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In the US, Aldesleukin (aldesleukin systemic) is a member of the following drug classes: interleukins, miscellaneous antineoplastics and is used to treat Melanoma and Renal Cell Carcinoma.
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Rec.INN
L03AC01
0110942-02-4
C690-H1115-N177-O203-S6
15600
Antineoplastic agent
Biological response modifier, BRM
Immunomodulator
125-L-serine-2-133-interleukin 2 (human reduced) (WHO)
2-133-Interleukin 2 (human reduced), 125-L-serine- (USAN)
Des-alanyl-1, serine-125 human interleukin-2 (BAN)
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| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
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Rec.INN
R06AE04
0000082-93-9
C18-H21-Cl-N2
300
Antiallergic agent
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Piperazine, 1-[(4-chlorophenyl)phenylmethyl]-4-methyl-
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| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Wellvone 750 mg/5 ml oral suspension
Each ml of suspension contains 150 mg atovaquone
A unit dose of 5 ml contains 750 mg atovaquone.
For a full list of excipients, see section 6.1.
Oral suspension.
Wellvone oral suspension is a bright yellow liquid
Wellvone Suspension is indicated for:
Acute treatment of mild to moderate Pneumocystis pneumonia (PCP, caused by Pneumocystis jiroveci, formerly classified as P. carinii) (alveolar - arterial oxygen tension difference [(A-a) DO2] < 45 mmHg (6 kPa) and oxygen tension in arterial blood (PaO2)
The importance of taking the full prescribed dose of Wellvone with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold.
Dosage in adults
Pneumocystis pneumonia:
The recommended oral dose is 750 mg twice a day (1 x 5 ml morning and evening) administered with food each day for 21 days.
Higher doses may be more effective in some patients (see section 5.2).
Dosage in Children
Clinical efficacy has not been studied.
Dosage in the Elderly
There have been no studies of Wellvone in the elderly (see section 4.4).
Renal or hepatic impairment
Wellvone has not been specifically studied in patients with significant hepatic or renal impairment (see section 5.2 for pharmacokinetics in adults). If it is necessary to treat such patients with Wellvone, caution is advised and administration should be closely monitored.
Wellvone Suspension is contra-indicated in individuals with known hypersensitivity to atovaquone or to any components of the formulation.
Diarrhoea at the start of treatment has been shown to be associated with significantly lower atovaquone plasma levels. These in turn correlated with a higher incidence of therapy failures and a lower survival rate. Therefore, alternative therapies should be considered for such patients and for patients who have difficulty taking Wellvone with food.
The concomitant administration of atovaquone and rifampicin or rifabutin is not recommended (see section 4.5).
The efficacy of Wellvone has not been systematically evaluated i) in patients failing other PCP therapy, including co-trimoxazole, ii) for treatment of severe episodes of PCP [(A-a) DO2 > 45 mmHg (6kPa)], iii) as a prophylactic agent for PCP, or iv) versus intravenous pentamidine for treatment of PCP.
No data are available in non-HIV immuno-compromised patients suffering with PCP.
No clinical experience of atovaquone treatment has been gained in elderly patients. Therefore use in the elderly should be closely monitored.
Patients with pulmonary disease should be carefully evaluated for causes of disease other than PCP and treated with additional agents as appropriate. Wellvone is not expected to be effective therapy for other fungal, bacterial, mycobacterial or viral diseases.
As experience is limited, care should be taken when combining other drugs with Wellvone.
Concomitant administration of rifampicin or rifabutin is known to reduce atovaquone levels by approximately 50% and 34%, respectively, and could result in sub therapeutic plasma concentrations in some patients (see section 4.4).
Concomitant treatment with tetracycline or metoclopramide has been associated with significant decreases in plasma concentrations of atovaquone. Caution should be exercised in prescribing these drugs with Wellvone until the potential interaction has been further studied.
In clinical trials of Wellvone small decreases in plasma concentrations of atovaquone (mean < 3 µg/ml) were associated with concomitant administration of paracetamol, benzodiazepines, acyclovir, opiates, cephalosporins, anti-diarrhoeals and laxatives. The causal relationship between the change in plasma concentrations of atovaquone and the administration of the drugs mentioned above is unknown.
Clinical trials have evaluated the interaction of Wellvone Tablets with:
Zidovudine -Zidovudine does not appear to affect the pharmacokinetics of atovaquone. However, pharmacokinetic data have shown that atovaquone appears to decrease the rate of metabolism of zidovudine to its glucuronide metabolite (steady state AUC of zidovudine was increased by 33% and peak plasma concentration of the glucuronide was decreased by 19%). At zidovudine dosages of 500 or 600 mg/day it would seem unlikely that a three week, concomitant course of Wellvone for the treatment of acute PCP would result in an increased incidence of adverse reactions attributable to higher plasma concentrations of zidovudine.
Didanosine (ddI) - ddI does not affect the pharmacokinetics of atovaquone as determined in a prospective multidose drug interaction study of atovaquone and ddI. However, there was a 24% decrease in the AUC for ddI when co-administered with atovaquone which is unlikely to be of clinical significance.
Nevertheless, the modes of interaction being unknown, the effects of atovaquone administration on zidovudine and ddI may be greater with atovaquone suspension. The higher concentrations of atovaquone possible with the suspension might induce greater changes in the AUC values for zidovudine or ddI than those observed. Patients receiving atovaquone and zidovudine should be regularly monitored for zidovudine associated adverse effects.
Concomitant administration of Wellvone and indinavir results in a significant decrease in the Cmin of indinavir (23% decrease; 90% CI 8-35%) and the AUC (9% decrease; 90% CI 1-18%). Caution should be exercised on the potential risk of failure of indinavir treatment if co-administered with atovaquone. No data are available regarding potential interactions of Wellvone and other protease inhibitor drugs.
In clinical trials of Wellvone the following medications were not associated with a change in steady state plasma concentrations of atovaquone: fluconazole, clotrimazole, ketoconazole, antacids, systemic corticosteroids, non-steroidal anti-inflammatory drugs, anti-emetics (excluding metoclopramide) and H2-antagonists.
Atovaquone is highly bound to plasma proteins and caution should be used when administering Wellvone concurrently with other highly plasma protein bound drugs with narrow therapeutic indices. Atovaquone does not affect the pharmacokinetics, metabolism or extent of protein binding of phenytoin in vivo. In vitro there is no plasma protein binding interaction between atovaquone and quinine, phenytoin, warfarin, sulfamethoxazole, indometacin or diazepam.
There is no information on the effects of atovaquone administration during human pregnancy. Atovaquone should not be used during pregnancy unless the benefit of treatment to the mother outweighs any possible risk to the developing foetus.
Insufficient data are available from animal experiments to assess the possible risk to reproductive potential or performance.
It is not known whether atovaquone is excreted in human milk, and therefore breast feeding is not recommended.
There have been no studies to investigate the effect of Wellvone on driving performance or the ability to operate machinery but a detrimental effect on such activities is not predicted from the pharmacology of the drug.
Patients participating in clinical trials with atovaquone have often experienced undesirable effects consistent with the course of advanced Human Immunodeficiency Virus (HIV) disease or of concomitant therapy. The following adverse reactions have been observed and reported to have a suspected (at least possible) causal relationship to treatment with atovaquone with the following frequencies:
The following convention is used for frequencies: very common (
Blood and the lymphatic system disorders
Common: anaemia, neutropenia
Metabolism and nutrition disorders
Common: hyponatraemia
Psychiatric disorders
Common: insomnia
Nervous system disorders
Common: headache
Gastrointestinal disorders
Very common: nausea
Common: diarrhoea, vomiting
Hepatobiliary disorders
Common: elevated liver enzymes levels
Immune System Disorders
Common: hypersensitivity reactions including angioedema, bronchospasm and throat tightness
Skin and subcutaneous tissue disorders
Very common: rash, pruritus
Common: urticaria
Not known: erythema multiforme, Stevens-Johnson Syndrome
General disorders and administration site conditions
Common: fever
Investigations
Uncommon: elevated amylase levels
There is insufficient experience to predict the consequences or suggest specific management of atovaquone overdose. However, in the reported cases of overdosage, the observed effects were consistent with known undesirable effects of the drug. If overdosage occurs, the patient should be monitored and standard supportive treatment applied.
Pharmacotherapeutic group:Antiprotozoals,
ATC Code: P01A X06.
Mode of Action
Atovaquone is a selective and potent inhibitor of the eukaryotic mitochondrial electron transport chain in a number of parasitic protozoaand the parasitic fungus P. jiroveci. The site of action appears to be the cytochrome bc1 complex (complex III). The ultimate metabolic effect of such blockade is likely to be inhibition of nucleic acid and ATP synthesis.
Microbiology
Atovaquone has potent activity against Pneumocystic sp, both in vitro and in animal models, (IC50 0.5-8μg/mL).
Atovaquone is a highly lipophilic compound with a low aqueous solubility. It is 99.9% bound to plasma proteins. The bioavailability of the drug demonstrates a relative decrease with single doses above 750 mg, and shows considerable inter-individual variability. Average absolute bioavailablility of a 750 mg single dose of atovaquone suspension administered with food to adult HIV positive males is 47% (compared to 23% for Wellvone tablets). Following the intravenous administration, the volume of distribution and clearance were calculated to be 0.62±0.19 l/kg and 0.15±0.09 ml/min/kg, respectively.
The bioavailability of atovaquone is greater when administered with food than in the fasting state. In healthy volunteers, a standardized breakfast (23 g fat; 610 kCal) increased bioavailability two to three-fold following a single 750 mg dose. The mean area under the atovaquone plasma concentration-time curve (AUC) was increased 2.5 fold and the mean Cmax was increased 3.4 fold. The mean (±SD) AUC values for suspension were 324.3 (±115.0) µg/ml.h fasted and 800.6 (±319.8) µg/ml.h with food.
In a safety and pharmacokinetic study in patients with PCP, the following results were obtained:
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In a small safety and pharmacokinetic study of two higher dosing regimens [750 mg three times daily (n=8) and 1500 mg twice daily (n=8)] in HIV infected volunteers with severity criteria comparable to patients with PCP, similar Cavg were reached with the two doses [respectively for the 750 mg tid and 1500 mg bid doses: 24.8 (7-40) and 23.4 µg/ml (7-35). Moreover, for both doses a Cavg, ss >15 µg/ml was reached in 87.5% of patients.
Average steady state concentrations above 15 µg/ml are predictive of a high (>90%) success rate.
In healthy volunteers and patients with AIDS, atovaquone has a half-life of 2 to 3 days.
In healthy volunteers there is no evidence that the drug is metabolised and there is negligible excretion of atovaquone in the urine, with parent drug being predominantly (>90%) excreted unchanged in faeces.
Carcinogenicity
Oncogenicity studies in mice showed an increased incidence of hepatocellular adenomas and carcinomas without determination of the no observed adverse effect level. No such findings were observed in rats and mutagenicity tests were negative. These findings appear to be due to the inherent susceptibility of mice to atovaquone and are not predictive of a risk in the clinical situation.
Reproductive toxicity
In the dosage range of 600 to 1200 mg/kg studies in rabbits gave indications of maternal and embryotoxic effects.
Benzyl alcohol
Xanthan Gum
Poloxamer 188
Saccharin Sodium
Purified water
Tutti Frutti Flavour (Firmenich 51.880/A) containing sweet orange oil, concentrated orange oil, propylene glycol, benzyl alcohol, vanillin, acetic aldehyde, amyl acetate and ethyl butyrate.
Not applicable
2 years
After first opening, the suspension may be stored for up to 21 days.
Do not store above 25°C.
Do not freeze.
A 240 ml high density polyethylene bottle with child resistant polypropylene closure, containing 226 ml of atovaquone suspension.
A 5 ml measuring spoon (polypropylene) is included.
Do not dilute
Glaxo Wellcome UK Ltd
trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge, Middlesex
UB11 1BT
PL 10949/0271
Date of first authorisation: 25 March 1997
Date of last renewal: 21 May 2006
15 April 2010
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| SPC | Summary of Product Characteristics (UK) |
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| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Rec.INN
C01EB19
0130308-48-4
C59-H89-N19-O13-S
1304
Treatment of hereditary angioedema
Bradykinin receptor B2 antagonist
(R)-arginyl-(S)-arginyl-(S)-prolyl-(2S,4R)-(4-hydroxyprolyl)glycyl-(S)-[3-(2-thienyl)alanyl]-(S)-seryl-(R)-[(1,2,3,4-tetrahydro-3-isochinolyl)carbonyl]-(2S,3aS,7aS)-[(hexahydro-2-indolin-3-yl)carbonyl]-(S)-arginin (IUPAC)
(R)-Arginyl-(S)-arginyl-(S)-prolyl-(2S,4R)-(4-hydroxyprolyl)glycyl-(S)-[3-(2-thienyl)alanyl]-(S)-seryl-(R)-[(1,2,3,4-tetrahydro-3-isoquinolyl)carbonyl]-(2S,3aS,7aS)-[(hexahydro-2-indolinyl)carbonyl]-(S)-arginine (WHO)
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| CAS | Chemical Abstracts Service |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
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| SPC | Summary of Product Characteristics (UK) |
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TerbiGalen may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of TerbiGalen in the following countries:
International Drug Name Search
Farmemax may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Farmemax in the following countries:
International Drug Name Search
K.H.3. may be available in the countries listed below.
Chloroprocaine hydrochloride (a derivative of Chloroprocaine) is reported as an ingredient of K.H.3. in the following countries:
International Drug Name Search
Amobronc may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Amobronc in the following countries:
International Drug Name Search
Lattulosio Dorom may be available in the countries listed below.
Lactulose is reported as an ingredient of Lattulosio Dorom in the following countries:
International Drug Name Search
Alotano may be available in the countries listed below.
Alotano (DCIT) is known as Halothane in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Mykoseptin may be available in the countries listed below.
Undecylenic Acid zinc salt (a derivative of Undecylenic Acid) is reported as an ingredient of Mykoseptin in the following countries:
International Drug Name Search
Comarol may be available in the countries listed below.
Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Comarol in the following countries:
Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Comarol in the following countries:
International Drug Name Search
Bimepen may be available in the countries listed below.
Phenoxymethylpenicillin benzathine (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Bimepen in the following countries:
International Drug Name Search
Phenylbutazone Molex Ayus may be available in the countries listed below.
Phenylbutazone is reported as an ingredient of Phenylbutazone Molex Ayus in the following countries:
International Drug Name Search
Fealin may be available in the countries listed below.
Atenolol is reported as an ingredient of Fealin in the following countries:
International Drug Name Search
Alfuzosine HCL A may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosine HCL A in the following countries:
International Drug Name Search
Xylometazoline HCl Sandoz may be available in the countries listed below.
Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Xylometazoline HCl Sandoz in the following countries:
International Drug Name Search
Remecon may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Remecon in the following countries:
International Drug Name Search
Rec.INN
A04AD
0132036-88-5
C17-H17-N3-O
279
Serotonin antagonist
(-)-(R)-1-methylindol-3-yl 4,5,6,7-tetrahydro-5-benzimidazolyl ketone
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Ebexantron may be available in the countries listed below.
Mitoxantrone is reported as an ingredient of Ebexantron in the following countries:
Mitoxantrone dihydrochloride (a derivative of Mitoxantrone) is reported as an ingredient of Ebexantron in the following countries:
International Drug Name Search
Acovil may be available in the countries listed below.
Ramipril is reported as an ingredient of Acovil in the following countries:
International Drug Name Search
Aflamid may be available in the countries listed below.
Meloxicam is reported as an ingredient of Aflamid in the following countries:
International Drug Name Search
Tilhasan may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Tilhasan in the following countries:
International Drug Name Search
Cardyn may be available in the countries listed below.
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Cardyn in the following countries:
International Drug Name Search
In the US, Isosorbide Mononitrate (isosorbide mononitrate systemic) is a member of the drug class antianginal agents and is used to treat Angina Pectoris Prophylaxis, Esophageal Spasm and Heart Failure.
US matches:
UK matches:
Isosorbide Mononitrate (BAN, JAN, USAN) is known as Isosorbide Mononitrate in the US.
Isosorbide is reported as an ingredient of Isosorbide Mononitrate in the following countries:
International Drug Name Search
Glossary
| BAN | British Approved Name |
| JAN | Japanese Accepted Name |
| SPC | Summary of Product Characteristics (UK) |
| USAN | United States Adopted Name |
In the US, Karidium (fluoride systemic) is a member of the drug class minerals and electrolytes.
US matches:
Clobazam is reported as an ingredient of Karidium in the following countries:
International Drug Name Search
Lormine may be available in the countries listed below.
Dexamethasone is reported as an ingredient of Lormine in the following countries:
International Drug Name Search
Ciprotenk may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprotenk in the following countries:
International Drug Name Search
Trecifan may be available in the countries listed below.
Isotretinoin is reported as an ingredient of Trecifan in the following countries:
International Drug Name Search
Carboplatino Pfizer may be available in the countries listed below.
Carboplatin is reported as an ingredient of Carboplatino Pfizer in the following countries:
International Drug Name Search
In the US, Torsemide (torsemide systemic) is a member of the drug class loop diuretics and is used to treat Ascites, Edema, Heart Failure, High Blood Pressure, Nonobstructive Oliguria and Renal Failure.
US matches:
Torsemide (USAN) is also known as Torasemide (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Fuluvamide may be available in the countries listed below.
Furosemide is reported as an ingredient of Fuluvamide in the following countries:
International Drug Name Search
