Generici vs. originali lijekova

[all_together]

Zanima me je li tko mozda primijetio razliku u ucinkovitosti generickih psihofarmaka i originala? Ja pijem Asentru 100mg i iako mi je ucinkovita razmisljam bi li mi mozda original Zolofta bio UCINKOVITIJI

Razlika izmedu generika i originala je samo u neaktivnim sastojcima, aktivni sastojak je isti. Problem je u tome sto neaktivni sastojci utjecu na brzinu otpustanja aktivnih sastojaka, maximalnu koncentraciju u krvi i sl. FDA (Food And Drug Administration) dopusta razliku u koncentraciji u krvi izmedu 80 i 120% u odnosu na original. Tvrtke koje proizvode generike ih testiraju, prema ovom clanku, samo na jako malom broju ljudi (oko 20)-zato su i puno jeftiniji.

Puno slucajeva je bilo o veliki razliki u brzini otpustanja generika (Budeprion) Wellbutrina XL. Ustanovljeno je da se prebrzo otpusta. Jos uvijek je na trzistu iako se vodi istraga, o cemu pise i u ovom clanku. Ima i drugih slucajeva drugih lijekova i to cak i kod pacijenata koji nisu znali da piju generik, i nekima se stanje jako pogorsalo, i cim su presli na original bi se normaliziralo.

Nesto sto me kopka je to da ako zakasnim samo par sati s pijenjem Asentre da sam taj dan i sljedeci depresivna i DOWN. Znam da Zoloft ima kratak half-life (vrijeme za koje se koncentracija lijeka u krvi smanji na 50%), ali mozda Asentra ima jos kraci???

I zna li tko koliko kosta Zoloft na bijeli recept (samoplacnisko)?

Evo jedan jako zanimljiv (poduzi) clanak:
http://www.self.com/health/2009/06/d...-generic-drugs

[all_together]

Jos par linkova od FDA:
http://www.fda.gov/Drugs/Development...rug%20Products

The statistical methodology for analyzing these bioequivalence studies is called the two one-sided test procedure. Two situations are tested with this statistical methodology. The first of the two one-sided tests determines whether a generic product (test), when substituted for a brand-name product (reference) is significantly less bioavailable. The second of the two one-sided tests determines whether a brand-name product when substituted for a generic product is significantly less bioavailable. Based on the opinions of FDA medical experts, a difference of greater than 20% for each of the above tests was determined to be significant, and therefore, undesirable for all drug products. Numerically, this is expressed as a limit of test-product average/reference-product average of 80% for the first statistical test and a limit of reference-product average/test-product average of 80% for the second statistical test. By convention, all data is expressed as a ratio of the average response (AUC and Cmax) for test/reference, so the limit expressed in the second statistical test is 125% (reciprocal of 80%).

http://www.fda.gov/Drugs/Development...%20Equivalents

The current practice of carrying out two one-sided tests at the 0.05 level of significance ensures that there is no more than a 5% chance that a generic product that is not truly equivalent to the reference will be approved.

[ray of light]

meni recimo ne sjeda isto xanax i helex, to su neke nijanse, ali ja ih osjetim

[all_together]

rejoflajt kaže:

meni recimo ne sjeda isto xanax i helex, to su neke nijanse, ali ja ih osjetim

Da, to sam procitala na netu negdje da Xanax i generici nekada ne djeluju jednako.
Koje razlike primijetis?

[ray of light]

all_together kaže:

Da, to sam procitala na netu negdje da Xanax i generici nekada ne djeluju jednako.
Koje razlike primijetis?

xanax me nekako ugodnije omekša nego helex, ne znam bolje objasniti

[ray of light]

ti si medicinkadaj mi reci jel to meni pulsira želudac ili što pri strahu, il su to one adrenalinske žlijezde, kao da imam čvor i on pulsira

[ray of light]

il je to dijafragma, neugodno čak kao da me malo i škaklja na neugodan način

[ray of light]

možeš odgovoriti na anksioznosti

[ray of light]

sad čitam da je generički naziv ativan za naš lorsilan, zanima me jel ga ima u ljekarnama

[GiRL]

Brijem da je ZOLOFT NA BIJELI RECEPT nekih 80-ak kuna!

Nema veze jel' generički ili ne, ja evo pijem generike Velafax i Loquen, djelatna je tvar ista, nema tu neke razlike, ti se lijekovi rigorozno testiraju i ne prolaze ispitivanja ako su manje djelotvorni.

[Okolosam]

Sve vam je to u glavi.

Što reče osoba gore, generik je istosmjaran lijek, istoučinkovit kao i "original".

Da vam netko potajice da ili Xanax, helex ili Misar, ne bi ni znali koji ste lijek uzeli.

[all_together]

http://http://www.accessdata.fda.gov...ocs/tempai.cfm

Okolosam kaže:

Sve vam je to u glavi.

Što reče osoba gore, generik je istosmjaran lijek, istoučinkovit kao i "original".

Da vam netko potajice da ili Xanax, helex ili Misar, ne bi ni znali koji ste lijek uzeli.

Oklosam, ne znam jesi li pogledao ov linkove-i na stranici od FDA pise da se tolerira razlika u bioekvivalentnosti od 80-120% u odnosu na original! Isto tako, mnogo lijecnika ne prepisuje bas rado generik warfarina (za razrjedivanje krvi), jer u razlicitoj mjeri od originala razrijedi krv-previse ili premalo, pa se ne moze biti siguran u dozu koju propisujes. Isto tako tu na ovim linkovima imas ocitu razliku kod nekih antiepileptika i Wellbutrina (ima graf koji ga usporeduje s generikom)..... Tako da.....

http://en.wikipedia.org/wiki/Generic_drug
The generic equivalent of name-brand warfarin has only been available under the trade name Coumadin in North America until recently. Warfarin (either under the trade name or the generic equivalent) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in the Canadian province of Ontario showed that replacing Coumadin with generic warfarin was considered safe.[26] In spite of the study, many physicians are not comfortable in allowing their patients to take the branded generic equivalent agents.[27] As such, in countries such as Australia where warfarin is prescribed under more than one brandname (Marevan in 1 mg, 3 mg, 5 mg respectively and Coumadin in 1 mg, 2 mg, 5 mg respectively, etc), the pharmacist may not substitute brandnames. In regards the specific example of Australia, this only occures if the Doctor has written the prescription out using a brandname & ticked the box on the prescription marked "Brand substitution not permitted". If the doctor has left that box unticked on the prescription, then the pharmacist can make out the prescription using any eqiuilivent brandname drug {that's available with the same active ingredient makeup in the same dosage with similar levels of sustained release) to the brandname drug the prescription is written out for, just as if the prescription was written out by the doctor using the certified name of the active ingredient/s in the 1st place rather than specifying a particular brandname for the same medication (for example "methadone 10mg" instead of "Physeptone 10mg").[28]

Ensuring bioequivalence
Most nations require generic drug manufacturers to prove that their formulation exhibits bioequivalence to the innovator product.[16][17][18][19][19][20][21] In the U.S., the FDA must approve generic drugs just as innovator drugs must be approved.[citation needed] The FDA requires the bioequivalence of the generic product to be between 80% and 125% of that of the innovator product.[22]

Ovo mi je malo ispalo smijesno, jer puno ljudi nevoljko kupuje generike cipseva, sokova, praska za ves, keksa itd. a pijemo generike lijekova Naravno, ima i onih koji su jednako ucinkoviti kao i original.

http://www.peoplespharmacy.com/2009/...rsy-wont-quit/
What the FDA does not tell you in this sentence is that generic drugs can have different "inert" ingredients or fillers. In other words, all the other stuff except the active ingredient could be completely different. What's more, the formulation can be be quite different. Take Wellbutrin XL 300, for example. This brand name antidepressant gradually releases the active ingredient bupropion over the course of a day. It uses a "membrane" technology for this slow release.

One generic equivalent, Budeprion XL 300, uses a "matrix" technology for its slow release. The same amount of bupropion (300 mg) is released, but the timing is quite different. Budeprion XL dissolves and releases its ingredient more quickly. The FDA confirms this in a report it has released on its Web site.


Budeprion XL 300 is not the only generic drug raising questions. Over the last several years we have received hundreds and hundreds of complaints about a variety of generic drugs. They range from the generic form of the anti-seizure drug Keppra (levetiracetam) to the heart drug Toprol XL (metoprolol succinate), the heartburn medicine Prilosec (omeprazole) and the pain reliever OxyContin (oxycodone).

http://www.originaldrugs.com/blog/ge...generic-drugs/
Several health-related organizations, including the Epilepsy Foundation of America and the American Thyroid Association, have raised concerns about the mandatory use of generic medications proposed by some states or required by health plans to save money. An example of the controversy about generic versus brand name medication is the drug levothyroxine, used to treat people with hypothyroidism. Since many people with low thyroid are sensitive to very small changes in the dose of their medication, switching between brand name and generic versions of levothyroxine can cause symptoms of too little thyroid medication or side effects from too much medication.

If brand-name drugs and g
eneric drugs are equivalent, why do they act and look different?

Although FDA requires that generic drugs have the same risks and benefits as their brand-name counterparts, the fact is many types of blood pressure medications, heart medications, hormones, antiepileptic drugs, antidepressants, many liquid form medications and some antibiotics are just not as effective as the brand.

http://www.accessdata.fda.gov/script...ob/default.cfm
Tu ima i Pliva odobrena od FDA, ali ne i Belupo, Krka, itd. (njih su odobrile Europske organizacije)

I za Venlafaxine

[all_together]

Danas sam isla psihijatrici po novi recept jer ce mi uskoro prifalit i pita me: "Recept za Zoloft, dal?" Ja kazem da zapravo za Asentru ali da rade Zoloft. Ona je rekla da je to isto, al sam ja rade htjela Zoloft jer nije neka razlika u cijeni, njoj to nije nis bilo cudno sto sam trazila original

Bas me zanima, sutra cu ga popit, pa cu vidit ima li kakve razlike Inace, psihijatrica (idem privatno i inace sama placam na bijeli recept) mi je dala iz ordinacije 3 kutije Zolofta po 50mg (ja pijem 100mg pa mi nece opet toliko dugo trajat), kako ona kaze, "da si malo prisparam"

Osjecala sam se ko putujuca ljekarna s 3 kutije Zolofta, kutijom Asentre i kutijom Wellbutrina u torbici

[all_together]

Ako PubMed nije pouzdan izvor onda ne znam sto je:
http://www.ncbi.nlm.nih.gov/pubmed/12860486

The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs.
Borgheini G.

Neurological and Psychiatric Department, University of Padua, and Casa di Cura Parco dei Tigli, Padua, Italy. [email protected]

Comment in:

Clin Ther. 2004 May;26(5):801-2.

Abstract
BACKGROUND: For the purposes of drug approval, the interchangeability of a generic drug and the corresponding brand-name drug is based on the criterion of "essential similarity," which requires that the generic drug have the same amount and type of active principle, the same route of administration, and the same therapeutic effectiveness as the original drug, as demonstrated by a bioequivalence study. However, bioequivalence and therapeutic effectiveness are not necessarily the same. OBJECTIVE: This review summarizes available data comparing the bioequivalence and therapeutic efficacy of brand-name psychoactive drugs with those of the corresponding generic products. METHODS: Relevant information was identified through searches of MEDLINE, Current Contents/Clinical Medicine, and EMBASE for English-language articles and English abstracts of articles in other languages published between 1975 and the present. The search terms used were generic drug, branded drug, safety, toxicity, adverse events, clinical efficacy, bioequivalence, bioavailability, psychoactive drugs, and excipients. RESULTS: Few publications compared the bioequivalence and efficacy of brand-name and generic psychoactive drugs. Those that were identified revealed differences in the efficacy and tolerability of brand-name and generic psychoactive drugs that had not been noted in the original bioequivalence studies. Specifically, 1 study found that plasma levels of phenytoin were 31% lower after a switch from a brand-name to a generic product. Several controlled studies of carbamazepine showed a recurrence of convulsions after the shift to a generic formulation. After a sudden recurrence of seizures when generic valproic acid was substituted for the brand-name product, an investigation by the US Food and Drug Administration found a difference in bioavailability between the 2 formulations. Statistically significant differences in pharmacokinetic variables have been reported in favor of brand-name versus generic diazepam (P < 0.001). Finally, a case report involving paroxetine mesylate cast doubt on the tolerability and efficacy of the generic formulation. CONCLUSION: The essential-similarity requirement should be extended to include more rigorous analyses of tolerability and efficacy in actual patients as well as in healthy subjects.

[all_together]

rejoflajt kaže:

ti si medicinkadaj mi reci jel to meni pulsira želudac ili što pri strahu, il su to one adrenalinske žlijezde, kao da imam čvor i on pulsira

Evo nasla sam ti super odgovor na netu
Uglavnom, kada si jako anksiozna ili imas panicni napad, tijelo te priprema na borbu, bijeg od neke opasne situacije tako da pojacano izlucuje adrenalin. Adrenalin uzrokuje ubrzane otkucaje srca, povecan tlak (od tuda taj tvoj osjecaj pulsiranja u trbuhu-u abdomenu je jedna velika arterija), suzenje kvnih zila u organima koji tada nisu nuzno potrebni (ako dode do ozlijede da krvarenje ne bude preveliko), krv salje u organe koji su tada bitni i tamo se krvne zile rasire (mozak, srce, noge). Ostale organe zapusti jer tada nisu vazni (zeludac i ostale probavne organe). Kako ti se sada odjedanput smanji kolicina krvi u zelucu i probavnom traktu, to mozes osjetiti kao grceve odnosno bol.

[ray of light]

xanax vs. xanax sr?

[all_together]

rejoflajt kaže:

xanax vs. xanax sr?

Sto si me htjela time pitati? Mislila si jel bolje Xanax sustained release ili Xanax koji odmah djeluje? To ti ja ne znam, ja sam ti tek prva godina Moras pitati svoju psihijatricu

[all_together]

Rekla sam da cu vam javit ima li kakve razlike izmedu Zolofta i Asentre IMA!! Pola sata nakon sto sam popila istu dozu koju pijem i inace, 100mg, me pocela bolit glava dosta intenzivno (inace nikada nemam problema s glavoboljom nit sam imala ikad prije, to mi je samo kada pocnem s antidepresivima na pocetku), pritisak kao i onda kada sam tek pocela s Asentrom. I tako je to trajalo negdje 4 sata dosta intenzivno i onda se pocelo smanjivat i sada samo jos blagi pritisak
To znaci da je Zoloft jaci od Asentre? Jer ne bi me trebala bolit glava posto sam na istoj dozi

Neka jos netko napravi experiment, ja od sad ostajem pri ZOLOFTU

[all_together]

Ovo je netko dobro opisao na ovoj stranici

"My wife works in the pharma industry and was completely matter of fact that generics are not formulated in the same manner as the non generic. Only the original developer has the original formulations, the generics only have the ingredients. And you know what different cooks can make with the same ingredients!! "

[all_together]

Alexander M.S, M.D. June 12th, 2009 04:04 ET

As a physician and former research fellow at the NIH, I have found that there are even differences between the same active ingredients. The proprietary synthesis and crystallization of the active ingredient is different for the brand name drug versus the generic. Whether that difference translates into real clinical differences in efficacy or side effect profile may not be known, but the studies that originally validated the drug in the first place are based upon the brand.