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Azithromycin Otc

azithromycin otc

OTC azithromycin launched

Chlamydia treatment in the form of Clamelle (azithromycin 500mg) was officially launched today (6 November 2008), following the POM to P reclassification of azithromycin.

The azithromycin tablet is being offered as part of a Clamelle chlamydia service, which includes a test kit, in partnership with the National Pharmacy Association’s chlamydia testing service. Pharmacies must first register with the NPA for the testing service before the tablets or test can be supplied.

Over-the-counter azithromycin is indicated for men and women aged 16 years and over who are asymptomatic and have tested positive for genital Chlamydia trachomatis infection. It is also indicated for treatment of their sexual partners without the need for a test.

Azithromycin OTC for chlamydia

The Medicines and Healthcare products Regulatory Agency has issued a press release advising that azithromycin is to be made available to purchase in pharmacies. This press release has been reported in the general media (BBC).

The product will be called Clamelle® and will be licensed for people over 16 year old who have tested positive for the infection and have no symptoms, and for their sexual partners.

Proof of infection, or contact with an infected individual, is likely to be through documentary evidence of a positive test result or a tear-off handed to a sexual contact by the individual who has tested positive.

This product is not currently available but is expected to be in pharmacies later this year. Patients will need to pay for this product themselves and therefore demand for this item is likely to depend upon the price point. This is expected to be £20, as confirmed by the manufacturer and therefore demand is expected to be low.

Special warnings and precautions for use

  • Hypersensitivity

As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalised exanthematous pustulosis (AGEP), Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.

If an allergic reaction occurs, the medicinal product should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Since liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin (see section 4.8). Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products.

In case of signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests / investigations should be performed immediately. Azithromycin administration should be stopped if liver dysfunction has emerged.

Effects of other medicinal products on azithromycin:

  • Antacids

In a pharmacokinetic study investigating the effects of simultaneous administration of antacids and azithromycin, no effect on overall bioavailability was seen, although the peak serum concentrations were reduced by approximately 25%. In patients receiving both azithromycin and antacids, the medicinal products should not be taken simultaneously. Azithromycin must be taken at least 1 hour before or 2 hours after the antacids.

Co-administration of azithromycin prolonged-release granules for oral suspension with a single 20 ml dose of co-magaldrox (aluminium hydroxide and magnesium hydroxide) did not affect the rate and extent of azithromycin absorption.

Co-administration of a 600 mg single dose of azithromycin and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.

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