Who can take Ultravana®
Ultravana can be recommended for women aged 15 to 50 years with primary dysmenorrhoea.
How to take Ultravana® for dysmenorrhoea
Ultravana should only be taken for a maximum of 3 days per menstrual cycle. The recommended dosage is3:
- Day 1: Two tablets to be taken initially and then one tablet, after 6-8 hours if required.
- Days 2 and 3: One tablet to be taken every 6-8 hours, if required.
Do not take more than 3 tablets (750mg) per day.
Patients should be advised to take Ultravana whole with water, with or after food. Ultravana is not to be broken or crushed3.
Who cannot take Ultravana®
The following patients cannot take Ultravana3:
- Those under the age of 15 years or over 50 years
- With a history of, or active, peptic ulceration and active gastrointestinal (GI) bleeding (two or more distinct episodes of proven ulceration or bleeding)
- With a history of GI bleeding or perforation, related to previous NSAID therapy
- Those who have experienced asthma, rhinitis, nasal polyps, angioedema or urticaria with aspirin or other NSAIDs as there is the potential for cross-sensitivity reactions. Severe anaphylactic-like reactions to naproxen have been reported in such patients3. This is known as aspirin-exacerbated respiratory disease with a prevalence of 7% in general adult asthmatics and 15% in those with severe asthma24. If an asthmatic has not previously had a reaction to aspirin or other NSAIDs, then Ultravana can be recommended3,24
- With severe heart failure, hepatic or renal failure
- During the last trimester of pregnancy
- Known hypersensitivity to naproxen or any of the other tablet excipients. These are - Methacrylic acid-ethyl acrylate copolymer, lactose, magnesium stearate, maize starch, Crospovidone, propylene glycol, sodium hydroxide, triethyl citrate, titanium dioxide (E171), potassium sorbate (E202), sodium citrate (E331), xanthan gum (E415), hydroxypropyl cellulose (E463) and beeswax.
Ultravana should not be taken with other NSAIDs due to the increased risk of side effects3.
Who needs to take care when considering Ultravana®
Caution should be exercised when considering whether to recommend Ultravana for the patients with the following conditions3:
- Respiratory problems as bronchospasm can occur in those with a history of bronchial asthma or allergic disease. Always ask about asthma before recommending Ultravana and advise patients to stop using if asthma worsens24. However, most asthmatics do not react to NSAIDs and Ultravana is only contra-indicated in those who have experienced an asthmatic or allergic reaction to aspirin or other NSAIDs3,24.
- Cardiovascular or hepatic impairment or renal failure NSAIDs can cause a dose-dependent reduction in prostaglandin formation, resulting in renal failure. Those most at risk are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and older patients and renal function should be monitored. It should be noted that naproxen and low-dose ibuprofen are the NSAIDs with the most favourable cardiovascular safety profile25.
- History of hypertension and/or mild-to-moderate heart failure. Patients with cardiac impairment, uncontrolled hypertension, congestive heart failure, established ischaemic disease, peripheral arterial disease and/or cerebrovascular disease should only take Ultravana under doctor supervision.
- GI conditions. NSAIDs are sometimes associated with GI adverse effects. Ultravana should also be used with caution in those with a history of GI disease, such as Crohn’s disease and ulcerative colitis, as their condition may be exacerbated.
- Coagulation disorders or those who are taking medication that interferes with coagulation.
- Systemic lupus erythematosus and mixed connective tissue disorders are at increased risk of aseptic meningitis.
- Those who are breastfeeding.
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Patients presenting with the following symptoms that suggest secondary dysmenorrhoea should be referred to their doctor for further investigation1,19.
- Chronic pelvic pain occurring before menstruation
- Deep pain during intercourse
- Rectal pain or bleeding
- Heavy menstrual bleeding (may or may not be accompanied by lower abdominal pain), bleeding or spotting between periods, or after intercourse, abnormal or postmenopausal bleeding
- Longer, heavier periods and more irregular periods
- Abnormal vaginal bleeding or discharge – mucoid, blood-stained, or purulent
Pelvic mass - Pelvic/lower abdominal pain and tenderness or abdominal distension
- Loss of appetite/early satiety
- Increased urinary urgency and frequency or pain when urinating or passing stools
- Dyspepsia and nausea
- Fever (if there is an acute infection)
- Pain after intra-uterine device (IUD) insertion 3–6 months earlier
Patients who complain of dysmenorrhoea or pelvic pain that is more severe than usual, which is not eased by analgesics, should be referred to a doctor urgently19.
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Ultravana interactions with the following medications have been reported3.
Medication Interaction Other NSAIDs Increased risk of adverse events Antacid or colestyramine Can delay naproxen absorption Anti-coagulants Can enhance the effect of anticoagulants, such as warfarin Anti-hypertensives Reduced anti-hypertensive effects. NSAIDs can also increase the risk of renal impairment seen with ACE-inhibitors Anti-platelet agents Increased risk of GI bleeding Cardiac glycosides Can exacerbate cardiac failure and increase plasma glycoside levels Ciclosporin Increased risk of nephrotoxicity Corticosteriods Increased risk of GI ulceration or bleeding Diuretics Decreased diuretic effect Lithium Increased plasma lithium concentrations Methotrexate Decreased methotrexate elimination, leading to possible toxicity Mifepristone Can reduce the effect of mifepristone, therefore should not be used for 8–12 days after mifepristone use Quinolone antibiotics May have an increased risk of convulsions with concomitant use Selective serotonin reuptake inhibitors Increased risk of GI bleeding Sulphonylureas Can cause overdosage of sulphonylureas, sulphonamides or hydantoin, therefore, dose adjustment of these medications may be required Tacrolimus Increased risk of nephrotoxicity Zidovudine Increased risk of haematological toxicity -
Like all medicines, and as an NSAID, Ultravana can cause side effects, although not everybody gets them.
These side effects can be minimised by using the lowest effective dose for the shortest duration needed to control symptoms3.- GI side effects are the most commonly reported effects, such as nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, heartburn and epigastric distress. Prescription dose naproxen is associated with an intermediate GI risk, while OTC dose ibuprofen has the lowest risk6.
- Blood and lymphatic system disorders, such as agranulocytosis, neutropenia, thrombocytopenia, aplastic anaemia, and haemolytic anaemia
- Cardiac disorders, such as oedema, palpitations, heart failure and congestive heart failure
- Naproxen and low-dose ibuprofen are the NSAIDs with the most favourable cardiovascular safety profile25.
- Ear and labyrinth disorders, e.g. tinnitus, hearing impairment and vertigo
- Eye disorders, e.g. visual disturbances, this requires ophthalmologist investigation
- General disorders, e.g. thirst, fever, fatigue, and malaise
- Hepatobiliary disorders, e.g. abnormal liver function, fatal hepatitis, and jaundice
- Immune system disorders, such as hypersensitivity reactions
- Metabolic and nutrition disorders, e.g. hyperkalaemia
- Musculoskeletal and connective tissue disorders, such as myalgia and muscle weakness
- Nervous system disorders, such as convulsions, dizziness, headaches, drowsiness, lack of concentration
- Psychiatric disorders, e.g. insomnia, depression, confusion, hallucinations, and dream abnormalities
- Renal and urinary disorders, such as glomerular or interstitial nephritis or renal failure
- Reproductive disorders – female infertility
- Respiratory, thoracic, and mediastinal disorders, such as asthma, shortness of breath and pulmonary oedema
- Skin and subcutaneous tissue disorders, e.g. Stevens-Johnson syndrome, skin rashes, urticaria, pruritus, sweating, alopecia
- Vascular disorders, e.g. hypertension and vasculitis.
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Ultravana® is only available from pharmacies
Analgesics are among the most common pharmacy request; therefore, the pharmacy team is already familiar with the OTC recommendation of NSAIDs. Many of the contraindications, precautions and interactions apply across the NSAID class and, therefore, also apply to Ultravana. As such, you and your team will already be accustomed at taking these considerations into account before making an appropriate analgesic recommendation.
The following Ultravana Pharmacy Supply Model acts as a reminder of the various considerations when making a treatment recommendation.