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Drugs online research references

J Indian Med Assoc. 1994 Jan;92(1):24-6.
Opportunistic infection in AIDS.

Sengupta D, Lal S, Shrinivas.

National AIDS Control Organisation, Ministry of Health and Family Welfare, New Delhi.

PIP: Opportunistic infections may be severe in people having acquired immunodeficiency syndrome (AIDS). These infectious agents often demonstrate an uncommon persistence and may even show a recurring trait. This report describes 10 of the most commonly seen opportunistic infectious agents found in AIDS patients in India. The authors briefly describe the immunologically debilitating effects of AIDS in humans. A suggested treatment program including specific drugs to use against each pathogen is described. Further, the authors note that drug hypersensitivity developed in many AIDS patients. The 10 infections described are candidiasis, tuberculosis (TB), Pneumocystis carinii, cryptococcus, histoplasmosis, toxoplasmosis, cryptosporidiosis, Mycobacterium avium, Herpes simplex, and cytomegalovirus. Multiple infections were common. A regime of fluconazole is used against candidiasis and cryptococcus. Standard antituberculines are prescribed for TB. Amphotericin and flucytosine are effective against cryptococcus. Histoplasmosis is treated with amphotericin or itraconazole. Sulfadiazine sodium and pyrimethamine are given to toxoplasmosis patients. Cryptosporidiosis is treated with paramomycin. Acyclovir is effective against Herpes simplex. Cytomegalovirus is treated with foscarnet and ganciclovir. Dosages for each drug are also provided.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8207276&dopt=Abstract

Am J Obstet Gynecol. 2000 Jan;182(1 Pt 1):159-63.
Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment.

Reiff-Eldridge R, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB.

Department of Worldwide Epidemiology, Glaxo Wellcome, Research TrianglePark, NC 27709, USA.

OBJECTIVE: Glaxo Wellcome becomes aware of prenatal exposures to its medications as early as the clinical trial phase of development. An international process for monitoring prenatal exposure to all Glaxo Wellcome medicines has been developed. For specific products there are prospective pregnancy registries. STUDY DESIGN: The registries are observational, case-registration, and follow-up studies designed to detect evidence of teratogenicity associated with specific medications. After prenatal exposure to the registry medication, pregnancies are registered prospectively, through voluntary reports by health care providers. An advisory committee of independent scientists for each registry reviews data and advises in dissemination of information. Risk of birth defects, as defined by the Centers for Disease Control and Prevention, is compared with published risks both in women in the general population and in women with the underlying condition being treated, if available. RESULTS: The following data show results from the prospective first-trimester exposures registered since establishment of each registry. The published risk of birth defects in the general population range is 3% to 5%, and the risk in women with epilepsy is 6% to 9%. The proportions of outcomes with birth defects are as follows: in the Acyclovir (antiviral medication) Pregnancy Registry (1984-1998) (19/581), 3.3% (95% confidence interval, 2.0%-5.2%); in the Lamotrigine (monotherapy and polytherapy antiepileptic medication) Pregnancy Registry (1992-September 1998) (8/123), 6.5% (95% confidence interval, 3.1%-12.8%); in the Sumatriptan (migraine medication) Pregnancy Registry (1996-October 1998) (7/183), 3.8% (95% confidence interval, 1.7%-8.0%). The Valacyclovir, Bupropion, and Naratriptan registries have insufficient data for analysis. CONCLUSION: None of the registries has provided a risk estimate exceeding that expected in the disorder treated, and no pattern of defects has been observed. Whereas information from the larger registries is reassuring regarding risk, these studies cannot rule out possible small excess risks from use of these drugs in pregnancy. Data obtained through these registries are shared with the medical community as a supplement to animal toxicology studies to assist in weighing potential risks and benefits of treatment for individual patients. The success of the registries depends on the continued willingness of the obstetrics and gynecology community to notify the registries of prenatal exposures.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10649172&dopt=Abstract

Prim. Care Update Ob Gyns. 1998 Jul 1;5(4):190-191.
Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment.

Eldridge RR, Ephross SA, Heffner CR, Tennis PS, Stender DM, White AD.

Glaxo Wellcome, Research Triangle Park, North Carolina, USA

Objectives: Glaxo Wellcome (G.W.) becomes aware of prenatal exposures to its medications from as early as the clinical trial phase of development. An international process for monitoring prenatal exposure to all G.W. medicines has been developed utilizing a passive surveillance system and, for specific products, pregnancy registries. Additionally, G.W. jointly sponsors the multi-company Antiretroviral and North American Antiepileptic Drug (AED) Pregnancy Registries.Study Design: The registries are observational, case-registration and follow-up studies designed to detect evidence of teratogenicity associated with specific medications. Pregnancies are registered prospectively following prenatal exposure to the registry medication. An advisory committee for each registry reviews data and assists in dissemination of information. Committee members include independent scientists with expertise in fields such as obstetrics, teratology, epidemiology, pediatrics, and the relevant therapeutic areas.Results: The following data are from the prospective first-trimester exposures in each registry. Through December 1996, the proportion of outcomes in the Acyclovir Pregnancy Registry with birth defects (n = 17/505) is 3.4% (95% CI 2.0%, 5.4%). Through March 1997, the proportion of outcomes in the Lamotrigine Pregnancy Registry with birth defects (n = 4/76) is 5.3% (95% CI 1.7%, 13.6%). Through April 1997, the proportion of outcomes in the Sumatriptan Pregnancy Registry with birth defects (n = 5/148) is 3.4% (95% CI 1.3%, 8.1%). The newer Valacyclovir and Bupropion Pregnancy Registries have insufficient data for analysis. None of the registries have provided a risk estimate exceeding that expected in the general population, and no pattern of defects has been observed.Conclusions: The outcomes accumulated to date represent a sample of insufficient size for reaching conclusions regarding the possible teratogenic risk of using these drugs in pregnancy. Data obtained through these registries are shared with the medical community as a supplement to animal toxicology studies and to assist in weighing potential risks and benefits of treatment for individual patients. The success of the registries depends on the continued willingness of the OB/GYN community to notify the registries of prenatal exposures.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10838360&dopt=Abstract [PubMed - as supplied by publisher]

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