL-Arginine (calculated as base)3.10g
L-Lysine (calculated as base)1.00gL-Histidine (calculated as base)0.50g
L-Methionine1.50gL-Alanine3.00g
L-Phenylalanine2.00gGlycine7.00g
L-Threonine1.00gL-Proline1.00g
L-Tryptophan0.50g

AMINOVEL® 600 is a sterile aqueous solution supplying approx. 600 calories per liter. Each lot is examined by exothermic substance test, sterility test and toxicity test and is manufactured under the severe standard.

INDICATIONS
AMINOVEL® 600 is recommended for parenteral nutrition supply in the following conditions:
  1. As supplement nutrition in the case of the impairment of the gastrointestinal tract as in clinical situation of short bowel syndrome, anorexia and severe gastrointestinal disorder.
  2. Prolonged gastrointestinal rest is necessary as in case of enterocutaneous fistulae and involving the gastrointestinal tract.
  3. In increased metabolic need as in the cases of severe burns,  trauma and after surgery.
  4. In other critical cases, which require exogenous nutrition such as tumor, severe infections, severe stress and protein deficiency.
CONTRA INDICATION
Patients with hypersensitivity to one of the components of solution.

DOSAGE AND ADMINISTRATION
  1. For internal disorder or presurgical protein deficiency: The usual adult dosage is 500 mL of AMINOVEL® 600 by intravenous drip infusion over 4-6 hours (20-30 drops per minute) simultaneously or followed by a 10% sugar solution 500 mL over 2 hours (60-80 drops per minute). These infusions are repeated at 12 hours intervals for 5-7 days.The intervals may be prolonged to 24 hours according to patients condition and response.
  2. For post surgical impairment of protein synthesis: The usual adult dosage is 500 mL of AMINOVEL® 600 by intravenous drip infusion over 4-6 hours (20-30 drops per minute) following drip infusion of Darrow's solution 1000 mL over 4 hours (60-100 drops per minute) and followed by drip infusion of a 10% sugar solution 500 mL over 2 hours (60-100 drops per minute). These infusions are started on the third post surgical day and repeated at 24 hours intervals for 5-7 days.
ACTIONS AND CHARACTERISTICS
AMINOVEL® 600 supplies the following essential components for parenteral nutrition:
  1. L-forms of amino acids which can be only utilized in the body for the synthesis of its various protein constituents; It is known that the body does not normally preserve nitrogen balance with D-isomers of amino acids.
    • The eight essential amino acids: L-Isoleucine, L-Leucine, L-Lysine, L-Methionine, L-Phenylalanine, L-Threonine, L-Tryptophan and L-Valine are indispensable for protein synthesis.
    • The semi essential amino acids:
      • L-Histidine utilizes optimally amino acid mixtures and is essential for infants and in uraemia;
      • L-Arginine utilizes optimally amino acid mixtures and is essential for detoxication.
    • L-Alanine and L-Proline are necessary for optimal utilization of amino acid mixtures.
    • Glycine is a source for nonspecific nitrogen.
  2. Sorbitol to supply sufficient non nitrogen calories to meet metabolic energy requirements.
  3. Vitamins to prevent deficiencies and to promote the bio synthesis of protein.
  4. Minerals to maintain electrolyte balance and to promote synthesis of protein.
  5. Water to meet the body's requirements.
AMINOVEL® 600 provides all these substances in the optimal and exactly balanced proportions necessary to ensure maximum protein synthesis without depletion of the body's own reserves.

CAUTION
  1. Careful checking should be done for urine volume not to be less than 60-70 mL per hour and reexamination of dosage schedule is necessary when the volume falls below the level.
  2. Use immediately after breaking the seal and do not use the remaining solution.
  3. Take special care of handling the instruments for injection as these preparation are liable to propagate germs.
  4. Open the outer wrap just before use.
  5. Do not use if bag is leaking, solution cloudy or contains foreign matters. I
  6. Maximum infusion rate is 3 cc per minute.
STORAGE
Store below 30°C, protect from light

PACKAGE
Box, 1 soft bag of 500 mL
REG NO.: DKL9218702749A1

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

Manufactured by:
PT. Otsuka Indonesia
Jl. Sumber Waras No. 25
Lawang, Malang 65216, Indonesia
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