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Return to PJ Online Home Page The Pharmaceutical Journal Vol 266 No 7142 p485
April 7, 2001

Products

    Prescription Products

Recall Calcitriol capsules

Price changes


Prescription Products

Kaletra capsules

Composition: Combination of lopinavir 133.3mg and ritonavir 33.3mg per capsule.

Presentation: Soft capsules.

Storage and stability: Store at 2-8C. If kept outside a refrigerator, do not store above 25C and discard any unused contents after 42 days. Avoid exposure to excessive heat.

Action: Antiviral.

Indications: Treatment of HIV-1 infected adults and children above the age of two years, in combination with other antiretroviral agents.

Contraindications: Hypersensitivity to lopinavir, ritonavir or excipients; severe hepatic insufficiency; co-administration with astemizole, terfenadine, midazolam, triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (eg, ergotamine, dihydroergotamine, ergonovine, methylergonovine), flecainide, propafenone, products containing St John's wort (Hypericum perforatum), rifampicin.

Dosage and administration: Adults and adolescents (12 years and over), recommended dose three capsules twice daily with food.

Paediatric use (two to 11 years), for children with a body surface area of 1.3m2 or greater, three capsules twice daily with food. For children with a body surface area of less than 1.3m2, oral solution is recommended (see below). Children under two years of age, not recommended.

Mild to moderate hepatic insufficiency, use with caution.

Renal impairment, no dosage adjustment necessary. Severe renal impairment, use with caution.

Pregnancy, should not be used unless necessary (see SPC).

Lactation, not known whether excreted in breast-milk (see SPC).

Overdosage: There is limited experience of acute overdose. No specific antidote (see SPC).

Precautions: See SPC for use in patients with co-existing conditions. When oestrogen-based oral contraceptives are co-administered with Kaletra, additional contraceptive measures are to be used. Capsules contain sunset yellow which may cause an allergic-type reaction.

Drug interactions: See contraindications section above. Concomitant use of any of the following products is not recommended: HMG-CoA reductase inhibitors, such as lovastatin and simvastatin; sildenafil; ketoconazole and itraconazole in high doses. A dosage increase to four capsules twice daily should be considered when co-administered with efavirenz. Dose adjustments for clarithromycin (in patients with renal or hepatic impairment) and rifabutin are recommended. See SPC for other interactions and further details.

Side effects: Adverse events in >=2 per cent of patients include diarrhoea, nausea, vomiting, abdominal pain, asthenia and headache. Adverse events in 1–2 per cent of patients include rash, abnormal stools and insomnia. See SPC for laboratory abnormalities and other adverse events.

Net price: 180 (2 bottles of 90) £332.31.

Supplier: Abbott Laboratories, Norden Road, Maidenhead, Berkshire SL6 4XE. Tel 01628 773355, fax 01628 644305.

Legal class: POM.

Kaletra oral solution

Composition: Lopinavir 400mg and ritonavir 100mg per 5ml.

Presentation: Oral solution.

Storage and stability; action; Indications; overdosage; side effects; supplier; legal class: As for capsules.

Contraindications: As for capsules. Also, pregnant women, hepatic or renal failure and patients treated with disulfiram or metronidazole.

Dosage and administration: As for capsules.

Adults and adolescents (12 years and over), recommended dosage 5ml twice daily with food.

Paediatrics (two to 11 years), recommended dosage 230/57.5mg per m2 twice daily with food, up to a maximum of 400/100mg twice daily. The 230/57.5mg per m2 dose might be insufficient in some children when co-administered with nevirapine or efavirenz and a dose increase to 300/75mg per m2 should be considered. See SPC for dosing guidelines with reference to body surface area.

Precautions: As for capsules. Oral solution contains propylene glycol. Patients taking it, particularly those with renal impairment or decreased ability to metabolise propylene glycol (eg, those of Asian origin) should be monitored for adverse reactions potentially related to propylene glycol toxicity. See SPC for further details on excipients.

Drug interactions: As for capsules. Disulfiram or other medicinal products that produce disulfiram-like reactions.

Net price: 300ml (5 bottles of 60ml) £332.31.

Prevenar vaccine

Wyeth Laboratories has launched Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed) for the prevention of invasive pneumococcal disease (including bacteraemia, bacteraemic pneumonia sepsis, meningitis) caused by seven serotypes of Streptococcus pneumoniae. It is licensed for use in infants and children from two months to two years of age (net price, 1 vial £39.25).

Sporanox IV infusion

Sporanox IV (itraconazole) 10mg/ml concentrate for solution for infusion has been launched by Janssen-Cilag (net price, 1 ampoule £71.43). Sporanox IV is licensed for the treatment of histoplasmosis and for the following systemic fungal conditions when first-line systemic antifungal therapy is inappropriate or has proved ineffective: aspergillosis, candidiasis and cryptococcosis (including cryptococcal meningitis).

Taxol support kit

In the support kits supplied with Taxol (paclitaxel) a Fresenius Freeflex 500ml non-PVC bag of sodium chloride 0.9 per cent intravenous solution has replaced the Braun glass bottle of dextrose 5 per cent solution.

Benzamycin gel

Bioglan's Benzamycin (erythromycin 3 per cent, benzoyl peroxide 5 per cent) gel is out of stock. A helpline has been set up to provide information on the product’s availability (tel 08000 185218).

Dalacin T topical solution

Pharmacia will be unable to supply Dalacin T (clindamycin) topical solution 30ml for the next few weeks. Dalacin T topical solution 50ml remains available.

Tenormin syrup

AstraZeneca says that Tenormin (atenolol) syrup is out of stock. Normal supply is expected to resume by the middle to end of April.

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Calcitriol capsules recalled (April 3, 2001)

APS/Berk is recalling the following batches of calcitriol

Strength Batch number Expiry date Pack size
0.25µg 559005 April 2002 30
0.50µg 560005 April 2002 30


Stability testing has shown that the batch of active ingredient used to manufacture these two batches has reduced activity.

Recipients are requested to quarantine stock from these batches and return it to APS/Berk for credit and replacement. Further information can be obtained from APS (tel 0800 590502 or 0800 526989).


Price changes

The price changes given below are in pounds and pence, light type indicating the price to pharmacists excluding VAT and heavy type the price to the public including VAT. In the case of medicines dispensed on a doctor's prescription, VAT is not charged to the patient.

GlaxoSmithKline (increased from April 1)
Lamictal tablets 25mg 56 £21.95, 50mg 56 £37.31, 100mg 56 £64.37, 200mg 56 £109.42; monotherapy starter pack tablets 25mg 42 £16.45; non-valproate add-on therapy starter pack tablets 50mg 42 £27.98; valproate add-on therapy starter pack tablets 25mg 21 £8.23; dispersible tablets 5mg 28 £8.75, 25mg 56 £21.95, 100mg 56 £64.37
(decreased from April 1) Flolan vials 0.5mg 1 £69.43.



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