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Sunday, January 31, 2010

Kenacort-A

KENACORT-A®
CREAM / OINTMENT
(triamcinolone acetonide)


DESCRIPTION
Kenacort-A Cream (Triamcinolone acetonide cream 0.1 %) provides Triamcinolone acetonide 1 mg per gram in a vanishing cream base.
Kenacort-A Ointment (Triamcinolone acetonide ointment 0.1 %) provides Triamcinolone acetonide 1 mg per gram in Plastibase® (Plasticized Hydrocarbon Gel), a polyethylane and mineral oil gel base.

ACTION
Kenacort-A Cream and Ointment are primarily effective because of their anti-inflammatory, antipruritic and vasoconstrictive actions.

INDICATIONS
Kenacort-A Cream and Ointment are Indicated for relief of the inflammatory manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS
Topical steroids are contraindicated in viral diseases of the skin, such as vaccinia and varicella, and in those patients with a history of hypersensitivity to any of the components of the preparations.
These preparations are not for ophthalmic use. Topical steroids should not be used when circulation is markedly impaired.

WARNINGS
Usage in Pregnancy
Although topical steroids have not been reported to have an adverse effect on the fetus, the safety of topical steroid preparations during pregnancy has not been absolutely established; therefore, they should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

PRECAUTIONS
If irritation develops, the product should be discontinued and appropriate therapy instituted.
In the presence of an infection, the use of appropriate antifungal or antibacterial agents should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
If extensive areas are treated or if the occlusive technique is used, the possibility exists of increased systemic absorption of the corticosteroid and suitable precautions should be taken.

ADVERSE REACTIONS
The following local adverse reactions have been reported with topical corticosteroids either with or without occlusive dressing: burning sensations, itching, irritation, dryness, folliculitis, secondary infection, skin atrophy, striae, miliaria, hypertrichosis acneform eruptions, maceration of the skin, and hypopigmentation. Contact sensitivity to a particular dressing material or adhesive may occur occasionally.

DOSAGE AND ADMINISTRATION
Apply a thin film to the affected area two to three times daily.

Occlusive Dressing Technique
Kenacort-A Cream:
Gently rub a small amount of the preparation into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion and cover with a pliable nonporous film. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the plastic film is applied or by briefly soaking the affected area in water. The frequency of changing dressing is best determined on an individual basis. Reapplication of the preparation is essential at each dressing change.
Kenacort-A Ointment :
Apply a thin coat of the ointment to the affected area and cover with a pliable nonporous film. If desired, the lesion may be moistened with a dampened clean cotton cloth before the plastic film is applied. The frequency of changing dressings is best determined on an individual basis.
Reapplication of the preparation is essential at each dressing change.

HOW SUPPLIED
Kenacort-A Cream and Ointment is available in tube of 10 gram.

STORAGE
Store below 30°C.

HARUS DENGAN RESEP DOKTER
Reg. No.Kenacort-A Cream 10 gD7812442 (Indonesia)
R1004A3893 (Myanmar)
Kenacort- A Ointment 10 gD7812441 (Indonesia)
0504A3851 (Myanmar)

Manufactured by
PT Bristol-Myers Squibb Indonesia Tbk
Bogor-Indonesia
Under authority of
Bristol-Myers Squibb, Co.
Princeton, New Jersey, U.S.A.
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Lotremin

LOTREMIN®
Krim dan Solution
CLOTRIMAZOLE
Schering-Plough

 
KOMPOSISI
Tiap gram krim dan tiap mL solusio mengandung 10 mg clotrimazole

 
URAIAN
Mengandung clotrimazole yang mempengaruhi permeabilitas fungi/ jamur dengan cara mengganggu/ merintangi biosintesa ergosterol sehingga menyebabkan disorganisasi pada membran plasma.

 
INDIKASI
Untuk pengobatan topikal dari infeksi kulit berikut ini: tinea pedis, tinea cruris dan tinea corporis karena Trichophyton rubrum. Trichophyton mentagrophytes, Epidermophyton floccosum dan Microsporum canis; kandidiasis (moniliasis) yang disebabkan oleh Candida albicans, dan tinea versicolor karena Malassezia furfur.

 
DOSIS DAN ATURAN PAKAI
Dewasa dan anak-anak: Gosokkan perlahan-lahan krim atau solusio secukupnya pada daerah kulit yang sakit dan sekitarnya dua kali sehari, pada pagi dan malam hari. Perbaikan klinis dengan hilangnya pruritus biasanya terjadi dalam minggu pertama pengobatan. Agar pengobatan berhasil, krim atau solusio harus digunakan secara teratur dan dalam jumlah yang cukup. Pada beberapa kasus mikosis kulit dapat tidak mempan, sebagian disebabkan oleh jenis jamur yang berbeda yang mempunyai sifat-sifat khusus. Oleh karena itu, lama pengobatan bervariasi dan tergantung pada luas serta lokasi penyakit. Pada umumnya, lama pengobatan untuk dermatomikosis adalah 2 sampai 4 minggu; untuk eritrasma dan pityriasis versicolor kurang lebih 3 minggu. Untuk Candida vulvitis dan balanitis karena Candida albicans pengobatan 6 sampai 14 hari sering memadai.

 
PERHATIAN
  • Bila pasien tidak menunjukkan perbaikan klinis setelah empat minggu pengobatan dengan krim atau solusio, harus dilakukan uji mikrobiologi yang sesuai untuk memastikan diagnosa dan mengesampingkan patogen kausatif lainnya.
  • Bila terjadi iritasi atau sensitifitas dengan pemakaian krim atau solusio, pengobatan harus dihentikan dan diberikan terapi yang sesuai.
  • Tidak untuk pemakaian pada mata.
  • Tidak ada data yang menunjang untuk keamanan pemakaian krim atau solusio pada trimester pertama kehamilan.
  • Pemakaian pada trimester kedua dan ketiga tidak menyebabkan efek-efek yang tidak menguntungkan. Karena belum diketahui apakah clotrimazole diekskresikan dalam air susu. pemakaiannya pada wanita menyusui harus hati-hati.
  • Belum ada laporan tentang sinergisme atau antagonisme antara clotiimazole dan nistatin. atau amfotericin B atau flusitosine terhadap strain-strain C. albicans.

EFEK SAMPING
Efek samping yang dilaporkan meliputi eritema, rasa tersengat, melepuh, mengelupas, bengkak (edema), pruritus, urtikaria, rasa terbakar dan iritasi umum kulit.

 
KONTRAINDIKASI
Individu yang terbukti hipersensitivitas terhadap salah satu komponennya.

 
PRESENTASI
LOTREMIN Krim, tube berisi 5 gram; No. Reg.: DTL7806606229A1
LOTREMIN Krim. tube berisi 10 gram; No. Reg : DTL7806606229A1
LOTREMIN Solution. Botol 10 mL No. Reg : DTL7806606141A1

 
P No. 3
Awas! Obat Keras
Hanya untuk bagian luar dari badan

 
Simpan pada suhu antara 2° - 30° C

Informasi lebih lanjut dapat diberikan atas permintaan.

 
Dibuat oleh
PT Schering-Plough Indonesia Tbk
Pandaan, Jawa-Timur.
Cabang dari:
Schering-Plough International Inc., U.S.A.

® Nama dagang terdaftar
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Myco-Z

MYCO-Z®
Ointment
(Nystatin and Zinc Oxide)

COMPOSITION
Each gram Myco-Z® ointment contains 100,000 units of nystatin and 200 mg of zinc oxide in a perfumed Plastibase®, an emollient and protective vehicle.

PHARMACOLOGY
Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeast and yeast like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components.
Nystatin is a polyene antibiotic of undetermined structural formula that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida (Monilia) albicans and other Candida species. It exhibits no appreciable activity against bacteria.

Nystatin provides therapy for all localized forms of candidiasis.
Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment.
Cure is effected both clinically and mycologically in most cases of localized candidiasis.

Zinc oxide is applied externally as a mild astringent for the skin, as a soothing and protective application in eczema and as a protective to slight excoriations.

INDICATIONS
Myco-Z® ointment is indicated in the treatment of cutaneous mycotic infections caused by Candida (Monilia) albicans. If the organism is the primary cause of infection, such dermatologic conditions as intertrigo(submammary, inguinal and perineal), paronychia, interdigital mycosis, 'diaper rash' and other cutaneous lesions can be expected to respond.

CONTRAINDICATIONS
MYCO-Z® ointment is contraindicated in patients with known hypersensitivity to these components.

ADVERSE REACTIONS
Nystatin is virtually nontoxic and nonsensitizing. Myco-Z® ointment is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

OVERDOSAGE
Since absorption of nystatin from the gastro-intestinal tract is negligible, accidental ingestion causes no systemic toxicity.

DOSAGE AND ADMINISTRATION
The ointment should be applied liberally to the affected areas two to four times daily, until healing is complete.

HOW SUPPLIED
Myco-Z® ointment is supplied in tubes of 10 grams.

STORAGE
Store below 30°C. Avoid freezing

HARUS DENGAN RESEP DOKTER
Reg. No.: DKL 9024402730 A1

Manufactured by
PT Bristol-Myers Squibb IndonesiaTbk
Bogor-Indonesia
Under authority of
Bristol-Myers Squibb Co.,
Princeton, New Jersey, U.S.A.
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Decoderm 3

Decoderm 3®
Fluprednidene-21-Acetate + Neomycin Sulphate + 5-Chloro-8-Hydroxyquinoline
Specific skin corticosteroid + Antibiotics + Antiseptics

Composition
Decoderm 3 cream contains : Fluprednidene-21-Acetate 0.1%, Neomycin Sulfate 0.5% and 5-Chloro-8-Hydroxyquinoline 0.5% in a well tolerated special cream base.

Mode of actions
The active ingredients of Decoderm 3 are:
  • Fluprednidene-21-Acetate is corticosteroid which has been synthesized by E. Merck's Hormone Research Department and which has properties for local treatment of dermatological diseases: intensive antiphlogistic, antiexudative and antipruritic action.
  • Neomycin Sulfate, has a bactericidal effect on all sensitive gram-negative and gram-positive pathogens, in the stages of both proliferatio and rest.
  • 5-Chloro-8-Hydroxyquinoline is an antiseptic.
Indications
For treatment of infected dermatitis or dermatitis with secondary infection.

Dosage and administration
In general, apply thinly twice a day after bath.

Precautions
- Avoid long term usage.
- Stop usage ifsensitisation or irritation occurred.

Side effect
Can cause irritation especially if applied on tightly occluded skin.

Contraindications
  • Like all topical corticosteroids, Decoderm 3 is contraindicated in varicella, vaccination reactions, skin tuberculosis and syphilis.
  • Hypersensitivity to drugs components.
Presentation
Tube of 5g

Storage
Store in a cool place

"On medical prescription only"

Manufactured by
PT.Merck Tbk.,Jakarta
under licence from
Merck KGaA, Germany
Reg. No.: DKL 7215805129


Decoderm 3®
Fluprednidene-21-Acetate + Neomycin Sulphate + 5-Chloro-8-Hydroxyquinoline
Kortikosteroid spesifik untuk kulit + Antibiotik + Antiseptik


Komposisi
Decoderm 3 krim mengandung Fluprednidene-21-Acetate O.l%, Neomycin Sulfate 0,5% dan 5-Chloro-8-Hydroxyquinoline 0,5% dalam suatu basis krim spesial yang toleransinya baik.

Mekanisme kerja
Komponen-komponen aktif Decoderm 3 krim:
  • Fluprednidene-21-Acetate merupakan kortikosteroid hasil riset E. Merck yang mempunyai siftat-sifat untuk mengobati penyakit kulit secara topikal :yaitu sifat antiphlogistik, antieksudatif dan anti gatal.
  • Neomycin Sulfate mempunyai efek bakterisidal pada semua kuman patogen gram negatif dan positif yang sensitif, baik dalam tahap proliferasi maupun tidak.
  • 5-Chloro-8-Hydroxyquinoline bersifat antiseptik.
Indikasi
Untuk dermatitis terinfeksi atau dermatitis yang tampak ada infeksi sekunder.

Takaran dan cara pemakaian
Pada umumnya 2 kali sehari, dioleskan sesudah mandi.

Perhatian
- Hindari penggunaan jangka panjang.
- Hentikan penggunaan bila terjadi sensitasi atau iritasi

Efek samping
Terutama di bagian kulit yang tertutup rapat dapat menimbulkan iritasi

Kontraindikasi
  • Seperti obat-obat kortikosteroid topikal lainnya, Decoderm 3 kontraindikasi pada varicella, reaksi-reaksi vaksinasi, tuberculosis kulit dan sifilis.
  • Hipersensitif terhadap komponen obat ini.
Kemasan
Tube5g

Penyimpanan
Simpanlah di tempat yang sejuk

"Harus dengan resep dokter"


Dibuat oleh
PT.Merck Tbk., Jakarta
dengan lisensi
Merck KGaA, Jerman
No. Reg.: DKL 7215805129 A1
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Decoderm

Decoderm®
Fluprednidene-21-Acetate
Specific skin corticoid

Decoderm is a highly effective and quick acting topical corticoid with a depot effect.

Composition
Decoderm plain contains Fluprednidene-21-Acetate 0.1% in a very well tolerated cream respectively emulsion base.

Action
Fluprednidene-21-Acetate is a very potent corticoid which has been synthesized by E. Merck's Hormone Research Department and which has ideal properties for local treatment of dermatological diseases: Intensive antiphlogistic, antiexudative and antipruritic action; rapid onset of action; prolonged effect and absence of systemic effects.
A modern mixed type base of Decoderm is between o/w and w/o emulsion and is suitable for either dry eczema or wet eczema.

Indications
Decoderm is indicated in all types of allergic, pruriticand inflammatory dermatoses which include : Acute and chronic eczema, Moist eczema, Contact eczema, Crural eczema due to ulcus cruris, Intertrigo, Seborrhoic eczema, Endogenous eczema, Erythroderma, Psoriasis, Lichen ruber planus, Lichen simplex chronicus, Contact dermatitis, Allergic dermatitis, Sunburn, Herpes simplex (caution : cornea), Insect bites.

Contraindications
Like all topical corticoids, Decoderm is contraindicated in varicella, vaccination reactions, tuberculosis of the skin and syphilis.

Application
In general once a day application is sufficient

Presentation
Tube of 10 gram

Storage
Store in a cool place

"On medical prescription only"

Manufactured by
PT. Merck Tbk., Jakarta
under licence from
Merck KGaA, Germany
Reg. No.: DL2011681


Decoderm®
Fluprednidene-21-Acetate
Krim spesial untuk kulit

Decoderm adalah obat penyakit kulit yang sangat manjur dan kerjanya cepat.

Komposisi
Decoderm mengandung Fluprednidene-21 -Acetate 0,1%.

Cara kerja
Obat ini berkhasiat untuk menyembuhkan penyakit kulit/ eksim dengan cepat menghilangkan gatal-gatal, bengkak, untuk eksim basah.
Obat ini dapat menghentikan cairan yang keluar.
Kerjanya cepat dan bisa bertahan lama.
Basis krim dari Decoderm dibuat spesial sehingga bisa dipakai untuk eksim kering maupun eksim basah.

Indikasi
Segala jenis penyakit kulit/ eksim, baik yang baru maupun yang lama, kulit terbakar karena sinar matahari, gigitan serangga.

Kontraindikasi
Seperti halnya obat-obat eksim yang lain, Decoderm tidak dianjurkan untuk dipakai pada : penyakit cacar, TBC kulit dan sifilis.

Cara pemakaian
Pada umumnya cukup satu kali sehari, dioleskan sesudah mandi.

Kemasan
Tube 10g ram

Penyimpanan
Simpanlah di tempat yang sejuk

"Harus dengan resep dokter"

Dibuat oleh
PT. Merck Tbk., Jakarta
dengan lisensi
Merck KGaA, Jerman
No. Reg. : DL2011681
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Dermovate

Dermovate™
Cream and Ointment
Clobetasol propionate

Presentation
Dermovate Cream and Ointment each contain 0.05% w/w clobetasol propionate. The water miscible cream and the paraffin based ointment are both white in appearance.

Mode of Action
Clobetasol 17-propionate is a highly active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy.
Corticosteroids, with the exception of deoxycortone, are absorbed from the gastrointestinal tract. When administered by topical application, particularly under an occlusive dressing or when the skin is broken,
sufficient corticosteroid may be absorbed to give systemic effects.
Corticosteroids in the circulation are extensively bound to plasma proteins, mainly to globulin and also to albumin.
The corticosteroids binding globulin has high affinity but low binding capacity, while the albumin has low affinity but large binding capacity.
Only unbound corticosteroid has pharmacological effects or is metabolised.
The synthetic corticosteroids are less extensively protein bound than hydrocortisone (cortisol). They also tend to have longer half-lives.
Corticosteroids are metabolised mainly in the liver but also in the kidney, and are excreted in the urine. The slower metabolism of the synthetic corticosteroids with their lower protein binding affinity may account for their increased potency compared with the natural corticosteroids.

Uses
Clobetasol propionate is a very active topical corticosteroid which is of particular value when used in short courses for the treatment of the more resistant dermatoses such as psoriasis (excluding widespread plaque
psoriasis), recalcitrant eczema, lichen planus, discoid lupus erythematosus and other conditions which do not respond satisfactorily to less active steroids.

Dosage and Administration
Apply sparingly to the affected area once or twice daily until improvement occurs and discontinue when control is achieved. In the more responsive conditions this may be within a few days. Treatment should not be continued for more than four weeks without the patient's condition being reviewed. Repeated short courses of Dermovate may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used.
In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of Dermovate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion.

Contra-Indications
Rosacea, acne and perioral dermatitis. Perianal and genital pruritus. Skin lesions caused by infection with viruses (eg herpes simplex, chickenpox).
Hypersensitivity to the preparation.
The use of Dermovate skin preparations is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria.
Dermatoses in children under one year of age, including dermatitis and napkin eruptions.

Precautions
Long-term continuous therapy with Dermovate should be avoided particularly in infants and children, in whom adrenal suppression occurs readily. If Dermovate is required for use in children, or on face, courses should be limited if possible to five days and occlusion should not be used. It should be noted that the infant's napkin may act as an occlusive dressing.
The face, more than other areas of the body, may exhibit atrophic change after prolonged treatment with potent topical corticosteroid. This must be borne in mind when treating facial conditions which warrant use of Dermovate, and frequent observation of the patient is important. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and institutional of suitable systemic chemotherapy.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.
Topical administration of corticosteroid to pregnant animals can caused abnormalitis of fetal development including cleft palate and intra-uterine growth retardation. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, ie. in large amounts or for prolonged periods.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic
toxicity due to impaired barrier function of the skin.
If used in psoriasis careful patient supervision is important. As with other topical corticosteroid, prolonged use of large amounts, or treatment of extensive areas can result in sufficient systemic absorption to produce
the feature of hypercorticism.

Side-Effects
Provided the weekly dosage is less than 50 g in adults, any pituitary-adrenal suppression is likely to be transient with a rapid return to normal values once the short courses of steroid therapy has ceased. The same
applies to children given proportionate dosage. Use ofocclusive dressings increases the absorption of topical corticosteroid.
Prolonged and intensive treatment with highly active corticosteroid preparations may cause atrophic changes, such as striae, thinning of the skin, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used, or when skin folds are involved.
There are reports of pigmentation changes and hypertrichosis with topical steroids.
In rare instances, treatment of psoriasis with corticosteroid (or its withdrawal) is thought to have provoked the pustular form of the disease.
Dermovate is usually well tolerated, but if signs of hypersensitivity appear application should be stopped immediately. Exacerbation symptoms may occur.

Drug Interactions
Standard works on adverse reactions and drug interactions are routinely examined; no firm effects other than those mentioned in this application have been found.

Legal Category
On medical prescription only.

Package Quantities and Registration Number
Dermovate Cream, 5 g tube, Reg. No. DKL9232000429A1
Dermovate Cream, 10 g tube, Reg. No. DKL9232000429A1
Dermovate Ointment, 10 g tube, Reg. No. DKL9232000330A1

Further Information
The least potent corticosteroid which will control the disease should be selected.
Dermovate preparations contain neither lanolin nor parabens.

HARUS DENGAN RESEP DOKTER
Store below 25°C

Manufactured by
PT. Glaxo Wellcome Indonesia
Jakarta, Indonesia

™Dermovate is a trade mark of the GlaxoSmithKline group of companies
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Haemocaine

HAEMOCAINE®
Ointment

COMPOSITIONS
Each gram contains:
Lidocaine HCl5%
Alumunium subacetate3,5%
Hydrocortisone acetate0.25%
Zinc oxide18%

EFFECTIVENESS
Haemocaine is an ointment with painless, astringent, antipruritic, antiseptic and anti-inflammatory actions.

INDICATIONS
  • Acute internal and external haemorrhoids
  • Anal fissure
  • Proctitis
DOSAGES AND ADMINISTRATION
  • The best time to apply it is after defecation.
  • Clean the anal area thoroughly before application of Haemocaine ointment.
  • Apply thinly to the affected area 2-4 times daily.
  • For lesions in deeper anal area such as acute internal haemorrhoid, use available applicator by way of screwing it on to the end of Haemocaine's tube.
  • Lubricate a little ointment to the outside tip of the applicator, around the anus and in the anal ring with a finger and use the fingertip to overcome the resistance of the sphincter.
  • Put the whole body of applicator into the anus.
  • Press Haemocaine tube until the content flow out sufficiently.
  • Pull out the applicator and clean thoroughly for the next application.
CONTRA INDICATIONS
Tuberculosis viral and fungal infection at the treatment area.
Hypersensitivity to local anaesthetic agent (especially amide group) or any of the components.

PRECAUTIONS
  • Although there is usually a rapid improvement, the treatment should not stop too soon
  • To avoid relapse of the disease, application of Haemocaine should be continued for at least one week.
  • The duration of treatment should not exceed 4 weeks.
  • Stop immediately if irritation or rectal haemorrhagic occur.
  • Apply with caution for nursing mother.
  • Systemic absorption of Lidocaine may happen through rectum in large dose usage and it can cause side effect to central nervous system.
ADVERSE REACTIONS
  • If applied for more than 4 weeks, local skin atrophy may develop.
  • Allergic skin reaction may occur in rare cases.
  • Urticaria, edema, anaphylactoid reaction
PACKING
Tube netto 15 g plus applicator.
Reg. No DKL7627804630A1

STORAGE
Store in cool (15-25°C) and dry place, protected from light.

On Medical Prescription Only

Galenium
PHARMASIA
Fur further information, please contact;
PT Galenium Pharmasia Laboratories PO BOX 1733 JKS 12020
Consumer Helpdesk : (021) 7226601 ext. 888. Fax. (021) 7257803 / 7393408
www.galenium.com


HAEMOCAINE®
Ointment


KOMPOSISI
Tiap 1 gram mengandung:
Lidocaine HCl5%
Alumunium subacetate3,5%
Hydrocortisone acetate0.25%
Zinc oxide18%

CARA KERJA
Haemocaine mengandung lidocaine HCl suatu anestetik lokal yang bekerja dengan cara berinteraksi langsung dengan kanal Na+ yang akan mengakibatkan peningkatan permeabilitas membran saraf terhadap ion Na, peningkatan ambang rangsang membran, melambatnya konduksi impuls sehingga akhimya menyebabkan kegagalan induksi saraf pada daerah yang diolesi.
Hydrocortisone merupakan golongan glukokortikoid yang bekerja sebagai antiinflamasi dan imunosupresif dengan cara menghambat pelepasan sel-sel yang berperan terhadap respon inflamasi, menurunkan pelepasan vasoaktif, faktor-faktor kemoatraktif, menghilangkan sekresi enzim lipofilik dan protelitik, menurunkan ekstravasasi lekosit pada daerah yang sakit. Zinc oxide sebagai astringen dan Aluminium subacetate sebagai astringen kuat yang bila digunakan pada mukosa atau daerah kulit lain yang sakit/rusak akan membentuk lapisan protektif superfisial yang tidak diserap sehingga mempunyai efek menyejukkan dan proteksi iritasi terhadap gesekan atau ekskoriasi.

EFEKTIVITAS
Haemocaine salep berfungsi mengurangi rasa sakit, rasa gatal, memberi rasa dingin, sebagai antiseptik dan menghilangkan tanda-tanda peradangan.

INDIKASI
  • Hemoroid internal dan ekstemal akut
  • Fisura anal
  • Proktitis
DOSIS DAN CARA PEMAKAIAN
  • Sebaiknya Haemocaine ointment digunakan setelah defekasi (BAB).
  • Bersihkan lebih dahulu daerah yang akan dioleskan Haemocaine ointment.
  • Oleskan secara tipis pada daerah yang sakit 2-4 kali sehari.
  • Untuk kelainan yang letaknya lebih dalam seperti hemoroid internal akut. gunakan aplikator >ang telah disediakan dan sambungkan pipa aplikator pada ujung tube Haemocaine ointment.
    Oleskan sedikit isi Haemocaine ointment pada bagian luar aplikator sebagai lubrikan. dan pada daerah lingkaran anus. Gunakan ujung jari untuk mengatasi tahaaaciotot-otot di daerah anus.
  • Masukkan aplikator seluruhnya ke dalam anus.
  • Tekan tube Haemocaine ointment sampai isi tube keluar secukupnya.
  • Tank kembali aplikator tersebut dan cud sampai bersih untuk pemakaian berikutnya.
KONTRA INDIKASI
Tuberkulosis kutis, infeksi virus dan infeksi jamur pada daerah yang diobati.
Penderita yang hipersensitif terhadap anestetik lokal (terutama tipe amida) atau pada salah satu komponen obat.

PERINGATAN DAN PERHATIAN
  • Walaupun biasanya terjadi perbaikan yang cepat, pengobatan tidak boleh dihentikan dengan segera.
  • Untuk menghindari kambuhnya kembali penyakit, pemakaian Haemocaine harus diteruskan selama
    sekurang-kurangnya 1 minggu.
  • Pengobatan tidak boleh lebih dari 4 minggu.
  • Hentikan segera penggunaan bila terjadi iritasi ataupun pendarahan pada rektal
  • Hati-hati penggunaan pada wanita menyusui karena Lidocaine dan Hydrocortisone dieksresikan ke dalam ASI.
  • Absorpsi sistemik dari Lidocaine dapat terjadi melalui rectum pada penggunaan dalam dosis besar, sehingga dapat menyebabkan efek samping pada "central nervous system".
EFEK SAMPING
  • Bila digunakan lebih dari 4 minggu, atrofi kulit lokal mungkin dapat terjadi.
  • Walaupun sangat jarang. reaksi alergi dapat terjadi.
  • Urtikaria, edema, anaphylactoid reaction.
KEMASAN
Tube 15 g dilengkapi aplikator.
Reg. No. OKL7627804630A1

Simpan di tempat sejuk (15-25°C) dan kering, teriindung dari cahaya.
Harus Dengan Resep Dokter

Galenium
PHARMASIA
Untuk informasi lebih lanjut, hubungi:
PT Galenium Pharmasia Laboratories PO BOX 1733 JKS 12020
Consumer Helpdesk : (021) 7226601 ext. 888. Fax. (021) 7257803 / 7393408
www.galenium.com
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Nebacetin

NEBACETIN®
Skin Ointment, powder, and Eye Ointment


COMPOSITION
Each gram of NEBACETIN® contains:
  • 5 mg of neomycin sulphate (equivalent to 2.244 IU of neomycin base).
  • 250 IU of bacitracin.
PHARMACOLOGY
NEBACETIN® is a combination between antibiotics - neomycin and bacitracin. Research and mechanism show that bacteria cells attacked/destroyed with 2 ways, bacitracin delaying the biosinthesis of cell's wall and neomycin destroy genetic code and synthesis sequel of protein and germ. Hence, NEBACETIN® works
synergistically.
Practical, NEBACETIN® is not absorbed by skin neither mucous, so far topical use it is acceptable in high dose. Using NEBACETIN® in high dose at the ulcer can prevent growth of resistant bacteria.
Mechanism of NEBACETIN® antibiotic can not be block by blood plasma, pus neither necrotic tissue.
Basically, NEBACETIN® indicated for all local skin and mucus infection.

INDICATIONS
Nebacetin Ointment and Powder:
Superficial bacterial infection of the skin, such as impetigo, varicose ulcers, pressures sores, trophic ulcers and burn.

Nebacetin Eye Ointment:
  • Ophtalmology
    Acute and chronic conjungtivitis, acute and chronic keratitis, kerato - konjungtivitis, dakriosistitis, cornea ulkus, peripheral cornea infiltrate, prevent and cure infection before and after eye surgery.
DOSAGE AND ADMINISTRATION
NEBACETIN® Ointment and Powder:
  • Administration and dosage adults:
    Before use, the area for application should be cleaned gently.
    Debris such as pus or crusts should be removed from the affected area. A thin film of the ointment/a ligh dusting of the powder should be applied to the affected area up to three times/day depending on the clinical condition. Treatment should not be continued for more 7 days without medical supervision.
  • Dosage in children:
    The adults dose is suitable for use in older children, however in infants dosage should be reduced. A possibility of increased absorption exists in very young children, thus ointment/powder is not recommended for use in neonatus.
  • Dosage in renal impairment:
    Dosage should be reduced in patients with reduced renal function.
NEBACETIN® Eye Ointment:
  • Recommended using eye ointment several times a day (2-3 times) into conjunctiva saccus until the sympton dissapears. Basis of the eye ointment has good local tolerance to conjunctiva.
WARNINGS AND PRECAUTIONS
  • Caution should be exercised so that the recommanded dosage is not exceeded.
  • Following significant systemic absorption, amynoglycoside such as neomycin can cause irreversible ototoxicity (and exacerbate existing partial nerve deafness); both neomycin sulphate and bacitracin have nephrotoxic potential.
  • After a treatment course, administration should not be repeated for at least three months.
  • In neonatus and infants, absorption by immature skin may be enhanced and renal function may be immature.
  • In renal impairment the plasma clearance of neomycin is reduced, this is associated with an increased risk of ototoxicity, therefore, a reduction in dose should be made that relates to the degree of renal impairment.
  • As with other antibacterial preparations, prolonged use may result in overgrowth by non-suspectible organism including fungi.
  • Concurrent administration of other amynoglycosides is not recommended.
CONTRAINDICATIONS
  • In patients who have demonstrated allergic hypersensitivity to the product or any of its constituents, or to cross-sensitising substances such as framycetin, kanamycin, gentamycin and other related antibiotics.
  • Patients with any degree of nerve deafness in circumstances in which significant systemic absorption could occur.
ADVERSE EFFECTS
  • The incidence of allergic hypersensitivity to neomycin sulphate in the general population is low. However, there is an increased incidence of sensitivity to neomycin in certain selected groups
    of patients in dermatological practice particularly those with venous stasis eczema and ulceration.
  • Allergic hypersensitivity to neomycin following topical application may manifest it self as a reddening and scalling of the effected skin, as an eczematous exacerbation of the lesion, or as a failure of the lesion to heal.
  • Allergic hypersensitivity following application of bacitracin has been reported but is rare.
  • Anaphylactic reactions following the topical administration of bacitracin have been reported but are rare.
DRUG INTERACTIONS
Following significant systemic absorption, neomycin sulphate can intensify and prolong the respiratory depressant effect of neuromuscular blocking agent.

PRESENTATION
NEBACETIN® Ointment
Tube of 5 g
No.Reg.DKL7221628830A1
NEBACETIN® Powder
Bottle of 5 g
No.Reg.DKL7221628724A1
NEBACETIN® Eye Ointment
Tube of 2,5 g
No. Reg.DKL7221603431A1

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

Store in a cool and dry place

Manufactured by:
PHAROS
Jakarta-Indonesia
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Saturday, January 30, 2010

Dermasolon

DERMASOLON®
FLUOCINOLONE ACETONIDE
SKIN CREAM/OINTMENT

Composition:
Each gram contains:
Fluocinolone acetonide .............. 0.25 mg.

Description:
The active principle of Dermasolon is Fluocinolone acetonide, a synthetic glucocorticoid for topical use. It has more potent local anti-inflammatory actions than Hydrocortisone and is used in the treatment of inflammatory, allergic and pruritic skin disorders.

Indications:
For the management of a wide range of acute or chronic dermatoses.
These include: atopic, contact, seborrheic, eczematous, stasis, and exfoliative dermatitis, neurodermatitis, pruritus ani, psoriasis, nummular eczema, intertrigo, intertriginous psoriasis.

Contraindications:
Tuberculosis, fungal and most viral lesions of the skin.

Dosage:
3 to 4 times applications daily to the affected skin.

Presentation:
Cream; tube of 5 gram. Reg. No. DKL 8909304429A1
Ointment; tube of 10 gram. Reg. No. DKL 7809310130A1

Produced by:
PT. IKAPHARMINDO PUTRAMAS
PHARMACEUTICAL LABORATORIES
JAKARTA - INDONESIA


DERMASOLON®:
FLUOSINOLON ASETONIDA
KRIM/SALEP KULIT

Komposisi:
Tiap gram mengandung:
Fluosinolon asetonida .............. 0,25 mg.

Uraian umum:
Zat aktif dalam Dermasolon adalah Fluosinolon asetonida, yaitu suatu glukokortikoid sintetik. Fluosinolon asetonida memiliki daya anti inflamasi lokal yang lebih kuat dari Hidrokortison dan dapat digunakan untuk pengobatan kulit yang meradang, alergi dan pruritus.

Indikasi:
Untuk mengobati penyakit-penyakit kulit yang akut atau kronis, seperti: dermatitis atopi, kontak, seboreik, ekzematus, statik, dan eksfoliatif, neurodermatitis, pruritus ani, psoriasis, ekzema numular, intertrigo, psoriasis intertriginus.

Kontraindikasi:
Lesi pada kulit karena tuberkulosa, jamur dan virus.

Aturan pakai :
3-4 kali sehari dioleskan pada bagian kulit yang sakit.

Kemasan:
Krim; tube @ 5 gram. No. Reg. DKL 8909304429A1
Salep; tube @ 10 gram. No. Reg. DKL 7809310130A1

Diproduksi oleh:
PT. IKAPHARMINDO PUTRAMAS
PHARMACEUTICAL LABORATORIES
JAKARTA - INDONESIA
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Cetinal

CETINAL
Cetirizine diHCl
Chewable tablet

Composition
Each chewable tablet of CETINAL contains:
Cetirizine diHCl 10mg

Description
CETINAL chewable tablet contains Cetirizine diHCl 10 mg, an antihistamine.

Pharmacology
Pharmacodynamics
Based on literature, Cetirizine is one of piperazine dehvate and metabolite of hydroxyzine, is a long acting and non sedating antihistamine with mast-cell stabilizing activities. Usual dosage of Cetirizine may cause very little drowsiness effect and almost does not posses muscarinic activities.

Pharmacokinetics
Absorption
Based on literature, oral Cetirizine was rapidly absorbed with a time to maximum concentration (Tmax) following oral administration in adults is approximately 1 hour. A mean peak plasma concentration (Cmax) of 311 ng/ml was observed after administered multiple doses of Cetirizine (10 mg tablets once daily for 10 days). No accumulation was observed. Food had no effect on the extent of AUC (Area Under The Curve) of the Cetirizine chewable tablet.

Distribution
Based on literature, at therapeutic concentration, the mean plasma protein binding of Cetirizine is 93%.

Metabolism
Based on literature, approximately 70% of the administered dose was recovered in the urine and 10% in the feces. Approximately 50% of the administered dose was identified in the urine as unchanged drug. Most of the rapid increase in peak plasma was associated with parent drug, suggesting a low degree of first-pass metabolism. Cetirizine is metabolized to a limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity. The enzymes responsible for this metabolism have not been identified.

Elimination
Based on literature, the mean elimination half-life was 8.3 hours and the total body clearance for Cetirizine was approximately 53 ml/min.

Indications
CETINAL is indicated for the relief of symptoms associated with seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiophatic urticaria In adults and children ≥ 6 years of age and older.

Dosage and administration
  • Adults and children older than 6 years:
    One 10 mg chewed tablet dally.
  • At present, there are no data suggest that the dose need to be reduced in elderly patients.
  • In patients with renal insufficiency, dosage should be reduced to half of a tablet daily.
    If desired, the dose may be taken as 5 mg in the morning and 5 mg in the evening.
CETINAL must be chewed well before swallowing. CETINAL can be taken with or without water and without regard to food consumption. The time of administration may be varied to suit individual patient needs.

Contraindications
CETINAL is contraindicated for:
Patients with a known hypersensitivity to Cetirizine or to Hydroxyzine or to other components of CETINAL.

Warnings and precautions
  • The occurrence of somnolence has been reported in some patients taking Cetirizine; due caution should therefore be exercised when driving a car or operating machinery.
  • Concurrent use of Cetirizine with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and impairment of central nervous system may occur.
Drug interactions
No clinically significant drug interactions have been found with Theophylline at a low dose, Azithromycin, Pseudoephedrine, Ketoconazole, or Erythromycin. There was a small decrease in the clearance of Cetirizine caused by a 400 mg dose ofTheophylline; it is possible that larger Theophylline doses could have a greater effect. Studied with Diazepam and Cetirizine have revealed no evidence of interactions. As with other antihistamines, it is adviseable to avoid excessive alcohol comsumption.

Pregnancy and lactation
The use of Cetirizine in pregnancy should be avoided. Because Cetirizine has been reported to be excreted in human breast milk, use of Cetirizine in nursing mothers is not recommended.

Adverse reactions
There have been occasional report of mild and transient side effects such as headache, dizzines, drowsiness, agitation, dry mouth and gastrojntestinat discomfort. In someindividuals, hypersensitivity reactions including skin reactions and angiodema may develop.

Overdosage and treatment
Drowsiness can be a symptom of overdosage, occuring from administration of 50 mg Cetirizine as a single dose. Agitation can occur if Cetirizine use in children. In the case of massive overdosage, gastric lavage should be performed together with the usual supportive measure. To date, there is no spesific antidote.

Presentation
CETINAL 10 mg chewable tablet: Box of 3 strips x 10 chewable tablets
Reg. No. DKL0811638463A1

Store below 30°C.


ON MEDICAL PRESCRIPTION ONLY.

PT KALBE FARMA Tbk.
Bekasi-Indonesia


CETINAL
Cetirizine diHCl
Tablet kunyah

Komposisi
Tiap tablet kunyah CETINAL mengandung:
Cetirizine diHCl 10mg

Deskripsi
CETINAL tablet kunyah mengandung Cetirizine diHCl 10 mg yang merupakan suatu antihistamin.

Farmakologi
Farmakodinamik
Berdasarkan literatur, Cetirizine merupakan derivat Piperazine dan metabolit Hydroxyzine yang mempunyai sifat sebagai long-acting-sedating antihistamin dengan aktifitas mast-cell stabilizing.Potensi Cetirizine menyebabkan kantuk pada dosis lazim sangat rendah dan hampir tidak mempunyai aktifitas muskarinik.

Farmakokinetik
Absorpsi
Berdasarkan literatur, Cetirizine secara peroral diabsorpsi secara cepat dan waktu untuk mencapai kadar maksimal (Tmax) setelah pemberian oral pada orang dewasa kira-kira 1 jam. Kadar puncak dalam plasma (Cmax) rata-rata 311 ng/ml dicapai setelah pemberian Cetirizine dosis multipel (tablet 10 mg sekali sehari selama 10 hari). Tidak tampak adanya akumulasi. Makanan tidak mempengaruhi luas AUC (Area Under The Curve) Cetirizine.

Distribusi
Berdasarkan literatur, pada kadar terapi, ikatan protein plasma rata-rata Cetirizine adalah 93%.

Metabolisme
Berdasarkan literatur, kira-kira 70% dari dosis yang diberikan ditemukan kembali dalam urin dan 10% dalam feses. Kira-kira 50% dari dosis yang diberikan ditemukan dalam urin dalam bentuk yang tidak berubah. Kenaikan puncak plasma yang cepat terutama dikaitkan dengan obat asal, hal ini menunjukkan derajat metabolisme jalur pertama yang rendah. Cetirizine dalam jumlah kecil dimetabolisme menjadi metabolit dengan aktivitas antihistamin yang dapat diabaikan melalui proses oksidatif 0-dealkilasi. Enzim yang
bertanggungjawab terhadap metabolisme tersebut belum teridentifikasi.

Eliminasi
Berdasarkan literatur, waktu paruh eliminasi rata-rata 8,3 jam dan klirens tubuh total untuk Cetirizine kira-kira 53 ml/menit.

Indikasi
CETINAL diindikasikan untuk mengatasi gejala-gejala rinitis alergi musiman, rinitis alergi perennial, dan urtikaria idiopatik kronik pada orang dewasa dan anak-anak usia 6 tahun atau lebih dari 6 tahun.

Dosis dan cara pemberian
  • Dewasa dan anak-anak lebih dari 6 tahun:
    Satu tablet kunyah 10 mg setiap hari.
  • Saat ini, tidak ada data yang mensyaratkan bahwa dosis perlu dikurangi pada pasien usia lanjut.
  • Pada pasien dengan fungsi ginjal yang terganggu, dosis harian sebaiknya dikurangi setengahnya. Jika dibutuhkan, dosis dapat dikonsumsi 5 mg pada waktu pagi hari dan 5 mg pada sore hari.
CETINAL harus dikunyah terlebih dahulu sebelum ditelan. CETINAL dapat diminum dengan atau tanpa air dan tidak dipengaruhi makanan. Waktu pemberian dapat bervariasi sesuai dengan kebutuhan masing-masing pasien.

Kontraindikasi
CETINAL dikontraindikasikan untuk:
Pasien dengan hipersensitivitas terhadap Cetirizine atau Hydroxyzine atau komponen lain dari CETINAL.

Peringatan dan perhatian
  • Kejadian mengantuk telah dilaporkan pada beberapa pasien yang mengkonsumsi Cetirizine: oleh karena itu hati-hati bila mengendarai kendaraan atau mengoperasikan mesin.
  • Penggunaan Cetirizine bersamaan dengan alkohol atau depresan sistem saraf pusat lain sebaiknya dihindari karena dapat terjadi peningkatan penurunan kewaspadaan dan kerusakan sistem saraf pusat.
Interaksi obat
Tidak terdapat interaksi obat yang secara klinis bermakna dengan Theophylline pada dosis rendah, Azithromycin, Pseudoephedrine, Ketoconazole, atau Erythromycin. Terdapat sedikit penurunan pada klirens Cetirizine yang disebabkan oleh Theophylline dengan dosis 400 mg; Theophylline dengan dosis yang lebih besar mungkin dapat memiliki efek yang lebih besar.
Percobaan terhadap Diazepam dan Cetirizine mengungkapkan bahwa tidak ada bukti adanya interaksi. Sebagaimana antihistamin lainnya, disarankan untuk menghindari konsumsi alkohol yang berlebihan.

Kehamilan dan menyusui
Penggunaan Cetirizine pada wanita hamil sebaiknya dihindari. karena Cetirizine telah dilaporkan diekskresikan ke dalam air susu ibu, maka tidak dianjurkan penggunaan Cetirizine pada ibu menyusui.

Efek samping
Ada beberapa laporan mengenai efek samping ringan dan bersifat sementara seperti sakit kepala, pusing, mengantuk, agitasi, mulut kering dan kelainan pencernaan. pada beberapa orang, reaksi hipersensitivitas termasuk reaksi kulit dan angioedema dapat terjadi.

Overdosis dan penanganan
Mengantuk, bisa merupakan salah satu gejala overdosis, timbul karena penggunaan dosis tunggal 50 mg Cetirizine. Agitasi dapat terjadi jika Cetirizine digunakan pada anak-anak. Dalam kasus overdosis, bilas lambung sebaiknya dilakukan bersama-sama dengan pengobatan biasa. Hingga saat ini, belum ada antidote spesifik.

Kemasan
CETINAL tablet kunyah 10 mg : Dus isi 3 strip x 10 tablet kunyah
Reg. No. DKL0811638463A1

Simpan pada suhu di bawah 30°C.


HARUS DENGAN RESEP DOKTER.

PT KALBE FARMA Tbk.
Bekasi - Indonesia
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Mederma

MEDERMA®
S K I N CARE FOR SCARS

SOOTHING TOPICAL GEL FOR SCARS

MEDERMA® SKIN CARE FOR SCARS helps scars appear softer and smoother.
It is a greaseless gel, easy and convenient to use.
(See down for instructions.)

MEDERMA® SKIN CARE FOR SCARS is manufactured by Merz Pharma GmbH & Co. KGaA of Germany.
Merz Pharma GmbH & Co. KGaA manufactures fine skin care products, including the highly respected MEDERMA line in Europe.

WHAT YOU SHOULD KNOW ABOUT SCARS
Scars can be caused by any type of skin injury or wound.
Ideally, a scar is smooth, flat, and blends in with surrounding skin, but sometimes very visible, unattractive scars can appear.
Scars can appear on any part of the body, including:
- Face
- Abdomen
- Hands
-  Legs
Nothing can make scars totally disappear, and nothing can hurry the natural healing process. However MEDERMA® SKIN CARE FOR SCARS helps scars appear softer and smoother.

MODE OF APPLICATION
MEDERMA® SKIN CARE FOR SCARS should be generously applied and gently rubbed for 2-3 minutes into .the scar 3 to 4 times a day for 8 weeks on new scars, and 3 to 4 times a day for 3 to 6 months on existing scars. During application, spread outward from the center of the scar.

MEDERMA USAGE RECOMMENDATION
Use after*Usage Period
Surgery8 weeks
Accidents2-6 months
Burns3-6 months
Stretch Marks3-6 months
Acne3-6 months
Old/Existing Scars3-6 months or longer
* Use once the wound is closed

INGREDIENT (INCI)
Aqua, PEG-4, xanthan gum, alcohol, Allium cepa, allontoin, parfum, methylparaben, sorbicacid.

WARNINGS
For external use only. Avoid contact with the eyes. Do not apply to open wounds. If irritation occurs, discontinue use. Keep out of the reach of children.

Store at room temperature
POM CL 1010101080

Marketing Authorization Holder:
Merz Pharmaceuticals GmbH, 60318 Frankfurt, Germany
Manufacturer:
Merz Pharma GmbH & Co. KGaA, 60318 Frankfurt, Germany
Imported by: PT. COMBIPHAR, Bandung, Indonesia


MEDERMA®
S K I N CARE FOR SCARS
(PERAWATAN KULIT UNTUK SCAR/KELOID)
GEL UNTUK MEMPERHALUS SCAR


MEDERMA® SKIN CARE FOR SCARS membantu scar menjadi lebih lunak dan lembut.
Gel tidak menimbulkan noda berlemak, mudah dan nyaman untuk digunakan.
(Lihat cara pemakaian.)
MEDERMA® SKIN CARE FOR SCARS Dibuat oleh Merz Pharma GmbH & Co. KGaA of Germany.
Merz Phnrma GmbH & Co. KGaA memproduksi produk perawatan kulit termasuk MEDERMA yang telah dikenal di Eropa.

YANG PERLU DIKETAHUI TENTANG SCAR
Scar dapat terjadi karena berbagai luka atau ruda paksa pada kulit. Idealnya, scar adalah lembut, datar dan menyatu dengan kulit sekitarnya, namun kadang-kadang sangat tampak jelas dan muncul scar yang sangat buruk.
Scar dapat timbul pada berbagai bagian tubuh, termasuk:
- Wajah
- Perut
- Tangan
- Kaki
Tidak ada yang dapat menghilangkan bekas luka secora menyeluruh dan tidak ada yang dapat mempercepat proses penyembuhan alami.
MEDERMA® SKIN CARE FOR SCARS membantu scar tampak lebih lunak dan lembut.

CARA PENGGUNAAN
MEDERMA® SKIN CARE FOR SCARS dioleskan secara rata 3-4 kali sehari dan digosok secara perlahan selama 2-3 menit pada scar. Lama pemakaian 3-6 bulan pada scar yang ada dan 8 minggu untuk scar baru. Oleskan MEDERMA dari bagian pusat scar, ratakan ke arah luar scar.

REKOMENDASI PENGGUNAAN MEDERMA
Digunakan setelah*Lama Penggunaan
Bedah8 minggu
Pasca Trauma2-6 bulan
Luka Bakar3-6 bulan
Stretch Marks3-6 bulan
Acne3-6 bulan
Scar Lama3-6 bulan atau lebih
* Gunakan setelah luka menutup

ISI
Aqua, PEG-4, xanthan gum, alcohol, Allium cepa, allantoin, parfum, methylparaben, sorbic acid.

PERINGATAN
Hindarkan kontak dengan mata.
Jangan dioleskan pada luka terbuka. Bila terjadi iritasi, hentikan pemakaian.
Jauhkan dari jangkauan anak-anak.

Simpan di suhu kamar. POM CL 1010101080
Hak Paten Atas Nama:
Merz Pharmaceuticals GmbH, 60318 Frankfurt, Buatan Jerman
Diproduksi oleh:
Merz Pharma GmbH & Co. KGaA, 60318 Frankfurt, Buatan Jerman
Di impor oleh: PT COMBIPHAR, Bandung, Indonesia
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Gentasolon

GENTASOLON®
FLUOCINOLONE ACETONIDE
GENTAMICIN


TOPICAL CREAM

Composition:
Each gram contains:
Fluocinolone Acetonide 0.25 mg; Gentamicin Sulfate equivalent to 1 mg of Gentamicin in a greaseless washable base.

Description:
Gentasolon topical cream contains Fluocinolone Acetonide, a successful topical corticosteroid, and Gentamicin Sulfate, a wide spectrum antibiotic. Fluocinolone Acetonide is a synthetic corticosteroid, well known for its remarkable success rate in the treatment of a wide range of dermatoses. Gentamicin is a broad spectrum antibiotic, which provides highly effective topical treatment in primary and secondary bacterial infections of the skin caused by a wide variety of Gram-positive and Gram-negative bacteria.
Gentasolon thus combines an outstandingly effective corticosteroid with a highly potent broad spectrum antibiotic. Because of its anti-inflammatory, anti allergic, antipruritic and antibacterial properties, Gentasolon is of particular value in those dermatoses complicated by local infection or when the possibility of such infection is suspected.

Indications:
Gentasolon cream is indicated in the topical treatment of dermatoses where local infection is an added or potential problem. Such disorders include: atopic dermatitis, particularly infected forms, neurodermatitis, seborrheic dermatitis, eczemas, contact dermatitis, exfoliative dermatitis, anogenital pruritus, etc.

Contraindications:
As with all preparations containing topical corticosteroids, Gentasolon is contraindicated in vaccinia, varicella and tuberculosis of the skin. Hypersensitivity to any component of Gentasolon is a contraindication to its use.

Dosage and administration:
Apply a sufficient amount of Gentasolon cream to completely cover the affected area two or three times daily until favorable results are obtained. It should be massaged gently butthoroughly into the skin.

Presentation:
Tube of 5 grams and 10 grams
Reg. No. DKL 9409308329 A1

Produced by:
PT. IKAPHARMINDO PUTRAMAS
PHARMACEUTICAL LABORATORIES
JAKARTA - INDONESIA


GENTASOLON®
FLUOCINOLONE ACETONIDE
GENTAMICIN


KRIM KULIT

Komposisi:
Tiap gram mengandung:
Fluosinolon Asetonida 0,25 mg; Gentamisina Sulfat setara dengan Gentamisina 1 mg dalam dasar krim tak berlemak yang mudah dicuci.

Deskripsi:
Gentasolon krim mengandung Fluosinolon Asetonida, suatu kortikosteroid topikal yang ampuh dan Gentamisina Sulfat, suatu antibiotika dengan spektrum lebar.
Fluosinolon Asetonida merupakan suatu kortikosteroid sintetik, yang terkenal karena hasilnya yang gemilang dalam pengobatan berbagai jenis dermatosis, Gentamisina merupakan suatu antibiotika berspektrum luas, yarg efektif untuk pengobatan infeksi kulit primer dan sekunder yang disebabkan berbagai bakteri Gram-positif dan Gram-negatif.
Dengan demikian Gentasolon krim merupakan suatu kombinasi kortikosteroid yang sangat efektif dengan suatu antibiotika berspektrum luas yang sangat ampuh. Oleh karena sifat-sifat anti inflamasi, anti alergi, anti pruritik dan anti bakterinya, Gentasolon krim amat berguna untuk pengobatan dermatosis dengan komplikasi infeksi lokal atau bila dikuatirkan kemungkinan terjadinya infeksi semacam itu.

Indikasi:
Gentasolon krim diindikasikan untuk pengobatan topikal dermatosis yang disertai potensi terjadinya infeksi lokal. Gangguan-gangguan semacam itu mencakup: dermatosis atopik, terutama bentuk-bentuk yang terinfeksi, neurodermatitis, dermatitis seboreik, ekzema, dermatitis kontak, dermatitis eksfoliatif, gatal-gatal pada daerah anogenital dsb.

Kontraindikasi:
Sebagaimana halnya dengan semua sediaan yang mengandung kortikosteroid topikal, vaccinia, varicella dan tuberkulosa kulit merupakan kontraindikasi untuk penggunaan Gentasolon krim, demikian pula hipersensitivitas terhadap salah satu komponennya.

Dosis dan pemakaian:
Oleskan Gentasolon krim secukupnya pada bagian kulit yang sakit dua sampai tiga kali sehari sampai diperoleh hasil yang memuaskan.

Kemasan:
Tube @ 5 gram dan @ 10 gram
No.Reg.DKL9409308329A1

Diproduksi oleh:
PT. IKAPHARMINDO PUTRAMAS
PHARMACEUTICAL LABORATORIES
JAKARTA - INDONESIA
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Decubal

DECUBAL
CLINIC CREAM

Description
Decubal Clinic cream is an oil-in water emulsion with a fat content of 38 %. It is based on lanolin in purified water and hypo-allergenic form. Decubal Clinic cream is non-irritating and fragrance free. Decubal's fatty components combine easily with the fatty substances of the skin, thus making Decubal easy to massage into the skin.

Composition
Anhydrous lanolin, IsopropyI myristate, Cetyl alcohol, Sorbitan monostearate, Polysorbate, Glycerol, Dimethicone, Sorbic acid and Purified water.

Use
Decubal is specifically developed for daily treatment of dry and sensitive skin and has been shown to contain moisturizing qualities. Decubal is recommended for the prevention of nappy rash, and long term bed-ridden patients as it increases the moisture and softness of the skin. Because of its moisturizing function, Decubal is also recommended for treatment of ordinary dry skin and scalp.

Directions for use
Apply at least once a day by massaging a thin layer into the skin on the areas affected. Apply Decubal at each nappy change for prevention of nappy rash. Avoid the use of Decubal around the eyes and mucous membranes. Decubal is not recommended for wound care.

Precautions
Individual known with hypersensitivity to the components.
It should not be used on open wounds.
For external use only.
Keep out of reach of children.

Presentation
Decubal Clinic Cream: available in 20 g and 40 g tube
Reg. No.: POM CD 1010302405
Store at 15°C – 30°C, dry place and away from light.

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


DECUBAL
CLINIC CREAM

Uraian
Decubal Clinic Cream adalah suatu emulsi minyak dalam air dengan kandungan lemak sebesar 38 %. Bahan dasar adalah lanolin dalam bentuk murni dan bersifat hipoalergenik. Decubal Clinic Cream tidak mengandung bahan yang dapat mengiritasi kulit dan tidak mengandung pewangi. Zat lemak yang terdapat dalam Decubal mudah menyatu dengan zat-zat lemak dalam kulit, sehingga membuat Decubal mudah meresap ke kulit.

Komposisi
Lanolin anhidrat, Isopropil miristat, Setil alkohol, Sorbitan monostearat, Polisorbat, Gliserol, Dimetikon, Asam sorbat dan aquadest.

Kegunaan
Decubal khusus dikembangkan untuk perawatan sehari-hari bagi kulit yang sensitif dan kering, karena mengandung pelembab.
Decubal dianjurkan untuk pencegahan ruam kulit karena popok dan untuk pasien yang memerlukan tirah baring di rumah-sakit mengingat Decubal dapat menjaga kelembaban dan kelembutan kulit. Karena fungsi pelembabnya, Decubal juga dianjurkan untuk perawatan kulit kering dan kulit kepala.

Cara Penggunaan
Oleskan tipis-tipis paling sedikit satu kali sehari pada bagian kulit yang dikehendaki. Untuk pencegahan ruam kulit akibat popok, gunakan Decubal pada setiap ganti popok. Hindarkanlah penggunaan Decubal sekitar mata dan membran mukosa.
Decubal tidak dianjurkan untuk perawatan luka.

Perhatian
Seseorang yang hipersensitif terhadap zat-zat yang dikandung dalam Decubal. Tidak dianjurkan untuk digunakan pada luka terbuka.
Hanya untuk penggunaan luar. Jauhkan dari jangkauan anak-anak.

Kemasan
Decubal Clinic Cream : tersedia dalam tube 20 g dan 40 g
No. Reg.: POM CD 1010302405
Simpan pada suhu 15°C - 30°C, kering dan terlindung dari cahaya.

Di produksi oleh :
PT Actavis Indonesia, Jakarta
(Grup Actavis, Islandia)
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Biolincom

BIOLINCOM®


KOMPOSISI :
Tiap kapsul mengandung :
Lincomycin HCl setara dengan Lincomycin 500 mg

Tiap 5ml sirup mengandung :
Lincomycin HCl setara dengan Lincomycin 250 mg

TINJAUAN UMUM :
Lincomycin HCl merupakan antibiotika yang dihasilkan oleh Streptomyces lincolnensis. Bersifat bakterisida atau bakteriostatika tergantung pada sensitivitas organisme dan konsentrasi antibiotika. Bekerja dengan menghambat sintesis protein bakteri dengan berikatan pada ribosom sub unit 50S organisme yang sensitif.
Secara in vitro, Lincomycin aktif terhadap Staphylococcus aureus, Staphylococcus albus, Streptococcus β-hemolitic, Streptococcus viridans, Diplococcus pneumoniae, Clostridium tetani, Clostridium perfringens, Corynebacterium diphtheriae dan Corynebacterium acnes.
Lincomycin tidak aktif terhadap Streptococcus faecalis, Neisseria gonorrhoeae, Neisseria meningitidis, Haemophillus influenzae atau organisme gram negatif lainnya dan ragi.

INDIKASI :
Untuk pengobatan infeksi serius yang disebabkan oleh Streptococci, Pneumococci dan Staphylococci. Lincomycin digunakan sebagai pengobatan alternatif untuk penderita yang alergi terhadap Penicillin atau atas pertimbangan dokter bahwa pengobatan dengan Penicillin tidak tepat. Lincomycin efektif dalam pengobatan infeksi Staphylococcus yang sudah resisten terhadap antibiotik lain dan peka terhadap Lincomycin.
Lincomycin digunakan untuk infeksi sebagai berikut:
  • Saluran nafas atas : tonsilitis, faringitis, otitis media, sinusitis, scarlet fever.
  • Saluran nafas bawah : bronkitis akut dan kronis dan pneumonia.
  • Kulit dan jaringan lunak : selulitis, furunkel, abses, impetigo, jerawat dan luka.
  • Tulang dan sendi : osteomielitis dan arthritis septik.
  • Septikemia dan endokarditis.
Tidak diindikasikan untuk pengobatan infeksi bakteri minor atau virus.

KONTRAINDIKASI :
  • Penderita yang sebelumnya hipersensitif terhadap Lincomycin dan Clindamycin.
  • Bayi baru lahir.
EFEK SAMPING :
  • Saluran pencernaan : glossitis, stomatitis, mual, muntah, diare persisten, enterokolitis dan pruritis anal.
  • Hematopoietik : neutropenia, leukopenia, agranulositosis, Trombositopenia, purpura.
  • Reaksi hipersensitif : edema angioneurotik, serum sicknes, anafilaksis.
  • Kulit dan membran mukosa : ruam kulit, urtikaria, vaginitis.
  • Hati : tes fungsi hati abnormal, jaundice.
  • Ginjal : disfungsi ginjal seperti azotemia, oliguria dan/atau proteinuria (jarang).
  • Lain-lain : tinitus, vertigo.
PERINGATAN DAN PERHAT1AN :
  • Terapi dengan Lincomycin dapat menyebabkan kolitis berat yang dapat bersifat fatal. Oleh karena itu digunakan untuk infeksi serius bila antibiotik yang kurang toksik tidak sesuai.
  • Tidak digunakan untuk infeksi non bakleri seperti kebanyakan infeksi saluran pernafasan bagian atas.
  • Bila terjadi diare selama pengobatan, obat dihentikan atau bila dibutuhkan, hanya dilanjutkan dibawah pengawasan dokter.
  • Diare, kolitis dan kolitis pseudomembranosa harus diamati dari permulaan pengobatan sampai beberapa minggu setelah terapi dengan Lincomycin dihentikan.
  • Hati-hati pemakaian pada penderita dengan riwayat asma atau alergi.
  • Dapat menyebabkan pertumbuhan yang berlebihan dari organisme yang tidak peka khususnya ragi. Bila terjadi super infeksi hentikan pemberian dengan diganti dengan pengobatan yang sesuai.
  • Pada penggunaan jangka panjang tes fungsi hati perlu dilakukan secara periodik, fungsi ginjal dan hitung jenis darah.
  • Prosedur pembedahan harus sudah ditentukan bila antibiotika ini digunakan.
  • Keamanan pemakaian pada wanita hamil belum ditetapkan.
  • Hati-hati pemakaian pada wanita menyusui karena Lincomycin ditemukan dalam air susu ibu.
INTERAKSI OBAT :
  • Bersifat menghambat neuromuskuler, sehingga dapat menaikkan kerja obat-obatan penghambat neuromuskuler lainnya.
  • Dengan obat-obatan golongan antiperistaltik seperti opiat dan diphenoxilat dapat memperpanjang dan/atau memperburuk keadaan pasien.
  • Dapat terjadi resistensi silang dengan Erythromycin.
DOSIS :
Dewasa :
Infeksi berat:500 mg, 3 kali sehari (setiap 8 jam)
Infeksi lebih berat:500 mg atau lebih, 4 kali sehari (setiap 6 jam)
Anak-anak diatas umur 1 bulan :
Infeksi berat:30 mg/kg BB sehari dalam 3 atau 4 dosis terbagi
Infeksi lebih berat:60 mg/kg BB sehari dalam 3 atau 4 dosis terbagi
Untuk infeksi Streptococcal β-hemolitic, pengobatan minimal 10 hari untuk mencegah kemungkinan timbulnya demam rematik atau glomerulonefritis. Agar absorpsi optimum, dianjurkan hanya minum air putih saja selama 1-2 jam sebelum dan sesudah meminum Lincomycin.

PENYIMPANAN :
Simpan di tempat sejuk dan kering, terlindung dari cahaya.

KEMASAN DAN NO. REGISTRASI :
BIOLINCOM® 500 kapsul : Box isi 10 strip @ 10 kapsul/ DKL8918806101B1
BIOLINCOM® sirup : Botol isi 60 ml/ DKL8918806237A1

HARUS DENGAN RESEP DOKTER

PT Otto Pharmaceutical Industries
BANDUNG - INDONESIA
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Thursday, January 28, 2010

Aldazide

ALDAZIDE®

Each ALDAZIDE tablet contains 25 mg spironolactone and 2.5mg isobutyl-hydrochlorothiazide (thiabutazide)

INDICATIONS
The treatment of essential hypertension; oedematous conditions, including congestive heart failure, cirrhosis of the liver (with or without ascites), the nephrotic syndrome; idiopathic oedema; in the treatment of diuretic-induced hypokalaemia when other measures are considered inappropriate or inadequate. Treatment of patients with congestive heart failure taking digitalis when other therapies are considered Inadequate or inappropriate.
Aldosterone may be an aetiologic factor in some cases involving malignant effusions and beneficial results have been reported with the use of spironolactone-thiazide combinations.

CONTRAINDICATIONS
Acute renal insufficiency, significant impairment of renal function, anuria, hyperkalaemia, or sensitivity to spironolactone, thiazide diuretics or to other sulfonamide-derived drugs.

WARNINGS
The concomitant administration of potassium supplements or of other potassium-sparing agents is not recommended as it may induce hyperkalaemia. Sulfonamide derivatives, including thiazides, have been reported to exacerbate or activate systemic lupus erythematosus.

PRECAUTIONS
Periodic estimation of serum electrolytes is desirable due to the possibility of hyperkalaemia, hyponatraemia and possible transient BUN elevation, especially in patients with pre-existing impaired renal function, in whom the risk/benefit ratio should always be weighed. Caution should be used in treating patients with acute or severe hepatic failure especially patients with lower effective plasma volume.
There may also be an increased potential to precipitate hepatic coma in such patients.
Both spironolactone and hydrochlorothiazide reduce the vascular responsiveness to nor adrenaline. Therefore, caution should be exercised in the management of patients subjected to regional or general anaesthesia while they are being treated with ALDAZIDE.
As carbenoxolone may cause sodium retention and thus decrease the effectiveness of ALDAZIDE, concurrent use of the two agents should be avoided.
Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function.
Spironolactone has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. It may be necessary to reduce the maintenance and digitalization doses when spironolactone is administered and the patient should be carefully monitored to avoid over-or under-digitalization.
Several reports of possible interference with digoxin radio-immunoassays by spironolactone, or its metabolites have appeared in the literature. Neither the extent nor the potential clinical significance of its interference (which may be assay-specific) has been fully established.

Usage in Pregnancy
Spironolactone or Its metabolites may, and thiazides do, cross the placental barrier. Therefore, the use of ALDAZIDE in pregnant women requires that the anticipated benefit be weighed against possible hazards to the mother and foetus.

Nursing Mothers
Thiazides, as well as canrenone, a metabolite of spironolactone, appear in breast milk. If use of the drug is deemed essential, an alternative method of infant feeding should be instituted.

Animal Findings
Spironolactone has been shown to be a tumorigen in chronic toxicity studies performed in rats, with its proliferative effects manifested on endocrine organs and the liver. In one study using 25, 75, and 250 times the usual daily human dose (2mg/kg), there was a statistically significant dose-related increase in benign adenomas of the thyroid and testes in female rats, there was a statistically significant increase in malignant mammary tumours at the mid-dose only. In male rats, there was a dose related increase in proliferative changes in the liver. At the highest dosage level (500mg/kg), the range of effects included hepatocytomegaly, hyperplastic nodules, and hepatocellular carcinoma; the last was not statistically significant at a value of p = 0.05.
Spironolactone is metabolized to a minor extent to canrenone.
Canrenone and canrenoic acid are the major metabolites of potassium canrenoate.
A dose-related (above 20mg/kg/day) incidence of myelocytic leukaemia was observed in rats fed dally doses of potassium canrenoate (Soldactone) for a period of one year. In one long term (two year) oral carcinogenicity study of potassium canrenoate in the rat, myelocytic leukaemia and hepatic, thyroid, testicular and mammary tumours were observed.
Potassium canrenoate did not produce a mutagenic effect in tests using bacteria or yeast. It did produce a positive mutagenic effect in several in vitro tests in mammalian cells following metabolic activation. In an in vivo mammalian system potassium canrenoate was not mutagenic. An increased incidence of leukaemia was not observed in chronic rat toxicity studies conducted with spironolactone at doses up to 500 mg/kg/day.

ADVERSE REACTIONS
Gynaecomastia may develop in association with the use of spironolactone, and physicians should be alert to its possible onset. The development of gynaecomastia appears to be related to both dosage level and duration of therapy and is normally reversible when ALDAZIDE is discontinued. In rare instances some breast enlargement may persist.
Other adverse effects associated with the use of spironolactone are infrequent and include: gastrointestinal symptoms including cramping and diarrhoea, drowsiness, lethargy, headache, maculopapular or erythematous cutaneous eruptions, urticaria, mental confusion, drug fever, ataxia, inability to achieve or maintain erection, irregular menses or amenorrhoea, and post-menopausal bleeding. A few cases of agranulocytosis have been reported in patients taking spironolactone.
Adverse reactions reported in association with the use of thiazides include: gastrointestinal symptoms (anorexia, nausea, vomiting, diarrhoea, abdominal cramps), purpura, thrombocytopenia, leukopenia, agranulocytosis, dermatologic symptoms, (cutaneous eruptions, pruritus, erythema multiforme), paraesthesia, acute pancreatitis, jaundice, dizziness, vertigo, headache, xanthopsia, photosensitivity, necrotizing angitis, aplastic anaemia, orthostatic hypotension, muscle spasm, weakness, and restlessness. Thiazides have been reported to decrease glucose tolerance and to induce hyperuricaemia.
Adverse reactions are usually reversible upon discontinuation of ALDAZIDE.

DOSAGE AND ADMINISTRATION
Adults:
For essential hypertension
Two to four tablets daily of ALDAZIDE in divided doses will be adequate for most patients provided treatment Is continued for two weeks or longer. The dosage of other antihypertensive drugs should first be decreased by at least 50% when ALDAZIDE is added to the regimen, and then adjusted as necessary. If desired, the daily dose may be given as a single dally dose.
For oedematous conditions
A daily dosage of four tablets of ALDAZIDE in divided doses will be adequate for most patients provided treatment is continued for two weeks or longer. However, dosage may range between one and eight tablets daily. If desired, the dally dose may be given as a single daily dose.
Children:
For oedema in children, the usual daily maintenance dose of ALDAZIDE should be that which provides 1.65 to 3.3mg of spironolactone per kilogram of body weight.

PRESENTATION
Tablets (8.7mm diameter), round, biconvex, ivory, peppermint flavoured, uncoated, stamped SEARLE, each containing 25mg spironolactone and 2.5mg isobutyl-hydrochlorothiazide.
Packs containing 100 tablets. Reg.No. DL 2013005

SEARLE

Manufactured in Indonesia under licence by
PT SOHO INDUSTRI PHARMASI, Jakarta
Searle,
Division of Monsanto Australia Limited
Sydney, Australia
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Monday, January 25, 2010

Mertigo

MERTIGO®
Tablet


Komposisi
Tiap tablet mengandung:
Betahistine mesilate ............. 6 mg

Farmakologi
Betahistine memperlebar spinchter prekapiler sehingga meningkatkan aliran darah pada telinga bagian dalam.
Betahistine mengatur permeabilitas kapiler pada telinga bagian dalam, dengan demikian menghilangkan endolymphatic hydrops.
Betahistine juga memperbaiki sirkulasi serebral dan meningkatkan aliran darah arteri karotis interna.

Indikasi
Mengurangi vertigo, dizzines yang berhubungan dengan gangguan keseimbangan yang terjadi pada gangguan sirkulasi darah atau sindrom meniere, penyakit meniere dan vertigo perifer.

Kontraindikasi
Pasien yang menderita feokromositoma.

Dosis
Dewasa: 1 - 2 tablet, 3 kali sehari
Dosis disesuaikan dengan umut penderita dan keadaan penyakit.

Efek samping
  • Saluran cerna: rasa mual, muntah atau gangguan saluran cerna lainnya.
  • Reaksi hipersensitivitas: ruam pada kulit (jarang terjadi)
Peringatan dan Perhatian
  • Hati-hati bila diberikan kepada penderita dengan gastric ulcer, active digestive ulcer, urtikaria atau rasher dan asma bronkial.
  • Keamanan penggunaannya pada masa kehamilan belum dibuktikan, sebaiknya diberikan hanya bila keuntungan terapi lebih besar dari risiko yang mungkin timbul.
Kemasan dan nomor registrasi
Kotak, 10 strip @ 10 tablet DKL9505016510A1

HARUS DENGAN RESEP DOKTER

SIMPAN PADA SUHU DIBAWAH 30° C,
TERLINDUNG DARI CAHAYA

Dibuat oleh:
DexaMedica
Jl. Bambang Utoyo 138
PALEMBANG-INDONESIA
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Lasgan

LASGAN®
Lansoprazole


KOMPOSISI
Tiap kapsul LASGAN® mengandung 30 mg Lansoprazole granul bersalut enterik.

CARA KERJA OBAT
Lansoprazole adalah penghambat sekresi asam lambung yang secara spesifik menghambat (H+/K+)ATP-ase (pompa proton) di sel parietal mukosa lambung.

INDIKASI
  • Ulkus duodenum
  • Ulkus gasterbenigna
  • Refluksesofagitis
  • Sindromazollingerellison

KONTRAINDIKASI
Penderita yang diketahui hipersensitif terhadap Lansoprazole.

POSOLOGI
Ulkus duodenum
 :
LASGAN® sehari 1 kapsul, selama 4 minggu.
Ulkus gaster benigna
 :
LASGAN® sehari 1 kapsul, selama 8 minggu.
Refluks esofagitis
 :
LASGAN® sehari 1 kapsul, selama 8 minggu.
Sindroma zollinger ellison
 :
LASGAN® sehari 2 - 4 kapsul, dalam dosis terbagi
Untuk mencapai efek terapi yang optimal, LASGAN® sebaiknya diberikan pagi hari sebelum makan.
Kapsul harus ditelan utuh, tidak boleh digerus atau dikunyah
Pengobatan jangka panjang dengan Lansoprazole tidak dianjurkan pada saat ini karena pengalaman klinisnya, terbatas.
- Orang tua
 :
tidak perlu penyesuaian dosis (30 mg sehari)
- Anak-anak
 :
tidak ada pengalaman pemberian Lansoprazole pada anak-anak
Lansoprazole pada dasarnya dimetabolisme di hati.
Penelitian klinis pada penderita penyakit hati, memperlihatkan bahwa metabolisme Lansoprazole diperpanjang bila ada gangguan fungsi hati berat, tetapi tidak perlu penyesuaian dosis; dosis tidak boleh melebihi 30 mg sehari. Tidak perlu mengubah dosis pada penderita dengan gangguan fungsi ginjal.

EFEK SAMPING
  • Selama penelitian klinis kadang-kadang terjadi efek samping seperti : sakit kepala, diare, nyeri abdomen, dispepsia, mual, muntah, mulut kering, sembelit, kembung, pusing, lelah, ruam kulit, urtikaria, pruritus.
  • Pada saat dilakukan uji faal fungsi hati dapat terjadi kenaikan nilai-nilai fungsi hati yang bersifat sementara dan akan normal kembali apabila pemberian obat dihentikan
  • Kadang-kadang dapat terjadi atralgia, edema perifer dan depresi tetapi tidak diketahui hubungannya dengan terapi Lansoprazole karena mekanisme kerja belum jelas.
  • Kelainan hematologi pernah dilaporkan, walaupun jarang terjadi, misal : trombositopenia, eosinofillia, leukopenia.
PERINGATAN DAN PERHATIAN
  • Pemberian Lansoprazole pada penderita tukak peptik dapat menyamarkan gejala-gejala dan memperlambat diagnosis adanya keganasan penyakit (penyakit lain pada lambung).
  • Penggunaan pada wanita hamil dan menyusui:
    Karena belum ada data penggunaan Lansoprazole pada wanita hamil dan menyusui, maka pemberian Lansoprazole pada kelompok penderita ini sebaiknya dihindari.
    Percobaan pada binatang, tidak ditemui efek teratogenik. Penelitian reproduksi pada tikus dan kelinci, Lansoprazole dosis tinggi menurunkan sedikit angka kehidupan dan berat badan jenis hewan-hewan tersebut.
INTERAKSI OBAT
Lansoprazole dimetabolisme di hati merupakan penginduksi lemah terhadap sitokrom P-450. Oleh sebab itu ada kemungkinan terjadi interaksi antara obat ini dengan obat-obat yang dimetabolisme di hati, misalnya kontrasepsi oral, fenitoin, teofilin atau warfarin.
Pemberian bersama obat-obat anti inflamasi non steroid atau diazepam tidak menimbulkan efek klinis yang bermakna. Antasid dan sukralfat dapat mengurangi bioavailabilitas Lansoprazole, karena itu tidak boleh diberikan satu jam sebelum atau sesudah makan Lansoprazole.

KEMASAN
LASGAN® : Kotak berisi 2 strip @ 10 kapsul
No. Reg. DKL 0113310501 A1

Simpan di tempat sejuk (15-25°C) dan kering.

HARUS DENGAN RESEP DOKTER

PT. LAPI LABORATORIES
CIKANDE-INDONESIA
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Gitas Plus

GITAS® PLUS
KAPLET SALUT SELAPUT

KOMPOSISI:
Tiap kaplet salut selaput mengandung:
Hyoscine N-butylbromide
10 mg
Paracetamol
500 mg

KHASIAT:
GITAS® PLUS mengandung kombinasi Hyoscine N-butylbromide sebagai obat antispasmodik dan Paracetamol sebagai obat analgesik.
Hyoscine N-butylbromide mempunyai efek anti muskarinik yang bekerja pada saraf serabut pasca-ganglion kolinergik.

INDIKASI:
Nyeri paroksismal pada penyakit-penyakit lambung atau usus halus, nyeri spastik pada traktus biliaris, traktus urinarius dan organ-organ genitalia (misalnya dismenore).

KONTRAINDIKASI:
  • Jangan diberikan pada penyakit-penyakit glaukoma, hipertrofi prostat dengan kecenderungan retensi urine, stenosis mekanis di daerah traktus gastrointestinal, takikardia, megakolon.
  • Penderita yang hipersensitif terhadap komponen tersebut di atas.
  • Porfiria.
  • Tidak boleh digunakan pada penderita gangguan fungsi hati.
EFEK SAMPING:
  • Kekeringan pada mulut dan kulit, konstipasi, palpitasi, flushing, aritmia jantung, bradikardia dan takikardia.
  • Pernah dilaporkan menyebabkan reaksi paradoxikal (gangguan waktu tidur) dan mempengaruhi penglihatan, oleh sebab itu hati-hati dalam mengemudikan kendaraan bermotor atau menjalankan mesin.
  • Dosis besar menyebabkan kerusakan hati.
PERINGATAN / PERHATIAN :
  • Penggunaan pada wanita hamil hanya jika benar-benar dibutuhkan, terutama pada trimester 1 kehamilan dengan mempertimbangkan resikonya terhadap janin.
  • Hati-hati penggunaan obat ini pada penderita penyakit ginjal.
  • Hati-hati penggunaan pada pasien lanjut usia, pasien dengan gangguan jantung, kolitis ulseratif, paralytic ileus dan pyloric stenosis.
  • Hindari minuman beralkohol.
  • Tidak boleh melebihi dosis yang dianjurkan.
  • Keamanan pada wanita menyusui belum dapat dibuktikan.

INTERAKSI OBAT:
  • Paracetamol dapat menyebabkan kerusakan hepar bila diberikan bersama-sama dengan obat yang bekerja menginduksi enzim, seperti obat-obat hipnotis dan anti-epilepsi (misalnya Glutethimide, Phenobarbital, Phenytoin, Carbamazepin) dan juga Rifampicin. Hal yang sama terjadi pula bila diberikan bersama-sama dengan alkohol yang berlebihan.
  • Apabila pengosongan asam lambung diperlambat misalnya dengan Propantheline, maka kecepatan absorpsi Paracetamol akan berkurang, sehingga mula kerjanya diperlambat.
  • Mempercepat pengosongan asam lambung, seperti pada pemberian Metoclopramide, akan meningkatkan kecepatan absorpsi.
  • Kombinasi dengan Chloramphenicol dapat memperpanjang waktu paruh, tetapi resikotoksisitas akan meningkat.
  • Penilaian secara klinis antara interaksi Paracetamol dan Warfarin serta derivat kumarin masih belum diketahui. Oleh karena itu, penggunaan Paracetamol untuk jangka panjang pada pasien yang sedang menjalani terapi dengan antikoagulan oral hanya dapat dilakukan di bawah pengawasan dokter.

ATURAN PAKAI:
Kecuali ditentukan lain oleh dokter, dosis yang dianjurkan adalah:
Dewasa: 1 - 2 kaplet, 3 kali sehari, ditelan utuh dengan sedikit air.
Dosis total sehari tidak boleh melebihi 6 kaplet.

KEMASAN:
Kotak berisi 5 strip @ 10 kaplet salut selaput
Reg.No.: DKL9817614709A1

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

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

Imox

IMOX®
Food supplements
Film-coated tablet

COMPOSITION
Each film-coated tablet contains:
Elderberry Extract 4:1 (fruit)
125 mg
Echinacea purpurea Extract 4:1
60 mg
Vitamin C (Ascorbic Acid)
250 mg
Garlic (deodorized) (bulb)
50 mg
Zinc (as Zinc Oxide)
7.5 mg

USE
As antioxidantand improves body immune.

DOSAGE
Adults: 2 tablets daily with a meal.

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

PRESENTATION
IMOX® film-coated tablet
Box of 2 strips @ 10 film-coated tablets
POM SI. 064 524 281

Manufactured by:
Northridge Laboratories, Inc.
20832 Dearborn St.,
Chatsworth, CA91311,USA
for:
Yale Nutraceutical, Inc.
20255 Paseo Del Prado, Walnut, CA91789, USA
Repacked and marketed by:
PT GRACIA PHARMINDO
Bandung-Indonesia



IMOX®
Suplemen makanan
Tablet salut selaput


KOMPOSISI
Tiap tablet salut selaput mengandung:
Elderberry Extract 4:1 (fruit)
125 mg
Echinacea purpurea Extract 4:1
60 mg
Vitamin C (Ascorbic Acid)
250 mg
Garlic (deodorized) (bulb)
50 mg
Zinc (as Zinc Oxide)
7,5 mg

KEGUNAAN
Sebagai antioksidan dan membantu memperbaiki daya tahan tubuh.

DOSIS
Dewasa: 2 tablet sehari saat makan.

PENYIMPANAN
Simpan di tempat sejuk (15 - 25° C) dan kering.

KEMASAN
IMOX® tablet salut selaput
Dus isi 2 strip @ 10 tablet salut selaput
POM SI. 064 524 281

Diproduksi oleh:
Northridge Laboratories, Inc.
20832 Dearborn St.,
Chatsworth,CA91311,USA
untuk:
Yale Nutraceutical, Inc.
20255 Paseo Del Prado, Walnut, CA91789, USA
Dikemas dan dipasarkan oleh:
PT GRACIA PHARMINDO
Bandung-Indonesia
Continue reading...

Ositin

OSITIN®
Food supplements
Film-coated caplet


COMPOSITION
Each film-coated tablet contains:
Glucosamine Sulphate 2KCl
400 mg
Chondroitin Sulphate
250 mg
Methylsulfonylmethane(MSM)
75 mg
Turmeric (root)
60 mg
Boswellia serrata extract
50 mg
White willow (bark)
37.50 mg

USE
Maintain joints health and its benefical for patient ofosteoarthntis.

DOSAGE
Adults: 2 caplets daily.

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

PRESENTATION
OSITIN, film-coated caplet
Box of 5 strips @ 4 film-coated caplets
POM SI. 074 525 331

Manufactured by:
Northridge Laboratories, Inc.
20832 Dearborn St.,
Chatsworth,CA91311,USA
for:
Yale Nutraceutical, Inc.
20255 Paseo Del Prado, Walnut, CA91789, USA i
marketed by:
PT GRACIA PHARMINDO
Bandung-Indonesia



OSITIN®
Suplemen makanan
Kaplet salut selaput


KOMPOSISI
Tiap kaplet salut selaput mengandung:
Glucosamine Sulphate 2KCl
400 mg
Chondroitin Sulphate
250 mg
Methylsulfonylmethane(MSM)
75 mg
Turmeric (root)
60 mg
Boswellia serrata extract
50 mg
White willow (bark)
37,50 mg

KEGUNAAN
Memelihara kesehatan persendian dan dapat digunakan pada penderita osteoarthritis.

DOSIS
Dewasa: 2 kaplet sehari.

PENYIMPANAN
Simpan di tempat sejuk (15 - 25° C) dan kering.

KEMASAN
OSITIN, kaplet salut selaput
Dus berisi 5 strip @ 4 kaplet salut selaput
POM SI. 074 525 331

Diproduksi oleh:
Northridge Laboratories, Inc.
20832 Dearborn St.,
Chatsworth,CA91311,USA
untuk:
Yale Nutraceutical, Inc.
20255 Paseo Del Prado, Walnut, CA91789, USA
dipasarkan oleh:
PT GRACIA PHARMINDO
Bandung-Indonesia
Continue reading...

Proliva

PROLIVA®
Food supplements
Film-coated caplet


COMPOSITION
Each film-coated caplet contains:
Selenium (sodium selenite)
200 mcg
Milk thistle (seed)
300 mg
Citrus bioflavonoids
120 mg
Bilberry (leaves)
100 mg
Alpha lipoic acid
100 mg
Quercetin 95%
50 mg
Turmeric (root)
40 mg
Licorice (root)
40 mg
Dandelion (root)
35 mg

USE
Maintain liver health.

DOSAGE
Adults: 1 caplet daily.

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

PRESENTATION
PROLIVA, film-coated caplet
Box of 5 strips @ 4 film-coated caplets
POM SI. 074 525 331

Manufactured by:
Northridge Laboratories, Inc.
20832 Dearborn St.,
Chatsworth,CA91311,USA
for:
Yale Nutraceutical, Inc.
20255 Paseo Del Prado, Walnut, CA91789, USA
marketed by:
PT GRACIA PHARMINDO
Bandung-Indonesia



PROLIVA®
Suplemen Makanan
Kaplet Salut Selaput


KOMPOSISI
Tiap kaplet salut selaput mengandung:
Selenium (sodium selenite)
200 mcg
Milk thistle (seed)
300 mg
Citrus bioflavonoids
120 mg
Bilberry (leaves)
100 mg
Alpha lipoic acid
100 mg
Quercetin 95%
50 mg
Turmeric (root)
40 mg
Licorice (root)
40 mg
Dandelion (root)
35 mg

KEGUNAAN
Memelihara kesehatan hati.

DOSIS
Dewasa: 1 kaplet sehari.

PENYIMPANAN
Simpan di tempat sejuk (15 - 25° C) dan kering.

KEMASAN
PROLIVA, kaplet salut selaput
Dus berisi 5 strip @ 4 kaplet salut selaput
POM SI. 074 525 331

Diproduksi oleh:
Northridge Laboratories, Inc.
20832 Dearborn St.,
Chatsworth,CA91311,USA
untuk:
Yale Nutraceutical, Inc.
20255 Paseo Del Prado, Walnut, CA91789, USA
dipasarkan oleh:
PT GRACIA PHARMINDO
Bandung-Indonesia
Continue reading...
 

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