Recent Posts

Recent Comments

Wednesday, February 24, 2010

Transpulmin BB Balsam

Transpulmin®
BB Balsam

Composition
1 g of balsam contains:
Eucalyptol100.00mg
Camomile concentrate III7.44mg

Pharmacology
The essential oils evaporating on the skin have a refreshing effect. This mixture will warm the body.

Indications
Transpulmin® BB Balsam is indicated for topical treatment to relieve back pain, headache, stomach ache and warms the influenza patients.

Dosage and Administration
Babies and infants : 2-4 times daily, to be rubbed over the chest, back and neck.

Warning and Precautions
Transpulmin® BB Balsam for children should not ba administered onto the face especially the nose and other sensitive skin parts.

Side effects
In rare cases mild irritation like redness of skin can be found.

Contraindications
Transpulmin® BB Balsam for children should not be administered in the case of hypersensitivity towards one of its components.

Storage conditions
Store at room temperature

Presentations
Tube 10 g and 20 g Reg. No.: POM QL 031700091

Manufactured by:
PT. MUGI LABORATORIES
Bekasi - Indonesia
Under License of:
VIATRIS GmbH and Co. KG
Frankfurt - Germany



Transpulmin
BB Balsam

Komposisi
1 g balsam mengandung:
Eucalyptol100.00mg
Camomile concentrate III7.44mg

Cara Kerja Obat
Penguapan dari minyak-mfnyak atsiri diatas kulit memberikan efek menyegarkan.
Campuran obat ini bekerja sebagai penghangat tubuh.

Indikasi
Transpulmin® BB Balsam digunakan sebagai obat gosok untuk meredakan nyeri di punggung, sakit kepala, sakit perut dan menghangatkan badan bila terserang influensa.

Dosis dan Cara pemberian
Bayi dan anak-anak : 2-4 kali sehari, digosokkan pada dada, punggung dan leher.

Peringatan dan Perhatian
Transpulmin® BB Balsam jangan digunakan pada muka khususnya di hidung dan bagian kulit yang sensitif.

Efek samping
Pada kasus yang jarang dapat terjadi iritasi ringan berupa kemerahan pada kulit.

Kontra Indikasi
Transpulmin® BB Balsam jangan diberikan pada anak-anak yang hipersensitif terhadap salah satu komponen dari obat ini.

Penyimpanan
Simpan pada temperatur ruang.

Kemasan
Tube 10 g dan 20 g Reg. No.: POM QL 031700091

Diproduksi oleh :
PT. MUGI LABORATORIES
Bekasi - Indonesia
Lisensi dari:
VIATRIS GmbH and Co. KG
Frankfurt - Germany
Continue reading...

Monday, February 22, 2010

Placta

PLACTA
Clopidogrel

Composition
Placta 75 mg Film Coated Tablet: Each film-coated tablet contains Clopidogrel bisulfate 97.87 mg (equivalent to 75.0 mg Clopidogrel base)

PHARMACOLOGYCAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutical group: platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC/04.
Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor, and the subsequent ADP-mediated activation of the GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Biotransformation of clopidogrel is necessary to produce inhibition of platelet aggregation. Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the amplification of platelet activation by released ADP. Clopidogrel acts by irreversibly modifying the platelet ADP receptor. Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7. At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%. Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued.

Pharmacokinetic properties
After repeated doses of 75 mg per day, clopidogrel is rapidly absorbed. However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/1) beyond 2 hours. Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Clopidogrel is extensively metabolized by the liver and the main metabolite, which is inactive, is the carboxylic acid derivative which represents about 85% of the circulating compound in plasma. Peak plasma levels of this metabolite (approx. 3 mg/1 after repeated 75 mg oral doses) occurred approximately 1 hour after dosing.
Clopidogrel is a prodrug. The active metabolite, a thiol derivative, is formed by oxidation of clopidogrel to 2-oxo-clopidogrel and subsequent hydrolysis. The oxidative step is regulated primarily by Cytochrome P450 isoenzymes 2B6 and 3A4 and to a lesser extent by 1 A1,1 A2 and 2C19. The active thiol metabolite, which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation. This metabolite has not been detected in plasma. The kinetics of the main circulating metabolite were linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150mgofclopidogrel.
Clopidogrel and the main circulating metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively). The binding is non-saturable in vitro over a wide concentration range.
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120 hour interval after dosing. The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration.
After repeated doses of 75 mg clopidogrel per day, plasma levels of the main circulating metabolite were lower in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) compared to subjects with moderate renal disease (creatinine clearance from 30 to 60 ml/min) and to levels observed in other studies with healthy subjects.
Although inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, the prolongation of bleeding was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day. In addition, clinical tolerance was good in all patients.

Indications
Clopidogrel is indicated for the reduction of atherothrombotic events in:
  • Patients who suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
  • Patients who suffering from non-ST segment elevation acute coronary syndrome (unstable angina or non Q-wave myocardial infarction) in combination with ASA.

Posology
Adults and elderly:
Clopidogrel should be given as a single daily dose of 75 mg with or without food.
In patients with non-ST segment elevation acute coronary syndrome (unstable angina or non Q-wave myocardial infarction), Clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with ASA 75 - 325 mg daily). Since higher doses of ASA were associated with higher bleeding risk, it is recommended that the dose of ASA should not be higher than 100 mg. The optimal duration of treatment has not been formally established.
Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months.

Children:
This product is not recommended for children and adolescents. Safety and efficacy in those below the age of 18 is not proven.
For oral administration.

Overdose
Overdose in treatment with clopidogrel may provoke prolongation of bleeding time, which may lead to hemorrhagic complications. With regards to mechanism of its action, it may be expected positive effect at infusion of thrombocytic mass.
There is no specific antidote.

Contraindications
Allergy to the active substance or any of the other ingredients;
Active pathological bleeding (like in peptic ulcer or intracranial hemorrhage);
Severe hepatic failure;
Pregnancy and breast-feeding;
Children.

DRUG INTERACTION
Warfarin: co-application of clopidogrel with warfarin is not recommended due to increased bleeding risk.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with great caution to patients with increased bleeding risk due to trauma, surgical manipulations or other pathological states and co-treated with glycoprotein IIb/IIIa inhibitors.
Acetylsalicylic acid (ASA): ASA does not change clopidogrel-mediated inhibition of thrombocyte aggregation (adhesion of thrombocytes), but clopidogrel potentates the effect of ASA on thrombocyte aggregation. It is possible this interaction between clopidogrel and ASA to lead to increased bleeding risk. Therefore their co-application should be done with caution, although there is accumulated experience in such application within one year.

Heparin: clopidogrel does not change either the general necessity of heparin or heparin action on blood clotting. Co-application with heparin has no effect on inhibition of thrombocyte aggregation induced by clopidogrel.
Thrombolytics (medicinal products destroying formation of thrombi): safety from co-application of clopidogrel, thrombolytic - recombinant plasminogen activator (rt-PA) and heparin is studied in clinical tests on patients with fresh myocardial infarction. The frequency of clinically significant bleedings is analogical to that, observed at application of rt-PA and heparin, co-administered with ASA. Safety at co-application of clopidogrel with other thrombolytics is not studied sufficiently due to which it should be carried out with caution.
Non-steroidal anti-inflammatory drugs (NSAIDs): in healthy volunteers, receiving naproxen, co-application of clopidogrel is associated with increasing the frequency of occult bleeding from gastrointestinal tract. NSAIDs and clopidogrel should be used jointly with caution.
Other concomitant therapy: no clinically significant interactions are observed when clopidogrel is co-administered with atenolol, nifedipine or simultaneously atenolol and nifedipine. Clopidogrel effect is affected insignificantly from the application of phenobarbital, cimetidine or estrogen.

WARNINGS AND PRECAUTIONS
Due to risk of bleeding and undesirable hematological effects, it is necessary to control blood cells count and/or to carry out other suitable tests when there are suspected clinical symptoms during the therapeutic course. The patients should be monitored accurately for symptoms of bleeding, incl. occult (imperceptible with bare eye) bleeding, especially in the first weeks of therapy and/or after instrumental cardiac procedures or operations. Co-application of clopidogrel with warfarin is not recommended because It may increase bleeding frequency.
Clopidogrel prolongs bleeding time and therefore it should be used with great caution in patients with high risk of intense bleeding in traumas, operations or other pathological states (especially gastrointestinal and intraocular) and in such who receive treatment with acetylsalicylic acid, non-steroidal anti-inflammatory drugs, heparin, glycoprotein IIb/IIIa inhibitors or thrombolytics. If the patients shall be subjected to surgical manipulation and antiaggregant effect is not desirable, the treatment with Clopidogrel Actavis should be discontinued 7 days prior to operation.
The patients should be informed that the time for discontinuance of bleeding may be prolonged more than the usual one, when they administer clopidogrel (alone or in combination with acetylsalicylic acid) and that they should report to their doctor about any unusual bleeding (site and duration).The patients should inform the doctors and dentists about the fact that they administer clopidogrel prior to each surgical manipulation and before starting the treatment with new medicinal product.
Thrombotic thrombocytopenic purpura (TTP) (lesion with symptoms of bleeding, due to reduced count of thrombocytes in blood) is reported very rare after application of clopidogrel, sometimes even after short application.
It is outlined by low thrombocyte count and anemia, due to accumulation of miniature thrombi in the smallest vessels of muscles and organs, leading to neurological changes, renal dysfunction or fever. TTP is a potential lifethreatening status, necessitating instant treatment, including plasmapheresis (purification of plasma by special device).
Clopidogrel Actavis should be prescribed with caution to patients with severely damaged hepatic function, in whom bleeding may arise, due to the limited experience with its application in such patients.
The experience with application of clopidogrel in patients with gravely damaged renal function is limited too, due to which it should be applied with caution to such patients.

Pregnancy and lactation
Pregnancy: There are no adequate and well controlled clinical studies for safety in administration of clopidogrel during pregnancy. Therefore Clopidogrel Actavis should not be applied during pregnancy except in absolute necessity.
Lactation: There are no data for excretion of clopidogrel in the human breast milk.
Due to potential risk for the suckling, Clopidogrel Actavis is not applied in the breastfeeding period. If its application is imperative, breast-feeding should be discontinued.

Undesirable effects
Hemorrhagic symptoms (bleeding): gastrointestinal bleeding (2.0%), hemorrhagic insult (0.4%), purpura (subcutaneous bleedings), epistaxis (nose bleeding), hematuria (blood in urine) and eye hemorrhage (mainly conjunctival).
Hematological disorders: neutropenia (reduced count of neutrophils type of white blood cells executing protection functions), thrombocytopenia (reduced count of thrombocytes).
Central and peripheral nervous system:
- headache, dizziness, paresthesia
- vertigo
Gastrointestinal system:
- heartburn, warmth, abdominal pains, diarrhea
- nausea, gastritis, flatulence, constipation, vomiting, stomach and duodenal ulcer
Disorders in thrombocytes, processes of bleeding and clotting:
- prolonged bleeding time, reduced thrombocytes count
Skin and appendices:
- rash, itching
Changes in white blood count:
- changes in the count of some cellular lines (leucopenia, neutropenia, eosinophilia)

Post-registration and post-marketing monitoring: Most frequently reported are the bleeding symptoms, mainly in the first month of therapy.

Blood and lymph system:
- Thrombotic thrombocytopenic purpura (TTP) (1/200 000), changes in the count of cells of various blood lines (severe thrombocytopenia.granulocytopenia, agranulocytosis, anemia, aplastic anemia/pancitopenia)

Immune system:
- anaphylactoid reactions
Mental:
- confusion, hallucinations.
Nervous system:
- taste disorder
Vascular system:
- vasculitis (vascular inflammation), hypotension (low arterial pressure)
Gastrointestinal system:
- colitis (incl. ulcerous or lymphocyte colitis), pancreatitis, stomatitis.
Hepatic:
- hepatitis, acute hepatic failure.
Skin and hypoderma:
- angioedema, bullous dermatitis (erythema multiforme, Stevens-Johnson syndrome), erythematous rash, urticaria, eczema, lichen planus.
Musculoskeletal:
- arthritis, muscular and articular pains
Renal:
- glomerulonephritis
General:
- fever.
Laboratory changes:
- elevated values of the indices of hepatic function, elevated serum creatinine.

Storage
Store at cool temperature (15-25°C)

Presentation
Placta 75 mg Film coated tablet:
Available in boxes containing 3 blisters@ 10 film coated tablets
Reg. No: DKL0905514917A1

Manufactured by
Actavis Ltd., Malta
Imported and secondary pack by
PT Actavis Indonesia, Jakarta
Actavis Group, Iceland
Continue reading...

Otopain

OTOPAIN®
EAR DROPS

COMPOSITION:
Each ml contains:
Polymyxin B sulfate10000IU
Neomycin sulfate5mg
Fludrocortisone acetate1mg
Lidocaine HCl40mg

ACTIONS:
OTOPAIN® is a combination of several active ingredients, effective to various ear disease. Polymyxin B sulfate and Neomycin sulfate are broad spectrum antibiotics, and considered active against the following microorganisms: Pseudomonas aeruginosa, Staphylococcus aureus, Eschericia coli, Klebsiella. Enterobacter sp., Neisseria sp..
Fludrocortisone acetate has anti-inflammatory, antiallergic and antipruritic activity. Lidocaine hydrochloride is a local anesthetic, effective to reduce pain in ear infections.

INDICATIONS:
Acute and chronic external otitis caused by bacteria sensitive to Polymyxin and Neomycin sulfate, also if the anti-inflammatory and local anesthetic actions of corticosteroids are essentially needed.

CONTRAINDICATIONS:
  • Patients who are hypersensitive to any components of this drug.
  • This product should not be used if external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, Herpes simplex virus or Varicella-zoster virus).
ADVERSE REACTIONS:
  • Hypersensitivity reactions may rarely occur.
  • Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported.
  • Adverse reactions have occured with topical use of antibiotics combination including Neomycin and Polymyxin B.
  • The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressing: burning, itching, irritation, dryness, folliculitis, hypertrichosis, and acne form eruption, hypo pigmentation, per oral dermatitis, allergic contact dermatitis, and maceration of the skin. Secondary infection, skin atrophy, striae and malaria.
  • Systemic adverse reactions are rare, may result from high plasma level caused by excessive dosage.
PRECAUTIONS/WARNINGS:
  • Neomycin sulfate may cause cutaneous sensitization or irritation occurs.
  • Treatment should not be continued for longer than 10 days because the risk of ototoxicity is greater with prolonged use. Patient being treated with eardrops containing Neomycin should under close clinical observation.
  • Due to its acidity which may cause burning and stinging, OTOPAIN® Ear Drops should not be used in any patients with a perforated tympani membrane.
  • If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed.
  • There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • When using Neomycin-containing product to control secondary infection in chronic dermatosis, such as chronic otitis external, it should be bear in mind that the skin in these conditions is more liable than normal skin to become sensitized to many substances, including Neomycin.
  • This product contains Sodium metabisulfite; a sulfite may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
  • Prolonged used of these antibiotics may cause the overgrowth of non-sensitive organisms, e.g.: fungus.
DRUG INTERACTIONS:
Concomitant use with penicillin groups and its derivatives should inhibit the bactericide activity.

DOSAGE AND ADMINISTRATION:
Instill 4-5 drops, 2-4 times daily, depending on the severity of the disease.
Therapy with this product should be limited to 10 consecutive days.

PRESENTATION:
Bottle of net 8 ml netto equipped with ear dropper
Reg.No.:DKL7217617148A1

KEEP OUT OF THE REACH OF CHILDREN
ON MEDICAL PRESCRIPTION ONLY
STORE BELOW 25°C
PROTECT FROM LIGHT
DO NOT FREEZE


Manufactured by:
PT. Interbat
Buduran-Sidoarjo
East Java, Indonesia



OTOPAIN®
TETES TELINGA

KOMPOSISI:
Tiap ml mengandung:
Polymyxin B sulfate10000IU
Neomycin sulfate5mg
Fludrocortisone acetate1mg
Lidocaine HCl40mg

KHASIAT:
OTOPAIN® merupakan kombinasi zat-zat yang efektif untuk mengobati bermacam-macam penyakit pada telinga.
Polymyxin B sulfate dan Neomycin sulfate merupakan antibiotika dengan spektrum luas, aktif terhadap berbagai mikroorganisme : Pseudomonas aeruginosa, Staphylococcus aureus, Escheria coli, Klebstella, Enterobacter sp., Neisseria sp..
Fludrocortisone acetate mempunyai khasiat antiradang, antialergi, dan antipruritis. Lidocaine hydrochloride merupakan anestesi lokal yang efektif untuk mengurangi rasa sakit pada infeksi telinga.

INDIKASI:
Otitis eksternal akut dan kronis disebabkan oleh bakteri yang peka terhadap Polymyxin dan Neomycin sulfate serta bila efek antiinflamasi dari kortikosteroid dan efek anestesi lokal diperlukan.

KONTRAINDIKASI:
  • Penderita-penderita yang hipersensitif terhadap salah satu komponen dalam obat ini.
  • Produk ini jangan digunakan, jika diduga atau diketahui adanya gangguan pada kanal bagian eksternal auditory yang disebabkan infeksi viral cutaneous (sebagai contoh : virus Herpes simpleks atau virus
  • Varicella-zoster).
EFEKSAMPING:
  • Berupa reaksi hipersensitivitas jarang terjadi.
  • Neomycin sering menimbulkan kepekaan pada kulit. Ototoksisitas dan nefrotoksisitas juga pernah dilaporkan.
  • Efek samping dijumpai pada penggunaan topikal kombinasi antibiotika termasuk Neomycin dan Polymyxin B.
  • Berikut adalah efek samping lokal yang dilaporkan pada penggunaan kortikosteroid topikal, terutama yang dibalut dengan kuat, yaitu : rasa terbakar, gatal, iritasi, kering, folikulitis, hipertrichosis, muncul seperti jerawat, hipopigmentasi, dermatitis peroral, alergi kontak dermatitis, maserasi pada kulit, infeksi sekunder, atropi kulit, stria dan malaria.
  • Efek samping sistemik jarang dan dapat terjadi dari kadar plasma yang tinggi karena dosis berlebihan.
PERINGATAN/PERHATIAN :
  • Neomycin sulfate dapat menyebabkan sensitisasi kutan atau timbul iritasi.
  • Pengobatan tidak boleh lebih dari 10 hari karena resiko ototoksisitas lebih besar pada penggunaan jangka panjang.
  • Penderita dalam pengobatan dengan tetes telinga yang mengandung Neomycin harus di bawah pengawasan klinik yang ketat.
  • Karena sifat asamnya yang dapat menyebabkan rasa terbakar dan menyengat, OTOPAIN® Tetes Telinga jangan digunakan pada penderita dengan perforasi membran tympani.
  • Jika infeksi tidak menunjukkan perbaikan dalam 1 minggu, uji kultur dan kepekaan harus diulangi untuk mengidentifikasi organisme penyebab dan menentukan apakah terapi harus diganti.
  • Tidak ada penelitian yang cukup memadai dan terkontrol dengan baik untuk penggunaan pada wanita hamil. Kortikosteroid hanya digunakan jika keuntungan yang didapat lebih besar dibanding resiko pada fetus.
  • Ketika menggunakan produk yang mengandung Neomycin untuk mengontrol infeksi sekunder pada dermatosis kronis, seperti otitis eksternal kronis, pada keadaan ini kulit menjadi lebih peka dibandingkan kulit normal, terhadap berbagai bahan termasuk Neomycin.
  • Produk ini mengandung Sodium metabisulfite, sulfit dapat menyebabkan berbagai reaksi alergi, termasuk gejala-gejala anafilaksis dan yang mengancam jiwa atau episode asmatik yang kurang berat pada orang-orang yang peka.
  • Pengobatan jangka panjang dengan antibiotika ini dapat menyebabkan pertumbuhan yang berlebihan dari organisme yang tidak peka seperti jamur.
INTERAKSI OBAT:
Neomycin sulfate bersifat bakteriostatik, menghambat aktivitas bakterisida dari golongan penisilin dan derivat-derivatnya.

ATURAN PAKAI:
OTOPAIN® diteteskan ke dalam lubang telinga dengan penetes. Sehari 2-4 kali 4-5 tetes, tergantung pada beratnya penyakit.
Lamanya pengobatan dengan produk ini seharusnya dibatasi sampai 10 hari berturut-turut.

KEMASAN:
Botol isi 8 ml netto dilengkapi dengan alat penetes
Reg.No.:DKL7217617148A1

JAUHKAN DARI JANGKAUAN ANAK - ANAK
HARUS DENGAN RESEP DOKTER
SIMPAN DIBAWAH 25°C
TERLINDUNG DARI CAHAYA
JANGAN SIMPAN DALAM LEMARI PEMBEKU

Diproduksi oleh:
PT. Interbat
Buduran, Sidoarjo
Jawa Timur, Indonesia
Continue reading...

Friday, February 19, 2010

Tilidon

TILIDON®
FILM-COATED TABLET - SYRUP

COMPOSITIONS:
TILIDON® Film-coated Tablet
Each film-coated tablet contains:
Domperidone ..................... 10 mg
TILIDON® Syrup
Each measuring spoonful (5 ml) contains:
Domperidone ..................... 5 mg

ACTIONS:
TILIDON® contains Domperidone, a dopamine antagonist with selective peripheral D2-receptor antagonist activity.
Domperidone has an antiemetic action similar to those of Metoclopramide.
Its antiemetic effect may be due to a combination of peripheral (gastro kinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the postrema area.
Oral administration of Domperidone increases the duration of antral and duodenal contractions, the gastric emptying and lower esophageal sphincter pressure.
After oral administration, peak plasma concentrations are attained in 10 to 30 minutes.

INDICATIONS:
  • The dyspeptic symptom complex that is often associated with delayed gastric emptying, esophagitis reflux.
  • Nausea and vomiting in gastroenteritis.
    Nausea and vomiting associated with dysmenorrhea, migraine, headache, haemodialysis, including radiotherapy.
CONTRAINDICATIONS:
  • Patients with hypersensitivity to Domperidone or any of its ingredients.
  • Do not use whenever stimulation of gastric motility might be dangerous (e.g.: in the presence of haemorrhage, mechanical obstruction or gastrointestinal perforation).
  • Patients with prolactinoma (a prolactin releasing hypofise tumour),
ADVERSE REACTIONS:
  • No evidence of extra pyramidal effects, because the drug does not penetrate the blood-brain barrier.
  • Domperidone may induce an increase in the plasma prolactin level (hyperprolactinemia), which at long term administration can cause galactorrhea and gynaecomastia,
  • Skin allergic reactions.
PRECAUTIONS/WARNINGS:
Caution in patients with liver and or renal dysfunction.
  • Caution in pregnancy and breastfeeding.
  • Not recommended for chronic administration.
  • Not recommended for routine prophylactic after operation.
DRUG INTERACTIONS:
  • Concomitant administration of opiate analgesic or antimuscarinic drugs may antagonize the gastrointestinal activity.
  • Domperidone may decrease hypoprolactinemia for Bromocriptine.
DOSAGE AND ADMINISTRATIONS:
Chronic dyspepsia postprandial:
Adults:
10 mg, 3 times daily. 15-30 minutes before meals and, if necessary, once more before bedtime.
0.3 mg / kg body weight, 3 times daily. 15-30 minutes before meals and, if necessary, once more before bedtime.

Nausea and vomiting:
Adults:
20 - 40 mg, 3-4 times daily
Children:
0.6 mg / kg body weight, 3 - 4 times daily.

PRESENTATIONS:
TILIDON® Film-coated Tablet
Box contains 3 blisters of 10 film-coated tablets
Reg.No.:DKL9617612217A1

ON MEDICAL PRESCRIPTION ONLY
STORE BELOW 30°C
PROTECT FROM LIGHT

TILIDON® Syrup
Bottle contains net 60 ml equipped with measuring spoon
Reg. No.: DKL9917615837A1

SHAKE WELL BEFORE USE
ON MEDICAL PRESCRIPTION ONLY
STORE BELOW 30°C
PROTECT FROM LIGHT
DO NOT FREEZE

Manufactured by :
PT Interbat





TILIDON®
TABLET SALUT SELAPUT - SIROP

KOMPOSISI:
TILIDON®-Tablet Salut Selaput
Tiap tablet salut selaput mengandung:
Domperidone ..................... 10mg

TILIDON® Sirop
Tiap sendok takar (5 ml) mengandung:
Domperidone ..................... 5 mg

KHASIAT:
TILIDON mengandung Domperidone yang merupakan antagonis dopamin yang secara periferal bekerja selektif pada reseptor D2.
Domperidone mempunyai khasiat antiemetik yang sama dengan Metoclopramide.
Efek antiemetik dapat disebabkan oleh kombinasi efek periferal (gastrokinetik) dengan antagonis terhadap reseptor dopamin di chemoreceptor trigger zone, yang terletakdiluarsawardarahotakdi area postrema.
Pemberian Domperidone per oral dapat menambah lamanya kontraksi antral dan duodenum, meningkatkan pengosongan lambung dan menambah tekanan pada sfingteresofagus bagian bawah. Puncak konsentrasi dicapai 10 - 30 menit setelah pemberian per oral.

INDIKASI:
  • Sindroma dispepsia yang sering disertai dengan pengosongan lambung yang terlambat, reflux esofagitis.
  • Mual dan muntah pada gastroenteritis.
  • Mual dan muntah yang disertai dysmenorrhea, migrain, sakit kepala, hemodialisis, termasuk radioterapi.
KONTRAINDIKASI:
  • Pasien yang hipersensitif terhadap Domperidone atau komponen obat.
  • Tidak boleh digunakanjika serangan motilitas dapat membahayakan (seperti, adanya perdarahan, obstruksi mekanik, atau perforasi gastrointestinal).
  • Penderita dengan prolactinoma (tumor hipofise yang mengeluarkan prolaktin).
EFEK SAMPING:
  • Efek ekstrapiramidal tidak terjadi, mungkin karena obat ini tidak melewati sawar darah otak.
  • Domperidone dapat merangsang peningkatan kadar prolaktin plasma (hiperprolaktinemia) yang dalam jangka panjang dapat menyebabkan galaktorea dan ginekomastia.
  • Reaksi alergi kulit.
PERINGATAN/PERHATIAN :
  • Hati-hati penggunaannya pada penderita dengan gangguan fungsi hati dan / atau ginjal.
  • Hati-hati penggunaannya pada wanita hamil dan menyusui.
  • Tidak dianjurkan untuk pemberian jangka panjang.
  • Tidak dianjurkan untuk profilaksis rutin setelah operasi.
INTERAKSI OBAT:
  • Pemberian obat analgesik opiat atau antimuskarinik secara bersamaan dapat mengantagonis aktivitas gastrointestinal.
  • Domperidone dapat menurunkan efek hipoprolaktinemia dari Bromocriptine.
ATURAN PAKAI:
Dispepsia postprandial kronik:
Dewasa:
10 mg, 3 kali sehari, 15 - 30 menit sebelum makan dan jika perlu sebelum tidur.
Anak-anak:
0,3 mg/kg berat badan, 3 kali sehari, 15-30menitsebelum makandanjika perlu sebelum tidur.

Mual dan muntah:
Dewasa:
20-40 mg,3-4kali sehari.
Anak-anak:
0,6 mg / kg berat badan, 3 - 4 kali sehari.

KEMASAN:
TILIDON Tablet Salut Selaput
Kotak berisi 3 blister @ 10 tablet salut selaput
Reg. No.: DKL9617612217A1

HARUS DENGAN RESEP DOKTER
SIMPAN DI BAWAH 30°C
TERLINDUNG DARI CAHAYA

TILIDON® Sirop
Botol berisi 60 ml netto dilengkapi dengan sendok takar
Reg.No.:DKL9917615837A1

KOCOK SETIAP KALI AKAN DIPAKAI
HARUS DENGAN RESEP DOKTER
SIMPAN DI BAWAH 30°C
TERLINDUNG DARI CAHAYA
JANGAN DISIMPAN DALAM LEMARI PEMBEKU

Diproduksi oleh :
PT. Interbat
Continue reading...

Zincare

ZINCARE
Zinc sulphate monohydrate
Dispersible tablet

Composition
Each dispersible tablet contains:
Zinc sulphate monohydrate 54.9 mg equivalent to elemental Zinc.............. 20 mg

Pharmacology
Zinc dispersible tablet complement the treatment of diarrhea in children under 5 years old. The use of Zinc is always combined with ORS (Oral Rehydration Salt). The diarrhea treatment is targeted for preventing and treating of dehydration (use Oral Rehydration Salt) and preventing of nutritional disorder (use Zinc mineral). Give Zinc as soon as possible in early diarrhea together with ORS. Zinc supplementation given can lower the incidence of diarrhea in the following 2 - 3 months.

Indication
ZINCARE is used for complement in the treatment of childhood diarrhea. Should be used in combination with ORS (Oral Rehydration Salt).

Contraindication
Zinc is contraindicated in those who are hypersensitive to any component of Zinc containing supplement.

Dosage and administration
  • Infants (2 - 6 months): Half tablet (10 mg elemental Zinc) once daily for 10 consecutive days (even when the diarrhea has stopped).
  • Children (6 month - 5 years): One full tablet (20 mg elemental Zinc) once daily for 10 consecutive days (even when the diarrhea has stopped). Put the dispersible tablet in a teaspoon and dissolve in a bit of water (± 5 ml), then give the entire spoonful to the children.
Adverse reactions
Zinc oral toxicity in adult can be associated with Zinc intake at doses › 150 mg/day (±10 times recommendation dosage) for a long period. High dose of Zinc for a long period can decrease lipoprotein concentration and Cuprum absorption.

Warning and precautions
During diarrhea, beside Zinc supplementation also given ORS (Oral Rehydration Salt). For lactating mothers are suggested to keep or increasing lactating frequency for kids during and post diarrhea.

Drug interactions
Concomitant intake with Iron, Calcium, Copper can decrease the absorption of Zinc. Concomitant intake with amino acids include L-Histidine, L-Cysteine, and L-Methionine may enhance the absorption of Zinc.

Presentation
ZINCARE : Box of 10 strips x 10 dispersible tablets
Reg. No. DTL0811638981A1

Store below 25°C.
Protect from heat and moisture.

PT KALBE FARMA Tbk.
Bekasi - Indonesia




ZINCARE
Zinc sulphate monohydrate
Tablet dispersible

Komposisi
Tiap tablet dispersible mengandung:
Seng sulfat monohidrat 54,9 mg yang setara dengan mineral Seng ........... 20 mg

Farmakologi
Tablet Seng dispersible untuk melengkapi pengobatan diare pada anak-anak usia di bawah 5 tahun. Penggunaannya selalu disertai dengan garam rehidrasi oral. Pengobatan diare ditujukan untuk pencegahan atau pengobatan dehidrasi (menggunakan garam rehidrasi oral) dan pencegahan gangguan nutrisi menggunakan mineral Seng). Berikan Seng sesegera mungkin pada awal diare, bersama dengan garam rehidrasi oral. Pemberian suplementasi Seng dapat menurunkan insidensi diare 2-3 bulan ke depan.

Indikasi
ZINCARE digunakan untuk terapi pelengkap diare pada anak-anak. Digunakan bersama dengan garam rehidrasi oral.

Kontraindikasi
Hipersensitif terhadap mineral Seng.

Dosis dan cara pemberian
  • Bayi (2-6 bulan): 1/2 tablet (10 mg mineral Seng) sekali sehari selama 10 hari (meskipun diare sudah berhenti).
  • Anak (6 bulan-5 tahun): 1 tablet (20 mg mineral Seng) sekali sehari selama 10 hari (meskipun diare sudah berhenti). Dengan cara melarutkan tablet dispersible dengan air secukupnya pada sendok teh (± 5 ml), kemudian diminumkan kepada anak.
Efek samping
Toksisitas Seng secara oral pada orang dewasa dapat terjadi akibat asupan Seng dengan dosis › 150 mg/hari (± 10 kali dosis yang direkomendasikan) selama periode lama. Dosis tinggi Seng untuk periode lama dapat menurunkan konsentrasi lipoprotein dan absorpsi Tembaga.

Peringatan dan perhatian
Selama diare masih berlangsung, selain diberikan suplementasi Seng juga diberikan garam rehidrasi oral. Para ibu menyusui dianjurkan untuk tetap menyusui atau meningkatkan frekuensi menyusui pada anak selama dan setelah diare.

Interaksi obat
Pemberian bersama dengan mineral Besi, Kalsium, Tembaga dapat menurunkan absorpsi mineral Seng.
Pemberian bersama dengan asam amino yaitu L-Histidine, L-Cisteine, dan L-Methionine dapat meningkatkan absorpsi mineral Seng.

Kemasan
ZINCARE : Dus 10 strip x 10 tablet dispersible
Reg.No.DTL0811638981A1

Simpan pada suhu di bawah 25°C.
Lindungi dari panas dan kelembaban.

PT KALBE FARMA Tbk.
Bekasi - Indonesia
Continue reading...

Silex

SILEX® Syrup
guaifenesin, ext thymi, ext primulae, ext althae, ext droserae, ext serphylli, ol. eucalypti, ol. anisi


COMPOSITION
Each measuring spoon (5 ml) contains:
guaifenesin37,5mg
extract thymi liquid250mg
extract primulae liquid50mg
extract althae liquid175mg
extract droserae25mg
extract serphylli175mg
Ol. eucalypti0,5mg
Ol. anisi1,25mg
Syrupus simplex2,5g
Excip. c. corrigen q.s, ad5ml

PHARMACOLOGY
SILEX® is antitussive preparation composed of several well-known ingredients to make the sputum thinner and less viscid and therefore more easily removed by coughing.
SILEX® help to relief bronchospasm and has a good antitussive effect for all kinds of coughs.

INDICATION
SILEX® could relief cough in bronchitis, influenza, upper respiratory tract infection, smokers

DOSAGE
Adult : 1 measuring spoon (15 ml) 3-4 times daily.
Children : 1 measuring spoon (5 ml) 3-4 times daily.

Store at 25°-30°C
Shake well before usage

PRESENTATION
Bottle of 100ml
DEPKES RI No. BTR. 991 600 161

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



SILEX® Sirup
guaifenesin, ext thymi, ext primulae, ext althae, ext droserae, ext serphylli, ol. eucalypti, ol. anisi

KOMPOSISI
Tiap sendok takar ( 5ml) mengandung:
guaifenesin37,5mg
extract thymi liquid250mg
extract primulae liquid50mg
extract althae liquid175mg
extract droserae25mg
extract serphylli175mg
Ol. eucalypti0,5mg
Ol. anisi1,25mg
Syrupus simplex2,5g
Excip. c. corrigen q.s, ad5ml

FARMAKOLOGI
SILEX® merupakan obat batuk yang mengandung gabungan ramuan bahan-bahan yang sudah lama dikenal guna mencairkan lendir yang melekat pada saluran nafas, sehingga mudah dikeluarkan.
SILEX® berkhasiat melebarkan dan mengurangi kejang saluran nafas dan SILEX® mempunyai efek antitusif yang baik pada segala jenis batuk.

INDIKASI
SILEX® dapat digunakan untuk batuk-batuk yang terdapat pada bronkhitis, influenza, radang pada tenggorokan, batuk rejan, batuk karena banyak merokok dan batuk sesak.

POSOLOGI
Dewasa : 1 sendok takar (15 ml) 3-4 kali sehari.
Anak-anak : 1 sendok takar (5 ml) 3-4 kali sehari.

Simpan pada suhu 25°-30°C
Kocok dahulu sebelum dipakai

KEMASAN
Botol berisi 100 ml
DEPKES RI No. BTR. 991 600 161

Diproduksi oleh :
PT Darya-Varia Laboratoria Tbk
Gunung Putri, Bogor-lndonesia
Continue reading...

Thursday, February 18, 2010

Rechol

RECHOL®
Tablet

 
COMPOSITION
RECHOL® 5:
Each film-coated tablet contains: Simvastatin 5 mg

RECHOL® 10
Each film-coated tablet contains: Simvastatin 10 mg

RECHOL® 20
Each flim-coated tablet contains: Simvastatin 20 mg

 
PHARMACOLOGY
Simvastatin which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which catalyzes an early and rate-limiting step in the biosynthesis of cholesterol. As a result, Simvastatin reduce low density (LDL)- and very low density (VLDL)-cholesterol, plasma triglyceride concentrations, and slightly increase high-density lipoprotein (HDL) concentrations, without the accumulation of potentially toxic sterols.

 
INDICATIONS
  • Reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolemia, when the response to diet and other nonpharmacological measures alone has been inadequate. Simvastatin raises HDL-cholesterol and therefore lowers the LDL/HDL and total cholesterol/HDL ratios.
  • Reduction of elevated cholesterol levels in patients with combined hypercholesterolemia and hypertriglyceridemia, when the hypercholesterolemia is the major abnormality.

CONTRAINDICATIONS
  • Hypersensitivity to any component of this medication.
  • Active liver disease or unexplained persistent elevations of serum transaminases.
  • Pregnancy and nursing.

PRECAUTIONS
  • Simvastatin may cause elevation of transaminase levels. When the drug was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels.
  • It is recommended that liver function tests be performed before treatment begins and periodically thereafter in all patients.
  • Simvastatin therapy should be temporarily withheld or discontinued in any patient having a risk factor predisposing to the development of renal failure secondary to rhabdomyolisis.
  • The drug should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history liver disease.
  • Safety and effectiveness in children and adolescents have not been established. Therefore, treatment of children or adolescents with Simvastatin is not recommend at this time.
  • In any patient with homozygous form of familial hypercholesterolemia, in whom there is a complete absence of LDL receptors, therapy with Simvastatin is unlikely to result in clinical benefit.
  • Simvastatin has only a moderate triglyceride lowering effect and it is not indicated where hypertriglyceridemia is the abnormally of most concern (i.e.hyperlipidemia types I, IV, and V).
  • Patients should be asked to report promptly unexplained muscle pain, tenderness or weakness. Therapy with Simvastatin should be discontinued if markedly elevated CPK (creatinine phosphokinase) levels occur or if myopathy is diagnose or suspected.

ADVERSE EFFECTS
Simvastatin is generally well-tolerated; for the most part side effects have been mild and transient in nature. Adverse effects occurring with a frequency of ≥ 1% were abdominal pain, constipation, flatulence and nausea. Other side effects occurring in 0.5 - 0.9 % of patients were asthenia, acid regulation, dyspepsia, headache, insomnia, diarrhea and rash.
Other adverse effects reported are:
  • Neurological : distinction of certain cranial nerves, tremor, vertigo, memory loss, peripheral neuropathy, peripheral nerve palsy, paresthesia.
  • Reproductive: gynecomastia, loss of libido, erectile dysfunction.

DRUG INTERACTIONS
  • Combined therapy with gemfibrozil, niacin, erythromycin or immunosuppressants should include careful monitoring for symptoms of myopathy or rhabdomyolysis.
  • Concurrent use with anticoagulants (coumarin or indandione-derivative) may increase bleeding or prothrombin-time.

DOSAGE AND ADMINISTRATION
Patient should be placed on a standard cholesterol-lowering diet before receiving Simvastatin and should continue on this diet during treatment with Simvastatin.
The usual starting dose is 10 mg/day given as a single dose in the evening.
Patients with mild to moderate hypercholesterolemia can be treated with a starting dose of 5 mg of Simvastatin. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 40 mg daily given as a single dose in the evening.
Lipid determination should be preformed at intervals of no less than four weeks and dosage adjusted according to the patient's respons to therapy.
If LDL-cholesterol levels fall below 75 mg/dL (1,94 mmol/L) or total plasma cholesterol levels fall below 140 mg/dL (3,6 mmol/L) consideration should be given to reducing the dose of Simvastatin.

 
Dosage In patients with renal insufficiency
Because Simvastatin does not undergo significant renal excretion, modification of dosage should not be necessary in patients with renal insufficiency. However, caution should be exercised when Simvastatin is administered to patients with severe renal insufficiency: such patients should be started at 5 mg/day and be closely monitored.

 
PRESENTATION
RECHOL® 5
Box of 3 strips @ 10 film-coated tablets
Reg. No. DKL9521618017A1

RECHOL® 10
Box of 3 strips @ 10 film-coated tablets
Reg.No. DKL9521618017B1

RECHOL® 20
Box of 3 strips @ 10 film-coated tablets
Reg. No. DKL9721618017C1

 
ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

 
Keep in a cool (15 - 25 °C) and dry place.

 
Manufactured by:
PHAROS
Jakarta - Indonesia
Continue reading...

Actazolam

ACTAZOLAM
Alprazolam

Composition
Actazolam 0.5 mg Tablet:
Each tablet contains Alprazolam 0.5 mg
Actazolam 1 mg Tablet:
Each tablet contains Alprazolam 1 mg

Description:
Alprazolam is-8-chloro-1-methyl-6phenyl-4H-s-triazolo [4,3-α][1,4] benzodiazepine.
Alprazolam is a white crystalline powder, soluble in methanol or ethanol, but with no appreciable solubility in water. It has a molecular weight of 308.76.

Mode of actions:
Anxiolytic.

Indication
Short-term treatment of anxiety, moderate or severe anxiety, and anxiety associated with depression.

Contra indications
  • Hypersensitivity to benzodiazepines.
  • Acute narrow-angle glaucoma.
  • Myasthenia gravis, acute pulmonary insufficiency, phobia and chronic obsessive psychosis, children and premature infants.
Posology
  • Adult: 0.25-0.5 mg, 3 times daily, may be increased at intervals of 3 - 4 days to maximum 4 mg daily in divided doses.
  • Elderly, debilitated patients and severe liver dysfunction: 0.25 mg, 2-3 times daily, may be increased gradually.
Side Effects
  • Drowsiness, muscle weakness, ataxia, amnesia, depression, light-headedness, confusion, hallucinations, blurred vision.
  • Rarely: headache, insomnia, paradoxical reactions, tremor, hypotension, gastrointestinal disturbances, rash, change in libido, menstrual irregularities, urinary retention, blood dyscrasias and jaundice.
Warnings and Precautions
  • May cause dependency.
  • Avoid single dose treatment in depression or combined anxiety-depression.
  • Avoid operating vehicles or machinery.
  • Should be used with caution in pregnancy and lactation, chronic renal and liver disorders, respiratory disorder, muscle weakness and a history of drug or alcohol abuse, marked personality disorders.
  • Safety efficacy has not been established for children under 10 years.
  • Avoid long-term therapy.
  • Should be used with cautions in patients with chronic pulmonary insufficiency.
Drug Interactions
  • Effects enhanced by CNS depressants, alcohol, barbiturates.
  • Excretion is inhibited by cimetidine.
Over dosage
  • Patients should be induced to vomit and gastric lavage.
  • Treatment ofalprazolam over dosage is generally symptomatic and supportive. Maintenance of cardiovascular function, respiratory and electrolyte balance.
Presentation
Actazolam 0.5 mg Tablet:
Available in box containing 3 blisters @ 10 tablets
Reg.No.:DPL0705514310A1
Actazolam 1 mg Tablet:
Available in box containing 3 blisters @ 10 tablets
Reg.No.: DPL0705514310B 1

Storage
Store in a dry place at temperature between (15°C-30°C).

ON MEDICAL PRESCRIPTION ONLY

Manufactured by
PT Actavis Indonesia, Jakarta
(Actavis Group, Iceland)



ACTAZOLAM
Alprazolam

Komposisi
Actazolam 0,5 mg Tablet:
Tiap tablet mengandung alprazolam 0,5 mg
Actazolam 1 mg Tablet:
Tiap tablet mengandung alprazolam 1 mg

Deskripsi
Alprazolam adalah-8-chloro-l -methyl-6-phenyl-4H-s-triazolo [4,3-α][1,4] benzodiazepine.
Serbuk kristal putih, larut dalam metanol atau etanol, tapi tidak larut dalam air. Berat molekul 308,76.

Cara Kerja Obat
Antiansietas

Indikasi
Pengobatan jangka pendek, ansietas sedang atau berat dan ansietas yang berhubungan dengan depresi.

Kontra indikasi
  • Pasien yang hipersensitif terhadap golongan benzodiazepin.
  • Glaukomasudutsempitakut.
  • Miastenia gravis, insufisiensi pulmonar akut, kondisi fobia dan obsesi psikosis kronik, anak dan bayi prematur.
Posology
  • Dewasa: 0,25-0,5 mg 3 kali sehari. Jika perlu dosis dapat dinaikkan dengan interval 3-4 hari hingga maksimum 4 mg sehari dalam dosis terbagi.
  • Untuk pasien lanjut usia, debil dan gangguan fungsi hati berat 0,25 mg 2-3 kali sehari, ditingkatkan bertahap jika perlu.
Efek samping
  • Mengantuk, kelemahan otot ataksia, amnesia, depresi, light-headedness, bingung, halusinasi, "blurred vision".
  • Jarang terjadi: nyeri kepala, insomnia, reaksi paradoksikal, tremor, hipotensi, gangguan gastrointestinal, rash, perubahan libido, menstruasi tidak teratur, retensi urin, "blood dyscrasias"dan "jaundice".

Peringatan dan perhatian
  • Dapat terjadi ketergantungan.
  • Jangan digunakan sebagai pengobatan tunggal pada pasien depresi atau kecemasan dengan depresi.
  • Selama menggunakan obat ini dilarang mengendarai atau mengoperasikan mesin.
  • Hati-hati bila diberikan pada wanita hamil dan menyusui, penderita penyakit hati dan ginjal kronis, penyakit respirasi, kelemahan otot dan riwayat penyalahgunaan obat atau alkohol, penderita kelainan kepribadian yang nyata.
  • Pemakaian pada anak dibawah usia 10 tahun tidak diketahui keamanannya dengan pasti.
  • Kurangi dosis pada usia lanjut dan debil.
  • Hindari pemakaianjangka panjang.
  • Hati-hati pemakaian pada penderita "pulmonary insufficiency" kronik.
Interaksi Obat
  • Efek ditingkatkan oleh depresan susunan syaraf pusat, alkohol, barbiturat.
  • Eksresi dihambat oleh Simetidin.

Overdosis
  • Penderita dirangsang untuk muntah dan bilas lambung.
  • Penderita dirawat intensif dengan terapi simtomatis dan suportif pemeliharaan fungsi kardiovaskular, pernafasan dan keseimbangan elektrolit.

Kemasan
Actazolam 0,5 mg Tablet: tersedia dalam kotak berisi 3 blister 010 tablet
No. Reg: DPL0705514310A1

Actazolam 1 mg Tablet: tersedia dalam kotak berisi 3 blister@ 10 tablet
No. Reg: DPL0705514310B1

Penyimpanan
Simpan di tempat kering pada temperatur (15°C-30°C).

HARUS DENGAN RESEP DOKTER

Di produksi oleh:
PT Actavis Indonesia, Jakarta
(Grup Actavis, Islandia)
Continue reading...

Euphyllin

EUPHYLLIN®
Retard Mite, Retard

KOMPOSISI
EUPHYLLIN® Retard Mite
Tiap tablet salut selaput EUPHYLLIN Retard Mite mengandung 125 mg teofilin anhidrat.
EUPHYLLIN® Retard
Tiap kaplet salut selaput EUPHYLLIN- Retard mengandung 250 mg teofilin anhidrat.

MEKANISME KERJA
Teofilin merupakan turunan metil xantin yang mempunyai efek antara lain merangsang susunan saraf pusat dan melemaskan otot polos, terutama bronkus.

INDIKASI
Untuk meringankan dan mengatasi serangan asma bronkial

KONTRA INDIKASI
Penderita yang hipersensitif terhadap teofilin, penderita tukak lambung atau tukak usus dua belas jari, diabetes, infark miokard, hipertensi berat, aritmia takikardia, kardiomiopati obstruktif hipertropika, hipertiroidi, epilepsi atau insufisiensi hati berat.
Seperti obat lainnya, penggunaan EUPHYLLIN® Retard pada kehamilan, terutama pada kehamilan trimester pertama dan pada wanita menyusui sebaiknya dilakukan dengan pengawasan dokter. Sebaiknya tidak diberikan pada bayi dan anak-anak di bawah usia 6 tahun.

EFEK SAMPING
EUPHYLLIN® Retard kadang-kadang dihubungkan dengan efek samping yang disebabkan karena gangguan pada sistem saraf pusat seperti gelisah, eksitabilitas, tremor, gangguan tidur dan sakit kepala. Kadang-kadang dapat dijumpai peningkatan denyut jantung, denyut nadi yang tidak teratur, palpitasi; gangguan pernafasan seperti tachypnea; gangguan gastrointestinal seperti mual, muntah dan diare; juga rash dan hiperglikemi. Hal ini dapat disebabkan karena penggunaan dosis yang relatif berlebihan (tergantung dari intensitas reaksi individu terhadap zat aktif obat ini) atau karena penggunaan dosis yang absolut berlebihan
(konsentrasi teofilin plasma › 20 mg/l). Efek ini dapat dikurangi dengan pengurangan dosis. Bila kadar teofilin dalam plasma › 20 mg/l, dapat timbul efek toksik seperti serangan epilepsi, aritmia ventrikular dan gangguan gastrointestinal berat.

INTERAKSI OBAT
  • Penggunaan teofilin bersamaan dengan furosemid, β-2 adrenergik atau metil xantin lainnya (seperti produk-produk yang mengandung kafein) dapat meningkatkan efek teofilin tersebut. Penggunaannya bersamaan dengan efedrin dan obat-obat yang mengandung efedrin juga dapat meningkatkan khasiat dan efek samping teofilin.
  • Pada perokok dan pemberian bersamaan dengan fenobarbital, rifampin, isoniazid, fenitoin, karbamazepin atau sulfinpirazon, bersihan teofilin dapat meningkat sehingga efeknya akan berkurang. Untuk itu diperlukan peningkatan dosis.
  • Pemberian bersamaan dengan zat-zat berikut ini dapat mengurangi bersihan teofilin : antibiotika makrolida (seperti eritromisin, troleandomisin), linkomisin, allopurinol, penghambat β, simetidin, kontrasepsi oral. Pada kasus-kasus tersebut diperlukan pengurangan dosis.
  • Bila diberikan bersamaan dengan enoxacin, dosis teofilin harus dikurangi menjadi seperempatnya. Bila digunakan bersamaan dengan inhibitor gyrase lainnya, pertimbangkan untuk mengurangi dosis teofilin yang diberikan
  • Efek garam lithium dan penghambat β dapat berkurang dengan adanya teofilin.
  • Penghambat β (seperti propranolol) mengantagonisasi efek bronkodilator dari teofilin. Karena penghambat β sendiri dapat menginduksi bronkokonstriksi, maka pemberian obat-obat ini dikontraindikasikan pada asma bronkial.
PERINGATAN DAN PERHATIAN
  • Hati-hati pada penderita hipoksemia, hipertensi atau penderita yang mempunyai riwayat tukak lambung.
  • Dapat mengiritasi saluran gastrointestinal.
  • Hati-hati pemberian pada wanita hamil, menyusui.
  • Jangan melampaui dosis yang dianjurkan dan bila dalam 1 jam gejala-gejalanya masih tetap atau bertambah buruk, hubungi Puskesmas atau Rumah Sakit terdekat.
  • Hati-hati pada penderita kerusakan fungsi hati, penderita di atas 55 tahun, terutama pria dan pada penderita penyakit paru-paru kronik (COPD, cor pulmonale).
DOSIS DAN CARA PEMAKAIAN
EUPHYLLIN® Retard Mite
Dewasa : 2 kali sehari 2 tablet.
Anak-anak 6-12 tahun : 2 kali sehari 1 tablet, atau menurut petunjuk dokter.
EUPHYLLIN® Retard
Dewasa : 2 kali sehari 1 tablet.

Pemberian obat-obat yang mengandung teofilin atau metil xantin lain sebelumnya, perlu dipertimbangkan.
Bersihan teofilin seringkali berkurang pada penderita insufisiensi jantung, hipoksia berat, gangguan fungsi hati, pneumonia dan infeksi virus dan pada penderita usia lanjut. Karenanya penderita-penderita tersebut memerlukan pengurangan dosis dan hati-hati bila ingin dilakukan peningkatan dosis.
Para perokok seringkali memerlukan teofilin dengan dosis yang lebih besar daripada bukan perokok, karena eliminasi teofilinnya yang lebih cepat.
Peningkatan atau pengurangan dosis sebaiknya dilakukan dibawah pengawasan dokter. Sebaiknya EUPHYLLIN® diberikan sesudah makan dengan sedikit air.

KEMASAN
EUPHYLLIN® Retard Mite
Dus berisi 10 strip @ 10 tablet salut selaput
No. Reg.DKL7821616717A1
EUPHYLLIN® Retard
Dus berisi 10 strip @ 10 kaplet salut selaput
No.Reg.DKL7821616717B1

HARUS DENGAN RESEP DOKTER

Simpan di tempat sejuk (15-25°C) dan kering
Jauhkan dari jangkauan anak-anak

Diproduksi oleh :
PHAROS
JAKARTA - INDONESIA
Continue reading...

Neo-Mercazole

NEO-MERCAZOLE®
CARBIMAZOLE

ANTITHYROID THERAPY

NEO-MERCAZOLE® Tablet exerts its antithyroid effect by inhibiting the iodination of tyrosine, thereby blocking the synthesis of thyroid hormone.

Composition:
Each tablet contains:
Carbimazole BP 5 mg

Indications:
NEO-MERCAZOLE® Tablet is indicated in all conditions where reduction of thyroid activity is required i.e.:
- Thyrotoxicosis (as the sole i.e. definitive treatment).
- Preparation prior to thyroidectomy (selected patients).
- In combination with radioactive ablative therapy.

Dosage:
Initial dosage:
- Mild cases 3-4 tablets daily in divided dosage.
- Moderate cases 6 tablets daily in divided dosage.
- Severe cases 8-9 tablets daily in divided dosage.
- Maintenance dosage: 1-3 tablets daily.

Contra Indications:
  • The patients who suffer from any degree of tracheal obstruction, as high dosage may produce thyroid enlargement and obstructive symptoms may become marked.
  • Hypersensitive to Carbimazole.

Side Effects:
  • Significant side effect of administration of NEO-MERCAZOLE® Tablet has not been reported.
  • In sensitive patients, possibly occurred nausea, headache and mild gastric distress, sometimes minor skin rashes occurred that can be healed by administration of antihistamin without stop using NEO-MERCAZOLE® Tablet.
  • If reactions to NEO-MERCAZOLE® Tablet are encountered which usually occur within the first eight weeks of starting treatment e.g. agranulocytosis, sore throat, fever, skin rashes, arthralgia, nausea, headache, loss of depigmentation of the hair.

Precautions:
  • Administration for lacting mother: during treatment, breast-feeding is not recommended.
  • Antithyroid agents may cause congenital goiter by inhibiting thyroxine synthesis in the fetus, during pregnancy these products should therefore only be used after carefully weighing the mothers needs against the risk to the fetus. The basal metabolic rate is raised during pregnancy and the dosage of Carbimazole must be adjusted accordingly.
  • The dosage during the last three months of pregnancy, should if possible not exceed 15 mg daily and should be discontinued three or four weeks before delivery.
  • Carbimazole should be stopped temporarily at the time of administration of radio-iodine.
  • The patients should be instructed to stop medication and report immediately to the Phycisian should symptoms like sore throat, fever or rash appear.
  • In such patients white blood cells counts should be performed, particularly where there is any clinical evidence of infection.

Presentations:
Bottle of 100 tablets
No. Reg. : DKL7217807210A1

ON MEDICAL PRESCRIPTION ONLY

Store below 25°C, protect from light.

Produced by:
PT. Nicholas Laboratories Indonesia
Jakarta, Indonesia


NEO-MERCAZOLE®
CARBIMAZOLE

TERAPI ANTITIROID

NEO-MERCAZOLE® Tablet mengandung bahan aktif Carbimazole BP, merupakan preparat antitiroid yang bekerja dengan cara menghambat yodinasi tirosin, dengan demikian mencegah pembentukan hormon tiroid.

Komposisi:
Tiap tablet mengandung:
Carbimazole BP 5 mg

Indikasi:
NEO-MERCAZOLE® Tablet diindikasikan pada keadaan di mana penurunan aktivitas tiroid diperlukan, yaitu:
- Pengobatan Tirotoksikosis (sebagai terapi utama).
- Persiapan sebelum Tiroidektomi (pasien tertentu).
- Pengobatan tombinasi dengan radioaktif ablatif.

Dosis:
Dosis awal:
- Kasus ringan : 3-4 tablet sehari, dibagi dalam beberapa kali pemberian.
- Kasus sedang : 6 tablet sehari, dibagi dalam beberapa kali pemberian.
- Kasus berat : 8-9 tablet sehari, dibagi dalam beberapa kali pemberian.
- Dosis pemeliharaan : 1-3 tablet sehari.

Kontra Indikasi:
  • Pada penderita yang telah mengalami penyumbatan pada trakhea (tracheal obstruction), karena dalam dosis tinggi dapat mempengaruhi pembesaran kelenjar tiroid, sehingga gejala-gejala obstruksi diperberat.
  • Penderita yang hipersensitif terhadap Carbimazole.
Efek Samping :
  • Belum pernah dilaporkan adanya efek samping yang berarti pada pengunaan NEO-MERCAZOLE® Tablet
  • Pada penderita yang sensitif, kemungkinan dapat terjadi efek samping, seperti : nausea, sakit kepala dan gangguan lambung ringan (mild gastric distress), kadang-kadang dapat pula terjadi gangguan ringan pada kulit (minor skin rashes) yang dapat disembuhkan dengan pemberian antihistamin tanpa penghentian penggunaan NEO-MERCAZOLE® Tablet
  • Bila timbul reaksi terhadap NEO-MERCAZOLE® Tablet, biasanya terjadi pada 8 minggu pertama pengobatan, misalnya : agranulositosis, tenggorokan kering, demam, ruam kulit, artralgia, nausea, sakit kepala, hilangnya atau berkurangnya pigmen rambut.
Peringatan dan Perhatian:
  • Pemberian pada ibu dalam masa laktasi dianjurkan untuk tidak menyusui bayinya selama dalam pengobatan dengan NEO-MERCAZOLE® Tablet
  • Obat-obat antitiroid dapat menyebabkan goiter kongenital dengan menghambat sintesa tirotein pada janin, sehingga selama kehamilan obat ini sebaiknya hanya digunakan setelah dipertimbangkan antara kebutuhan ibu dengan resiko terhadap janin. Selama kehamilan taraf metabolisme meningkat, maka bila diperlukan dosis Carbimazole disesuaikan.
  • Pemberian pada kehamilan 3 bulan terakhir, bila mungkin tidak melebihi 15 mg/hari dan sebaiknya pemberian dihentikan 3-4 minggu sebelum melahirkan.
  • Pemberian Carbimazole sebaiknya dihentikan sementara pada saat penggunaan yodium radioaktif.
  • Sebaiknya pengobatan dihentikan dan segera memberitahu dokter bila terjadi gejala-gejala sakit tenggorokan, demam atau gangguan pada kulit.
  • Pada beberapa penderita, hitung sel darah putih perlu dilakukan, terutama bila ada bukti klinis infeksi.
Kemasan:
Box berisi botol @ 100 tablet
No. Reg. : DKL721780721 OA1

HARUS DENGAN RESEP DOKTER

Simpan di bawah 25°C, terlindung dari cahaya.

Diproduksi oleh:
PT. Nicholas Laboratories Indonesia
Jakarta, Indonesia
Continue reading...

Sunday, February 14, 2010

Etaphylline

ETAPHYLLINE®
acefylline piperazine

Composition:
Each tablet film coating contains:
250 mg of acepifylline (= acefylline piperazine = theopylline ethanoatepiperazine).

Each injectable ampoule (5 ml) contains :
500 mg acepifylline (100 mg/ml).

Properties:
Etaphylline has pharmacological properties identical with theophylline.However, it is the most soluble theophylline that explains the best efficacy it can offer. The solution of Etaphylline is aqueous and neutral
(pH 7) and stable that permits a totally painless intra muscular injections. Unlike the theophylline, Etaphylline can be given without causing any gastric disorders which are usually encountered with the theophylline, such as anorexia, nausea, vomitus, gastrict discomfort etc.

Action on Respiratory System :
  • Increase in respiratory amplitude and rhythm.
  • Relaxation of smooth muscles in bronchi.
  • Suppression of bronchospasm.
  • Suppression of experimental dyspnea in man.
  • Improvement of Cheyne-Stokes dyspnea.

Action on Cardiovascular System :
  • Increase in rate and force of myocardial contraction, in cardiac out-put
  • Reduction in venous filling pressure.
Action On Renal System :
  • Increase in renal circulation, in volume of water, urea and chloride elimination (mild diuretic action)
Indications:
Bronchial asthma, bronchospasm in bronchitis, general dyspnea, dyspnea of effort in cardiac insufficiency; emphysema and other chronic pulmonary obstructive disorders.
Etaphylline injection still remain one of the best choice for treatment of emergency relief of status asthmatcus.

Dosage:
Tablet: 
2 - 8 tablets daily in divided doses

Injectable solution :
Intra muscular: 3-4 ampoules daily.
Intra venous : 1-2 ampoules daily.

In case of necessary, the contents of the ampoule can be taken orally after dilution in half a glass of water.

Contra Indications:
Patients with known intolerance to theophylline should not be treated with Etaphylline.

Tolerance:
Etaphylline is well tolerated in the recommended dosage range and does not give rise to troublesome side effects :
  • Gastric irritation
  • Intra muscular injection are painless due to the neutral pH (pH 7).
  • Intra venous injection : Like all theophylline, Etaphylline IV. Injection must be inserted extremely slowly by experienced persons after diluting the solution by half with normal saline. The injections are also well tolerated.
Above all, Etaphylline is the least toxic of the theophylline groups (4 to 7 time less toxic than aminophylline and theophylline). The acute and chronic toxicity studies in the experimental animals have shown a high therapeutic index and wide margin or safety.

Presentation :
Tablets 250 mg : Box of 2 strips @ 10 film coated tablets. Reg. No. DL 2010362
Ampoules 500 mg / 5 ml: Box of 6 ampoules @ 5 ml. Reg. No. DL 2010361

Store at room temperature (below 30°C)
ON MEDICAL PRESCRIPTION ONLY.

Ampoules
Manufactured by :
PT. LUCAS DJAJA for PT. CORSA INDUSTRIES,
Tangerang - Indonesia
Under license of :
Delalande Synthelabo Groupe
France


ETAPHYLLINE®
acefylline piperazine

Komposisi:
Tiap tablet salut selaput mengandung :
250 mg acepifylline ( = acefylline piperazine = theophylline ethanoate piperazine).
Tiap ampul untuk injeksi (5 ml) mengandung :
500 mg acepifylline (100 mg/ml).

Khasiat:
Etaphylline mempunyai khasiat farmakologis yang identik dengan teofilin. Namun ia merupakan derivat teofilin yang paling larut dalam air yang menjelaskan mengenai efektifitasnya yang tinggi.
Larutan Etaphylline bersifat stabil dan netral (pH 7) sehingga memungkinkan suatu injeksi infra muskuler yang sama sekali tidak nyeri.
Tidak seperti halnya dengan teofilin, Etaphylline dapat diberikan kepada penderita tanpa menyebabkan gangguan-gangguan lambung seperti tidak nafsu makan, mual, muntah, rasa nyeri pada lambung dll.

Daya kerja pada sistim pernafasan :
  • Meningkatkan amplitude dan irama pernafasan.
  • Relaksasi otot-otot polos pada bronkhi.
  • Penekanan terhadap bronkhospasme.
  • Penekanan terhadap dyspnea experimental pada manusia.
  • Perbaikan terhadap dispnea Cheyne-Stokes.
Daya kwja pada sistim jantung :
  • Meningkatkan frekwensi dan kekuatan kontraksi miokardium, serta meningkatkan output jantung.
  • Mengurangi tekanan pengisian pada vena cava.
Daya kerja pada sistim urinarius :
  • Meningkatkan sirkulasi ginjal, meningkatkan pengeluaran volume cairan, ureum dan klorida (efek diuresis ringan).
Indikasi:
Asma bronkial, keadaan spasme bronkhus pada bronkhitis, keadaan-keadaan sesak secara umum, sesak pada aktivitas-aktivitas fisik oleh karena insufisiensi jantung, emfisema dan keadaan-keadaan gangguan obstruksi paru kronik lainnya.
Suntikan Etaphylline masih merupakan salah satu pilihan terbaik pada pengobatan keadaan darurat pada status asmatikus.

Dosis :
Tablet : 
2-8 tablet sehari dalam dosis terbagi.
Larutan injeksi : 
Intra muskuler : 3-4 ampul sehari.
Intra vena : 1-2 ampul sehari.
Bila dianggap perlu, isi dari ampul Etaphylline dapat diminum sesudah dilarutkan dalam setengah gelas air.

Kontra Indikasi :
Penderita yang diketahui tidak tahan terhadap teofilin jangan diobati dengan Etaphylline.

Toleransi :
Etaphylline umumnya ditolerir dengan baik dalam dosis yang dianjurkan dan tidak menimbulkan efek samping yang mengganggu seperti :
  • Iritasi lambung.
  • Suntikan intra muskuler tidak menimbulkan rasa nyeri oleh karena pH nya yang netral (pH 7).
  • Suntikan intra vena : seperti halnya dengan teofilin, maka suntikan Etaphylline secara intra vena harus diberikan secara amat lambat oleh tenaga medis yang berpengalaman dan dilakukan sesudah melarutkan cairan Etaphylline dengan cairan garam fisiologis dalam volume yang sama. Suntikan intra vena ini ditolerir dengan baik.
Sebagai tambahan, Etaphylline merupakan derivat teofilin yang paling tidak toksik (4 - 7 x kurang toksik daripada aminophylline dan / atau teofilin). Penelitian-penelitian toksikologi akut maupun kronis pada binatang-binatang percobaan telah menunjukkan index terapeutik yang tinggi serta "margin of safety" yang luas.

Kemasan :
Tablet 250 mg : Dus, 2 strip @ 10 tablet salut selaput. No. Reg . DL 2010362
Ampul 500 mg /5 ml: Dus, 6 ampul @ 5 ml. No. Reg . DL 2010361

Simpanlah di tempat kering, di bawah suhu 30°C
HARUS DENGAN RESEP DOKTER

Ampul
Diproduksi oleh :
PT. LUCAS DJAJA untuk PT. CORSA INDUSTRIES
Tangerang - Indonesia
Dengan lisensi dari:
Delalande Synthelabo Groupe
Perancis
Continue reading...

Fenistil Drops

Fenistil® Drops
Antihistaminic, Antialergic

Composition
Each ml contains dimethindene maleate 1 mg.

Properties
Fenistil® is a potent antipruritic, antihistamine, characterized by the small size of its effective dose and its rapidity of action.
Its effect sets in after 20 to 60 minutes and lasts several hours.
Fenistil® drops are particularly, indicated in pediatric practice.

Indications
Drug or food-induced allergies, respiratory allergies (hay fever, allergic rhinitis, etc.), insect bites, serum sickness, Quincke's oedema, urticaria, prevention of desensitization reactions.

Contraindications
None known to date.
Hypersensitivity to any of the components of this preparations.

    Dosage
    Fenistil® drops: Average daily dose (in three doses spread over the day).
    Drops
    Infants up to 1 year10-30
    Infants of 1 to 3 years30-45
    Children over 3 years 45-60
    Adults60-120
    20 drops (1 ml) = 1 mg

    The doctor should determine the optimum dose. In sensitive patients presenting apathy during the day, prescribe 40 drops before retiring, 20 drops before breakfast.

    Contraindications
    None known to date.
    Hypersensitivity to any of the components of this preparations.

    Important note
    Fenistil® drops should not be subjected to high temperatures. Add them to the baby's bottle at the last minute, when it is look warm. If the baby is spoon-fed, give the drops undiluted in a small coffee spoon.
    Fenistil® drops are pleasant-tasting.
    Drugs should be kept out of the reach of children.

    Storage
    Do not store above 30°C, protect from heat and light.

    Packing
    Fenistil® drops: bottle of 10 ml, Reg. No. DKL0430412636A1

    PRESCRIPTION ONLY

    Manufactured by PT Novartis Indonesia, Citeureup, Bogor, Indonesia, under license
    of Novartis Consumer Health SA, Nyon, Switzerland


    Fenistil® Drops
    Antihistamin, Anti alergi

    Komposisi
    Tiap 1 ml mengandung dimethindene maleate 1 mg.

    Khasiat
    Fenistil® sebagai obat antipruritik dan antihistamin mempunyai daya yang kuat, terbukti dari takaran efektif yang kecil dan kecepatan daya kerjanya.
    Efeknya terlihat setelah 20 - 60 menit dan tahan untuk beberapa jam. Obat tetes Fenistil® khusus digunakan untuk pengobatan anak-anak.

    Indikasi
    Alergi terhadap obat ataupun makanan, alergi saluran pernafasan (hay fever, rhinitis alergika, dan lain-lain), gigitan serangga, penyakit serum, Quincke's oedema, urtikaria, pencegahan terhadap desensitisasi.

    Kontraindikasi
    Tidakdiketahui.
    Hipersensitif terhadap salah satu komponen yang ada pada produk ini

    Takaran pemakaian
    Obat tetes Fenistil®: Takaran rata-rata sehari (dibagi dalam 3 dosis yang merata dalam sehari).
    Tetes
    Bayi10-30
    Anak-anak dari 1-3 tahun30-45
    Anak-anak di atas 3 tahun45-60
    Dewasa60-120
    20 tetes (1 ml) = 1 mg

    Takaran optimal ditentukan oleh dokter. Untuk pasien yang peka yang menunjukkan sifat apatis sepanjang hari, diberikan 40 tetes sebelum tidur, 20 tetes sebelum makan pagi.

    Catatan
    Obat tetes Fenistil® tidak boleh diletakkan di tempat yang panas. Tambahkanlah Fenistil® ke dalam botol bayi pada saat terakhir, waktu masih hangat kuku. Apabila memberi makan bayi dengan sendok, berikanlah obat tetes ini dalam sendok yang kecil tanpa diencerkan. Obat tetes Fenistil® mempunyai rasa yang enak.
    Jauhkan obat dari jangkauan anak-anak.

    Penyimpanan
    Simpan pada suhu tidak lebih dari 30®C, terlindung dari cahaya dan panas.

    Kemasan
    Obat tetes Fenistil®: botol berisi 10 ml, No. Reg. DKL0430412636A1

    HARUS DENGAN RESEP DOKTER

    Dibuat oleh PT Novartis Indonesia, Citeureup, Bogor, Indonesia, dengan lisensi dari
    Novartis Consumer Health SA, Nyon, Switzerland
    Continue reading...

    Friday, February 12, 2010

    Cardiomin

    CARDIOMIN
    CARDIO PROTECTIVE VITAMIN
    FOOD SUPPLEMENT


    Hyperhomocysteinemia increases the risk of developing cardiovascular, cerebrovascular and peripherial diseases independent of traditional risk factors such as elevated serum cholesterol, hypertension and diabetes.
    Vascular damage due to hyperhomocysteinemia includes endothelial cell injury increased platelet adhesiveness, enhanced LDL deposition in the arterial wall and coagulation abnormalities. Supplementation with folic acid alone or in combination with vitamin B6 and B12 has been shown to lower serum homocystein levels. Folic acid acts as a co substrate in the remethylation cycle, while vitamin B6 and B12 act as cofactor of various enzymes involved in homocystein remethylation (methionine synthesa) and transulfuration (cystamionin p-synthase and y-cystathionase). Vitamin E through its antioxidant effect, helps reduce low-density lipoprotein (LDL) oxidation, which is one of the mechanisms in the pathogenesis of Atherosclerosis.

    FORMULA
    Each soft capsule contains:
    Pyridoxin Hydrochloride (Vitamin B6)25mg
    Cyanocobalamin (Vitamin B12)25mcg
    Folic Acid500mcg
    Natural Vitamin E400IU

    USAGE
    As a supplement to help fulfill requirements for Vitamin B6, Vitamin B12, Folic Acid and Vitamin E.

    DOSAGE
    1 soft capsule daily or as prescribed by the physician.

    SIDE EFFECT
    This preparation is usually non-toxic if taken at the recommended dosage.

    CONTRAINDICATION
    Hypersensitivity to any component in the formulation.

    PRESENTATION
    Box of 20 soft capsules (5 strips @ 4 capsules)
    Box of 60 soft capsules (15 strips @ 4 capsules)
    Reg. No. POM SD 041315661

    STORE BETWEEN 25° AND 30°C

    Manufactured:
    Darya-Varia
    LABORATORIA
    Gunung Putri, Bogor - Indonesia

    UNITED AMERICAN PHARMACEUTICALS, LTD.


    CARDIOMIN
    CARDIO PROTECTIVE VITAMIN
    SUPLEMEN MAKANAN

    Hyperhomocysteinemia meningkatkan faktor-faktor risiko yang memicu terjadinya penyakit pembuluh darah pada jantung, otak dan pembuluh darah perifer, disamping karena faktor independen seperti kolesterol, hipertensi dan diabetes.
    Mekanisme terjadinya kerusakan pada pembuluh darah yang diakibatkan oleh hyperhomocysteinemia antara lain berupa kerusakan sel-sel endothelial, meningkatnya adhesivitas dari platelet, peningkatan penumpukan LDL di dinding arteri dan koagulasi yang tidak normal. Pemberian Asam Folat secara sendiri atau bersamaan dengan Vitamin B6 dan B12 terbukti menurunkan kadar serum homocystein. Asam Folat berperan sebagai kosubstrat di dalam siklus remetilasi, sementara Vitamin B6 dan B12 berperan sebagai kofaktor pada berbagai enzym yang terlibat dalam homocystein remetilasi (sintesa methionin) dan transulfurasi (cystathionin p-synthase dan y-cystathionase). Vitamin E melalui efek antioksidan-nya membantu menurunkan oksidasi low-density lipoprotein (LDL) yang merupakan salah satu faktor penyebab Atherosklerosis.

    KOMPOSISI
    Setiap kapsul lunak mengandung:
    Piridoksin Hidroklorida (Vitamin B6)25mg
    Sianokobalamin (Vitamin B12)25mcg
    Asam Folat500mcg
    Vitamin E Alamiah400IU

    KEGUNAAN
    Suplemen untuk membantu memenuhi kebutuhan vitamin pada kondisi defisiensi Vitamin B6, Vitamin B12, Asam Folat dan Vitamin E.

    ATURAN PAKAI
    1 kapsul lunak sehari atau sesuai petunjuk dokter.

    EFEK SAMPING
    Tidak ditemukan efek samping yang berarti selama digunakan sesuai aturan pakai.

    KONTRAINDIKASI
    Pasien yang hipersensitif terhadap salah satu komponen dalam CARDIOMIN.

    KEMASAN
    Dus berisi 20 kapsul lunak (5 strip @ 4 kapsul)
    Dus berisi 60 kapsul lunak (15 strip @ 4 kapsul)
    Reg. No. POM SD 041315661

    SIMPAN PADA SUHU 25° - 30°C

    Diproduksi oleh;
    Darya-Varia
    LABORATORIA
    Gunung Putri, Bogor - Indonesia

    UNITED AMERICAN PHARMACEUTICALS, LTD.
    Continue reading...

    Thursday, February 11, 2010

    Sofra-tulle

    Sofra-tulle®
    Framycetin Sulphate BP 1%

    Composition
    Each antibacterial gauze dressing size 10 cm x 10 cm contains 2.1 g Ointment.
    Each gram ointment contains:
    Active constituent:
    1. Framycetin sulphate0.011 g
    Excipients:
    2. Wool Fat (BP)0.100 g
    3. White Soft Paraffin0.889 g
    Total1.000 g

    Properties
    Sofra-tulle is a lightweight, Lano-paraffin gauze dressing impregnated with framycetin sulphate BP 1%(Soframycin)

    Indications
    Sofra-tulle has antibacterial activity and is an ideal dressing for immediate use in a variety of infected lesions.

    Thermal:
    Light and not too extensive burns or scalds.

    Traumatic:
    Lacerations, abrasions, bites, wounds, crash injures.

    Miscellaneous:
    Secondary infected skin condition (e.g. eczema, dermatitis, herpes zoster).

    Contra-indcations/Warnings
    Sofra-tulle is contraindicated where there is known allergy to lanolin or to framycetin, or where organisms are known to be resistant to the latter.

    Precautions
    Cross-sensitisation to framycetin may occur in patients known to be allergic to Streptomyces-derived antibiotics (neomycin, paramomycin, kanamycin). In most cases, absorption of the antibiotic is negligible.
    However, where large body areas are involved, e.g. 30% or more body burn, the possibility of ototoxicity being produced by prolonged applications should be borne in mind.

    Dosage and administration
    If necessary, the lesion should first be cleansed, than a single layer of Sofra-tulle applied and covered with a suitable dressing.
    When dressing ulcers, the tulle should be shaped to fit the ulcer crater. If the lesion exudes profusely it is advisable to change the dressings at least once a day.

    Storage
    Keep it flat. Store below 25°C.

    Expiry Date:
    Do not use later than the date of expiry

    Presentation
    Each antibiotic gauze dressing, placed between two layers of parchment.
    Box contains
    10 sachets of 10 cm x 10 cm
    Reg. No. DKI0174200551A1

    ON MEDICAL PRESCRIPTION ONLY

    Manufactured by
    Patheon UK Limited, Swindon, England for
    Aventis Intercontinental, France
    Imported by
    PT Aventis Pharma
    Jakarta, Indonesia


    Sofra-tulle®
    Framycetin Sulphate BP 1%

    Komposisi
    Untuk satu kain kasa ukuran 10 cm x 10 cm mengandung 2.1 g salep.
    Tiap gram salep mengandung:
    Bahan Berkhasiat:
    1. Framicetin sulfat0.011 g
    Bahan penambah:
    2. Wool Fat (BP)0.100 g
    3. White Soft Paraffin0.889 g
    Total1.000 g

    Sifat-sifat
    Merupakan kain kasa yang diresapi antibiotika framisetin sulfat BP 1% dalam basis lano-parafin.

    Indikasi
    Sofra-tulle mempunyai cakupan aktifitas anti bakteri dan merupakan kasa ideal yang dapat segera digunakan untuk menutup bermacam-macam lesi yang terinfeksi, antara lain:
    • Luka bakar/melepuh yang ringan.
    • Laserasi, abrasi, luka gigit, luka terkoyak.
    • Infeksi kulit sekunder (misalnya pada eksema, dermatitis, herpes zoster).
    Kontraindikasi / Peringatan
    Sofra-tulle tidak boleh digunakan pada orang yang telah diketahui alergi terhadap lanolin atau framisetin dan juga jika organisme penyebab infeksi telah diketahui resisten terhadap framisetin.

    Perhatian
    Sensitisasi silang terhadap framisetin dapat timbul pada pasien yang diketahui alergi terhadap antibiotik derivat streptomises (neomisin, paramomisin, kanamisin). Pada umumnya antibiotika yang terabsorpsi oleh
    kulit dapat diabaikan jumlahnya. Tetapi jika digunakan pada permukaan kulit yang luas (30% atau lebih dari permukaan tubuh) dalam waktu lama, maka kemungkinan terjadinya ototoksik perlu dipertimbangkan.

    Dosis dan Cara Pemakaian
    Jika perlu dan memungkinkan, bersihkan lesi lebih dahulu sebelum ditutup dengan selapis sofra-tulle. Kemudian dibalut sebagaimana mestinya. Untuk ulkus, Sofra-tulle digunting lebih dahulu sebatas luka ulkus.
    Jika lesi merupakan lesi basah dengan banyak eksudat, dianjurkan mengganti Sofra-tulle sekurang-kurangnya sekali sehari.

    Catatan : Kasa Sofra-tulle ditempatkan diantara 2 lembar kertas pelapis.
    Untuk mendapatkan ukuran yang diinginkan guntinglah Sofra-tulle bersama kertas pelapisnya. Buang kertasnya sewaktu ditempelkan diatas lesi.

    Penyimpanan
    Simpanlah secara rata (tidak digulung) pada
    suhu di bawah 25°C.

    Waktu Daluwarsa
    jangan digunakan setelah lewat waktu daluwarsanya

    Kemasan
    Dalam kotak berisi
    10 sachet ukuran 10 cm x 10 cm
    Reg. No. DKI0174200551 A1

    HARUS DENGAN RESEP DOKTER

    Manufactured by
    Patheon UK Limited, Swindon, England for
    Aventis Intercontinental, France
    Imported by
    PT Aventis Pharma
    Jakarta, Indonesia
    Continue reading...

    Sunday, February 7, 2010

    Antrain

    ANTRAIN®
    TABLET - INJECTION

    COMPOSITIONS :
    ANTRAIN® Tablet
    Each tablet contains:
    Metamizole Na ...................................................... 500 mg
    ANTRAIN® Injection
    Each ml contains:
    Metamizole Na ...................................................... 500 mg
    ACTIONS:
    Metamizole Na is a methanesulphonate derivative from aminopyrine with analgesic activity. The mechanism of action is central and peripheral inhibition of pain transmission.
    Metamizole Na acts as analgesic. It is absorbed from gastrointestinal tract, with half-life 1-4 hours.
    INDICATIONS:
    To relieve pain, especially in colic and post-operation.
    CONTRAINDICATIONS :
    • Patients who has known hypersensitivity to Metamizole Na.
    • Pregnant or lactating women.
    • Patients with systolic blood pressure ‹ 100 mmHg.
    • Infants under 3 months or weighing ‹ 5 kg.
    ADVERSE REACTIONS:
    • Hypersensitivity reaction: skin reactions, e.g.: urticaria.
    • Agranulocytosis.
    PRECAUTIONS/WARNINGS :
    • ANTRAIN® should not be used for muscle pain in flu symptoms, rheumatism, lumbago, back pain, bursitis, shoulder-arm syndrome.
    • Prolonged treatment or continued use of ANTRAIN® is not recommended as it may cause agranulocytosis and can be fatal.
    • Caution should be observed when prescribing to patients with a history of impaired blood formation, hepatic or renal function impairment. In prolonged use more than for relieves acute pain, functions of liver and blood need to be controlled.
    • Prolonged use may cause neuropathic syndrome which will gradually disappear if the treatment has been stopped.
    DRUG INTERACTIONS:
    Concomitant use with Chlorpromazine may cause hypothermia.
    DOSAGE AND ADMINISTRATIONS:
    Adults:
    • Tablet : 1 tablet when pain occurs, followed by 1 tablet every 6-8 hours, maximum of 4 tablets a day.
    • Injection : 500 mg when pain occurs, followed by 500 mg every 6-8 hours, maximum of 3 times a day, I.M. or I.V. administration.
    PRESENTATIONS :
    ANTRAIN® Tablet
    Box contains 10 strips of 10 tablets
    Reg.No.:DKL7617611210A1
    ON MEDICAL PRESCRIPTION ONLY
    STORE BELOW 30°C
    PROTECT FROM LIGHT
    ANTRAIN®Injection
    Box contains 5 ampoules of net 2 ml
    Reg.No.:DKL0117616843A1
    KEEP OUT OF THE REACH OF CHILDREN
    ON MEDICAL PRESCRIPTION ONLY
    STORE BELOW 30°C
    PROTECT FROM LIGHT
    DO NOT FREEZE
    Manufactured by ;
    PT. Interbat
    Jl. H.R.M. Mangundiprojo no. 1
    Buduran, Sidoarjo-61252
    East Java, Indonesia

    ANTRAIN®
    TABLET - INJEKSI


    KOMPOSISI:
    ANTRAIN® Tablet
    Tiap tablet mengandung:
    Metamizole Na ...................................................... 500 mg
    ANTRAIN® Injeksi
    Tiap ml mengandung:
    Metamizole Na ...................................................... 500 mg
    CARA KERJA OBAT:
    Metamizole Na adalah derivat metansulfonat dari aminopirin yang mempunyai khasiat analgesik. Mekanisme kerjanya adalah menghambat transmisi rasa sakit ke susunan saraf pusat dan perifer.
    Metamizole Na bekerja sebagai analgesik, diabsorpsi dari saluran pencernaan mempunyai waktu paruh 1 -4 jam.
    INDIKASI:
    Untuk meringankan rasa sakit, terutama nyeri kolik dan sakit setelah operasi.

    KONTRAINDIKASI:
    • Penderita hipersensitif terhadap Metamizole Na.
    • Wanita hamil dan menyusui.
    • Penderita dengan tekanan darah sistolik ‹ 100 mmHg.
    • Bayi di bawah 3 bulan atau dengan berat badan ‹ 5 kg.
    EFEK SAMPING:
    • Reaksi hipersensitivitas: reaksi pada kulit misal kemerahan.
    • Agranulositosis.
    PERINGATAN / PERHATIAN :
    • Tidak untuk mengobati sakit otot pada gejala-gejala flu dan tidak untuk mengobati rematik, lumbago, sakit punggung, bursitis, sindroma bahu lengan.
    • Karena dapat menimbulkan agranulositosis yang berakibat fatal, maka sebaiknya tidak digunakan dalam jangka panjang.
    • Hati-hati pada penderita yang pernah mengalami gangguan pembentukan darah/ kelainan darah. gangguan fungsi hati atau ginjal.
    • Karena itu perlu dilakukan pemeriksaan fungsi hati dan darah pada penggunaan yang lebih lama dari penggunaan untuk mengatasi rasa sakit akut.
    • Pada pemakaian jangka lama dapat menimbulkan sindrom neuropathy yang akan berangsur hilang bila pengobatan dihentikan.
    INTERAKSI OBAT:
    Bila Metamizole Na diberikan bersamaan dengan Chlorpromazine dapat mengakibatkan hipotermia.
    ATURAN PAKAI:
    Dewasa:
    • Tablet : 1 tablet jika sakit timbul, berikutnya 1 tablet tiap 6-8 jam, maksimum 4 tablet sehari.
    • Injeksi : 500 mg jika sakit timbul, berikutnya 500 mg tiap 6-8 jam, maksimum 3 kali sehari, diberikan secara injeksi I.M. atau I.V.
    KEMASAN:
    ANTRAIN® Tablet
    Kotak berisi 10 strip @ 10 tablet
    Reg. No.: DKL7617611210A1

    HARUS DENGAN RESEP DOKTER
    SIMPAN DI BAWAH 30°C
    TERLINDUNG DARI CAHAYA

    ANTRAIN® Injeksi
    Kotak berisi 5 ampul @ 2 ml netto
    Reg. No.: DKL0117616843A1

    JAUHKAN DARI JANGKAUAN ANAK-ANAK
    HARUS DENGAN RESEP DOKTER
    SIMPAN DI BAWAH 30°C
    TERLINDUNG DARI CAHAYA
    JANGAN DISIMPAN DALAM LEMARI PEMBEKU

    Diproduksi oleh :
    PT. Interbat
    Jl, H.R.M. Mangundiprojo no, 1
    Buduran, SJdoarjo-61252
    Jawa Timur, Indonesia
    Continue reading...
     

    Followers

    Add to Technorati FavoritesTopOfBlogsobat, info, tablet,syrup, injection, ampul, cream, ointment, solution, blogarama - the blog directoryBlog Directory & Search engineMedicine Blogs - Blog Catalog Blog Directory Health Free Page Rank ToolPowered by  MyPagerank.Net Ping your blog, website, or RSS feed for Free
    review http://www.obatinfo.com on alexa.com

    Masukkan alamat email anda di bawah ini untuk mendapatkan informasi obat terbaru

       

    ObatInfo.com hanya memberikan informasi-informasi yang tertera pada kemasan dan brosur obat serta dari berbagai sumber. Informasi-informasi di ObatInfo.com tidak dimaksudkan sebagai pengganti nasihat, saran, konsultasi ataupun kunjungan kepada dokter Anda. Kunjungi dokter anda, bila memiliki masalah kesehatan. ObatInfo.com tidak bertanggung jawab atas segala dampak yang terjadi atas penggunaan/ penyalahgunaan informasi-informasi yang disajikan disini.

    ObatInfo.com | all about drugs Copyright © 2009 Not Magazine 4 Column is Designed by Ipietoon Sponsored by Dezigntuts