Safety-related issues resulting in labelling amendments made to the local package inserts are listed below. Please note that there might be lag time in the availability of the package insert which reflect the latest change(s). Please refer to the company representative for details.
April 2008
- Budesonide (Pulmicort®, AstraZeneca) Special warnings: Concomitant treatment with itraconazole should be avoided.
Decreased liver function may affect the elimination of budesonide which may be clinically relevant in patients with severely compromised liver function.
Precautions: Patients who may be at risk of impaired adrenal function include those who have required high dose emergency corticosteroid therapy, prolonged treatment at the highest recommended dose of inhaled corticosteroids or patients administering concomitant medication metabolised by CYP3A4. Consider additional systemic glucocorticosteroid cover for these patients during periods of stress, severe asthma attack or elective surgery.
Possible systemic effects of inhaled steroids include cataracts & glaucoma.
Interaction: Inhibition of enzyme CYP3A by itraconazole can increase systemic exposure to budesonide.
Dosage & administration: During transfer from oral corticosteroid therapy to Pulmicort®, patients may suffer from lassitude & depression.
- Darunavir (Prezista®, J&J) Special warnings: In clinical studies with Prezista®/ritonavir, the incidence & severity of rash was similar in patients with or without a history of sulphonamide allergy.
Data has shown that no dose adjustment is required in patients with mild or moderate hepatic impairment. No data is available regarding the use of Prezista®/ritonavir when co-administered to patients with severe hepatic impairment. Use with caution in such patients.
Interactions: As darunavir is metabolised by CYP3A, medicinal products that induce or inhibit CYP3A activity may increase or decrease the clearance of darunavir, resulting in lower or increased plasma concentrations of darunavir respectively.
Combination of Prezista® co-administered with 100mg ritonavir & didanosine can be used without dose adjustments.
The lowest dose of digoxin should initially be prescribed & digoxin dose titrated to obtain the desired clinical effect when co-administered with Prezista®/ritonavir.
Patients should be monitored for potential carbamazepine-related adverse events if combination of Prezista®/ritonavir & carbamazepine is used. Carbamazepine dose may need to be reduced by 25% to 50% in the presence of Prezista®/ritonavir.
Lowest possible dose of pravastatin & titration up to the desired clinical effects while monitoring safety recommended when administration of pravastatin & Prezista®/ritonavir is required.
No adjustment of methadone dosage is required when initiating co-administration of Prezista®/ritonavir, however, clinical monitoring is recommended as maintenance therapy may need to be adjusted in some patients.
Alternative methods of non-hormonal contraception are recommended when ethinylestradiol & norethindrone are co-administered with Prezista®/ritonavir.
A dosage reduction of rifabutin by 75% of the usual dose of 300mg/day & increased monitoring for rifabutin-related adverse events is warranted in patients receiving Prezista®/ritonavir & rifabutin.
ADR: Hepatitis.
Increased spontaneous bleeding in haemophiliac patients receiving protease inhibitors has been reported.
- Deferasirox (Exjade®, Novartis) Special warnings: Although uncommon, elevations of transaminases > 10Xs the upper limit of the normal range, suggestive of hepatitis, have been observed in clinical trials. Most post-marketing reports of hepatic failure in patients treated with Exjade® involved those with significant co-morbidities including liver cirrhosis & multi-organ failure; fatal outcomes reported in some of them.
Upper GI ulceration & haemorrhage have been reported in patients, including children & adolescents, receiving Exjade®. Promptly initiate additional evaluation & treatment if a serious GI adverse event is suspected. Exercise caution in patients who are taking Exjade® in combination with drugs that are ulcerogenic, such as NSAIDs, corticosteroids or oral bisphosphonates & in patients receiving anticoagulants.
Risk of toxicity of Exjade® may be increased when inappropriately high doses are given in patients with a low iron burden or with serum ferritin levels that are only slightly elevated.
Interactions: Study has shown that the concomitant administration of Exjade® & midazolam, a CYP3A4 substrate, resulted in a decrease of midazolam exposure by 17%. Therefore, caution should be exercised when deferasirox is combined with substances metabolised through CYP3A4 e.g. ciclosporin, simvastatin, hormonal contraceptive agents.
Concomitant administration of Exjade® with drugs that have ulcerogenic potential, such as NSAIDs, corticosteroids or oral bisphosphonates & use of Exjade® in patients receiving anticoagulants may increase the risk of GI irritation.
ADRs: Optic neuritis, GI haemorrhage, gastric/duodenal ulcer, oesophagitis, renal tubulopathy (Fanconi's syndrome), hepatic failure.
Posology & method of administration: Decision to remove accumulated iron should be individualized based on anticipated clinical benefit & risks of chelation therapy.
- Estradiol (Estrofem®, Novo Nordisk) Special warnings: For oral doses of estradiol > 2mg, safety of added progestagens have not been studied.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take Estrofem®.
ADRs reported in association with other oestrogen treatment: Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis & pulmonary embolism, oestrogen-dependent neoplasms benign & malignant.
- Estramustine (Estracyt®, Pfizer) Special warning: Administration of live or live-attenuated vaccines in patients immunocompromised by estramustine, may result in serious or fatal infections. Killed or inactivated vaccines may be administered, however response to such vaccines may be diminished.
- Heparin (DBL Heparin®, Hospira) Precaution: Heparin-induced thrombocytopenia (HIT) & heparin-induced thrombocytopenia & thrombosis (HITT) can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT & HITT.
- Ketoconazole (Nizoral®, J&J) ADR: Photosensitivity.
- Lapatinib (Tykerb®, GSK) Precaution: Hepatotoxicity has occurred with lapatinib use & rarely may be severe. Liver function (transaminases, bilirubin & alkaline phosphatase) should be monitored before initiation of treatment & monthly thereafter, or as clinically indicated. Lapatinib dosing should be discontinued if changes in liver function are severe & patients should not be retreated.
ADR: Hepatotoxicity.
- Soya bean oil, triglycerides, olive oil, fish oil (SMOFlipid®, Fresenius Kabi) Contraindication: Hypersensitivity to peanut protein.
Special warning: SMOFlipid® emulsion for infusion contains soya bean oil, fish oil & egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya bean & peanut.
- Sumatriptan (Imigran®, GSK) Warnings & precautions: Rare cases of patients with serotonin syndrome (including altered mental status, autonomic instability & neuromuscular abnormalities) have been reported following use of selective serotonin reuptake inhibitors (SSRIs) & sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans & serotonin noradrenaline reuptake inhibitors (SNRIs).
Concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.
Overuse of acute migraine treatments has been associated with the exacerbation of headache (medication overuse headache, MOH) in susceptible patients & withdrawal of treatment may be necessary.
ADRs: Sensory disturbance including paraesthesia & hypoaesthesia, dyspnoea, sensations of cold, angina.
- Zoledronic acid (Zometa®, Novartis) Special warning: Post-marketing experience & literature suggest a greater frequency of reports of osteonecrosis of the jaw based on tumour type (advanced breast cancer, multiple myeloma), & dental status (dental extraction, periodontal disease, local trauma including poorly fitting dentures).
ADRs: Anaphylactic reaction/shock & urticaria.
Dosage & administration: Zometa® must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer's solution, & should be administered as a single IV solution in a line separate from other drugs.
 |
March 2008
- Abacavir (Ziagen®, GSK) Special warning: Studies have shown that carriage of the HLA-B*5701 allele is associated with a significantly increased risk of a hypersensitivity reaction to abacavir. Screening for such allele carrier should be performed in any HIV-infected patient, irrespective of racial origin before initiating treatment. Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available based on treatment history & resistance testing.
Even in the absence of the allele, patients on abacavir can still develop a hypersensitivity reaction, which may be severe or even fatal.
- Activated charcoal (Charcodote®, IDS) Drug interaction: Charcodote® should not be used for diabetics unless recommended by a physician.
- Desferrioxamine (Desferal®, Novartis) Special warning: Rare cases of mucormycosis, some fatal, have been reported.
ADR: Lung infiltration.
- Estradiol, dydrogesterone (Femoston®, Solvay Pharma) Contraindications: Known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer), undiagnosed genital bleeding, untreated endometrial hyperplasia, angina, myocardial infarction, porphyria, known or suspected pregnancy in non-postmenopausal women.
Warnings & special precautions: Patients who have risk factors for estrogen dependent tumours, cholelithiasis or a history of endometrial hyperplasia should be closely supervised due to possible recurrence or aggravation of these conditions during treatment with Femoston®.
Therapy with Femoston® should be discontinued when deterioration in liver function is present.
Estrogens may cause fluid retention & therefore patients with cardiac or renal dysfunction, terminal renal insufficiency should be closely observed, since the level of circulating active ingredients in Femoston® may be increased.
Rare cases of large increases of plasma TGs leading to pancreatitis have been reported with estrogen therapy in women with pre-existing hypertriglyceridemia.
Estrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Femoston®.
Patients in the perimenopausal phase should be advised to take non hormonal contraceptive precautions as Femoston® is not a contraceptive.
Posology & method of administration: For initiation & continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
Interactions: Effect of estrogens may be reduced by concomitant use of enzyme drug inducers e.g. phenobarbital, rifabutin, nevirapine, efavirenz.
Ritonavir & nelfinavir which are strong inhibitors, exhibit inducing properties when used concomitantly with steroid hormones.
St. John's Wort may induce the metabolism of estrogens & progestagens.
Clinically, an increased metabolism of estrogens & progestagens may lead to decreased effect & changes in the uterine bleeding profile.
ADRs: Breast pain, pelvic pain, estrogen dependent neoplasms e.g. endometrial cancer, nervousness, venous thromboembolism, gall bladder disease, back pain, alterations in liver function, haemolytic anaemia, myocardial infarction, stroke, vascular purpura, angioedema, probable dementia.
- Estradiol, norethisterone (Kliogest®, Novo Nordisk) Special warning: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take kliogest®.
- Lamotrigine (Lamictal®, GSK) Warnings & precautions: 25% to 50% of patients with bipolar disorder attempt suicide at least once, & may experience worsening of their depressive symptoms &/or the emergence of suicidal ideation & behaviours (suicidality) whether or not they are taking medications, including Lamictal®.
Patients with epilepsy have an elevated risk for suicidality.
Certain patients, such as those with a history of suicidal behaviour or thoughts, young adults, & those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, may be at a greater risk of suicidal thoughts or suicide attempts, & should receive careful monitoring during treatment.
Interactions: Lopinavir/ritonavir significantly induce glucuronidation of lamotrigine.
Felbamate, gabapentin, levetiracetam, pregabalin, topiramate, zonisamide do not significantly inhibit or induce glucuronidation of lamotrigine.
- Meropenem (Meronem®, AstraZeneca) Special warning: As Meronem® may reduce serum valproic acid levels, subtherapeutic levels may be reached in some patients.
ADR: Haemolytic anaemia.
- Omalizumab (Xolair®, Novartis) Special warning: Anaphylaxis & anaphylactoid reactions have been reported postmarket following the first or subsequent administration of Xolair®, mostly occurring within 2 hours & some beyond 2 hours.
ADRs: Anaphylaxis & anaphylactoid reactions, alopecia, idiopathic severe thrombocytopenia, allergic granulomatous angiitis (Churg Strauss syndrome), arthralgia, myalgia, joint swelling.
- Risedronate (Actonel®, Sanofi-Aventis) Precautions: Osteonecrosis of the jaw (ONJ) has been reported in cancer patients receiving iv bisphosphonates & in patients with osteoporosis receiving oral bisphosphonates.
A dental examination with appropriate preventive dentistry should be considered prior to bisphosphonates treatment in patients with concomitant risk factors e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene.
Dental surgery may exacerbate ONJ in patients who develop the condition while on bisphosphonate therapy.
ADRs: Abdominal pain, osteonecrosis of the jaw, uveitis, iritis, urinary tract infection.
- Risperidone (Risperdal®, J&J) ADRs: Alopecia, pancreatitis.
- Telbivudine (Sebivo®, Novartis) Special warning: An increased risk of developing peripheral neuropathy has been observed with the combination use of telbivudine & pegylated interferon alfa-2a.
ADR: Peripheral neuropathy.
- Tretinoin (Locacid®, Orient Europharm) Pregnancy: Tretinoin proved to be teratogenic in animals by local route & at high dosages inducing minor skeletal malformations. Therefore, tretinoin must not be used during the first quarter of the pregnancy.
|
February 2008
- Atovaquone, proguanil (Malarone®, GSK) Interaction: Proguanil may potentiate the anticoagulant effect of other coumarin based anticoagulants besides warfarin. Caution is advised when initiating or withdrawing malaria treatment with Malarone® in patients on continuous treatment with coumarin based anticoagulants.
New ADRs: Vasculitis & cholestasis.
- Cefoperazone (Cefobid®, Pfizer) Special warnings: Advisable to check periodically for organ system dysfunction (renal, hepatic & haematopoietic) during extended therapy with Cefobid® particularly in neonates & infants.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including cefoperazone, & may range in severity from mild diarrhoea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents.
- Domperidone (Motilium®, J&J) New ADRs: Anaphylactic shock, angioneurotic oedema, agitation, nervousness, convulsion, somnolence, headache, pruritus, rash, liver function test abnormal.
Convulsion, agitation & somnolence are very rare & primarily reported in infants & children.
- Gestodene, ethinyl estradiol (Minulet®, Wyeth) Contraindications: Minulet® is contraindicated in hereditary or acquired thrombophilias, headache with focal neurological symptoms such as aura, undiagnosed vaginal bleeding.
Special warnings: Combined oral contraceptives (COCs) should be discontinued four weeks prior to & for two weeks after elective surgery with increased risk of thrombosis.
Use of COCs increases the risk of transient ischemic attack.
Precaution: A small proportion of women will have adverse lipid changes while taking OCs. Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias. Elevations of plasma TGs may lead to other complications besides pancreatitis.
Interaction: Ethinyl estradiol may induce hepatic drug conjugation & plasma/tissue concentrations of lamotrigine may be decreased.
New ADRs: Hepatic adenomas, hepatocellular carcinomas.
- Lidocaine (Xylocaine® inj, AstraZeneca) Contraindication: Formulations of lidocaine containing parabens (methyl-/propyl) should be avoided in patients allergic to ester local anaesthetics or its metabolite PABA.
Precautions: Hypotension as a result of epidural anaesthesia should be treated promptly with an IV sympathomimetic & repeated as necessary.
Xylocaine® plain solution for injection is probably porphyrinogenic & should only be prescribed to patients with caution & risk-benefit assessment.
Adverse reactions: Cardiovascular toxic effects are generally preceded by signs of toxicity in the CNS, unless the patient is receiving general anaesthetics or is heavily sedated with drugs such as a benzodiazepine or barbiturate.
In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during general anaesthesia.
- Methylphenidate (Ritalin®, Novartis) Contraindications: Ritalin® is contraindicated in phaeochromocytoma & in treatment with MAOIs, & also within a minimum of 14 days following discontinuation of MAOI (hypertensive crises may result).
Special Warnings: Stimulant products should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems, as they are more susceptible to their sympathomimetic effects.
Sudden death, stroke, & myocardial infarction reported in adults taking stimulant drugs at usual doses for ADHD. As adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary heart disease, or other serious cardiac problems, they should not be treated with stimulant drugs.
Patients who develop exertional chest pain, unexplained syncope or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Patients with pre-existing CNS abnormalities, e.g. cerebral aneurysm &/or other vascular abnormalities such as vasculitis or pre-existing stroke should not be treated with Ritalin®. Those with additional risk factors (history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed regularly for neurological/psychiatric signs & symptoms after initiating treatment with Ritalin®.
Co-morbidity of psychiatric disorders (including acute psychosis, acute mania or suicidality) in ADHD is common & should be taken into account when prescribing Ritalin®. These acute conditions should be treated & controlled before ADHD treatment is considered. In case of emergent psychiatric symptoms or exacerbation of pre-existing psychiatric symptoms, Ritalin® should not be given to patients unless the benefit outweighs the potential risk.
Methylphenidate should not be used as treatment for severe depression due to possible exacerbation of symptoms of behavioural disturbance & thought disorder in psychotic patients.
Caution in using stimulants to treat ADHD in patients with comorbid bipolar disorder due to concern for possible induction of a mixed/manic episode.
Treatment emergent psychotic or manic symptoms, e.g. hallucinations, delusional thinking or mania in children & adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If symptoms occur, consideration should be given to a possible causal role of the stimulant & discontinuation of treatment may be appropriate.
Emergent aggressive behaviour or an exacerbation of baseline aggressive behaviour has been reported with Ritalin® but patients with ADHD may experience aggression as part of their medical condition. Adjustment of treatment regimen or treatment interruption in such patients may be needed.
Patients with emergent suicidal ideation & behaviour during treatment for ADHD should be evaluated immediately for appropriate treatment of the underlying psychiatric condition & consider a possible change in the ADHD treatment regimen.
Methylphenidate should not be used for the prevention or treatment of normal fatigue states.
Methylphenidate may lower the convulsion threshold in patients with a history of seizures, with prior EEG abnormalities in the absence of seizures & rarely, in the absence of a history of seizures & no prior EEG evidence of seizures. Safe concomitant use of anticonvulsants & methylphenidate has not been established. In the presence of seizures, the drug should be discontinued.
The possibility of habituation or abuse must be considered, particularly in emotionally unstable patients & those with a history of drug dependence or alcoholism because they may increase the dose on their own.
Alcohol may exacerbate the CNS adverse reactions of methylphenidate, therefore patients are advised to abstain from alcohol during treatment.
Chronic abuse of methylphenidate can lead to marked tolerance & psychic dependence with varying degrees of abnormal behaviour. Frank psychotic episodes may occur, esp. in response to parenteral abuse. Methylphenidate abuse or dependence appears to be a problem in children treated with methylphenidate for ADHD.
Careful supervision is required during drug withdrawal since this may unmask depression & effects of chronic overactivity.
Retardation of growth is usually followed by catch-up growth when medication is discontinued. To minimise complications, drug-free periods over weekends, school holidays & long vacations are advocated.
Interactions: Ritalin® may inhibit dopamine reuptake when coadministered with direct & indirect dopamine agonists (including DOPA & TCAs) & dopamine antagonists (antipsychotics, e.g. haloperidol).
New ADRs: Nervousness, insomnia, irritability, vasculitis, cerebral haemorrhages, cerebrovascular accidents.
- Mycophenolate mofetil (Cellcept®, Roche) Warnings & precautions:
Cases of Progressive Multifocal Leukoencephalopathy (PML), sometimes fatal, have been reported in Cellcept® treated patients. Reported cases generally had risk factors for PML, including immunosuppressant therapies & impairment of immune function.
Cellcept® i.v. should never be administered by rapid or bolus i.v. injection.
Interactions: In renal transplant patients, concomitant administration of Cellcept® & Cyclosporin A resulted in reduced mycophenolic acid (MPA) exposures by 30-50% compared with patients receiving the combination of sirolimus & similar doses of Cellcept®.
After correction for dose, a 70% decrease in MPA exposure has been observed with concomitant rifampicin administration in a single heart-lung transplant patient, therefore MPA exposure levels monitoring is recommended & Cellcept® doses should be adjusted accordingly.
Combination of norfloxacin & metronidazole reduced the MPA AUC by 30% following a single dose of Cellcept®.
Concomitant administration of sevelamer & Cellcept® in adults & pediatric patients decreased the MPA Cmax & AUC by 30% & 25% respectively. Sevelamer & other calcium free phosphate binders preferentially should be given 2 hours after Cellcept® intake.
New ADRs: Decrease in renal function, elevated serum creatinine, metabolic or respiratory acidosis, elevated LFTs including AST & ALT, actinic keratosis, elevated PTH level.
Congenital malformations including ear malformations have been reported in offspring of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy.
- N(2)-L-alanyl-L-glutamine (Dipeptiven®, Fresenius Kabi) Contraindications: Dipeptiven® should not be administered to patients with severe metabolic acidosis or known hypersensitivity to the active substances or to any of the excipients.
Special warnings & precautions: Serum electrolytes, serum osmolarity, water balance, acid-base status & liver function tests (alkaline phosphatase, ALT, AST), possible symptoms of hyperammonaemia should be controlled. GPT, GOT, bilirubin level should be monitored.
Choice of a peripheral or central vein for infusion depends on the final osmolarity of the mixture.
Experience with the use of Dipeptiven® for longer periods than nine days is limited.
Posology & method of administration: Solutions of mixtures with an osmolarity above 800 mosmol/l should be infused by the central venous route.
Safety & efficacy in children have not been established.
Pregnancy & lactation: Due to lack of experience, Dipeptiven® should not be administered during pregnancy & lactation.
- Olanzapine (Zyprexa®, Eli Lilly) Special warnings: Undesirable alterations in lipids have been observed in olanzapine-treated patients. Appropriate clinical monitoring is recommended.
Hepatitis, cholestatic or mixed liver injury have been reported postmarket.
Undesirable effects: In adult clinical trial findings compared to placebo, olanzapine was associated with a greater mean change in glucose & HbA1c, olanzapine-treated patients had a greater mean increase in fasting total cholesterol, LDL cholesterol & triglycerides.
New ADRs: Fasting borderline to high total cholesterol/ triglycerides/ glucose, glycosuria, pulmonary embolism, deep vein thrombosis, hyperglycaemia, jaundice, alopecia, increased alkaline phosphatase, increased total bilirubin.
- Phenytoin (Phenytoin® Inj, Hospira) Interaction: Increased phenytoin plasma concentrations have been reported during concomitant use of phenytoin with capecitabine or its metabolite fluorouracil, likely due to inhibition of CYP2C9. Serum levels of phenytoin above the optimal range may produce encephalopathy, confusional states (delirium psychosis), or rarely irreversible cerebellar dysfunction. Phenytoin plasma levels of patients taking phenytoin with capecitabine or fluorouracil should be regularly monitored.
- Regular human insulin (Humulin R®, Eli Lilly) Interaction: Hypoglycemia can occur when insulin interacts with drugs that lower blood glucose eg. ACE inhibitors & angiotensin II receptor blockers.
- Ropivacaine (Naropin®, AstraZeneca) Precautions: Naropin® is possibly porphyrinogenic & should only be prescribed to patients with acute porphyria when no safer alternative is available.
Neonates need special attention due to immaturity of some organs & functions & slower elimination of drug (esp. during continuous epidural infusion) with regular monitoring for systemic toxicity (e.g. by signs of CNS toxicity, ECG, SpO2).
Adverse effects: Total spinal block may occur if an epidural dose is inadvertently administered intrathecally, or if a too large intrathecal dose is administered.
Bradycardia, headache, vomiting, urinary retention, hypoaesthesia, syncope, dyspnoea, hypothermia are more frequent after spinal anaesthesia.
Symptoms of acute systemic toxicity usually occur because of inadvertent intravascular injection, overdose or rapid absorption.
Hypotension is less frequent in children.
Vomiting is more frequent in children.
New ADRs: Anaphylactoid reactions, angioneurotic oedema & urticaria.
Dosage & administration: Use of Naropin® in premature children has not been documented.
- Sildenafil (Viagra®, Pfizer) Special warning: Sudden decrease or loss of hearing has been reported with the use of sildenafil. Most of these patients had risk factors for sudden decrease or loss of hearing. Discontinue sildenafil if such an event occurs.
New ADRs: Seizure, recurrence of seizure.
|
January 2008
- Celecoxib (Celebrex®, Pfizer) Co-administration of an angiotensin-converting enzyme (ACE) inhibitor &/or an angiotensin II antagonist (AIIA) together with a selective or non-selective cyclooxygenase inhibitor can further impair renal function, potentially resulting in acute renal failure (although this effect is usually reversible).
- Estradiol, cyproterone (Climen®, Zuellig) Special warning: In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
New ADRs: Erythema nodosum, urticaria, hirsutism, acne.
- Iodixanol (Visipaque®, GE healthcare) Special warning: Correlation of the time of contrast media injection with the haemodialysis session is not necessary as there is no evidence that haemodialysis protects patients with impaired renal function from contrast media induced nephropathy, therefore patients on haemodialysis may receive Visipaque® for radiological procedures.
New ADRs: Dyspnoea, non-cardiogenic pulmonary oedema, cough.
- Iohexol (Omnipaque®, GE healthcare) Special warning: Correlation of the time of contrast media injection with the haemodialysis session is not necessary as there is no evidence that haemodialysis protects patients with impaired renal function from contrast media induced nephropathy, therefore patients on haemodialysis may receive Omnipaque® for radiological procedures.
New ADRs: Dyspnoea, bronchospasm, laryngospasm, non-cardiogenic pulmonary oedema, cough, thyrotoxicosis, flushing, injection site reactions, transient blindness, diarrhoea, neck pain.
- Itraconazole (Sporanox®, J&J) Special warning: Transient or permanent hearing loss has been reported. Some reports included concurrent administration of quinidine, which is contraindicated. The hearing loss usually resolves when treatment is stopped, but can persist in some patients.
Interaction: Fluticasone plasma concentration, effect or side effect should be monitored when used with itraconazole & dosage reduced if necessary.
New ADR: Transient or permanent hearing loss.
- Lopinavir/ritonavir (Kaletra®, Abbott) Rosuvastatin can interact with Kaletra®. Use lowest possible dose of rosuvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors like pravastatin or fluvastatin in combination with Kaletra®.
- Nystatin (pms-Nystatin®, IDS) Contraindication: If irritation or sensitization occurs, pms-Nystatin® suspension should be discontinued.
Precaution: Patients with full or partial dentures who have symptomatic oral candidiasis may need to soak their dentures nightly in reconstituted nystatin for oral suspension to eliminate Candida species from the dentures. Rarely, when this does not eliminate the fungus, it may be necessary to have new dentures made.
Pms-Nystatin® should be used with caution in nursing women.
- Sodium polystyrene sulfonate (pms-Sodium polystyrene sulfonate®, IDS) Warning: As the drug resin action is slow, treatments that facilitate shift of K+ into cells, such as administration of sodium bicarbonate &/or dextrose (with or without insulin), &/or other treatments (e.g. a calcium salt) are indicated in patients with hyperkalemia evidenced by conduction defects (widening of the QRS complex) or arrhythmias.
Drug interactions: Sodium polystyrene sulfonate may bind with magnesium or calcium found in nonsystemic antacids & laxatives, preventing neutralization of bicarbonate ions & leading to systemic alkalosis that may be severe, hence concurrent use is not recommended, although risk may be less with rectal administration of the resin.
Sodium polystyrene sulfonate reduces potassium concentrations by replacing potassium with sodium & fluid retention may occur in some patients because of the increased sodium intake.
Precaution: The elderly may be more likely to develop faecal impaction.
- Sotalol (pms-Sotalol®, IDS) Precaution: If vagal dominance occurs during the use of pms-Sotalol® with anaesthetic agents that depress the myocardium, it may be corrected with atropine (1 to 2 mg i.v.).
Drug interaction: Concomitant use of pms-Sotalol® with calcium blocking drugs may have additive effects on blood pressure, possibly leading to hypotension.
New ADRs: Colon problem, extremity/back/localized pain, perspiration, altered consciousness, appetite disorder, stroke, genitourinary disorder, infection, pulmonary/upper respiratory tract problem, asthma, abnormal lab value, weight change.
- Strontium (Protos®, Servier) Special warning: The outcome in most cases of DRESS (drug rash with eosinophilia & systemic symptoms) syndrome is favourable upon discontinuation of Protos® & after initiation of corticosteroid therapy.
- Sultamicillin (Unasyn®, Pfizer) Special warning: Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including sultamicillin, & may range in severity from mild diarrhoea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents.
|
