View updates as a PDF file. In order to view PDF files, Acrobat Reader should be installed on your computer 
NEW SECTION
Date:November 2008
Sexually Transmitted Infection: Chlamydia (Chlamydia trachomatis infection)
CAUSES
Chlamydia is a sexually transmitted infection (STI) caused by the bacterium Chlamydia trachomatis. It is the most commonly diagnosed STI in the United Kingdom, with an estimated prevalence of up to 12%; incidence is highest in women aged 16 to 24 years and in men aged 18 to 29. Infection rates are increasing, particularly in those under 25 years of age. In women, chlamydia is the most common cause of pelvic inflammatory disease (PID), which can result in ectopic pregnancy, infertility and chronic pelvic pain. In men, it can cause sperm damage and infertility as well as serious conditions including sexually acquired reactive arthritis (SARA). Chlamydia represents an insidious threat to the reproductive health of young women and men as the infection is asymptomatic in up to 80% of cases.
TREATMENT
Azithromycin
Azithromycin is a macrolide antibacterial, recommended as a first-line therapy for the treatment of uncomplicated Chlamydia trachomatis infection. It is licensed for supply without prescription for men and women, aged 16 years and over, who are asymptomatic and who have tested positive for genital Chlamydia trachomatis infection. The treatment is given orally as a 1g single dose (2 × 500mg tablets) and should be taken as soon as possible after positive diagnosis. Azithromycin is the first oral antibiotic to be reclassified as a non-prescription medicine, although it is available only under strict controls following confirmed diagnosis of Chlamydia trachomatis infection, and only from pharmacies registered with the National Pharmacy Association (NPA) to provide testing kits and courses of treatment.
Diagnosis is made by nucleic acid amplification test (NAAT), which detects the presence of Chlamydia trachomatis nucleic acid in a urine sample. Test kits are purchased from NPA-registered pharmacies and posted by the patient to a laboratory contracted by the company marketing the treatment to carry out the analyses. A test should not be carried out until at least 2 weeks after suspected infection has occurred, to allow bacterial nucleic acid to reach a detectable level; the test is then 90-95% sensitive. The patient receives the test result from the laboratory and, if positive, takes the test result letter to any pharmacy registered under the scheme to obtain the treatment. The pharmacist checks the result against a database held by the laboratory and can then supply the treatment. A course can also be supplied to an asymptomatic sexual partner without a test, but they must present at the pharmacy, have a consultation with the pharmacist and meet the protocol supply criteria. A further test may be supplied on request to a patient if they have had a further incident of unprotected sex since taking the treatment.
Contraindications
Licensing conditions for non-prescription azithromycin prohibit supply to individuals who:
- have symptomatic infection
- are under 16 years of age
- are pregnant or breast feeding
- have a history of heart disease
- are taking medicines with significant interactions with azithromycin, including: ciclosporin, digoxin, disopyramide, ergotamine, rifabutin, theophylline, warfarin and other coumarin anticoagulants.
Adverse and side-effects
Azithromycin is well tolerated with a low incidence of adverse drug reactions (ADRs). Rare ADRs associated with a single 1g dose are gastro-intestinal disturbances and neutropenia. Possible side-effects are dizziness and drowsiness, and patients should be advised not to drive or operate machinery if affected.
ANTIBIOTIC RESISTANCE
Concerns about the development of resistance has been an issue that has delayed the reclassification from POM to P of antibiotics (applications have been made for trimethoprim and nitrofurantoin for the treatment of cystitis, but they have not yet been approved). Current evidence is that resistance to azithromycin in Chlamydia trachomatis infection is rare. There is a small risk of increase of gonorrhoea resistance when that condition occurs together with chlamydia and the latter is treated with azithromycin, but the risk for non-prescription supply is believed to be no greater than already exists with prescribed treatment. Also, a person infected with gonorrhoea will experience symptoms; the licensing conditions for non-prescription azithromycin prohibits treatment of any patient displaying symptoms of an STI, so any patients with both infections would be referred for medical investigation and treatment.
PRODUCTS
- Clamelle Azithromycin 500mg Tablets and Clamelle Chlamydia Test Kit (Actavis UK)
REVISED SECTIONS
| Constipation |
61 |
Subclasses of stimulant laxatives |
Laxoberal elixir rebranded as Dulcolax liquid. |
Jun 08 |
| Cough |
79 |
Cough (following initial paragraph) |
Following a review by the Commission on Human Medicines (CHM) of over-the-counter products used for treating cough and colds in children, the MHRA advised that medicines containing any of the following constituents should no longer be used in children under the age of two:
- brompheniramine, chlorphenamine & diphenhydramine (antihistamines);
- dextromethorphan and pholcodine (antitussives);
- guaifenesin and ipecacuanha (expectorants);
- phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline (decongestants).
The pharmaceutical industry agreed to change the labels on products to remove dosage instructions for children under 2, and to add additional instructions in relation to children aged 2-6 years. |
Apr 08 |
| Irritable bowel syndrome |
254 |
Treatment |
A systematic review and meta-analysis of 45 randomised controlled trials of fibre, antispasmodics, and peppermint oil in the treatment of irritable bowel syndrome (BMJ 2008; 337: a2313), concluded that they were all more effective than placebo in the treatment of irritable bowel syndrome. The numbers needed to treat with these therapies were 11 (for ispaghula husk), 5 and 2.5, respectively. |
Nov 08 |
| Pain |
313 |
(New) Diclofenac |
Diclofenac potassium 12.5mg tablets were marketed as a P medicine in July 2008. (Diclofenac oral preparations were all previously POM; the new product is half the strength of the weakest POM oral preparation.) They are marketed as Voltarol Pain-eze tablets (Novartis Consumer Health). The product is licensed for short-term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever, in adults and children aged 14 years and over. The dose is two tablets initially, followed by one or two tablets every 4-6 hours as needed, to a maximum of 6 tablets (75mg) in any 24-hour period. The preparation should not be used for more than 3 days. Cautions and contraindications are essentially the same as for NSAIDs in the British National Formulary. Common side-effects are listed by the manufacturer as headache, dizziness, vertigo, gastrointestinal disturbances, anorexia, increased transaminases, and rash.
Efficacy: A single dose of diclofenac potassium 12.5mg is the lowest recommended effective dose. A two-tablet single dose of 25mg is at least as effective as ibuprofen 400mg. A flexible dosing regimen of an initial two tablets followed by one or two tablets up to a total daily dose of 75mg is as effective as ibuprofen used in comparable fashion up to a total daily dose of 1200mg. The incidence of adverse events in patients taking single or multiple doses of diclofenac potassium is similar to that of ibuprofen and placebo.1 In single doses of 12.5mg and 25mg diclofenac have been found as effective for tension headache as ibuprofen 400mg.2 The same doses significantly reduced fever and throat pain in patients with acute febrile sore throat, and the overall efficacy of these doses was rated significantly higher than that of paracetamol 1000mg or placebo.3
References:
1. Moore N. Diclofenac potassium 12.5mg tablets for mild to moderate pain and fever: a review of its pharmacology, clinical efficacy and safety. Clin Drug Investig 2007; 27: 163-195.
2. Kubitzek F, Ziegler G, Gold MS, et al. Low-dose diclofenac potassium in the treatment of episodic tension-type headache. Eur J Pain 2003; 7: 155-162.
3. Gehanno P, Dreiser RL, Ionescu E, et al. Lowest effective single dose of diclofenac for antipyretic and analgesic effects in acute febrile sore throat. Clin Drug Investig 2003; 23: 263-271.
|
Jul 08 |
| Pain |
315 |
Treatment with paracetamol/Product examples |
Infadrops discontinued |
Oct 08 |
| Pain |
321 |
(New subsection) Naproxen for dysmenorrhoea |
Naproxen is an NSAID. It is considered more potent than ibuprofen with a low incidence of side effects, although higher than ibuprofen. In April 2008, naproxen 250mg tablets were reclassified from POM to P status for the treatment of dysmenorrhoea. Licensing restrictions include:
- use only for females between 15 and 50 years of age
- maximum dosage: three tablets daily for a maximum of 3 days
- pack size: 9 tablets.
Other cautions, contraindications and interactions as for ibuprofen.
A comparative study of five clinical trials1 found that naproxen provided greater pain relief in dysmenorrhoea than paracetamol or ibuprofen, with no reports of serious side-effects.
Product: Feminax Ultra. Bayer Healthcare.
1. Milsom I, Minic M, Dawood MY, et al. Comparison of the efficacy and safety of nonprescription doses of naproxen and naproxen sodium with ibuprofen, acetaminophen and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies. Clin Ther 2002; 24: 1384-1400. |
Apr 08 |
| Vaginal candidiasis |
401 |
Products |
Diflucan One oral capsule (150mg) discontinued |
Aug 08 |
|
 |
Choose Location