Company: Scope Ophthalmics Ltd.

Legal category: Prescription. OTC. GMS. Sport pending.

Active ingredients: Sodium hyaluronate 0.1% w/v, dexpanthenol 2% w/v.

Description: Preservative-free, sterile eye drops.

Presentation: 7.5ml, €6.06 (PTW); €7.13 (trade price).

Indication: To aid the natural healing of a damaged surface of the eye due to surgical procedures or dry eyes.

Pharmacology: Sodium hyaluronate forms an even and long lasting lubricating film on the surface of the eye without impairing vision. Dexpanthenol belongs to the group of B vitamins and assists regeneration of the corneal and conjunctival epithelia.

Dosage: Adult/Child: Instill 1 drop into conjunctival sac of each eye 3 times daily or as required.

Contraindications: Hypersensitivity to any of the ingredients.

Special precautions: Consult ophthalmologist if used more than 10 times daily, or if complaints persist.

Drug interactions: Apply at least 30 minutes after other eye drops. Administer eye ointments after Hylo-Care.

Full prescribing information and references available from Scope Ophthalmics Ltd. Telephone: 1800 816 005.
E-mail: info@scopeophthalmics.com

Tara Boland

Company: Servier Laboratories (Ireland) Ltd.

Legal category: Prescription. GMS. Sport permitted.

Active ingredient: Perindopril arginine 5mg, 10mg.

Description: White, round orodispersible tabs.

Presentation: 5mg-30, €4.80; 10mg-30, €7.83.

Indications: Both strengths: Treatment of hypertension. Stable coronary artery disease (CAD) – reduction of risk of cardiac events in patients with history of myocardial infarction (MI) and/or revascularisation. 5mg only: Treatment of symptomatic heart failure (HF).

Pharmacology: Perindopril inhibits the angiotensin converting enzyme (ACE) leading to reduced aldosterone secretion, increased plasma renin activity and increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system).

Dosage: Adult: Hypertension: Initially, 5mg once daily in morning before a meal. Strongly activated renin-angiotensin-aldosterone system (RAAS): Initially, 2.5mg once daily; may increase to 10mg after 1 month. Discontinue diuretic 2-3 days beforehand. If not possible, initiate with 2.5mg. Symptomatic HF: Initially 2.5mg in the morning before a meal (under medical supervision). If tolerated, increase to 5mg after 2 weeks. Severe HF: Initiate under careful supervision. CAD: Initially 5mg once daily in the morning before a meal for two weeks; if well tolerated increase to 10mg once daily. Renal impairment: Cc ≥60ml/min, 5mg per day; 30ml/min< cc <60ml/min, 2.5mg per day; 15ml/min< cc <30ml/min, 2.5mg every other day; cc <15ml/min, 2.5mg on day of dialysis. Elderly: Hypertension: Initially, 2.5mg once daily; increase to 5mg after one month, then 10mg if necessary. Symptomatic HF: As per adults. CAD: Initially 2.5mg once daily for one week; then 5mg once daily the next week; may then be increased up to 10mg once daily. Only increase dose if previous lower dose is well tolerated. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active ingredients or to any of the excipients. History of angioedema. Pregnancy, lactation.

Special precautions: If dual blockade of the RAAS is considered absolutely necessary, use only under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure (BP). Assess risk/benefit if any unstable angina pectoris episode occurs during 1st month of treatment. Closely monitor initiation and dose adjustment in patients at higher risk of symptomatic hypotension (volume/salt-depletion, severe renin-dependent hypertension, severe degrees of HF), or with ischaemic heart or cerebrovascular disease in whom an excessive fall in BP could result in MI or cerebrovascular accident. Discontinue if angioedema (administer emergency therapy if tongue, glottis or larynx involved) or jaundice or marked elevations of hepatic enzymes occur. Intestinal angioedema reported rarely. May be less effective in black people. Non-productive, persistent cough reported. Risk of development of hyperkalemia; monitor serum potassium regularly. Caution: Mitral valve stenosis and obstruction in outflow of left ventricle (aortic stenosis, hypertrophic cardiomyopathy). Renal impairment; monitor potassium and creatinine routinely. Renal artery stenosis; start treatment under close medical supervision with low doses and careful dose titration. Recent kidney transplantation (no experience). Anaphylaxis reported in dialysis with high flux membranes, during LDL apheresis with dextran sulphate, or during desensitisation treatment. Neutropenia/agranulocytosis, thrombocytopenia and anaemia reported;  use with extreme caution in collagen vascular disease (especially if pre-existing renal impairment). Monitor white blood cell counts periodically and advise  patients to report any sign of infection (e.g. sore throat, fever). Discontinue one day prior to major surgery. Diabetes (monitor glycaemia levels closely). Driving/using machines. Contains lactose, aspartame.

Drug interactions: Contraindicated: Aliskiren (diabetes, renal impairment). Not recommended: Angiotensin II receptor blockers (especially in diabetic nephropathy), aliskiren, lithium, potassium sparing drugs, potassium supplements or potassium-containing salt substitutes, estramustine. Caution: Other drugs associated with increases in serum potassium (e.g. heparin), immunosuppressant therapy, allopurinol, procainamide, antidiabetics, non-steroidal anti-inflammatory drugs (especially in elderly or renal impairment), antihypertensives, vasodilators, other drugs with BP-reducing potential, tricyclic antidepressants, antipsychotics, anaesthetics, sympathomimetics, baclofen, non-potassium-sparing diuretics, gliptins, injectable gold.

Adverse drug reactions: Headache, dizziness, vertigo, paraesthesia, visual impairment, tinnitus, hypotension, cough, dyspnoea, gastrointestinal disorders, rash, pruritus, muscle cramps, fatigue.

Full prescribing information and references available from Servier Laboratories (Ireland) Ltd. Telephone: (01) 663 8110.

Tara Boland

Company: Servier Laboratories (Ireland) Ltd.

Legal category: Prescription. GMS. Sport prohibited in specific sports.

Active ingredients: Bisoprolol fumarate/ perindopril arginine 5/5mg, 5/10mg, 10/5mg, 10/10mg.

Description: Pink beige, oblong, oblong, round or oblong, bilayer film-coated tablets marked with company logo on one side and strength on reverse, respectively. 5/5mg and 5/10mg tablets are scored.

Presentation: 5/5mg-30, €7.13; 5/10mg-30, €10.16; 10/5mg-30, €7.13; 10/10mg-30, €10.16.

Indications: All strengths: As substitution therapy for treatment of hypertension and/or stable coronary artery disease (with a history of myocardial infarction (MI) and/or revascularisation) in patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level. 5/5mg and 10/5mg only: For stable chronic heart failure (HF) with reduced systolic left ventricular function in patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level.

Pharmacology: Bisoprolol is a highly beta1-selective-adrenoreceptor blocking agent, lacking intrinsic sympathomimetic and relevant membrane stabilising activity. It is generally not expected to influence airway resistance and beta2-mediated metabolic effects. Perindopril inhibits the angiotensin converting enzyme (ACE) leading to reduced aldosterone secretion, increased plasma renin activity and increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system).

Dosage: Adult: Titration of individual components recommended. One tablet (or half tablet) daily in the morning before a meal. Patients should be stabilised at the same dose for at least 4 weeks. Renal impairment: Creatinine clearance (Cc) ≥60ml/min, one tablet of 5/5mg or 10/5mg or half tablet of 5/10mg; 30ml/min< cc <60ml/min, one half tablet of 5/5mg only. Elderly: As per adults. Children: Not recommended.

Contraindications: Hypersensitivity to the active substances, or to any of the excipients. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy, cardiogenic shock, second or third degree AV block (without pacemaker), sick sinus syndrome, sinoatrial block, symptomatic bradycardia, symptomatic hypotension, severe bronchial asthma, severe chronic obstructive pulmonary disease, severe peripheral arterial occlusive disease, severe Raynaud’s syndrome, untreated phaeochromocytoma, metabolic acidosis, history of angioedema. Pregnancy, lactation.

Special precautions: If dual blockade of the renin-angiotensin-aldosterone system (RAAS) is considered absolutely necessary, use only under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure (BP). Closely monitor initiation and dose adjustment in patients at higher risk of symptomatic hypotension (volume/salt-depletion, severe renin-dependent hypertension, severe degrees of HF), or with ischaemic heart or cerebrovascular disease in whom an excessive fall in BP could result in MI or cerebrovascular accident. Discontinue if angioedema (administer emergency therapy if tongue, glottis or larynx involved) or jaundice or marked elevations of hepatic enzymes occur. Intestinal angioedema reported rarely. May be less effective in black people. Non-productive, persistent cough reported. Risk of development of hyperkalemia; monitor serum potassium regularly. Downtitrate using individual components if symptomatic bradycardia occurs. Caution: First degree AV block, mitral valve stenosis and obstruction in outflow of left ventricle (aortic stenosis, hypertrophic cardiomyopathy), diabetics with large fluctuations in blood glucose, strict fasting. Prinzmetal’s angina. Renal impairment; monitor potassium and creatinine routinely. Renal artery stenosis; start treatment under close medical supervision with low doses and careful dose titration. Recent kidney transplantation (no experience). Anaphylaxis reported in dialysis with high flux membranes, during LDL apheresis with dextran sulphate, or during desensitisation treatment. Neutropenia/agranulocytosis, thrombocytopenia and anaemia reported;  use with extreme caution in collagen vascular disease (especially if pre-existing renal impairment). Monitor white blood cell counts periodically and advise  patients to report any sign of infection (e.g. sore throat, fever). Bronchial asthma or other chronic obstructive lung diseases. Aggravation of peripheral arterial occlusive disease may occur. Discontinue one day prior to major surgery. Psoriasis (or with a history of). Thyreotoxicosis may be masked. No therapeutic experience  treatment of HF in patients with: Insulin dependent diabetes mellitus (type I), severe renal/hepatic impairment, restrictive cardiomyopathy, congenital heart disease, haemodynamically significant organic valvular disease, MI within the last 3 months. Discontinue gradually over 2 weeks. Driving/using machines (especially at start of treatment or change of therapy, in conjunction with alcohol).

Drug interactions: Contraindicated: Aliskiren (diabetes, renal impairment). Not recommended: Angiotensin II receptor blockers (especially in diabetic nephropathy), aliskiren, lithium, potassium sparing drugs, potassium supplements or potassium-containing salt substitutes, calcium antagonists (verapamil or diltiazem type), class I antiarrhythmics, centrally acting antihypertensives, estramustine. Caution: Other drugs associated with increases in serum potassium (e.g. heparin), immunosuppressant therapy, allopurinol, procainamide, antidiabetics, non-steroidal anti-inflammatory drugs (especially in elderly or renal impairment), antihypertensives, vasodilators, other drugs with BP-reducing potential, tricyclic antidepressants, antipsychotics, anaesthetics, sympathomimetics, calcium antagonists (dihydropyridine type), class III antiarrhythmics, parasympathomimetics, topical beta-blockers, digitalis glycosides, baclofen, non-potassium-sparing diuretics. Mefloquine, monoamine oxidase inhibitors (except MAO-B inhibitors), gliptins, injectable gold.

Adverse drug reactions: Headache, dizziness, vertigo, dysgeusia, paraesthesia, visual impairment, tinnitus, bradycardia, HF worsening, hypotension, coldness or numbness in extremities, cough, dyspnoea, gastrointestinal disorders, rash, pruritus, muscle cramps, fatigue.

Full prescribing information and references available from Servier Laboratories (Ireland) Ltd. Telephone: (01) 663 8110.

Tara Boland

Company: MSD Ireland (Human Health) Ltd.

Legal category: Prescription. Hospital only. Sport permitted.

Active ingredients: Ceftolozane/tazobactam 1g/500mg.

Description: Powder for concentrate for solution for infusion.

Presentation: 10 vials, price on request.

Indications: Treatment of complicated intra‑abdominal infections (in combination with metronidazole when anaerobic pathogens are suspected), acute pyelonephritis, and complicated urinary tract infections (UTIs).

Pharmacology: Ceftolozane belongs to the cephalosporin class of antimicrobials, and exerts bactericidal activity through binding to important penicillin-binding proteins, resulting in inhibition of bacterial cell‑wall synthesis and subsequent cell death. Tazobactam is a beta‑lactam structurally related to penicillins. It is an inhibitor of many Molecular Class A beta-lactamases.

Dosage: Adult: 1g/500mg every 8 hours by intravenous (IV) infusion over 1 hour. Duration 4 – 14 days in intra-abdominal infection, 7 days in Urinary Tract Infection and pyelonephritis. Renal impairment: Creatinine clearance (cc) 30-50ml/min, 500/250mg every 8 hours; cc 15-29ml/min, 250/125mg every 8 hours; End stage renal disease on haemodialysis, loading dose of 500/250mg followed 8 hours later by 100/50mg every 8 hours. All doses administered by IV infusion over 1 hour. Elderly: As per adults. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Hypersensitivity to any cephalosporin. Severe hypersensitivity to other beta‑lactams. Lactation.

Special precautions: Caution: Hypersensitivity to penicillins or other beta-lactams. Discontinue if severe allergic reaction occurs. Renal impairment. No data: Immunocompromised patients, severe neutropenia. May occur: Clostridium difficile‑associated diarrhoea (consider discontinuation), super infection, decline in renal function, positive Coombs test. Pregnancy (assess risk/benefit). Driving/using machines. Contains sodium.

Drug interactions: Inhibitors of OAT1 or OAT3.

Adverse drug reactions: Thrombocytosis, hypokalaemia, insomnia, anxiety, headache, dizziness, hypotension, gastrointestinal disorders, rash, pyrexia, infusion site reactions, increased alanine aminotransferase, increased aspartate aminotransferase.

Full prescribing information and references available from MSD Ireland (Human Health) Ltd. Telephone: (01) 299 8700.

The post Zerbaxa ▼ appeared first on Irish Medical Times.

Company: Boehringer Ingelheim Ltd.

Legal category: Pharmacy only. Sport permitted.

Active ingredient: Ambroxol hydrochloride 20mg (lozenges), 17.86mg/ml (spray).

Description: Round, white, mint or lemon lozenges. Oromucosal spray.

Presentation: Lozenges: 18, €3.99. Spray: 20ml, €5.74.

Indications: Lysopadol mint: Pain relief of mild to moderate symptoms of acute sore throat. Spray and lysopadol lemon: Pain relief in acute sore throat.

Pharmacology: Ambroxol hydrochloride exerts a local anaesthetic effect which is likely to result from its sodium channel blocking properties. It also exerts an anti-inflammatory effect.

Dosage: Adult: 1 dose: 1 lozenge (sucked) or 4 actuations (into back of throat). Maximum 6 doses per day for 3 days. Children: Over 12 years, as per adults. Under 12 years, not recommended.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy, lactation.

Special precautions: Not for oral ulcers. Seek medical advice: If signs of progressive skin rash occur (discontinue immediately), if symptoms worsen or persist after 3 days, before use in patients with renal impairment or severe hepatopathy. Dyspnoea may occur. Lysopadol lemon (also contains sucrose) and lysopadol mint (also contains lactose) contain sorbitol. Spray contains ethanol, propylene glycol.

Drug interactions: None reported.

Adverse drug reactions: Dysgeusia, oral and pharyngeal hypoaesthesia, nausea.

Full information and references available from Boehringer Ingelheim Ltd. Telephone: (01) 295 9620.
E-mail: medinfo.bra@boehringer-ingelheim.com

The post Lysopadol appeared first on Irish Medical Times.

Company: Pharmacosmos UK Ltd.

Legal category: Prescription. Sport permitted.

Active ingredient: Iron (as iron(III) isomaltoside 1000) 50mg/ml.

Description: Solution for injection.

Presentation: 25 x 2ml, €735.29.

Indication: Treatment of iron deficiency in patients with chronic kidney disease on dialysis, when oral iron preparations are ineffective or cannot be used.

Pharmacology: Iron isomaltoside is a haematinic. The strongly bound complex comprising iron and isomaltoside 1000 enables a controlled and slow release of bioavailable iron to iron-binding proteins with little risk of free iron. Reticuloendothelial system cells rapidly take up iron isomaltoside 1000, remove circulating iron from the plasma and split the complex into its components. The released iron is immediately bound to the available protein moieties to form hemosiderin, ferritin or transferrin. This iron, which is subject to physiological control, replenishes haemoglobin and depleted iron stores.

Dosage: Adult: Up to 200mg (based on response, see SPC) by intravenous bolus injection or directly into venous limb of dialyser; maximum 1000mg weekly. Elderly: As per adults. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substance, or any of its excipients. Known serious hypersensitivity to other parenteral iron products. Non-iron deficiency anaemia (eg. haemolytic anaemia). Iron overload or disturbances in utilisation of iron (eg. haemochromatosis, haemosiderosis). Decompensated liver cirrhosis and hepatitis.

Special precautions: Risk of anaphylaxis; facilities for full resuscitation must be available; monitor patient during and for 30 minutes after each administration. Ongoing bacteraemia (do not use). Caution: Acute or chronic infection, known allergies, history of severe asthma or eczema, immune or inflammatory conditions (eg. systemic lupus erythematosus, rheumatoid arthritis). Hypotensive episodes may occur if IV injection too rapid. Pregnancy (2nd or 3rd trimester), lactation. Contains sodium.

Drug interactions: Caution: Oral iron, do not start earlier than 5 days after last injection.

Adverse drug reactions: None common.

Full prescribing information and references available from Pharmacosmos UK Ltd. Telephone: +44 1844 269007.
E-mail: support@pharmacosmos.ie

The post Diafer ▼ appeared first on Irish Medical Times.

Company: Rowex Ltd.

Legal category: Prescription. GMS reimbursable. Sport permitted.

Active ingredients: Alendronic acid (as alendronate sodium trihydrate)/ colecalciferol 70mg/5600 IU.

Description: White, oval tablet marked 714.

Presentation: 4, €7.49.

Indications: Treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency not receiving vitamin D supplementation. Reduces the risk of vertebral and hip fractures.

Pharmacology: Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption. Vitamin D3 is an essential dietary nutrient (in the absence of adequate sunlight exposure). The active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 increases intestinal absorption of both calcium and phosphate as well as regulating serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.

Dosage: Adult: One tablet once weekly. Consider supplementation with calcium or additional vitamin D. Swallow whole. Take at least 30 minutes before first food, drink, or drug of the day with plain water only and do not lie down for at least 30 minutes. Elderly: As per adults. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Abnormalities of the oesophagus and other factors which delay oesophageal emptying (such as stricture or achalasia). Inability to stand or sit upright for at least 30 minutes. Hypocalcaemia. Pregnancy, lactation.

Special precautions: Not recommended: Creatinine clearance less than 35ml/min. Caution: Active upper gastrointestinal (GI) problems (such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers), recent history of major GI disease (such as peptic ulcer), active GI bleeding, surgery of the upper GI tract other than pyloroplasty. Re-evaluate periodically based on the benefit/risk ratio, especially after 5 or more years of use. Barrett’s oesophagus (assess benefit/risk). Reported: Osteonecrosis of the jaw (consider dental examination prior to therapy in patients at risk, avoid invasive dental procedures); oesophagitis, oesophageal ulcers, oesophageal erosions; bone, joint and/or muscle pain; atypical subtrochanteric and diaphyseal femoral fractures (consider discontinuation pending evaluation). Discontinue if dysphagia, pain on swallowing, retrosternal pain, new or worsening heartburn develops. Reported rarely, gastric and duodenal ulcers (severe). Correct hypocalcaemia and other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) before starting treatment; monitor serum calcium and symptoms of hypocalcaemia during treatment. Symptomatic hypocalcaemia reported rarely (occasionally severe). Ear symptoms (consider osteonecrosis of the external auditory canal). Patients should report any thigh, hip or groin pain; evaluate for incomplete femur fracture. Monitor urine and serum calcium in patients with disease associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis). Patients with malabsorption may not adequately absorb vitamin D3. Contains sucrose. Driving/using machines.

Drug interactions: Caution: Non steroidal anti-inflammatory drugs. Olestra, mineral oils, orlistat, bile acid sequestrants (e.g. cholestyramine, colestipol), anticonvulsants, cimetidine, thiazides, glucocorticoids.

Adverse drug reactions: Headache, dizziness, vertigo, GI disorders, alopecia, pruritus, musculoskeletal (bone, muscle or joint) pain, joint swelling, asthenia, peripheral oedema.

Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: 027 50417.
E-mail: rowex@rowa-pharma.ie

The post Alendronate/Colecalciferol Rowex appeared first on Irish Medical Times.

Company: Eli Lilly and Co (Ireland) Ltd.

Legal category: Prescription. High tech reimbursable. Sport permitted.

Active ingredient: Ixekizumab 80mg/ml.

Description: Solution for injection in pre-filled syringe or pen.

Presentation: 1 syringe; 1 or 2 pens. Price available on request.

Indication: Treatment of moderate to severe plaque psoriasis in candidates for systemic therapy.

Pharmacology: Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity and specificity to interleukin 17A. Elevated concentrations of IL‑17A have been implicated in the pathogenesis of psoriasis by promoting keratinocyte proliferation and activation. Neutralisation of IL‑17A by ixekizumab inhibits these actions.

Dosage: Adult: Administer by subcutaneous injection. Consider discontinuation if no response after 16 to 20 weeks. Avoid skin areas that show psoriasis. 160mg at Week 0, followed by 80mg at Weeks 2, 4, 6, 8, 10, and 12. Maintenance, 80mg every 4 weeks. Elderly: As per adults. 75 years and older, limited data. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Clinically important active infections.  Pregnancy. Women should use contraception and not breast feed (assess risk/benefits) during treatment and ≤10 weeks after.

Special precautions: Caution: Inflammatory bowel disease, chronic infection (closely monitor if develops; suspend if serious or if no response to standard therapy). Latent tuberculosis (TB), consider anti-TB therapy prior to initiation. Discontinue immediately if hypersensitivity reactions occur.

Drug interactions: Not recommended: Live vaccines. CYP450 substrates with a narrow therapeutic index.

Adverse drug reactions: Upper respiratory tract infection, tinea infection, oropharyngeal pain, nausea, injection site reactions.

Full prescribing information and references available from Eli Lilly and Co (Ireland) Ltd. Telephone: (01) 664 0446. E-mail: ukmedinfo@lilly.com

The post Taltz ▼ appeared first on Irish Medical Times.

Company: Santen UK Limited.

Legal category: Prescription. GMS reimbursable. Sport permitted.

Active ingredient: Ciclosporin 1mg/ml.

Description: Eye drops.

Presentation: 30 x 0.3ml single-dose containers, €86.50.

Indications: Treatment of severe keratitis in patients with dry eye disease not improved by tear substitutes.

Pharmacology: Ciclosporin is a cyclic polypeptide immunomodulator with immunosuppressant properties and an anti-inflammatory effect. Following ocular administration, ciclosporin is passively absorbed into T-lymphocyte infiltrates in the cornea and conjunctiva and inactivates calcineurin phosphatase. Ciclosporin-induced inactivation of calcineurin inhibits the dephosphorylation of the transcription factor NF-AT and prevents NF-AT translocation into the nucleus, thus blocking the release of pro-inflammatory cytokines such as IL-2.

Dosage: Adult: Must be initiated by an ophthalmologist or HCP qualified in ophthalmology. One drop to affected eye(s) once daily at bedtime (maximum). Review at least every 6 months. Elderly: As per adults. Children: Under 18 years, no relevant use.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active or suspected ocular or peri-ocular infection. Pregnancy, lactation; assess risk/benefit.

Special precautions: Remove contact lenses before instillation (may reinsert at wake-up time); carefully monitor patients with severe keratitis. Caution: Glaucoma (especially with beta-blockers), history of ocular herpes. May affect immune system. Driving/usingmachines (ensure clear vision). Contains cetalkonium chloride.

Drug interactions: Administer other ophthalmic products at least 15 minutes apart with Ikervis last. Corticosteroids.

Adverse drug reactions: Instillation site pain, instillation site irritation, instillation site erythema, instillation site lacrimation, eyelid erythema, eyelid oedema, increased lacrimation, ocular hyperaemia, blurred vision, conjunctival hyperaemia, eye irritation, eye pain.

Full prescribing information and references available from Santen. Telephone: (01) 695 0008. E-mail: medinfo@santen.co.uk

The post Ikervis appeared first on Irish Medical Times.

Company: Rowex Ltd.

Legal category: Prescription. GMS reimbursable. Sport permitted.

Active ingredient: Desogestrel 75mcg.

Description: Round, plain, white film-coated tablets.

Presentation: 3 x 28, €6.92.

Indications: Contraception.

Pharmacology: The progestogen desogestrel inhibits ovulation and increases viscosity of cervical mucus.

Dosage: Adult: One tablet taken daily at the same time every day with first tablet taken on first day of menstrual bleeding. Start new blister directly the day after previous one. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Active venous thromboembolic disorder, severe hepatic disease (or history) as long as liver function values not normal, sex-steroid sensitive malignancies, undiagnosed vaginal bleeding.

Special precautions: Withdraw immediately if pregnancy occurs during use. Assess risk/benefit if presence/ appearance/ aggravation of: Breast cancer, liver cancer, liver function disturbances. Caution: History of thrombo-embolic disorders, diabetes. Discontinue if: Thrombosis, long-term immobilisation due to surgery or illness, sustained hypertension. Avoid sun/UV if tendency to chloasma. Bleeding disturbances may occur; consider another contraceptive method if very frequent and irregular. Consider ectopic pregnancy if amenorrhoea or abdominal pain occurs. Contains lactose, soya-bean oil.

Drug interactions: Microsomal enzyme-inducing drugs, use a barrier method during and for 28 days after administration. Medicinal charcoal.

Adverse drug reactions: Mood changes, decreased libido, headache, nausea, acne, breast pain, irregular menstruation, amenorrhoea, increased weight.

Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie

The post Desogestrel Rowex appeared first on Irish Medical Times.

Company: MSD Ireland (Human Health) Ltd.

Legal category: Prescription. GMS reimbursable. Sport permitted.

Active ingredients: Elbasvir/grazoprevir 50/100mg.

Description: Beige, oval film‑coated tablet marked 770.

Presentation: 28, price on request.

Indication: Treatment of chronic hepatitis C in patients with genotypes 1a, 1b and 4.

Pharmacology: Elbasvir (HCV NS5A inhibitor) and grazoprevir (HCV NS3/4A inhibitor) combine two direct-acting antiviral agents which provide distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle. HCV NS5A, is essential for viral RNA replication and virion assembly. The HCV NS3/4A protease is necessary for the proteolytic cleavage of the HCV encoded polyprotein and is essential for viral replication.

Dosage: Adult: Swallow whole once daily. Genotype 1a, Zepatier for 12 weeks (consider Zepatier for 16 weeks plus ribavirin in patients with baseline HCV RNA level >800,000 IU/ml and/or presence of specific NS5A polymorphisms causing ≥5-fold reduction in elbasvir activity); genotype 1b, Zepatier for 12 weeks; genotype 4, Zepatier for 12 weeks (consider Zepatier for 16 weeks plus ribavirin in patients with baseline HCV RNA level >800,000 IU/ml). If vomiting occurs within 4 hours, take additional tablet. Elderly: As per adults. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Moderate or severe hepatic impairment. Lactation.

Special precautions: Not recommended: HCV genotypes 2, 3, 5 and 6. Perform hepatic testing prior to therapy, at week 8, and as clinically indicated (with additional testing at week 12 for patients receiving 16 weeks of therapy). Seek immediate medical advice if onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discoloured faeces occur. Consider discontinuation if ALT levels >10 X ULN. Discontinue if ALT elevation accompanied by signs of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalised ratio. Safety and efficacy not established: Liver transplant recipients, HCV/HBV co‑infected patients. Retreatment (including drugs of same class), efficacy not established. Pregnancy (assess risk/ benefit). Male patients and female partners of male patients taking ribavirin must use effective form of contraception; see ribavirin SPC. Patients requiring ribavirin (see ribavirin SPC prior to initiation). Driving/using machines (fatigue reported). Contains lactose, sodium.

Drug interactions: Contraindicated: Organic anion transporting polypeptide 1B (OATP1B) inhibitors, CYP3A or P-gp inducers, St. John’s wort, bosentan, efavirenz, etravirine, elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (fixed-dose combination), modafinil, some anticonvulsants/ protease inhibitors/ immunosuppressants. Not recommended: Strong CYP3A inhibitors, some antifungals/ antimycobacterials. P-gp inhibitors (minimal effect), BCRP substrates, BSEP, tacrolimus, some anticoagulants. Atorvastatin, fluvastatin, lovastatin, simvastatin daily doses >20mg; rosuvastatin daily doses >10mg. Laboratory abnormalities.

Adverse drug reactions: Decreased appetite, insomnia, anxiety, depression, headache, dizziness, gastrointestinal disorders, pruritus, alopecia, arthralgia, myalgia, fatigue, irritability.

Full prescribing information and references available from MSD Ireland (Human Health) Ltd. Telephone: (01) 2998700.

The post Zepatier ▼ appeared first on Irish Medical Times.

Company: Rowex Ltd.

Legal category: Prescription. GMS reimbursable. Sport permitted.

Active ingredient: Pramipexole (as dihydrochloride monohydrate) 1.05mg, 2.1mg.

Description: White, cylindrical, biconvex prolonged-release tablets marked 105 or 210, respectively.

Presentation: 1.05mg-30, €39.63; 2.1mg-30, €69.93.

Indications: Treatment of signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.

Pharmacology: Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. It alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. It inhibits dopamine synthesis, release, and turnover.

Dosage: Adult: Swallow whole at same time each day. Week 1, 0.26mg base (0.375mg salt) daily, may increase daily dose every 5-7 days if tolerated; Week 2, 0.52mg base (0.75mg salt); Week 3, 1.05mg base (1.5mg salt). May further increase daily dose by 0.52mg base (0.75mg salt) at weekly intervals (maximum 3.15mg base (4.5mg salt) per day). May switch from pramipexole immediate-release tablets to prolonged-release tablets overnight, at same daily dose and adjust depending on therapeutic response. When co-prescribed, reduce dose of levodopa while titrating pramipexole. Renal impairment: See SPC. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (unless clearly necessary), lactation.

Special precautions: Inform patients that somnolence/sudden sleep onset (reduce dose/ discontinue) and hallucinations may occur. Dyskinesia may occur during initial titration (reduce dose). Monitor for impulse control disorders, mania and delirium (reduce dose/ discontinue). Patients with psychotic disorders (assess risk/benefit). Regular ophthalmologic monitoring recommended or if vision abnormalities occur. Severe cardiovascular disorders (monitor blood pressure). Renal impairment. Neuroleptic malignant syndrome reported with abrupt withdrawal (see SPC). Hepatic impairment, no data. Driving/using machines.

Drug interactions: Avoid: Antipsychotics. Caution: Alcohol, sedating drugs. Levodopa, other anti-parkinsonian drugs. Inhibitors/competitors of active renal elimination pathway (reduce pramipexole dose).

Adverse drug reactions: Abnormal dreams, insomnia, dizziness, headache, somnolence, gastrointestinal disorders, fatigue, behavioural symptoms of impulse control disorders and compulsions, confusion, hallucinations, dyskinesia, amnesia, visual disturbances, hypotension, peripheral oedema, weight loss.

Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie

The post Prapexin appeared first on Irish Medical Times.

Company: Rowex Ltd.

Legal category: Prescription. Hi tech reimbursable. Sport permitted.

Active ingredient: Imatinib (as mesilate) 100mg, 400mg.

Description: Very dark yellow to brownish orange, round or ovaloid, biconvex film-coated tablets marked with NVR or 400 on one side and SA or SL on either side of score line on reverse, respectively.

Presentation: 100mg-60, €470.86; 400mg-30, €941.72.

Indications: Newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) when bone marrow transplantation not considered as first line treatment. Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. Adults only: Relapsed or refractory Ph+ ALL as monotherapy; myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements; advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRa rearrangement; unresectable dermatofibrosarcoma protuberans (DFSP) and recurrent and/or metastatic DFSP when not eligible for surgery.

Pharmacology: Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit protooncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta). It also inhibits cellular events mediated by activation of these receptor kinases.

Dosage: Adult: Take with meal and large glass of water, if unable to swallow may disperse in glass of still water or apple juice. CML: Chronic phase, 400mg once daily; accelerated phase or blast crisis, 600mg once daily. May consider increasing dose to up to 800mg/day (maximum) as 400mg twice daily (morning and evening) in certain circumstances (see SPC). Ph+ ALL (supervise): 600mg once daily until disease progression. MDS/MPD: 400mg once daily. HES/CEL: 100mg once daily, may increase to 400mg if tolerated and response insufficient. Continue as long as patient benefits. DFSP: 800mg/day. Dose adjustments: See SPC. Hepatic impairment: 400mg daily, reduce if not tolerated. Renal impairment, dialysis (caution): Initially 400mg daily, increase/reduce if tolerated/not tolerated, respectively. Elderly: As per adults. Children: CML: Chronic or advanced phase, 340mg/m2 once daily dose or split (morning and evening); may consider increasing dose to 570mg/m2 daily in certain circumstances (see SPC); maximum 800mg total dose. Under 2 years, no experience. Ph+ ALL: 340mg/m2 (maximum 600mg total dose). Under 1 year, no experience. MDS/MPD, DFSP, HES/CEL: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (unless clearly necessary), lactation.

Special precautions: Evaluate renal function (closely monitor during therapy) prior to initiation, correct clinically significant dehydration and high uric acid levels prior to initiation, assess risk/benefit of HES/CEL patients prior to initiation. Hepatitis B reactivation may occur (consult expert if positive for serology prior to initiation or if HBV infection occurs during treatment); closely monitor carriers during therapy and for several months following discontinuation. Caution: Severe renal impairment, cardiac dysfunction. Cardiac disease (monitor for cardiac failure). Monitor liver enzymes (especially in patients with hepatic impairment, also monitor peripheral blood counts). Severe fluid retention (weigh patients regularly). Thyroidectomy patients undergoing levothyroxine replacement (closely monitor thyroid-stimulating hormone levels). Monitor for gastrointestinal (GI) haemorrhage (consider discontinuation). Closely monitor growth in children. Perform complete blood counts regularly. Cytopenias may occur in CML patients; may need to suspend or reduce dose. Driving/using machines (caution).

Drug interactions: Avoid: Strong CYP3A4 inducers, coumarin derivatives (use low-molecular-weight or standard heparin instead). Caution: CYP3A4 substrates, inducers, and inhibitors, paracetamol (with high dose Imatinib), CYP2D6 substrates with a narrow therapeutic window, levothyroxine, L-asparaginase.

Adverse drug reactions: Neutropenia (including febrile), thrombocytopenia, anaemia, pancytopenia, anorexia, insomnia, headache, dizziness, paraesthesia, taste disturbance, hypoaesthesia, fluid retention, oedema (including eyelid, face, periorbital), increased lacrimation, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision, flushing, haemorrhage, dyspnoea, epistaxis, cough, GI disorders, increased hepatic enzymes, dermatitis/ eczema/ rash, pruritus, dry skin, erythema, alopecia, night sweats, photosensitivity reaction, muscle spasm and cramps, pain (bone, musculoskeletal including myalgia), arthralgia, joint swelling, fatigue, weakness, pyrexia, anasarca, chills, rigors, increased/ decreased weight.

Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie

The post Imatinib Rowex appeared first on Irish Medical Times.

Company: Dermal Laboratories Ltd.

Legal category: OTC. Sport permitted.

Therapeutic ingredients: Isopropyl myristate/ liquid paraffin 15%/15% w/w.

Description: Emollient gel.

Presentation: 100g, €3.42.

Indications: Management of dry or chapped skin conditions (e.g. eczema, psoriasis, ichthyosis).

Pharmacology: Isopropyl myristate and liquid paraffin are oily ingredients that help rehydrate and soften dry skin while being relatively non-greasy. They form an occlusive barrier within the skin surface, which reduces drying from evaporation of water that diffuses from underlying layers, thus restoring normal protective skin function. The excipient glycerol is a humectant which also helps retain moisture.

Dosage: Adult: Apply over and around affected areas as often as necessary, even when skin appears normal. Elderly: As per adults. Children: As per adults.

Contraindications: Hypersensitivity to the therapeutic ingredients or to any of the excipients.

Special precautions: Do not rub skin vigorously. Avoid oral ingestion (treat symptomatically if diarrhoea occurs, do not induce vomiting). Discontinue if local skin reactions occur (rare). Contains glycerol, carbomer, sorbitan laurate, trolamine, phenoxyethanol.

Drug interactions: None (if using other topical treatments, allow sufficient time for previous application to soak in before administration).

Adverse drug reactions: None common.

Full prescribing information and references available from Dermal Laboratories Ltd. E-mail: info@dermal.co.uk

The post Doublebase appeared first on Irish Medical Times.

Company: Teva Pharmaceuticals Ireland.

Legal category: Prescription. GMS reimburseable. Sport permitted.

Active ingredient: Tiotropium (as bromide) 10mcg per delivered dose.

Description: Hard capsule containing inhalation powder for use with Zonda device.

Presentation: 30 + Zonda inhaler, €28.93.

Indications: Maintenance bronchodilator treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD).

Pharmacology: Tiotropium, an anticholinergic, is a long-acting, specific muscarinic receptor antagonist which competitively and reversibly binds to M3 receptors in bronchial smooth musculature, antagonising the cholinergic (bronchoconstrictive) effects of acetylcholine, resulting in bronchial smooth muscle relaxation.

Dosage: Adult: Inhale one capsule once daily with Zonda inhaler at same time each day (maximum). Elderly: As per adults. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active ingredient or to any of the excipients.

Special precautions: Not for use in acute episodes of bronchospasm. Immediate hypersensitivity reactions may occur after administration. Discontinue immediately if paradoxical bronchospasm occurs. Caution: Narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction, recent myocardial infarction <6 months, unstable or life-threatening cardiac arrhythmia requiring intervention or a change in drug therapy in the past year, hospitalisation for heart failure during previous year. May be associated with dental caries with long term use. Moderate-severe renal impairment (assess risk/benefit). Discontinue and seek immediate specialist advice if eye symptoms develop. Driving/using machines (dizziness, blurred vision). Pregnancy (avoid), lactation (assess risk/benefit).Contains lactose.

Drug interactions: Not recommended: Other anticholinergics.

Adverse drug reactions: Dry mouth.

Full prescribing information and references available from Teva Pharmaceuticals Ireland. Telephone: 1800 201700.

The post Braltus appeared first on Irish Medical Times.

Company: Raisio.

Legal category: OTC.

Composition: Plant stanol ester 0.5g per piece.

Description: Lemon & lime soft chews (food supplement).

Presentation: 45, €9.67.

Indications: Helps to lower cholesterol.

Dosage: Adult: 1.5-3g (3-6 pieces) maximum per day taken with a meal. Children: Under 5 years, contraindicated. Keep out of reach of small children.

Contraindications: Pregnancy, lactation.

Special precautions: Should not be considered as a substitute for a varied, balanced diet and lifestyle. Contains xylitol, glycerol, trisodium citrate, malic acid. Packaging contains rapeseed oil.

Drug interactions: Seek medical advice if taking cholesterol lowering drugs.

Adverse drug reactions: None.

Full prescribing information and references available from AM Brands. Telephone: (0044) 2892 605 621. Fax: (0044) 2892 604 738.

E-mail: info@am-brands.co.uk

The post Benecol appeared first on Irish Medical Times.