*first listing

4-aminosalicylic acid (4-amino-2-hydroxybenzoic acid)

Quadrasa, Norgine: Germany

powder for reconstitution 2 g (for rectal administration)

anti-inflammatory agent

Indications: Treatment of mild to moderate active distal ulcerative colitis.

*balsalazide

Colazide, Astra: Switzerland

capsule 750-mg

anti-inflammatory agent

Indication: Ulcerative colitis.

botulism toxin

Botox: Allergan: Germany

injection solution Clostridium botulinum toxin type A/haemagglutinin complex 100 units/vial

Clostridium botulinum type A toxin-haemagglutinin complex

Indications: Treatment of blepharospasm and coexisting hemifacial dystonia in adults; symptomatic treatment of idiopathic spasmodic torticollis; sequelae of infantile cerebral palsy (2 years and older).

*brimonidine tartrate

Alphagan, Allergan: Switzerland

eyedrops 0.2% (2-mg/ml)

a2-adrenoreceptor agonist

Indications: Wide-angle glaucoma, ocular hypertension.

*capecitabine

Xeloda: Roche: Germany, Switzerland

coated tablets 150-mg, 500-mg

antineoplastic agent

Indication: Treatment of colorectal cancer.

cefepime

Maxipime, Bristol-Myers Squibb: Australia

solution for injection 500 mg in 15 mL vials, 1 g in 15 mL vials, 2 g in 77 mL vials

cefalosporin antibiotic

Indications: Septicaemia, peritonitis, genito- urinary tract infections or infections due to susceptible microorganisms.

danaparoid sodium

Orgaran, Organon: Germany

injection fluid 750 anti-Xa units/0.6 ml ampoule

low molecular weight heparinoid

Indications: Prophylaxis of deep vein thrombosis when heparin is not indicated, especially in patients with heparin-induced thrombocytopenia (type II); treatment of thromboembolic diseases in patients who need an immediate parenteral anticoagulant and either develop or have a history of heparin-induced thrombocytopenia.

daunorubicin

DaunoXome: NeXstar: Australia

concentrated solution for injection 50-mg/25 mL (liposomal daunorubicin)

antineoplastic agent

Indications: AIDs-related Kaposi’s sarcoma.

*dorzolamide + timolol

Cosopt, Dorzolamid/Timolol: Chibret: Germany

eyedrops 20-mg + 5-mg/ml

carbonic anhydrase inhibitor + ß-adrenoreceptor antagonist

Indications: Treatment of raised intra-ocular pressure in patients with wide-angle glaucoma or pseudoexfoliative glaucoma when monotherapy with a ß-adrenoreceptor antagonist is ineffective.

efavirenz

Stocrin: MSD: Switzerland

capsules 50-mg, 100-mg, 200-mg

antiviral agent

Indications: Infections due to HIV.

Note: See also Pharmaceuticals Newsletter Nos. 11&12, November & December 1998.

ibandronic acid

Bondronat, Boehringer Mannheim: EU

infusion concentrate 1-mg/ml, 2-mg/2ml

biphosphonate

Indication: Treatment of hypercalcaemia caused by malignant tumours.

imidapril hydrochloride

Imidapril Thiemann; Tanatril: Thiemann: Germany

tablets 2.5-mg, 5-mg, 10-mg, 20-mg

angiotensin-converting enzyme (ACE) inhibitor

Indications: Essential hypertension.

*imiquimod

Aldara, Zartra: 3M Santé: EU

topical cream 5% w/w (sachets 250-mg)

immune response modifier

Indication: Topical treatment of external genital and perianal warts (condyloma acuminata).

Adverse reactions: Itching, burning, pain; headache, influenza-like symptoms, myalgia.

irbesartan

Aprovel: Sanofi Pharma Bristol-Myers Squibb: EU, Norway

tablet 150-mg, 300-mg

angiotensin II antagonist; antihypertensive

Indication: Hypertension.

*irbesartan + hydrochlorothiazide

Karvezide, Bristol-Myers Squibb Pharma EEIG: EU CoAprovel, Sanofi Pharma Bristol-Myers Squibb

tablets 150-mg + 12.5-mg, 300-mg + 12.5-mg

angiotensin II antagonist; antihypertensive + thiazide diuretic

Indication: Essential hypertension.

latanoprost

Xalatan, Pharmacia & Upjohn: Spain

eyedrops 50 micrograms/ml (vial 2.5 ml)

antiglaucoma agent

Indications: [Not stated].

leflunomide

Arava, Hoechst Marion Roussel: Switzerland

tablets 10-mg, 20-mg, 100-mg

nonsteroidal anti-inflammatory agent (NSAID)

Indications: Active rheumatoid arthritis.

Note: See also Pharmaceuticals Newsletter Nos. 9&10, September & October 1998.

nonacog alfa

BeneFIX, Genetics Institute: EU

powder for reconstitution (intravenous injection) 250, 500, 1000 IU/vial

recombinant human coagulation factor IX

Indications: Control and prevention of haemorrhagic episodes and for routine and surgical prophylaxis in previously treated patients with Haemophilia B.

omeprazole magnesium

Antra MUPS, Gastroloc MUPS, Astra: Germany

enteric-coated capsule 10.3-mg, 20.6-mg, 41.3-mg (10-mg, 20-mg, 40-mg omeprazole)

anticholinergic antisecretory agent

Indications: Recurrent reflux oesophagitis and duodenal ulcer.

perindopril erbumine + indapamide

Bi Preterax; Bi Predenium, Servier: Germany

tablet 4-mg + 1.25-mg

angiotensin-converting enzyme (ACE) inhibitor + thiazide diuretic

Indications: Essential hypertension when monotherapy has failed.

rabeprazole sodium

Pariet, Eisai: Germany, UK

enteric coated cap sule 10-mg, 20-mg

antisecretory agent

Indications: Treatment of active duodenal ulcer, active benign gastric ulcer or symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD).

Contraindications, precautions & warnings: As for other drugs of this class.

raloxifene hydrochloride

Celvista; Evista, Eli Lilly: EU, Germany, UK

tablet 60-mg

selective estrogen receptor modulator

Indications: Prevention of non-traumatic vertebral fractures in postmenopausal women at increased risk of osteoporosis.

reboxetine

Edronax, Pharmacia & Upjohn: Germany

scored tablet 4-mg

noradrenaline antagonist; antidepressant

Indications: Depressive illness.

reteplase

Rapilysin, Boehringer Mannheim: Australia

powder for reconstitution 10 Units/vial

recombinant human tissue plasminogen activator (TPA)

Indication: Myocardial infarction.

*rivastigmine

Prometax, Novartis: EU

hard capsules 1.5-mg, 3-mg, 4.5-mg, 6-mg

acetylcholinesterase inhibitor

Indications: Symptomatic treatment of mild to moderately severe Alzheimer’s dementia.

*rizatriptan

Maxalt lingua; Maxalt tablets, MSD: Germany

melt wafers 5-mg, 10-mg; tablets 5-mg, 10-mg

serotonin receptor agonist

Indications: Acute treatment of headache due to migraine attacks with and without aura.

Note: See also Pharmaceuticals Newsletter Nos. 11&12, November & December 1998.

tacrolimus

Prograf, Janssen-Cilag: Australia

capsules 1-mg, 5-mg; solution for injection 5-mg/ml

immunosuppressant

Indications: Immunosuppression for liver transplantation.

*telmisartan

Micardis, Boehringer Ingelheim; Pritor, Glaxo Wellcome: Switzerland

tablet 40-mg, 80-mg

angiotensin II antagonist; antihypertensive

Indication: Hypertension.

temocapril

Acecor, Sankyo: Germany

coated tablets 5-mg, 10-mg, 20-mg

angiotensin-converting enzyme (ACE) inhibitor

Indication: Essential hypertension.

tiludronic acid

Skelid, Sanofi Winthrop: Australia

tablet 200-mg

biphosphonate

Indication: Osteitis deformans (Paget’s disease).

topiramate

Topamax; Topiramat-Cilag, Janssen-Cilag: Australia, Germany

tablets 25-mg, 50-mg, 100-mg, 200-mg

Germany: also 300-mg, 400-mg

antiepileptic agent Indications: Adjunctive therapy in epilepsy for adults with partial onset epileptic seizures with or without secondary generalized seizures.